Document ID: FDA-2011-N-0510-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Substances Prohibited from Use in Animal Food or Feed
Posted Date: 2011-10-19T04:00Z

[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Pages 64950-64951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27020]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0510]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Substances Prohibited 
From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 18, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0627. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Substances Prohibited From Use in Animal Food or Feed--21 CFR Part 589 
(OMB Control Number 0910-0627)--(Extension)

    The final rule on bovine spongiform encephalopathy (BSE) (73 FR 
22720, April 25, 2008) prohibits the use of certain cattle origin 
materials in the food or feed of all animals to help prevent the spread 
of BSE in U.S. cattle. BSE is a progressive and fatal neurological 
disorder of cattle that results from an unconventional transmissible 
agent. BSE belongs to the family of diseases known as transmissible 
spongiform encephalopathies (TSEs). All TSEs affect the central nervous 
system of infected animals. These measures will further strengthen 
existing safeguards against BSE.
    In the Federal Register of July 28, 2011 (76 FR 45259), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    Description of Recordkeeping for Respondents: Rendering facilities, 
medicated feed manufacturers, livestock feeders.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                    operating &
                     21 CFR Section                        recordkeepers    records per       records           per         Total hours     maintenance
                                                                           recordkeeper                    recordkeeper                        costs
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589.2001 (c)(2)(vi) and (c)(3)(i).......................             175               1             175              20           3,500         $59,500
589.2001 (c)(2)(ii).....................................              50               1              50              20           1,000          17,000
589.2001 (c)(3)(i)(A)...................................             175               1             175              26           4,550          80,580
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............           9,050         157,080
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\1\ There are no capital costs associated with this collection of information.

    The number of recordkeepers times the number of records per 
recordkeeper equals total annual records. Total annual records times 
average burden per recordkeeper equals total hours.
    Description of Respondents for Reporting: The final rule on BSE (73 
FR 22720) included a provision that exempts cattle materials prohibited 
in animal feed (CMPAF) from designated countries from the prohibition 
on its use in animal feed (21 CFR 589.2001(b)(1)(vi)). A foreign 
country seeking this designation will submit a written request to FDA 
that includes a variety of information about the countries' BSE status 
(21 CFR 589.2001(f)). FDA estimates that 10 countries could submit a 
request to FDA to be exempted from CMPAF restrictions.
    FDA estimates the reporting burden for this information collection 
as follows:

                         Table 2--Estimated One-Time and Recurring Reporting Burden \1\
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                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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589.2001(b)(1) \2\..............              10               1              10              80             800
589.2001(f).....................              10               1              10              26             260
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\1\ There are no capital costs or operating costs associated with the collection of information.
\2\ One-time burden.

[[Page 64951]]

    Dated: October 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27020 Filed 10-18-11; 8:45 am]
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