Notice2025-18184
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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 90 Issue 180 (Friday, September 19, 2025)</title>
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45227-45229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18184]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0429]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Meetings With
Industry and Investigators on the Research and Development of Tobacco
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 October 20, 2025.
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 0910-0731. Also include the FDA docket
number found in brackets in the heading of this document.
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,
<a href="/cdn-cgi/l/email-protection#78282a392b0c191e1e381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="124240534166737474527476733c7a7a613c757d64">[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.
Meetings With Industry and Investigators on the Research and
Development of Tobacco Products
OMB Control Number 0910-0731--Extension
This information collection supports FDA guidance. The Federal
Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to regulate the
manufacture, marketing, and distribution of tobacco products to protect
the public health generally and to reduce tobacco use by minors.
Tobacco products are governed by chapter IX of the FD&C Act
(sections 900 through 920) (21 U.S.C. 387 through 21 U.S.C. 387t). The
FD&C Act offers tobacco product manufacturers several pathways to
obtain an order from FDA to authorize the marketing of a new tobacco
product before it may be introduced or delivered into interstate
commerce.
To provide assistance with these pathways to market products, FDA
will meet with tobacco product manufacturers, importers, researchers,
and investigators (or their representatives) when appropriate as
described in FDA's guidance titled ``Meetings with Industry and
Investigators on the Research and Development of Tobacco Products
(Revised)'' (September 2022; <a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products-revised">www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products-revised</a>). This guidance is intended to
assist persons who seek meetings with FDA relating to their research to
inform the regulation of tobacco products, or to support the
development or marketing of tobacco products.
This guidance describes two collections of information: (1) the
submission of a meeting request containing certain information and (2)
the submission of an information package in advance of the meeting. The
purpose of this proposed information collection is to allow FDA to
conduct meetings with tobacco manufacturers, importers, researchers,
and investigators in an effective and efficient manner. FDA issued this
guidance and the revisions consistent with FDA's good guidance
practices regulations (21 CFR 10.115).
Meeting Requests: The guidance sets forth FDA's recommendations for
materials to be included in a request for a meeting with FDA to discuss
the research and development of tobacco products. In the guidance, FDA
recommends that the following information be included in the meeting
request:
1. Product name;
2. FDA-assigned Submission Tracking Number(s) of prior submissions
(e.g., premarket applications, meeting requests) for the product and
relevant product version(s) (if applicable);
3. Product category (e.g., cigarettes, smokeless tobacco) (if
applicable);
4. Product use (indicate for consumer use or for further
manufacturing);
5. Contact information for the authorized point of contact for the
company requesting the meeting;
6. The topic of the meeting being requested (e.g., a new tobacco
product application, an application for permission to market a modified
risk tobacco product, or proposed investigational use of a new tobacco
product);
7. A brief statement of the purpose of the meeting, which could
include a discussion of the types of studies or data to be discussed at
the meeting, the general nature of the primary questions to be asked,
and where the meeting fits in the overall product development plans;
8. A preliminary list of the specific objectives/outcomes expected
from the meeting;
9. A preliminary proposed agenda, including an estimate of the time
needed and a designated speaker for each agenda item;
10. A preliminary list of specific critical questions, grouped by
discipline (e.g., chemistry, clinical, nonclinical);
11. A list of all individuals who will attend the meeting on behalf
of the
[[Page 45228]]
tobacco product manufacturer, importer, researcher, or investigator,
including titles, responsibilities, and if applicable, identification
of prior FDA employment;
12. The date on which the meeting information package will be
received by FDA; and
13. Suggested format of the meeting (e.g., conference call, in-
person meeting at FDA offices, video conference, or written response)
and suggested dates and times for the meeting.
Meetings are usually scheduled for 1 hour. FDA is proposing the
inclusion of a new recommendation that a meeting request identify prior
FDA employment for any individual who will attend the meeting on behalf
of the tobacco product manufacturer, importer, researcher, or
investigator, if applicable. This information would indicate if the
individual is subject to certain post-government employment
restrictions.
This information contained in the meeting request will be used by
the agency to: (1) determine the utility of the meeting, (2) identify
agency staff necessary to discuss proposed agenda items, and (3)
schedule the meeting.
Meeting Information Packages: An individual submitting a meeting
information package to FDA in advance of a meeting should provide
summary information relevant to the product and supplementary
information pertaining to any issue raised by the individual or FDA to
be discussed at the meeting. As stated in the guidance, FDA recommends
that meeting information packages generally include updates of
information that was submitted with the meeting request and, as
applicable:
1. Product composition and design data summary;
2. Manufacturing and process control data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data summary;
6. User and nonuser perception data summary; and
7. Investigational plans for studies and surveillance of the
tobacco product, including a summary of proposed study protocols
containing the following information (as applicable):
a. Study objective(s);
b. Study hypotheses;
c. Study design;
d. Study population (inclusion/exclusion criteria, comparison
group(s));
e. Human subject protection information, including Institutional
Review Board information;
f. Primary and secondary endpoints (definition and success
criteria);
g. Sample size calculation;
h. Data collection procedures;
i. Duration of follow up and baseline and follow up assessments,
and
j. Data analysis plan(s).
The purpose of the meeting information package is to provide agency
staff the opportunity to adequately prepare for the meeting, including
the review of relevant data concerning the product. In the agency's
experience, reviewing such information is critical to achieving a
productive meeting. If the meeting information package was previously
submitted in the meeting request, it should be revised, as applicable,
so that the information reflects the most current and accurate
information available. As discussed in the guidance document,
electronic submission is not required, although we strongly encourage
electronic submission via the CTP Portal Next Generation (CTP Portal
NextGen) using FDA's eSubmitter tool. Instructions on obtaining a CTP
Portal NextGen account are available at <a href="http://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal-next-generation">www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal-next-generation</a>.
In the Federal Register of June 27, 2025 (90 FR 27636), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; guidance section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Meeting Requests
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Combining and sending meeting 20 1 20 12 240
request letters for
manufacturers, importers, and
researchers; Guidance section
III.E..........................
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Meeting Information Packages
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Combining and submitting meeting 20 1 20 18 360
information packages for
manufacturers, importers, and
researchers; Guidance section
III.K..........................
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Total....................... .............. .............. .............. .............. 600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Following the publication of the 60-day Federal Register notice,
FDA has revised the annual number of respondents from 60 to 20 for this
information collection. The original figure of 60 represented the total
number of respondents across a three-year period rather than an annual
average.
FDA's estimate of the number of respondents for meeting requests in
Table 1 is based on the number of meeting requests received and
projected over the next three years. FDA estimates that 60 meetings
will be requested over the next three years (20 each year on average).
Between the previous information collection and this extension, we have
revised this estimate from 65 respondents to 20 respondents annually.
The hours per response for combining and sending meeting request
letters are estimated at 12 hours each, and the total burden hours for
meeting requests are expected to be 240 hours. We have revised the
average burden per response from 10 hours to 12 hours. Based on FDA's
experience, the agency expects it will take respondents 240 hours to
prepare, gather, copy, and submit brief statements about the product
and a description of the purpose and details of the meeting, including
identifying prior FDA employment for any individual who will attend the
meeting on behalf of the
[[Page 45229]]
tobacco product manufacturer, importer, researcher, or investigator.
FDA estimates that 20 respondents will compile and submit meeting
information packages at 18 hours per response. Based on FDA's
experience, the agency expects that it will take respondents,
collectively, 360 hours to gather, copy, and submit brief statements
about the product, a description of the details of the anticipated
meeting, and data and information that generally would already have
been generated for the planned research and/or product development.
The total annual number of burden hours for this collection of
information is estimated to be 600 hours (240 hours to prepare and
submit meeting requests and 360 hours to prepare and submit information
packages). Our estimated burden for the information collection reflects
an overall decrease of 1,220 hours and a corresponding decrease of 45
responses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18184 Filed 9-18-25; 8:45 am]
BILLING CODE 4164-01-P
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