Document ID: FDA-2011-N-0781-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of 
Management and Budget Review; Comment Request; Record Retention 
Requirements for the Soy Protein and Risk of Coronary Heart Disease Health 
Claim
Posted Date: 2021-04-23T04:00Z

[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21748-21749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08480]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0781]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Record Retention 
Requirements for the Soy Protein and 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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by May 24, 2021.

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 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 coronary heart disease. Accordingly, 
we established the previously referenced information collection in 
support of the regulation.
    In the Federal Register of October 31, 2017 (82 FR 50324), we 
published a proposed rule to revoke the underlying regulation found at 
Sec.  101.82. We are taking this action based on our review of the 
totality of publicly available scientific evidence currently available 
and our tentative conclusion that such evidence does not support our 
previous determination that there is significant scientific agreement 
among qualified experts for a health claim regarding the relationship 
between soy protein and reduced risk of coronary heart disease. Upon 
finalization of 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.
    In the Federal Register of October 21, 2020 (85 FR 66999), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
         21 CFR section               Number        records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeping      records      recordkeeping
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101.82(c)(2)(ii)(B).............              25               1              25               1              25
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\1\ There are no capital costs 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. The records currently required to be retained under Sec.  
101.82(c)(2)(ii)(B) are the

[[Page 21749]]

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.

    Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08480 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P