Notice2025-14222
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification Procedures for Statements of Dietary Supplements
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
July 29, 2025
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 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35694-35695]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14222]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5234]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Notification
Procedures for Statements of 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 August 28, 2025.
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
[[Page 35695]]
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: 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,
<a href="/cdn-cgi/l/email-protection#b6e6e4f7e5c2d7d0d0f6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="f5a5a7b4a681949393b5939194db9d9d86db929a83">[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.
Food Labeling: Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93
OMB Control Number 0910-0331--Extension
Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) 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 an alternative format may
opt to do so; however, Form FDA 3955 prompts respondents to include
certain data elements in their structure/function claim notification
(SFCN), as 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. We also provide information on our website
at <a href="https://www.fda.gov/food/information-industry-dietary-supplements/notifications-structurefunction-and-related-claims-dietary-supplement-labeling">https://www.fda.gov/food/information-industry-dietary-supplements/notifications-structurefunction-and-related-claims-dietary-supplement-labeling</a>, which may serve as a helpful resource to respondents.
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 19, 2024 (89 FR 103835), we
published a 60-day notice soliciting 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 Total Average
21 CFR section; activity; Form No. Number of responses per annual burden per Total
respondents respondent responses response hours
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101.93; Statements for Dietary Supplements; 3,690 1 3,690 0.75 2,768
Form FDA 3955............................... (45
minutes)
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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: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14222 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
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