Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Reduced Risk of Coronary Heart Disease Health Claim, 4309-4311 [2024-01239]
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Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
an electronic copy of the document.
Please use the document number
GUI00020051 and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
Topic
807, subpart E .........................................................................
814, subparts A through E ......................................................
812 ...........................................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
800, 801, 809 and 830 ............................................................
Premarket notification ..............................................................
Premarket approval .................................................................
Investigational Device Exemption ...........................................
Q-submissions and Early Payor Feedback Request Programs for Medical Devices.
Medical Device Labeling Regulations; Unique Device Identification.
Good Laboratory Practice (GLP) Regulations for Nonclinical
Laboratory Studies.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01158 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) authorizes FDA to
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA is required to
publish notice of the issuance of priority
review vouchers as well as the approval
of products redeeming a priority review
voucher. FDA has determined that the
supplemental application (Supplement1) for ZEPOSIA (ozanimod), approved
May 27, 2021, meets the criteria for
redeeming a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the approval of a product
redeeming a rare pediatric disease
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following table have
been approved by OMB:
21 CFR part or guidance
58 .............................................................................................
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
priority review voucher. Under section
529 of the FD&C Act (21 U.S.C. 360ff),
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
supplemental application (Supplement1) for ZEPOSIA (ozanimod) meets the
redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about ZEPOSIA (ozanimod), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01160 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5746]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Record Retention
Requirements for the Soy Protein and
Reduced Risk of Coronary Heart
Disease Health Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
4309
OMB control No.
0910–0120
0910–0231
0910–0078
0910–0756
0910–0485
0910–0119
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 record
retention requirements for the soy
protein/coronary heart disease (CHD)
health claim.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
March 25, 2024.
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
March 25, 2024. 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
E:\FR\FM\23JAN1.SGM
23JAN1
4310
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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–5746 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Record
Retention Requirements for the Soy
Protein and Reduced Risk of Coronary
Heart Disease Health Claim.’’ 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
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
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
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
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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.
Record Retention Requirements for the
Soy Protein and Reduced Risk of
Coronary Heart Disease Health Claim—
21 CFR 101.82
OMB Control Number 0910–0428—
Extension
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health-related
condition only where that statement
meets the requirements of the
regulations issued by the Secretary of
Health and Human Services to authorize
the use of such a health claim. Section
101.82 (21 CFR 101.82) of our
regulations authorizes a health claim for
food labels about soy protein and the
risk of CHD. Accordingly, we
established this information collection
in support of the regulation.
This information collection enables us
to review food labeling ingredient
information to determine the basis of
soy protein/CHD health claims.
Respondents are required to retain
records for FDA inspection regarding
calculation of the ratio of soy protein to
total protein in a food when that food
bears a soy protein/CHD health claim.
While we are currently proposing to
revoke the regulation (RIN 0910–AH43)
as announced in the Federal Register of
October 31, 2017 (82 FR 50324), the
regulation remains in effect. Once we
finalize the proposed rule, the
associated information collection
requirements under this OMB control
number will be revoked. Until such time
and in accordance with the PRA, we
retain our currently approved burden
estimate for this information collection.
Description of Respondents:
Respondents include businesses
engaged in the manufacture of foods
containing soy and other proteins that
bear soy protein/CHD health claims.
Respondents to the information
collection are from the private sector
(for-profit businesses).
We estimate the burden of this
collection of information as follows:
E:\FR\FM\23JAN1.SGM
23JAN1
4311
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
recordkeepers
21 CFR Section; activity
101.82; Soy protein/CHD health claim ................................
1 There
ADDRESSES:
Dated: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2024–01239 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0073]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Irradiation in the
Production, Processing, and Handling
of Food
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, us, or
we) 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 our
requirements for food irradiation
processors.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
25
Total annual
records
1
25
Average
burden per
recordkeeping
1
Total hours
25
are no capital costs or operating and maintenance costs associated with this collection of information.
The records currently required to be
retained under § 101.82(c)(2)(ii)(B) are
the records, e.g., the formulation or
recipe, that a manufacturer has and
maintains as a normal course of its
doing business. Thus, the burden to the
food manufacturer is limited to
assembling and retaining the records.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
records per
recordkeeper
Either electronic or written
comments on the collection of
information must be submitted by
March 25, 2024.
DATES:
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
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
March 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–0073 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Irradiation in the Production,
Processing, and Handling of Food.’’
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
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
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4309-4311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5746]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Record Retention Requirements for the Soy Protein and
Reduced Risk of Coronary Heart Disease Health Claim
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 record retention
requirements for the soy protein/coronary heart disease (CHD) health
claim.
DATES: Either electronic or written comments on the collection of
information must be submitted by March 25, 2024.
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 March 25, 2024. 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
[[Page 4310]]
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-5746 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Record Retention Requirements for
the Soy Protein and Reduced Risk of Coronary Heart Disease Health
Claim.'' 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 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.
Record Retention Requirements for the Soy Protein and Reduced Risk of
Coronary Heart Disease Health Claim--21 CFR 101.82
OMB Control Number 0910-0428--Extension
Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(r)(3)(A)) provides for the use of food label statements
characterizing a relationship of any nutrient of the type required to
be in the label or labeling of the food to a disease or a health-
related condition only where that statement meets the requirements of
the regulations issued by the Secretary of Health and Human Services to
authorize the use of such a health claim. Section 101.82 (21 CFR
101.82) of our regulations authorizes a health claim for food labels
about soy protein and the risk of CHD. Accordingly, we established this
information collection in support of the regulation.
This information collection enables us to review food labeling
ingredient information to determine the basis of soy protein/CHD health
claims. Respondents are required to retain records for FDA inspection
regarding calculation of the ratio of soy protein to total protein in a
food when that food bears a soy protein/CHD health claim.
While we are currently proposing to revoke the regulation (RIN
0910-AH43) as announced in the Federal Register of October 31, 2017 (82
FR 50324), the regulation remains in effect. Once we finalize the
proposed rule, the associated information collection requirements under
this OMB control number will be revoked. Until such time and in
accordance with the PRA, we retain our currently approved burden
estimate for this information collection.
Description of Respondents: Respondents include businesses engaged
in the manufacture of foods containing soy and other proteins that bear
soy protein/CHD health claims. Respondents to the information
collection are from the private sector (for-profit businesses).
We estimate the burden of this collection of information as
follows:
[[Page 4311]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section; activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
101.82; Soy protein/CHD health 25 1 25 1 25
claim..........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The records currently required to be retained under Sec.
101.82(c)(2)(ii)(B) are the records, e.g., the formulation or recipe,
that a manufacturer has and maintains as a normal course of its doing
business. Thus, the burden to the food manufacturer is limited to
assembling and retaining the records.
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. 2024-01239 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P
