Proposed Rule2022-10942
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Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
May 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification." The draft guidance, when finalized, will advise the dietary supplement industry of our intent to exercise enforcement discretion, for a limited time and in limited circumstances,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.
Full Text
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<title>Federal Register, Volume 87 Issue 98 (Friday, May 20, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Draft Guidance for Industry; Availability; Agency Information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availability of a draft guidance for industry entitled ``Policy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 The draft
guidance, when finalized, will advise the dietary supplement industry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:
<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'').
[[Page 30844]]
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-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 <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.'' 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 <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.
Submit comments on the information collection under the Paperwork
Reduction Act of 1995 to the Office of Management and Budget (OMB) at
<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 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, <a href="/cdn-cgi/l/email-protection#48181a091b3c292e2e082e2c296620203b662f273e"><span class="__cf_email__" data-cfemail="c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0">[email protected]</span></a>.
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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient">https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient</a>.
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
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