Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle, 5241-5243 [2024-01586]
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Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002 or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the document.
FOR FURTHER INFORMATION CONTACT: Sara
Camilli, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 3486, Silver Spring,
MD 20993–0002, 301–796–4203,
Sara.Camilli@fda.hhs.gov; or James
Myers, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a final document entitled ‘‘Best
Practices for FDA Staff in the
Postmarketing Safety Surveillance of
Human Drug and Biological Products.’’
Title IX, section 915 of the Food and
Drug Administration Amendments Act
of 2007 (FDAAA) (Pub. L. 110–85)
added section 505(r) to the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(r)), requiring FDA to
prepare a summary analysis of the
adverse drug reaction reports received
for a drug by 18 months after approval
or after use of the drug by 10,000
individuals, whichever is later. The
analysis includes identification of any
new risks not previously identified,
potential new risks, or known risks
reported in unusual number.
Section 3075 of the Cures Act (Pub. L.
114–255) amended section 505(r)(2)(D)
of the FD&C Act to eliminate the
requirement for summary analyses for
drugs as required by FDAAA. In place
of the summary analyses, section 3075
amended section 505(r)(2)(D) of the
FD&C Act to include the requirement
that FDA make publicly available on its
internet website best practices for drug
safety surveillance activities for drugs
approved under section 505 of the FD&C
Act or section 351 of the Public Health
Service Act (PHS Act).
Section 3075 of the Cures Act also
amended section 505(k)(5) of the FD&C
Act to strike ‘‘bi-weekly screening,’’ in
subparagraph (A), and insert
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18:02 Jan 25, 2024
Jkt 262001
‘‘screenings’’; it also added the
requirement that FDA make publicly
available on its internet website
guidelines, developed with input from
experts qualified by scientific training
and experience to evaluate the safety
and effectiveness of drugs, that detail
best practices for drug safety
surveillance using the Adverse Event
Reporting System.
The final document entitled ‘‘Best
Practices for FDA Staff in the
Postmarketing Safety Surveillance of
Human Drugs and Biological Products’’
sets forth risk-based principles for
FDA’s conduct of ongoing
postmarketing safety surveillance for
human drug products and human
biological products to address the Cures
Act requirements. Although section
3075 of the Cures Act only references
drugs approved under section 505 of the
FD&C Act or section 351 of the PHS Act,
the document additionally discusses
other products, including
nonprescription drug products,
compounded drug products, and
homeopathic products. The document
also includes a high-level overview of
other drug safety surveillance data
sources, tools, methods, and activities
that extend beyond use of FDA’s
adverse event reporting systems, as well
as regulatory and other actions that can
be taken in response to identified safety
signals. These additional topics are
included to provide context and a
general overview of FDA’s safety
surveillance process.
This document finalizes the draft
document entitled ‘‘Best Practices in
Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff,’’
issued on November 7, 2019 (84 FR
60094). FDA considered comments
received on the draft document as the
document was finalized. Changes from
the draft to the final document include:
(1) document title revised to emphasize
this document’s focus on postmarketing
safety surveillance and to clarify that
this document only refers to human
drug and biological products that are
regulated by FDA, as this document
does not refer to animal drugs regulated
by FDA; (2) additional content to
distinguish between the use of the terms
adverse event and adverse reaction; (3)
clarification of products that generally
are subject to more extensive monitoring
and types of safety information for
focus; (4) addition of a description of
the FDA Adverse Event Reporting
System Public Dashboard; (5) revisions
to the content on medication errors, for
clarity; (6) revisions to the section on
the pregnant population to align with
the most recently issued documents
pertaining to clinical trials and
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Fmt 4703
Sfmt 4703
5241
postapproval pregnancy safety studies;
(7) inclusion of citations referencing the
Sentinel System; (8) revisions to the
description of the process for signal
evaluation and documentation,
including addition of a reference to the
Center for Drug Evaluation and
Research’s ‘‘Manual of Policies and
Procedures for Collaborative
Identification, Evaluation, and
Resolution of a Newly Identified Safety
Signal’’; (9) inclusion of an expanded
discussion of product labeling changes;
and (10) additional content regarding
Drug Safety Communications. Editorial
changes were made to improve clarity.
II. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/about-fda/center-drugevaluation-and-research-cder/cderoffice-surveillance-and-epidemiology or
https://www.regulations.gov.
Dated: January 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01584 Filed 1–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2853]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
and Reporting Requirements for
Human Food and Cosmetics
Manufactured From, Processed With,
or Otherwise Containing Material From
Cattle
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 February
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
SUMMARY:
E:\FR\FM\26JAN1.SGM
26JAN1
5242
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
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 0910–0623. Also include
the FDA docket number found in
brackets in the heading of this
document.
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, PRAStaff@
fda.hhs.gov.
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:
Recordkeeping and Reporting
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle—21
CFR 189.5 and 700.27
lotter on DSK11XQN23PROD with NOTICES1
OMB Control No. 0910–0623—Extension
This information collection supports
FDA regulations in §§ 189.5 and 700.27
(21 CFR 189.5 and 700.27) that set forth
bovine spongiform encephalopathy
(BSE)-related restrictions applicable to
FDA-regulated human food and
cosmetics. The regulations designate
certain materials from cattle as
‘‘prohibited cattle materials,’’ including
specified risk materials (SRMs), the
small intestine of cattle not otherwise
excluded from being a prohibited cattle
material, material from nonambulatory
disabled cattle, and mechanically
separated (MS) beef. Sections 189.5(c)
and 700.27(c) set forth the requirements
for recordkeeping and records access for
FDA-regulated human food, including
dietary supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
from cattle. FDA issued these
recordkeeping regulations under the
adulteration provisions in sections
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c),
and 701(a) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c),
and 371(a)). Under section 701(a) of the
FD&C Act, we are authorized to issue
regulations for the FD&C Act’s efficient
enforcement. With regard to records
concerning imported human food and
cosmetics, FDA relied on our authority
under sections 701(b) and 801(a) of the
FD&C Act (21 U.S.C. 371(b) and 381(a)).
Section 801(a) of the FD&C Act provides
requirements with regard to imported
human food and cosmetics and provides
VerDate Sep<11>2014
18:02 Jan 25, 2024
Jkt 262001
for refusal of admission of human food
and cosmetics that appear to be
adulterated into the United States.
Section 701(b) of the FD&C Act
authorizes the Secretaries of Treasury
and Health and Human Services to
jointly prescribe regulations for the
efficient enforcement of section 801 of
the FD&C Act.
These requirements are necessary
because once materials are separated
from an animal it may not be possible,
without records, to know the following:
(1) whether cattle material may contain
SRMs (brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the
transverse processes of the thoracic and
lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia from
animals 30 months and older and
tonsils and distal ileum of the small
intestine from all animals of all ages);
(2) whether the source animal for cattle
material was inspected and passed; (3)
whether the source animal for cattle
material was nonambulatory disabled,
or MS beef; and (4) whether tallow in
human food or cosmetics contain less
than 0.15 percent insoluble impurities.
FDA’s regulations in §§ 189.5(c) and
700.27(c) require manufacturers and
processors of human food and cosmetics
manufactured from, processed with, or
otherwise containing material from
cattle establish and maintain records
sufficient to demonstrate that the
human food or cosmetics are not
manufactured from, processed with, or
otherwise contain prohibited cattle
materials. These records must be
retained for 2 years at the manufacturing
or processing establishment or at a
reasonably accessible location.
Maintenance of electronic records is
acceptable, and electronic records are
considered to be reasonably accessible if
they are accessible from an onsite
location. Records required by these
sections and existing records relevant to
compliance with these sections must be
available to FDA for inspection and
copying. Existing records may be used
if they contain all of the required
information and are retained for the
required time period.
Because we do not easily have access
to records maintained at foreign
establishments, FDA regulations in
§§ 189.5(c)(6) and 700.27(c)(6),
respectively, require that when filing for
entry with U.S. Customs and Border
Protection, the importer of record of
human food or cosmetics manufactured
from, processed with, or otherwise
containing, cattle material must affirm
that the human food or cosmetics were
manufactured from, processed with, or
otherwise contains, cattle material and
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
must affirm that the human food or
cosmetics were manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. In
addition, if human food or cosmetics
were manufactured from, processed
with, or otherwise contains cattle
material, the importer of record must
provide within 5 business days records
sufficient to demonstrate that the
human food or cosmetics were not
manufactured from, processed with, or
otherwise contains prohibited cattle
material, if requested.
Under FDA’s regulations, we may
designate a country from which cattle
materials inspected and passed for
human consumption are not considered
prohibited cattle materials, and their use
does not render human food or
cosmetics adulterated. Sections 189.5(e)
and 700.27(e) provide that a country
seeking to be designated must send a
written request to the Director of the
Center for Food Safety and Applied
Nutrition. The information the country
is required to submit includes
information about a country’s BSE case
history, risk factors, measures to prevent
the introduction and transmission of
BSE, and any other information relevant
to determining whether SRMs, the small
intestine of cattle not otherwise
excluded from being a prohibited cattle
material, material from nonambulatory
disabled cattle, or MS beef from the
country seeking designation should be
considered prohibited cattle materials.
We use the information to determine
whether to grant a request for
designation and to impose conditions if
a request is granted.
Sections 189.5 and 700.27 further
state that countries designated under
§§ 189.5(e) and 700.27(e) will be subject
to future review by FDA to determine
whether their designations remain
appropriate. As part of this process, we
may ask designated countries to confirm
their BSE situation and the information
submitted by them, in support of their
original application, has remained
unchanged. We may revoke a country’s
designation if we determine that it is no
longer appropriate. Therefore,
designated countries may respond to
periodic FDA 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 manufacturers,
processors, and importers of FDAregulated human food, including dietary
supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
E:\FR\FM\26JAN1.SGM
26JAN1
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
from cattle, as well as, with regard to
§§ 189.5(e) and 700.27(e), foreign
governments seeking designation under
those regulations.
In the Federal Register of August 11,
2023 (88 FR 54617), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment
5243
that was not related to the PRA and
therefore will not be addressed in this
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
189.5(c)(6) and 700.27(c)(6); affirmation of
compliance.
189.5(e) and 700.27(e); request for designation.
189.5(e) and 700.27(e); response to request
for review by FDA.
Total ...........................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per
response
Total hours
54,825
1
54,825
0.033 (2 minutes) .............
1,809
1
1
1
80 ......................................
80
1
1
1
26 ......................................
26
........................
........................
........................
...........................................
1,915
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of respondent
Total annual
records
Average burden per
recordkeeper
Total hours
Domestic Facilities ............................................
Foreign Facilities ...............................................
697
916
52
52
36,244
47,632
0.25 (15 minutes) .............
0.25 (15 minutes) .............
9,061
11,908
Total ...........................................................
........................
........................
........................
...........................................
20,969
1 There
are no capital 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.
Dated: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01586 Filed 1–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6827]
Advisory Committee; Vaccines and
Related Biological Products Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the Vaccines
and Related Biological Products
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Vaccines and
SUMMARY:
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Number of
records per
recordkeeper
VerDate Sep<11>2014
18:02 Jan 25, 2024
Jkt 262001
Related Biological Products Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
December 31, 2025, expiration date.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2025, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Sussan Paydar, Division of Scientific
Advisors and Consultants, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring,
MD 20993–0002, 202–657–8533,
Sussan.Paydar@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Vaccines and Related
Biological Products Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective vaccines and related biological
products for human use, and as
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and as required, any
other products for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner.
Pursuant to its charter, the Committee
shall consist of a core of 15 voting
members, including the Chairperson
(the Chair). Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology or
biostatistics, vaccine policy, vaccine
safety science, federal immunization
activities, vaccine development
including translational and clinical
evaluation programs, hypersensitivity
reactions to the vaccines, preventive
medicine, infectious diseases,
pediatrics, microbiology, and
biochemistry. Members will be invited
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5241-5243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01586]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2853]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recordkeeping and
Reporting Requirements for Human Food and Cosmetics Manufactured From,
Processed With, or Otherwise Containing Material From Cattle
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 February 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
[[Page 5242]]
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 0910-0623. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle--21 CFR 189.5 and 700.27
OMB Control No. 0910-0623--Extension
This information collection supports FDA regulations in Sec. Sec.
189.5 and 700.27 (21 CFR 189.5 and 700.27) that set forth bovine
spongiform encephalopathy (BSE)-related restrictions applicable to FDA-
regulated human food and cosmetics. The regulations designate certain
materials from cattle as ``prohibited cattle materials,'' including
specified risk materials (SRMs), the small intestine of cattle not
otherwise excluded from being a prohibited cattle material, material
from nonambulatory disabled cattle, and mechanically separated (MS)
beef. Sections 189.5(c) and 700.27(c) set forth the requirements for
recordkeeping and records access for FDA-regulated human food,
including dietary supplements, and cosmetics manufactured from,
processed with, or otherwise containing material derived from cattle.
FDA issued these recordkeeping regulations under the adulteration
provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c),
and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under
section 701(a) of the FD&C Act, we are authorized to issue regulations
for the FD&C Act's efficient enforcement. With regard to records
concerning imported human food and cosmetics, FDA relied on our
authority under sections 701(b) and 801(a) of the FD&C Act (21 U.S.C.
371(b) and 381(a)). Section 801(a) of the FD&C Act provides
requirements with regard to imported human food and cosmetics and
provides for refusal of admission of human food and cosmetics that
appear to be adulterated into the United States. Section 701(b) of the
FD&C Act authorizes the Secretaries of Treasury and Health and Human
Services to jointly prescribe regulations for the efficient enforcement
of section 801 of the FD&C Act.
These requirements are necessary because once materials are
separated from an animal it may not be possible, without records, to
know the following: (1) whether cattle material may contain SRMs
(brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal
root ganglia from animals 30 months and older and tonsils and distal
ileum of the small intestine from all animals of all ages); (2) whether
the source animal for cattle material was inspected and passed; (3)
whether the source animal for cattle material was nonambulatory
disabled, or MS beef; and (4) whether tallow in human food or cosmetics
contain less than 0.15 percent insoluble impurities.
FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) require
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contain prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
Because we do not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of human
food or cosmetics manufactured from, processed with, or otherwise
containing, cattle material must affirm that the human food or
cosmetics were manufactured from, processed with, or otherwise
contains, cattle material and must affirm that the human food or
cosmetics were manufactured in accordance with the applicable
requirements of Sec. Sec. 189.5 or 700.27. In addition, if human food
or cosmetics were manufactured from, processed with, or otherwise
contains cattle material, the importer of record must provide within 5
business days records sufficient to demonstrate that the human food or
cosmetics were not manufactured from, processed with, or otherwise
contains prohibited cattle material, if requested.
Under FDA's regulations, we may designate a country from which
cattle materials inspected and passed for human consumption are not
considered prohibited cattle materials, and their use does not render
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e)
provide that a country seeking to be designated must send a written
request to the Director of the Center for Food Safety and Applied
Nutrition. The information the country is required to submit includes
information about a country's BSE case history, risk factors, measures
to prevent the introduction and transmission of BSE, and any other
information relevant to determining whether SRMs, the small intestine
of cattle not otherwise excluded from being a prohibited cattle
material, material from nonambulatory disabled cattle, or MS beef from
the country seeking designation should be considered prohibited cattle
materials. We use the information to determine whether to grant a
request for designation and to impose conditions if a request is
granted.
Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec. 189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, we may ask designated countries
to confirm their BSE situation and the information submitted by them,
in support of their original application, has remained unchanged. We
may revoke a country's designation if we determine that it is no longer
appropriate. Therefore, designated countries may respond to periodic
FDA 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 manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived
[[Page 5243]]
from cattle, as well as, with regard to Sec. Sec. 189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
In the Federal Register of August 11, 2023 (88 FR 54617), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment that was not related
to the PRA and therefore will not be addressed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6); affirmation 54,825 1 54,825 0.033 (2 minutes)............................ 1,809
of compliance.
189.5(e) and 700.27(e); request for 1 1 1 80........................................... 80
designation.
189.5(e) and 700.27(e); response to 1 1 1 26........................................... 26
request for review by FDA.
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Total................................ .............. .............. .............. ............................................. 1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Type of respondent Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
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Domestic Facilities...................... 697 52 36,244 0.25 (15 minutes)............................ 9,061
Foreign Facilities....................... 916 52 47,632 0.25 (15 minutes)............................ 11,908
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Total................................ .............. .............. .............. ............................................. 20,969
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\1\ There are no capital 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.
Dated: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01586 Filed 1-25-24; 8:45 am]
BILLING CODE 4164-01-P
