Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient

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Published

January 17, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or we) 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 89 Issue 11 (Wednesday, January 17, 2024)</title>
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[Federal Register Volume 89, Number 11 (Wednesday, January 17, 2024)]
[Notices]
[Pages 2957-2960]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00732]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2780]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 February 16, 2024.

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 0910-0330. Also include the FDA docket
number found in brackets in the heading of this document.

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#b7e7e5f6e4c3d6d1d1f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="0e5e5c4f5d7a6f68684e686a6f2066667d20696178">[email&#160;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.

Premarket Notification for a New Dietary Ingredient--21 CFR 190.6

OMB Control Number 0910-0330--Revision

This information collection supports Agency regulation, guidance,
and associated Form FDA 3880. Under section 413(a)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the
manufacturer or distributor of a new dietary ingredient (NDI) or a
dietary supplement that contains the NDI, must submit an NDI
notification (NDIN) to FDA (as delegate for the Secretary of Health and
Human Services) at least 75 days before introducing the product into
interstate commerce, unless the NDI and any other dietary ingredients
in the dietary supplement ``have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered'' (21 U.S.C. 350b(a)(1)).
The notification must contain the information, including any
citation to published articles, which provides the basis on which the
manufacturer or distributor of the NDI or dietary supplement (the
notifier) has concluded that the dietary supplement containing the NDI
will reasonably be expected to be safe (21 U.S.C. 350b(a)(2)). If the
required premarket notification is not submitted to FDA, section 413(a)
of the

[[Page 2958]]

FD&C Act provides that the dietary supplement containing the NDI is
deemed to be adulterated under section 402(f) of the FD&C Act (21
U.S.C. 342(f)). Even if the notification is submitted as required, the
dietary supplement containing the NDI is adulterated under section
402(f) of the FD&C Act unless there is a history of use or other
evidence of safety establishing that the NDI, when used under the
conditions recommended or suggested in the labeling of the dietary
supplement, will reasonably be expected to be safe.
Section 190.6 (21 CFR 190.6) specifies the information a notifier
must include in its NDIN and establishes the administrative procedures
for these notifications. Section 190.6(a) requires each manufacturer or
distributor of an NDI, or of a dietary supplement containing an NDI, to
submit to the Center for Food Safety and Applied Nutrition's (CFSAN's)
Office of Dietary Supplement Programs (ODSP) notification of the basis
for their conclusion that said supplement or ingredient will reasonably
be expected to be safe. Section 190.6(b) requires that the notification
include the following: (1) the complete name and address of the
manufacturer or distributor, (2) the name of the NDI, (3) a description
of the dietary supplement(s) that contain the NDI, including the level
of the new dietary ingredient in the dietary supplement and the dietary
supplement's conditions of use, (4) the history of use or other
evidence of safety establishing that the dietary ingredient will
reasonably be expected to be safe when used under the conditions
recommended or suggested in the labeling of the dietary supplement, and
(5) the signature of a responsible person designated by the
manufacturer or distributor.
These NDIN requirements are designed to enable us to monitor the
introduction into the marketplace of NDIs and dietary supplements that
contain NDIs in order to protect consumers from ingredients and
products whose safety is unknown. We use the information collected in
the NDINs to evaluate more efficiently the safety of NDIs in dietary
supplements and to support regulatory action against ingredients and
products that are potentially unsafe.
FDA developed guidance to further assist industry with NDINs. In
the Federal Register of July 5, 2011 (76 FR 39111), we announced the
availability of a draft guidance for industry entitled ``Dietary
Supplements: New Dietary Ingredient Notifications and Related Issues''
(the 2011 draft guidance). We gave interested parties an opportunity to
submit comments on the substance of the guidance by October 3, 2011. In
the Federal Register of September 9, 2011 (76 FR 55927), we extended
the comment period to December 2, 2011. We received numerous comments
on the 2011 draft guidance. Based on those comments and our meetings
with industry and other stakeholders, we revised the 2011 draft
guidance. In the Federal Register of August 12, 2016 (81 FR 53486), we
announced the availability of a revised draft guidance for industry
with the same title (the 2016 revised draft guidance) that supersedes
the 2011 draft guidance (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notifications-and-related-issues">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notifications-and-related-issues</a>). We gave
interested parties another opportunity to submit comments on the
substance of the guidance by October 11, 2016. In the Federal Register
of October 4, 2016 (81 FR 68434), we extended the comment period to
December 12, 2016. It is with this notice that we solicit comments on
the information collection in the guidance.
The 2016 revised draft guidance, when finalized, is intended to
provide instruction and further assist industry in deciding when a
premarket safety notification for a dietary supplement containing an
NDI is necessary and in preparing an NDIN. The draft guidance discusses
in question-and-answer format FDA's views on what qualifies as an NDI,
when an NDIN is required, the types of data and information that
manufacturers and distributors should consider when they evaluate the
safety of a dietary supplement containing an NDI, and what should be
included in an NDIN as well as other topics. We intend to divide the
2016 revised draft guidance into discrete sections for ease of use,
consistent with stakeholder requests (including from industry)
submitted in the form of comments to the docket for the draft guidance,
and issue a series of several guidances. These guidances will reflect,
among other things, public comments submitted to the docket in response
to the 2011 draft guidance and the 2016 revised draft guidance.
Sections of the 2016 revised draft guidance that FDA is prioritizing to
issue at this time address administrative procedures, identity, safety,
and master files. Per our standard process, FDA will announce guidance
documents we plan to issue within a calendar year via our FDA Foods
Program Guidance Agenda, available at <a href="https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development">https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development</a>. The following
sections discuss the various topics related to NDINs, all of which were
previously referenced or discussed in the 2016 revised draft guidance.
1. Administrative Procedures
The recommendations found in section V, NDI Notification Procedures
and Timeframes, of the 2016 revised draft guidance and certain
recommendations in section IV.C., Other Questions About When an NDI
Notification Is Necessary, provide instruction for certain ways
manufacturers and distributors can reduce the number of NDINs they must
file and provide some clarification with regard to when data and
information from a previous NDIN may be used in a notification. We
recommend that certain information should be provided in list form for
ease of reference and to help ensure completeness.
Certain recommendations found in the 2016 revised draft guidance,
section IV.C., Determining Whether a New Dietary Ingredient (NDI)
Notification Is Required; Other Questions About When an NDI
Notification Is Necessary, discusses information that should be
included if referring to non-public information from a previous
notification. Such information to include with a notification could
involve written authorization to reference information from another
firm. The option to reference certain information from a previous
notification should reduce notifiers' burden for preparing and
submitting identity, manufacturing, and safety information.
We encourage manufacturers or distributors of NDIs to submit their
NDINs electronically via the CFSAN Online Submission Module (COSM).
Although we encourage electronic submission, notifiers also have the
option of submitting a paper NDIN for us to review. The recommendations
found in the 2016 revised draft guidance, section V, Recommended
Template for Organizing an NDI Notification, recommend that information
in a paper NDIN should be organized in a specific manner, and that some
information should be provided in list form, for ease of reference and
to ensure completeness. Doing so will help notifiers provide a
complete, well-organized NDIN, which should facilitate an efficient and
timely FDA review.
These sections of the 2016 revised draft guidance provide
instruction and help dietary supplement manufacturers and distributors
understand what to

[[Page 2959]]

expect when submitting an NDIN and enhance industry's ability to submit
a complete notification that FDA can efficiently review.
2. Identity Information About the NDI and the Dietary Supplement
Certain recommendations found in the 2016 revised draft guidance,
section VI.A., What to Include in an NDI Notification; Identity
Information About the NDI and the Dietary Supplement, provide
instruction and discuss information that is important in describing the
identity of an NDI and the dietary supplement containing the NDI. We
will recommend that certain information should be provided in table
form for ease of reference and to help ensure completeness.
3. History of Use or Other Evidence of Safety
Certain recommendations in the 2016 revised draft guidance,
sections VI.B., History of Use or Other Evidence of Safety, and VI.C.,
Summary of the Basis for Your Conclusion of Safety, as well as table 3,
the Safety Testing Recommendations Matrix, provide instruction and
discuss information that is important in describing the basis for which
a dietary supplement containing the NDI will reasonably be expected to
be safe. While the FD&C Act does not specify the type or amount of
information that must be included in an NDIN, the notification should
include a dietary supplement safety narrative containing the objective
evaluation of the history of use or other evidence of safety cited in
the notification, along with an explanation of how the evidence of
safety provides a basis to conclude that the dietary supplement
containing the NDI, when used under the conditions described in the
NDIN, will reasonably be expected to be safe. Once finalized, the
recommendations will instruct and help dietary supplement manufacturers
and distributors understand what to consider when evaluating the safety
of a dietary supplement containing an NDI and what should be included
in an NDIN in this regard.
4. Electronic Submission
We developed an electronic portal that respondents may use to
electronically submit their notifications to ODSP via COSM. COSM
assists respondents filing regulatory submissions and is specifically
designed to aid users wishing to file submissions with CFSAN. COSM
allows safety and other information to be uploaded and submitted online
via Form FDA 3880. This form provides a standard format to describe the
history of use or other evidence of safety on which the manufacturer or
distributor bases its conclusion that the NDI is reasonably expected to
be safe under the conditions of use recommended or suggested in the
labeling of the dietary supplement, as well as a description of the
ingredient and other information. Firms that prefer to submit a paper
notification in a format of their own choosing have the option to do
so; however, Form FDA 3880 prompts a notifier to input the elements of
an NDIN in a standard format that we will be able to review
efficiently. Form FDA 3880 may be accessed 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>.
In the Federal Register of August 2, 2023 (88 FR 50876), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment, which was not PRA-
related, so we will not address it in this document.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Activity; type of respondent; Number of responses per annual Average burden per Total
citation respondents respondent responses response hours
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NDIN submission; Sec. 190.6.. 55 1 55 20........................ 1,100
List Form and Template; 1 1 1 1......................... 1
Administrative Procedures;
Section V.
Written Authority; Master 10 1 10 0.4 (24 minutes).......... 4
Files; Section IV.C.1 and 4.
Table Form; Identity 55 1 55 1......................... 55
Specifications; Section VI.A.
Manufacturing Process 55 1 55 5......................... 275
Information; Identity
Information; Section VI.B. and
C.
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Total...................... .............. .............. .......... .......................... 1,435
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Our estimate is based on our experience with information
collections related to past NDIN submissions. The estimated burden also
reflects an industry average, although the burden associated with
individual submissions may vary depending on the complexity of the
notification. Due to a program change, we are revising this information
collection request to include recommendations found in the 2016 revised
draft guidance. Therefore, we have increased our total burden hour
estimate by 335. However, the number of respondents remains the same.
We estimate that 55 respondents each submits 1 NDIN annually. We
estimate that extracting and summarizing the relevant information from
what exists in the company's files and presenting it in a format that
meets the requirements of Sec. 190.6 will take approximately 20 hours
of work per notification. We believe that the burden of the premarket
notification requirement is reasonable because we are requesting only
safety and identity information that the manufacturer or distributor
should already have developed to satisfy itself that a dietary
supplement containing the NDI is in compliance with the FD&C Act. If
the required premarket notification is not submitted to FDA, section
413(a) of the FD&C Act provides that the dietary supplement containing
the NDI is deemed to be adulterated under section 402(f) of the FD&C
Act. Even if the notification is submitted as required, the dietary
supplement containing the NDI is adulterated under section 402(f) of
the FD&C Act unless there is a history of use or other evidence of
safety establishing that the NDI, when used under the conditions
recommended or suggested in the labeling of the dietary supplement,
will reasonably be expected to be safe. This requirement is separate
from and additional to the requirement to submit a premarket
notification for the NDI.
FDA's regulation on NDINs, Sec. 190.6(a), requires the
manufacturer or distributor of the NDI or dietary supplement containing
the NDI to submit to FDA the information that forms the basis for its
conclusion that the NDI, or dietary supplement containing the NDI, will
reasonably be expected to be safe. Thus, Sec. 190.6 only requires the
manufacturer or distributor to extract and summarize information that
should have already been developed to meet the safety

[[Page 2960]]

requirement in section 413(a)(2) of the FD&C Act.
We estimate that 95 percent of respondents submit electronically,
leaving about 3 who submit their NDIN in paper format (5% x 55 = 2.75,
rounded up to 3). However, we have seen a trend of decreased paper
submissions over the past 2 years and expect usage to remain low. Thus,
we estimate only one NDIN will be submitted in paper format. We
estimate that information in this NDIN regarding the table of contents,
names of contacts, and reference lists will be provided in list form.
Because the underlying information should be already readily available,
we estimate that it will take about 60 minutes to prepare the
information in list form, which would create a burden of 1 hour (1 x 1
hour).
We estimate that 10 notifiers will each reference information once
from a previous notification and will provide written authorization to
do so. We estimate that it will take about 24 minutes to prepare a
written authorization. We calculate that the burden for this activity
will be 4 hours annually (10 notifiers x 1 authorization x 0.4 hour).
We estimate that 55 notifiers each will provide identity
specifications in table form with their NDIN submissions. Because the
underlining information should be already readily available, we
estimate that it will take about 1 hour to prepare the information in
table form, which would create a burden of 55 hours (55 tables x 1
hour).
We estimate that 55 notifiers each will provide information about
the manufacturing process with their NDIN submissions. We estimate that
it will take about 5 hours to prepare this information, which would
create a burden of 275 hours (55 manufacturing process x 5 hours).

Dated: January 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00732 Filed 1-16-24; 8:45 am]
BILLING CODE 4164-01-P

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