[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69493-69494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27518]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 January 20, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

[[Page 69494]]

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 United States' 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Average burden                   Operating and
 21 CFR Section 589.2001; substances prohibited from use     Number of      records per    Total annual         per         Total hours     maintenance
                 in animal food or feed                    recordkeepers   recordkeeper       records      recordkeeper                        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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.
    FDA estimates the reporting burden for this information collection 
as follows:

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

One-Time (initial) Reporting Burden

    There will be 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: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27518 Filed 11-20-14; 8:45 am]
BILLING CODE 4164-01-P