[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51279-51282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23948]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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

[[Page 51280]]

collection provisions of existing FDA regulations concerning substances 
prohibited for use in animal food or feed.

DATES: Submit either electronic or written comments on the collection 
of information by January 2, 2018.

ADDRESSES: You may submit comments as follows: Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 2, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0510 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Substances Prohibited From Use in 
Animal Food or Feed.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 589.2001

OMB Control Number 0910-0627--Extension

    This information collection supports Agency regulations regarding 
substances prohibited from use in animal food or feed. Bovine 
spongiform encephalopathy (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. Our regulation at Sec.  589.2001 (21 CFR 
589.2001) entitled,

[[Page 51281]]

``Cattle materials prohibited in animal food or feed to prevent the 
transmission of bovine spongiform encephalopathy'' is designed to 
further strengthen existing safeguards against the establishment and 
amplification of BSE in the United States through animal feed. The 
regulation prohibits the use of certain cattle origin materials in the 
food or feed of all animals. These materials are referred to as 
``cattle materials prohibited in animal feed'' or CMPAF. Under Sec.  
589.2001, no animal feed or feed ingredient can contain CMPAF. As a 
result, we impose requirements on renderers of specifically defined 
cattle materials, including reporting and recordkeeping requirements. 
For purposes of the regulation, we define a renderer as any firm or 
individual that processes slaughter byproducts, animals unfit for human 
consumption, including carcasses of dead cattle, or meat scraps. 
Reporting and recordkeeping requirements are necessary because once 
materials are separated from an animal it may not be possible, without 
records, to know whether the cattle material meets the requirements of 
our regulation.
    Recordkeeping: Renderers that receive, manufacture, process, blend, 
or distribute CMPAF, or products that contain or may contain CMPAF, 
must take measures to ensure that the materials are not introduced into 
animal feed, including maintaining adequate written procedures 
specifying how such processes are to be carried out Sec.  
589.2001(c)(2)(ii)). Renderers that receive, manufacture, process, 
blend, or distribute CMPAF, are required to establish and maintain 
records sufficient to track the CMPAF to ensure that they are not 
introduced into animal feed (Sec.  589.2001(c)(2)(vi)).
    Renderers that receive, manufacture, process, blend, or distribute 
any cattle materials must establish and maintain records sufficient to 
demonstrate that material rendered for use in animal feed was not 
manufactured from, processed with, or does not otherwise contain, CMPAF 
(Sec.  589.2001(c)(3)(i)).
    Renderers that receive, manufacture, process, blend, or distribute 
any cattle materials must, if these materials were obtained from an 
establishment that segregates CMPAF from other materials, establish and 
maintain records to demonstrate that the supplier has adequate 
procedures in place to effectively exclude CMPAF from any materials 
supplied (Sec.  589.2001(c)(3)(i)). Records will meet this requirement 
if they include either: (1) Certification or other documentation from 
the supplier that materials supplied do not include CMPAF (Sec.  
589.2001(c)(3)(i)(A)) or (2) documentation of another method acceptable 
to FDA, such as third-party certification (Sec.  589.2001(c)(3)(i)(B)).
    Reporting: Under our regulations, we may designate a country from 
which cattle materials are not considered CMPAF. Section 589.2001(f) 
provides that a country seeking to be so designated must send a written 
request to the Director of the Center for Veterinary Medicine. The 
information the country is required to submit includes information 
about that country's BSE case history, risk factors, measures to 
prevent the introduction and transmission of BSE, and any other 
information relevant to determining whether the cattle materials from 
the requesting country do or do not meet the definitions set forth in 
Sec.  589.2001(b)(1). We use the information to determine whether to 
grant a request for designation and to impose conditions if a request 
is granted. Section 589.2001(f) further states that countries 
designated under that section will be subject to our future review to 
determine whether their designations remain appropriate. As part of 
this process, we 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 may 
revoke a country's designation if we determine that it is no longer 
appropriate. Therefore, designated countries may respond to our 
periodic requests by submitting information to confirm their 
designations remain appropriate. We use the information to ensure their 
designations remain appropriate.
    Description of Respondents: Respondents to this information 
collection include rendering facilities, feed manufacturers, livestock 
feeders, and foreign governments seeking designation under Sec.  
589.2001(f).
    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
         21 CFR section             Number of       records per    Total annual     burden per      Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
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589.2001(c)(2)(ii), maintain                  50               1              50              20           1,000
 written procedures............
589.2001(c)(2)(vi) and                       175               1             175              20           3,500
 (c)(3)(i), maintain records...
589.2001(c)(3)(i)(A) and (B),                175               1             175              26           4,550
 certification or documentation
 from the supplier.............
                                --------------------------------------------------------------------------------
    Total......................  ...............  ..............  ..............  ..............           9,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Except where otherwise noted, this estimate is based on our 
estimate of the number of facilities affected by the final rule 
entitled, ``Substances Prohibited From Use in Animal Food or Feed'', 
published in the Federal Register of April 25, 2008 (73 FR 22720 at 
22753). The estimated recordkeeping burden is derived from Agency 
resources and discussions with affected industry. Our regulations 
require the maintenance of certain written procedures if cattle not 
inspected and passed for human consumption are to be rendered for use 
in animal feed. The recordkeeping burden associated with the 
requirement to maintain written procedures (Sec.  589.2001(c)(2)(ii)) 
will apply to only those renderers that choose to render for use in 
animal feed cattle not inspected and passed for human consumption. The 
recordkeeping requirement in Sec.  589.2001(c)(2)(vi) will apply to the 
limited number of renderers that will handle CMPAF. We estimate that 
the recordkeeping burden associated with Sec.  589.2001(c)(3)(i) would 
apply to the balance of the rendering firms not handling CMPAF. Table 1 
also reflects the estimated 26 hours each renderer will need to satisfy 
the requirement in Sec.  589.2001(c)(3)(i)(A) and (B) under which 
renderers must maintain records from their supplier, certifying that 
materials provided were free of CMPAF.

[[Page 51282]]



                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total  annual    burden per      Total hours
                                    respondents     respondent       responses       response
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589.2001(f); request for                       1               1               1              80              80
 designation....................
589.2001(f); response to request               1               1               1              26              26
 for review by FDA..............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of the reporting burden for designation under Sec.  
589.2001(f) is based on estimates in the final rule entitled, 
``Substances Prohibited From Use in Animal Food or Feed,'' published in 
the Federal Register of April 25, 2008, our experience, and the average 
number of requests for designation received in the past 3 years. The 
reporting burden for Sec.  589.2001(f) is minimal because requests for 
designation are seldom submitted. Since 2009, we have received two 
requests for designation. In the last 3 years, we have not received any 
new requests for designation; therefore, we estimate that one or fewer 
requests for designation will be submitted annually. Although we have 
not received any new requests for designation in the last 3 years, we 
believe these information collection provisions should be extended to 
provide for the potential future need of a foreign government to 
request designation under Sec.  589.2001(f). Table 2, row 1 presents 
the expected burden of requests for designation. Countries designated 
under Sec.  589.2001(f) are subject to review by FDA to ensure that 
their designation remains appropriate. We assume a country's response 
to a request for review will take about one third the time and effort 
of a request for designation. Table 2, row 2 presents the expected 
burden of a request for review. The burden for this information 
collection has not changed since the last OMB approval.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23948 Filed 11-2-17; 8:45 am]
BILLING CODE 4164-01-P