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, 54617-54619 [2023-17273]
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Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
274 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: Not Applicable. The applicant
claims no investigational device
exemption (IDE) for the regulatory
review period.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): April 23, 2020.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for VERCISE GENUS DBS
SYSTEM was initially submitted April
23, 2020.
3. The date the application was
approved: January 21, 2021. FDA has
verified the applicant’s claim that PMA
P150031 S034 was approved on January
21, 2021.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 273 days of patent
term extension.
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III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
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16:59 Aug 10, 2023
Jkt 259001
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17259 Filed 8–10–23; 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; 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.
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 https://
www.regulations.gov 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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54617
• 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
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–
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
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
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Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
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
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, PRAStaff@
fda.hhs.gov.
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
VerDate Sep<11>2014
16:59 Aug 10, 2023
Jkt 259001
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 §§ 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
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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 §§ 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
§§ 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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Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
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 §§ 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
from cattle, as well as, with regard to
§§ 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
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per
response
Total hours
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.
54,825
1
54,825
0.033 (2 minutes) ......
1,809
1
1
1
1
1
1
80 ..............................
26 ..............................
80
26
Total ..................................................................
........................
........................
........................
....................................
1,915
1 There
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
Number of
records per
recordkeeper
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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17273 Filed 8–10–23; 8:45 am]
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]]>Agencies
[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54617-54619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17273]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
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 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-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 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
[[Page 54618]]
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: 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: 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
[[Page 54619]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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.
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 1,915
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic Facilities......................... 697 52 36,244 0.25 (15 minutes)......................... 9,061
Foreign Facilities.......................... 916 52 47,632 0.25 (15 minutes)......................... 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: 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
