Notice2024-12359
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Reduced Risk of Coronary Heart Disease Health Claim
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 110 (Thursday, June 6, 2024)</title>
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[Federal Register Volume 89, Number 110 (Thursday, June 6, 2024)]
[Notices]
[Pages 48434-48435]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5746]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
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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 July 8, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
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 0910-0428. 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,
<a href="/cdn-cgi/l/email-protection#b9e9ebf8eacdd8dfdff9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="16464457456277707056707277387e7e6538717960">[email protected]</span></a>.
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.
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
[[Page 48435]]
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).
In the Federal Register of January 23, 2024 (89 FR 4309), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average burden
21 CFR section; activity Number of records per annual per Total hours
recordkeepers recordkeeper records recordkeeping
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101.82; Soy protein/CHD health 25 1 25 1 25
claim............................
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\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: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12359 Filed 6-5-24; 8:45 am]
BILLING CODE 4164-01-P
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