
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21378-21379]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of existing FDA regulations regarding countries seeking to 
be designated as not subject to certain bovine spongiform 
encephalopathy (BSE)-related restrictions applicable to FDA-regulated 
human food and cosmetics.

DATES: Submit either electronic or written comments on the collection 
of information by June 14, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 21379]]

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--21 CFR 189.5 and 
700.27 (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 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 Sec. Sec.  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.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual 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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Sec.  Sec.   189.5 and 700.27-- request for designation.......                 1                 1                 1                80                80
Sec.  Sec.   189.5(e) and 700.27(e)--response to request for                   1                 1                 1                26                26
 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.

    This estimate is based on FDA's experience and the average number 
of requests for designation under Sec. Sec.  189.5 and 700.27 received 
in the past 3 years. FDA received one request for designation in 2009 
and one in 2010. Based on this experience, FDA estimates the annual 
number of new requests for designation will be 1. FDA estimates that 
preparing the information required by Sec. Sec.  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 Sec. Sec.  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.

    Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9154 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P


