[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68504-68506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26172]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

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

[[Page 68505]]

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: Submit either electronic or written comments on the collection 
of information by January 31, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end January 31, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2021-N-1222 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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: 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: 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. 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

[[Page 68506]]

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.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
              21 CFR section                   Number of     responses per   Total annual            Average burden per response            Total hours
                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.93....................................           3,690               1           3,690  0.75 (45 minutes)...........................           2,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26172 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P


