[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Proposed Rules]
[Pages 30843-30845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 190

[Docket No. FDA-2022-D-0281]


Policy Regarding Certain New Dietary Ingredients and Dietary 
Supplements Subject to the Requirement for Pre-Market Notification; 
Draft Guidance for Industry; Availability; Agency Information 
Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Policy 
Regarding Certain New Dietary Ingredients and Dietary Supplements 
Subject to the Requirement for Pre-market Notification.'' The draft 
guidance, when finalized, will advise the dietary supplement industry 
of our intent to exercise enforcement discretion, for a limited time 
and in limited circumstances, regarding the requirement to submit a new 
dietary ingredient (NDI) notification prior to marketing. The purpose 
of the policy is to encourage manufacturers and distributors of certain 
NDI-containing dietary supplements to correct any past failures to 
submit a required NDI notification.

DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2022 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 
guidance. Submit written comments (including recommendations) on the 
collection of information under the Paperwork Reduction Act of 1995 by 
July 19, 2022.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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'').

[[Page 30844]]

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-2022-D-0281 for ``Policy Regarding Certain New Dietary Ingredients 
and Dietary Supplements Subject to the Requirement for Pre-market 
Notification.'' Received comments 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.'' We will review 
this copy, including the claimed confidential information, in our 
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.
    Submit comments on the information collection under the Paperwork 
Reduction Act of 1995 to the Office of Management and Budget (OMB) at 
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 title of this 
proposed collection is ``Policy Regarding Certain New Dietary 
Ingredients and Dietary Supplements Subject to the Requirement for Pre-
market Notification; Draft Guidance for Industry.''
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Dietary Supplement Programs, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Laura Rich, Office of Dietary Supplement Programs (HFS-810), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-8152; or Alexandra 
Jurewitz, Office of Regulations and Policy (HFS-024), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2378.
    With regard to the proposed collection of information: 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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Policy Regarding Certain New Dietary Ingredients and Dietary 
Supplements Subject to the Requirement for Pre-market Notification.'' 
We are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.
    The draft guidance, when finalized, will advise manufacturers and 
distributors of certain NDI-containing dietary supplements (namely, 
those that are subject to the premarket notification requirement and 
are being marketed without such a notification) of FDA's intent to 
exercise enforcement discretion for such firms to submit a late NDI 
notification for a limited time and in limited circumstances.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

III. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (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 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

[[Page 30845]]

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.

Policy Regarding Certain New Dietary Ingredients and Dietary 
Supplements Subject to the Requirement for Pre-Market Notification

OMB Control Number 0910--NEW

    This draft guidance, when finalized, is intended to advise the 
dietary supplement industry of our intent to exercise enforcement 
discretion, for a limited time and in limited circumstances, regarding 
the requirement to submit an NDI notification prior to marketing. The 
purpose of the policy is to encourage manufacturers and distributors of 
certain NDI-containing dietary supplements to correct any past failures 
to submit an NDI notification as required by Sec.  190.6 (21 CFR 
190.6). The proposed information collection requests that manufacturers 
and distributors who submit a late NDI notification under the 
enforcement discretion policy in the draft guidance supplement the 
notification with the following additional information: (1) A copy of 
the current label for the dietary supplement containing the NDI and (2) 
documentation to demonstrate the date that the dietary supplement was 
first introduced or delivered for introduction into interstate 
commerce.
    We are developing a new submission type in the CFSAN Online 
Submission Module that will be used for late notifications submitted 
under the temporary enforcement discretion policy if the draft guidance 
is finalized. A draft screenshot of the questions specific to late 
notifications is available for comment at https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient.
    Description of Respondents: The respondents to this collection of 
information are manufacturers and distributors in the dietary 
supplement industry; specifically, firms that failed to comply with the 
NDI notification requirements in Sec.  190.6 and that wish to take 
advantage of FDA's temporary enforcement discretion policy to submit a 
late NDI notification.
    FDA estimates the burden of this collection of information as 
follows:

                                                    Table 1--Estimated One-Time Reporting Burden \1\
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                                                                  Number of
                   Activity                       Number of     responses per       Total        Average burden per response (in hours)     Total hours
                                                 respondents     respondent       responses
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Submit product label and documentation of               3,500               1           3,500  0.30 (18 minutes)........................           1,050
 date of introduction into interstate
 commerce to FDA.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 1 are based on our experience with our 
current NDI program. We estimate that 3,500 respondents will submit 
their product labels and documentation of dates of introduction into 
interstate commerce and that each respondent will submit 1 product 
label and corresponding documentation of date of introduction into 
interstate commerce. We further estimate that preparing and submitting 
each response will take approximately 0.30 hour (18 minutes), resulting 
in a total reporting burden of 1,050 hours (3,500 responses x 0.30 
hour). This will be a temporary collection of information, as we expect 
to conduct this program for 6 months.
    This draft guidance also refers to previously approved FDA 
collections of information. The collections of information in Sec.  
190.6 have been approved under OMB control number 0910-0330.

    Dated: May 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10942 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P


