[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5693-5694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03064]



[[Page 5693]]

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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Replacement Therapy Drug Products; Draft Guidance for Industry; 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 or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Smoking 
Cessation and Related Indications: Developing Nicotine Replacement 
Therapy Drug Products.'' 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.

DATES: Submit either electronic or written comments on the draft 
guidance by April 23, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 on any guidance 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-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Alina Salvatore, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240-
402-0379.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Smoking Cessation and Related Indications: Developing 
Nicotine Replacement Therapy Drug Products.'' This draft guidance 
reflects the FDA's current recommendations 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. In November 2017, FDA published a notice in the Federal 
Register requesting comments on the Agency's approach to evaluating the 
safety and efficacy of NRT drug products, including how they should be 
used and labeled (82 FR 56759; Docket No. FDA-2017-N-6529). The Agency 
hosted a public hearing in January 2018 to obtain input from 
stakeholders on these issues. This draft

[[Page 5694]]

guidance takes into consideration the feedback received and is intended 
to serve as a focus for continued discussions among the Agency, 
pharmaceutical sponsors, the academic community, and the public on this 
topic.
    The draft 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. 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 an over-the-
counter 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 draft guidance is being issued 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 ``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. This guidance is not subject to Executive 
Order 12866.

II. 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 collection of information in 21 CFR part 314 for the submission 
of new drug applications (NDAs), including the submission of labeling 
under Sec. Sec.  314.50(e)(2)(ii) and 314.50(l)(1)(i), as well as the 
submission of 505(b)(2) applications and abbreviated new drug 
applications, has been approved under OMB control number 0910-0001. The 
submission of biologics license applications (BLAs) has been approved 
under OMB control number 0910-0338. The collection of information in 21 
CFR part 312 has been approved under OMB control number 0910-0014.
    The submission of prescription drug labeling under 21 CFR 201.56 
and 201.57 has 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 0910-0755.
    The collection of information in the draft guidance for industry 
entitled ``Formal Meetings Between FDA and Sponsors and Applicants for 
PDUFA Products,'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf) including 
requests for pre-NDA and pre-BLA meetings, has been approved under OMB 
control number 0910-0429.
    The submission of special protocol assessments has been approved 
under OMB control number 0910-0470.
    In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any information collections recommended in this guidance 
that are new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: February 15, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03064 Filed 2-21-19; 8:45 am]
 BILLING CODE 4164-01-P