[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]
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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.
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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\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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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