Notice2022-16388
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
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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
August 1, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, 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 87 Issue 146 (Monday, August 1, 2022)</title>
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[Federal Register Volume 87, Number 146 (Monday, August 1, 2022)]
[Notices]
[Pages 46965-46966]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16388]
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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, Agency, 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 August 31, 2022.
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#82d2d0c3d1f6e3e4e4c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="025250435176636464426466632c6a6a712c656d74">[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
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) 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 ``Guidance on Meetings with Industry and Investigators on the
Research and Development of Tobacco Products,'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products</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. The original guidance issued in 2012 was revised for updating
and clarity in July 2016.
In the guidance, the Agency discusses, among other things:
<bullet> What information FDA recommends persons include in a
meeting request;
<bullet> How and when to submit a request; and
<bullet> What information FDA recommends persons submit prior to a
meeting.
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 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 and responsibilities;
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 that a meeting request include
the FDA-assigned submission tracking numbers of relevant product
version(s), if applicable, to allow for FDA to reference such
information to better assess and respond to the issues and questions
raised in the meeting request.
[[Page 46966]]
This information 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 followup and baseline and followup assessments; and
j. Data analysis plan(s).
The purpose of the 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 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.
In the Federal Register of February 2, 2022 (87 FR 5824), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received that was not PRA
related.
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 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 65 1 65 10 650
request letters for
manufacturers, importers, and
researchers....................
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Meeting Information Packages
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Combining and submitting meeting 65 1 65 18 1,170
information packages for
manufacturers, importers, and
researchers....................
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Total....................... .............. .............. .............. .............. 1,820
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
On March 15, 2022, after publication of the 60-day notice,
President Biden signed H.R. 2471--the Consolidated Appropriations Act,
2022. As a result, the Federal Food, Drug, and Cosmetic Act now
includes specific language that makes clear FDA has the authority to
regulate tobacco products containing nicotine from any source. Our
estimate for this collection now includes meeting requests from
manufacturers of products containing non-tobacco nicotine. We based our
updated estimate on the number of bundled premarket tobacco product
applications we might receive (15) assuming \1/3\ of these submissions
(5) will submit a meeting request. As such, we have increased our
estimated respondents for meetings from 60 to 65. 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 now estimates that 65 preapplication meetings will be
requested.
The hours per response for combining and sending meeting request
letters are estimated at 10 hours each, and the total burden hours for
meeting requests are expected to be 650 hours. Based on FDA's
experience, the Agency expects it will take respondents this amount of
time to prepare, gather, copy, and submit brief statements about the
product and a description of the purpose and details of the meeting.
FDA estimates that 65 respondents will compile meeting information
packages and submit to FDA at 18 hours per response. Based on FDA's
experience, the Agency expects that it will take respondents,
collectively, 1,170 hours to gather, copy, and submit brief statements
about the product, a description of the details of the anticipated
meeting, and data and information, including identifying prior FDA
submissions for the product or relevant versions of the product, 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 1,820 hours (650 hours to prepare and submit meeting
requests and 1,170 hours to prepare and submit information packages).
Our estimated burden for the information collection reflects an overall
decrease of 504 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: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16388 Filed 7-29-22; 8:45 am]
BILLING CODE 4164-01-P
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