Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed, 21257-21259 [2024-06438]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices
Agency also noted that the organization
that conducts the BA or BE study is
responsible for retaining the reserve
samples to eliminate potential sample
substitution by the study sponsor and/
or drug manufacturer and alteration of
any reserve samples from a study before
release of drug product samples to FDA.
FDA has observed a number of
concerning handling and retention
practices upon inspections of clinical
and analytical sites that perform BA and
BE studies for study sponsors and/or
drug manufacturers seeking approval of
drug products under NDAs and ANDAs.
Based on this experience, FDA is
updating and clarifying our
recommendations for applicants of
NDAs and ANDAs, including
supplemental applications, and CROs
regarding the procedures related to the
handling and retention of reserve
samples from relevant BA and BE
studies, as required by §§ 320.38 and
320.63. In the context of §§ 320.38 and
320.63, the term applicant includes, as
appropriate, study sponsor and/or drug
manufacturer and the term CRO refers to
any party contracted to help conduct BA
or BE testing, including, as appropriate,
site management organizations,
investigators, and testing sites.
Specifically, the guidance highlights: (1)
how the T and RS for BA and BE studies
should be distributed to the testing sites,
(2) how testing sites should randomly
select samples for testing and material
to maintain as reserve samples, and (3)
how the reserve samples should be
retained. Examples of typical roles of
each stakeholder for the handling and
retention of reserve samples in various
study settings are also discussed in the
guidance.
In response to comments received to
the August 2020 Compliance Policy, the
Agency has updated its policy on the
conditions under which FDA generally
does not intend to enforce the quantity
requirement at § 320.38(c) (to retain
reserve samples of sufficient quantity to
permit FDA to perform five times all the
release tests required in an application
or supplemental application) to reduce
further the recommended minimum
quantity of reserve samples to be
retained. The additional reduction in
the recommended minimum quantity
described in this guidance relative to
what was described in the August 2020
Compliance Policy is reflective of
adjustments made to the Agency’s
procedures to accommodate continued
concerns from industry, particularly for
studies involving multiple shipments to
multiple testing sites, regarding the
ability to retain a sufficient quantity of
reserve samples.
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17:03 Mar 26, 2024
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FDA has determined that, using the
Agency’s current testing methodology,
the updated recommended minimum
quantities of reserve samples described
in this guidance are sufficient for FDA
to conduct the necessary testing of the
T and RS samples used in a BA or BE
study as intended by the regulation.
Accordingly, at this time and based on
FDA’s current understanding of the
risks involved, FDA generally does not
intend to enforce the requirement to
retain a sufficient quantity to perform
five times all the release tests required
in the application or supplemental
application, so long as the
recommended lower quantities in this
guidance are retained. This compliance
policy is applicable to all reserve
samples for BA and BE studies held to
date, including reserve samples from
previously completed BA or BE studies.
This guidance is being issued
consistent with FDA’s GGP regulation
(§ 10.115). The draft portion of the
guidance, when finalized, will represent
the current thinking of FDA on
‘‘Handling and Retention of BA and BE
Testing Samples.’’ A guidance does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 for
investigational new drug products have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 314 for new
drug applications and abbreviated new
drug applications have been approved
under OMB control number 0910–0001.
The collections of information in part
320 for ‘‘Investigational New Drug
Safety Reporting Requirements for
Human Drug and Biological Products
and Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ have been
approved under OMB control number
0910–0672. The recordkeeping
requirement for current good
manufacturing practice sample retention
in 21 CFR 211.170 has been approved
under OMB control number 0910–0139.
PO 00000
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Fmt 4703
Sfmt 4703
21257
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: March 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06500 Filed 3–26–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4181]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cattle Materials
Prohibited From Use in Animal Food or
Feed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Submit written comments
(including recommendations) on the
collection of information by April 26,
2024.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0627. The title of this
information collection is ‘‘Cattle
Materials Prohibited From Use in
Animal Food or Feed.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
ADDRESSES:
E:\FR\FM\27MRN1.SGM
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21258
Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Cattle Materials Prohibited From Use in
Animal Food or Feed
OMB Control Number 0910–0627—
Extension
This information collection helps to
support implementation of section 402
of the Federal Food, Drug and Cosmetic
Act (21 U.S.C. 342(a)(5)), which governs
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. Our regulation at
§ 589.2001 (21 CFR 589.2001) is
designed to safeguard 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 § 589.2001, no animal
feed or feed ingredient can contain
CMPAF. As a result, we impose
requirements to maintain adequate
written procedures and recordkeeping
on renderers that receive, manufacture,
process, blend, or distribute raw
material from cattle and to make these
records available for inspection and
copying by FDA to demonstrate they are
taking measures to ensure that CMPAF
is not introduced into animal feed.
Under § 589.2001(f), we may
designate a country from which cattle
materials are not considered CMPAF. A
country seeking to be so designated
must send a written request to the
Director of the Center for Veterinary
Medicine, including certain required
information. We use the information
provided to determine whether to grant
a request for designation and to impose
conditions if a request is granted.
Additionally, designated countries will
be subject to our future review to
determine whether their designations
remain appropriate. As part of this
process, we may ask designated
countries at any 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.
The 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.
Description of Respondents:
Respondents to this information
collection are foreign governments
seeking designation under § 589.2001(f)
and private sector rendering facilities
that process cattle materials under
§ 589.2001(c).
In the Federal Register of October 12,
2023 (88 FR 70676), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although three comments
were received, the comments were not
responsive to the four collection of
information topics solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part; activity
Number of
respondents
Number of
responses per
respondent
589.2001(f); Request for designation by FDA for exemption from requirements of this regulation and response to request for review by FDA .....
1
2
1 There
Total
annual
responses
I
2
Average
burden per
response
I
33
Total
hours
I
66
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last renewal, we reduced
the request for designation average
burden per response by 40 hours (from
80 hours to 40 hours). We take this
reduction because foreign governments
are required to provide this information
to other entities in order to comply with
international standards and therefore
will have already compiled the
necessary information. The average
burden per response to a request for
review by FDA remains the same (26
hours). The burden we attribute to
reporting activities is assumed to be
distributed among the individual
elements of the information collection
activities.
Since the effective date of the
regulations in 2009, only two requests
for designation have been received;
however, we retain our current estimate
of one respondent to permit such
requests for designation by respondents
and also to permit related responses to
FDA.
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part; activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
589.2001(c)(2)(ii), 589.2001(c)(2)(vi), and (c)(3)(i), and
589.2001(c)(3)(i)(A) and (B); Rendering facilities maintain written
procedures and records, and certification or documentation from
the supplier .........................................................................................
145
1
145
45
6,525
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 reflects an adjustment
decrease in our recordkeeping burden
estimate, based primarily on
consolidation within the industry and
VerDate Sep<11>2014
17:03 Mar 26, 2024
Jkt 262001
the related decrease in the estimated
number of respondents subject to
recordkeeping requirements. The
burden we attribute to recordkeeping
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
activities is assumed to be distributed
among the individual elements and
averaged among respondents. The total
number of recordkeepers contains a
E:\FR\FM\27MRN1.SGM
27MRN1
Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices
subset of 50 recordkeepers who
maintain written procedures and
records specifically required by
§ 589.2001(c).
Based on our review since the last
OMB approval, there is an overall
adjustment decrease of 2,565 burden
hours. The adjustment is attributable to
decreases in the average reporting
burden time and in respondents subject
to recordkeeping requirements.
Dated: March 21, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the AIDS Research Advisory
Committee, NIAID.
This will be a hybrid meeting held inperson and virtually and will be open to
the public as indicated below.
Individuals who plan to attend inperson or view the virtual meeting and
need special assistance or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
can be accessed from the NIH Videocast
at the following link: https://videocast.
nih.gov/.
Name of Committee: AIDS Research
Advisory Committee, NIAID.
Date: June 3, 2024.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: Report of Division Director and
Division Staff.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Grand Hall,
Rockville, MD 20852 (Hybrid Meeting).
Contact Person: Pamela Gilden, Branch
Chief, Science Planning and Operations
Branch, Division of AIDS, National Institute
of Allergy and Infectious Diseases, National
Institutes of Health, 5601 Fishers Lane, MSC
9831, Rockville, MD 20852–9831, 301–594–
9954, pamela.gilden@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Jkt 262001
[FR Doc. 2024–06461 Filed 3–26–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Allergy and
Infectious Diseases; Notice of
Meetings
BILLING CODE 4164–01–P
17:03 Mar 26, 2024
Dated: March 21, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2024–06438 Filed 3–26–24; 8:45 am]
VerDate Sep<11>2014
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Advisory
Allergy and Infectious Diseases Council.
A portion of the meetings will be
open to the public as indicated below,
with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council.
Date: June 3, 2024.
Open: 10:30 a.m. to 11:30 a.m.
Agenda: Report of Institute Director.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Grand Hall,
Rockville, MD 20852 (Hybrid Meeting).
Closed: 11:45 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Grand Hall,
Rockville, MD 20852 (Hybrid Meeting).
Contact Person: Kelly Y. Poe, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40B, Bethesda, MD
20892–9834, (240) 669–5036, poeky@
mail.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council;
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21259
Microbiology and Infectious Diseases
Subcommittee.
Date: June 3, 2024.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Garden Room 2,
Rockville, MD 20852 (Hybrid Meeting).
Open: 1:00 p.m. to 4:00 p.m.
Agenda: Report of the Division Director
and Division Staff.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Garden Room 2,
Rockville, MD 20852 (Hybrid Meeting).
Contact Person: Kelly Y. Poe, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40B Bethesda, MD
20892–9834, (240) 669–5036, poeky@
mail.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council;
Immunology and Transplantation
Subcommittee.
Date: June 3, 2024.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Garden Room 1,
Rockville, MD 20852 (Hybrid Meeting).
Open: 1:00 p.m. to 4:00 p.m.
Agenda: Report of the Division Director
and Division Staff.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Garden Room 1,
Rockville, MD 20852 (Hybrid Meeting).
Contact Person: Kelly Y. Poe, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Health, NIAID, National
Institutes of Health, 5601 Fishers Lane, Room
3F40B, Bethesda, MD 20892–9834, (240)
669–5036, poeky@mail.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council;
Acquired Immunodeficiency Syndrome
Subcommittee.
Date: June 3, 2024.
Closed: 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Grand Hall,
Rockville, MD 20852 (Hybrid Meeting).
Open: 1:00 p.m. to 4:00 p.m.
Agenda: Report of the Division Director
and Division Staff.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, Conference Room: Grand Hall, 5601
Fishers Lane, Rockville, MD 20852 (Hybrid
Meeting).
Contact Person: Kelly Y. Poe, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40B, Bethesda, MD
20892–9834, (240) 669–5036, poeky@
mail.nih.gov.
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 89, Number 60 (Wednesday, March 27, 2024)]
[Notices]
[Pages 21257-21259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06438]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4181]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Cattle Materials
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 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: Submit written comments (including recommendations) on the
collection of information by April 26, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0627. The title of this information
collection is ``Cattle Materials Prohibited From Use in Animal Food or
Feed.'' Also include the FDA docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
[[Page 21258]]
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.
Cattle Materials Prohibited From Use in Animal Food or Feed
OMB Control Number 0910-0627--Extension
This information collection helps to support implementation of
section 402 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
342(a)(5)), which governs 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. Our regulation at Sec. 589.2001
(21 CFR 589.2001) is designed to safeguard 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 to maintain adequate written procedures
and recordkeeping on renderers that receive, manufacture, process,
blend, or distribute raw material from cattle and to make these records
available for inspection and copying by FDA to demonstrate they are
taking measures to ensure that CMPAF is not introduced into animal
feed.
Under Sec. 589.2001(f), we may designate a country from which
cattle materials are not considered CMPAF. A country seeking to be so
designated must send a written request to the Director of the Center
for Veterinary Medicine, including certain required information. We use
the information provided to determine whether to grant a request for
designation and to impose conditions if a request is granted.
Additionally, designated countries will be subject to our future review
to determine whether their designations remain appropriate. As part of
this process, we may ask designated countries at any 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.
The 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.
Description of Respondents: Respondents to this information
collection are foreign governments seeking designation under Sec.
589.2001(f) and private sector rendering facilities that process cattle
materials under Sec. 589.2001(c).
In the Federal Register of October 12, 2023 (88 FR 70676), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, the
comments were not responsive to the four collection of information
topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR part; activity Number of responses per annual burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
589.2001(f); Request for designation by 1 2 2 33 66
FDA for exemption from requirements of
this regulation and response to request
for review by FDA........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since the last renewal, we reduced the request for designation
average burden per response by 40 hours (from 80 hours to 40 hours). We
take this reduction because foreign governments are required to provide
this information to other entities in order to comply with
international standards and therefore will have already compiled the
necessary information. The average burden per response to a request for
review by FDA remains the same (26 hours). The burden we attribute to
reporting activities is assumed to be distributed among the individual
elements of the information collection activities.
Since the effective date of the regulations in 2009, only two
requests for designation have been received; however, we retain our
current estimate of one respondent to permit such requests for
designation by respondents and also to permit related responses to FDA.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average burden
21 CFR part; activity Number of records per annual per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
589.2001(c)(2)(ii), 145 1 145 45 6,525
589.2001(c)(2)(vi), and (c)(3)(i),
and 589.2001(c)(3)(i)(A) and (B);
Rendering facilities maintain written
procedures and records, and
certification or documentation from
the supplier.........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2 reflects an adjustment decrease in our recordkeeping burden
estimate, based primarily on consolidation within the industry and the
related decrease in the estimated number of respondents subject to
recordkeeping requirements. The burden we attribute to recordkeeping
activities is assumed to be distributed among the individual elements
and averaged among respondents. The total number of recordkeepers
contains a
[[Page 21259]]
subset of 50 recordkeepers who maintain written procedures and records
specifically required by Sec. 589.2001(c).
Based on our review since the last OMB approval, there is an
overall adjustment decrease of 2,565 burden hours. The adjustment is
attributable to decreases in the average reporting burden time and in
respondents subject to recordkeeping requirements.
Dated: March 21, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06438 Filed 3-26-24; 8:45 am]
BILLING CODE 4164-01-P
