Notice2023-17273
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
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Published
August 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.
Full Text
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<title>Federal Register, Volume 88 Issue 154 (Friday, August 11, 2023)</title>
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[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54617-54619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2853]
Agency Information Collection Activities; Proposed Collection;
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 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 information collection provisions of
existing FDA regulations concerning FDA-regulated human food, including
dietary supplements, and cosmetics manufactured from, processed with,
or otherwise containing material derived from cattle.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 10, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 10, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> 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-2023-N-2853 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping and Reporting
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing Material From Cattle.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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,
<a href="/cdn-cgi/l/email-protection#adfdffecfed9cccbcbedcbc9cc83c5c5de83cac2db"><span class="__cf_email__" data-cfemail="045456455770656262446260652a6c6c772a636b72">[email protected]</span></a>.
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.
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 Number 0910-0623--Extension
This information collection supports FDA regulations in Sec. Sec.
189.5 and 700.27 (21 CFR 189.5 and 700.27), which 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 that
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
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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 from cattle, as well as, with regard to Sec. Sec. 189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
We estimate 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 of 54,825 1 54,825 0.033 (2 minutes)......................... 1,809
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 request 1 1 1 26........................................ 26
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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17273 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
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