[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68341-68342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23840]


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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Product Perception and Intention Studies; Draft Guidance for Industry; 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availability of a draft guidance for industry entitled ``Tobacco 
Products: Principles for Designing and Conducting Tobacco Product 
Perception and Intention Studies.'' The draft guidance provides 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 The draft guidance is intended to discuss a 
variety of scientific issues applicants may want to consider as they 
design and conduct TPPI studies.

DATES: Submit either electronic or written comments on the draft 
guidance by December 28, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments 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; Draft 
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 office 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.
    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 draft guidance to 
the Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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 draft guidance may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability for public comment of a draft 
guidance for industry entitled ``Tobacco Products: Principles for 
Designing and Conducting Tobacco Product Perception and Intention 
Studies.''
    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act) into law. The Tobacco Control Act grants 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 Federal Food, Drug, and Cosmetic Act (FD&C Act) requires new 
tobacco products to undergo review and receive an order from FDA before 
being

[[Page 68342]]

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),
     Submission of a SE report under section 905(j)(1)(A) (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) 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 draft 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. Conducting TPPI studies can assist applicants 
submitting tobacco product applications demonstrate that their product 
meets applicable requirements to receive marketing authorization under 
the appropriate pathway. For example, TPPI studies can be used to 
assess, among other things, individuals' perceptions of tobacco 
products, understanding of tobacco product information, and intention 
to use tobacco products. The draft 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.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on designing and 
conducting tobacco product perception and intention studies. 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.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 in section 
905(j) of the FD&C Act have been approved under OMB control number 
0910-0673.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft guidance at either https://www.regulations.gov or 
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance.

    Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23840 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P