Notice2022-18073
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies; Guidance for Industry; Availability
Primary source
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Published
August 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled "Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies." The final guidance provides information intended to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence (SE) report. The final guidance discusses a variety of scientific issues applicants may want to consider as they design and conduct TPPI studies.
Full Text
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<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
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[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51996-51997]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-4188]
Tobacco Products: Principles for Designing and Conducting Tobacco
Product Perception and Intention Studies; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry entitled ``Tobacco
Products: Principles for Designing and Conducting Tobacco Product
Perception and Intention Studies.'' The final guidance provides
information intended to assist applicants design and conduct tobacco
product perception and intention (TPPI) studies that may be submitted
as part of a modified risk tobacco product application (MRTPA), a
premarket tobacco product application (PMTA), or a substantial
equivalence (SE) report. The final guidance discusses a variety of
scientific issues applicants may want to consider as they design and
conduct TPPI studies.
DATES: The announcement of the guidance is published in the Federal
Register on August 24, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-D-4188 for ``Tobacco Products: Principles for Designing and
Conducting Tobacco Product Perception and Intention Studies; Guidance
for Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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
[[Page 51997]]
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#97d4c3c7c5f2f0e2fbf6e3fef8f9e4d7f1f3f6b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="35766165675052405954415c5a5b46755351541b5d5d461b525a43">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Tobacco Products: Principles for Designing and Conducting
Tobacco Product Perception and Intention Studies.''
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and granted FDA authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect public
health generally and to reduce tobacco use by minors. The FD&C Act, as
amended by the Tobacco Control Act, requires new tobacco products to
undergo premarket review and receive an order from FDA before being
introduced or delivered for introduction into interstate commerce. The
FD&C Act establishes three pathways to market for new tobacco products:
<bullet> Submission of a PMTA under section 910(b) of the FD&C Act
(21 U.S.C. 387j(b)) and receipt of a marketing order under section
910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)),
<bullet> Submission of a SE report under section 905(j)(1)(A) of
the FD&C Act (21 U.S.C. 387e(j)(1)(A)) and receipt of an SE marketing
order, or
<bullet> Submission of a request for an exemption from the
requirements of demonstrating SE under section 905(j)(3) of the FD&C
Act (21 U.S.C. 387e(j)(3)) and receipt of an exemption from FDA
(implemented at Sec. 1107.1 (21 CFR 1107.1)).
To introduce or deliver for introduction into interstate commerce a
modified risk tobacco product, there must be in effect an order under
section 911(g) of the FD&C Act (21 U.S.C. 387k(g)) and the applicant
must satisfy any applicable premarket review requirements under section
910 of the FD&C Act.
The final guidance is intended to assist applicants design and
conduct TPPI studies that may be submitted as part of an MRTPA, a PMTA,
or a SE report. TPPI studies can help applicants demonstrate that their
product meets the applicable premarket authorization standard. For
example, TPPI studies can be used to assess, among other things,
individuals' perceptions of tobacco products, understanding of tobacco
product information, and intentions to use tobacco products. The final
guidance is intended to address a variety of scientific issues
applicants may consider as they design and conduct TPPI studies to
support tobacco product applications.
A notice of availability for the draft guidance appeared in the
Federal Register of October 28, 2020 (85 FR 68341). FDA considered
comments received and revised the final guidance as appropriate in
response to the comments. This included, for example, reorganizing the
structure of the guidance to ensure the document is more user-friendly,
defining additional terms to improve clarity, and providing additional
information on various recommendations related to the development of
TPPI studies.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on designing and conducting tobacco product
perception and intention studies, and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. This guidance provides non-binding recommendations on TPPI
studies and does not establish requirements for submitting studies in
support of an application. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in Sec. 1107.1(b) and (c) have been approved under OMB
control number 0910-0684. The collections of information under section
910 of the FD&C Act have been approved under OMB control number 0910-
0768. The collections of information under 21 CFR part 1114 have been
approved under OMB control number 0910-0879. The collections of
information in 21 CFR part 1107, subparts B through E, have been
approved under OMB control number 0910-0673.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidance at <a href="https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance">https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18073 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P
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