[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65681-65683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0520]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Prohibited From Use in Animal Food or Feed;
Animal Proteins Prohibited in Ruminant 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 recordkeeping requirements regarding
animal proteins prohibited in ruminant feed.
DATES: Submit either electronic or written comments on the collection
of information by February 19, 2019.
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 February 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 19, 2019. 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
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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-2013-N-0520 for '' Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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; Animal Proteins
Prohibited in Ruminant Feed--21 CFR 589.2000(e)(1)(iv) OMB Control
Number 0910-0339--Extension
Section 701(a) (21 U.S.C. 371(a)) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) gives us the authority to issue regulations for
the efficient enforcement of the FD&C Act. Our regulation at 21 CFR
589.2000 provides that animal protein derived from mammalian tissue
(with some exclusions) is not generally recognized as safe (GRAS) for
use in ruminant feed and is a food additive subject to certain
provisions of the act (62 FR 30936, June 5, 1997).
This information collection was established because epidemiological
evidence gathered in the United Kingdom suggested that bovine
spongiform encephalopathy (BSE), a progressively degenerative central
nervous system disease, is spread to ruminant animals by feeding
protein derived from ruminants infected with BSE. This regulation
places general requirements on persons that manufacture, blend,
process, and distribute products that contain, or may contain, protein
derived from mammalian tissue, and feeds made from such products.
Specifically, this regulation requires renderers, feed
manufacturers, and others involved in feed and feed ingredient
manufacturing and distribution to maintain written procedures
specifying the cleanout procedures or other means and specifying the
procedures for separating products that contain or may contain protein
derived from mammalian tissue from all other protein products from the
time of receipt until the time of shipment. These written procedures
are intended to help the firm formalize their processes, and then to
help inspection personnel confirm that the firm is operating in
compliance with the regulation. Inspection personnel will evaluate the
written procedure and confirm it is being followed when they are
conducting an inspection.
These written procedures must be maintained as long as the facility
is operating in a manner that necessitates the record, and if the
facility makes changes to an applicable procedure or process the record
must be updated. Written procedures required by this
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section shall be made available for inspection and copying by FDA.
Description of Respondents: Respondents include renderers, feed
manufacturers, and others involved in feed and feed ingredient
manufacturing and distribution.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Number of records Total annual Average burden
21 CFR Section; activity recordkeepers per recordkeeper records per recordkeeping Total hours
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589.2000(e)(1)(iv); written procedures................... 320 1 320 14 4,480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our experience with similar requirements
to maintain written procedures. We base our estimate of the number of
recordkeepers on inspectional data. Based on a review of the
information collection since our last request for OMB approval, we have
made no adjustments to our burden estimate.
Dated: December 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27656 Filed 12-20-18; 8:45 am]
BILLING CODE 4164-01-P