[Federal Register Volume 89, Number 11 (Wednesday, January 17, 2024)]
[Notices]
[Pages 2957-2960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00732]


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

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.

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

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 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 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 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notifications-and-related-issues). 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 https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development. 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 https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient.
    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\
----------------------------------------------------------------------------------------------------------------
                                                    Number of       Total
 Activity; type of respondent;      Number of     responses per    annual        Average burden per       Total
            citation               respondents     respondent     responses           response            hours
----------------------------------------------------------------------------------------------------------------
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.
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..........  ..........................    1,435
----------------------------------------------------------------------------------------------------------------
\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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>