Notice2023-09170
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry; Availability
Primary source
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
May 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry." The document provides guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same title issued on February 22, 2019.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 83 (Monday, May 1, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26559-26561]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0297]
Smoking Cessation and Related Indications: Developing Nicotine
Replacement Therapy Drug Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Smoking
Cessation and Related Indications: Developing Nicotine Replacement
Therapy Drug Products; Guidance for Industry.'' The document provides
guidance to assist sponsors in the clinical development of nicotine
replacement therapy (NRT) drug products, including but not limited to
those intended for smoking cessation and related chronic indications.
This guidance finalizes the draft guidance of the same title issued on
February 22, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on May 1, 2023.
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-0297 for ``Smoking Cessation and Related Indications:
Developing Nicotine Replacement Therapy Drug Products.'' 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
[[Page 26560]]
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
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
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Heather Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20903-0002, 240-429-4192,
<a href="/cdn-cgi/l/email-protection#c7afa2a6b3afa2b5e9a3a8b5b4a2be87a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="b2dad7d3c6dad7c09cd6ddc0c1d7cbf2d4d6d39cdadac19cd5ddc4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Smoking Cessation and Related Indications: Developing
Nicotine Replacement Therapy Drug Products.'' This guidance reflects
the FDA's current thinking regarding overall development programs to
support the approval of NRT drug products for smoking cessation and
related chronic indications. There are several FDA-approved
prescription and nonprescription NRT drug products for cessation of
smoking cigarettes, but the Agency encourages the development of
additional NRT drug products, which could help more smokers quit.
The guidance focuses on drug development and trial design issues
that are specific to the study of NRT drug products. NRT drug products
are typically studied and labeled for use as adjuncts to behavioral
self-help materials and to date have involved single treatment regimens
that begin on the patient's quit day (first day without a cigarette).
Alternate treatment regimens (e.g., pretreatment before quit day,
quitting by gradual reduction (reduce to quit), using multiple NRT drug
products together) are discussed in the guidance.
As outlined in the guidance, NRT drug products can be developed for
smoking cessation and/or reduction in risk of relapse. NRT drug
products that first have demonstrated efficacy for at least one of
these indications can also include additional information in labeling
by demonstrating efficacy in certain secondary endpoints. Sponsors can
evaluate reduction in the urge to smoke or relief of cue-induced
craving in former smokers as secondary endpoints. Additionally,
sponsors that can demonstrate, via a secondary endpoint, that the drug
product provides relief of withdrawal symptoms in smokers who are not
trying to quit smoking may be able to include labeling instructions to
address situations when such individuals are required to abstain and
therefore experience withdrawal symptoms (e.g., while traveling on an
airplane).
FDA is aware of the serious risks associated with smoking and is
committed to facilitating the development of therapies to support
smoking cessation efforts. Both the regulatory pathway for an NRT drug
product and the amount of nonclinical or clinical data needed to
support approval will depend on the characteristics of the proposed NRT
drug product relative to an approved NRT drug product. This guidance
outlines general considerations for NRT drug development and trial
design, and FDA encourages sponsors to contact FDA for feedback on
their proposed development plans. Sponsors developing nonprescription
drug product should bear in mind that it is often not possible to
answer all regulatory questions in a single trial, and additional
sequential steps may be needed.
This guidance finalizes the draft guidance entitled ``Smoking
Cessation and Related Indications: Developing Nicotine Replacement
Therapy Drug Products'' issued on February 22, 2019 (84 FR 5693). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include
clarification that the document does not address the development of NRT
to aid in the cessation of non-combustible tobacco products (e.g., e-
cigarettes); information regarding the pathway described in section
505(b)(2) (21 U.S.C. 355(b)(2)) of the Federal Food, Drug, and Cosmetic
Act and reliance on published literature; and clarification regarding
mode of administration and route of administration. In addition,
editorial changes were made to improve clarity. 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
``Smoking Cessation and Related Indications: Developing Nicotine
Replacement Therapy Drug Products.'' 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 21 CFR part 312 pertaining to the submissions of
investigational new drug applications, including clinical trial design
and study protocols, have been approved under OMB control number 0910-
0014. The
[[Page 26561]]
collections of information in 21 CFR part 314 regarding the submission
of new drug applications including formal meetings with sponsors and
applicants for Prescription Drug User Fee Act products, abbreviated new
drug applications and supplemental applications have been approved
under OMB control number 0910-0001. The collections of information in
21 CFR part 601 pertaining to the submission of biologics license
applications have been approved under OMB control number 0910-0338. The
collections of information relating to expedited program for serious
conditions for drug and biological product development programs have
been approved under OMB control number 0910-0765. The collections of
information pertaining to the submission of special protocol
assessments have been approved under OMB control number 0910-0470. The
collections of information in 21 CFR 201.56 and 201.57 for the
submission of certain prescription drug product labeling have been
approved under OMB control number 0910-0572. The collections of
information in 21 CFR parts 50 and 56 (Protection of Human Subjects:
Informed Consent; Institutional Review Boards) have been approved under
OMB control number 0910-0130. The collections of information pertaining
to good clinical practice have been approved under OMB control number
0910-0843. The collections of information pertaining to adverse events
reporting have been approved under OMB control number 0910-0291.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</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: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09170 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 1, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.