[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27636-27638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11948]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0429]
June 27, 2025--Agency Information Collection Activities; Proposed
Collection; 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, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in FDA's guidance titled ``Meetings with Industry and
Investigators on the Research and Development of Tobacco Products
(Revised).''
DATES: Either electronic or written comments on the collection of
information must be submitted by August 26, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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'').
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-2012-D-0429 for ``Guidance on Meetings with Industry and
Investigators on the Research and Development of Tobacco Products.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the 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, including
each proposed extension of an existing 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
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assumptions used; (3) ways to enhance the quality, utility, and clarity
of the 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.
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; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products-revised). 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 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.
FDA estimates the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Activity; guidance section Number of responses per annual burden per Total hours
respondents respondent responses response
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Meeting Requests
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Combining and sending meeting request 60 1 60 12 720
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 information 60 1 60 18 1,080
packages for manufacturers, importers, and
researchers; Guidance section III.K........
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Total................................... ........... .............. ........... ........... 1,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 3 years. FDA estimates that 60 meetings will be
requested over the next 3 years. We have revised this estimate from 65
respondents to 60 respondents.
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 720 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 720 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 tobacco product manufacturer, importer,
researcher, or investigator.
FDA estimates that 60 respondents will compile and submit meeting
information packages at 18 hours per response, and the total burden
hours for submitting meeting information packages are expected to be
1,080 hours. We have revised this estimate from 65 respondents to 60
respondents. Based on FDA's experience, the Agency expects that it will
take respondents, collectively, 1,080 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 number of burden hours for this collection of information
is estimated to be 1,800 hours (720 hours to prepare and submit meeting
requests and 1,080 hours to prepare and submit information packages).
Our estimated burden for the information collection reflects an
overall decrease of 20 hours. We attribute this adjustment to a
decrease in the number of submissions we received over the last few
years and our projections for the next 3 years.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11948 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P