Notice2022-12625
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling: Notification Procedures for Statements on 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
June 13, 2022
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 87 Issue 113 (Monday, June 13, 2022)</title>
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[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Page 35789]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#cd9d9f8c9eb9acabab8daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="83d3d1c2d0f7e2e5e5c3e5e7e2adebebf0ade4ecf5">[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) (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
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