[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51996-51997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 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

[[Page 51997]]

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.
    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: [email protected].

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:
     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)),
     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
     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 https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    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