Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed, 4626-4628 [2022-01731]
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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
To obtain approval for an individual
generic collection submission that meets
the conditions of this generic clearance,
an abbreviated supporting statement
will be submitted to OMB along with
supporting documentation (e.g., a copy
of the survey or experimental design
and stimuli for testing).
FDA will submit individual
quantitative collections under this
generic clearance to OMB. Individual
quantitative collections will also
undergo review by FDA’s Research
Involving Human Subjects Committee,
senior leadership in the Center for Food
Safety and Applied Nutrition, and PRA
specialists.
Respondents to this collection of
information may include a wide range
of consumers and other FDA
stakeholders, such as producers and
manufacturers who are regulated under
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed.
In the Federal Register of September
9, 2021 (86 FR 50544), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and, therefore, will not be
discussed in this document.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
Number of
respondents
Survey type
Average
burden per
response
Total annual
disclosures
Total
hours
Cognitive Interviews Screener ...................................
Cognitive Interviews ...................................................
Pre-test Study Screener ............................................
Pre-test Study ............................................................
Self-administered Surveys/Experimental Studies
Screener.
Self-administered Surveys/Experimental Studies ......
720
144
2,400
480
75,000
1
1
1
1
1
720
144
2,400
480
75,000
0.083 (5 minutes) ....
1 ...............................
0.083 (5 minutes) ....
0.25 (15 minutes) ....
0.083 (5 minutes) ....
60
144
199
120
6,225
15,000
1
15,000
0.25 (15 minutes) ....
3,750
Total ....................................................................
........................
........................
........................
..................................
10,498
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. The
total estimated annual burden is 10,498
hours. Current estimates are based on
both historical numbers of participants
from past projects as well as estimates
for projects to be conducted in the next
3 years. The number of participants to
be included in each new survey will
vary, depending on the nature of the
compliance efforts and the target
audience.
Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01730 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0520]
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Number of
disclosures
per
respondent
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.
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18:03 Jan 27, 2022
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ACTION:
Electronic Submissions
Notice.
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 March 29, 2022.
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 March 29,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 29, 2022. 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.
SUMMARY:
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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
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28JAN1
jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
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 ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
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, 240–402–7500.
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, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), 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.
SUPPLEMENTARY INFORMATION:
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
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4627
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 FD&C 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
consistent processes, and then to help
inspection personnel confirm that the
firm is conducting these processes 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 if 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 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:
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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Written procedures; 589.2000(e)(1)(iv) ......................
300
1
300
14
4,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 adjusted our
burden estimate, which has resulted in
a decrease to the currently approved
burden. Review of our inspection data
suggests that the number of facilities
that need to conduct these separation
practices is gradually decreasing,
therefore we have decreased the number
of facilities who must comply, as well
as the total number of hours needed to
comply with this burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
SUMMARY:
Food and Drug Administration
[Docket Nos. FDA–2011–N–0742;
FDA–2018–N–0180; FDA–2019–N–2854;
FDA–2021–N–0515; FDA–2014–N–1960;
FDA–2017–D–6069; and FDA–2019–N–3325]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
[FR Doc. 2022–01731 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution ............................................
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................
Premarket Tobacco Product Applications and Recordkeeping Requirements .......................................................
Postmarketing Adverse Experience Reporting and Recordkeeping .......................................................................
MedWatch: Adverse Event and Product Experience Reporting System (Paper Based) .......................................
De Novo Classification Process (Evaluation of Automatic Class III Designation) ..................................................
Laboratory Accreditation for Analyses of Foods .....................................................................................................
Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01692 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
jspears on DSK121TN23PROD with NOTICES1
AGENCY:
The National Biodefense
Science Board (NBSB or the Board) is
authorized under Section 319M of the
SUMMARY:
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18:03 Jan 27, 2022
Jkt 256001
Public Health Service (PHS) Act, as
added by Section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by Section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act. The
Board is governed by the Federal
Advisory Committee Act, which sets
forth standards for the formation and
use of advisory committees. The NBSB
provides expert advice and guidance on
scientific, technical, and other matters
of special interest to the Department of
Health and Human Services (HHS)
regarding current and future chemical,
biological, nuclear, and radiological
agents, whether naturally occurring,
accidental, or deliberate. Authority to
manage and operate the NBSB,
including to receive advice and
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Sfmt 4703
0910–0045
0910–0810
0910–0879
0910–0230
0910–0291
0910–0844
0910–0898
Date approval
expires
12/31/2024
12/31/2024
12/31/2024
1/31/2025
1/31/2025
1/31/2025
1/31/2025
recommendations from the Board, has
been delegated by the Secretary of HHS
to the Assistant Secretary for
Preparedness and Response (ASPR). The
NBSB will meet in public (virtually) on
March 7, 2022, beginning at 12:30 p.m.
Eastern time. ASPR invites stakeholders
and the general public to attend and
participate as appropriate. A detailed
agenda and instructions to register to
attend the meeting will be available on
the NBSB meeting website https://
www.phe.gov/nbsb.
Procedures for Public Participation:
Members of the public may attend the
meeting via a toll-free phone number or
Zoom teleconference, which requires
pre-registration. The meeting link to
pre-register will be posted on the
meeting website https://www.phe.gov/
E:\FR\FM\28JAN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4626-4628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01731]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 March 29, 2022.
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 March 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 29, 2022. 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
[[Page 4627]]
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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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. 3501-3521), 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 FD&C 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 consistent processes, and then
to help inspection personnel confirm that the firm is conducting these
processes 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 if 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 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:
[[Page 4628]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written procedures; 589.2000(e)(1)(iv)........................ 300 1 300 14 4,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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 adjusted our burden estimate, which
has resulted in a decrease to the currently approved burden. Review of
our inspection data suggests that the number of facilities that need to
conduct these separation practices is gradually decreasing, therefore
we have decreased the number of facilities who must comply, as well as
the total number of hours needed to comply with this burden.
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01731 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
