[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Page 35789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1222]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Labeling: 
Notification Procedures for Statements on Dietary Supplements

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 13, 2022.

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 0910-0331. 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.

Food Labeling: Notification Procedures for Statements on Dietary 
Supplements--21 CFR 101.93

OMB Control Number 0910-0331--Extension

    Section 403(r)(6) (21 U.S.C. 343(r)(6)) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) and Sec.  101.93 (21 CFR 101.93) require 
that, no later than 30 days after the first marketing, we be notified 
by the manufacturer, packer, or distributor of a dietary supplement 
that it is marketing a dietary supplement product that bears on its 
label or in its labeling a statement provided for in section 403(r)(6) 
of the FD&C Act. In accordance with these requirements, submissions 
must include: (1) the name and address of the manufacturer, packer, or 
distributor of the dietary supplement product; (2) the text of the 
statement that is being made; (3) the name of the dietary ingredient or 
supplement that is the subject of the statement; (4) the name of the 
dietary supplement (including the brand name); and (5) the signature of 
a responsible individual or the person who can certify the accuracy of 
the information presented, and who must certify that the information 
contained in the notice is complete and accurate, and that the 
notifying firm has substantiation that the statement is truthful and 
not misleading.
    Our electronic form (Form FDA 3955) allows respondents to the 
information collection to electronically submit notifications to FDA 
via the Food Applications Regulatory Management (FARM) system. Firms 
that prefer to submit a paper notification in a format of their own 
choosing will still have the option to do so; however, Form FDA 3955 
prompts respondents to include certain elements in their structure/
function claim notification (SFCN) described in Sec.  101.93 in a 
standard electronic format and helps respondents organize their SFCN to 
include only the information needed for our review of the claim. Note 
that the SFCN, whether electronic or paper, is used for all claims made 
pursuant to section 403(r)(6) of the FD&C Act, including nutrient 
deficiency claims and general well-being claims in addition to 
structure/function claims. The electronic form, and any optional 
elements prepared as attachments to the form (e.g., label), can be 
submitted in electronic format via FARM. Submissions of SFCNs will 
continue to be allowed in paper format. We use this information to 
evaluate whether statements made for dietary ingredients or dietary 
supplements are permissible under section 403(r)(6) of the FD&C Act.
    Description of Respondents: Respondents to this collection of 
information include manufacturers, packers, or distributors of dietary 
supplements that bear section 403(r)(6) of the FD&C Act statements on 
their labels or labeling.
    In the Federal Register of December 2, 2021 (86 FR 68504), FDA 
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 Reporting Burden \1\
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                                                                  Number of
      21 CFR section; activity; form No.          Number of     responses per    Total annual          Average burden per response          Total hours
                                                 respondents     respondent       responses
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101.93; Statements for Dietary Supplements;             3,690               1           3,690   0.75 (45 minutes).......................           2,768
 Form FDA 3955.
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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. This estimate is based on our experience with this 
information collection and the number of notifications received in the 
past 3 years, which has remained constant.

    Dated: June 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12625 Filed 6-10-22; 8:45 am]
BILLING CODE 4164-01-P