[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45259-45261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 recordkeeping requirements 
for substances prohibited for use in animal food or feed.

DATES: Submit electronic or written comments on the collection of 
information by September 26, 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: Juanmanuel Vilela, Office of

[[Page 45260]]

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[email protected].

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.

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.
    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 and
                     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 45261]]

    Dated: July 20, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19139 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P