[Federal Register Volume 89, Number 110 (Thursday, June 6, 2024)]
[Notices]
[Pages 48434-48435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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