Notice2024-30231
Agency Information Collection Activities; Proposed Collection; 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
December 19, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the regulation requiring the manufacturer, packer, or distributor of a dietary supplement to notify us that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 89 Issue 244 (Thursday, December 19, 2024)</title>
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[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103835-103836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30231]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5234]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the regulation requiring the manufacturer, packer, or
distributor of a dietary supplement to notify us that it is marketing a
dietary supplement product that bears on its label or in its labeling a
statement provided for in the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: Either electronic or written comments on the collection of
information must be submitted by February 18, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 18, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-5234 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling: Notification
Procedures for Statements on Dietary Supplements.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#1c4c4e5d4f687d7a7a5c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="4b1b190a183f2a2d2d0b2d2f2a65232338652c243d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party.
[[Page 103836]]
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 a format of their own
choosing 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. 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.
FDA estimates 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
respondents respondent responses hours
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101.93; Statements for Dietary Supplements; Form 3,690 1 3,690 0.75 (45 minutes).......................... 2,768
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: December 12, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30231 Filed 12-18-24; 8:45 am]
BILLING CODE 4164-01-P
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