[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21378-21379]
From the Federal Register Online via the Government Publishing 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