[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Page 26477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12216]


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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: Fax written comments on the collection of information by July 9, 
2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0428. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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 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, 
FDA 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 the information 
collection displayed in table 1 of this notice.
    In the Federal Register of March 8, 2018 (83 FR 9856), 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 Recordkeeping Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of      records per    Total  annual    burden per     Total  hours
                                   recordkeepers   recordkeeper       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 our current experience with the use of health claims, we 
estimate 25 firms market products bearing a soy protein/coronary heart 
disease health claim and that perhaps one of each firm's products might 
contain non-soy sources of protein along with soy protein. 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, which we estimate will take 1 hour annually.

    Dated: May 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12216 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P


