Document ID: FDA-2005-N-0033-0013
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-25T05:00Z

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<SPAN STYLE="position:absolute;left:71.76pt;top:917.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:977.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">DEPARTMENT OF HEALTH AND HUMAN SERVICES</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1000.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Food and Drug Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1023.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Parts 211, 226, 300, 500, 530, 600, 895, and 1271</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1046.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">[Docket No. 2005N-0373]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1070.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">RIN 0910-AF54</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1093.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1116.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs Intended for Use in Ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1139.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AGENCY:  Food and Drug Administration, HHS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1162.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ACTION:  Proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1185.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">SUMMARY:  The Food and Drug Administration (FDA) is proposing to prohibit the use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1208.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1231.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical devices intended for use in humans and human cells, tissues, and cellular and tissue-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1255.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1278.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use in ruminant animals (drugs for ruminants).  FDA is also proposing new recordkeeping</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1301.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements for medical products for humans and drugs for ruminants that are manufactured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1324.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from or otherwise contain material from cattle.  FDA is proposing these actions as part of its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1347.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1370.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">bovine spongiform encephalopathy (BSE) and related human disease in the United States.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1393.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">DATES:  Submit written or electronic comments on the proposed rule by </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">[insert date 60 days</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1416.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">after date of publication in the FEDERAL REGISTER</FONT></u><FONT STYLE="font-size: 10.05pt">]. Submit written comments on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1439.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information collection requirements by </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">[insert date 30 days after date of publication in the</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1463.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">FEDERAL REGISTER</FONT></u><FONT STYLE="font-size: 10.05pt">]. Requests for an informal hearing on the proposed ban related to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:1709.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:1739.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1769.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical devices must be submitted by [i</FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nsert date 30 days after date of publication in the</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1792.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">FEDERAL REGISTER</FONT></u><FONT STYLE="font-size: 10.05pt">].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1815.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ADDRESSES:  You may submit comments, identified by Docket No. 2005N-0373 and RIN</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1838.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">number 0910-AF54, by any of the following methods:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1862.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Electronic Submissions</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:1885.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Submit electronic comments in the following ways:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:1907.85pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:1909.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Federal eRulemaking Portal: </FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.regulations.gov">http://www.regulations.gov</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Follow the instructions for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:1932.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submitting comments.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:1954.75pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:1955.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Agency Web site: </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/dockets/ecomments">http://w</a></FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/dockets/ecomments">ww.fda.gov/dockets/ecomments</a></FONT></u><FONT STYLE="font-size: 10.05pt">.  Follow the instructions for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:1979.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submitting comments on the agency Web site.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2002.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Written Submissions</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Submit written submissions in the following ways:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:2047.95pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2049.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FAX:  301-827-6870.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:2071.80pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2073.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2096.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2119.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rm. 1061, Rockville, MD  20852.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2142.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">To ensure more timely processing of comments, FDA is no longer accepting comments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2165.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submitted to the agency by e-mail.  FDA encourages you to continue to submit electronic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2188.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comments by using the Federal eRulemaking Portal or the agency Web site, as described in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2211.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Electronic Submissions </FONT></u><FONT STYLE="font-size: 10.05pt">portion of this paragraph.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2234.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Instructions</FONT></u><FONT STYLE="font-size: 10.05pt">: All submissions received must include the agency name and Docket No(s). and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2257.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Regulatory Information Number (RIN) for this rulemaking. All comments received may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2280.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">posted without change to </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/default.htm">http</a></FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/default.htm">://www.fda.gov/ohrms/dockets/default.htm</a></FONT></u><FONT STYLE="font-size: 10.05pt">, including any personal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:2501.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:2531.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2561.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information provided. For detailed instructions on submitting comments and additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2584.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information on the rulemaking process, see section VII “Effective Date and Opportunity for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2607.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Public Comment” in the SUPPLEMENTARY INFORMATION section of this document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2630.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Docket</FONT></u><FONT STYLE="font-size: 10.05pt">:  For access to the docket to read background documents or comments received, go to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2654.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/default.htm">http://www</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT><FONT COLOR="000000"></FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/default.htm">fda.gov/ohrms/dockets/default.htm </a></FONT></u><FONT STYLE="font-size: 10.05pt">and insert the docket number(s), found in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2677.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">brackets in the heading of this document, into the "Search" box and follow the prompts and/or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2700.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:2723.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Information Collection Provisions:  To ensure that comments on the information collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2746.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">are received, Office of Management and Budget (OMB) recommends that written comments be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2769.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2792.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">202</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:2792.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">– 395¹74.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2815.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FOR FURTHER INFORMATION CONTACT:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:2839.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">For information concerning products regulated by the Center for Drug Evaluation an</FONT></u><FONT STYLE="font-size: 10.05pt">d</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:2862.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Research</FONT></u><FONT STYLE="font-size: 10.05pt">:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2885.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Vikki Kinsey,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2908.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Center for Drug Evaluation and Research (HFD-006),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2931.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2954.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:2954.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">515 Security Lane, rm. 5110,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:2977.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Rockville, MD 20852,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3000.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3000.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">01-44</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:118.90pt;top:3000.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3-55</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:137.30pt;top:3000.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">78</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:147.35pt;top:3000.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3023.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">e-mail: vikki.kinsey@fda.hhs.gov.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3047.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">For information concerning products regulated by the Center for Biologics Evalua</FONT></u><FONT STYLE="font-size: 10.05pt">tion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:3070.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">and Research</FONT></u><FONT STYLE="font-size: 10.05pt">:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3293.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:3323.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3353.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Stephen M. Ripley,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3376.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Center for Biologics Evaluation and Research (HFM-17),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3399.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3422.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3422.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">401 Rockville Pike, rm 594N,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3446.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Rockville, MD 20852-1448,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">01-82</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:118.90pt;top:3469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7-62</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:137.35pt;top:3469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:147.35pt;top:3469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3492.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">e-mail: stephen.ripley@fda.hhs.gov.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3515.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">For information concerning products regulated by the Center for Devices an</FONT></u><FONT STYLE="font-size: 10.05pt">d</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:3538.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Radiological Health</FONT></u><FONT STYLE="font-size: 10.05pt">:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3561.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scott G. McNamee,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3584.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Center for Devices and Radiological Health,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3607.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3631.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3631.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">094 Gaither Rd., rm. 230,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3654.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Rockville, MD 20850,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3677.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3677.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">40-27</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:118.90pt;top:3677.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6-01</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:137.30pt;top:3677.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">05</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:147.35pt;top:3677.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3700.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">e-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.30pt;top:3700.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">mail: scott.mcnamee@fda.hhs.gov.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3723.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">For information concerning products regulated by the Center for Veterinary Medicine</FONT></u><FONT STYLE="font-size: 10.05pt">:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3746.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Michael J. Popek,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3769.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Center for Veterinary Medicine (HFV-144),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3792.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3815.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3815.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500 Standish Pl.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:3839.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Rockville, MD 20855,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:3862.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:3862.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">01-82</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:118.90pt;top:3862.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7-64</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:137.35pt;top:3862.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">62</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:147.35pt;top:3862.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4085.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:4115.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:4145.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">e-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.30pt;top:4145.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">mail: michael.popek@fda.hhs.gov.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:4168.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">SUPPLEMENTARY INFORMATION:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:220.30pt;top:4191.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Table of Contents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:4214.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">I.  Introduction</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:4238.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">II.  Background</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:4261.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A.  Transmissible Spongiform Encephalopathies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:4284.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B. Bovine Spongiform Encephalopathy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:4307.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">C.  Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:4330.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D. BSE Risk Assessments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4353.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4353.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Harvard-Tuskegee Study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4376.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4376.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA Surveillance Program</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4399.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:4399.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE Testing for Product Safety Purposes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4423.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4423.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE Infectivity via Medical Products for Humans and Drugs for Ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:4446.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:104.15pt;top:4446.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle Materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4469.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4469.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Specified Risk Material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4492.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4492.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Small Intestine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4515.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4515.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mechanically Separated Beef</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4538.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4538.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Nonambulatory Disabled Cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4561.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4561.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle Not Inspected and Passed for Human Consumption</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4584.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:4584.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Tallow and Tallow Derivatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4607.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4607.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Fetal Calf Serum</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4631.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:4631.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Additional Requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4877.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:4907.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:4937.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">F. Medical Products for Humans and Drugs for Ruminants That May Contain Cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:4960.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:4983.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:4983.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs for Humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5006.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:5006.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Biologics for Humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5030.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:5030.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5053.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5053.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Medical Devices for Humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5076.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5076.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs for Ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5099.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">III.  USDA/FSIS IFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5122.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">IV.  FDA Actions on BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5145.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A.  Regulations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5168.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5168.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA 1997 Ruminant Feed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5191.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:5191.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA/USDA Animal Feed ANPRM and FDA 2005 Animal Feed Proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5215.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods IFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5261.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5261.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods Recordkeeping/Access Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5284.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B.  FDA Guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5307.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">V.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.05pt;top:5307.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Description of Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5330.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A.  Definitions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5353.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B.  Proposed Requirements for Prohibited Cattle Materials and Permission for an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5376.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Exception or Alternative to These Requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5399.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">C.  Tallow and Tallow Derivatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5423.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D.  Proposed Requirements Regarding Extralabel Drug Use in Animals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5446.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:104.10pt;top:5446.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed Recordkeeping Requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:5669.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:5699.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5729.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:5729.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Types of Records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5752.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5752.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed Periods for Records Retention</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:125.65pt;top:5775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:5775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Location of Records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5798.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">VI.  Legal Authority</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5822.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">VII. Effective Date and Opportunity for Public Comment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5845.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">VIII.  Analysis of Impacts</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5868.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A.  Need for the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5891.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B.  Scope of the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:5914.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">C.  Costs of the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5937.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.05pt;top:5937.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Potential Market Adjustments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:5960.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:5960.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cost of Requests for Exception or Alternatives to the Limitation on the Use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:5983.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited Cattle Material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6007.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:6007.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cost of Substitutes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6030.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:6030.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Recordkeeping Requirements of the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6053.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:6053.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Labeling Costs for Drugs Prohibited from Extralabel Use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6076.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:6076.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Summary of the Cost for the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:6099.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D.  Benefits of the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6122.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:6122.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Reduced Risk of Exposure to BSE Infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6145.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.10pt;top:6145.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Value of the Potential Reduction of Human Illness</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:6168.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:104.10pt;top:6168.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Summary of the Potential Costs and Benefits of the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:6191.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">F.  Regulatory Options Considered</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:6215.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">G. Regulatory Flexibility Analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6238.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">IX.  Paperwork Reduction Act Analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:6461.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:6491.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6521.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">X.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.00pt;top:6521.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Environmental Impact Analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6544.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">XI.  Federalism</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6567.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">XII.  References</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:225.95pt;top:6590.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">I.  Introduction</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:6614.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">On January 26, 2004, the U.S. Department of Health and Human Services announced its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:6613pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6637.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">plan to establish new safeguards to strengthen existing firewalls against transmission of BSE in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6660.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the United States.  Consumption of products contaminated with the agent that causes BSE has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6683.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">been linked to the human disease variant Creutzfeldt-Jakob disease (vCJD).  Current protections</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6706.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">against the spread of BSE in the United States include:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:6706pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:6729.20pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6730.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA’s ruminant feed regulation (the 1997 ruminant feed rule) (62 FR 30936,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6753.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">June 5, 1997) (see section V.A.8 of this document for definition of ruminant),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:6776.10pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:6777.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.90pt;top:6777.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6800.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(FSIS) interim final rule banning specified risk materials (SRMs) and certain other cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6823.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material in human food (the USDA/FSIS IFR) (69 FR 1862, January 12, 2004; as amended, 70</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:6846.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FR 53043, September 7, 2005),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.50pt;top:6869.30pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.55pt;top:6870.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA’s interim final rule banning the use of SRMs and certain other cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:6893.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material in human food, including dietary supplements, and cosmetics (the Foods IFR) (69 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:6916.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">422</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:6916.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">56, July 14, 2004; as amended, 70 FR 53063, September 7, 2005), and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.50pt;top:6939.35pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.55pt;top:6940.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Import controls.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:6963.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has also proposed requirements for establishment and maintenance of records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:6986.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">concerning use of materials derived from cattle in human food and cosmetics (the Foods</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:7009.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule) (69 FR 42275, July 14, 2004). In addition, FDA, in conjunction with USDA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:7033.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">issued an advance notice of proposed rulemaking (ANPRM) to solicit comment on additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:6604.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 6.73pt">Formatted: </FONT></b><FONT STYLE="font-size: 6.73pt">Indent: First line: 36 pt</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:6616.90pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 6.73pt">Formatted: </FONT></b><FONT STYLE="font-size: 6.73pt">Bullets and Numbering</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:6696.40pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:6461.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background8.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:7253.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.75pt;top:7283.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7313.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">measures under consideration, including measures related to animal feeds (the joint ANPRM)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7336.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(69 FR 42288, July 14, 2004).  On October 6, 2005 (70 FR 58570), we issued a proposed rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7359.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that would prohibit certain cattle materials from all animal feed (FDA 2005 Animal Feed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7382.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:7406.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In this medical products proposed rule, FDA is proposing to prohibit use of SRMs and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7429.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">certain other cattle material in, or in the manufacture (including processing) of, medical products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7452.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for humans and drugs for ruminants because of the risk of transmission of BSE.  FDA is also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7475.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposing recordkeeping requirements for medical products for humans and drugs for ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7498.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that are manufactured from or otherwise contain material from cattle to ensure compliance with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7521.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the prohibitions in this proposed rule.  The proposed requirements are consistent with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7544.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements in the USDA/FSIS IFR and the Foods IFR, as well as the proposals in the Foods</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7567.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Recordkeeping/Access proposed rule.  The proposed requirements in this medical products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7591.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule only apply to medical products for humans and drugs for ruminants.  They do not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7614.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">apply to any other product regulated by FDA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:224.60pt;top:7637.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">II.  Background</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:158.75pt;top:7660.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A. Transmissible Spongiform Encephalopathies</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:7683.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Transmissible spongiform encephalopathies (TSEs) are fatal neurodegenerative disorders</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7706.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that have been identified in humans and a number of animal species (e.g., cattle, sheep, goats,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7729.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">elk, deer, cats, and mink), but primarily in ruminants (i.e., animals that have a stomach with four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7752.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compartments, such as cattle and buffalo). A TSE is characterized by a long incubation period,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">followed by a shorter course of neurological symptoms, followed by death (Ref. 1).  Postmortem</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:7799.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">histopathology of the brain tissue from humans and animals with TSEs is characterized by a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:8045.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:8075.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8105.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sponge-like appearance of the brain and deposits of abnormal forms of certain cell-associated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8128.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proteins (normal prion proteins) in the brain.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:8151.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">TSEs in humans include CJD, vCJD, Gerstmann-Sträussler-Scheinker syndrome, kuru,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8174.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">fatal familial insomnia, and sporadic fatal insomnia (Ref. 8).  Nonhuman TSEs include BSE in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8198.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle, scrapie in sheep and goats, transmissible mink encephalopathy (TME) in mink, feline</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8221.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">spongiform encephalopathy (FSE) in cats, and chronic wasting disease (CWD) in deer and elk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8244.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Ref. 8).  Scrapie and CWD occur, and TME has occurred, in the United States.  On December</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8267.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">23, 2003, USDA diagnosed BSE in an adult cow in the United States that had been imported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8290.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from Canada.  Since then, USDA has confirmed two other cases of BSE in adult cows in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8313.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United States.  One cow, which was diagnosed on June 24, 2005, was born and raised in Texas.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8336.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The other cow, which was diagnosed on March 15, 2006, had been on a farm in Alabama for less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8359.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">than a year. The Texas cow was 12 years old and the Alabama cow was determined to be more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8383.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">than 10 years old.  Therefore, both cows were born before the 1997 ruminant feed rule was in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8406.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">place. USDA determined that no part of the animals entered the human food or animal feed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8429.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">chains.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:8452.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The pathogenesis of TSEs is poorly understood.  TSE agents resist complete inactivation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8475.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by treatments that destroy conventional microorganisms, like bacteria and viruses.  Thus,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8498.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">conventional microorganisms are not likely causes of TSEs (Ref. 9).  The most widely accepted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8521.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">explanation for TSEs, the prion theory, suggests that the infectious agents of TSEs are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8544.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">abnormally folded forms of normal prion proteins (Refs. 10 and 11).  Normal prion protein genes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8567.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">are found widely in nature.  In mammals, normal prion proteins are primarily expressed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8591.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">neurons, but also can be found in other tissues in lower concentrations, depending on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:8837.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:8867.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8897.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">mammalian species (Ref. 12).  It is not well understood how the abnormal folding of prion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8920.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proteins occurs or why hosts cannot efficiently dispose of or develop immunity to these proteins.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:8943.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The current lack of an antemortem diagnostic test for TSEs in either humans or animals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8966.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">limits surveillance for these diseases, studies of disease pathogenesis, and other research efforts.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:8990.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Diagnosis is confirmed by special postmortem examination of brain tissue by identification of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9013.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">abnormal prion proteins in advanced stages of the disease.  At earlier stages of disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9036.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">development, abnormal prion proteins are undetectable in brain tissue. Presently, there are no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9059.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">effective treatments for TSEs, and all TSEs are invariably fatal (Ref. 1).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:175.75pt;top:9082.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B.  Bovine Spongiform Encephalopathy</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:9105.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE is a TSE of cattle with a long incubation period (up to 8 years or longer), most likely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9128.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">acquired following consumption of an animal product containing the BSE infectious agent (Refs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9151.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13 and 14).  The British Ministry of Agriculture, Fisheries and Food (now known as the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9175.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Department for Environment, Food, and Rural Affairs) first recognized BSE as a distinct disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9198.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in November 1986.  The clinical signs of BSE include behavioral, gait, and postural</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9221.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">abnormalities.  The disease usually presents in cattle as increased apprehension, increased</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9244.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reaction to sound and touch, and a swaying gait. These signs are accompanied by subtle changes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9267.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in the normal behavior of the cow, such as separation from the herd while at pasture,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9290.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disorientation, staring, and excessive licking of the nose or flanks.  The disease progresses to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9313.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">stumbling and falling, and ends with seizures, coma, and death (Ref. 15).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:9336.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Experiments indicate that the infectious dose for cattle is very low.  One gram of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9359.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">homogenized brain from affected cattle caused BSE in 7 out of 10 calves fed the brain sample.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9383.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Six years after oral consumption of lower doses of brain material, 3 of 15 calves fed 0.1 gram,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:9629.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:9659.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9689.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and 1 of 15 calves fed 0.01 gram, and 1 of 15 calves fed 0.001 gram (1 mg) of brain sample had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9712.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">developed the disease.  This experiment is ongoing (Ref. 16).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:9735.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Epidemiological studies have characterized the outbreak of BSE in the United Kingdom</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9758.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">as a prolonged epidemic in which early cases were seen simultaneously at various locations, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9782.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with all occurrences presumably due to a common point source of infection (Ref. 17).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9805.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Consistent with this observation, the subsequent spread of BSE was associated with the feeding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9828.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of meat-and-bone-meal from rendered BSE-infected cattle to non-infected cattle (Ref. 17).  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9851.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">appears likely that the BSE agent was transmitted among cattle at an increasing rate by ruminant-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9874.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to-ruminant feeding until the United Kingdom ban on such practices went into effect in 1988</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9897.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Ref. 13).  The United Kingdom instituted a ruminant-to-ruminant feed ban to stop the cycle of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9920.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infection, restrict the geographic spread of the disease, and eliminate potential sources of new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9943.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infections.  Since BSE was first identified in the United Kingdom, approximately 185,000 cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9967.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">have been diagnosed with the disease there (Ref. 18).  The precautionary slaughter of millions of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:9990.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">British cows and increasingly stringent prohibitions on certain animal feeding practices appear to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10013.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">have slowed, but not eradicated, the BSE epidemic in the United Kingdom. In 1992 (the peak</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10036.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">year of the epidemic), there were over 37,000 cases of BSE in the United Kingdom; in 2005,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10059.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">there were 225 cases (Ref. 18).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:10082.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The introduction of BSE into other countries presumably originated from their import of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10105.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle, or animal feed made with cattle material, from the United Kingdom during the BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10128.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">epidemic (Ref. 13).  In addition to the United Kingdom, BSE has been detected in indigenous</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10151.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle in Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10175.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Greece, Israel, Italy, Japan, Liechtenstein, Luxembourg, the Netherlands, Poland, Portugal, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:10421.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:10451.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10481.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Republic of Ireland, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United States (Ref.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10504.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">19).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:124.85pt;top:10527.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">C.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:139.05pt;top:10527.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:10550.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Creutzfeldt-Jakob Disease (CJD) is a sporadic disease of humans that exists throughout</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10574.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the world with an annual incidence of approximately one case per million population (Ref. 10).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10597.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The highest death rates in the United States and the United Kingdom occur in individuals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10620.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">between the ages of 60 and 70 (Ref. 20).  Death generally occurs after less than a year of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10643.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">progressive neurological deterioration (Ref. 10).  Early symptoms typically include changes in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10666.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sleeping and eating patterns, followed by inappropriate behavior and eventual dementia, lack of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10689.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">coordination, and myoclonic spasms. CJD is always fatal (Ref. 20).  The cause of sporadic CJD</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10712.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is not fully understood, but genetic susceptibility may play a role (Ref. 10). CJD has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10735.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inadvertently transmitted between humans during medical treatment or diagnostic procedures via</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10759.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contaminated neurosurgical instruments, transplants of dura mater and corneas, and injection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10782.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">pituitary extract (Ref. 10).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:10805.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In April 1996, British scientists reported a previously undetected new vCJD in young</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10828.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">patients, with symptoms somewhat different from sporadic CJD (Refs. 21 and 22).  All cases of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10851.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vCJD had histopathologic evidence of spongiform changes in the brain, but also showed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10874.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">formation of “florid” plaques (a core of amyloid protein with surrounding halos of vacuoles) not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10897.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">typically seen in other forms of CJD (Ref. 10).  Clinically, vCJD usually begins with a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10920.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">psychiatric presentation, such as depression, anxiety, nightmares, or hallucinations.  These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10943.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">symptoms are followed by memory impairment, then dementia in the late stages.  The clinical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10967.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">course generally ranges from 9 months to 3 years before death occurs (Ref. 23).  The probable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:10990.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">incubation period for vCJD in humans may range from 5 to more than 20 years (Ref. 39).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:11213.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:11243.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:11273.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scientists have concluded that exposure to the BSE agent is the most plausible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11296.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">explanation for the occurrence of vCJD (Refs. 24 through 27).  Monkeys (genetically the closest</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11319.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal model to humans) inoculated with samples of brain from BSE-infected cattle have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11342.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">found to develop a TSE that is histopathologically similar to vCJD (Ref. 28), as have mice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11366.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inoculated or fed with BSE-infected tissue (Ref. 29).  Studies have shown that abnormal prion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11389.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proteins from vCJD patients are molecularly similar to abnormal prion proteins from BSE-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11412.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infected cattle, but different from abnormal prion proteins from patients with CJD (Ref. 23).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11435.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Although the exact route of exposure is not known, most scientists believe that vCJD in humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11458.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">has been caused by consumption of cattle products contaminated with the agent that causes BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11481.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Refs. 20, 30, and 31). There is thought to be a 10- to 10,000-fold increase in the amount of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11504.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infectious material needed to cause illness in humans as compared with cattle because of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11527.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">species barrier, although the European Commission’s Scientific Steering Committee cautioned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11551.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that this range is uncertain and in an unlikely, but worst case scenario, the species barrier may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11574.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not exist (Ref. 40).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:11597.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As of August 2006, 162 probable and confirmed cases of vCJD have been reported in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11620.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United Kingdom (Ref. 32).  In addition, there have been 15 vCJD cases in France, 3 in Ireland, 2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11643.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in the United States ,and 1 each in Canada, Italy, the Netherlands, Portugal, Japan, Spain, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11666.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Saudi Arabia (Refs. 33 through 38 and 70).  The two cases in the United States, one of the three</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11689.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from Ireland, and the single cases from Canada and Japan are likely due to the individual’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11712.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exposure to BSE in the United Kingdom (Refs. 34, 36, and 70).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:11735.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The infectious dose for humans is not known.  Despite widespread exposure in the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:11759.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Kingdom to BSE-contaminated meat products, only a very small percentage of the exposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:12005.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:12035.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">15</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12065.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">population has been diagnosed with vCJD to date. This may reflect a partial species barrier to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12088.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disease transmission from cattle to humans via the oral route of exposure (Ref. 40).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:217.30pt;top:12111.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:232.05pt;top:12111.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE Risk Assessments</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12134.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:12134.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Harvard-Tuskegee Study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:12158.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In 1998, USDA asked the Harvard Center for Risk Analysis (HCRA) and the Center for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12181.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Computational Epidemiology at Tuskegee University to evaluate United States measures to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12204.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent the spread of BSE to animals and humans if it were to occur in this country.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12227.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Harvard-Tuskegee risk assessment (the Harvard-Tuskegee study determined that the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12250.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">States was highly resistant to any proliferation of BSE or a similar disease (Ref. 41).  The risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12273.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">assessment model also demonstrated that certain new control measures could reduce the small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12296.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk even further.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:12319.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Harvard-Tuskegee study involved a probabilistic simulation model to determine the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12343.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">consequences of introducing BSE into the U.S. cattle population. This simulation indicated that,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12366.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in a hypothetical situation in which 10 infected cattle were imported into the United States, on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12389.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">average only 4 new cases of BSE would arise, and the disease would be eliminated in 20 years.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12412.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Harvard-Tuskegee study determined that these new cases of BSE would most likely arise in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12435.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the United States from incomplete compliance with the FDA 1997 ruminant feed rule (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12458.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section III.A.1 of this document), and also concluded that an epidemic of BSE in this country</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12481.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from scrapie, CWD, or another TSE is unlikely.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:12504.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Harvard-Tuskegee study estimated the number of cattle infectious doses that might</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12527.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be available for human exposure, but it did not estimate the likelihood of human disease from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12551.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this exposure because the relationship between the two is not known.  According to the study, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12574.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">estimated total infectivity available for human exposure from the importation of 10 infected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:12797.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:12827.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">16</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle is 39 cattle infectious doses over 20 years.  The Harvard-Tuskegee study determined that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12880.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the greatest sources of infectivity to consumers from food are direct consumption of cattle brain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12903.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and spinal cord and also meat that contains central nervous system tissue from advanced meat</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12926.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recovery systems.  The Harvard-Tuskegee study did not address potential human exposure to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12950.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE agent through food, medical products for humans, or drugs for ruminants that contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12973.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ingredients of bovine origin, such as gelatin (from bovine bones and hides), heparin and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:12996.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">surfactants (from bovine lung), insulin (from bovine pancreas), hormones (from bovine urine and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13019.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">serum), enzymes (from bovine intestine), or glycosphingolipids (from bovine brains).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:13042.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Harvard-Tuskegee study identified three pathways that could lead to cattle or human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13065.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exposure to the BSE agent through food or feed:  (1) Noncompliance with the FDA 1997</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13088.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminant feed rule prohibiting the use of certain proteins in feed for cattle and other ruminants;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13111.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) rendering of animals that die on the farm and use (through illegal diversion or cross-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13135.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contamination) of the rendered product in ruminant feed; and (3) the inclusion of high-risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13158.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissues from cattle, such as brain and spinal cord, in products for human oral consumption.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13181.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Evaluation of potential risk mitigation measures in the study found that a prohibition against</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13204.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rendering of animals that die on the farm would reduce the potential cases of BSE following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13227.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hypothetical exposure by 82 percent.  In addition, a ban on including SRMs (defined in the study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13250.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">as brain, spinal cord, gut, eyes, and advanced meat recovery products without reference to age of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13273.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the animals at slaughter) in human and animal food would reduce potential BSE cases in cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13296.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by 88 percent and potential human exposure to BSE by 95 percent.  The Harvard-Tuskegee study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13319.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">also noted the value of ensuring that low-risk cattle tissues are not cross-contaminated with high-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13343.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk tissue.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:13366.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA recently released an updated version of the BSE risk assessment model and report,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:13589.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:13619.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">17</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13649.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">completed by HCRA  (Ref. 42).  USDA requested that HCRA utilize an updated risk assessment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13672.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">model to evaluate the impact of measures implemented after the discovery of a BSE-positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13695.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cow in Washington State in December 2003, and recommendations made by an international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13718.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE panel. The updated risk assessment </FONT></FONT><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">estimates </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that </FONT></FONT><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">the </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">measures </FONT></FONT><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">adopted </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by USDA </FONT></FONT><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:414pt;top:13729pt;width:10pt;height: 1pt;background-color:#ff0101;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:52pt;top:13718pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13742.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="ff0101"><u><FONT STYLE="font-size: 10.05pt">January 2004 will result in a 99.6 percent (at the mean) relative reduction in potential hum</FONT></u><FONT STYLE="font-size: 10.05pt">an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:13741pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13765.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">exposure to the BSE agent through consumption of beef and beef products</FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:13764pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13788.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:13788.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA Surveillance Program</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:13811.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The USDA has led targeted BSE surveillance efforts since 1990.  On June 1, 2004, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13834.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">response to a recommendation from the international scientific review panel that assessed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA’s investigation into the discovery of a BSE positive cow in Washington State on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13880.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">December 23, 2003, USDA began an enhanced BSE surveillance effort.  This effort continued to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13903.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">focus on the targeted subpopulation of cattle, with a goal to obtain as many samples as possible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13927.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from the targeted population, to help determine whether BSE is present in the United States.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13950.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Targeted cattle are defined as nonambulatory cattle; cattle exhibiting signs of a central nervous</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13973.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">system disorder; cattle exhibiting other signs that may be associated with BSE, such as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:13996.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">emaciation or injury; or dead cattle. To date, USDA has sampled more than 700,000 targeted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14019.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle, only two of which were positive for BSE (Ref. 43).  A detailed analysis of surveillance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14042.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">data obtained through March 2006 concluded that the prevalence of BSE in the United States is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14065.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">less than one infected animal per million adult animals (Ref. 7).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14088.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:14088.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE Testing for Product Safety Purposes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:14111.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">No validated antemortem tests for BSE exist. The currently available postmortem tests,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14135.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">although useful for disease surveillance (i.e., determining the rate of disease in the population of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14158.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle), are not appropriate as safety indicators for food, medical products for humans, or drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13708.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:13709.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">found</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13721.60pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:13722.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">enacted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13755.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:514.50pt;top:13755.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">after the 2003 BSE case</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13763.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">reduced potential human exposure to BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13771.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13783.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:13783.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">The model shows that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13791.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">removing nonambulatory cattle from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13799.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">human food supply reduces exposure by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13807.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">3 percent; prohibiting the use of advanced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13814.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">meat recovery only on animals over 30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13822.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">months old reduces potential exposure by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13830.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">approximately 40 percent; and removing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13837.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">SRMs from animals over 30 months of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13845.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">age almost completely eliminates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:13853.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">potential human exposure.</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:13589.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background17.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:14381.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:14411.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">18</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14441.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for ruminants.  This is due, in part, to limitations on the existing testing methods, which rely on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14464.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the use of postmortem brain tissue.  Experimental evidence demonstrates that, in cattle infected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14487.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">orally, certain potentially infective tissues (such as the distal ileum and tonsil) are the first tissues</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14510.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to accumulate infectivity in the incubation period and this infectivity occurs prior to any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14534.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">demonstrated infectivity in brain tissue (Refs. 3, 45, and 46). Therefore, tests conducted on brain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14557.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissue may not reflect accurately the potential infectivity in other tissues that develop infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14580.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">earlier, such as the distal ileum. Development of effective safety indicators for food, medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14603.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans, and drugs for ruminants will require improved understanding of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14626.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">pathogenesis of the disease and improved laboratory methods.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14649.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:14649.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE Infectivity via Medical Products for Humans and Drugs for Ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:14672.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">While BSE is usually a concern identified with food safety or animal health, medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14695.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans or drugs for ruminants, because of the ways they are used or come into</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14719.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contact with the body, provide another route for human or ruminant exposure to the BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14742.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infectious agent.  Medical products for humans and drugs for ruminants may contain or be made</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14765.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">using a variety of cattle-derived materials. Examples of materials that are sometimes derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14788.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from cattle and that are used in, or in the manufacture of, these products include gelatin, heparin,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14811.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">surfactants, hormones, enzymes, glycosphingolipids, amino acids, glycerol, detergents, blood,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14834.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">collagen, fetal calf serum, bovine meat, and tallow and tallow derivatives.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:14857.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The route by which TSE-contaminated material is introduced into a host is an important</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14880.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determinant of TSE transmissibility.  Animal studies have indicated that injection of a TSE agent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14903.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">directly into the brain or spinal cord is the most efficient route of transmission, followed by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14927.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intravenous, intraperitoneal, and subcutaneous routes, and then by the oral route (Refs. 2 and 47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:14950.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">through 56).  Topical administration on intact skin is unlikely to lead to disease transmission, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:15173.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:15203.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">19</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15233.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">topical products presumably can cause disease if administered to skin with cuts, abrasions, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15256.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">open wounds, or if administered to the eyes or other mucosal tissue (Refs. 57 through 59).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:15279.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Currently, no validated method for testing products for humans and ruminants for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15302.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agent that causes BSE is available; therefore, we do not have a means of distinguishing products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15326.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that contain infectious material from products that do not.  End users (e.g., consumers,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15349.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">physicians, farmers, veterinarians) also often are not able to determine which products contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15372.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials and which products do not because such information is generally not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15395.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">included in product labels or labeling. For example, rendered material including brain and spinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15418.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cord may become an ingredient in a medical product for humans or a drug for ruminants,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15441.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">although its presence may not be indicated on the label.  Furthermore, end users have no way to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15464.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determine whether cattle material in these products was sourced from nonambulatory disabled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15487.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle or from cattle that were not inspected and passed for human consumption.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:15511.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Based on what is known about transmission of BSE, there is risk of occurrence of vCJD</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15534.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in humans and of TSE in ruminants from the use of high-risk cattle-derived materials in medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15557.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans and drugs for animals.  While the results from USDA's ongoing testing are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15580.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reassuring and so far have identified only two additional BSE-infected cows in the United States,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15603.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">one cannot rule out the possibility of future discovery of additional positive animals in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:15603pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15626.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United States or in a country allowed to export cattle material to the United States, or of a future</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15649.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">introduction of BSE.    To provide consistent protection across the range of FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15672.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products, it is necessary to put in place measures to reduce further the risk of spread of BSE in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15695.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle and the risk of vCJD in humans.  These risks may be reduced by restricting the use of high-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15719.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk cattle materials in the manufacture of drugs for ruminants and medical products for humans,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:15742.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">similar to existing restrictions for food and cosmetics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:15593.30pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:15594.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">no surveillance program can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:15601.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">give absolute assurance of the absence of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:15609.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">BSE. In addition,</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:15173.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background19.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:15965.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:15995.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">20</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:217.20pt;top:16025.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">E.  Cattle Materials</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:16048.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposed rule would apply to medical products for humans and drugs for ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16071.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that are manufactured from or otherwise contain certain cattle material.  This section discusses</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16094.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the reasons for FDA’s decision to propose to restrict the use of such material in medical products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16118.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for humans and drugs for ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16141.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:16141.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Specified Risk Materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:16164.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposed rule would designate SRMs as prohibited cattle materials in medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16187.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans and drugs for ruminants. Specified risk materials would be defined,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16210.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">consistent with the Foods IFR (69 FR 42256 at 42259 and 70 FR 53063 at 53064 through 53065;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16233.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">discussed in section IV.A.3 of this document) and the USDA/FSIS IFR (69 FR 1862 and 70 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16256.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">530</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:16256.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">43; discussed in section III of this document) as the brain, skull, eyes, trigeminal ganglia</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16279.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(clusters of nerve cells connected to the brain that lie close to the exterior of the skull), spinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16303.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16326.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (clusters of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16349.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nerve cells attached to the spinal cord that are contained within the bones of the vertebral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16372.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">column) of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16395.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:16418.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In a pathogenesis study in which cattle were orally inoculated with BSE and then one to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16441.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">three animals were killed and tested at sequential 4- to 6-month intervals, Wells et al. found</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16464.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infectivity using a mouse bioassay at 32 months postinoculation in brain, spinal cord, dorsal root</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16487.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ganglia, and trigeminal ganglia (Ref. 3). Unequivocal clinical disease was first observed at 38</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16511.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">months postinoculation.  It is not known how representative these results are, given the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16534.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extremely small number of cattle tested and the limitations inherent in the mouse bioassay.  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:16757.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:16787.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16817.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">also should be noted that only one animal was tested at 26 months postinoculation and no testing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16840.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">was performed again until 32 months postinoculation.  Thus, no conclusion can be drawn as to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16863.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">when, in the period between 26 and 32 months postinoculation, infectivity appeared in the tested</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16886.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissues.  The studies will continue for several more years, using a more sensitive cattle assay, to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16910.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determine if any of the tissues that initially did not appear to be infective actually contain low</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16933.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">levels of infection (Refs. 2 through 6 and 60).  Infectivity has also been found at 6 months</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:16956.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">postinoculation in distal ileum and at 10 months postinoculation in tonsils (Refs. 4 and 60).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:16979.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In cattle infected with BSE under field conditions (i.e., not intentionally exposed to BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17002.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">as part of an experiment), infectivity has been found in the brain, spinal cord, and retina of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17025.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">eye in animals with clinical disease (Ref. 60).  The Scientific Steering Committee of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17048.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">European Union (Ref. 31) has reported on the proportion of total infectivity in various tissues.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17071.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">They estimate that in an animal with clinical disease, approximately 64 percent of the infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17095.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is in the brain, 26 percent is in the spinal cord, 4 percent is in the dorsal root ganglia, 2.5 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17118.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is in the trigeminal ganglia, and 3 percent is in the distal ileum. The eyes are estimated to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17141.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain less than 1 percent of the infectivity.  In 2003, P. J. Comer and P. J. Huntly reported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17164.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">generally similar estimates of infectivity (i.e., 60.2 percent in brain, 24.1 percent in the spinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17187.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cord, 3.6 percent in the dorsal root ganglia, 2.4 percent in the trigeminal ganglia and 9.6 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17210.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in the distal ileum) (Ref. 44).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:17233.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Clinical cases of BSE in cattle under 30 months old are rare. For example, according to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17256.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the United Kingdom’s Department of Environment, Food and Rural Affairs, among the birth</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17279.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cohort of cattle in the United Kingdom that had the highest incidence of BSE (those born in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17303.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">198</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:17303.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7-88), cattle under 3 years old represented less than 0.16 percent of cattle with BSE (61 out</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17326.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of 39,140 cattle with BSE) (Ref. 61).  Another report, looking at selected herds whose ages were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:17549.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:17579.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">22</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17609.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">known, found that in the first 6 months of 1989 and 1990, the BSE incidence in 2-year-old cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17632.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(0.04 percent in 1989 and 0.05 percent in 1990) was approximately 15-fold lower than that in 3-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17655.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">year-old cattle (0.56 percent in 1989 and 0.86 percent in 1990), and was 45- to 75-fold lower</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17678.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">than the incidence in 4-year-old cattle (2.83 percent in 1989 and 2.76 percent in 1990) (Ref. 62).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17702.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Two-year-old cattle represented only about one-half of 1 percent of the total BSE cases in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17725.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">selected herds in those 6-month periods. The incidence in 2-year-old cattle (0.01 percent)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17748.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">decreased considerably in 1991, presumably reflecting the fact that they were born after July</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17771.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">198</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.30pt;top:17771.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8, when the United Kingdom instituted measures prohibiting the use of meat and bone meal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17794.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in cattle feed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:17817.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We recognize that certain tissue from infected animals will be infectious a number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17840.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">months before the animals exhibit clinical symptoms.  However, in BSE, as in other TSEs, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17863.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">total amount of infectivity in an animal increases throughout the incubation period reaching the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17887.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">highest load when an animal begins to demonstrate clinical signs (Ref. 44).  Because of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17910.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">evidence combined with the very low incidence of clinical BSE in cattle younger than 30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17933.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">months,  we are proposing, consistent with the Foods IFR (69 FR 42256 at 42259) and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17956.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA/FSIS IFR (69 FR 1862), that brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:17979.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18002.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebrae, and the wings of the sacrum), and dorsal root ganglia should be considered SRMs only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18025.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in cattle 30 months and older.  We include the skull and the vertebral column in the list of SRMs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18048.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">because, even though they have not been shown to harbor BSE infectivity, they contain tissues</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18071.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i.e., brain and spinal cord) that have been shown to be infectious. We did not include, consistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18095.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the Foods IFR (69 FR 42256 at 42259) and the USDA/FSIS IFR (69 FR 1862 at 1868), the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18118.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:18341.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:18371.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">23</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18401.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the sacrum as SRMs with the rest of the vertebral column because they do not contain spinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18424.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cord or dorsal root ganglia.  As the science and epidemiology on this issue develop, FDA may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18447.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">find it necessary through future rulemaking to modify the tissues classified as SRMs and the age</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18470.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">at which these tissues are classified as SRMs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:18494.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Based on the previously mentioned experimental evidence indicating that tonsils become</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18517.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infective by 10 months postinoculation and distal ileum by 6 months postinoculation (Refs. 3 and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18540.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4), we are proposing, consistent with the Foods IFR (69 FR 42256 at 42259 and 70 FR 53063 at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18563.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">530</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:18563.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">64 through 53065) and USDA/FSIS IFR (69 FR 1862 and 70 FR 53043), that the tonsil and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18586.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">distal ileum of the small intestine of all cattle be considered SRMs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18609.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:18609.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Small Intestine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:18632.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The small intestine is not considered prohibited cattle material if the distal ileum is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18655.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18679.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine as measured from the caeco-colic junction and progressing proximally towards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18702.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">jejunum or by a procedure that the establishment can demonstrate is equally effective in ensuring</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18725.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">complete removal of the distal ileum.  In this medical products proposed rule, we are proposing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18748.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to prohibit the use of small intestine of all cattle in medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18771.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants if procedures that completely remove the distal ileum are not used.  This provision is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18794.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">consistent with USDA (70 FR 53043) and FDA (70 FR 53063) requirements.  .</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18817.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:18817.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mechanically Separated Beef</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:18840.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mechanically Separated (Species) is a standardized food defined by USDA in 9 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18863.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">319</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:18863.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.5 (see section V.A of this document for the proposed definition of mechanically separated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18887.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">beef).  The standard does not limit the amount of spinal cord and dorsal root ganglia allowed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:18910.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column used to produce the product. Consequently, mechanically separated beef may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:19133.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:19163.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">24</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19193.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain concentrated amounts of such tissues.  Because we are proposing that spinal cord, dorsal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19216.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">root ganglia and vertebral column be considered SRMs, we are also proposing, consistent with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19239.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the USDA/FSIS and Foods IFRs (69 FR 1862 at 1866 through 1867 and 69 FR 42256 at 42259),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19262.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to include mechanically separated beef as a prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19286.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:19286.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Nonambulatory Disabled Cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:19309.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Experience has shown that nonambulatory disabled cattle (see section V.A of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19332.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document for the proposed definition) are the population at greatest risk for harboring BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19355.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Surveillance data in the European Union in 2002 showed that there were 29 positive/10,000 tests</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19378.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for BSE among healthy-appearing cattle of all ages and 148 positive/10,000 tests for BSE among</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19401.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nonambulatory animals of all ages (Ref. 63).  In Switzerland, sampling of particular populations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19424.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of cattle revealed that BSE-positive animals were 49 to 58 times more likely to be found in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19447.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nonambulatory population than in the population selected for passive surveillance (Ref. 64).  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19471.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Harvard-Tuskegee study estimated that, following importation of 10 infected cattle, a prohibition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19494.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">against rendering animals that die on the farm (these animals could be nonambulatory disabled)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19517.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would decrease the number of new cases of BSE by 82 percent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:19540.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Because typical clinical signs of BSE cannot always be observed in nonambulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19563.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disabled cattle, and because evidence has indicated these cattle are more likely to have BSE than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19586.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">apparently healthy cattle, FDA is proposing, consistent with the Foods IFR (69 FR 42256 at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19609.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">422</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:19609.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">59), to include material from nonambulatory disabled cattle as prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19632.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposal is also consistent with USDA’s requirement that all nonambulatory disabled cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19655.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">presented for slaughter be condemned (69 FR 1862 at 1870 and 1871).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:19925.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:19955.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">25</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:19985.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:19985.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle Not Inspected and Passed for Human Consumption</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:20008.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle that have not been inspected (see section V.A of this document for the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20031.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">definition) are at higher risk of having BSE, as well as other diseases, because they will not have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20054.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">been examined by USDA for their disease status in general and potential for harboring BSE in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20078.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">particular. In addition, such cattle are likely to have died on the farm or en route to slaughter,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20101.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and these animals are not eligible for inspection by USDA.  For cattle that are inspected but not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20124.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">passed, a regulatory authority (USDA or other) has made a determination that they are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20147.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">appropriate for use in human food (69 FR 42256 at 42259).  Such a determination may be based,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20170.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">among other things, on evidence of a neurological disorder associated with a higher risk of BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20193.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Moreover, material from cattle not inspected or inspected and not passed for human consumption</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20216.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is prohibited from human food (69 FR 42256 at 42259). In this rulemaking, FDA is proposing to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20239.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extend this prohibition to medical products for humans and drugs for ruminants.  By requiring</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20263.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that material from cattle for use in medical products for humans and drugs for ruminants be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20286.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption, we would minimize the risk to humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20309.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants of exposure to the agent that causes BSE.  6.  Tallow and Tallow Derivatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:20332.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Tallow is an animal-derived hard fat that has been heat processed; most tallow is derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20355.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from cattle.  In this proposed rule, we use the term tallow to refer only to tallow derived from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20378.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle.  Any risk of BSE transmission from tallow is a result of protein that is present as an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20401.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurity in the tallow. Taylor et al. (Refs. 65 and 66) found in rendering studies with abnormal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20424.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prion protein that the prion protein did not preferentially migrate into the fat fraction, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20447.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">remained with the protein fraction.  Therefore, there is no reason to believe that tallow is likely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20471.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to contain unusually high amounts of prion protein as a constituent of the insoluble impurities</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20494.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">fraction that remains in tallow after rendering.  Taylor et al. (Refs. 65 and 66) also reported that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:20717.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:20747.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">26</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20777.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the various rendering processes used for tallow production in the United Kingdom were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20800.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sufficient to produce tallow that did not result in infection when injected into the brains of mice,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20823.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">even though the starting material was highly spiked with the scrapie agent. Wilesmith et al.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20846.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Ref. 67) noted that the geographical variation in the incidence of BSE in the United Kingdom</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20870.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">was not consistent with the use of tallow in cattle feed and concluded that the most likely source</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20893.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of infection in cattle was BSE-contaminated meat and bone meal.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:20916.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The World Organisation for Animal Health (OIE) (formerly the Office International des</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20939.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Epizooties), the international animal health standard setting body, categorizes tallow with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20962.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">insoluble impurities of no more than 0.15 percent as protein-free tallow and indicates that tallow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:20985.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that meets this standard can be safely consumed by animals, regardless of the starting materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21008.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Ref. 68).  FDA’s Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21031.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">considered the safety of tallow in 1998 (Ref. 69).  Although members of the TSEAC indicated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21055.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that tallow is a food with extremely low risk of transmitting BSE to humans or animals, they did</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21078.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not see a need to change FDA’s recommendation that tallow not be sourced from cattle born,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21101.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">raised, or slaughtered in countries where BSE is known to exist.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:21124.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Based on the research and the opinions noted previously that show that tallow is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21147.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inherently a low risk material because of the procedures by which it is manufactured, we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21170.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposing to permit tallow from any country to be used in medical products for humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21193.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drugs for ruminants, as we have for human food and cosmetics (69 FR 42256 at 42260 and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21216.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">422</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:21216.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">61), if it contains no more than 0.15 percent insoluble impurities regardless of the starting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21239.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or if it otherwise complies with these regulations (e.g., made without the use of any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21263.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials).  We recognize that the TSEAC did not see a need to change FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21286.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tallow import policy, which recommended against use of tallow from cattle born, raised, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:21509.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:21539.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">27</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21569.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">slaughtered in countries where BSE is known to exist.  However, the TSEAC was not asked to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21592.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provide recommendations regarding import of tallow that met our proposed requirements.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21615.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">believe we are proposing a tallow standard for medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21638.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants that is consistent with statutory safety standards and the recommendations by OIE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21662.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with respect to bovine-derived tallow to prevent BSE in cattle and vCJD in humans.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:21685.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Distinct from tallow are tallow derivatives.  These derivatives are produced by subjecting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21708.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tallow to chemical processes (hydrolysis, trans-esterification, or saponification) that involve high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21731.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">temperature and pressure.  The TSEAC considered tallow derivatives in 1998 (Ref. 69) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21754.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determined that the rigorous conditions of manufacture are sufficient to further reduce the BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21777.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk in tallow derivatives.  In addition, the OIE also recommends that derivatives of protein-free</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21800.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tallow be freely traded among countries because they pose an insignificant BSE risk to animals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21823.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Ref. 68).  Because we believe that tallow has negligible risk of transmitting BSE, and tallow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21847.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derivatives undergo additional processing, we do not believe that tallow derivatives pose a risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21870.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of transmitting the agent that causes BSE to humans.  Therefore, we are proposing, consistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21893.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the Foods IFR (69 FR 42256 at 42261), that tallow derivatives not be considered a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21916.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle material. FDA proposes to clarify, as in the amendments to the Foods IFR (70</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21939.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FR 53063), that the “no more than 0.15 percent insoluble impurities” restriction for tallow does</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21962.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not apply to tallow derivatives.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:21985.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:21985.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Fetal Calf Serum</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:22008.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Current evidence suggests that cow-to-calf transmission of BSE is unlikely to occur</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22031.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Refs. 14 and 46). Therefore, the serum of fetal calves is unlikely to contain any BSE infectious</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22055.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material, irrespective of the age of the mother.  However, because fetal calf serum (FCS) is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22078.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">generally collected from fetuses of dairy cows culled for low milk production or for health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:22301.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:22331.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">28</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22361.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasons, these cows are often considerably older than 30 months.  FDA believes that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22384.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers commonly take appropriate steps to prevent contamination of the FCS with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22407.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">specified risk materials from the mother.  These steps include the normal dressing procedures</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22430.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in slaughter houses, consisting of removing the uterus completely from the carcass and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22454.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">other viscera of cows that were inspected and passed, taking it to a separate space free of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22477.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials for cardiac puncture, and collecting the fetal blood in a closed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22500.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">collection system using aseptic technique.  Other procedures could also be used to provide</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22523.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adequate assurance that contamination has been prevented.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22546.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:22546.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Additional Requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:22569.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">If the agency finds that additional protections are needed for specific products or classes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22592.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of products covered by applications (e.g., products with direct routes of exposure into the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22615.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">bloodstream or neural tissue such as injectable, ophthalmic, intranasal, or implanted FDA-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22639.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulated products), it intends to provide those protections through the application review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22662.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">process or through other means, such as special controls for Class II devices.  The agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22685.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">believes it is possible that injectable, ophthalmic, intranasal, or implanted FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22708.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products that contain cattle material other than prohibited cattle materials and that do not have an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22731.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA approval covering use of that material may appear to be adulterated or misbranded under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22754.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">certain circumstances. If the agency finds that classes of such products or specific products do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22777.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not meet the applicable statutory standards, it may take action even if the products comply with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:22800.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the requirements in this proposed regulation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:23093.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:23123.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">29</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.50pt;top:23153.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">F.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:80.55pt;top:23153.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Medical Products for Humans and Drugs for Ruminants That May Contain Cattle Material</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23176.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:23176.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs for Humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:23204.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under this proposed rule, drugs for humans cannot be manufactured from or otherwise</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23227.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain prohibited cattle materials without written permission from FDA.  For drugs subject to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23250.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applications, the agency may provide additional protections through the application review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23273.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">process on a case-by-case basis to ensure that the products are safe and effective for their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23296.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intended uses under section 505 of the Federal Food, Drug and Cosmetic Act (the act)(21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23319.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">355</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:23319.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) and safe, pure, and potent under section 351 of the Public Health Service Act (the PHS Act)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23342.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(42 U.S.C. 262).  For drugs not subject to applications, if the agency finds that specific products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23365.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or product classes do not meet the applicable statutory standards regarding adulteration and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23388.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">misbranding, it may take action even if the products comply with the requirements in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23412.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:23439.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Many approved human drugs, as well as investigational human drugs, contain ingredients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23462.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that are derived from cattle.  Over the last 10 years, FDA has maintained a database that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23485.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">identifies these drugs and their cattle-derived ingredients.  Based on the information in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23508.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">database, we are aware of no approved drugs and no investigational drugs that are manufactured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23531.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with cattle material that would be prohibited under this proposed rule based on the type of cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23554.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissue used.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.10pt;top:23553.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:23578.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In addition to human drugs with approved applications, a number of human drugs are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23601.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">marketed without an approved application and, therefore, have not been subject to the new drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23624.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">application (NDA) review process (e.g., products marketed under FDA’s over-the-counter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23647.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(OTC) monograph system, Active Pharmaceutical Ingredients, homeopathic preparations, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:23676pt;width:120pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23680.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.88pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.60pt;top:23682.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">All manufacturers would have to ensure that any cattle material they use comes from cattle that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:23885.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:23915.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23945.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products that purport to be “grandfathered”).  Although FDA’s database of these products is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23968.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">incomplete, some of them may contain cattle materials that would be prohibited under this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:23991.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule.  The requirements proposed in this rulemaking apply to all drugs for humans,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24014.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">including those marketed without an approved application.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24038.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:24038.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Biologics for Humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:24061.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Many biological products are manufactured with, or otherwise use, cattle-derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24084.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material because this material can provide necessary nutrients for cell growth.  For example,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24107.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">microorganisms used for vaccine manufacture are typically grown under controlled conditions in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24130.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">media that may contain cattle materials.  Animal-derived products used in vaccine manufacture</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24153.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">include amino acids, glycerol, detergents, gelatin, enzymes, and blood.  Cattle skeletal muscle is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24176.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used to prepare broths used in certain complex media.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:24199.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Many microorganisms that are difficult to grow and cells that are used to propagate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24223.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">viruses require serum in the growth media, which is typically derived from cattle blood. Cattle-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24246.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derived materials (e.g., fetal calf serum, insulin, aprotinin, enzymes) are often used in cell culture</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24269.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">techniques to manufacture hematological, cell, and gene-therapy products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:24292.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Manufacturers of licensed products and sponsors of investigational new drug products are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24315.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">currently requested to provide, in their biologics license application (BLA) or investigational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24338.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">new drug application (IND), information regarding the source of all bovine-derived materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24361.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in the manufacture of their product.  This information is reviewed by FDA along with other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24384.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information provided in the application. SRMs are not ordinarily used in the manufacture of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24407.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">biological products.  Biological products that are not intended for use in or on the body (e.g., in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24431.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vitro diagnostics) would not be subject to the provisions of this proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:24472pt;width:392pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24477.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">inspected and passed and otherwise complies with the other requirements proposed in this rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:24677.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:24707.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">31</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24737.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:24737.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:24760.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposed rule would affect all HCT/Ps.  HCT/Ps are defined in part 1271 (21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24783.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">part 1271) as “articles containing or consisting of human cells or tissues that are intended for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24806.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24830.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">include, but are not limited to, bone, ligament, skin, dura mater, heart valve, cornea,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24853.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24876.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24899.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissue” (§ 1271.3(d)).  Certain exceptions apply (§ 1271.3(d)(1) through (d)(7)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:24922.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps are regulated according to a tiered, risk-based framework.  HCT/Ps meeting the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24945.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">criteria listed in § 1271.10 (e.g., minimally manipulated, intended for homologous use only (i.e.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24968.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">perform the same basic function(s) in the recipient as in the donor), not combined with a drug or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:24991.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">device, and  not having a systemic effect) are regulated solely under the authority of section 361</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the PHS Act (42 U.S.C. 264).  These ñ”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.40pt;top:25015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps are required to comply only with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25038.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicable requirements in part 1271.  Premarket review is not required for such products;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25061.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">therefore, FDA does not review any information regarding cattle-derived material that might be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25084.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in such products.  This proposed rule would ban the use of prohibited cattle material in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25107.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">these products, which we believe would help reduce any possible BSE transmission through the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25130.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use of ñ” HCT/Ps manufacture</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.70pt;top:25130.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">d using cattle-derived material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:25153.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps that do not meet the criteria in § 1271.10 are regulated as drugs and devices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25176.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under the act, and/or biological products under section 351 of the PHS Act and the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25199.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Establishments that manufacture such HCT/Ps must comply with the requirements in subparts C</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25223.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and D of part 1271 in addition to all other applicable regulations, including submission of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25246.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">appropriate premarketing applications, and are included in this proposed rule.  Information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:25469.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:25499.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">32</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25529.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regarding the use of cattle-derived material in the manufacture of such HCT/Ps would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25552.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submitted as part of the premarket review, giving us the opportunity to evaluate any potential for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25575.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk of BSE transmission.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25603.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:25603.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Medical Devices for Humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:25630.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Center for Devices and Radiological Health (CDRH) has an administrative database</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25653.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that FDA reviewers use to record PMA and 510(k) submissions.  In 2002, FDA added an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25676.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“animal tissue flag” to the CDRH administrative database. This “flag” indicates that the device</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25699.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contains or is manufactured with animal tissue of some kind; the species of animal tissue is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25722.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">identified.  The animal tissue flag has been recorded for 68 PMAs and 2,164 510(k)s. These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25746.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">numbers represent only devices for which PMAs or 510(k)s were filed since the animal tissue</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25769.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">flag was added in 2002.  They do not account for devices cleared or approved for marketing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25792.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">before that time that may contain or that may be manufactured with animal tissue.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:25815.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Examples of cattle material used in devices range from high risk tissues (such as bovine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25838.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">pituitary extract used as a component of growth media) used in a low risk clinical setting (such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25861.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">as a topical application), to low risk cattle tissues (such as collagen from cattle hide or muscle)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25884.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in a high risk clinical setting (such as direct application to the central nervous system).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:25907.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Premarket submissions for devices do not always include complete information about the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25930.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">source of animal components.  In addition, not all devices are subject to premarket review, either</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25954.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">because they are exempt from such review or because they have already been cleared or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:25977.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approved.  FDA believes that it is important to help ensure that all devices that are intended for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26000.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use in or on the body do not contain prohibited cattle materials.  Examples of devices intended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26023.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for use in or on the body include, but are not limited to, vascular grafts, bone fillers, lacrimal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26046.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">plugs, sutures, wound dressings, and heart valves (other than human heart valve allografts</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:26261.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:26291.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">33</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26321.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulated solely under section 361 of the PHS Act). FDA has determined that the banning and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26344.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping provisions of this proposed rule are necessary to help ensure the safety of devices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26367.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intended for use in or on the body.  Medical devices that are not intended for use in or on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26390.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">body (e.g., in vitro diagnostics, x-ray machines) would not be subject to the provisions of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26414.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule.  FDA is not aware of any currently marketed device that is manufactured with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26437.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle material that would be prohibited under this proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26460.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:26460.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs for Ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:26483.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The requirements proposed in this rulemaking would cover new animal drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26506.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants.  Ruminants present the highest risk of any animals for contracting BSE from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26529.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials. Because FDA has other mechanisms to restrict the extralabel use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26552.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approved human and animal drugs that contain prohibited cattle materials in ruminants (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26575.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section V.D of this document), this proposed rule would only prohibit the use of certain cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26599.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material in drugs intended for use in ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:26622.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Some drugs for ruminants may contain or be manufactured with cattle-derived materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26645.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We are not aware of any drugs for ruminants that contain, as a component of the drug, cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26668.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material that would be prohibited by the proposed rule.  However, although the FDA animal drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26691.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">database lists materials contained in drugs for animals, it does not identify materials that are used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26714.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in the manufacture of drugs for animals but that are not intended to be components of the drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26737.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(e.g., materials used in fermentation or cell culture production of drugs for animals).  Because</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26760.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the FDA database does not contain information on materials used in the manufacture of drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26783.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animals, we cannot definitively conclude that no drugs for ruminants are manufactured with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26807.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use of cattle material that would be prohibited by this proposed rule.  However, based on our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:26830.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">knowledge of the processes and materials used in manufacture of drugs for ruminants, as well as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:27053.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:27083.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">34</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27113.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the fact that very little cattle material is prohibited if sourced from cattle that were inspected and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27136.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">passed and were younger than 30 months old when slaughtered, we do not believe that prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27159.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle material is needed in the manufacture (through fermentation, cell culture or otherwise) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27182.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drugs for ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:213.25pt;top:27206.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">III.  USDA/FSIS IFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:27229.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">On January 12, 2004, in response to the diagnosis of BSE in a cow in the United States,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27252.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA published a series of interim final rules, including "Prohibition of the Use of Specified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27275.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27298.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Disabled Cattle" (69 FR 1862).  The USDA/FSIS IFR declared that SRMs were inedible and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27321.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">unfit for food and prohibited their use as human food. It also prohibited the use of the entire</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27344.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">small intestine of all cattle in human food.  In 2005, the USDA/FSIS IFR was amended, in part,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27367.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to permit use of the small intestine of all cattle in human food if appropriate procedures are used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27391.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to completely remove the distal ileum (70 FR 53043). In the Foods IFR, FDA extended similar</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27414.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">protections to FDA-regulated human food and cosmetics.  (See section IV.A.3 of this document</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27437.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for a discussion of the Foods IFR.)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:27460.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The USDA/FSIS and Foods IFRs will reduce but will not, by themselves, eliminate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27483.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use of prohibited cattle materials in domestic and imported FDA-regulated medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27506.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants.  Even when excluded from human food produced in USDA-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27529.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected establishments, prohibited cattle materials that have been denatured may leave the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27552.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishments for rendering or destruction. These materials, which previously have not been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27575.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">explicitly prohibited in medical products for humans and drugs for ruminants by FDA, might</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27599.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">then be used in FDA-regulated medical products for humans and drugs for ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:27845.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:27875.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">35</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:27905.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under the USDA/FSIS IFR, SRMs and carcasses of nonambulatory disabled cattle are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27928.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">designated as inedible.  However, certain products, such as gelatin and collagen (which are both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27951.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">covered by the provisions of this medical products proposed rule) used in FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27974.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans and drugs for ruminants, have traditionally been produced from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:27998.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle material deemed inedible by the USDA.  Therefore, such a designation by the USDA may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28021.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not be enough to preclude use of prohibited cattle materials in FDA-regulated products without</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28044.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">additional regulation by FDA.  Furthermore, some cattle are not slaughtered under continuous</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28067.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA inspection (e.g., some are sent directly to rendering without first passing inspection).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28090.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle material from these animals, such as brains or bones, which include SRMs, could end up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28113.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">as starting material for medical products for humans and drugs for ruminants.  If prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28136.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials were unlawfully used in FDA-regulated medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28159.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants, this proposed rule if finalized would facilitate FDA’s ability to use the enforcement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28183.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">mechanisms of the act that apply to adulterated products (e.g., seizure) to prevent human or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28206.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminant exposure to the prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:28229.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Imported products also may contain the types of materials prohibited by the USDA, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28252.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would not fall within the scope of the USDA’s import regulations either because of the nature of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28275.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the products or their country of origin.  Specifically, although both FSIS and USDA’s Animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28298.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and Plant Health Inspection Service (APHIS) impose BSE-related prohibitions, these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28321.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibitions collectively do not cover all FDA-regulated medical products for humans and drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28344.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for ruminants.  For example, APHIS’ BSE-related restrictions on imports do not cover gelatin for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28367.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human use (beyond requiring a permit) and apply only to a limited number of countries (9 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28391.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">94.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:28391.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">18).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:28637.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:28667.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">36</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:203.50pt;top:28697.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">IV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:221.60pt;top:28697.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA Actions on BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:224.90pt;top:28720.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A.  Regulations</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28743.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:28743.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA 1997 Ruminant Feed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:28766.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In the Fed</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">eral Register </FONT></u><FONT STYLE="font-size: 10.05pt">of June 5, 1997 (62 FR 30936), FDA published a regulation that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28790.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibits, with some exceptions, the use of protein derived from mammalian tissue in feed for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28813.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle and other ruminant animals (21 CFR 589.2000).  The agency published the FDA 1997</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28836.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminant feed rule to prevent the establishment and amplification of BSE in the United States</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28859.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and thereby minimize any risk to animals and humans.  FDA recently proposed changes to these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28882.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements to further strengthen the rule (see section IV.A.2 of this document).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28928.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:28928.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA/USDA Animal Feed ANPRM and FDA 2005 Animal Feed Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:28951.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Following detection of BSE in an imported dairy cow in Washington State in December</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28975.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:28975.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3, the Secretaries of the U.S. Departments of Agriculture and Health and Human Services</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:28998.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">announced a series of regulatory actions and policy changes to strengthen protections against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29021.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">spread of BSE in U.S. cattle and against human exposure to the BSE agent.  The Secretary of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29044.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Agriculture also convened an international panel of experts on BSE to review the U.S. response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29067.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to the Washington case and make recommendations that could provide meaningful additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29090.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">public or animal health benefits.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:29113.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In the Fed</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">eral Register </FONT></u><FONT STYLE="font-size: 10.05pt">of July 14, 2004 (69 FR 42287), FDA and USDA’s FSIS and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29136.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">APHIS jointly published an ANPRM to solicit comment on additional measures under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29159.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">consideration based on those recommendations and other factors.  FDA has since received</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29183.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comments on the joint ANPRM, and in the F</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ederal Register </FONT></u><FONT STYLE="font-size: 10.05pt">of October 6, 2005 (70 FR 58570),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:29429.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:29459.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">37</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29489.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">published the FDA 2005 Animal Feed proposed rule to prohibit certain material from all animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29512.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">food or feed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29535.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:29535.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods IFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:29558.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In the Fed</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">eral Register </FONT></u><FONT STYLE="font-size: 10.05pt">of July 14, 2004 (69 FR 42256), FDA published an IFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29582.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibiting the use of certain cattle material to address the potential risk of BSE in human food,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29605.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">including dietary supplements, and cosmetics. This rule took effect immediately upon</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29628.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">publication.  On September 7, 2005, FDA amended the Foods IFR to revise or clarify provisions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29651.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with regard to: (1) Use of small intestine (see section II.E.2 of this document) (2) use of hide and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29674.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hide-derived products (see section V.A of this document), (3) use of milk and milk products (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29697.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section V.A of this document), (4) source tallow for tallow derivatives (see section II.E.6 of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29720.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document), and (5) testing method cited for determining the level of insoluble impurities in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29743.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tallow (see section V.C of this document). As a result, cattle materials prohibited in human food</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29767.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and cosmetics include SRMs, small intestine of all cattle if procedures that completely remove</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29790.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the distal ileum are not used, material from nonambulatory disabled cattle, material from cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29813.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not inspected and passed for human consumption, and mechanically separated beef.  SRMs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29836.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29859.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29882.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29905.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ileum of the small intestine of all cattle.  Prohibited cattle materials do not include tallow that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29928.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29951.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derived products, and milk and milk products.  This action was taken to minimize human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29975.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exposure to materials that are highly likely to contain the BSE agent in cattle infected with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:29998.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disease.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:30221.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:30251.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">38</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30281.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:30281.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods Recordkeeping/Access Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:30304.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In the Fed</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">eral Register </FONT></u><FONT STYLE="font-size: 10.05pt">of July 14, 2004 (69 FR 42275), FDA also published a proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30327.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule to require that manufacturers and processors of human food and cosmetics that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30350.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from, processed with, or otherwise contain, material from cattle establish and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30374.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintain records sufficient to demonstrate that the food and cosmetics are in compliance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30397.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods IFR.  FDA believes that records documenting the absence of prohibited cattle materials in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30420.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human food and cosmetics are critical for manufacturers, processors, and FDA to ensure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30443.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compliance with the ban on the use of prohibited cattle materials in the Foods IFR. FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30466.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">solicited comment on the types of records that may already be available to document the absence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30489.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of prohibited cattle materials in human food and cosmetics and the types of records that could be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30512.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">established to document the absence of prohibited cattle materials in these FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30535.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products.  The comment period on the Foods Recordkeeping/Access proposed rule closed on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30559.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">August 13, 2004.  Until the Foods Recordkeeping/Access proposed rule is finalized, FDA is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30582.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensuring that it can enforce the new prohibitions in the Foods IFR through the provisions in that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30605.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule requiring that FDA be given access to any existing records relevant to compliance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30628.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ban on prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:30651.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposed rule for medical products for humans and drugs for ruminants is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30674.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">companion to the Foods IFR and responds to the same public health concerns.  This proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30697.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule serves as an additional safeguard to reduce human exposure to the agent that causes BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30720.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that may be present in cattle-derived medical products for humans and drugs for ruminants that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:30743.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">are from domestic and imported sources.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:31013.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:31043.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">39</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:218.60pt;top:31073.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:232.75pt;top:31073.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA Guidance</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:31096.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">During the past decade, we have communicated with the public and manufacturers,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:31119.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicants, importers, and processors of FDA-regulated human and animal products regarding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:31142.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">appropriate steps to increase product safety and minimize the risk of products being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:31166.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contaminated with the BSE agent.  Most of our communications have been in the form of letters</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:31189.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and guidance to industry and import alerts.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:31188pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:31211.85pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31213.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">November 1992--We wrote to manufacturers of dietary supplements to alert them to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31236.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">developing concern about TSEs in animals and CJD in humans and recommended that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31259.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">they investigate the geographic sources of any bovine and ovine material used in their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31282.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:31305.00pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31306.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">December 1993--We wrote to manufacturers of drugs, biologics, and medical devices and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31329.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recommended against the use of bovine-derived materials from cattle that have resided</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31352.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in, or originated from, BSE countries.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:31375.05pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31376.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">August 1994--We published a notice in the Fe</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">deral Register </FONT></u><FONT STYLE="font-size: 10.05pt">(59 FR 44592, August 29,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31399.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:31399.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">994) entitled "Bovine-Derived Materials; Agency Letters to Manufacturers of FDA-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31422.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Regulated Products."  In the notice, we published the text of the November 1992 and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31445.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">December 1993 letters previously described and, in addition, the text of letters to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31468.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of FDA-regulated products for animals (August 17, 1994), and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31491.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers and importers of dietary supplements and cosmetics (August 17, 1994).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:31514.50pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31515.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">October 1994--We issued Import Alert 17-04, which allowed for the detention, without</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31538.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">physical examination, of bulk shipments of high-risk bovine tissues and tissue-derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31561.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ingredients from BSE countries.  We have updated this alert whenever APHIS has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31585.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">revised the list of countries in 9 CFR 94.18.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31179.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:31179.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">The rule, if finalized, will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31187.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">supersede prior communications that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31195.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">address the same issues.</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:31013.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background39.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:31805.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:31835.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">40</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:31865.15pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31866.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">October 1997--We published a notice of availability (62 FR 52345, October 7, 1997) of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31889.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">guidance for industry entitled "The Sourcing and Processing of Gelatin to Reduce the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31912.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:31935.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Products for Human Use."</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:31958.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="ff0101"><u><FONT STYLE="font-size: 10.05pt">The rule, if finalized, will supersede prior communications that address the same is</FONT></u><FONT STYLE="font-size: 10.05pt">sues,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:31958pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:31981.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">including the communications identified above.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:31981pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:189.30pt;top:32004.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">V.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:204.05pt;top:32004.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Description of Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:226.25pt;top:32028.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A.  Definitions</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:32051.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For the purposes of this regulation, we are proposing  to define the terms “prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32074.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials,” “inspected and passed,” “mechanically separated beef,” “nonambulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32097.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disabled cattle,” “specified risk materials,” “tallow,” “tallow derivative,” and “ruminant”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32120.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(proposed §§ 300.200(a), 500.200(a), 600.16(a), 895.102(a) and 1271.470(a)).  The proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32143.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">terms and definitions are the same as those used in the Foods IFR (69 FR 42256 and 70 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32166.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">530</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:32166.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">63), except that we are now including in proposed § 500.200(a) a definition for ruminant and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32189.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">we have revised the definition of prohibited cattle materials as it relates to fetal calf material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32213.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We have also made minor editorial revisions to the definition of inspected and passed. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32236.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed definitions are consistent with definitions used by the USDA (69 FR 1862 and 70 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32259.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">530</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:32259.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">43).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:32282.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:32282.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:102.95pt;top:32282.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials </FONT></u><FONT STYLE="font-size: 10.05pt">means specified risk materials, small intestine of all cattle if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32305.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">procedures that completely remove the distal ileum are not used, material from nonambulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32328.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disabled cattle, material from cattle not inspected and passed, or mechanically separated beef.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32351.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials do not include tallow that contains no more than 0.15 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32374.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">insoluble impurities, tallow derivatives, hides and hide-derived products, and milk and milk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31948.85pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><b><FONT STYLE="font-size: 6.73pt">Formatted: </FONT></b><FONT STYLE="font-size: 6.73pt">Left, No widow/orphan</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31957.00pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.73pt">control, Don't keep with next, Don't</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31965.10pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.73pt">keep lines together, Tabs: Not at 36</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:31973.25pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.73pt">pt</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:31805.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background40.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:32597.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:32627.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">41</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32657.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products.  Prohibited cattle materials also do not include materials obtained from fetal calves of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32680.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cows that were inspected and passed as long as the materials were obtained by procedures</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32703.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adequate to prevent contamination with specified risk materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:32726.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">With regard to hides and hide-derived products, we are proposing that these products not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32750.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be included in the definition of “prohibited cattle materials.”  We are proposing this exemption</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32773.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">because cattle hide has been determined to be a tissue with negligible risk of transmitting the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32796.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agent that causes BSE; the OIE recommends that it be freely traded regardless of the BSE risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32819.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">status of the exporting countries.  Even though we are proposing to exempt hides and hide-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32842.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derived products from the provisions of this proposed rule, applicants and manufacturers would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32865.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be required to take precautions to avoid cross contamination of hides and other nonprohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32888.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle material with prohibited cattle material during slaughter and processing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:32911.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">With regard to milk and milk products, we are proposing that these products also not be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32935.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">included in the definition of “prohibited cattle materials.”  We recognize that milk and milk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32958.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products present a negligible risk of transmitting the agent that causes BSE.  The OIE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:32981.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recommends that milk and milk products be freely traded among countries, regardless of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33004.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE risk status of the exporting country. In addition, the prohibitions for medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33027.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants applies to materials from cattle slaughtered on or after the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33050.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">effective date of the rule and is not meant to apply to milk and milk products, which come from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33073.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">live cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:33096.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.  Inspected and </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">passed</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:190.30pt;top:33096.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">means that the material is from an animal that has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33119.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption by the appropriate regulatory authority, and at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33143.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time the animal was inspected and passed, it was found to be not adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:33389.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:33419.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:33449.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:33449.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:33449.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Mechanically separated beef </FONT></u><FONT STYLE="font-size: 10.05pt">means a meat food product that is finely comminuted,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33472.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from the mechanical separation and removal of most of the bone from attached skeletal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33495.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33518.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 319.5, USDA’s regulation that prescribes the standard of identity for Mechanically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33542.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Separated (Species).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:33565.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:33565.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:102.95pt;top:33565.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nonambulatory disabled cattle </FONT></u><FONT STYLE="font-size: 10.05pt">means cattle that cannot rise from a recumbent position</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33588.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or that cannot walk, including, but not limited to, those with broken appendages, severed tendons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33611.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:33634.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:33634.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Specified risk </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">material </FONT></u><FONT STYLE="font-size: 10.05pt">means the brain, skull, eyes, trigeminal ganglia, spinal cord,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33657.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33680.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33703.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">older, and the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:33727.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:33726.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow </FONT></u><FONT STYLE="font-size: 10.05pt">means the rendered fat of cattle obtained by pressing or by applying any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33750.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extraction process to tissues derived directly from discrete adipose tissue masses or to other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33773.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33796.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or must contain not more than 0.15 percent insoluble impurities as determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33819.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33842.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.75pt;top:33840.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.50pt;top:33842.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in accordance with 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33865.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:33865.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33888.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33911.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AOCS (</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">http</a></FONT><FONT STYLE="font-size: 10.05pt">://</FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">www.aocs.org</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) 2211 W. Bradley Ave., Champaign, IL 61821.  Copies may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33935.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:33958.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Pkwy., College Park, MD 20740, or at the National Archives and Records Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:34181.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:34211.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">43</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34241.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NARA).  For information on the availability of this material at NARA, call 202-741-6030, or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34264.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to: </FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">http://www.arch</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">i</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">ves</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">gov/federal_regis</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">er/code_of_federal_regulations/ibr_loca</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">ti</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">ons</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">h</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">m</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">l</FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:34287.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:34287.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow derivative </FONT></u><FONT STYLE="font-size: 10.05pt">means any chemical obtained through initial hydrolysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34310.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">saponification, or trans-esterification of tallow; chemical conversion of material obtained by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34334.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:34357.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:102.95pt;top:34357.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Ruminant </FONT></u><FONT STYLE="font-size: 10.05pt">means any member of the suborder of animals that has a stomach with four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34380.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compartments (rumen, reticulum, omasum, and abomasum) through which feed passes in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34403.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">digestion.  The suborder includes, but is not limited to, cattle, buffalo, sheep, goats, deer, elk, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34426.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">antelopes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:66.20pt;top:34449.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B.  Proposed Requirements for Prohibited Cattle Materials and Permission for an Exception or</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:186.05pt;top:34472.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Alternative to These Requirements</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:34495.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA and FDA prohibit the use of SRMs, and mechanically separated beef in human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34519.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">food (69 FR 1862; 69 FR 42256).  USDA also requires that all nonambulatory disabled cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34542.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">presented for slaughter be condemned (69 FR 1862), while FDA prohibits use of such cattle in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34565.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human food (69 FR 42256).  USDA and FDA permit use of the small intestine of all cattle in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34588.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human food if appropriate procedures are used to completely remove the distal ileum (70 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34611.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">530</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:34611.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">43; 70 FR 53063).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:34634.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA imposes these prohibitions for cosmetics as well, and also prohibits material from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34657.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle not inspected and passed in both human food and cosmetics (69 FR 42256; 70 FR 53063).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34680.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">To ensure that the same materials are not incorporated into other FDA-regulated products, we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34703.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">now proposing to prohibit the use of these materials in, or in the manufacture of, medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34727.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans and drugs for ruminants. As with human food and cosmetics, we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:34750.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposing the following five categories of material as prohibited cattle materials:  (1) The small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:34973.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:35003.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">44</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35033.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine from all cattle if procedures that would completely remove the distal ileum are not used,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35056.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) SRMs, (3) mechanically separated beef, (4) material from nonambulatory disabled animals,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35079.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and (5) material from cattle not inspected and passed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:35102.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scientists believe that the human disease vCJD is likely caused by the consumption of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35126.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products contaminated with the agent that causes BSE.  The relationship between the agent that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35149.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">causes BSE and human cases of vCJD has been described previously in section II.C of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35172.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document.  Consumption of contaminated material is thought to cause illness in humans,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35195.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">although scientific research has not determined the infectious dose (see section II.C of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35218.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document), and there is not a test that would allow screening of cattle materials or derivative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35241.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for infectious material (see section II.D of this document).  Therefore, we are proposing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35264.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in § 300.200(b)(1) that, except as provided in proposed § 300.200(b)(2), no human drug be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35287.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise contain prohibited cattle materials obtained from cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35311.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">slaughtered on or after the effective date of the final rule based on this proposal.  We are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35334.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposing similar limitations for other products: drugs for ruminants, human biological products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35357.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(including blood products) and medical devices that are intended for use in or on the body, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35380.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps (defined at 21 CFR 1271.3(d)) (proposed §§ 500.200(b), 600.16(b), 895.102(b), and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35403.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:35403.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:35403.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0(b)).  With regard to HCT/Ps, this proposed prohibition (proposed § 1271.470(b))</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35426.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applies to use of prohibited cattle materials in the manufacture of the HCT/P rather than the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35449.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacture of the HCT/P from prohibited cattle materials because HCT/Ps exclude animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35472.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissues (§ 1271.3(d)(2)(vi)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:35495.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA is proposing to apply the requirements of this proposed rule to all products or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35519.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">components of products manufactured for use in the United States or imported into the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35542.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">States. This proposed rule contains the basic requirements needed to provide further protection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:35765.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:35795.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">45</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35825.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of humans and ruminants from the potential risks of BSE posed by the use of cattle material in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35848.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the manufacture of these products.  Additional measures that FDA determines are needed for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35871.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">individual products would be addressed on a case-by-case basis through the application review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35894.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">process.  For non-application products, if the agency finds that specific products or product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35918.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">classes do not meet the applicable statutory standards regarding adulteration and misbranding, it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35941.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">may take action even if the products comply with the requirements in this proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:35964.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The provisions in this proposed rule would apply to medical products for humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:35987.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drugs for ruminants that are manufactured from or that otherwise contain material from cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36010.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">slaughtered on or after the effective date of any final rule. The restrictions would not apply to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36033.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">such products (including cell lines used in the manufacture of products) that use or contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36056.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials from cattle slaughtered before the effective date of any final rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:36079.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The proposed rule would provide applicants and manufacturers a mechanism for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36103.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requesting FDA to grant written permission for an exception or alternative to the limitations on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36126.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the use of prohibited cattle materials in medical products for humans or drugs for ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36149.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(proposed §§ 300.200(b)(2), 500.200(b)(2), 600.16(b)(2), 895.102(b)(2), and 1271.470(b)(2)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36172.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Applicants and manufacturers that choose to request such permission would be required to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36195.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submit the request in writing to the applicable FDA Center with the requisite information as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36218.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">detailed below.  For products subject to an application or premarket notification, this written</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36241.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request would be required to reference the product’s application number.  The Center Director</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36264.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">may permit an exception or alternative to this proposed rule’s limitation on the use of prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36287.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials upon the submitter's request or on his or her own initiative.  Including the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36311.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">application number of the product in a written request for products subject to applications or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36334.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">premarket notifications would ensure that existing applications and clearances reflect when an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:36557.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:36587.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">46</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36617.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exception or alternative to these proposed requirements has been submitted and when an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36640.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exception or alternative has been approved.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:36663.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA expects that applicants or manufacturers may submit a request for an exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36686.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative when filing a new application or premarket notification for a product containing cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36710.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material that would be prohibited under this proposed rule.  Applicants or manufacturers may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36733.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">also submit a request for an exception or alternative if an existing product contains prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36756.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials under this proposal. Although FDA believes it is unlikely that applicants or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36779.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers who currently are not using prohibited cattle materials in their products will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36802.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reformulate their products to include prohibited cattle materials, proposing to do so would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36825.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">require not only a request for an exception or alternative but also a supplement to the approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36848.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">application or a new premarket notification, consistent with existing regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:36871.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A request for an exception or alternative to the requirements would include:  (1) The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36895.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasons why an exception or alternative to the requirements is needed, (2) a description of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36918.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product, including the type of prohibited cattle materials used in its manufacturing, its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36941.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturing and purification processes, and its route of administration, (3) a description of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36964.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">source of the prohibited cattle materials, including information on the location where the cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:36987.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were born, raised, and slaughtered and any other information relevant to the likelihood of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37010.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle having ingested material prohibited under § 589.2000, and (4) any other relevant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37033.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information (paragraphs (b)(2)(ii)(A) through ((b)(2)(ii)(C) and (b)(2)(ii)(E) of proposed §§</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37056.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">300</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:37056.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:37056.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">, 500.200, 600.16, 895.102, and 1271.470).  For medical products for humans, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37079.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request would be required to include a description of how the requirement is not necessary based</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37103.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on the risks of the prohibited cattle materials in the product and the benefits of the product or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37126.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">how such restrictions are not necessary to ensure the safety of the product (paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:37349.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:37379.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37409.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(2)(ii)(D) of proposed §§ 300.200, 600.16, 895.102, and 1271.470).  For drugs for ruminants,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37432.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the request would be required to include either:  (1) A description of how the requirements are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37455.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not necessary:  (i) Based on the risks of the prohibited cattle materials in the product to the target</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37478.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal and the benefits of the product to the target animal and (ii) to ensure a reasonable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37502.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">certainty of no harm to humans from any food derived from the target animal to which the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37525.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product was administered, or (2) a description of how the requirements are not necessary to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37548.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensure the safety of the product with respect to both the target animal and any food derived from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37571.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the target animal to which the product is administered (proposed § 500.200(b)(2)(ii)(D)).  FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37594.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would respond to all requests in writing and could impose conditions in granting a request. FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37617.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">could also grant permission for an exception or alternative to the requirements on its own</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37640.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">initiative based on an evaluation of the criteria described previously.  A record of any exception</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37663.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or alternative to the requirements in paragraph (b)(1) of proposed §§ 300.200, 500.200, 600.16,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37687.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">895</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:37687.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.102</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:37687.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">, and 1271.470 that is granted by FDA would be required to be maintained by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37710.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicant or manufacturer under the proposed recordkeeping requirements discussed in section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37733.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">V.E of this document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:37756.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Although FDA believes that exceptions or alternatives to the requirements of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37779.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule would be rare, the proposal would allow medical products for humans and drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37802.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for ruminants to be manufactured from or otherwise contain prohibited cattle materials if the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37825.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency determines that the risk posed by the use of prohibited cattle materials in the product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37848.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would be outweighed by the benefits of the particular product or if the agency determines that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37871.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibiting the use of these materials would be otherwise unnecessary to ensure the safety of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37895.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product.  In the case of drugs intended for use in food-producing ruminant species, the benefits</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:37918.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the product relate primarily to the target animal species (ruminants), whereas the risks relate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:38141.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:38171.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">48</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38201.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">both the health of the target animal as well as the safety of the food derived from the target</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38224.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal.  However, the agency does not weigh the benefits of a drug to an animal against the risks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38247.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the drug to human health, but rather considers whether there is a reasonable certainty of no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38270.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">harm to humans from the use of the drug in animals. Therefore, the reasonable certainty of no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38294.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">harm standard would be applied when considering requests for exceptions or alternatives to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38317.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed requirements for drugs intended for use in food-producing ruminant species. In all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38340.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cases, FDA intends to apply existing statutory safety standards in determining whether to grant a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38363.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">written request for an exception or alternative to the proposed limitations on the use of prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38386.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials. (See section V.E of this document for discussion.)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:38409.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In the joint ANPRM, USDA’s FSIS sought comment on the issue of equivalence and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38432.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE requirements (whether the agency should consider a country’s BSE risk when determining</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38455.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">whether a country has implemented equivalent sanitary measures to those required by the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38479.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">States to prevent human exposure to the BSE agent) (69 FR 42287 at 42299 and 42300).  In the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38502.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods IFR, FDA sought comment on the standards that should be applied when determining</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38525.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">another country’s BSE status, providing an exemption for “BSE-free” countries, and how to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38548.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determine that countries meet any standards that might be developed (69 FR 42256 at 42263).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38571.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA here again requests comment on whether and, if so, on what basis to exempt products and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38594.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">components of products from “BSE-free” countries from our respective requirements related to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38617.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE, including those issued by this proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:38640.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed §§ 211.116 and 226.60, which would be part of FDA’s current good</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38663.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturing practice (CGMP) requirements for finished pharmaceuticals for humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38687.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants and for type A medicated articles for ruminants would prohibit use of certain cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38710.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials, as described in proposed §§ 300.200, 500.200 and 600.16.  The CGMP requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:38933.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:38963.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">49</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:38993.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain the minimum methods that must be used for the manufacture, processing, packing, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39016.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">holding of a drug to ensure that the drug meets the quality and purity characteristics that it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39039.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">purports or is represented to possess. The CGMP requirements contained in part 211 (21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39062.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">part 211) apply to finished pharmaceuticals and components of finished pharmaceuticals for both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39086.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and animals.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:39109.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The CGMP requirements contained in part 226 (21 CFR part 226) apply to Type A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39132.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medicated articles. Type A medicated products are intended solely for use in the manufacture of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39155.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">another Type A medicated article or a Type B or Type C medicated feed.  A Type A medicated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39178.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">article consists of a new animal drug(s), with or without carrier, with or without inactive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39201.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ingredients. Type A medicated articles are new animal drugs, and the manufacture of a Type A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39224.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medicated article requires an approved new animal drug application (21 CFR part 514).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:186.50pt;top:39247.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">C.  Tallow and Tallow Derivatives</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:39270.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Tallow would be defined as "the rendered fat of cattle obtained by pressing or by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39294.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applying any other extraction process to tissues derived directly from discrete adipose tissue</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39317.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">masses or to other carcass parts and tissues" (proposed §§ 300.200(a)(6), 500.200(a)(6),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39340.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">600</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:39340.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.16(a)(6), 895.102(a)(6) and 1271.470(a)(6)).  Tallow derivatives would be defined as any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39363.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">chemical obtained through initial hydrolysis, saponification, or trans-esterification of tallow;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39386.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">chemical conversion of material obtained by hydrolysis, saponification, or trans-esterification</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39409.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">may be applied to obtain the desired product (proposed §§ 300.200(a)(7), 500.200(a)(7),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39432.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">600</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:39432.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.16(a)(7), 895.102(a)(7) and 1271.470(a)(7)).  For the reason described in section II.K of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39455.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document, we are proposing that tallow with no more than 0.15 percent insoluble impurities and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39479.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tallow derivatives would not be defined as prohibited cattle materials under this rule even when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39502.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured with prohibited materials (proposed §§ 300.200(a)(1), 500.200(a)(1), 600.16(a)(1),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:39725.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:39755.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39785.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">895</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:39785.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.102</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.95pt;top:39785.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(1) and 1271.470(a)(1)).  (Tallow made without using prohibited cattle materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39808.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would not be subject to this purity requirement.)  We are proposing that the insoluble impurities</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39831.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in tallow be measured by the method entitled “Insoluble Impurities” (AOCS Official Method Ca</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39854.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3a-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:73.15pt;top:39854.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:78.15pt;top:39854.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6), American Oil Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:268.55pt;top:39853.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.30pt;top:39854.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39878.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39901.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">precision, and sensitivity to the AOCS Official Method Ca 3a-46 (proposed §§ 300.200(a)(6),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39924.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:39924.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:39924.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(6), 600.16(a)(6), 895.102(a)(6) and 1271.470(a)(6)).  The AOCS Official Method Ca</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39947.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3a-46 is currently used by the domestic tallow industry. Reference to the AOCS Official Method</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39970.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Ca 3a-46 in this proposed definition does not exclude use of another method.  Any testing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:39993.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method may be used that is equivalent to the AOCS Official Method Ca 3a-46 in accuracy,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40016.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">precision, and sensitivity. Those wishing to use an alternate test would be responsible for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40039.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determining that it is equivalent to the AOCS Official Method Ca 3a-46; it would not be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40063.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary for FDA to approve the use of an alternate test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:40096.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Tallow that contains more than 0.15 percent insoluble impurities could be used if it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40119.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">complies with the proposed requirements for cattle materials in proposed § 300.200 for drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40142.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans, proposed § 500.200 for drugs for ruminants, proposed § 600.16 for biological products,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40165.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed § 895.102 for medical devices for humans that are intended for use in or on the body,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40188.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and proposed § 1271.470 for HCT/Ps (e.g., made without the use of any prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40211.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:40244.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We note that, regardless of its purity level, tallow to be used in medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40268.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants would be subject to the other provisions of the act and would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40291.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulterated if, for example, it has been prepared, packed, or held under insanitary conditions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:40517.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:40547.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">51</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40577.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">whereby it may have become contaminated with filth (section 501(a)(2)(A) of the act)(21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40600.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">351</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:40600.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(2)(A)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:112.80pt;top:40623.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:127.55pt;top:40623.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed Requirements Regarding Extralabel Drug Use in Animals</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:40646.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In 1994, Congress enacted the Animal Medicinal Drug Use Clarification Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40670.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(AMDUCA)(Public Law 103-396).  This act authorizes the extralabel use of approved animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40693.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and human drugs in animals.  The act, as well as FDA regulations in part 530 (21 CFR part 530),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40716.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sets out certain conditions for extralabel use and authorizes FDA to prohibit the extralabel use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40739.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approved animal or human drugs in animals.  Because FDA, elsewhere in this proposed rule,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40762.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would prohibit the use of certain cattle materials in drugs for ruminants only, the agency is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40785.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">concerned that ruminants could still be exposed to prohibited cattle materials through the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40808.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extralabel use in ruminants of a drug that was approved for a nonruminant species.  Also, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40831.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency is concerned about the extralabel use in ruminants of a drug that was approved for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40855.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans to the extent an exception or alternative to these proposed requirements has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40878.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">granted.  Therefore, in order to prevent the intentional or unintentional use of a drug containing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40901.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials in ruminants, FDA is proposing to revise § 530.41 to prohibit in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40924.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants the extralabel use of drugs containing prohibited cattle material and approved for use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40947.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in other animals (nonruminants) or for humans (proposed § 530.41(c)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:40975.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA is also proposing to add new § 530.42 that would require labels for drugs prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:40998.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from extralabel use in ruminants and described under proposed § 530.41(c) to bear or be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41021.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accompanied by labeling information to communicate to the user that extralabel use in ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41044.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is prohibited. The proposed regulation would require label information to include the statement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41068.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">"Federal law prohibits the extralabel use of this product in ruminants."  AMDUCA and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41091.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">implementing regulation at § 530.11, however, prohibit the extralabel use of an approved new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:41309.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:41339.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">52</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41369.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal drug or human drug in or on animal feed. Since the extralabel use of all drugs in or on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41392.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal feed is excluded from the extralabel use provisions of AMDUCA, FDA believes it is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41415.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">unnecessary and potentially confusing to include the previous statement only on those feed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41438.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products that contain drugs described in proposed § 530.41(c).  Therefore, the labeling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41462.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirement under proposed § 530.42 would apply to all products that contain drugs described in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41485.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed § 530.41(c) except those products used in or on an animal feed.  FDA intends for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41508.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sponsors of approved products that would be subject to proposed § 530.42 to revise their labeling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41531.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by the effective date of the final rule based on this proposal.  If necessary, FDA also would have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41554.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the ability under proposed § 300.200(b)(2)(iii) to impose a labeling condition on a human drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41577.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regarding the extralabel use in ruminants of that human drug if an exception or alternative is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41600.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">granted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:169.95pt;top:41623.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">E.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:183.55pt;top:41623.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed Recordkeeping Requirements</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:41646.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We are proposing that applicants and manufacturers of medical products for humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41670.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drugs for ruminants that are manufactured from or otherwise contain material from cattle be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41693.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">required to establish and maintain records that demonstrate that the material from cattle meets</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41716.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the requirements of this proposed rule (proposed §§ 300.200(c)(1), 500.200(c)(1), 600.16(c)(1),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41739.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">895</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:41739.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.102</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:41739.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)(1) and 1271.470(c)(1)).  Because at this time there is no way to screen reliably for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41762.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">presence of the BSE agent or for the presence of prohibited cattle materials, applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41785.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of medical products for humans and drugs for ruminants must depend on records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41808.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from the suppliers of cattle material to demonstrate that their source material is free from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41831.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials. Similarly, without adequate records, FDA may not know whether</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41855.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicants and manufacturers of medical products for humans and drugs for ruminants have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:41878.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">complied with the prohibitions against use of prohibited cattle materials.  Therefore, under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:42101.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:42131.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">53</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42161.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed §§ 300.200(c)(1), 500.200(c)(1), 600.16(c)(1), 895.102(c)(1) and 1271.470(c)(1),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42184.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicants and manufacturers of medical products for humans and drugs for ruminants that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42207.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise contain material from cattle would be required to establish and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42230.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintain records sufficient to demonstrate that the medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42254.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants do not contain prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42277.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:42277.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Types of Records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:42300.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For example, to satisfy the requirement in proposed §§ 300.200(c)(1), 500.200(c)(1),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42323.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">600</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:42323.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.16(c)(1), 895.102(c)(1), and 1271.470(c)(1) that records show the absence of prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42346.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials, applicants and manufacturers of medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42369.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants that are manufactured from or otherwise contain brain from cattle would have to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42392.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establish and maintain records to demonstrate, among other things, that the cattle brain used is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42415.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not from cattle over 30 months of age.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:42439.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In general, we would expect that having the following types of records on FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42462.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans or drugs for ruminants containing cattle material would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42485.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sufficient to demonstrate that the product is not manufactured from and does not otherwise</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:42508.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain prohibited cattle materials:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:42531.00pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42532.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A signed and dated affirmation (with contact information) by a slaughter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42555.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishment that cattle material supplied by that establishment in a particular</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42578.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">shipment does not contain prohibited cattle materials.  If two or more lots of cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42601.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material from different slaughter establishments are pooled into a final product,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42624.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">then having records from each slaughter establishment should be sufficient.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.50pt;top:42647.40pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42648.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For products containing tallow, records from a slaughter establishment affirming</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42671.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that the tallow was produced from material containing no prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:42893.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:42923.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">54</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42953.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or records (i.e., signed, dated, with contact information) from the tallow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42976.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">supplier affirming that the tallow contains no more than 0.15 percent insoluble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:42999.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurities (e.g., a certificate of analyses).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:43022.50pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43023.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For products containing fetal calf materials, records from a slaughter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43046.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishment affirming that the fetal calf material was obtained: (1) From cows</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43069.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that were inspected and passed and (2) using procedures that ensure that the fetal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43093.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material was not contaminated with prohibited cattle materials during slaughter or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43116.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">processing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:43139.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Consistent with CGMP recordkeeping requirements, applicants and manufacturers who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43162.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintain documentation of compliance should maintain that information on a lot-by-lot basis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43185.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The lot-by-lot records would ensure that each time a shipment of cattle material is sent or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43208.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">received, there is documentation that a management official confirmed that the shipment was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43231.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">free of any prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:43254.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We request comments on alternative recordkeeping requirements that would ensure the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43277.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements of the proposed rule would be met.  We also request comments on whether existing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43301.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping practices include the required information and, if not, what changes the proposal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43324.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would necessitate.  In addition, we request comment on whether the rule should specifically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43347.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">require certain types of records.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:43370.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:43370.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed Periods for Records Retention</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:43393.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:101.60pt;top:43393.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">e following record retention time periods would be required by this proposal:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:43416.15pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43417.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For drugs for humans, we are proposing, consistent with our CGMP regulations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43440.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for these products (§ 211.180), to require that records be retained for at least 1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43463.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">year after the expiration date of the drug (proposed § 300.200(c)(2)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:43685.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:43715.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">55</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:43745.15pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43746.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For drugs for humans lacking an expiration date, we are proposing, consistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43769.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with our CGMP regulations for these products (§ 211.180), to require that records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43792.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be retained for at least 3 years after distribution of the last lot of the drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43815.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(proposed § 300.200(c)(2)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:43838.30pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43839.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For drugs for ruminants other than Type A medicated articles, we are proposing,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43862.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">consistent with our CGMP regulations for these products (§ 211.180), to require</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43885.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that records be retained for at least 1 year after the expiration date of the product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43908.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(proposed § 500.200(c)(2)(ii)).  Because all new animal drugs are required to have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43932.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">an expiration date, only the proposed 1-year records retention period would apply</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43955.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to all drugs for ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:43977.75pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:43978.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For Type A medicated articles intended for use in ruminants, records would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44002.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">retained, consistent with our CGMP regulations for these products (§ 226.110),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44025.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for at least 2 years after distribution by the manufacturer (proposed §</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44048.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:44048.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:153.20pt;top:44048.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)(2)(i)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:44070.95pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44072.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For human biological products, we reference 21 CFR 600.12(b) for consistency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44095.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with established recordkeeping periods.  Records would be retained for no less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44118.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">than 5 years after the records of manufacture have been completed or 6 months</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44141.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">after the latest expiration date for the individual product, whichever represents a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44164.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">later date (proposed § 600.16(c)(2)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:44187.25pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44188.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For medical devices that are intended for use in or on the body, we reference 21</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44211.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 820.180(b) for consistency with established recordkeeping periods.  Records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44234.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would be retained for a period of time equivalent to the design and expected life</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:44477.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:44507.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">56</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44537.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the device, but in no case less than 2 years from the date of release for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44560.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">commercial distribution by the manufacturer (proposed § 895.102(c)(2)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:105.55pt;top:44583.35pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44584.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For HCT/Ps, we reference § 1271.270(d) for consistency with established</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44607.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping periods.  Records would be retained for 10 years after their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:44630.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">creation unless otherwise stated in part 1271 (proposed § 1271.470(c)(2)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:44653.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As discussed previously, records documenting the absence of prohibited cattle materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44677.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in medical products for humans and drugs for ruminants are needed to help applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44700.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers ensure that they meet the proposed requirements of this rulemaking and to help</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44723.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA monitor compliance.  It is important for recall purposes that records be retained for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44746.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">likely period of time during which the product might be used, so that FDA can assess compliance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44769.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the requirements for cause or otherwise.  The proposed timeframes for retaining records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44792.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reflect the likely period of time during which medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44815.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants covered by this proposed rule might be used.  The proposed timeframes for retaining</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44838.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records are consistent with the relevant CGMP requirements in current rules.  Because of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44861.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lengthy incubation period of BSE (see section II.C of this document), we are requesting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44885.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comment on whether records should be required for a longer period of time than proposed in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44908.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rulemaking.  This may assist with traceback and may assist applicants and manufacturers in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44931.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proving that their products are not the source of BSE infection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:44954.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In the Foods Recordkeeping/Access proposed rule, we proposed that records for FDA-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:44977.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulated human food and cosmetics be retained for 2 years after the date the records were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45000.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">created (69 FR 42256 at 42277).  FDA proposed this timeframe for these products so that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45023.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records would be available during the entire shelf life of the products covered by that rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:45269.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:45299.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">57</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45329.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.35pt;top:45329.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:45329.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Location of Records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:45352.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We are proposing that records be maintained at the applicant’s or manufacturer’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45375.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishment or at a reasonably accessible location.  Records would be considered to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45398.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasonably accessible if they are accessible from an onsite location (proposed §§ 300.200(c)(3),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45422.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:45422.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.95pt;top:45422.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)(3), 600.16(c)(3), 895.102(c)(3) and 1271.470(c)(3)). Electronic recordkeeping</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45445.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements for all types of FDA required recordkeeping are addressed under part 11 (21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45468.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">part 11).  These requirements would pertain to any records that would be required by this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45491.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:45514.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed §§ 300.200(c)(4), 500.200(c)(4), 600.16(c)(4), 895.102(c)(4) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45537.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:45537.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:45537.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0(c)(4) provide that records required by this subpart must be readily available to FDA for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45560.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspection and copying.  All the records would be required to be in English.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:45583.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Because of inherent difficulties in accessing records maintained at foreign</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45607.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishments, we are proposing requirements for importers of record of medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45630.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants (proposed §§ 300.200(c)(5), 500.200(c)(5), 600.16(c)(5),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45653.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">895</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:45653.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.102</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:45653.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)(5) and 1271.470(c)(5)).  When filing entry with the U.S. Customs and Border</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45676.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Protection, importers of record of a product manufactured from or otherwise containing cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45699.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material would be required to affirm that the product for import was manufactured from or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45722.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains cattle material and affirm that the product was manufactured in accordance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45745.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with proposed §§ 300.200(b), 500.200(b), 600.16(b), 895.102(b) and 1271.470(b), as applicable.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45768.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">If the product was manufactured from or otherwise contains cattle material, then the importer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45791.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record would be required, if requested, to provide to FDA within 5 days records that would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:45815.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sufficient to demonstrate that the product was not manufactured from and does not contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:46061.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:46091.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">58</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46121.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle material.  FDA expects that the content of these records would be the same as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46144.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that described as being sufficient for domestic products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:46167.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA believes 5 days is a reasonable amount of time for the importer of record to respond</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46190.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">while still allowing FDA sufficient time to review the documents to make an initial admissibility</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46214.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">decision before the conditional release period for the product expires.  If the importer of record</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46237.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">fails to provide FDA with the records within 5 days, the product would be subject to detention</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46260.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">because it would appear to be adulterated, and the owner or consignee would be afforded notice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46283.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and an opportunity for hearing in accordance with section 801(a) of the act (21 U.S.C. 381).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:215.00pt;top:46306.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">VI.  Legal Authority</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:46329.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has the authority to take the actions proposed in this rule under various statutory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46352.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provisions.  These provisions include sections 201, 301, 501, 502, 505, 512, 516, 519, 701, 704,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46375.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and 801(a) of the act (21 U.S.C. 321, 331, 351, 352, 355, 360b, 360f, 360i, 371, 374, and 381(a))</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46399.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and sections 351, 361, and 368 of the PHS Act (42 U.S.C. 262, 264, and 271).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:46422.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">With respect to drugs for humans, including drugs that are biological products, FDA is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46445.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposing these regulations under the adulteration provision in section 501(a)(2)(B) of the act,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46468.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and under sections 201, 505, 701(a) and (b), 704, and 801(a) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:46491.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under section 501(a)(2)(B) of the act, FDA has the authority to impose requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46514.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary to ensure that drugs meet the requirements of the act with respect to identity, strength,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:46537.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">quality, and purity.  Under section 501(a)(2)(B) of the act, a drug is adulterated if:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46560.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the methods used in, or the facilities and controls used for, its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46583.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacture, processing, packing, or holding do not conform to or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46607.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">are not operated or administered in conformity with current good</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46630.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturing practice to assure that such drug meets the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:46853.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:46883.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">59</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46913.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements of this Act as to safety and has the identity and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46936.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">strength, and meets the quality and purity characteristics, which it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:46959.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">purports or is represented to possess.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:46982.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA is proposing to amend its CGMP regulations (proposed § 211.116) to prohibit the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47006.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use of certain cattle materials in human drug products and components, including biological</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47029.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products, as provided by proposed §§ 300.200 and 600.16.  Proposed §§ 300.200 and 600.16</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47052.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would require that no drug or biological product "be manufactured from or otherwise contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47075.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials" unless FDA has granted a request for an exception or alternative to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47098.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the requirements.  Proposed § 211.116 would apply to drugs, including biological products, that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47121.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">are directly subject to the CGMP regulations.  For drugs not directly subject to the CGMP</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47144.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulations, such as active pharmaceutical ingredients and source materials, section 501(a)(2)(B)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47167.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the act supports the proposed requirements in §§ 300.200 and 600.16.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:47191.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As provided in proposed §§ 300.200(d) and 600.16(d), a drug or biological product that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47214.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">fails to comply with the requirements of §§ 300.200(b) and 600.16(b), respectively, would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47237.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulterated under section 501(a)(2)(B) of the act.  Because of the possibility of disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47260.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">transmission to humans from exposure to prohibited cattle materials, prohibiting such cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47283.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials in drugs and biological products will help ensure that they meet the requirements of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47306.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">act with respect to safety and have the identity, and meet the quality and purity characteristics</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47329.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">they are purported or represented to possess.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:47352.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 201(p) of the act defines a new drug to include "[a]ny drug *** the composition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47375.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of which is such that such drug is not generally recognized, among experts qualified by scientific</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47399.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47422.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use under the conditions prescribed, recommended, or suggested in the labeling thereof ***."</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:47645.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:47675.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">60</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47705.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Based on the scientific data and information available to FDA regarding the possibility of disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47728.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">transmission to humans from exposure to prohibited cattle materials, under this proposed rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47751.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">any human drug manufactured from, or otherwise containing, prohibited cattle materials is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47774.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">generally recognized as safe and effective (GRAS/GRAE), and therefore is a new drug under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47798.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section 201(p) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:47821.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 505(a) of the act requires that "[n]o person shall introduce or deliver for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47844.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">introduction into interstate commerce any new drug, unless an approval of an application filed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47867.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">pursuant to subsection (b) or (j) [of section 505] is effective with respect to such drug."  Under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47890.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section 505 of the act, new drug applications must demonstrate that a drug is safe and effective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47913.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for its intended use(s).  Because of the possibility of disease transmission to humans from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47936.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exposure to prohibited cattle materials, prohibiting such cattle materials in drugs will help ensure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47959.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that drugs are safe for their intended use(s).  Based on the scientific data and information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:47983.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">available to FDA regarding the possibility of disease transmission to humans from exposure to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48006.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials, under this proposed rule FDA would not approve an application or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48029.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">supplement for a drug containing prohibited cattle materials unless an exception or alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48052.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">has been granted based upon the Center Director’s determination that the safety standard in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48075.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section 505 of the act would still be met. In addition, under the proposed rule, a drug containing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48098.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials that is already subject to an approval would no longer be shown to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48121.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">safe based on the presence of prohibited cattle materials, and would be in violation of section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48144.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">505</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.85pt;top:48144.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the act unless an exception or alternative for use of the prohibited cattle materials has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48167.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">been granted.  Section 505 of the act also allows FDA to impose additional conditions on an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48191.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">application product on a case-by-case basis, should such conditions be necessary to ensure that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48214.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product meets the standard for approval set forth in section 505 of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:48437.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:48467.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">61</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:48497.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under section 701(a) of the act, FDA is authorized to issue regulations for the act's</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48520.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">efficient enforcement.  The proposed regulations would require measures to ensure that drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48543.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans, including biologics, are being manufactured, processed, packed, or held in conformity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with CGMP, and to ensure that new drugs comply with section 505 of the act, which would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48590.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">allow for efficient enforcement of the act.  Under the proposed regulations, applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48613.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of drugs for humans that are manufactured from or otherwise contain material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48636.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from cattle also would be required to establish and maintain records that document the absence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48659.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of prohibited cattle materials in such products and have such records readily available to FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48682.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for inspection and copying. These proposed recordkeeping requirements are also authorized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48705.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under sections 501(a)(2)(B) and 505(k) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:48728.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Once material is removed from cattle, we may not be able to obtain the information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48751.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary to determine whether it is prohibited cattle material.  For example, we would not know</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48775.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from examination of a spinal cord whether the source animal was 30 months of age or over at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48798.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time of slaughter, or whether it was inspected and passed.  Because at this time there is no way to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48821.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">test reliably for the presence of the BSE agent or the presence of the cattle materials prohibited in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48844.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed § 300.200, applicants and manufacturers of drugs for humans would have to depend on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48867.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records from their suppliers of cattle materials to ensure that their source material does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48890.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain any cattle materials prohibited under proposed § 300.200.  Without adequate records,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48913.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA cannot know whether applicants and manufacturers of drugs for humans have complied</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48936.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the prohibitions against certain cattle materials under proposed § 300.200.  Therefore, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48959.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed recordkeeping requirements are necessary for the efficient enforcement of these rules</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:48983.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and authorized under section 701(a) of the act.  Under proposed § 300.200(e) and 600.16(e), the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:49229.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:49259.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">62</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49289.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">failure of an applicant or manufacturer to comply with the requirements of §§ 300.200(c) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49312.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">600</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:49312.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.16(c), respectively, would render a drug or biological product adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:49335.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We are also proposing provisions relating to records regarding imported drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49358.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans under sections 801(a) and 701(b) of the act.  Importers of record of such a drug product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49382.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise containing cattle material would be required to affirm that such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49405.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">a drug product for import was manufactured from or contains cattle material, and affirm that it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49428.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">was manufactured in compliance with the proposed rule.  If such a drug was manufactured from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49451.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or otherwise contains cattle material, then importers of record would also be required, if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49474.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requested, to provide records to FDA within 5 days sufficient to demonstrate compliance.  Under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49497.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed §§ 300.200(f) and 600.16(f), failure of an importer of record to comply with those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49520.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements causes a drug for humans to appear to be adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:49543.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 801(a) of the act provides requirements with regard to imported drugs and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49567.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provides for refusal of admission into the United States of drugs for humans that appear to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49590.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulterated.  Section 701(b) of the act authorizes the Secretaries of Treasury</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:366.55pt;top:49588.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.40pt;top:49590.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and Health and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49613.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49636.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:49659.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Because most biological products, including blood, are also drugs, the sections of the act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49682.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">discussed previously provide legal authority for issuing a regulation limiting the use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49705.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials in such biological products. There is, however, additional legal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49728.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">authority for the proposed rule's requirements with respect to biological products generally.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49751.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 351(a)(2)(A) of the PHS Act (42 U.S.C. 262(a)(2)(A)) requires that FDA "establish, by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:49781pt;width:120pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49785.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.88pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.80pt;top:49786.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">Under the Homeland Security Act of 2002 (Public Law 107-296), the Secretary of the Treasury has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49797.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">delegated all relevant Customs revenue authorities to the Secretary of Homeland Security, who has, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49807.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">turn, delegated them to the Commissioner of Customs and Border Protection (CBP or Customs).  If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:49818.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">finalized, we will issue this rule jointly with the Department of Homeland Security.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:50021.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:50051.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">63</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50081.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulation, requirements for the approval, suspension, and revocation of biologics licenses.”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50104.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Approval of a biologics license application (BLA) must be based on a demonstration that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50127.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">biological product is “safe, pure, and potent” (section 351(a)(2)(C)(i)(I) of the PHS Act).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50150.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Limiting the use of prohibited cattle materials in biological products is designed to ensure the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50174.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">safety, purity, and potency of such licensed biological products.  Based on the scientific data and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50197.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information available to FDA regarding the possibility of disease transmission to humans from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50220.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exposure to prohibited cattle materials, under the proposed rule FDA would not approve a BLA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50243.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or supplement for a biological product containing prohibited cattle materials unless an exception</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50266.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or alternative has been granted based upon the Center Director's determination that the safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50289.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standard in section 351(a)(2)(C) of the PHS Act would still be met. In addition, under the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50312.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule, a biological product containing prohibited cattle materials that is already licensed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50335.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would no longer be demonstrated to be safe based on the presence of prohibited cattle materials,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50359.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and would be in violation of section 351(a)(1) of the PHS Act and section 505 of the act, unless</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50382.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">an exception or alternative for use of the prohibited cattle materials has been granted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50405.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Accordingly, FDA is proposing to amend its biological product regulations to prohibit the use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50428.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">certain cattle materials in biological products as provided by proposed § 600.16.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:50451.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">With respect to devices, FDA is proposing to issue these regulations under the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50474.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulteration provision in section 501(g) of the act, under the misbranding provision in section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50497.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">502</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:50497.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(t)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:87.35pt;top:50497.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the act, and under sections 516, 519(a), 701(a) and (b), and 801 of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:50520.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under section 516 of the act, FDA may issue a regulation making a device a banned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50543.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">device if the agency determines, on the basis of all available data and information, that a device</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50567.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">presents an unreasonable and substantial risk of illness or injury that can not be corrected or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50590.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">eliminated by labeling.  A banned device is deemed adulterated under section 501(g) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:50619pt;width:392pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;left:71.76pt;top:50813.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:50843.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">64</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50873.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">There are several routes through which devices intended for use in or on the body have the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50896.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">potential to introduce the BSE agent into humans if the devices contain prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50919.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials.  It is well documented that central nervous system tissue, including the optic nerve,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50942.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carries infectivity in animals with TSEs and humans with vCJD.  Infectivity has also been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50966.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">transmitted to animals via mucosal tissue.  Finally, although transmission through intact skin is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:50989.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not likely, the BSE agent has the potential to be introduced into the body through cut or abraded</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51012.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">skin.  FDA has concluded, therefore, that devices intended for use in or on the body that contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51035.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials have the potential to expose recipients of those devices if the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51058.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">originating cattle had BSE.   Although the over all risk of exposure is low given the low rate of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51081.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE in U.S. cattle, this risk is deemed unacceptable given the fatal nature of vCJD.  The agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51104.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is not aware of any device that can be manufactured only with prohibited cattle materials; thus,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51127.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">there should be no benefit to the public health from the continued marketing of devices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51151.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">containing these materials. FDA has determined, therefore, that devices intended for use in or on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51174.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the body that contain prohibited cattle materials present an unreasonable risk to health in relation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51197.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to the benefit to the public health from their continued marketing.  Moreover, because there is no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51220.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">safe way to use these devices, the risk of disease cannot be corrected or eliminated by labeling.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:51243.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">It is clear, based on all available data and information, that the risk of BSE exposure may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51266.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be significantly reduced by banning devices intended for use in or on the body that contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51289.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials. The agency is proposing to ban such devices, therefore, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51312.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with section 516 of the act.  Devices already in commercial distribution or already</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51335.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sold to the ultimate user are not subject to this ban because FDA is not aware of any currently</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51359.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">marketed device that contains prohibited cattle materials. Manufacturers currently are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51382.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">required to maintain records that contain information about bovine materials that would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:51605.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:51635.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">65</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51665.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">needed to identify devices that might contain such materials. In accordance with section 516 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51688.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the act and 21 CFR part 895, interested persons may request an informal hearing on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51711.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provisions of the proposed regulation with respect to medical devices within 30 days.  If a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51734.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request for an informal hearing is granted, the hearing will be conducted as a regulatory hearing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51758.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under 21 CFR part 16.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:51781.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The proposed recordkeeping requirements for devices in this proposed rule are authorized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51804.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under section 519(a) of the act.  Under section 519(a), the agency may, by regulation, require</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51827.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that manufacturers and importers establish and maintain records, make reports, and provide</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51850.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information that the agency determines is necessary to ensure that devices are not adulterated or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51873.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">misbranded and to otherwise ensure their safety and effectiveness.  FDA has determined that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51896.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping requirements in this proposed rule are necessary to ensure that devices intended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51919.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for use in or on the body do not contain prohibited cattle materials and, thus, are not adulterated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51943.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under section 501(g) of the act.  A device for which there is a failure or refusal to furnish any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51966.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material or information required under this proposed regulation would be deemed misbranded</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:51989.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under section 502(t) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:52012.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The proposed recordkeeping requirements are also authorized under sections 701(a) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52035.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b) and 801(a) of the act. Because at this time there is no way to screen reliably for the presence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52058.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the BSE agent or the presence of the cattle materials prohibited under this proposed rule,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52081.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicants and manufacturers of medical devices would have to depend on records from their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52104.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">suppliers of cattle materials to ensure that their source material does not contain any prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52127.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials. The proposed requirements also would allow the agency to monitor compliance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52151.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the proposed ban and, therefore, are necessary for the efficient enforcement of the act, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52174.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with section 701(a) of the act.  Section 801(a) of the act contains requirements with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:52397.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:52427.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">66</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52457.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regard to imported devices and provides for refusal of admission into the United States of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52480.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">devices that appear to be adulterated or misbranded. Section 701(b) of the act authorizes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52503.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Secretaries of the Treasury and Health and Human Services to jointly prescribe regulations for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52526.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the efficient enforcement of section 801 of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:52550.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">With respect to new animal drugs, FDA is proposing to issue these regulations under the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52573.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulteration provision in section 501(a)(2)(B) of the act and sections 512, 701(a) and (b) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52596.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">801</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:52596.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a) of the act.  The adulteration provision in section 501(a)(2)(B) of the act provides FDA the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52619.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">same authority for new animal drugs as described for drugs for humans previously in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52642.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:52665.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA is proposing to amend its CGMP regulations to prohibit the use of certain cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52688.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials in drug products and components intended for use in ruminant animals (proposed §</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52711.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">211</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:52711.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.116</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:52711.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:96.35pt;top:52711.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.80pt;top:52711.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Proposed § 500.200 would require that no drug product or component intended for use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52735.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in ruminants "be manufactured from or otherwise contain prohibited cattle materials."  Proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52758.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 211.116 would apply to drugs that are directly subject to the CGMP regulations.  For drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52781.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants that are not directly subject to the CGMP regulations, section 501(a)(2)(B) of the act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52804.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">supports the proposed requirements in proposed § 500.200.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:52827.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As provided in proposed § 500.200(d), a drug that fails to comply with the requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52850.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of § 500.200(b) would be adulterated under section 501(a)(2)(B) of the act.  Because of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52873.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">possibility of disease transmission to ruminants from exposure to prohibited cattle materials and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52896.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to humans from consuming food from animals exposed to prohibited cattle material, prohibiting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52919.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">such cattle materials in drugs for ruminants would help ensure that new animal drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52943.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants meet the requirements of the act with respect to safety, and have the identity, and meet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:52966.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the quality and purity characteristics they are purported or represented to possess.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:53189.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:53219.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">67</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:53249.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 201(v) of the act defines a new animal drug to include "[a]ny drug intended for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53272.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use for animals other than man *** the composition of which is such that such drug is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53295.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">generally recognized, among experts qualified by scientific training and experience to evaluate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53318.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the safety and effectiveness of animal drugs, as safe and effective for use under the conditions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53342.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prescribed, recommended, or suggested in the labeling thereof ***." Based on the scientific data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53365.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and information available to FDA regarding the possibility of disease transmission to ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53388.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from exposure to prohibited cattle materials, under this proposed rule any drug for ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53411.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise containing prohibited cattle materials is not GRAS/GRAE, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53434.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">therefore is a new animal drug under section 201(v) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:53457.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 512 of the act provides that a new animal drug is unsafe for purposes of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53480.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulteration provisions in section 501(a)(5) and section 402(a)(2)(C)(ii) of the act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53503.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">342</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:53503.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(2)(c)(ii)) unless there is an approval of that new animal drug application in effect.  For a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53527.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">new animal drug application to be approved, the drug must be safe and effective for its intended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53550.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use(s).  Based on the scientific data and information available to FDA regarding the possibility of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53573.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">disease transmission to humans from exposure to prohibited cattle materials, under the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53596.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule FDA would not approve an application or supplement for a drug for ruminants containing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53619.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials unless an exception or alternative has been granted based upon the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53642.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Center Director’s determination that the safety standard in section 512 of the act would still be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53665.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">met.  In addition, under the proposed rule, a drug for ruminants containing prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53688.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials that is already subject to an approval would no longer be shown to be safe based on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53711.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">presence of prohibited cattle materials, and would be in violation of section 512 of the act unless</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:53735.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">an exception or alternative for use of the prohibited cattle materials has been granted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:53981.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:54011.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">68</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:54041.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under section 512(a)(4) and section (a)(5) of the act, extralabel use of an approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54064.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal drug or human drug in animals is authorized if done under certain conditions set out in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54087.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA regulations. However, section 512(a)(4)(A) of the act also allows FDA to prohibit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54110.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">particular extralabel uses of an approved new animal drug.  Thus, for example, a drug approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54134.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for use in treating an animal of a nonruminant species could legally be used extralabelly to treat a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54157.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminant animal, if it meets required conditions, unless specifically prohibited.  Such drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54180.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nonruminant animals are allowed to contain cattle materials prohibited from use in drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54203.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants.  Absent a special prohibition, these drugs also could be used in ruminants, through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54226.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extralabel use, thereby providing an avenue through which ruminants could be exposed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54249.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle material.  Any human drug for which an exception or alternative is granted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54272.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">could also be used extralabelly in ruminants, which could also provide another avenue through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54295.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">which ruminants could be exposed to prohibited cattle materials.  Therefore, under section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54319.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">512</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:54319.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(4)(A) of the act (for drugs for animals) and section 512(a)(5) of the act (for drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54342.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans), FDA is proposing to prohibit such extralabel use in ruminants of drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54365.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nonruminants or for humans containing the prohibited material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:54388.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA is issuing the proposed labeling requirement under sections 502(a) and 201(n) of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54411.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">act (21 U.S.C. 352(a) and 321(n)).  Section 502(a) provides that a drug is deemed misbranded if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54434.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its labeling is false or misleading in any particular.  Section 201(n) provides that “*** in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54457.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">determining whether the labeling *** is misleading, there shall be taken into account (among</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54480.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">other things) not only representations made or suggested by statement, word, design, device, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54503.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">any combination thereof, but also the extent to which the labeling *** fails to reveal facts</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54527.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material in the light of such representations or material with respect to consequences which may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54550.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">result from the use of the article to which the labeling *** relates under the conditions of use ***</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:54773.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:54803.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">69</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54833.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">as are customary or usual."  The proposed rule would require drugs for non-ruminants that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54856.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain prohibited materials that are prohibited from extralabel use in ruminants to be labeled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54879.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">"Federal law prohibits the extralabel use of this product in ruminants."  We believe this statement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54902.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is material with respect to the consequences that may result from the extralabel use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54926.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nonruminant drugs with prohibited materials in ruminants.  As discussed in other sections of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54949.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">preamble, the use of materials prohibited in drugs for ruminants presents a risk of BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54972.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Therefore, under this proposed rule, the failure to include the labeling statement on drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:54995.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">nonruminants which contain prohibited materials would render the drugs misbranded under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55018.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section 502(a) of the act. Under section 701(a) of the act, FDA is authorized to issue regulations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55041.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for the act's efficient enforcement.  Regulations that propose measures to ensure that drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55064.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animals are being manufactured, processed, packed, or held in conformity with CGMP, and to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55087.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensure that they comply with section 512 of the act, allow for efficient enforcement of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55111.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">These proposed regulations would require applicants and manufacturers of drugs for ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55134.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that are manufactured from or otherwise contain material from cattle to establish and maintain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55157.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records that document the absence of prohibited cattle materials in such products and make such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55180.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records readily available to FDA for inspection and copying. These proposed recordkeeping</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55203.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements are also authorized under sections 501(a)(2)(B) and 512(l) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:55226.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Once material is removed from cattle, we may not be able to obtain the information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55249.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary to determine whether it is prohibited cattle material.  As noted previously, we would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not know from examination of a spinal cord whether the source animal was over 30 months of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55295.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">age at the time of slaughter or whether it was inspected and passed.  Because at this time there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55319.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">no way to test reliably for the presence of the BSE agent or the presence of the cattle materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55342.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited in proposed § 500.200, applicants and manufacturers of drugs for ruminants must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:55565.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:55595.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">70</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55625.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">depend on records from their suppliers of cattle materials to ensure that their source material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55648.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">does not contain any cattle materials prohibited under proposed § 500.200.  Therefore, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55671.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed recordkeeping requirements are necessary for the efficient enforcement of the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55694.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule.  Under proposed § 500.200(e), the failure of an applicant or manufacturer to comply with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55718.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the requirements of § 500.200(c) would render a drug for ruminants adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:55741.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We are also proposing provisions relating to records regarding imported drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55764.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants under sections 801(a) and 701(b) of the act.  Importers of record of a drug for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55787.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants that was manufactured from or otherwise contains cattle material would be required to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55810.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">affirm that the drug product for import was manufactured from or contains cattle material, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55833.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">affirm that it was manufactured in compliance with the proposed rule.  If a drug was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55856.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise contains cattle material, then importers of record would also be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55879.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">required, if requested, to provide records to FDA within 5 days sufficient to demonstrate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55903.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compliance.  Under proposed § 500.200(f), failure of an importer of record to comply with these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55926.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements causes a drug to appear to be adulterated. Section 801(a) of the act provides</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55949.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements with regard to imported drugs and provides for refusal of admission into the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55972.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">States of drugs for ruminants that appear to be adulterated. Section 701(b) of the act authorizes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:55995.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Secretaries of Treasury</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.70pt;top:55993.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:174.60pt;top:55995.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and Health and Human Services to jointly prescribe regulations for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56018.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the efficient enforcement of section 801 of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:56041.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has invoked section 361 of the PHS Act (42 U.S.C. 264) to prevent the transmission</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56064.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of numerous communicable diseases, including diseases spread through certain shellfish, turtles,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56087.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">birds, and human tissue intended for transplantation (see 21 CFR 1240.60 (molluscan shellfish),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:56117pt;width:120pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56121.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.88pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.80pt;top:56122.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">Under the Homeland Security Act of 2002 (Public Law 107-296), the Secretary of the Treasury has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56133.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">delegated all relevant Customs revenue authorities to the Secretary of Homeland Security, who has, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56143.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">turn, delegated them to the Commissioner of Customs and Border Protection (CBP or Customs).  If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56154.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">finalized, we will issue this rule jointly with the Department of Homeland Security.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:56357.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:56387.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">71</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56417.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">124</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:56417.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0.62</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.40pt;top:56417.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(turtles), 1240.65 (parrots and other psittacine birds), and parts 1270 and 1271 (human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56440.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tissue)).  Recently, FDA also issued under section 361 of the PHS Act regulations designed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56463.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent the spread of monkeypox from African rodents to humans (21 CFR 1240.63).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:56486.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 361 of the PHS Act provides legal authority for FDA to limit the use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56510.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials in drugs, biological products, devices, new animal drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56533.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants, and HCT/Ps and to inspect and copy pertinent manufacturing records to ensure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56556.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compliance.  Section 361(a) of the PHS Act authorizes issuance and enforcement of regulations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56579.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary to prevent the introduction, transmission, or spread of communicable diseases from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56602.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">foreign countries or between states.   Section 361(a) of the PHS Act also provides for such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56625.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspection and destruction of articles found to be so infected or contaminated as to be "sources of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56648.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">dangerous infection to human beings," as well as other measures that may be necessary to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56671.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent the introduction, transmission, or spread of communicable diseases from a foreign</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56695.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">country into a State, or from one State to another State.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:56718.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Because the use of prohibited cattle materials in medical products for humans and drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56741.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for ruminants increases the risk that the agent that causes BSE could be transmitted to humans,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56764.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">limiting the use of prohibited cattle materials in medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56787.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants is a needed component of our efforts to prevent the transmission and spread of TSEs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56810.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">including vCJD, in humans.  Scientists have concluded that exposure to the BSE agent is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56833.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">most plausible explanation for the occurrence of vCJD (Refs. 24 through 27).  For medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56856.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans, by prohibiting use of certain cattle materials, the proposed rule would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56879.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reduce the risk that the BSE agent would be transmitted directly into any person through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56903.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exposure to an infectious medical product.  For drugs for ruminants, by prohibiting use of certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:56926.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials, the proposed rule would reduce the risk that the BSE agent would be transmitted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:56955pt;width:392pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;left:71.76pt;top:57149.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:57179.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">72</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57209.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">directly into any ruminant.  By protecting ruminants from exposure to the BSE agent through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57232.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal drugs, the proposed rule would also prevent transmission of the BSE agent to humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57255.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">who may be exposed to products containing any ruminant materials.  Consistent with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57278.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">authority granted by section 361 of the PHS Act to issue and enforce such regulations as are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57302.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary to prevent communicable disease transmission from foreign countries into the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57325.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">States and from one State or possession into another, this proposed rule would provide for FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57348.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to be able to inspect and copy pertinent manufacturing records.  Because at this time there is no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57371.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">way to screen reliably for the presence of the BSE agent or the presence of the cattle materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57394.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited under this proposed rule, the requirements with respect to the maintenance,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57417.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspection, and copying of manufacturing records are directly necessary to permit FDA to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57440.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">enforce the other measures designed to prevent transmission of BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:57463.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The proposed rule contains a procedure under which FDA could permit a manufacturer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57487.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">an exception or alternative to the restrictions on the use of prohibited cattle materials under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57510.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">limited circumstances.  Specifically, a manufacturer would submit a written request for an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57533.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exception or alternative to the requirements by describing: (1) Why an exception or alternative is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57556.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">needed; (2) the implicated product, including the type of prohibited cattle material, its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57579.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturing and purification processes, and its route of administration; (3) the source of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57602.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle material including information on the location where the cattle was born, raised,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57625.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and slaughtered; and (4) any other information relevant to the likelihood of the cattle having</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57648.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ingested material prohibited under § 589.2000.  For medical products for humans, the written</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57671.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request also would include:  (1) How the limitations are not necessary based on the risks of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57695.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials in the product and the benefits of the product or (2) how such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:57718.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">restrictions are not necessary to ensure the safety of the product. For drugs for ruminants, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:57941.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:57971.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">73</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58001.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">written request would also include:  (1) How the requirement is not necessary:  (i) Based on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58024.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risks of the prohibited cattle materials in the product to the target animal and the benefits of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58047.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product to the target animal and (ii) to ensure a reasonable certainty of no harm to humans from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58070.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">any food derived from the target animal to which the product is administered, or (2) how the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58094.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirement is not necessary to ensure the safety of the product with respect to both the target</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58117.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal and any food derived from the target animal to which the product is administered. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58140.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">relevant Center Director could also grant written permission for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58163.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed requirements on his own initiative, based on these same criteria.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:58186.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As discussed previously, under this proposal, FDA expects that applicants or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58209.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers may submit a request for an exception or alternative when filing a new application</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58232.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or premarket notification for a product containing prohibited cattle materials, or if an existing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58255.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product contains prohibited cattle materials.  Although FDA believes it is unlikely that applicants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58279.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or manufacturers who currently are not using prohibited cattle materials in their products will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reformulate their products to include prohibited cattle materials, proposing to do so would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58325.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">require not only a request for an exception or alternative but also a supplement to the approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58348.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">application or a new premarket notification, consistent with existing regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:58371.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In considering whether an exception or alternative to requirements of this proposed rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58394.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would meet the criteria described previously and therefore be appropriate, FDA would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58417.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">required to ensure that the statutory safety standards would still be met if the exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58440.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative were permitted.  For drugs for humans, FDA intends to apply the safety standards set</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58463.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">forth in sections 501(a)(2)(B) and 505 of the act.  Specifically, FDA would only approve a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58487.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request for an exception or alternative to the proposed limitations on prohibited cattle material if,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58510.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">notwithstanding the exception or alternative: (1) The drug and the methods used in, or the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:58733.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:58763.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">74</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58793.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">facilities or controls used for, its manufacturing, processing, packing, or holding conform to or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58816.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">are operated or administered in conformity with CGMP to ensure that such drug meets the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58839.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements of the act as to safety and (2) the drug is safe for its intended use(s).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:58862.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For biological products, FDA intends to apply the safety standard provided in section 351</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58886.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the PHS Act.  Specifically, FDA would only approve a request for an exception or alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58909.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to the proposed limitations on prohibited cattle material if, notwithstanding the exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58932.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative:  (1) The biological product that is the subject of the application is safe and (2) the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58955.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">facility in which the biological product is manufactured, processed, packed, or held meets</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:58978.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standards designed to ensure that the biological product continues to be safe.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:59001.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For human cells, tissues, and cellular and tissue-based products and other products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59024.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulated under the authority of section 361 of the PHS Act, FDA would only approve a request</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59047.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for an exception or alternative to the proposed limitations on prohibited cattle material if such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59071.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">limitations are not necessary to prevent the introduction, transmission, or spread of TSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:59094.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For devices, FDA intends to apply the standard in section 516 of the act.  Specifically,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59117.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA would approve a request for an exception or alternative to the proposed ban on prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59140.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials only if, notwithstanding the exception or alternative, the device does not present</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59163.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">an unreasonable and substantial risk of illness or injury.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:59186.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For new animal drugs, FDA intends to apply the safety standards set forth in section 512</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59209.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and 501(a)(2)(B) of the act.  Specifically, FDA would approve a request for an exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59232.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative to the proposed limitations on prohibited cattle material only if, notwithstanding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59255.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exception or alternative: (1) The drug and the methods used in, or the facilities or controls used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59279.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for, its manufacturing, processing, packing, or holding conform to or are operated or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:59525.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:59555.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">75</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59585.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">administered in conformity with CGMP to ensure that such drug meets the requirements of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59608.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">act as to safety and (2) the drug is safe for its intended use(s).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:141.00pt;top:59631.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">VII. Effective Date and Opportunity for Public Comment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:59654.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We are proposing that any final rule based on this proposal be effective 30 days after its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59678.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">issuance in the Fed</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">eral Register</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:59701.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Requests for an informal hearing on the proposed ban related to medical devices must be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59724.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submitted by [insert d</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ate 30 days after date of publication in the FEDERAL REGISTER</FONT></u><FONT STYLE="font-size: 10.05pt">].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:59747.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA invites public comment on this proposed rule, including the proposed effective date</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59770.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for any final rule issued as a result of this proposal.  The comment period on this proposed rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59793.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">will be 60 days.  The agency will consider modifications to this proposed rule based on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59816.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comments made during the comment period.  Interested persons may submit to the Division of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59839.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Dockets Management (see ADDRESSES) written or electronic comments regarding this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59863.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule.  Submit a single copy of electronic comments or two paper copies of any mailed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59886.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comments, except that individuals may submit one paper copy.  Comments are to be identified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59909.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the docket number found in brackets in the heading of this document.  Received comments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59932.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:59955.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">through Friday.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:203.65pt;top:59978.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">VIII.  Analysis of Impacts</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:60001.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has examined the impacts of the proposed rule under Executive Order 12866, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60024.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60047.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Public Law 104-4).  Executive Order 12866 directs agencies to assess all costs and benefits of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60071.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">available regulatory alternatives and, when regulation is necessary, to select regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60094.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approaches that maximize net benefits (including potential economic, environmental, public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:60317.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:60347.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">76</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60377.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">health and safety, and other advantages; distributive impacts; and equity). The agency believes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60400.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that this proposed rule is not an economically significant regulatory action as defined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60423.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Executive Order.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:60446.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Regulatory Flexibility Act requires agencies to analyze regulatory options that would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60470.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">minimize any significant impact of a rule on small entities.  Because FDA has taken regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60493.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">action to reduce the risk of exposure to BSE in the United States and kept affected entities</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60516.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">informed on best practices, FDA believes the proposed rule would codify current practices of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60539.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">most affected entities and ensure regulatory consistency across FDA-regulated products.  Few</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60562.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">entities will need to reformulate with alternative ingredients, submit a request for exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60585.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative to the limitation on the use of prohibited cattle material, or cease marketing.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60608.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA believes most market adjustments have taken place and this rule will not have a significant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60631.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">economic impact on a substantial number of small entities.  A few manufacturers of certain drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60655.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited from extralabel use in ruminants would incur one-time costs to add a warning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60678.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">statement to the product labeling.  In addition, all manufacturers that use cattle material would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60701.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">incur minor annual incremental recordkeeping costs.  Over 10 years, the annualized costs of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60724.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule range from about $235,000 to $922,000 (at a 3 percent discount rate) and from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60747.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">about $235,000 to $923,000 (at a 7 percent discount rate).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:60775.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60798.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prepare a written statement, which includes an assessment of anticipated costs and benefits,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60821.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">before proposing “any rule that includes any Federal mandate that may result in the expenditure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60844.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by State, local, and tribal governments, in the aggregate, or by the private sector, of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60868.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">$100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:60891.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">after adjustment for inflation is $118 million, using the most current (2004) Implicit Price</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:61109.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:61139.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">77</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61169.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Deflator for the Gross Domestic Product.  FDA does not expect this rule to result in any 1-year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61192.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">expenditure that would meet or exceed this amount.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:193.10pt;top:61215.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A. Need for the Proposed Rule</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:61238.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The need for this rule stems from inadequate information.  Consumers, physicians,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61262.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">farmers, and veterinarians lack the information necessary to determine whether medical products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61285.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for humans or drugs for ruminants have the potential to contain materials contaminated with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61308.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agent that causes BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:61331.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Currently, no validated method exists for testing medical products for humans and drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61354.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for ruminants for the agent that causes BSE; therefore, we do not have a means of distinguishing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61377.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products that contain infectious material from products that do not.  For example, rendered</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61400.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material including brain and spinal cord may become an ingredient in medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61423.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans or drugs for ruminants even though its presence may not be indicated as such on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61447.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">label.  Furthermore, end users have no way to determine whether cattle material in these products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61470.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">was sourced from nonambulatory disabled cattle or from cattle that were not inspected and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61493.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">passed for human consumption.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:61516.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Based on what is known about the transmission of BSE, there is some risk of occurrence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61539.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of vCJD in humans or of BSE in ruminants from the use of certain cattle-derived materials in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61562.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans and drugs for ruminants, respectively.  While the results from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61585.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA's ongoing testing are reassuring, one cannot rule out the possible future discovery of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:158.50pt;top:61584.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:61585pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61608.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">other positive animals in the United States or in a country allowed to export cattle material to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61631.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United States, or of a future introduction of BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.90pt;top:61631.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">To provide consistent protection across the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61655.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">range of FDA-regulated products, it is necessary to put in place measures to reduce further the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:61685pt;width:120pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61689.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.88pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.60pt;top:61691.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">USDA began a BSE testing program for cattle on June 1, 2004, after discovery of a case of BSE in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61701.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">cow in Washington State on December 23, 2003.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:61575.55pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:61576.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">no surveillance program can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:61583.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">give absolute assurance of the absence of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:61591.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">BSE. In addition,</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:61109.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background77.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:61901.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:61931.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">78</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61961.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk of spread of BSE in cattle and the risk of vCJD in humans. This risk may be reduced by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:61984.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">restricting the use of high-risk cattle materials in the manufacture of drugs for ruminants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62007.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans, similar to existing restrictions for food and cosmetics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:62030.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As discussed in section IV of this document, for over a decade the FDA has taken various</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62054.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">actions to reduce the risk of exposure to BSE in agency-regulated medical products for humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62077.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and drugs for ruminants, including: (1) Providing information (through letters to manufacturers),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62100.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">import alerts, and guidances to industry related to bovine materials, (2) convening TSE advisory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62123.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">committee meetings to provide guidance on the sourcing of certain bovine products, including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62146.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">gelatin, (3) encouraging companies to be aware of and to document sourcing of bovine material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62169.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">through letters to manufacturers of drugs, biologics, and medical devices, and through the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62192.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product approval processes, and (4) recommending that manufacturers develop plans to ensure,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62215.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with a high degree of certainty, that bovine and ovine materials used in their products were not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62239.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from countries where BSE exists (“BSE countries” specified by USDA’s APHIS in 9 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62262.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">94.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:62262.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">18) or from sheep flocks (foreign or domestic) infected with scrapie.  Moreover,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62285.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers who also operate in Europe have taken steps to comply with European Union TSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62308.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulations and guidances.  The agency has also taken regulatory action to decrease the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62331.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">likelihood of human and ruminant exposure to BSE (e.g., FDA 1997 ruminant feed rule,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62354.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA/USDA Animal Feed ANPRM, FDA 2005 Animal Feed proposed rule, Foods IFR, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62377.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods Recordkeeping/Access proposed rule).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:62400.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The agency is proposing additional regulatory action with this rule for medical products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62423.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for humans and drugs for ruminants that contain certain cattle material.  Existing regulations do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62447.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not explicitly bar the use of prohibited cattle material for these products.  By requiring that no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62470.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical product for humans or drug for ruminants be manufactured from or otherwise contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:62693.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:62723.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">79</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62753.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials, this proposed rule adds another safeguard to minimize human and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62776.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminant exposure to cattle material that scientific studies have demonstrated could contain the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62799.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE agent.  This proposed rule is consistent with interim final rules issued by the USDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62822.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(USDA/FSIS IFR) and FDA (Foods IFR) that exclude certain cattle material from human food,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62846.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">including dietary supplements, and cosmetics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:193.30pt;top:62874.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">B. Scope of the Proposed Rule</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:62897.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Both the USDA/FSIS and Foods IFRs define SRMs as: (1) Brain, skull, eyes, trigeminal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62920.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse process</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62943.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62966.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle 30 months and older, and (2) the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:62989.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The USDA/FSIS IFR: (1) Declares SRMs, mechanically separated beef, and the carcasses and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63012.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">parts of nonambulatory disabled cattle to be inedible and unfit for human food, and prohibits</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63036.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">their use in human food and (2) requires that the entire small intestine of all cattle be removed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63059.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and disposed of as inedible if procedures that completely remove the distal ileum are not used.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63082.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The Foods IFR limits the use of prohibited cattle materials in FDA-regulated human food,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63105.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">including dietary supplements, and cosmetics.  Prohibited cattle material includes: (1) All</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63128.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials declared inedible by the USDA/FSIS IFR and (2) material from cattle not inspected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63151.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and passed for human consumption.  However, prohibited cattle materials do not include tallow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63174.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63197.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derived products, and milk and milk products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:63220.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposed rule would define SRMs consistent with both the USDA/FSIS and Foods</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63244.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">IFRs and would define prohibited cattle materials consistent with the Foods IFR. The proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63267.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule would also clarify for medical products for humans and drugs for ruminants that prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:63485.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:63515.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">80</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63545.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials do not include materials obtained from fetal calves of cows that were inspected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63568.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and passed, as long as the materials were obtained from suppliers who follow procedures</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63591.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adequate to prevent contamination with SRMs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:63614.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Current industry practices and full compliance with the USDA/FSIS and Foods IFRs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63638.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">serve as the baseline for this proposed rule.  As discussed in section IV of this document, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63661.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency has taken various actions over 10 years to reduce the risk of exposure to the agent that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63684.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">causes BSE in FDA-regulated products.  We believe that most affected manufacturers have taken</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63707.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">steps to address FDA's existing recommendations regarding the use of cattle material in FDA-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63730.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulated products.  Because medical products for humans and drugs for ruminants normally use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63753.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">edible cattle material, we assume that the prohibited materials are not widely used in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63776.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacture and processing of these FDA-regulated products.  By determining that medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63799.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans and drugs for ruminants manufactured from, or otherwise containing,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63823.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials violate the act and the PHS act, this proposed rule would clarify</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63846.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA’s ability to bar the use of prohibited cattle materials in medical products for humans and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63869.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drugs for ruminants that would be outside the scope of other BSE regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:194.40pt;top:63892.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">C.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:208.60pt;top:63892.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Costs of the Proposed Rule</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:63915.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We assume that the recent USDA/FSIS and Foods IFRs have already led to most market</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63938.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adjustments regarding prohibited cattle materials. The manufacturers of products currently using</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63961.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials from the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:63984.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the vertebrae of the tail, the transverse process of the thoracic and lumbar vertebrae, and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64007.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">wings of the sacrum), and dorsal root ganglia of cattle would presumably be able to continue to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64031.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use these ingredients, but exclusively from cattle younger than 30 months of age.  However, if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64054.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers use cattle tonsils, the distal ileum of small intestine of cattle, or mechanically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:64277.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:64307.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">81</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64337.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">separated beef in the manufacture of medical products for humans or drugs for ruminants, they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64360.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would need to reformulate with alternative ingredients, submit a request for exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64383.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative to the requirements of the proposed rule, or cease marketing the products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64406.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:64406.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Potential Market Adjustments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:64430.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">To the best of our knowledge, there are only a small number of manufacturers with drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64453.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that do not have FDA approval (such as homeopathic drugs) that may be using prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64476.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material.  We believe the recent USDA/FSIS and Foods IFRs may have led any existing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64499.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers to find substitutes for prohibited materials.  The agency requests information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64522.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">about the impact of the proposed rule on manufacturers or importers of record of drugs that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64545.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">marketed without an approved application for any reason.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64568.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:64568.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cost of Requests for Exceptions or Alternatives to the Limitation on the Use of Prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64591.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle Material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:64615.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We estimate that very few firms would submit requests for exceptions or alternatives to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64638.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the proposed rule's requirements.  We estimate that those that do would spend between 60 hours</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64661.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and 120 hours to prepare and submit requests for exceptions or alternatives to the limitation on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64684.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the use of prohibited cattle material.  With an average loaded wage of $41.50, including 33</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64707.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">percent for benefits ($31.16 x 1.33), each request would cost from $2,500 to $5,000 (source:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64730.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Bureau of Labor Statistics (BLS) National Compensation Survey:  Occupational Wages in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64753.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United States, July 2002, for executive, administrative, and managerial employees).  Under this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64776.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule, we estimate industry would submit three requests in the first year.  Depending on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64799.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the time needed to prepare and submit the request, first-year costs could range from $7,500 to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:64823.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">$15,000.  Moreover, as markets adjust further, we expect manufacturers would seek and obtain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:65069.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:65099.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">82</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65129.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternatives to prohibited cattle material, eliminating the need for future requests for exceptions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65152.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or alternatives to the requirements of the proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65175.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:65175.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cost of Substitutes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:65198.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Since the USDA/FSIS and Foods IFRs bar prohibited cattle material from edible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65222.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rendering (i.e., processing of edible cattle waste material into marketable products such as gelatin</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65245.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or tallow), manufacturers of FDA-regulated human medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65268.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants using rendered material could continue to use edible rendered products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:65291.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Some companies may need to find substitutes for other prohibited cattle material used in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65314.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the manufacture of medical products for humans or drugs for ruminants.  Agency records suggest</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65337.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that, because adequate substitutes exist, it is unlikely that the proposed rule would adversely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65360.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">affect markets.  Nevertheless, we request comment from affected manufacturers about the costs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65383.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and extent of substitution.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65407.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:65407.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Recordkeeping Requirements of the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:65435.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The USDA/FSIS IFR and the Foods IFR may affect the availability of prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65458.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials, but would not ensure that FDA-regulated medical products for humans or drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65481.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants are free of prohibited cattle materials.  Because at this time there is no way to screen</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65504.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reliably for the presence of the BSE agent or for the presence of cattle materials prohibited under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65527.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this proposed rule, applicants and manufacturers would have to depend on records from their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65550.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">suppliers of cattle materials to ensure that their source material does not contain any cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65573.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials prohibited under this proposal.  In addition, the agency must be able to determine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65596.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">whether prohibited cattle materials are used in the products it regulates.  Without records, FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65620.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">may not be able to determine the inspectional status or age of the source animal once cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65643.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material is separated from its source. The proposed rule would require that applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:65861.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:65891.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">83</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65921.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers using cattle material establish and maintain records.  Records must be kept at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65944.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturing or processing establishment or another reasonably accessible location, and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:65967.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency’s inspectors must have access to these records.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:65996.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The agency also proposes that importers of record of a medical product for humans or drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66019.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for ruminants that was manufactured from or otherwise contains cattle material affirm that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66042.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product was manufactured from or otherwise contained cattle material and affirm that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66065.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product was manufactured in accordance with the requirements in this proposed rule.  Upon</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66088.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency request, importers of record of affected products would provide to FDA within 5 days</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66111.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records that are sufficient to demonstrate compliance.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:66139.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">a. </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Number of affected establishments</FONT></u><FONT STYLE="font-size: 10.05pt">.  The proposed rule is expected to affect all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66162.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishments with medical products for humans or drugs for ruminants that are manufactured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66185.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from, or otherwise contain cattle materials.  According to 2002 Economic Census data, up to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66209.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6,195 establishments manufactured affected products.  In addition, for the current good tissue</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66232.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">practice (CGTP) final rule, the agency estimated there are about 1,300 HCT/P establishments,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66255.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">most of which would be considered small (69 FR 68612 at 68654 and 68674).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:66278.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has developed an automated system, the Operational and Administrative System for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66301.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Import Support (OASIS), to process shipments of foreign products.  According to a preliminary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66324.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examination of OASIS data from fiscal year 2005, approximately 3,800 unique filers requested</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66347.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">entry of FDA-regulated products into the United States. We believe, however, that the actual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66370.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">number of affected filers would be less than this number because some companies may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66393.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">specialize in imports of products such as food, dietary supplements or cosmetics that are outside</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66417.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the scope of this proposed rule.  Nevertheless, for this analysis we assume that all filers identified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66440.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by OASIS could be affected by the proposed requirements for importers of record.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:66653.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:66683.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">84</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:66713.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As shown in table 1 of this document, about 1,280 manufacturing establishments and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66736.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3,800 importers of record could be affected by the recordkeeping requirements. The agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66759.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">seeks comment on these estimates from affected entities.   In addition, although we believe the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66782.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Foods Recordkeeping/Access proposed rule accounts for the recordkeeping burden to domestic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66806.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and foreign suppliers, the agency requests comment from firms supplying cattle material to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66829.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of medical products for humans or drugs for ruminants about any additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:66852.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">burden that may be imposed by the recordkeeping requirements of this proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:67445.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:67475.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">85</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:157.55pt;top:67506.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Table 1.--Estimated Number of Affected Establishments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:70.40pt;top:67517.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">North American Industry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.40pt;top:67527.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Classification Scheme</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:87.50pt;top:67536.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">(NAICS) Code</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:175.40pt;top:67517.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total Number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:176.75pt;top:67527.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Establishments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:227.45pt;top:67526.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:254.60pt;top:67517.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Estimated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.45pt;top:67527.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Percentage of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:246.00pt;top:67536.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Establishments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:250.25pt;top:67546.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Using Cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:255.80pt;top:67556.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.20pt;top:67555.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:314.95pt;top:67517.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Estimated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:313.45pt;top:67527.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:317.00pt;top:67536.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Affected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:306.30pt;top:67546.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Establishments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:386.10pt;top:67517.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Percent of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:377.90pt;top:67527.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Establishments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:371.95pt;top:67536.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Considered Small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:431.80pt;top:67535.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67516pt;width:106pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67516pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67516pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67516pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67516pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67516pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67517pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67517pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67517pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67517pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67517pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67517pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1--medicinal &</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67576.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">botanical manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:197.15pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.55pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.05pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:271.40pt;top:67566.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5 275  98</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67565pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67565pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67565pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67565pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67565pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67565pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67565pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67565pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67565pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67565pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67565pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67566pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67566pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67566pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67566pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67566pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67566pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.20pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2--pharmaceutical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67596.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">preparation manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:149.40pt;top:67595.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:197.15pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.55pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.05pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:271.40pt;top:67587.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5 674  91</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67586pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67586pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67586pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67586pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67586pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67586pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67586pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67586pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67586pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67586pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67586pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67587pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67587pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67587pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67587pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67587pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67587pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4--biological product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67617.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:109.15pt;top:67616.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:197.15pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:205.55pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.05pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:271.35pt;top:67607.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5 253  96</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67606pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67606pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67606pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67606pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67606pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67606pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67606pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67606pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67606pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67606pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67606pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67607pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67607pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67607pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67607pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67607pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67607pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">339</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:85.50pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">, 339113, 339114,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67637.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">339</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:67637.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67637.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:67637.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5--medical devices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:194.05pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4,631</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:263.90pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:270.25pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.45pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5 12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.05pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:403.25pt;top:67627.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67626pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67626pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67626pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67626pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67626pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67626pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67626pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67626pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67626pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67626pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67626pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67627pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67627pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67627pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67627pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67627pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67627pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">621</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1--HCT/P</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:114.80pt;top:67647.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:194.00pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1,302</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:269.20pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5 65</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.05pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:403.25pt;top:67648.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67647pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67647pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67647pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67647pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67647pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67647pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67647pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67647pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67647pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67647pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67648pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67648pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67648pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67648pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67648pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67648pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67658.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Subtotal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:193.95pt;top:67658.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.30pt;top:67658.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,497 -- 1,278 92</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67657pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67657pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67657pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67657pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67657pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67657pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67657pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67657pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67657pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67657pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67657pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67658pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67658pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67658pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67658pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67658pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67658pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67669.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Importers of record</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:125.45pt;top:67668.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:193.95pt;top:67669.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.30pt;top:67669.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,787 unknown 3,787 unknown</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67668pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67668pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67668pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67668pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67669pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67669pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67669pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67669pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67669pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67669pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67680.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:191.90pt;top:67680.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:196.25pt;top:67680.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:200.35pt;top:67680.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,284</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:322.20pt;top:67680.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5,065</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67679pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67679pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67679pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:166pt;top:67679pt;width:75pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67679pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67679pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67679pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67679pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67679pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:362pt;top:67679pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67679pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67680pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:165pt;top:67680pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:241pt;top:67680pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:301pt;top:67680pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:361pt;top:67680pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67680pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67689.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.70pt;top:67690.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Source: NAICS 325411, 325412, 325414, 339112, 339113, 339114, and 339115, table 4 of the 2002 Economic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67700.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Census, Manufacturing, Industry Series; NAICS 621991, table 3 in 69 FR 68612 at 68654.  Number of importers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67710.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">of record estimated from FDA’s OASIS data for FY 2005.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67718.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.25pt;top:67719.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Percentages are absed on FDA’s knowledge of products containing cattle material. We assume equal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67729.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">distribution of affected products across all establishments.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67737.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.10pt;top:67739.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">The SBA considers entities small if they have less than: (1) 750 employees for NAICS 325411 and 325412, (2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67748.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">500 employees for NAICS 32514, 339112, 339113, 339114, and 339115, or (3) $9.0 million in revenues or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67758.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">receipts for NAICS 621991. Because the Economic Census uses different size categories than SBA, this analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67767.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">treats establishments in NAICS 325411 and 325412 with less than 999 employees as small.  The agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67777.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">previously estimated that about 66 percent of establishments in NAICS 621991 are small (table 14 in 69 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67787.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">686</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:67787.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:67787.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:83.30pt;top:67787.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">at 68674).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67795.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.25pt;top:67796.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">We assume that cattle materials are used by 70 percent of establishments primarily manufacturing products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67806.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">veterinary use and 75 percent of establishments primarily manufacturing products for human use.  Source for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67816.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">total number of establishments and the number of establishments manufacturing each primary product class:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67825.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Tables 4 and 5 of the 2002 Economic Census, Manufacturing, Industry Series, EC02-311-325412.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67834.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.25pt;top:67835.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">We assume that cattle materials are used by 70 percent of establishments primarily manufacturing products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67844.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">veterinary use and 90 percent of establishments primarily manufacturing products for human use.  Source for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67854.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">total number of establishments and the number of establishments manufacturing each primary product class:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67864.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Tables 4 and 5 of the 2002 Economic Census, Manufacturing, Industry Series, EC02-311-325412.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67872.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.25pt;top:67873.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">We assume that from 1 to 5 percent of establishments use cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67882.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.25pt;top:67883.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Based on FY 2005 data in OASIS; equals the total number of unique filers for all FDA-regulated products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67689pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:59pt;top:67689pt;width:385pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67689pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:444pt;top:67689pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:67916.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">b.  Re</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">cordkeeping costs</FONT></u><FONT STYLE="font-size: 10.05pt">.  Manufacturers of medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67939.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants would need to establish and maintain appropriate records that document the absence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67962.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of prohibited cattle materials in their products.  This would require that manufacturers verify and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:67985.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintain records from suppliers of any material derived from cattle.  In addition, when filing an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68008.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">entry with the U.S. Customs and Border Protection, importers of record of affected products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68032.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would be required to affirm that the product was manufactured from or otherwise contains cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:68237.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:68267.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">86</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68297.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material and affirm that the product was manufactured in accordance with the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68320.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provisions.  If a product was manufactured from, or otherwise contains, cattle material, then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68343.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">importers of record would also be required, if requested, to provide within 5 days records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68366.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sufficient to demonstrate that the product was not manufactured from and does not contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68390.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:68413.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As noted previously, we believe that most entities have taken steps to address the sources</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68436.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of cattle materials.  Moreover, the CGMP and CGTP regulations covering medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68459.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants require that procedures be in place for purchasing controls.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68482.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">believe, however, that some affected manufacturers currently may not keep adequate records and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68505.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">might incur minor incremental recordkeeping costs.  For this analysis, therefore, we assume that,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68528.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on average, all affected small manufacturers may spend slightly more than 1 hour annually to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68551.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintain records.  Similarly, we assume that, on average, all affected large manufacturers may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68575.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">spend slightly less than 3 hours annually to maintain records.  With a loaded wage rate of $33.00</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68598.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(source: Bureau of Labor Statistics (BLS) National Compensation Survey: Occupational Wages</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68621.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in the United States, July 2002, adding 33 percent overhead for a computer programmer), small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68644.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and large manufacturers might incur about $45 and $90, respectively, to ensure full compliance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68667.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the requirements to establish and maintain records.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:68695.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This rule would require importers of record of affected products to affirm that the product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68718.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">was manufactured from or otherwise contains cattle material and affirm that the product was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68741.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured in accordance with the proposed provisions.  Although the marginal burden of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68764.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">each affirmation would be negligible, we believe the cumulative burden might cause smaller</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68788.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">importers to spend about the same level of effort as small manufacturers (i.e., $45 annually).  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:68811.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contrast, we assume that larger importers might spend about 5 times the level of effort as small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:69029.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:69059.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">87</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69089.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">importers (i.e., $225 annually).  Because the agency lacks information about importer size, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69112.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">include a range of possible recordkeeping costs for this analysis.  Table 2 shows the estimated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69135.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recurring recordkeeping costs for this proposed rule.  However, because there is some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69158.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">uncertainty about the new burden that might be imposed and the number of firms that might be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69182.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">affected by this proposed rule, the agency requests comment from affected manufacturers and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69205.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">importers of record on this estimated recordkeeping burden.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:87.55pt;top:69233.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Table 2.--Estimated Annual Recordkeeping Burden by Industry and Establishment Size</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:383.10pt;top:69232.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:210.25pt;top:69243.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Small Large</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69242pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69242pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69242pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69242pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69242pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69242pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69243pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69243pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69243pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69243pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69243pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:66.30pt;top:69243.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">NAICS or Type of Industry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.05pt;top:69253.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:178.10pt;top:69262.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Affected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:229.75pt;top:69253.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Cost ($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.40pt;top:69253.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:275.40pt;top:69262.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Affected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:319.30pt;top:69253.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Cost ($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:363.40pt;top:69243.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total Cost ($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69252pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69252pt;width:187pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69252pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69253pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.95pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">26</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:207.35pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:243.05pt;top:69272.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">12,100 7 600 12,700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69272pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69272pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69272pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69272pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.95pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">61</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:207.35pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:243.05pt;top:69282.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">27,700 58 5,200 32,900</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69282pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69282pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69282pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69282pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.95pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">24</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:207.35pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:243.05pt;top:69292.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">11,000 9 800 11,800</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69292pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69292pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69292pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69292pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">339</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:85.50pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">, 339113, 339114,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69312.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.50pt;top:69312.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:68.70pt;top:69312.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:69312.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:69312.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:203.15pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:253.40pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:257.75pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:261.90pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">0 0 0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:400.45pt;top:69303.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69302pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69302pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69302pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69302pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">621</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.10pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:87.50pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">(HCT/P)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:203.15pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">43</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:247.25pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1,900</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:296.60pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">22</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:332.85pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:337.10pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:394.15pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:398.40pt;top:69322.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,900</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69322pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69322pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69322pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69332.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Subtotal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:192.65pt;top:69332.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1,182</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:243.05pt;top:69332.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">53,200 96 8,600 61,800</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69332pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69332pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69332pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:177.80pt;top:69342.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Lower Bound (i.e., 3,787</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:192.50pt;top:69352.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">small importers)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:282.20pt;top:69342.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Upper Bound (i.e.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:69352.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3,787 large importers)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69342pt;width:301pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69342pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69342pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69342pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69342pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69342pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69342pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69342pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69362.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Importers of record</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:127.55pt;top:69361.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.85pt;top:69362.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">170,400 852,100 170,400 to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:390.30pt;top:69372.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">852,100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69361pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69361pt;width: 5pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:421pt;top:69361pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:421pt;top:69362pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69382.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:381.75pt;top:69382.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">232,200 to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:390.30pt;top:69391.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">913,900</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69381pt;width:366pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:169pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:215pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:270pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:309pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:421pt;top:69382pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69400.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.05pt;top:69401.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Totals may not multiply or sum due to rounding.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69401pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:356pt;top:69401pt;width:60pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:417pt;top:69401pt;width: 5pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:421pt;top:69401pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69410.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.70pt;top:69411.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Because we lack data on the size of affected importers of record, we calculate the lower and upper</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69421.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">bounds for these costs, assuming that either all firms are small or all firms are large.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69459.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5. Labeling Costs for New Animal Drugs Prohibited from Extralabel Use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:69487.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Manufacturers of new animal drugs prohibited from extralabel use in ruminants would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69510.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">need to add a warning statement to the product labeling.  We estimate manufacturers of about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69533.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">eight animal products would spend from $1,600 to $6,400 to change the product labeling and file</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69556.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">a labeling supplement for each affected product.  Costs are based on discussions with experts in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:69579.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Center for Veterinary Medicine and are presented in table 3 of this document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:69821.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:69851.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">88</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.65pt;top:69881.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Table 3.--Estimated One-Time Costs of Labeling Changes and Filing a Supplement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.75pt;top:69891.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Cost Component</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:250.65pt;top:69891.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Hours/Establishment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:367.95pt;top:69891.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total Cost ($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:403.10pt;top:69890.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1 </FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69890pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69890pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69890pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69891pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69891pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69891pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69891pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:69901.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Regulatory review and approval</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.15pt;top:69901.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3 to 12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.80pt;top:69901.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1,000 to 3,980</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69901pt;width:374pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69901pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69901pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69901pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69901pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:69911.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Artwork</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:96.30pt;top:69910.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:69911.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:406.20pt;top:69911.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:410.45pt;top:69911.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69911pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69911pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69911pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69911pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:69921.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.10pt;top:69921.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">4 to 12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:383.00pt;top:69921.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">57</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:391.35pt;top:69921.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:397.60pt;top:69921.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">to 1,710</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69921pt;width:374pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69921pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69921pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69921pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69921pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:69931.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Inventory Loss</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:118.30pt;top:69930.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.30pt;top:69931.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.45pt;top:69931.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.75pt;top:69931.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,640 to 40,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69931pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69931pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69931pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69931pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:69941.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Supplement preparation and Submission</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.20pt;top:69941.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2 to 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:383.00pt;top:69941.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">66</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:391.35pt;top:69941.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:397.60pt;top:69941.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">to 1,660</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69941pt;width:374pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69941pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69941pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69941pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69941pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:69951.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total Cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:69950.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:368.30pt;top:69951.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">12,870 to 51,350</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69951pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:208pt;top:69951pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:347pt;top:69951pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69951pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:65.00pt;top:69960.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:69.75pt;top:69961.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">We calculated using a loaded wage rate for regulatory review and filing a supplement of $41.50, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.00pt;top:69971.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">manufacturing changes $17.80.  Source: BLS National Compensation Survey: Occupational Wages in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.00pt;top:69981.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">United States, July 2002, adding 33 percent for benefits.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69961pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:69961pt;width:374pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69961pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:69961pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:65.00pt;top:69989.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:69.75pt;top:69990.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">We assume the unit costs for artwork are $500 per product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.00pt;top:69999.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:69.75pt;top:70000.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">We assume the unit costs for inventory loss range from $830 to $5,000 per product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.00pt;top:70008.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:69.75pt;top:70009.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Totals may not add or multiply due to rounding.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70036.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:70036.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Summary of the Costs for the Proposed Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:70059.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Few firms will incur one-time costs for requests for exceptions or alternatives to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70082.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">limitation on the use of prohibited cattle material.  In addition, manufacturers of about eight</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70105.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal products prohibited from extralabel use in ruminants would incur one-time costs to add a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70128.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">warning statement to the product labeling. All firms that use cattle material or import products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70152.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that do would incur annual incremental costs for additional recordkeeping.  The total one-time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70175.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">costs range from $20,400 to $66,300; annual costs range from $232,200 to $913,900. The total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70198.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">annualized costs of this option range from $234,600 to $921,700 (at a 3 percent discount rate)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70221.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and from $235,100 to $923,300 (at a 7 percent discount rate) over 10 years.  These costs are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70244.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">summarized in table 4 of this document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:161.00pt;top:70272.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Table 4.--Summary of Total Compliance Costs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:318.65pt;top:70271.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:148.90pt;top:70287.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">One-Time Cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.95pt;top:70282.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Lower Bound</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:322.20pt;top:70292.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.80pt;top:70287.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Upper Bound ($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70281pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70281pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70281pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70281pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70282pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70282pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70282pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70282pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70302.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Requests for exception or alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:336.90pt;top:70302.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7,500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.05pt;top:70302.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">15</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.40pt;top:70302.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70301pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70301pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70301pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70301pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70301pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70312.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Change labeling and file a supplement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:332.75pt;top:70312.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">12,900</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.10pt;top:70312.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">51</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.40pt;top:70312.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,300</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70311pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70312pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70312pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70312pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70312pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70322.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total one-time cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:332.75pt;top:70322.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">20,400</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.10pt;top:70322.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">66</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.45pt;top:70322.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">,300</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70321pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70322pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70332.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Annual recordkeeping cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:328.50pt;top:70332.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">232,200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:394.80pt;top:70332.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.05pt;top:70332.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:403.20pt;top:70332.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3,900</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70331pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70332pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70342.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total annualized cost at 3 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:328.60pt;top:70342.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">234,600</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:394.90pt;top:70342.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.15pt;top:70342.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:403.30pt;top:70342.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1,700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70341pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70342pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70342pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70342pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70342pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70352.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total annualized cost at 7 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:328.60pt;top:70352.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">235,100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:394.90pt;top:70352.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.15pt;top:70352.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:403.30pt;top:70352.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3,300</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70351pt;width:371pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70352pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70352pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70352pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70352pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70361.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.05pt;top:70362.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Numbers may not add due to rounding.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:55pt;top:70361pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:293pt;top:70361pt;width:66pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:360pt;top:70361pt;width:66pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70361pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:426pt;top:70361pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;left:71.76pt;top:70613.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:70643.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">89</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:188.60pt;top:70673.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:203.30pt;top:70673.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Benefits of the Proposed Rule</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70696.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.80pt;top:70696.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Reduced Risk of Exposure to BSE Infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:70719.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">USDA analyses to date have found the United States is highly resistant to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70742.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">introduction or establishment of BSE and predict that even if BSE were introduced into the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70766.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United States, only a small amount of potentially BSE-contaminated tissues would reach the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70789.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human food supply and be available for consumption (Ref. 41).  Moreover, their models predict</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70812.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that implementation of a ban on specified risk materials (e.g., spinal cords, brains, vertebral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70835.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">columns) from both human food and animal feed would reduce substantially the very low risk of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70858.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">additional BSE cases in cattle and the potential human exposure to infectivity from meat and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70881.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">meat products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:70904.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">None of these risk assessments considered the potential exposure to BSE infectivity from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70927.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">certain FDA-regulated products containing bovine material.  The risks of exposure to BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70951.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infectivity from medical products for humans and drugs for ruminants are unknown, but the risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70974.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of transmission could be higher than for foods and cosmetics assuming the presence of BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:70997.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infectivity.  For example, the routes of administration for some of these products (such as from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71020.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">injectable and implantable products) are associated with higher risk than oral or topical exposure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71043.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">associated with foods and cosmetics. This proposed rule covers products not included in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71066.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recent USDA or Foods IFRs and would ensure that medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71089.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants containing cattle material meet specific requirements designed to reduce the risk of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71112.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human exposure to BSE-infective materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:71135.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The proposed rule would decrease the likelihood of human and ruminant exposure to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71159.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE in several ways.  First, this rule would provide additional regulatory protection, beyond</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71182.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">existing rules, by making clear that prohibited cattle material cannot be used in FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:71405.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:71435.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">90</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71465.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans or drugs for ruminants.  Second, because affected products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71488.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise containing prohibited cattle materials would be adulterated and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71511.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the failure of an importer of record to comply with applicable reporting requirements creates the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71534.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">appearance of adulteration under section 801, the proposed rule would clarify FDA’s ability to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71558.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">bar importation of medical products for humans or drugs for ruminants that contain prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71581.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials. For example, imported products may contain the types of materials prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71604.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by FDA, but may not fall under the scope of USDA’s import restrictions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71627.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.85pt;top:71627.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Value of the Potential Reduction of Human Illness</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:71650.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The public health benefit of this proposed rule is the value of the reduction in the risk of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71673.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the human illness associated with exposure to the agent that causes BSE. If we define the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71696.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">baseline risk as the expected annual number of cases of vCJD per year, then the annual benefits</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71719.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of barring prohibited cattle materials from use in affected products would be:  (baseline annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71743.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cases of vCJD--annual cases of vCJD under FDA PR) x (value of preventing a case of vCJD).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:71766.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We do not know the baseline expected annual number of cases, but based on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71789.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">epidemiology of vCJD in the United Kingdom, we anticipate much less than one case of vCJD</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71812.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">per year in the United States.  Because the proposed rule would reduce rather than eliminate risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71835.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of exposure to BSE infectious materials, the reduction in the number of cases would be some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71858.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">fraction of the expected number.  FDA uses the concept of the Value of a Statistical Life (VSL)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71881.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in order to describe the value of preventing a case of vCJD. This term refers to the sum of risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71904.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reductions expected in a population exposed to small changes in risk.  It has no application to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71927.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">identifiable individuals or large reductions in risk.  Most recent studies suggest values ranging</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:71951.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from about $1 million to $10 million.  In recent rulemakings, we have used $5 million and $6.5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:72197.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:72227.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">91</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72257.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">million as the value of a statistical life, and we believe it is reasonable to use a similar VSL to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72280.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">value the cases of vCJD avoided.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:115.50pt;top:72303.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">E.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:129.10pt;top:72303.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Summary of the Potential Costs and Benefits of the Proposed Rule</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:72326.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The total annualized costs of this proposed rule range from $234,600 to $921,700 (at a 3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72350.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">percent discount rate) and from $235,100 to $923,300 (at a 7 percent discount rate) over 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72373.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">years.  By reducing exposure to potentially infectious materials, the requirements of the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72396.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule would provide an additional safeguard against a case of vCJD occurring in humans if cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72419.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infected with BSE were used in the manufacture or processing of medical products for humans</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72442.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and drugs for ruminants.  We are unable to estimate the value of this potential reduction in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72465.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">risk of cases of vCJD, even though we estimate the value of avoiding one death at $5.8 million.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72488.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Nonetheless, we believe the potential benefits of the proposed rule justify the small costs of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72511.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:186.05pt;top:72535.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">F.  Regulatory Options Considered</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:72558.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For this proposed rule, FDA considered three regulatory options:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:72581.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:72581.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">No new regulation</FONT></u><FONT STYLE="font-size: 10.05pt">.  By definition, no costs and benefits are associated with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72604.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">baseline.  As noted previously, USDA and FDA actions to date would reduce, but not eliminate,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72627.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the availability and use of prohibited cattle materials in domestic and imported FDA-regulated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72650.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans and drugs for ruminants.  Without regulation, FDA would not be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72673.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">explicitly barring the use of prohibited cattle materials that could potentially contain the BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72696.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">infectious agent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:72719.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Propose a rule that (i) bars the use of prohibited cattle materials in medical products</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72743.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for humans and drugs for ruminants, unless a request for exception or alternative to the limitation</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:72766.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the use of prohibited cattle material has been granted, and (ii) requires establishment,</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:72989.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:73019.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">92</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73049.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintenance, and access to records demonstrating that no medical products for humans or drugs</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73072.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">for ruminants are manufactured from or otherwise contain prohibited cattle material</FONT></u><FONT STYLE="font-size: 10.05pt">.  These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73095.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would be the minimum basic requirements, and would not preclude the imposition of additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73118.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">measures through the application review process or other means if FDA determined that they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73142.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were necessary for ensuring the safety of individual products on a case-by-case basis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:73165.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This is the regulatory option selected.  The agency believes that this is the best option to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73188.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">meet its goal of minimizing human and ruminant exposure to materials that scientific studies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73211.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">have demonstrated are likely to contain the BSE agent in cattle infected with the disease. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73234.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ban on use of prohibited materials would eliminate exposure to the highest risk animals and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73257.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">majority of the infectivity in an animal infected with the BSE agent.  This option would provide</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73280.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasonable balance by explicitly barring from medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73303.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants the use of potentially infectious materials already deemed unfit for foods by USDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73327.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and FDA and by imposing minimal regulatory burden.  The agency must be able to determine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73350.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that the products it regulates contain no prohibited cattle materials.  Applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73373.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers must depend on records to ensure that affected products do not contain any cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73396.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials prohibited under the proposal.  Without recordkeeping requirements, FDA may not be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73419.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">able to determine the source or age of cattle material once it is separated from the animal.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73442.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">addition, records would allow the agency to determine the inspectional status of the source</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73465.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animals.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:73488.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3) </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Propose a rule that, in addition to the requirements listed in option (2), bars the use in</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73511.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">medical products for humans and drugs for ruminants of all neural material from cattle from</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73535.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">countries with a high or medium risk of BSE if the cattle were slaughtered when over 6 mo</FONT></u><FONT STYLE="font-size: 10.05pt">nths</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73558.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">old, unless a request for exception or alternative to the requirements has been granted</FONT></u><FONT STYLE="font-size: 10.05pt">.  This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:73781.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:73811.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">93</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73841.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approach would be more consistent with recommendations of OIE and would add an additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73864.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">layer of protection to that provided by option (2).  This alternative would put an additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73887.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">burden on those parts of the affected industries that source cattle materials from such countries</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73910.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and do not already have procedures in place ensuring and documenting compliance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73934.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirement.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:73957.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Compared to the preferred option (2), we believe this alternative would impose higher</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:73980.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">costs on, at most, a small segment of the affected industries.  In fact, we know of no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74003.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of U.S. licensed or approved medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74026.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants for which this alternative would impose any additional burdens beyond those imposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74049.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under option (2), because they do not source such materials from such countries.  However, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74072.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">also believe it would not provide significant additional risk reduction because so few animals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74095.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">diagnosed with BSE are younger than 3 years old. For example, cattle born in 1987/1988 in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74119.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United Kingdom had the highest incidence of BSE, with over 39,000 cattle diagnosed with BSE.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74142.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Among those animals, cattle under 3 years old represented only 0.16 percent of cattle with BSE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74165.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(61 cattle).  Once controls were put in place, that number decreased, so that of animals born after</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74188.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">199</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:74188.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6, all cattle diagnosed with BSE have been 3 years old or older.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:185.50pt;top:74211.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">G.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:200.30pt;top:74211.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Regulatory Flexibility Analysis</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:74234.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has examined the economic implications of this proposed rule as required by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74257.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Regulatory Flexibility Act (5 U.S.C. 601-612).  If a rule has a significant economic impact on a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74280.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74303.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulatory options that would lessen the economic effect of the rule on small entities. The FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74327.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">believes this proposed rule will not have a significant economic impact on a substantial number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74350.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of small entities and requests comment.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:74573.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:74603.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">94</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:74633.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The proposed rule may affect entities classified in several industries including Medicinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74656.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">& Botanical Manufacturing (NAICS 325411), Pharmaceutical Preparation Manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74679.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NAICS 325412), Biological Product (Except Diagnostic) Manufacturing (NAICS 325414),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74702.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Surgical and Medical Instrument Manufacturing (NAICS 339112), Surgical Appliance and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74726.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Supplies Manufacturing (NAICS 339113), Dental Equipment and Supplies Manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74749.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NAICS 339114), Ophthalmic Goods Manufacturing (NAICS 339115), and Blood and Organ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74772.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Banks (NAICS 621991).  The Small Business Administration (SBA) regards an entity as small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74795.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">based on the number of employees or the average annual receipts.  The size standards are:  (1)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74818.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">750</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.85pt;top:74818.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">employees for NAICS categories 325411 and 325412, (2) 500 employees for NAICS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74841.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">categories 325414, 339112, 339113, 339114 and 339115, and (3) $9.0 million average annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74864.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">receipts for NAICS 621991.  The U.S. Census gathers employment data for establishments by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74887.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">NAICS and uses size categories that differ from those of the SBA for NAICS 325411 and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74911.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">325</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:74911.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">412.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.90pt;top:74911.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">For this regulatory flexibility analysis, therefore, we consider entities in these NAICS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74934.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">categories with less than 999 employees to be small.  Using these size standards, 2002 Census</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74957.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">data, and the CGTP final rule (69 FR 68612 at 68654 and 68674), over 90 percent of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:74980.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishments would be considered small (see tables 1 and 2 of this document).  However, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75003.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency lacks information on the types of importers of record that might be affected by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75026.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed rule.  Agency data on filers that import FDA-regulated products into the United States</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75049.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">does not include the size of the importer of record.  Therefore, for the initial regulatory flexibility</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75072.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">analysis, we assume that all affected importers of record would be classified as small.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75095.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency requests comment on this assumption.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:75119.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We believe requirements in this proposed rule must apply to all entities, regardless of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75142.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">size.  No new skills are needed.  To meet the proposed requirements, those applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:75365.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:75395.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">95</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75425.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of medical products for humans or drugs for ruminants manufactured from or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75448.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise containing cattle tonsils, the distal ileum of the small intestine of cattle, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75471.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">mechanically separated beef might need to switch to an alternative source material, submit a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75494.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request for exception or alternative to the limitation on prohibited cattle material in this proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75518.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule, or cease marketing the products.  We expect that other affected manufacturers would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75541.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">continue to use age-specific cattle material from animals under 30 months of age.  A few small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75564.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">entities could incur from $2,500 to $5,000 for each request submitted unless a request for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75587.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exception or alternative to requirements of the proposed rule has already been granted.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75610.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">addition, manufacturers of about eight animal products prohibited from extralabel use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75633.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants would incur costs of between $1,600 and $6,400 per product to add a warning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75656.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">statement to the product labeling and file a labeling supplement. Although it is uncertain if any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75679.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">small entities will incur these costs, Table 5 shows that for very small establishments with less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75703.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">than 10 employees these one-time costs would equal less than 1.6 percent of the average annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75726.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">value of shipments. Moreover, for all small establishments in each of the affected industries, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75749.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">one-time costs to revise labeling or prepare a request for exception or alternative to requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75772.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of the proposed rule would equal no more than 0.15 percent of the average annual value of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:75795.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">shipments.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:64.40pt;top:75829.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Table 5.  Potential direct compliance costs of the proposed rule as a percentage of average annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:122.65pt;top:75840.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">shipments for affected establishments with less than 10 employees.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:394.10pt;top:75839.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:268.25pt;top:75859.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Compliance costs as a percentage of average</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:320.10pt;top:75871.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">annual shipments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:392.60pt;top:75869.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:75852pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:75852pt;width:113pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:75852pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:75852pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75852pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75852pt;width:203pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:75852pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:75852pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:75853pt;width: 1pt;height:29pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:75853pt;width: 1pt;height:29pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75853pt;width: 1pt;height:29pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:75853pt;width: 1pt;height:29pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:75929.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">NAICS category</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:183.25pt;top:75906.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Average annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:186.80pt;top:75917.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">shipments per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:178.85pt;top:75929.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishment  ($)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:259.80pt;top:75907.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Recordkeeping</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:273.30pt;top:75918.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">($45 per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:260.85pt;top:75930.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establishment)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:340.20pt;top:75895.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Labeling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:340.20pt;top:75907.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Revision</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:334.85pt;top:75918.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">($6,500 per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:341.05pt;top:75930.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:402.60pt;top:75883.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Request for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:400.90pt;top:75895.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:404.70pt;top:75907.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:402.70pt;top:75918.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">($5,000 per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:409.65pt;top:75930.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:75882pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:75882pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75882pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75882pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:75882pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:75882pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:75882pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:75882pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:75882pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:75883pt;width: 1pt;height:58pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:75941pt;width:113pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:75883pt;width: 1pt;height:58pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:75941pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75883pt;width: 1pt;height:58pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:75941pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:75883pt;width: 1pt;height:58pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:75941pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:75883pt;width: 1pt;height:58pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:75941pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:75883pt;width: 1pt;height:58pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:75941pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;left:71.76pt;top:76157.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:76187.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">96</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76227.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3254</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76227.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">11, Medicinal and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">botanical manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:218.85pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1,059,245</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.15pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.95pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">004</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.85pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.15pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.75pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.6%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.05pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.65pt;top:76238.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.5%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76217pt;width:113pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76217pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76217pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76217pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76217pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76217pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76218pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76218pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76218pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76218pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76218pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76218pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76258.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3254</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76258.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">12, Pharmaceutical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">preparation manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:218.95pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1,656,743</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.20pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:302.05pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">003</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.95pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.20pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.85pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.4%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.10pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.70pt;top:76269.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.3%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76248pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76248pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76248pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76248pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76248pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76248pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76248pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76248pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76248pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76248pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76248pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76249pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76249pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76249pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76249pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76249pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76249pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76281.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3254</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76281.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">14, Biological product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76291.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">(except diagnostic)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">manufacturing 1,057,862</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.20pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:302.00pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">004</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.90pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.20pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.80pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.6%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.10pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.70pt;top:76302.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.5%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76279pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76279pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76279pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76279pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76279pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76279pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76279pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76279pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76279pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76279pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76279pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76280pt;width: 1pt;height:31pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76280pt;width: 1pt;height:31pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76280pt;width: 1pt;height:31pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76280pt;width: 1pt;height:31pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76280pt;width: 1pt;height:31pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76280pt;width: 1pt;height:31pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76322.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3391</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76322.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">12, Surgical and medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">instrument manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:225.60pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">610,138</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.05pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.90pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">007</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.80pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.10pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.70pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.0%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.00pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.60pt;top:76333.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.8%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76312pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76312pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76312pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76312pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76312pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76312pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76312pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76312pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76312pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76312pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76312pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76313pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76313pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76313pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76313pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76313pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76313pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76354.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3391</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76354.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">13, Surgical appliance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">and supplies manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:225.65pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">618,207</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.15pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.95pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">007</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.85pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.15pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.75pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.0%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.00pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.65pt;top:76364.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.8%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76343pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76343pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76343pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76343pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76343pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76343pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76343pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76343pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76343pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76343pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76343pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76344pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76344pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76344pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76344pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76344pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76344pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76385.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3391</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76385.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">14, Dental equipment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">and supplies manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:225.65pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">396,666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.15pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.95pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">011</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.85pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.15pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.75pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.6%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.00pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.65pt;top:76395.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.3%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76374pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76374pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76374pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76374pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76374pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76374pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76374pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76374pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76374pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76374pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76374pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76376pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76376pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76376pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76376pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76376pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76376pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76416.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">3391</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76416.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">15, Ophthalmic goods</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:116.95pt;top:76425.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.88pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:218.80pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">1,121,083</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.15pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.95pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">004</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.90pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.15pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.80pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.6%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.05pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.65pt;top:76426.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.4%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76406pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76406pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76406pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76406pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76406pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76406pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76406pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76406pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76406pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76406pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76406pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76407pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76407pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76407pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76407pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76407pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76407pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76447.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">6219</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:79.35pt;top:76447.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">91 Blood and organ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">banks 4,281,172</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:295.15pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.95pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:315.85pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:372.15pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:376.75pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.1%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:440.05pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:444.65pt;top:76458.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.20pt">.1%</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76437pt;width:112pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76437pt;width:82pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76437pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:76437pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:392pt;top:76437pt;width:67pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76438pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:173pt;top:76438pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:256pt;top:76438pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:76438pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:391pt;top:76438pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76438pt;width: 1pt;height:30pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76468.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:66.00pt;top:76471.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Source: Table 4 of 2002 Economic Census for NAICS 325411, 325412, 325414, 339112, 339113, 339114, 339115,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:76481.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">and 621991.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76489.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:66.00pt;top:76492.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Averages based on the sum of data for establishments with 1 to 4 employees and 5 to 9 employees. For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:76502.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">establishments with 1 to 4 employees, recordkeeping costs equal less than 0.02 percent of average annual shipments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:76512.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">for all NAICS categories. It is unlikely that entities with 1 to 4 employees would incur compliance costs for a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:76521.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">labeling revision or a request for exception or alternative to requirements of the proposed rule. Nevertheless, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:76531.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">these smallest entities, as a percentage of average annual shipments, a labeling revision equals less than 2.6 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.85pt;top:76540.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">and a request for exemption or alternative equals less than 2.0 percent for all NAICS categories.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.95pt;top:76549.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:66.00pt;top:76552.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">No information for establishments with 1 to 4 employees.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76468pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:76468pt;width:399pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76468pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:459pt;top:76468pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:76573.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Besides the one-time compliance burden that a few small entities might incur, most</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:76596.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">affected small manufacturers would incur minor new compliance costs for recordkeeping.  For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:76620.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">small manufacturers and small importers of record, these annual costs would equal about $45, a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:76643.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">negligible amount for even the smallest entities.  Table 5 shows that these incremental</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:76666.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping costs for establishments with less than 10 employees would equal less than 0.02</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:76689.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">percent of their average annual value of shipments..</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:76712.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA lacks the data required to estimate the number of requests, the distribution of one-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:76735.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time labeling costs, and the new annual recordkeeping burden on small entities.  We anticipate,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:76949.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:76979.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">97</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77009.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">however, that the potential costs might represent a very small percentage of their annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77032.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">revenues and would not be a significant economic impact on affected small entities.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77055.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Nevertheless, the agency requests detailed data on small business impacts from affected firms.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:77078.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As discussed in section VIII. F. of this document,  FDA considered other regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77102.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">options.  The proposed rule is the least burdensome option that meets FDA’s goal of minimizing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77125.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">human and ruminant exposure to materials that scientific studies have demonstrated are likely to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77148.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain the BSE agent in cattle infected with the disease.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:176.15pt;top:77171.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">IX.  Paperwork Reduction Act Analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:77194.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">This proposed rule contains information collection requirements that are subject to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77217.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77240.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A description of these provisions is given below with an estimate of the annual reporting and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77263.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping burden.  Included in the estimate is the time for reviewing instructions, searching</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77287.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">existing data sources, gathering and maintaining the data needed, and completing and reviewing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77310.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">each collection of information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:77333.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA invites comments on the following topics: (1) Whether the proposed collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77356.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information is necessary for the proper performance of FDA’s functions, including whether the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77379.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77402.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed collection of information, including the validity of the methodology and assumptions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77425.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77448.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) ways to minimize the burden of the collection of information on respondents, including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77471.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">through the use of automated collection techniques, when appropriate, and other forms of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77495.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information technology.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:77741.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:77771.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">98</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:77801.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Title</FONT></u><FONT STYLE="font-size: 10.05pt">:  Use of Materials Derived from Cattle in Medical Products Intended for Use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77824.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Humans and Drugs Intended for Use in Ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:77847.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Description</FONT></u><FONT STYLE="font-size: 10.05pt">:  As discussed previously in this document, we are proposing to prohibit the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77870.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use of certain cattle material in medical products for humans and drugs for ruminants because of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77894.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the risk of BSE and related human disease. The rulemaking contains reporting and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77917.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping requirements that are subject to review by OMB.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:77940.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Reporting</FONT></u><FONT STYLE="font-size: 10.05pt">.  Under proposed §§ 300.200(b)(2)(i) and (b)(2)(ii) for drugs for humans,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77963.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:77963.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:77963.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(2)(i) and (b)(2)(ii) for drugs for ruminants, 600.16(b)(2)(i) and (b)(2)(ii) for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:77986.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">biological products, 895.102(b)(2)(i) and (b)(2)(ii) for human medical devices that are intended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78009.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for use in or on the body, and 1271.470(b)(2)(i) and (b)(2)(ii) for HCT/Ps, applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78032.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers could request permission for an exception or alternative to the requirements in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78055.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed §§ 300.200(b)(1), 500.200(b)(1), 600.16(b)(1), 895.102(b)(1), and 1271.470(b)(1) that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78079.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">no medical product for humans or drug for ruminants be manufactured from or otherwise contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78102.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials obtained from cattle slaughtered on or after the effective date of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78125.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regulation.  To obtain written permission from FDA for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78148.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements, applicants and manufacturers would send a written request to the director of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78171.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Center having jurisdiction over the relevant product.  Any request would contain the following:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:78194.10pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:78195.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A statement of the reasons why an exception or alternative is needed;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:78218.00pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78219.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A description of the product, including the type of prohibited cattle materials used in its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78242.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturing, its manufacturing and purification processes, and its route of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78265.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">administration;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:78288.00pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78289.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A description of the source of the prohibited cattle materials, including information on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78312.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the location where the cattle were born, raised, and slaughtered, and any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:78533.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.30pt;top:78563.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">99</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:78593.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information relevant to the likelihood of the cattle having ingested material prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:78616.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under  589.2000;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:78639.35pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78640.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A description, if applicable, of how the requirements that pertain to their product in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78663.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed §§ 300.200(b)(1), 600.16(b)(1), 895.102(b)(1), or 1271.470(b)(1) are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78686.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary based on the risks of the prohibited cattle materials in the product and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78709.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">benefits of the product, or how such restrictions are not necessary to ensure the safety of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78733.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:78755.65pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78756.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A description, if applicable, of:  (1) How the requirements that pertain to their product in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78780.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed § 500.200(b)(1) are not necessary: (i) Based on the risks of the prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78803.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials in the product to the target animal and the benefits of the product to the target</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78826.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">animal and (ii) to ensure a reasonable certainty of no harm to humans from any food</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78849.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derived from the target animal to which the product was administered, or (2) how such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78872.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">restrictions are not necessary to ensure the safety of the product with respect to both the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78895.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">target animal and any food derived from the target animal to which the product is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78918.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">administered; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:78941.35pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:78942.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Any other relevant information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.65pt;top:78965.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">As discussed in the Analysis of Impacts (see section VIII of this document), we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:78988.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">estimate that a request for an exception or alternative to the requirements would take between 60</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79011.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and 120 hours to complete and submit to FDA. For purposes of this information collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79034.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">analysis, we estimate, as indicated in table 6 of this document, that each request would take</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79058.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approximately 120 hours.  We estimate that only three requests would be submitted to FDA in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79081.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the first year by applicants and manufacturers of medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79104.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants because only a small number of such products are currently manufactured with cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:79325.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:79355.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:79355.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79385.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials that would be prohibited under this rule.  We expect that applicants and manufacturers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79408.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would seek, and obtain, alternatives to prohibited cattle materials, eliminating the need for future</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79431.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requests for an exception or alternative to the requirements of the proposed rule.  We request</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79454.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comments on our estimates of the number of exception/alternative requests, the time for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79478.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">preparation and submission of the request, and the likelihood of requests beyond the first year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79501.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">after the rule would be in effect.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:79524.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under proposed §§ 300.200(c)(5), 500.200(c)(5), 600.16(c)(5), 895.102(c)(5), and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79547.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:79547.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:79547.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0(c)(5), when filing entry with the U.S. Customs and Border Protection, importers of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79570.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of a medical product for humans or a drug for ruminants that was manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79593.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material would be required to affirm that the product was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79616.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from or otherwise contained cattle material and affirm that the product was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79639.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured in accordance with the requirements in this proposed rule.  If a product was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79663.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from, or otherwise contains, cattle material, then importers of record would also, if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79686.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requested, have to provide to FDA within 5 days records that would be sufficient to demonstrate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79709.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that the product was not manufactured from, and does not contain, prohibited cattle material.  As</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79732.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">discussed in the Analysis of Impacts (see section VIII of this document), we estimate that 3,787</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79755.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">importers of record would be subject to this affirmation and potential record submission and that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79778.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">it would take each of them between 1 and 5 hours annually to process.  For purposes of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79801.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">information collection analysis, we estimate, as indicated in table 6 of this document, that this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79824.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed provision would take each importer of record approximately 2.5 hours annually to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79847.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">process.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:79871.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Under proposed § 530.42, FDA would require that labels for drugs prohibited from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:79894.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extralabel use in ruminants by proposed § 530.41(c) bear or be accompanied by the statement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:80117.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:80147.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:80147.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80177.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Federal law prohibits the extralabel use of this product in ruminants.” This labeling statement is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80200.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">not subject to review by OMB because it is “originally supplied by the Federal Government to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80223.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)) and, therefore,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80246.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">does not constitute a “collection of information” under the PRA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:80270.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Recordkeeping</FONT></FONT></u><FONT COLOR="000000"><i><FONT STYLE="font-size: 10.05pt">. </FONT></i><FONT STYLE="font-size: 10.05pt">Under proposed §§ 300.200(c), 500.200(c), 600.16(c), 895.102(c), and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80293.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:80293.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.95pt;top:80293.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0(c), applicants and manufacturers of medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80316.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants that are manufactured from, or otherwise contain, material from cattle would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80339.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">required to establish and maintain records demonstrating that their products have not been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80362.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from and do not otherwise contain, prohibited cattle materials and make such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80385.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records available to FDA for inspection and copying.  These proposed requirements are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80408.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary because, once materials are separated from an animal, it may not be possible without</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80431.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records to know the following:  (1) Whether the cattle material contains SRMs, (2) whether the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80455.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material was sourced from an animal that was inspected and passed for human consumption, (3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80478.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">whether the material was sourced from a nonambulatory disabled animal, and (4) whether the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80501.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">product contains mechanically separated beef.  Under the proposed rule, applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80524.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers must retain records the varying periods of time consistent with the applicable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80547.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CGMP or CGTP requirements (e.g., for drugs for humans, it would be at least 1 year after the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80570.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">expiration date of the drug; for drugs for humans lacking an expiration date, it would be at least 3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80593.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">years after distribution of the last lot of the drug).  These records would be required to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80616.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintained at the applicant’s or manufacturer’s establishment or another reasonably accessible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80639.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">location.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:80663.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Recordkeeping requirements currently exist for applicants and manufacturers of medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80686.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">products for humans and drugs for ruminants under FDA’s CGMP and CGTP regulations.  For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:80909.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:80939.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:80939.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80969.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drugs and biological products for humans and drugs for ruminants, these requirements are at part</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:80992.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">210</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.85pt;top:80992.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(21 CFR part 210) and part 211 (CGMP), and the information collection requirements for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81015.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">these regulations are already approved by OMB under OMB Control Number 0910-0139 until</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81038.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">September 30, 2008.  For blood and blood components, these requirements are at 21 CFR part</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81062.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">606</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.85pt;top:81062.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(CGMP), and the information collection requirements for these regulations are already</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81085.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">approved by OMB under OMB Control Number 0910-0116 until December 31, 2008.  For Type</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81108.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A medicated articles, these requirements are at part 226 (CGMP), and the information collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81131.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements for these regulations are already approved by OMB under OMB Control Number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81154.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">091</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:81154.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0-015</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.80pt;top:81154.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4 until December 31, 2007.  For medical devices for humans, these requirements are at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81177.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR part 820 (CGMP/quality system regulations), and the information collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81200.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements for these regulations are already approved by OMB under OMB Control Number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81223.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">091</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:81223.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0-007</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.80pt;top:81223.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3 until September 30, 2007.  For HCT/Ps, these requirements are at part 1271, subpart</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81247.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">D (CGTP regulations), and the information collection requirements for these regulations are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81270.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">already approved by OMB under OMB Control Number 0910-0559 until November 30, 2007.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81293.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In accordance with the previously mentioned CGMP and CGTP regulations, applicants and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81316.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufacturers of medical products for humans and drugs for ruminants would be responsible for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81339.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">maintaining records regarding use of cattle materials in, or in the manufacture of, their products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81362.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">However, FDA estimates that, in accordance with this rulemaking, applicants and manufacturers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81385.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">would expend a small amount of additional effort to comply with the proposed recordkeeping</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81408.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements.  FDA has determined, as indicated in table 7 of this document, that there are 1,278</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81431.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicants and manufacturers of a medical product for humans or drug for ruminants that would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81455.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be responsible for recordkeeping. This would include verifying records and storing records that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81478.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain information on sources of cattle materials that are to be used in medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:81701.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:81731.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:81731.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81761.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants. As discussed in the Analysis of Impact (see section VIII of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81784.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">document), we estimate that this recordkeeping burden will be about 1 to 3 hours per year.  For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81807.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">purposes of this document, we estimate, as indicated in table 7, that this burden would take about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81830.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2 hours/year. Therefore, the total annual burden will be 2 hrs x 1,278 = 2,556 hours, as shown in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81854.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">table 7 of this document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:81877.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Description of Respondents: </FONT></u><FONT STYLE="font-size: 10.05pt">Applicants and manufacturers of medical products for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81900.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">humans and drugs for ruminants that are manufactured from, or otherwise contain, material from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:81923.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle slaughtered on or after the effective date of the regulation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:191.95pt;top:81946.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Table 6.--Estimated Reporting Burden</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:320.80pt;top:81945.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:99.10pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">21</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:109.55pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">CFR Section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:215.40pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:212.30pt;top:81966.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Respondents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:269.20pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Frequency per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:277.25pt;top:81966.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:344.70pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:335.95pt;top:81966.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Responses</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:390.35pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Hours per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:390.95pt;top:81966.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:439.60pt;top:81956.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:438.25pt;top:81966.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Hours</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:81955pt;width:155pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:81955pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:264pt;top:81955pt;width:58pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:81955pt;width:61pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:81955pt;width:44pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:81955pt;width:37pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:81955pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:81956pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:81976.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">300.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:81976.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">200(b)(2)(i) and (b)(2)(ii),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:81986.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">500.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:81986.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">200(b)(2)(i) and (b)(2)(ii),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:81995.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">600.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:81995.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">16(b)(2)(i) and (b)(2)(ii),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82005.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">895.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:82005.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">102(b)(2)(i) and (b)(2)(ii), and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:65.80pt;top:82015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:70.05pt;top:82015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:72.10pt;top:82015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">470</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:84.65pt;top:82015.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">(b)(2)(i) and (b)(2)(ii)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:254.60pt;top:81976.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3 1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:375.20pt;top:81976.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3 120 360</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:48pt;top:81975pt;width:154pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:81975pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:264pt;top:81975pt;width:58pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:81975pt;width:61pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:81975pt;width:44pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:81975pt;width:37pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:81975pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:81976pt;width: 1pt;height:48pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">300.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">200(c)(5), 500.200(c)(5), 600.16(c)(5),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82034.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">895.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:82034.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">102(c)(5), and 1271.470(c)(5)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:242.00pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:246.25pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:250.40pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">87 1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:362.60pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:366.85pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:371.00pt;top:82025.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">87 2.5 9467.5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:48pt;top:82024pt;width:154pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:82024pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:264pt;top:82024pt;width:58pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:82024pt;width:61pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82024pt;width:44pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82024pt;width:37pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82024pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82025pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:439.30pt;top:82045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">98</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:447.60pt;top:82045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">27.5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82044pt;width:419pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:203pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:263pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:322pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82045pt;width: 1pt;height: 9pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82054.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:57.35pt;top:82055.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">There are no capital costs or operating and maintenance costs associated with this collection of information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82054pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82054pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:170.00pt;top:82076.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Table 7.--Estimated Annual Recordkeeping Burden</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.80pt;top:82075.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:91.55pt;top:82086.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">21 CFR Section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:200.25pt;top:82086.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:197.15pt;top:82096.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Respondents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:255.35pt;top:82086.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Annual Frequency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:263.95pt;top:82096.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">per Response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:332.00pt;top:82086.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total Annual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:336.60pt;top:82096.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Responses</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:390.35pt;top:82086.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Hours per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:390.95pt;top:82096.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Response</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:439.65pt;top:82086.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:438.25pt;top:82096.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">Hours</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82086pt;width:140pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:188pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:188pt;top:82086pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:248pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:249pt;top:82086pt;width:74pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:82086pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82086pt;width:44pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82086pt;width:37pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82086pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:188pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:248pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82086pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82106.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">300.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:82106.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">200(c), 500.200(c), 600.16(c),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82116.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">895.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:67.90pt;top:82116.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">102(c), and 1271.470(c)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:224.80pt;top:82106.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">1,278 1 1,278 2 2,556</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:48pt;top:82105pt;width:139pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:188pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:188pt;top:82105pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:248pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:249pt;top:82105pt;width:74pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:324pt;top:82105pt;width:59pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82105pt;width:44pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82105pt;width:37pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82105pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:188pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:248pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:323pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:384pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:429pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82106pt;width: 1pt;height:19pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:53.30pt;top:82125.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.43pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:57.35pt;top:82126.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.39pt">There are no capital costs or operating and maintenance costs associated with this collection of information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:47pt;top:82125pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:467pt;top:82125pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:82148.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82171.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">agency has submitted the information collection </FONT></FONT><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">provisions </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of this proposed rule to OMB for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:82170pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82194.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">review.  Interested persons are requested to </FONT></FONT><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">send </FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comments regarding information collection to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:82193pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82217.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">OMB </FONT></FONT><u><FONT COLOR="ff0101"><FONT STYLE="font-size: 10.05pt">(see DATES and ADDRESSES)</FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:52pt;top:82217pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:185.00pt;top:82240.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">X.  Environmental Impact Analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.65pt;top:82263.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA has carefully considered the potential environmental effects of this proposed rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82286.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i.e., ban use of prohibited cattle materials in medical products for humans and drugs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:82161.05pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:82161.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:82184.15pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:82184.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">fax</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:82207.20pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:82207.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">the Office of Information and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:82215.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Regulatory Affairs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:82227.70pt;z-index:3;"><FONT FACE ="Tahoma" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">Deleted:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.90pt;top:82228.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">, Attn: FDA Desk Officer,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:482.40pt;top:82236.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">FAX: 202
¶974</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:81701.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1373748794.htm_files\outputfile-1373748794_background103.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:82493.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:82523.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:82523.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82553.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ruminants, unless a request for exception or alternative to the requirements has been granted) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82576.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of two possible alternative actions:  (1) No action and (2) in addition to the requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82599.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">proposed in this rule, ban use in medical products for humans and drugs for ruminants of all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82622.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">neural material from cattle from countries with a high or medium risk of BSE if the cattle were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82646.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">slaughtered when over 6 months old, unless a request for exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82669.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements has been granted.  In doing so, the agency focused on the environmental impacts of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82692.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its action, specifically, disposal of unused cattle byproducts (e.g., dead animals and slaughter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82715.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">byproducts) that can no longer be used in medical products for humans or drugs for ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82738.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">after the rule becomes effective.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.65pt;top:82761.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The environmental assessment (EA) considered each of the alternatives in terms of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82784.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">need to provide maximum reasonable protection of human health without resulting in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82807.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">significant impact on the environment. The EA considered environmental impacts related to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82831.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">landfill, incineration, composting, and land burial.  The additional waste that might result from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82854.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the selected action would be an extremely small amount compared to the total amount of waste</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82877.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">generated by the cattle industry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.65pt;top:82900.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The agency has concluded that the proposed rule will not have a significant impact on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82923.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the human environment and that an environmental impact statement is not required.  FDA's</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82946.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">finding of no significant impact (FONSI) and the evidence supporting that finding, contained in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82969.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">an EA prepared under 21 CFR 25.40, may be seen in the Dockets Management Branch (see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:82992.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. FDA invites comments and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83015.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">submission of data concerning the EA and FONSI.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:83285.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:83315.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:83315.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:224.95pt;top:83345.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">XI.  Federalism</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:83368.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">We have analyzed this proposed rule in accordance with the principles in Executive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83391.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Order 13132.  We have determined that the proposed rule does not contain policies that have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83414.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">substantial direct effects on the States, on the relationship between the National Government and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83438.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the States, or on the distribution of power and responsibilities among the various levels of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83461.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">government. Accordingly, we have concluded that the proposed rule does not contain policies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83484.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that have federalism implications as defined in the Executive order and, consequently, a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83507.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">federalism summary impact statement has not been prepared.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:223.20pt;top:83530.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">XII.  References</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:83553.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The following references have been placed on display in the Division of Dockets</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83576.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83599.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">p.m</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:83599.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">., Monday through Friday.  (FDA has verified the Web site address, but we are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83623.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">responsible for subsequent changes to the Web site after this document publishes in the </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Fede</FONT></u><FONT STYLE="font-size: 10.05pt">ral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:83646.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Register</FONT></u><FONT STYLE="font-size: 10.05pt">.)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:83669.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:83669.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Johnson, R. T. and C. J. Gibbs, Jr., “Creutzfeldt-Jakob</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:83692.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Disease and Related Transmissible Spongiform Encephalopathies,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:83715.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">New England Journal of Medicine</FONT></u><FONT STYLE="font-size: 10.05pt">, 339(27):1994-2004, 1998.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:83743.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:83743.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Herzog, C., N. Sales, N. Etchegaray, et al., “Tissue</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:83766.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Distribution Of Bovine Spongiform Encephalopathy Agent in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:83789.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Primates After Intravenous or Oral Infection,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Lancet</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:83812.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">363</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:83812.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(9407):422-28, 2004.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:83836.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:83836.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.30pt;top:83836.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Wells, G. A. H., S. A. C. Hawkins, R. B. Green, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:83859.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Preliminary Observations on the Pathogenesis of Experimental</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:84077.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:84107.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:84107.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84137.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Bovine Spongiform Encephalopathy (BSE):  An Update,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84160.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Veterinary Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 142:103-106, 1998.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:84183.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:84183.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.30pt;top:84183.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Wells, G. A. H., M. Dawson, S. A. C. Hawkins, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84206.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Infectivity in the Ileum of Cattle Challenged Orally With Bovine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84230.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Spongiform Encephalopathy,”  Veterinar</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">y Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 135:40-41,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84253.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">199</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:84253.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:84276.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:84276.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.30pt;top:84276.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Wells, G. A. H., S. A. C. Hawkins, R. B. Green, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84299.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Limited Detection of Sternal Bone Marrow Infectivity in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84322.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Clinical Phase of Experimental Bovine Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84345.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy (BSE),” Veterinar</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">y Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 144:292-294, 1999.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:84368.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:84368.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:163.30pt;top:84368.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Brown, K. L, D. L. Ritchie, P. A. McBride, and M. E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84391.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Bruce, “Detection of PrP in Extraneural Tissues,” </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Microscopy</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84414.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Research and Technique</FONT></u><FONT STYLE="font-size: 10.05pt">, 50:40-45, 2000.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:84438.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7.  U. S. Department of Agriculture, APHIS, “Summary of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84461.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Enhanced BSE Surveillance in the United States,” 2006 accessed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84484.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84507.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/print">http://www</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/print">aphis.usda.gov/newsroom/ho</a></FONT><FONT STYLE="font-size: 10.05pt">t</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/print">_issues/bse/content/print</a></FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84530.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">able_version/SummaryEnhancedBSE-Surv4-26-06.pdf.8.  Council</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84553.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for Agricultural Science and Technology, “Transmissible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84576.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Spongiform Encephalopathies in the United States,” Task Force</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84599.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Report No. 136, 2000.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:84869.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:84899.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:84899.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:84929.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:84929.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Prusiner, S. B., “Prions,”  Pro</FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ceedings of the National</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84952.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Academy of Sciences of the United States of America</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:84975.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">95(23):13363-13383, 1998.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:84998.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10.  Prusiner, S. B., “Shattuck Lecture—Neurodegenerative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85022.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Diseases and Prions,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">New England Journal of Medicine</FONT></u><FONT STYLE="font-size: 10.05pt">, 344(20):</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:85045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6-152</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:159.10pt;top:85045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6, 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85068.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85068.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85068.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Legname, G., I.V. Baskakov, H. B. Nguyen, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85091.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Synthetic Mammalian Prions,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Science</FONT></u><FONT STYLE="font-size: 10.05pt">, 305:673-676, 2004.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85114.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85114.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85114.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Collins, S. J., V. A. Lawson, and C. L. Masters,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85137.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Transmissible Spongiform Encephalopathies,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Lancet</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:85160.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(9402):51-61, 2003.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85183.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13.  Collee, J. G. and R. Bradley, “BSE: A Decade On--</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85206.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Part I,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Lancet</FONT></u><FONT STYLE="font-size: 10.05pt">, 349:636-641, 1997.</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85230.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85230.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Anderson, R. M., C. A. Donnelly, N. M. Ferguson, et</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85253.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">al., “Transmission Dynamics and Epidemiology of BSE in British</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85276.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cattle,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nature</FONT></u><FONT STYLE="font-size: 10.05pt">, 382:779-788, 1996.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85299.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85299.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85299.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Wells, G. A. H., A. C. Scott, C. T. Johnson, et al., “A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85322.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Novel Progressive Spongiform Encephalopathy in Cattle,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85345.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Veterinary Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 121:419-420, 1987.</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85368.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85368.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Vossen, P., J. Kreysa, and M. Goll, “Overview of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85391.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">BSE Risk Assessments of the European Commission’s Scientific</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85415.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Steering Committee (SSC) and Its TSE/BSE Ad Hoc Group,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:85661.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:85691.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:85691.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85721.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:85721.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85744.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out364_en.pdf">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out364_en.pdf">europa.eu.int/comm/food</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out364_en.pdf">fs/sc/ssc/out364_en.pdf</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85767.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85767.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85767.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Kimberlin, R. H. and J. W. Wilesmith, “Bovine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85790.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Spongiform Encephalopathy: Epidemiology, Low Dose Exposure,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85814.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and Risks,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Annals of the New York Academy of Sciences</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85837.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">724</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:85837.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">:210-220, 1994.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85860.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85860.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85860.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  World Organisation for Animal Health (OIE),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85883.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Number of Cases of BSE Reported in the United Kingdom,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85906.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Accessed online at </FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbru.htm">http:/</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbru.htm">www.o</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">i</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbru.htm">e.in</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbru.htm">/eng/info/en_esbru.htm</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:85929.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:85929.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:85929.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  World Organisation for Animal Health (OIE),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85952.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Number of Reported Cases of bovine spongiform encephalopathy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85975.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(BSE) in Farmed Cattle Worldwide (excluding the United</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:85999.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Kingdom),” accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86022.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbmonde.htm">ht</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbmonde.htm">p://www.oie.int/eng/info</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/info/en_esbmonde.htm">en_esbmonde.htm</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86045.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Brown, P., “The Risk of Bovine Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86068.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy (‘Mad Cow Disease’) to Human Health,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Jo</FONT></u><FONT STYLE="font-size: 10.05pt">urnal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86091.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">of the American Medical Association</FONT></u><FONT STYLE="font-size: 10.05pt">, 278(12):1008-1011, 1997.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86114.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21.  Will, R. G., J. W. Ironside, M. Zeidler, et al., “A New</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86137.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Variant of Creutzfeldt-Jakob Disease in the UK,”  </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Lancet</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86160.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">347</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:86160.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">:921-925, 1996.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86183.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86183.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86183.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Chazot, G., E. Broussolle, C. I. Lapras, et al., “New</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86207.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Variant of Creutzfeldt-Jakob Disease in a 26-Year-Old French</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86230.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Man,” Lancet, 347:1181, 1996.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:148pt;top:86240pt;width:27pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;left:71.76pt;top:86453.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:86483.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:86483.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86513.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86513.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86513.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Collinge, J., “Prion Diseases of Humans and Animals:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86536.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Their Causes and Molecular Basis,” Annua</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">l Review </FONT></u><FONT STYLE="font-size: 10.05pt">of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86559.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Neuroscience</FONT></u><FONT STYLE="font-size: 10.05pt">, 24:519-550, 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86582.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86582.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86582.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Almond, J. and J. Pattison, “Human BSE,” Natu</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">re</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:86606.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">:437-438, 1997.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86629.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86629.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86629.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Scott, M. R., R. Will, J. Ironside, et al., “Compelling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86652.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Transgenetic Evidence for Transmission of Bovine Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86675.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy Prions to Humans,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Proceedings of the Nationa</FONT></u><FONT STYLE="font-size: 10.05pt">l</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86698.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Academy of Sciences of the United States of America</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86721.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">96(26):15137-15142, 1999.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86744.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86744.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86744.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Hill, A. F., M. Desbruslais, S. Joiner, et al., “The Same</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86767.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prion Strain Causes vCJD and BSE,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nature</FONT></u><FONT STYLE="font-size: 10.05pt">, 389:448-450, 1997.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86790.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86790.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86790.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Collinge, J., “Variant Creutzfeldt-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86814.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Jakob Disease,” L</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ancet</FONT></u><FONT STYLE="font-size: 10.05pt">, 354:317-323, 1999.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86837.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:86837.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:86837.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Lasmezas, C. I., J-G. Fournier, V. Nouvel, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86860.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Adaptation of the Bovine Spongiform Encephalopathy Agent to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86883.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Primates and Comparison With Creutzfeldt-Jakob Disease:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86906.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Implications for Human Health,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Proceedings of the Nationa</FONT></u><FONT STYLE="font-size: 10.05pt">l</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86929.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Academy of Sciences of the United States of America</FONT></u><FONT STYLE="font-size: 10.05pt">, 98(7):4142-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86952.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">414</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:86952.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7, 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:86975.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">29.  Bruce, M. E., R. G. Will, J. W. Ironside, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:86999.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Transmissions to Mice Indicate That ‘New Variant’ CJD Is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87022.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Caused by the BSE Agent, </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nature</FONT></u><FONT STYLE="font-size: 10.05pt">, 389:498-501, 1997.</FONT></FONT></FONT></SPAN>
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<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:87275.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:87275.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87305.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">30.  Brown, P., R. G. Will, R. Bradley, et al., “Bovine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87328.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Spongiform Encephalopathy and Variant Creutzfeldt-Jakob</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87351.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Disease: Background, Evolution, and Current Concerns,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87374.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Emerging Infectious Diseases</FONT></u><FONT STYLE="font-size: 10.05pt">, 7(1):6-16, 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87398.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:87398.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.35pt;top:87398.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scientific Steering Committee, European Commission,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87421.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Opinion of the Scientific Steering Committee on the Human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87444.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Exposure Risk (HER) via Food With Respect to BSE,” 1999.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87467.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">32.  The National Creutzfeldt-Jakob Disease Surveillance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87490.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Unit, United Kingdom, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87513.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.cjd.ed.ac.uk/figures.htm">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.cjd.ed.ac.uk/figures.htm">cjd.ed.ac.uk/figures.htm</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87536.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:87536.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:87536.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Public Health Agency of Canada, “First Canadian Case</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87559.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of Variant Creutzfeldt-Jakob Disease (Variant CJD),” accessed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87583.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">online at </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.phac-aspc.gc.ca/cjd-mcj/vcjd-ca_e.html.">h</a></FONT><FONT STYLE="font-size: 10.05pt">t</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.phac-aspc.gc.ca/cjd-mcj/vcjd-ca_e.html.">tp://www.phac-aspc.gc</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.phac-aspc.gc.ca/cjd-mcj/vcjd-ca_e.html.">ca/cjd-mc</a></FONT><FONT STYLE="font-size: 10.05pt">j</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.phac-aspc.gc.ca/cjd-mcj/vcjd-ca_e.html.">/vcjd-ca_e.htm</a></FONT><FONT STYLE="font-size: 10.05pt">l.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87606.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:87606.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:87606.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Wiersma, S., S. Cooper, R. Knight et al., “Probable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87629.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Variant Creutzfeldt-Jakob Disease in a U.S. Resident-Florida,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87652.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:87652.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2,” Mo</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">rbidity and Mortality Weekly Report</FONT></u><FONT STYLE="font-size: 10.05pt">, 51:927-929, 2002.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87675.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:87675.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:87675.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  “Probable Case of Indigenous vCJD diagnosed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87698.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Ireland,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Eurosurveillance Weekly</FONT></u><FONT STYLE="font-size: 10.05pt">, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87721.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.eurosurveillance.org/ew/2004/041111.asp">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.eurosurveillance.org/ew/2004/041111.asp">eurosurveillance.org/ew/2004/041111.asp</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:87744.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:87744.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:87744.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Belay, E.D., J.J. Sejvar, W-J Shieh, et al., “Variant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87767.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Creutzfeldt-Jakob disease death, United States,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Emergi</FONT></u><FONT STYLE="font-size: 10.05pt">ng</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87791.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Infectious Diseases</FONT></u><FONT STYLE="font-size: 10.05pt">, 11 (9), 1351-1354, 2005, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:87814.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.cdc.gov/ncidod/EID/vol11no09/05-0371.htm">http://www</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.cdc.gov/ncidod/EID/vol11no09/05-0371.htm">cdc.gov/ncidod/EID/vo</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">l</FONT><FONT COLOR="000000"></FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.cdc.gov/ncidod/EID/vol11no09/05-0371.htm">11no09/05-0371.htm</a></FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:88037.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:88067.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:88067.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88097.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:88097.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88097.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The European and Allied Countries Collaborative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88120.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Study Group of CJD (EUROCJD), accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88143.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.eurocjd.ed.ac.uk/vCJD.htm">ht</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.eurocjd.ed.ac.uk/vCJD.htm">p://www.eurocjd.ed.ac.uk/vCJD</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.eurocjd.ed.ac.uk/vCJD.htm">htm</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88166.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:88166.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88166.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Fuyuno, I., “Japan Plans Blood-Donor Restrictions to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88190.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Combat vCJD,” Nature, 434:260, 2005.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:187pt;top:88200pt;width:27pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88213.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:88213.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88213.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Brown, P., “Bovine Spongiform Encephalopathy and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88236.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Variant Creutzfeldt-Jakob Disease,” B</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ritish Medical Journal</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88259.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">322</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:88259.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">:841-844, 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88282.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:88282.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.35pt;top:88282.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scientific Steering Committee, European Commission,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88305.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Oral Exposure of Humans to the BSE Agent: Infective Dose and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88328.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Species Barrier,” 2000, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88351.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf">europa.eu.int/comm/food</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf">fs/sc/ssc/out79_en</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf">pdf</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88374.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">41</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88374.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.30pt;top:88374.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Harvard Center for Risk Analysis, Harvard School of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88398.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Public Health, “Evaluation of the Potential for Bovine Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88421.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy in the United States,” 2003, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88444.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.hcra.harvard.edu/pdf/madcow.pdf">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.hcra.harvard.edu/pdf/madcow.pdf">hcra.harvard</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.hcra.harvard.edu/pdf/madcow.pdf">edu/pdf/madcow.pdf</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88467.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88467.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.30pt;top:88467.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Harvard Center for Risk Analysis, Harvard School of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88490.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Public Health, “Harvard Risk Assessment of Bovine Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88513.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy Update, Phase IA,” 2005, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88536.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000ff"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp#bs">http</a></FONT></FONT><FONT COLOR="0000ff"><FONT STYLE="font-size: 10.05pt">:</FONT></FONT><FONT COLOR="0000ff"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp#bs">//www.fsis</a></FONT></FONT><FONT COLOR="0000ff"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000ff"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp#bs">usda.gov/Science/Risk_Assessments/index.asp#bs</a></FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88559.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000ff"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp#bse">e</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:88829.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:88859.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:88859.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88889.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:88889.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88889.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  U.S. Department of Agriculture, APHIS, accessed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88912.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88935.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html">http:</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">//</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html">www.aphis.usda.gov/lpa/issues/bse_</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html">esting/test_results.htm</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">l</FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:88958.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:88958.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:88958.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Comer, P.J. and P.J. Huntly, “Exposure of the human</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:88982.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">population to BSE infectivity over the course of the BSE epidemic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89005.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in Great Britain and the impact of changes to the Over Thirty</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89028.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Month Rule,” 2003, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89051.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.food.gov.uk/multimedia/pdfs/otmcomer.pdf">http:</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">//</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.food.gov.uk/multimedia/pdfs/otmcomer.pdf">www</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT><FONT COLOR="000000"></FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.food.gov.uk/multimedia/pdfs/otmcomer.pdf">food.gov.uk/multimedia/pdfs/otmcomer.pdf</a></FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89074.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89074.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89074.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Lasmezas, C.I., J-P. Deslys, O. Robain, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89097.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Transmission of the BSE Agent to Mice in the Absence of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89120.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Detectable Abnormal Prion Protein,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Science</FONT></u><FONT STYLE="font-size: 10.05pt">, 275:402-405, 1997.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89143.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89143.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89143.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Race, R., A. Raines, G. J. Raymond, et al., “Long-term</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89167.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Subclinical Carrier State Precedes Scrapie Replication and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89190.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Adaptation in a Resistant Species: Analogies to Bovine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89213.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Spongiform Encephalopathy and Variant Creutzfeldt-Jakob</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89236.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Disease in Humans,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Journal of Virology</FONT></u><FONT STYLE="font-size: 10.05pt">, 75(21):10106-10112,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89259.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:89259.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89282.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89282.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89282.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Kimberlin, R. H., S. Cole, et al., “Pathogenesis of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89305.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scrapie Is Faster When Infection Is Intraspinal Instead of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89328.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Intracerebral,” Mic</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">robial Pathogenesis</FONT></u><FONT STYLE="font-size: 10.05pt">, 2(6):405-415, 1987.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89351.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89351.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89351.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Kimberlin, R. H. and C. A. Walker. “Pathogenesis of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89375.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mouse Scrapie:  Effect of Route of Inoculation on Infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:89621.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:89651.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:89651.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89681.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Titres and Dose-Response Curves,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Journal of Compar</FONT></u><FONT STYLE="font-size: 10.05pt">ative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89704.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Pathology</FONT></u><FONT STYLE="font-size: 10.05pt">, 88(1):39-47, 1978.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89727.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89727.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89727.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Kimberlin, R. H. and C. A. Walker, “Pathogenesis of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89750.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mouse Scrapie: Dynamics of Agent Replication in Spleen, Spinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89774.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cord and Brain After Infection by Different Routes,” Journal of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:336pt;top:89784pt;width:40pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89797.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Comparative Pathology</FONT></u><FONT STYLE="font-size: 10.05pt">, 89(4):551-562, 1979.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89820.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89820.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89820.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Baier, M., S. Norley, J. Schultz, et al.,  “Prion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89843.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Diseases:  Infectious and Lethal Doses Following Oral Challenge,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89866.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Journal of General Virology</FONT></u><FONT STYLE="font-size: 10.05pt">, 84(Pt 7):1927-1929, 2003.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89889.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89889.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89889.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Gibbs, C. J., Jr., H. L. Amyx, A. Bacote, et al., “Oral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89912.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Transmission of Kuru, Creutzfeldt-Jakob Disease, and Scrapie to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89935.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Nonhuman Primates,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Journal of Infectious Diseases</FONT></u><FONT STYLE="font-size: 10.05pt">, 142(2):205-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:89958.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">208</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:89958.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">, 1980.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:89982.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:89982.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:89982.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Pattison, I. H., M. N. Hoare, J.N. Jebbett, and W.A.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90005.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Watson, “Spread of Scrapie to Sheep and Goats by Oral Dosing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90028.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">With Foetal Membranes From Scrapie-Affected Sheep,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90051.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Veterinary Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 90(17):465-468, 1972.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90074.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90074.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90074.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Pattison, I. H., M. N. Hoare, J.N. Jebbett, and W.A.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90097.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Watson, “Further Observations on the Production of Scrapie in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90120.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Sheep by Oral Dosing With Foetal Membranes From Scrapie-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90143.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Affected Sheep,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">British Veterinary Journal</FONT></u><FONT STYLE="font-size: 10.05pt">, 130(4):lxv-lxvii,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90167.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">197</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:90167.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:90413.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:90443.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:90443.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90473.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90473.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90473.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Pattison, I. H. and G. C. Millson, "Experimental</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90496.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Transmission of Scrapie to Goats and Sheep by the Oral Route,”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90519.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Journal of Comparative Pathology</FONT></u><FONT STYLE="font-size: 10.05pt">, 71:171-176, 1961.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90542.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90542.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90542.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Race, R., M. Oldstone, and B. Chesebro,  “Entry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90566.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Versus Blockade Of Brain Infection Following Oral or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90589.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Intraperitoneal Scrapie Administration:  Role of Prion Protein</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90612.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Expression in Peripheral Nerves and Spleen,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Journal of Virology</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90635.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">74(2):828-833, 2000.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90658.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90658.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90658.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Kimberlin, R. H. and Walker, C. A., “Pathogenesis of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90681.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Experimental Scrapie” in Nov</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">el Infectious Agents and the Ce</FONT></u><FONT STYLE="font-size: 10.05pt">ntral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90704.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nervous System</FONT></u><FONT STYLE="font-size: 10.05pt">,  Eds. G. Bock and J. Marsh, Wiley, Chichester</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90727.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(Ciba Foundation Symposium 135): Wiley, 37-62, 1988.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90750.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90750.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90750.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Scott, J. R., J. D. Foster and H. Fraser, “Conjunctival</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90774.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Instillation of Scrapie in Mice Can Produce Disease,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Veterina</FONT></u><FONT STYLE="font-size: 10.05pt">ry</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90797.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Microbiology</FONT></u><FONT STYLE="font-size: 10.05pt">, 34(4):305-309, 1993.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90820.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90820.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90820.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Klitzman R. L., M. P. Alpers, and D. C. Gajdusek, et</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90843.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">al., “The Natural Incubation Period of Kuru and the Episodes of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90866.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Transmission in Three Clusters of Patients,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Neuroepidemiology</FONT></u><FONT STYLE="font-size: 10.05pt">,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90889.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3(1):3-20, 1984.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:90912.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:90912.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:90912.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Sugaya, M., K. Nakamura, T. Watanabe, et al.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90935.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Expression of Cellular Prion-Related Protein by Murine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90958.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Langerhans Cells and Keratinocytes,” </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Journal of Dermatological</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:90981.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Science</FONT></u><FONT STYLE="font-size: 10.05pt">, 28:126-134, 2002.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:91205.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:91235.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:91235.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:91265.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:91265.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.35pt;top:91265.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scientific Steering Committee, European Commission,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91288.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Update of the Opinion on TSE Infectivity Distribution in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91311.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Ruminant Tissues,” initially adopted by the Scientific Steering</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91334.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Committee at its meeting of January, 10-11, 2002, and amended at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91358.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its meeting of November 7-8, 2002, following the submission of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91381.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) a risk assessment by the German Federal Ministry of Consumer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91404.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Protection, Food and Agriculture and (2) new scientific evidence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91427.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">regarding BSE infectivity distribution in tonsils, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91450.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/bse/scientific_advice08_e">http:</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">//</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/bse/scientific_advice08_e">www.europa.eu.int/comm/food/fs/bse/sc</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">i</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/bse/scientific_advice08_e">entific_advice08_e</a></FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91473.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/bse/scientific_advice08_en.html">n.h</a></FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:91473.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/fs/bse/scientific_advice08_en.html">m</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">l</FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:91496.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:91496.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:91496.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Department for Environment Food and Rural Affairs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91519.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">United Kingdom, “BSE: Statistics--Age at Clinical Onset in Years</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91543.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by Birth Cohort,” accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91566.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.defra.gov.uk/animalh/bse/statistics/bse/age.htm">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.defra.gov.uk/animalh/bse/statistics/bse/age.htm">defra.gov.uk</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.defra.gov.uk/animalh/bse/statistics/bse/age.htm">animalh/bse/sta</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.defra.gov.uk/animalh/bse/statistics/bse/age.htm">istics/bse</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.defra.gov.uk/animalh/bse/statistics/bse/age.htm">age.htm</a></FONT></FONT></u><b><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></i></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:91589.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:91589.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:91589.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.   Wilesmith, J. W. and J. B. M. Ryan, “Bovine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91612.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Spongiform Encephalopathy: Recent Observations on the Age-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91635.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Specific Incidences,” Veterinary </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 130:491-492, 1992.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:91658.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:91658.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:91658.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Health and Consumer Protection Directorate-General,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91681.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">European Commission, “Report on the Monitoring and Testing of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91704.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Ruminants for the Presence of Transmissible Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91727.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy (TSE) in 2002,” 2003, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91751.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/food/biosafety/bse/annual_re">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/food/biosafety/bse/annual_re">europa.eu.int/comm/food</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/food/biosafety/bse/annual_re">food/biosafety</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">/</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/food/biosafety/bse/annual_re">bse/annual_re</a></FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:91774.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.europa.eu.int/comm/food/food/biosafety/bse/annual_report_2002_en.pdf">port_2002_en.pdf</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:91997.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:92027.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:92027.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92057.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92057.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92057.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Doherr, M. G., D. Heim, R. Fatzer, et al., “Targeted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92080.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Screening of High-Risk Cattle Populations for BSE to Augment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92103.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Mandatory Reporting of Clinical Suspects,” Pre</FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ventive Veterinary</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92126.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Medicine</FONT></u><FONT STYLE="font-size: 10.05pt">, 51:3-16, 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92150.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92150.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92150.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Taylor, D. M., S. L. Woodgate, and M. J. Atkinson,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92173.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Inactivation of the Bovine Spongiform Encephalopathy Agent by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92196.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Rendering Procedures,” </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Veterinary Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 137:605-610, 1995.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92219.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92219.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92219.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Taylor, D. M., S. L. Woodgate, A. J. Fleetwood, and R.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92242.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">J. G. Cawthorne, “The Effect of Rendering Procedures on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92265.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Scrapie Agent,” V</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">eterinary Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 141:643-649, 1997.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92288.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92288.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92288.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Wilesmith, J. W., G. A. H. Wells, M. P. Cranwell, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92311.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">J. B. M. Ryan, “Bovine Spongiform Encephalopathy:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92334.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Epidemiological Studies,” Veterinar</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">y Record</FONT></u><FONT STYLE="font-size: 10.05pt">, 123:638-644, 1988.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92358.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92358.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92358.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  World Organisation for Animal Health (OIE),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92381.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">“Terrestrial Animal Health Code, Bovine Spongiform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92404.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Encephalopathy,” 2005, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92427.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm.">http://www</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm.">oie</a></FONT><FONT STYLE="font-size: 10.05pt">.i</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm.">nt/eng/normes/mcode/en_chapitre_2.3.13.htm</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92450.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92450.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92450.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  U.S. Department of Health and Human Services, Food</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92473.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and Drug Administration, Transcript of meeting of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92496.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Transmissible Spongiform Encephalopathies Advisory Committee,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92519.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">April 16, 1998, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92543.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t2.pdf">http://www</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t2.pdf">fda.gov/ohrms/dockets/ac/98/transcpt/3406</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t2.pdf">2</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3406t2.pdf">pdf</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:92789.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:92819.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:92819.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:150.80pt;top:92849.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:155.75pt;top:92849.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:160.80pt;top:92849.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:173.30pt;top:92849.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S. Department of Health and Human Services,  Centers for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92872.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Disease Control and Prevention, “Probable Variant Creutzfeldt-Jakob Disease in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92895.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.K</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:137.60pt;top:92895.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">. Citizen Who Had Temporarily Resided in Texas, 2001-2005, November 18,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92918.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:135.65pt;top:92918.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5, accessed online at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92942.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.cdc.gov/ncidod/dvrd/vcjd/other/probablevcjd_texas2001_2005_11180">http://www</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.cdc.gov/ncidod/dvrd/vcjd/other/probablevcjd_texas2001_2005_11180">cdc.gov/ncidod/dvrd/vc</a></FONT><FONT STYLE="font-size: 10.05pt">j</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.cdc.gov/ncidod/dvrd/vcjd/other/probablevcjd_texas2001_2005_11180">d/other/probablevcjd_texas2001_2005_11180</a></FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:120.60pt;top:92965.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5.h</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:133.15pt;top:92965.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tm.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:224.75pt;top:92988.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">List of Subjects</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93011.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 211</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93034.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs, Labeling, Laboratories, Packaging and containers, Prescription drugs, Reporting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93057.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and recordkeeping requirements, Warehouses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93080.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 226</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93103.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Animal drugs, Animal feeds, Labeling, Packaging and containers, Reporting and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93126.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">recordkeeping requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93150.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 300</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93173.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs, Incorporation by reference, Prescription drugs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93196.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 500</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93219.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Animal drugs, Animal feeds, Cancer, Incorporation by reference, Labeling, Packaging</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93242.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and containers, Polychlorinated biphenyls (PCBs).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93265.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 530</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93288.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Administrative practice and procedure, Advertising,  Animal drugs, Labeling, Reporting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93311.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and recordkeeping requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93334.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 600</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93357.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Biologics, Incorporation by reference, Reporting and recordkeeping requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:93581.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:93611.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:93611.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93641.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 895</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93664.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Administrative practice and procedure, Incorporation by reference, Labeling, Medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93687.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">devices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93710.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">21 CFR Part 1271</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93734.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Biologics, Drugs, Human cells and tissue-based products, Incorporation by reference,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93757.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Medical devices, Reporting and recordkeeping requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93780.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93803.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">delegated to the Commissioner of Food and Drugs, FDA proposes to amend 21 CFR parts 211,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93826.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">226</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:93826.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">, 300, 500, 530, 600, 895, and 1271 as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93849.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93872.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PHARMACEUTICALS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93895.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:93895.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The authority citation for 21 CFR part 211 continues to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93918.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Authority</FONT></u><FONT STYLE="font-size: 10.05pt">: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93942.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:93942.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:102.95pt;top:93942.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 211.116 is added to subpart F to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:93965.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 211.116  U</FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">se of cattle material</FONT></FONT></u><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:93988.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Use of certain cattle material in drug products and components is prohibited as provided</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94011.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by §§ 300.200, 500.200, and 600.16 of this chapter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94034.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94057.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ARTICLES</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94080.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:94080.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The authority citation for 21 CFR part 226 continues to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94103.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Authority</FONT></u><FONT STYLE="font-size: 10.05pt">: 21 U.S.C. 351, 352, 360b, 371, 374.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94126.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:94126.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:94126.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 226.60 is added to subpart C to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:94373.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:94403.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:94403.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94433.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 226.60 </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Use of cattle material</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94456.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Use of certain cattle material in Type A medicated articles for ruminants is prohibited as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94479.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provided by § 500.200 of this chapter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94502.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 300--GENERAL</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94526.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:94526.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The authority citation for 21 CFR part 300 is revised to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94549.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Authority</FONT></u><FONT STYLE="font-size: 10.05pt">: 21 U.S.C. 321, 331, 351, 352, 355, 360b, 361, 371, 381; 42 U.S.C. 264, 271.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94572.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:94572.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:94572.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Section 300.200 is added to subpart C to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94595.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 300.200  Proh</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ibited cattle materials</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94618.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:106pt;top:94628pt;width:45pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94641.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94664.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in this section.  The following definitions also apply:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94687.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials </FONT></u><FONT STYLE="font-size: 10.05pt">means specified risk materials; small intestine of all cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94710.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94734.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94757.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials do not include tallow that contains no more than 0.15 percent insoluble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94780.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94803.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials also do not include materials obtained from fetal calves of cows that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94826.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were inspected and passed, as long as the materials were obtained by procedures adequate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94849.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent contamination with specified risk materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:94872.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:94872.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Inspected and passed </FONT></u><FONT STYLE="font-size: 10.05pt">means that the material is from an animal that has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94895.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption by the appropriate regulatory authority, and at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:94919.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time the animal was inspected and passed, it was found to be not adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:95165.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:95195.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:95195.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:95225.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Mechanically separated beef </FONT></u><FONT STYLE="font-size: 10.05pt">means a meat food product that is finely comminuted,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95248.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from the mechanical separation and removal of most of the bone from attached skeletal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95271.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95294.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95318.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standard of identity for Mechanically Separated (Species).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:95341.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nonambulatory disabled cattle </FONT></u><FONT STYLE="font-size: 10.05pt">means cattle that cannot rise from a recumbent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95364.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">position or that cannot walk, including, but not limited to, those with broken appendages, severed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95387.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:95410.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Specified risk materials </FONT></u><FONT STYLE="font-size: 10.05pt">means the brain, skull, eyes, trigeminal ganglia, spinal cord,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95433.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95456.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95479.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">older, and the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.65pt;top:95502.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(6)  Tallow means the rendered fat of cattle obtained by pressing or by applying any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:115pt;top:95513pt;width:28pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95526.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">other extraction process to tissues derived directly from discrete adipose tissue masses or to other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95549.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95572.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or must contain not more than 0.15 percent insoluble impurities as determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95595.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95618.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.75pt;top:95616.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.50pt;top:95618.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in accordance with 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95641.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:95641.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95664.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95687.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AOCS (</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">http</a></FONT><FONT STYLE="font-size: 10.05pt">://</FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">www.aocs.org</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95711.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:95734.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Pkwy., College Park, MD 20740, or at the National Archives and Records Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:95957.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:95987.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:95987.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96017.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NARA).  For information on the availability of this material at NARA, call 202-741-6030, or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96040.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to: </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">http</a></FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">://www.arch</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">i</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">ves</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">gov/federal_regis</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">er/code_of_federal_regulations/ibr_loca</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ti</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">ons</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">h</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">m</a></FONT><FONT COLOR="000000"></FONT><FONT STYLE="font-size: 10.05pt">l</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:96063.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(7</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)  </FONT></FONT></i><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow derivative </FONT></u><FONT STYLE="font-size: 10.05pt">means any chemical obtained through initial hydrolysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96086.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">saponification, or trans-esterification of tallow; chemical conversion of material obtained by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96110.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:96133.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Requirements. </FONT></u><FONT STYLE="font-size: 10.05pt">(1)  At a minimum, except as provided in paragraph (b)(2) of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96156.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section, no drug intended for use in humans shall be manufactured from, or otherwise contain,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96179.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials obtained from cattle slaughtered on or after [insert effective date of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96202.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">final rule].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:96225.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96248.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials shall not apply if FDA grants written permission for an exception or alternative to such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96271.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:96295.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  To obtain written permission from FDA, you must send a written request to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96318.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Director of the Center for Drug Evaluation and Research, Food and Drug Administration, 5600</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96341.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Fishers Lane, Rockville, MD 20857.  For a drug subject to an application, your written request</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96364.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">must reference its application number.  The Center Director may also grant written permission</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96387.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for an exception or alternative to the requirements in paragraph (b)(1) of this section on his own</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96410.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">initiative and shall base such a determination on an evaluation of the criteria described in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96433.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">paragraph (b)(2)(ii) of this section.  You must maintain a record of any exception or alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96456.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to the requirements in paragraph (b)(1) of this section that is granted by FDA, in accordance with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96479.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">paragraph (c) of this section.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:96503.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii)  A written request for an exception or alternative to the requirements in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96526.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(1) of this section must include, for each applicable product:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:96749.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:96779.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:96779.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:96809.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(A)  A statement of the reasons why an exception or alternative is needed;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:96832.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(B)  A description of the product, including the type of prohibited cattle materials used in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96855.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its manufacturing, its manufacturing and purification processes, and its route of administration;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:96878.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(C)  A description of the source of the prohibited cattle materials, including information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96902.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on the location where the cattle were born, raised, and slaughtered, and any other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96925.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96948.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this chapter;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:96971.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(D)  A description of how the requirements in paragraph (b)(1) of this section are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:96994.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary based on the risks of the prohibited cattle materials in the product and the benefits of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97017.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product or how such restrictions are not necessary to ensure the safety of the product; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97040.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(E)  Any other relevant information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97063.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(iii)  FDA shall respond in writing to all requests for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97087.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements and may impose conditions in granting any such request.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97110.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:97110.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The small intestine is not considered prohibited cattle material if the distal ileum is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97133.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97156.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine, as measured from the caeco-colic junction and progressing proximally towards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97179.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">jejunum, or by a procedure that the establishment can demonstrate is equally effective in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97202.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensuring complete removal of the distal ileum.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97225.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)  Record</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">s</FONT></u><FONT STYLE="font-size: 10.05pt">.  (1) Applicants and manufacturers of a drug that is manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97248.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material must establish and maintain records sufficient to demonstrate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97271.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that the material is not manufactured from, and does not contain, prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97295.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) Records must be retained for at least 1 year after the expiration date of the drug or,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97318.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">for drugs lacking an expiration date, at least 3 years after distribution of the last lot of the drug.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:97541.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:97571.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:97571.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97601.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:97601.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records must be retained at the applicant’s or manufacturer’s establishment or at a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97624.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasonably accessible location.  Records are considered to be reasonably accessible if they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97647.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accessible from an onsite location.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97670.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) Records required by this section must be readily available to FDA for inspection and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97694.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">copying.  All the records must be in English.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:97717.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.10pt;top:97717.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">When filing entry with the </FONT></FONT><FONT COLOR="323232"><FONT STYLE="font-size: 10.05pt">U.S. Customs and Border Protection, </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the importer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97740.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of a drug manufactured from, or otherwise containing, cattle material must affirm that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97763.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">drug was manufactured from, or otherwise contains, cattle material and must affirm that the drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97786.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">was manufactured in accordance with this section.  If a drug was manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97809.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material, then the importer of record must, if requested, provide to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97832.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">FDA within 5 days records that are sufficient to demonstrate that the drug is not manufactured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97855.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from, and does not contain, prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:97879.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(d) A human drug that is not in compliance with the requirements of paragraph (b) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:97902.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this section is adulterated under section 501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:97925.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(e)  Failure of an applicant or manufacturer to comply with the requirements of paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:97948.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) of this section renders a drug adulterated under section 501(a)(2)(B) of the act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:97971.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">351</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.30pt;top:97971.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(2)(B)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:97994.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:98017.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this section causes a drug to appear to be adulterated under section 801(a) of the act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.25pt;top:98040.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">381</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.30pt;top:98040.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:98063.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(g) A human drug that is a new drug and that is not in compliance with the requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98087.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of paragraph (b) of this section is in violation of section 505 of the act (21 U.S.C. 355).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:98333.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:98363.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:98363.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:98393.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(h) Failure of an applicant or manufacturer to comply with the requirements of paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98416.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) of this section is a violation of section 301(e) of the act (21 U.S.C. 331(e)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:98439.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  Any person who violates the requirements of paragraph (b) or (c) of this section shall</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98462.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be subject to the penalties provided in section 368 of the Public Health Service Act (42 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98486.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">271</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:98486.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98509.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 500--GENERAL</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:98532.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:98532.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">. The authority citation for 21 CFR part 500 is revised to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:98555.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Authority</FONT></u><FONT STYLE="font-size: 10.05pt">:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 381; 42 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98578.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">264</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:98578.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">, 271.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:98601.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:103.00pt;top:98601.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">New subpart F is added to part 500 to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98624.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Subpart F--Substances Prohibited From Animal Drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98647.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Sec.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98671.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:98671.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.85pt;top:98671.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials in drugs intended for use in ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98694.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Subpart F--Substances Prohibited From Animal Drugs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98717.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 500.200  Proh</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ibited cattle materials in drugs intended for use in ruminants</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:98740.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:106pt;top:98750pt;width:45pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98763.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98786.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in this section.  The following definitions also apply:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:98809.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials </FONT></u><FONT STYLE="font-size: 10.05pt">means specified risk materials; small intestine of all cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98832.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98855.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle; material from cattle not inspected and passed; or mechanically separated beef.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.90pt;top:98855.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98879.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials do not include tallow that contains no more than 0.15 percent insoluble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:98902.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:99125.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:99155.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:99155.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99185.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials also do not include materials obtained from fetal calves of cows that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99208.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were inspected and passed, as long as the materials were obtained by procedures adequate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99231.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent contamination with specified risk materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:99254.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:99254.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Inspected and passed </FONT></u><FONT STYLE="font-size: 10.05pt">means that the material is from an animal that has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99278.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption by the appropriate regulatory authority, and at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99301.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time the animal was inspected and passed, it was found to be not adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:99324.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Mechanically separated beef </FONT></u><FONT STYLE="font-size: 10.05pt">means a meat food product that is finely comminuted,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99347.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from the mechanical separation and removal of most of the bone from attached skeletal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99370.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99393.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99416.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standard of identity for Mechanically Separated (Species).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:99439.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nonambulatory disabled cattle </FONT></u><FONT STYLE="font-size: 10.05pt">means cattle that cannot rise from a recumbent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99462.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">position or that cannot walk, including, but not limited to, those with broken appendages, severed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99486.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tendons or ligaments, nerve paralysis, fractured vertebral column or metabolic conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:99509.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Specified risk materials </FONT></u><FONT STYLE="font-size: 10.05pt">means the brain, skull, eyes, trigeminal ganglia, spinal cord,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99532.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99555.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99578.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">older and the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:99601.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(6)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:99601.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow </FONT></u><FONT STYLE="font-size: 10.05pt">means the rendered fat of cattle obtained by pressing or by applying any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99624.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extraction process to tissues derived directly from discrete adipose tissue masses or to other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99647.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99671.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or must contain not more than 0.15 percent insoluble impurities as determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99694.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:99917.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:99947.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:99947.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:99977.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.75pt;top:99975.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.50pt;top:99977.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in accordance with 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100000.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:100000.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100023.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sensitivity to AOCS Official Method Ca 3a-46.  You may obtain copies of the method from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100046.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AOCS (</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">http</a></FONT><FONT STYLE="font-size: 10.05pt">://</FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">www.aocs.org</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100070.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100093.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Pkwy., College Park, MD 20740, or at the National Archives and Records Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100116.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NARA).  For information on the availability of this material at NARA, call 202-741-6030, or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100139.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to: </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">http://www.arch</a></FONT><FONT STYLE="font-size: 10.05pt">i</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">ves</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">gov/federal_regis</a></FONT><FONT STYLE="font-size: 10.05pt">t</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">er/code_of_federal_regulations/ibr_loca</a></FONT><FONT STYLE="font-size: 10.05pt">ti</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">ons</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">h</a></FONT><FONT STYLE="font-size: 10.05pt">t</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">m</a></FONT><FONT STYLE="font-size: 10.05pt">l.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:100162.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(7</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)  </FONT></FONT></i><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow derivative </FONT></u><FONT STYLE="font-size: 10.05pt">means any chemical obtained through initial hydrolysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100185.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">saponification, or trans-esterification of tallow; chemical conversion of material obtained by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100208.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:100231.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(8) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Ruminant </FONT></u><FONT STYLE="font-size: 10.05pt">means any member of the suborder of animals that has a stomach with four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100254.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compartments (rumen, reticulum, omasum, and abomasum) through which feed passes in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100278.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">digestion.  The suborder includes, but is not limited to, cattle, buffalo, sheep, goats, deer, elk, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100301.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">antelopes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:100324.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)  </FONT></FONT></i><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Requirements. </FONT></u><FONT STYLE="font-size: 10.05pt">(1) At a minimum, except as provided in paragraph (b)(2) of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100347.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section, no drug intended for use in ruminants shall be manufactured from, or otherwise contain,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100370.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials obtained from cattle slaughtered on or after [effective date of final</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100393.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:100416.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100439.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials shall not apply if FDA grants written permission for an exception or alternative to such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100463.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:100709.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:100739.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:100739.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:100769.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  To obtain written permission from FDA, you must send a written request to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100792.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Director of the Center for Veterinary Medicine, 7519 Standish Place, Rockville, Maryland</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100815.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">208</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:100815.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">55.  For a drug intended for use in ruminants that is subject to a new animal drug application,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100838.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">your written request must reference its application number.  The Center Director may also grant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100862.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">written permission for an exception or alternative to the requirements in paragraph (b)(1) of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100885.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section on his own initiative and shall base such a determination on an evaluation of the criteria</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100908.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">described in paragraph (b)(2)(ii) of this section.  You must maintain a record of any exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100931.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative to the requirements in paragraph (b)(1) of this section that is granted by FDA, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:100954.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with paragraph (c) of this section.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:100977.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii)  A written request for an exception or alternative to the requirements in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101000.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(1) of this section must include, for each applicable product:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101023.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(A)  A statement of the reasons why the exception or alternative is needed;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101047.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(B)  A description of the product, including the type of prohibited cattle materials used in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101070.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its manufacturing, its manufacturing and purification processes, and its route of administration;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101093.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(C)  A description of the source of the prohibited cattle materials, including information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101116.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on the location where the cattle were born, raised, and slaughtered, and any other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101139.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101162.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this chapter;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101185.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(D)(1)  A description of how the requirements in paragraph (b)(1) of this section are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101208.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101231.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i) Based on the risks of the prohibited cattle materials in the product to the target animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101255.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and the benefits of the product to the target animal; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:101501.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:101531.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:101531.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101561.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii) To ensure a reasonable certainty of no harm to humans from any food derived from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101584.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the target animal to which the product was administered; or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101607.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) A description of how the requirements in paragraph (b)(1) of this section are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101630.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary to ensure the safety of the product with respect to both the target animal and any food</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101654.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">derived from the target animal to which the product is administered; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101677.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(E)  Any other relevant information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101700.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(iii)  FDA shall respond in writing to all requests for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101723.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements and may impose conditions in granting any such request.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101746.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:101746.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The small intestine is not considered prohibited cattle material if the distal ileum is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101769.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101792.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine, as measured from the caeco-colic junction and progressing proximally towards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101815.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">jejunum, or by a procedure that the establishment can demonstrate is equally effective in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101839.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensuring complete removal of the distal ileum.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101862.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)  Record</FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">s</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:139.55pt;top:101862.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:147.05pt;top:101862.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) Applicants and manufacturers of a drug intended for use in ruminants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101885.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that is manufactured from, or otherwise contains, any cattle material must establish and maintain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101908.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">records sufficient to demonstrate that the material is not manufactured from, and does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:101931.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain, prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101954.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) The following record retention periods apply:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:101977.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  Records for a Type A medicated article intended for use in ruminants that is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102000.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from, or otherwise contains, any cattle material must be retained for at least 2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102023.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">years after distribution by the manufacturer.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:102293.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:102323.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:102323.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:102353.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii) Records for a drug intended for use in ruminants, other than a Type A medicated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102376.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">article, that is manufactured from, or otherwise contains, any cattle material must be retained for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102399.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">at least 1 year after the expiration date of the drug.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:102422.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:102422.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records must be retained at the applicant’s or manufacturer’s establishment or at a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102446.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasonably accessible location.  Records are considered to be reasonably accessible if they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accessible from an onsite location.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:102492.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:102492.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records required by this section must be available to FDA for inspection and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102515.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">copying.  All the records must be in English.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:102538.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.10pt;top:102538.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">When filing entry with the </FONT></FONT><FONT COLOR="323232"><FONT STYLE="font-size: 10.05pt">U.S. Customs and Border Protection, </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the importer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102561.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of a drug intended for use in ruminants that was manufactured from, or otherwise</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102584.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contains, cattle material must affirm that the drug was manufactured from, or otherwise contains,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102607.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle material and must affirm that the drug was manufactured in accordance with this section. If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102631.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">a drug was manufactured from, or otherwise contains, cattle material, then the importer of record</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102654.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">must, if requested, provide to FDA within 5 days records that are sufficient to demonstrate that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102677.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the drug is not manufactured from, and does not contain, prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:102700.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(d)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:102700.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A drug intended for use in ruminants that is not in compliance with the requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102723.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of paragraph (b) of this section is adulterated under section 501(a)(2)(B) of the act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102746.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">351</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.30pt;top:102746.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(2)(B)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:102769.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(e)  Failure of an applicant or manufacturer to comply with the requirements of paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102792.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) of this section renders a drug intended for use(s) in ruminants adulterated under section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:102815.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">501</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.30pt;top:102815.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:103085.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:103115.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:103115.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:103145.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103168.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this section causes a drug intended for use(s) in ruminants to appear to be adulterated under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103191.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section 801(a) of the act (21 U.S.C. 381(a)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:103214.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(g) A drug intended for use in ruminants that is a new animal drug and that is not in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103238.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">compliance with the requirements of paragraph (b) of this section is in violation of section 512 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103261.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the act (21 U.S.C. 360b).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:103284.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(h) Failure of an applicant or manufacturer to comply with the requirements of paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103307.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) of this section is in violation of section 301(e) of the act (21 U.S.C. 331(e)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:103330.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  Any person who violates the requirements of paragraph (b) or (c) of this section shall</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103353.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be subject to the penalties provided in section 368 of the Public Health Service Act (42 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103376.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">271</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:103376.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103399.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 530--EXTRALABEL DRUG USE IN ANIMALS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:103423.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:103423.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">. The authority citation for 21 CFR part 530 is revised to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:103446.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Authority</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:129.50pt;top:103446.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">360</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:103469.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">b, 371, 379e; 42 U.S.C. 264, 271.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:103492.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:103492.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:103492.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Section 530.41 is amended by removing the word “for” from the section heading,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103515.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">paragraph (a) introductory text, and paragraph (b) and adding in its place the word “from”; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103538.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">by adding paragraph (c) to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103561.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 530.41 </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drugs prohibited from extralabel use in animals.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103584.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">* * * * *</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:103607.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) Drugs that contain prohibited cattle material as defined in §§ 300.200(a)(1) and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103631.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">500</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:103631.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.85pt;top:103631.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(1) of this chapter are prohibited from extralabel use in ruminants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:98.65pt;top:103654.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">11.  Section 530.42 is added to subpart E to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:103877.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:103907.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:103907.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103937.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 530.42 </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Labeling requirements for new animal drugs prohibited from extralabel use in animals</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:103960.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a) The labeling of any approved new animal drug that is prohibited from extralabel use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:103983.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">in ruminants by § 530.41(c) must bear the statement “Federal law prohibits the extralabel use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104006.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this product in ruminants.”</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:104030.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b) Failure to comply with the labeling requirements in paragraph (a) of this section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104053.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">renders a drug misbranded under section 502(a) of the act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104076.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 600--BIOLOGICAL PRODUCTS: GENERAL</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:104099.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:104099.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:104099.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The authority for 21 CFR part 600 is revised to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:104122.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Authority</FONT></FONT></u><FONT COLOR="000000"><b><FONT STYLE="font-size: 10.05pt">:  </FONT></b><FONT STYLE="font-size: 10.05pt">21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 374, 381; 42 U.S.C. 216,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104145.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">262</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:104145.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">, 263, 263a, 264, 271, 300aa-25.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:104168.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:104168.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:104168.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Section 600.16 is added to subpart B to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104191.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 600.16 </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:104214.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:106pt;top:104225pt;width:45pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104238.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), section 351 of the Public Health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104261.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Service Act (the PHS Act) (42 U.S.C. 262), and § 600.3 apply to such terms when used in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104284.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section.  The following definitions also apply:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:104307.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials </FONT></u><FONT STYLE="font-size: 10.05pt">means specified risk materials; small intestine of all cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104330.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104353.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104376.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials do not include tallow that contains no more than 0.15 percent insoluble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104399.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104423.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials also do not include materials obtained from fetal calves of cows that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:104669.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:104699.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:104699.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104729.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were inspected and passed, as long as the materials were obtained by procedures adequate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104752.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent contamination with specified risk materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:104775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:104775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Inspected and passed </FONT></u><FONT STYLE="font-size: 10.05pt">means that the material is from an animal that has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104798.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption by the appropriate regulatory authority, and at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104822.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time the animal was inspected and passed, it was found to be not adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:104845.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Mechanically separated beef </FONT></u><FONT STYLE="font-size: 10.05pt">means a meat food product that is finely comminuted,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104868.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from the mechanical separation and removal of most of the bone from attached skeletal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104891.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104914.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104937.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standard of identity for Mechanically Separated (Species).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:104960.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nonambulatory disabled cattle </FONT></u><FONT STYLE="font-size: 10.05pt">means cattle that cannot rise from a recumbent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:104983.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">position or that cannot walk, including, but not limited to, those with broken appendages, severed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105007.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:105030.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Specified risk materials </FONT></u><FONT STYLE="font-size: 10.05pt">means the brain, skull, eyes, trigeminal ganglia, spinal cord,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105053.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105076.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105099.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">older, and the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:105122.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(6)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:105122.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow </FONT></u><FONT STYLE="font-size: 10.05pt">means the rendered fat of cattle obtained by pressing or by applying any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105145.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extraction process to tissues derived directly from discrete adipose tissue masses or to other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105168.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105191.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or must contain not more than 0.15 percent insoluble impurities as determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105215.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105238.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.75pt;top:105236.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.50pt;top:105238.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in accordance with 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:105461.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:105491.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:105491.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105521.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:105521.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105544.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105567.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AOCS (</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">http</a></FONT><FONT STYLE="font-size: 10.05pt">://</FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">www.aocs.org</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105590.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105614.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Pkwy., College Park, MD 20740, or at the National Archives and records Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105637.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NARA).  For information on the availability of this material at NARA, call 202-741-6030, or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105660.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to: </FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">http://www.arch</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">i</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">ves</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">gov/federal_regis</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">er/code_of_federal_regulations/ibr_loca</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">ti</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">ons</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">h</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">m</a></FONT></FONT><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt">l.</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:105683.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(7</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)  </FONT></FONT></i><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow derivative </FONT></u><FONT STYLE="font-size: 10.05pt">means any chemical obtained through initial hydrolysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105706.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">saponification, or trans-esterification of tallow; chemical conversion of material obtained by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105729.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:105752.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)  </FONT></FONT></i><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Requirements</FONT></u><FONT STYLE="font-size: 10.05pt">.  (1)  At a minimum, except as provided in paragraphs (b)(2) and (b)(4)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105775.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of this section, no biological product intended for use in humans shall be manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105799.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contain, prohibited cattle materials obtained from cattle slaughtered on or after [insert</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105822.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">effective date of final rule].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:105845.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105868.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials shall not apply if FDA grants written permission for an exception or alternative to such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105891.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:105914.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  To obtain written permission from FDA, you must send a written request to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105937.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Director of the Center for Biologics Evaluation and Research (see § 600.2 for mailing address) or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105960.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Director of the Center for Drug Evaluation and Research, Food and Drug Administration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:105983.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">560</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:105983.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0 Fishers lane, Rockville, MD 20857, depending on the Center with primary jurisdiction over</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106007.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product.  Your written request must reference its application number. The Center Director</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106030.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">may also grant written permission for an exception or alternative to the requirements in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:106253.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:106283.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:106283.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106313.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">paragraph (b)(1) of this section on his own initiative and shall base such a determination on an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106336.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">evaluation of the criteria described in paragraph (b)(2)(ii) of this section.  You must maintain a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106359.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of any exception or alternative to the requirements in paragraph (b)(1) of this section that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106382.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">is granted by FDA, in accordance with paragraph (c) of this section.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106406.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii)  A written request for an exception or alternative to the requirements in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106429.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(1) of this section must include, for each applicable product:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106452.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(A)  A statement of the reasons why an exception or alternative is needed;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106475.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(B)  A description of the product, including the type of prohibited cattle materials used in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106498.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its manufacturing, its manufacturing and purification processes, and its route of administration;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106521.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(C)  A description of the source of the prohibited cattle materials, including information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106544.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on the location where the cattle were born, raised, and slaughtered, and any other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106567.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106591.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this chapter;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106614.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(D)  A description of how the requirements in paragraph (b)(1) in this section are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106637.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary based on the risks of the prohibited cattle materials in the product and the benefits of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106660.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product or how such restrictions are not necessary to ensure the safety of the product; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106683.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(E)  Any other relevant information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106706.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(iii)  FDA shall respond in writing to all requests for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106729.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements and may impose conditions in granting any request.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:106752.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:106752.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The small intestine is not considered prohibited cattle material if the distal ileum is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106775.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:106799.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine, as measured from the caeco-colic junction and progressing proximally towards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:107045.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:107075.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:107075.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107105.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">jejunum, or by a procedure that the establishment can demonstrate is equally effective in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107128.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensuring complete removal of the distal ileum.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107151.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) Biological products that are not intended for use in or on the body (e.g., in vitro</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107174.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">diagnostics) are not subject to the requirements of paragraph (b)(1) of this section.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:107198.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)  Record</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">s</FONT></u><FONT STYLE="font-size: 10.05pt">. (1) Establishments that manufacture a biological product intended for use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107221.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or on the body that is manufactured from, or otherwise contains, cattle material must establish</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107244.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and maintain records sufficient to demonstrate that the material is not manufactured from, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107267.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">does not contain, prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107290.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) Records must be retained consistent with § 600.12(b).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107313.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:107313.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records must be retained at the manufacturer’s establishment or at a reasonably</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107336.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accessible location.  Records are considered to be reasonably accessible if they are accessible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107359.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from an onsite location.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107383.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:107383.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records required by this section must be available to FDA for inspection and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107406.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">copying.  All the records must be in English.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107429.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.10pt;top:107429.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">When filing entry with the </FONT></FONT><FONT COLOR="323232"><FONT STYLE="font-size: 10.05pt">U.S. Customs and Border Protection, </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the importer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107452.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of a biological product intended for use in or on the body that was manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107475.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material must affirm that the product was manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107498.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material and must affirm that the product was manufactured in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107521.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with this section.  If a product was manufactured from, or otherwise contains, cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107544.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material, then the importer of record must, if requested, provide to FDA within 5 days records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107567.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that are sufficient to demonstrate that the product is not manufactured from, and does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107591.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">contain, prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:107837.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:107867.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:107867.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107897.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(d) A biological product that is a drug and that is not in compliance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107920.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements of paragraph (b)  of this section is adulterated under section 501(a)(2)(B) of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107943.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) and not safe, pure, and potent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:107966.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under section 351 of the PHS Act (42 U.S.C. 262).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:107990.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(e)  Failure of an applicant or manufacturer of a biological product that is a drug to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108013.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">comply with the requirements of paragraph (c) of this section renders such product adulterated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108036.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108059.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">351</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:108059.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)(2)(B)) and not safe, pure, and potent under section 351 of the PHS Act (42 U.S.C. 262).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108082.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108105.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this section causes a biological product to appear to be adulterated under section 801(a) of the act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108128.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(21 U.S.C. 381).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108151.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(g) A biological product that is a new drug and that is not in compliance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108175.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements of paragraph (b) of this section is in violation of section 505 of the Federal Food,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108198.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Drug, and Cosmetic Act (21 U.S.C. 355) and section 351 of the PHS Act (42 U.S.C. 262).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:108221.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(h) A biological product that is a device and that is not in compliance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108244.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements of paragraph (b) of this section is adulterated under section 501(g) of the Federal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108267.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Food, Drug, and Cosmetic Act (21 U.S.C. 351(g)) and in violation of section 351 of the PHS Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108290.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(42 U.S.C. 262).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:108313.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  Failure of an applicant or manufacturer to comply with the requirements of paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108336.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) of this section is a violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108359.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(21 U.S.C. 331(e)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:108383.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(j)  Any person who violates the requirements of paragraph (b) or (c) of this section shall</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108406.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be subject to the penalties provided in section 368 of the PHS Act (42 U.S.C. 271).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:108629.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:108659.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:108659.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108689.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 895--BANNED DEVICES</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108712.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:108712.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:108712.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The authority citation for 21 CFR part 895 is revised to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108735.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Authority</FONT></u><FONT STYLE="font-size: 10.05pt">:  21 U.S.C. 331, 351, 352, 360f, 360h, 360i, 371, 381; 42 U.S.C. 264, 271.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108758.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:108758.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:108758.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Section 895.102 is added to subpart B to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108782.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 895.102  Proh</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">ibited cattle materials</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108805.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:106pt;top:108815pt;width:45pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108828.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108851.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">used in this section.  The following definitions also apply:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:108874.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials </FONT></u><FONT STYLE="font-size: 10.05pt">means specified risk materials; small intestine of all cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108897.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108920.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108943.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials do not include tallow that contains no more that 0.15 percent insoluble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108967.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:108990.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials also do not include materials obtained from fetal calves of cows that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109013.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were inspected and passed, as long as the materials were obtained by procedures adequate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109036.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent contamination with specified risk materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:109059.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:109059.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Inspected and passed </FONT></u><FONT STYLE="font-size: 10.05pt">means that the material is from an animal that has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109082.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption by the appropriate regulatory authority, and at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109105.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time the animal was inspected and passed, it was found to be not adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:109128.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Mechanically separated beef </FONT></u><FONT STYLE="font-size: 10.05pt">means a meat food product that is finely comminuted,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109151.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from the mechanical separation and removal of most of the bone from attached skeletal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109175.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:109421.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:109451.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:109451.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109481.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109504.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standard of identity for Mechanically Separated (Species).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:109527.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nonambulatory disabled cattle </FONT></u><FONT STYLE="font-size: 10.05pt">means cattle that cannot rise from a recumbent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109550.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">position or that cannot walk, including, but not limited to, those with broken appendages, severed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109574.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:109597.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Specified risk materials </FONT></u><FONT STYLE="font-size: 10.05pt">means the brain, skull, eyes, trigeminal ganglia, spinal cord,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109620.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109643.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109666.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">older and the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:109689.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(6)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:109689.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow </FONT></u><FONT STYLE="font-size: 10.05pt">means the rendered fat of cattle obtained by pressing or by applying any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109712.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extraction process to tissues derived directly from discrete adipose tissue masses or to other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109735.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109759.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or must contain not more than 0.15 percent insoluble impurities determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109782.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109805.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.75pt;top:109803.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.50pt;top:109805.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in accordance with 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109828.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:109828.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109851.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109874.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AOCS (</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">http</a></FONT><FONT STYLE="font-size: 10.05pt">://</FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">www.aocs.org</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109897.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109920.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Pkwy., College Park, MD 20740, or at the National Archives and Records Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109943.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NARA).  For information on the availability of this material at NARA, call 202-741-6030, or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:109967.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to: </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">http</a></FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">://www.arch</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">i</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">ves</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">gov/federal_regis</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">er/code_of_federal_regulations/ibr_loca</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ti</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">ons</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">h</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">t</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html">m</a></FONT><FONT COLOR="000000"></FONT><FONT STYLE="font-size: 10.05pt">l</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:110213.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:110243.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:110243.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:110273.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(7) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow derivative </FONT></u><FONT STYLE="font-size: 10.05pt">means any chemical obtained through initial hydrolysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110296.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">saponification, or trans-esterification of tallow; chemical conversion of material obtained by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110319.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:110342.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Requirements</FONT></u><FONT STYLE="font-size: 10.05pt">.  (1)  At a minimum, except as provided in paragraph (b)(2) of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110366.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section, no medical device for humans that is intended for use in or on the body shall be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110389.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured from, or otherwise contain, prohibited cattle materials obtained from cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110412.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">slaughtered on or after [effective date of final rule].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:110435.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110458.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials shall not apply if FDA grants written permission for an exception or alternative to such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110481.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:110504.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  To obtain written permission from FDA, you must send a written request to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110527.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Director of the Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110551.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">MD 20850.  For a device subject to premarket approval or premarket clearance, your written</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110574.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">request must reference its application number.  The Center Director may also grant written</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110597.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">permission for an exception or alternative to the requirements in paragraph (b)(1) of this section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110620.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on his own initiative and shall base such a determination on an evaluation of the criteria</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110643.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">described in paragraph (b)(2)(ii) of this section.  You must maintain a record of any exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110666.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative to the requirements in paragraph (b)(1) of this section that is granted by FDA, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110689.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with paragraph (c) of this section.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:110712.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii)  A written request for an exception or alternative to the requirements in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:110735.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(1) of this section must include, for each applicable product:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:110759.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(A)  A statement of the reasons why an exception or alternative is needed;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:111005.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:111035.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:111035.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111065.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(B)  A description of the product, including the type of prohibited cattle materials used in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111088.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its manufacturing, its manufacturing and purification processes, and its route of administration;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111111.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(C)  A description of the source of the prohibited cattle materials, including information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111134.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on the location where the cattle were born, raised, and slaughtered, and any other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111158.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111181.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this chapter;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111204.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(D)  A description of how the requirements in paragraph (b)(1) of this section are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111227.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary based on the risks of the prohibited cattle materials in the product and the benefits of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111250.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product or how such restrictions are not necessary to ensure the safety of the product; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111273.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(E)  Any other relevant information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111296.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(iii)  FDA shall respond in writing to all requests for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111319.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements and may impose conditions in granting any such request.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111343.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:111343.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The small intestine is not considered prohibited cattle material if the distal ileum is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111366.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111389.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine, as measured from the caeco-colic junction and progressing proximally towards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111412.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">jejunum, or by a procedure that the establishment can demonstrate is equally effective in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111435.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensuring complete removal of the distal ileum.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111458.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)  Record</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">s</FONT></u><FONT STYLE="font-size: 10.05pt">. (1) Applicants and manufacturers of a medical device that is intended for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111481.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">use in or on the body that is manufactured from, or otherwise contains, cattle material must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111504.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">establish and maintain records sufficient to demonstrate that the material is not manufactured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111527.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from, and does not contain, prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111551.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) Records must be retained consistent with § 820.180(b) of this chapter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:111797.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:111827.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:111827.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:111857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records must be retained at the applicant’s or manufacturer’s establishment or at a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111880.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">reasonably accessible location.  Records are considered to be reasonably accessible if they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111903.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accessible from an onsite location.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111926.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:111926.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records required by this section must be available to FDA for inspection and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111950.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">copying.  All the records must be in English.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:111973.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.10pt;top:111973.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">When filing entry with the </FONT></FONT><FONT COLOR="323232"><FONT STYLE="font-size: 10.05pt">U.S. Customs and Border Protection, </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the importer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:111996.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of a medical device intended for use in or on the body that was manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112019.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material must affirm that the device was manufactured from, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112042.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">otherwise contains, cattle material and must affirm that the device was manufactured in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112065.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accordance with this section.  If a device was manufactured from, or otherwise contains, cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112088.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">material, then the importer of record must, if requested, provide to FDA within 5 days records</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112111.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">that are sufficient to demonstrate that the device is not manufactured from, and does not contain,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112135.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:112158.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(d)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:112158.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">A medical device that is intended for use in or on the body that is not in compliance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112181.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">with the requirements of paragraph (b) of this section is adulterated under section 501(g) of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112204.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">act (21 U.S.C. 351(g)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:112227.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(e)  Failure of an applicant or manufacturer of a medical device that is intended for use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112250.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or on the body to comply with the requirements of paragraph (c) of this section renders the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112273.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">device misbranded under section 502(t) of the act (21 U.S.C. 352(t)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:112296.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112319.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this section causes a medical device that is intended for use in or on the body to appear to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112343.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">adulterated under section 801 of the act (21 U.S.C. 381).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:112589.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:112619.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:112619.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:112649.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(g) Failure of an applicant or manufacturer to comply with the requirements of paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112672.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c) of this section is a violation of section 301(e) of the act (21 U.S.C. 331(e)).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:112695.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(h) Any person who violates the requirements of paragraph (b) or (c) of this section shall</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112718.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">be subject to the penalties provided in section 368 of the Public Health Service Act (42 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112742.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">271</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:112742.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112765.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112788.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">PRODUCTS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:112811.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:112811.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:112811.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  The authority citation for 21 CFR part 1271 continues to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.45pt;top:112834.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Authority</FONT></u><FONT STYLE="font-size: 10.05pt">:  42 U.S.C. 216, 243, 263a, 264, 271.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:112857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.45pt;top:112857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.50pt;top:112857.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.  Part 1271 is amended by adding new subpart G to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112880.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Sec.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112903.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:112903.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.46</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:112903.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5  Applicability.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112927.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:112927.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.47</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:92.90pt;top:112927.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">0  Prohibited cattle materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112950.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Subpart G--Prohibited Cattle Materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:112973.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 1271.465  A</FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">pplicability</FONT></FONT></u><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:112996.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The provisions set forth in this subpart are applicable only to HCT/Ps described in §</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113019.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">127</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:113019.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">1.10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.40pt;top:113019.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">and regulated solely under section 361 of the Public Health Service Act (the PHS Act)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113042.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(42 U.S.C. 264) and the regulations in this part, and to the establishments that manufacture those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113065.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">HCT/Ps.  HCT/Ps that are drugs or devices regulated under the Federal Food, Drug, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113088.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Cosmetic Act, or are biological products regulated under section 351 of the PHS Act (42 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113111.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">262</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.35pt;top:113111.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">), are not subject to the regulations set forth in this subpart.  Such products are subject to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113135.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">applicable regulations for biological products and for drugs or devices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:113381.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:113411.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:113411.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113441.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">§ 1271.470  P</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">rohibited cattle materials</FONT></u><FONT STYLE="font-size: 10.05pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:113464.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(a)  Definitions.  The following definitions apply to this section:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:106pt;top:113474pt;width:45pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:113487.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(1) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials </FONT></u><FONT STYLE="font-size: 10.05pt">means specified risk materials; small intestine of all cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113510.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113534.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113557.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">cattle materials do not include tallow that contains no more than 0.15 percent insoluble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113580.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113603.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Prohibited cattle materials also do not include materials obtained from fetal calves of cows that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113626.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">were inspected and passed, as long as the materials were obtained by procedures adequate to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113649.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prevent contamination with specified risk materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:113672.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:113672.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Inspected and passed </FONT></u><FONT STYLE="font-size: 10.05pt">means that the material is from an animal that has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113695.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">inspected and passed for human consumption by the appropriate regulatory authority, and at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113719.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">time the animal was inspected and passed, it was found to be not adulterated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:113742.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Mechanically separated beef </FONT></u><FONT STYLE="font-size: 10.05pt">means a meat food product that is finely comminuted,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113765.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">resulting from the mechanical separation and removal of most of the bone from attached skeletal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113788.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113811.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113834.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">standard of identity for Mechanically Separated (Species).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:113857.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Nonambulatory disabled cattle </FONT></u><FONT STYLE="font-size: 10.05pt">means cattle that cannot rise from a recumbent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113880.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">position or that cannot walk, including, but not limited to, those with broken appendages, severed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113903.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:113927.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Specified risk materials </FONT></u><FONT STYLE="font-size: 10.05pt">means the brain, skull, eyes, trigeminal ganglia, spinal cord,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:113950.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:114173.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:114203.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:114203.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114233.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114256.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">older, and the tonsils and distal ileum of the small intestine of all cattle.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:114279.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(6)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:114279.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow </FONT></u><FONT STYLE="font-size: 10.05pt">means the rendered fat of cattle obtained by pressing or by applying any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114302.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">extraction process to tissues derived directly from discrete adipose tissue masses or to other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114326.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114349.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials or must contain not more than 0.15 percent insoluble impurities as determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114372.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114395.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Chemists’ Society (AOCS), 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.75pt;top:114393.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 6.68pt">th</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:187.50pt;top:114395.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Edition, 1997, incorporated by reference in accordance with 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114418.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">U.S</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:75.60pt;top:114418.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114441.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114464.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">AOCS (</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">http</a></FONT><FONT STYLE="font-size: 10.05pt">://</FONT></FONT><u><FONT COLOR="0000cc"><FONT STYLE="font-size: 10.05pt"><a href="http://www.aocs.org">www.aocs.org</a></FONT></FONT></u><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114487.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114511.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Pkwy., College Park, MD 20740, or at the National Archives and Records Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114534.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(NARA).  For information on the availability of this material at NARA, call 202-741-6030, or go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114557.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">to: </FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">http://www.arch</a></FONT><FONT STYLE="font-size: 10.05pt">i</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">ves</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">gov/federal_regis</a></FONT><FONT STYLE="font-size: 10.05pt">t</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">er/code_of_federal_regulations/ibr_loca</a></FONT><FONT STYLE="font-size: 10.05pt">ti</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">ons</a></FONT><FONT STYLE="font-size: 10.05pt">.</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">h</a></FONT><FONT STYLE="font-size: 10.05pt">t</FONT><FONT STYLE="font-size: 10.05pt"><a href="http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.">m</a></FONT><FONT STYLE="font-size: 10.05pt">l.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:114580.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(7</FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">)  </FONT></FONT></i><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Tallow derivative </FONT></u><FONT STYLE="font-size: 10.05pt">means any chemical obtained through initial hydrolysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114603.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">saponification, or trans-esterification of tallow; chemical conversion of material obtained by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114626.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:114649.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b) </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">Requirements. </FONT></u><FONT STYLE="font-size: 10.05pt">(1)  At a minimum, except as provided in paragraph (b)(2) of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114672.75pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">section, no HCT/P intended for use in humans shall be manufactured using, or otherwise contain,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114695.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">prohibited cattle materials obtained from cattle slaughtered on or after [effective date of final</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:114719.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">rule].</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:114965.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:114995.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:114995.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115025.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115048.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials shall not apply if FDA grants written permission for an exception or alternative to such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115071.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115094.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(i)  To obtain written permission from FDA, you must send a written request to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115118.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Director of the Center for Biologics Evaluation and Research (see § 600.2 of this chapter for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115141.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">mailing address).  The Center Director may also grant written permission for an exception or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115164.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">alternative to the requirements in paragraph (b)(1) of this section on his own initiative and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115187.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">sh145ll base such a determination on an evaluation of the criteria described in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115210.55pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(2)(ii) of this section.  You must maintain a record of any exception or alternative from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115233.65pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements in paragraph (b)(1) of this section that is granted by FDA, in accordance with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115256.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">paragraph (c) of this section.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115279.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(ii)  A written request for an exception or alternative to the requirements in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115303.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(b)(1) of this section must include, for each applicable product:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115326.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(A)  A statement of the reasons why an exception or alternative is needed;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115349.25pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(B)  A description of the product, including the type of prohibited cattle materials used in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115372.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">its manufacturing, its manufacturing and purification processes, and its route of administration;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115395.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(C)  A description of the source of the prohibited cattle materials, including information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115418.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">on the location where the cattle were born, raised, and slaughtered, and any other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115441.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115464.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this chapter;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115487.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(D)  A description of how the requirements in paragraph (b)(1) of this section are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115511.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">necessary based on the risks of the prohibited cattle materials in the product and the benefits of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115534.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the product or how such restrictions are not necessary to ensure the safety of the product; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:115757.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:115787.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:115787.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115817.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(E)  Any other relevant information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115840.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(iii)  FDA shall respond in writing to all requests for an exception or alternative to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115863.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">requirements and may impose conditions in granting any request.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:115886.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:115886.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">The small intestine is not considered prohibited cattle material if the distal ileum is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115910.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115933.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">intestine, as measured from the caeco-colic junction and progressing proximally towards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115956.35pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">jejunum, or by a procedure that the establishment can demonstrate is equally effective in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:115979.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">ensuring complete removal of the distal ileum.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:116002.50pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(c)  Record</FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.05pt">s. </FONT></u><FONT STYLE="font-size: 10.05pt">(1)  Establishments that manufacture an HCT/P that is manufactured using,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116025.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">or otherwise contains, cattle material must establish and maintain records sufficient to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116048.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">demonstrate that the material is not manufactured using, and does not contain, prohibited cattle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116071.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">materials.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:116095.00pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(2) Records must be retained for the period specified in § 1271.270(d).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:116118.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(3)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:116118.10pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records must be retained at the manufacturer’s establishment or at a reasonably</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116141.20pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">accessible location.  Records are considered to be reasonably accessible if they are accessible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116164.30pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">from an onsite location.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:116187.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(4)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.20pt;top:116187.40pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Records required by this section must be available to FDA for inspection and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116210.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">copying.  All the records must be in English.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:116233.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(5)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.15pt;top:116233.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">When filing entry with the </FONT></FONT><FONT COLOR="323232"><FONT STYLE="font-size: 10.05pt">U.S. Customs and Border Protection, </FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the importer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116256.80pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">record of an HCT/P manufactured using, or otherwise containing, cattle material must affirm that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116279.90pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the HCT/P was manufactured using, or otherwise contains, cattle material and must affirm that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116303.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">the HCT/P was manufactured in accordance with this section.  If an HCT/P was manufactured</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116326.15pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">using, or otherwise contains, cattle material, then the importer of record must, if requested,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:116549.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:116579.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:116579.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116609.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">provide to FDA within 5 days records that are sufficient to demonstrate that the HCT/P is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116632.70pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">manufactured using, and does not contain, prohibited cattle material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.50pt;top:116655.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">(d)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:107.15pt;top:116655.85pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">An HCT/P that is not in compliance with the requirements of paragraph (b) or (c) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116678.95pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">this section is a violative HCT/P that is subject to retention, recall, destruction, and/or cessation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:116702.05pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">of manufacturing under § 1271.440.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:117341.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:248.75pt;top:117371.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:258.80pt;top:117371.45pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:60.30pt;top:117401.60pt;z-index:3;"><FONT FACE ="Times New Roman" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.05pt">Dated:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:87pt;top:117411pt;width:124pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:60pt;top:117504pt;width:150pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;left:71.76pt;top:118133.00pt"> </SPAN>
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