[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Notices]
[Pages 35897-35899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15142]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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\
----------------------------------------------------------------------------------------------------------------
No. of Average
21 CFR section No. of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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...
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 106
----------------------------------------------------------------------------------------------------------------
\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