Document ID: FDA-2011-N-0264-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
Posted Date: 2011-06-20T04:00Z

[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Notices]
[Pages 35897-35899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15142]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0264]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Request for 
Designation as Country Not Subject to the Restrictions Applicable to 
Human Food and Cosmetics Manufactured From, Processed With, or 
Otherwise Containing, Material From Cattle

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 July 
20, 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,

[[Page 35898]]

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 0910-0623. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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.

Request for Designation as Country Not Subject to the Restrictions 
Applicable to Human Food and Cosmetics Manufactured From, Processed 
With, or Otherwise Containing, Material From Cattle--(OMB Control 
Number 0910-0623)--Extension

    Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 381(a)) provides requirements with regard to 
imported food and cosmetics and provides for refusal of admission into 
the United States of human food and cosmetics that appear to be 
adulterated. Section 701(b) of the FD&C Act (21 U.S.C. 371(b)) 
authorizes the Secretaries of Treasury and Health and Human Services to 
jointly prescribe regulations for the efficient enforcement of section 
801 of the FD&C Act. To address the potential risk of bovine spongiform 
encephalopathy (BSE) in human food and cosmetics, FDA regulations in 
Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and 700.27) designate certain 
materials from cattle as ``prohibited cattle materials,'' including 
specified risk materials, the small intestine of cattle not otherwise 
excluded from being a prohibited cattle material, material from 
nonambulatory disabled cattle, and mechanically separated (MS)(Beef). 
Under the regulations, no human food or cosmetic may be manufactured 
from, processed with, or otherwise contain prohibited cattle materials. 
However, the Agency may designate a country from which cattle materials 
inspected and passed for human consumption are not considered 
prohibited cattle materials and their use does not render a human food 
or cosmetic adulterated.
    Sections 189.5(e) and 700.27(e) provide that a country seeking to 
be so designated must send a written request to the Director, Center 
for Food Safety and Applied Nutrition (CFSAN). The information the 
country is required to submit includes information about a country's 
BSE case history, risk factors, measures to prevent the introduction 
and transmission of BSE, and other information relevant to determining 
whether specified risk materials, the small intestine of cattle not 
otherwise excluded from being a prohibited cattle material, material 
from nonambulatory disabled cattle, or MS(Beef) from the country 
seeking designation should be considered prohibited cattle materials. 
FDA uses the information to determine whether to grant a request for 
designation, and whether to impose conditions if a request is granted.
    Sections 189.5 and 700.27 further state that countries that have 
been designated under 189.5(e) and 700.27(e) will be subject to future 
review by FDA to determine whether designation remains appropriate. As 
part of this process, FDA may ask designated countries to confirm that 
their BSE situation and the information submitted by them in support of 
their original application remain unchanged. FDA may revoke a country's 
designation if FDA determines that it is no longer appropriate. 
Therefore, designated countries may respond to periodic requests by FDA 
by submitting information to confirm that their designation remains 
appropriate. FDA uses the information to ensure that their designation 
remains appropriate.
    This estimate is based on FDA's experience and the average number 
of requests for designation under 189.5 and 700.27 received in the past 
3 years. FDA received 1 request for designation in 2009 and 1 in 2010. 
Based on this experience, FDA estimates the annual number of new 
requests for designation will be one. FDA estimates that preparing the 
information required by 189.5 and 700.27 and submitting it to the 
Agency in the form of a written request to the Director, CFSAN will 
require a burden of approximately 80 hours per request. Thus, the 
annual burden for new requests for designation is estimated to be 80 
hours, as shown in table 1, row 1 of this document. Under 189.5(e) and 
700.27(e), designated countries are subject to future review by FDA and 
may respond to periodic requests by FDA by submitting information to 
confirm that their designation remains appropriate. In the last 3 
years, FDA has not requested any reviews. Thus, the Agency estimates 
that one or fewer will occur annually in the future. We estimate that 
the designated country undergoing a review in the future will need one 
third the time it took preparing its request for designation to respond 
to FDA's request for review, or 26 hours (80 hours x 0.33 = 26.4 hours, 
rounded to 26). The annual burden for reviews is estimated to be 26 
hours, as shown in table 1, row 2 of this document. The total annual 
burden for this information collection is estimated to be 106 hours.
    In the Federal Register of April 15, 2011 (76 FR 21378), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of                          Average
         21 CFR section               No. of       responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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189.5 and 700.27--request for                  1               1               1              80              80
 designation....................
189.5(e) and 700.27(e)--response               1               1               1              26              26
 to request for review by FDA...
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    Total.......................  ..............  ..............  ..............  ..............             106
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 35899]]

    Dated: June 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15142 Filed 6-17-11; 8:45 am]
BILLING CODE 4160-01-P