
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12486-12487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 April 
8, 2015.

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, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0627. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.

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.

Substances Prohibited From Use in Animal Food or Feed--21 CFR Part 589 
(OMB Control Number 0910-0627--Revision)

    This regulation prohibits the use of certain cattle origin 
materials in the food or feed of all animals to help prevent the spread 
of bovine spongiform encephalopathy (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.
    In the Federal Register of November 21, 2014 (79 FR 69493), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received however it did not 
respond to any of the four information collection topics solicited and 
is therefore not addressed by the Agency.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                             Number of                        Average                      Operating and
21 CFR Section 589.2001;  Substances prohibited from use     Number of      records per    Total annual     burden per      Total hours     maintenance
                 in  animal food or feed                   recordkeepers   recordkeeper       records      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.

    Description of Respondents for Recordkeeping: Rendering facilities, 
medicated feed manufacturers, livestock feeders.
    The Agency's recordkeeping burden estimate was calculated by 
multiplying the number of recordkeepers times the number of records per 
recordkeeper to determine the total annual number of records. The total 
number of annual records were then multiplied by the average burden per 
recordkeeper to determine the total number of burden hours.

[[Page 12487]]



                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of
   21 CFR section 589.2001(f)        Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses    per respondent
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One-time (initial) burden.......               1               1               1              80              80
Burden from future review.......               1               1               1              26              26
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\1\ There are no capital costs or operating costs associated with the collection of information.

    Description of Respondents for Reporting: The final regulation 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. A foreign country seeking this 
designation will submit a written request to FDA that includes a 
variety of information about the country's BSE status (Sec.  
589.2001(f)). During the past 6 years, FDA received 2 requests from 
countries to be exempted from CMPAF restrictions.

One-Time (Initial) Reporting Burden

    There is a one-time burden to countries that apply to FDA seeking 
to be designated as not subject to restrictions applicable to CMPAF. We 
estimate that each country that applies for an exclusion will spend 80 
hours putting information together to submit to FDA. Table 2 row 1 
presents the one-time burden for the exclusion. (See final BSE 
regulation at 73 FR 22754).

Recurring Burden

    Countries that successfully petition FDA to be designated as exempt 
from certain BSE-related restrictions applicable to animal feed will be 
subject to future review by FDA to ensure that their designation 
remains appropriate. As part of this process, FDA may ask designated 
countries from time-to-time to confirm that their BSE situation and the 
information submitted by them in support of their original application 
remains unchanged. We assume it will take FDA and the designated 
country undergoing a review in the future about one third the time and 
effort it did when the information was submitted. Table 2 row 2 
presents the expected recurring burden.

    Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05356 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P


