The Food and Drug Administration's Approach To Evaluating Nicotine Replacement Therapies; Public Hearing; Request for Comments, 56759-56763 [2017-25671]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Proposed Rules
• CSU retail sales or shipments,
especially information about the type of
CSUs sold and the number of units sold
in recent years;
• the number of CSUs in use;
• studies, tests, or descriptions of
technologies or design changes that
address tip-over injuries and estimates
of costs associated with those features,
including manufacturing costs and
wholesale prices;
• the expected impact of technologies
or design changes that address tip-over
injuries on manufacturing costs or
wholesale prices;
• the potential impact of design
changes to address CSU stability on
consumer utility; and
• information about whether any
stability requirements for CSUs in ether
a voluntary standard or potential
mandatory rule could have a disparate
impact on small entities, such as small
manufacturers or importers.
In addition, the Commission invites
interested parties to submit any existing
standards, or portions of them, for
consideration as a consumer product
safety standard. The Commission also
invites interested persons to submit a
statement of intention to modify or
develop a voluntary consumer product
safety standard addressing the risk of
injury associated with CSU tip overs,
including a description of the plan to
develop or modify such a standard.
Please submit comments in
accordance with the instructions in the
ADDRESSES section at the beginning of
this ANPR.
Alberta E. Mills,
Acting Secretary, Consumer Product Safety
Commission.
[FR Doc. 2017–25779 Filed 11–29–17; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
18 CFR Part 40
nshattuck on DSK9F9SC42PROD with PROPOSALS
[Docket No. RM16–22–000]
Coordination of Protection Systems for
Performance During Faults and
Specific Training for Personnel
Reliability Standards
Correction
Proposed Rule document 2017–25586
beginning on page 56186 was
incorrectly published in the issue of
Tuesday, November 28, 2017.
[FR Doc. C1–2017–25586 Filed 11–29–17; 8:45 am]
BILLING CODE 1505–01–D
VerDate Sep<11>2014
15:27 Nov 29, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2017–N–6529]
The Food and Drug Administration’s
Approach To Evaluating Nicotine
Replacement Therapies; Public
Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public hearing on FDA’s
approach to evaluating the safety and
efficacy of nicotine replacement therapy
(NRT) products, including how they
should be used and labeled.
DATES: The public hearing will be held
on Friday, January 26, 2018, from 9 a.m.
to 5 p.m. The public hearing may be
extended or may end early depending
on the level of public participation.
Persons seeking to attend or to present
at the public hearing must register by
Tuesday, January 2, 2018. Section II
provides attendance and registration
information. Electronic or written
comments will be accepted after the
public hearing until Thursday, February
15, 2018.
ADDRESSES: The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room A,
Silver Spring, MD 20993–0002.
Entrance for public hearing participants
(non-FDA employees) is through
Building 1 where routine security check
procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before February 15, 2018. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of February 15, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
You may submit comments as
follows:
SUMMARY:
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
56759
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–
2017–N–6529 for ‘‘FDA’s Approach to
Evaluating Nicotine Replacement
Therapies’’; Public Hearing; Request for
Comments. 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
Division of Dockets Management
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
E:\FR\FM\30NOP1.SGM
30NOP1
56760
Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Proposed Rules
nshattuck on DSK9F9SC42PROD with PROPOSALS
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
received electronic and written/paper
comments, 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.
FOR FURTHER INFORMATION CONTACT:
Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 1314, Silver Spring,
MD 20993, 301–796–9203,
OMPTFeedback@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A majority (roughly 70%) of adult
smokers in the United States report that
they want to quit, and nearly half of
them make a quit attempt each year.
Many of those quit attempts involve the
use of NRT products, which are
designed to help people quit smoking by
supplying controlled amounts of
nicotine to ease their withdrawal
symptoms. FDA has approved two types
of prescription 1 NRT products—a
nicotine nasal spray and nicotine
inhaler—and three types of over-thecounter (OTC) NRT products—a
nicotine gum, transdermal nicotine
patch, and nicotine lozenge (see
Appendix A). Most of these products
1 Non-nicotine prescription medications are also
available to aid in smoking cessation, but are
beyond the scope of this document.
VerDate Sep<11>2014
15:27 Nov 29, 2017
Jkt 244001
have been approved for over 20 years.2
The use of approved prescription and
OTC NRT products is generally
considered to double the likelihood of a
successful quit attempt, although there
is variation in efficacy among the types
of products.
Although the formulations and routes
of administration of currently approved
NRT products have remained relatively
unchanged for decades, there have been
developments in research regarding
NRT products and corresponding
changes in the regulatory landscape. For
example, in 2013, FDA recommended
changing the statements on concomitant
use and duration of use in the labeling
for OTC NRT products because evidence
gathered since 1984—the year the first
NRT product was approved—suggested
that the statements were no longer
necessary to ensure the safe use of OTC
NRT products for smoking cessation.3
Specifically, the Agency recommended
that the statement in the labeling for
OTC NRT products warning consumers
that they should not use an NRT
product if they are still smoking, or
using any other product that contains
nicotine—including another NRT—be
removed. FDA also recommended that
the directions in the labeling for OTC
NRT products be modified to remove
the statement advising consumers to
stop using the product at the end of the
labeled duration of use. Instead of this
statement, FDA recommended that
consumers be advised to talk to their
health care provider if they feel the need
to use the product for longer than the
labeled duration of use to keep from
smoking. To facilitate these labeling
changes, FDA invited the submission of
supplemental new drug applications
(labeling supplements).
On July 28, 2017, the FDA announced
a new comprehensive plan that places
nicotine, and the issue of addiction, at
the center of the Agency’s tobacco
regulation efforts. This plan will serve
as a multi-year roadmap to better protect
children and significantly reduce
tobacco-related disease and death in the
United States. One of the first actions of
this comprehensive approach will be an
advanced notice of proposed
rulemaking (ANPRM) to seek input on
the potential impacts of reducing
nicotine levels in cigarettes to
minimally or non-addictive levels. A
2 Only the lozenge formulation has been approved
for less than 20 years; it was approved in 2002.
3 See the Federal Register, available at https://
www.federalregister.gov/documents/2013/04/02/
2013-07528/modifications-to-labeling-of-nicotinereplacement-therapy-products-for-over-the-counterhuman-use. Recommendations also included other
language revisions that were not related to dosing
or duration.
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
key piece of the FDA’s comprehensive
plan is a recognition that nicotine—
while highly addictive—is delivered
through products that represent a
continuum of risk and is most harmful
when delivered through combustible
tobacco products. Accordingly, the
Agency is committed to increasing
access to and use of nicotine
replacement therapy, which could help
more smokers quit. Therefore, the
Agency is seeking public input on its
approach to evaluating the safety and
efficacy of NRT products.
As a part of its mission to protect and
promote public health, FDA is
responsible for ensuring that approved
drugs, including NRT products, are safe
and effective.4 For FDA to approve a
new drug, it must find that the applicant
has submitted ‘‘substantial evidence’’ of
effectiveness based on adequate and
well-controlled studies 5 and that the
drug is safe for use under the conditions
set forth in the labeling.6 Generally, the
safety of a product is assessed by
determining whether its benefits
outweigh its risks. The benefit–risk
assessment takes into account the
extensive evidence of safety and
effectiveness submitted by a sponsor in
a marketing application as well as many
other factors.7
II. Purpose and Scope of the Public
Hearing
To enable a thorough assessment of its
approach for evaluating the safety and
efficacy NRT products and how they
should be used and labeled, FDA is
holding a public hearing to receive
information and comments from a broad
group of stakeholders, including the
public health community, researchers,
health care professionals,
manufacturers, interested industry and
professional organizations, and the
public, on the appropriate study designs
and methods for evaluating the safety
and efficacy of OTC NRT drug products.
FDA is also seeking input on the
warnings and directions sections of the
Drug Facts labeling (among other
4 Section 1003(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), 21 U.S.C. 393(b).
5 Section 505(d) of the FD&C Act; 21 U.S.C.
355(d).
6 21 U.S.C. 355(d). FDA also noted in the
preamble to the final rule on new drug approvals
(NDA final rule) that the new drug approval process
and the supplemental application requirements
‘‘are intended to ensure that the drug is safe, that
its benefits outweigh its risks, and that it is
effective.’’ See 50 FR 7452, 7469 (February. 22,
1985).
7 See FDA’s Structured Approach to Benefit–Risk
Assessment in Drug Regulatory Decision-Making,
Draft PDUFA V Implementation Plan—February
2013, Fiscal Years 2013–2017, available at https://
www.fda.gov/downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/UCM329758.pdf.
E:\FR\FM\30NOP1.SGM
30NOP1
Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Proposed Rules
nshattuck on DSK9F9SC42PROD with PROPOSALS
aspects) for approved OTC NRT
products, specifically regarding the
possible impact of current warnings on
likelihood of use. The Agency has
determined that a public hearing is the
most appropriate way to ensure public
engagement on these important public
health issues. FDA believes it is critical
to obtain input across the research and
medical fields, the tobacco and
pharmaceutical industries, and among
public health stakeholders regarding
how evolving science could influence
FDA’s approach to evaluating the safety
and effectiveness of NRT products.
Questions for Commenters To Address
Although FDA welcomes all feedback
on any public health, scientific,
regulatory or legal considerations
relating to NRT products and their use
in tobacco use cessation, we encourage
commenters to consider the following
questions as they prepare their
comments or statements. Responses to
questions should include supporting
scientific justification.
1. Might there be ways to improve
upon the currently available delivery
systems to yield new OTC NRT
products that might be more effective?
If so, what evidence would be needed to
support such changes, and how should
they be evaluated?
2. Are there additional indications or
regimens for OTC NRT products that
could be explored? Concepts to consider
could include relapse prevention,
craving reduction, maintenance, reduce
to quit, use of short- and long-acting
products in combination, or cessation of
non-cigarette tobacco products. What
evidence would be needed to support
each indication or regimen?
3. What data would be required to
demonstrate health benefits of reduction
in consumption of combustible tobacco
products?
4. Are there OTC NRT products that
could be studied for use in combination
that might result in reduced tobaccorelated health impacts? What evidence
would be needed to support the safety
and efficacy of these products when
used in combination?
5. Is there other information that
could be added to labeling for currently
approved or new dosage forms of OTC
NRT products that would maximize
their ability to be used to support
smoking cessation? Please consider the
various sections of the Drug Facts
labeling, including the Uses, Warnings,
and Directions sections.
6. Generally, the labeling of OTC NRT
products contains a dosing schedule
based on duration of use, and FDA has
recommended the labeling on OTC NRT
products be modified to include the
VerDate Sep<11>2014
15:27 Nov 29, 2017
Jkt 244001
following: ‘‘If you feel you need to use
[the NRT product] for a longer period to
keep from smoking, talk to your health
care provider.’’ What is the impact of
longer term NRT treatment? What is the
impact on likelihood of cessation or
relapse prevention? What data would
support an affirmative recommendation
to use approved OTC NRT products for
durations that exceed those currently
included in the Drug Facts labeling of
approved OTC NRT products, or would
support a chronic or maintenance drug
treatment indication for such products?
Registration and Requests for Oral
Presentations: The FDA Conference
Center at the White Oak location is a
Federal facility with security procedures
and limited seating. Attendance will be
free and on a first-come, first-served
basis. If you wish to attend (either in
person or by webcast (see Streaming
Webcast of the Public Hearing)) and/or
present at the hearing, please register for
the hearing and/or make a request for
oral presentations or comments by email
to OMPTfeedback@fda.hhs.gov by
Tuesday, January 2, 2018. The email
should contain complete contact
information for each attendee (i.e.,
name, title, affiliation, address, email
address, and telephone number). For
those wishing to present at the hearing,
the email should also include a
presentation title. Those without email
access can register by contacting Allison
Hoffman at 301–796–9203 by Tuesday,
January 2, 2018 (see FOR FURTHER
INFORMATION CONTACT).
FDA will try to accommodate all
persons who wish to make a
presentation. Individuals wishing to
present should identify the number of
the specific question, or questions, they
wish to address. This will help FDA
organize the presentations. Individuals
and organizations with common
interests should consolidate or
coordinate their presentations and
request time for a joint presentation.
FDA will notify registered presenters of
their scheduled presentation times. The
time allotted for each presentation will
depend on the number of individuals
who wish to speak. Presenters are
encouraged to submit an electronic copy
of their presentation to OMPTfeedback@
fda.hhs.gov on or before Friday, January
19, 2018. Persons registered to make an
oral presentation are encouraged to
arrive at the hearing room early and
check in at the onsite registration table
to confirm their designated presentation
time. An agenda for the hearing and any
other background materials will be
made available 5 days before the hearing
at https://www.fda.gov/NewsEvents/
MeetingsConferencesWorkshops/
ucm580561.htm.
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
56761
If you need special accommodations
because of a disability, please contact
OMPTFeedback@fda.hhs.gov (see FOR
FURTHER INFORMATION CONTACT) no later
than Tuesday, January 2, 2018, at 12
noon Eastern Time.
Streaming Webcast of the Public
Hearing: For those unable to attend in
person, FDA will provide a live webcast
of the hearing. To join the hearing via
the webcast, please go to https://
collaboration.fda.gov/part15nicotine.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES).
III. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with 21 CFR
part 15. The hearing will be conducted
by a presiding officer, who will be
accompanied by FDA senior
management from the Office of the
Commissioner, the Center for Drug
Evaluation and Research, and the Center
for Tobacco Products. Under § 15.30(f),
the hearing is informal and the rules of
evidence do not apply. No participant
may interrupt the presentation of
another participant. Only the presiding
officer and panel members can pose
questions; they can question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (21 CFR part 10, subpart C).
Under § 10.205, representatives of the
media may be permitted, subject to
certain limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b) (see Transcripts). To the
extent that the conditions for the
hearing, as described in this notice,
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in
§ 15.30(h).
IV. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
E:\FR\FM\30NOP1.SGM
30NOP1
56762
Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Proposed Rules
Register, but Web sites are subject to
change over time.
1. Babb S, Malarcher A, Schauer G, Asman
K, and Jamal A. 2017. Quitting Smoking
Among Adults—United States, 2000–
2015. Morbidity and Mortality Weekly
Report 65:1457–1464.
Product name
(NDA #; holder)
2. Etter J-F and Stapleton JA. 2006. Nicotine
Replacement Therapy for Long-Term
Smoking Cessation: A Meta-Analysis.
Tobacco Control 15:280–285.
3. Silagy C, Mant D, Fowler G, and Lodge M.
1994. Meta-Analysis on Efficacy of
Nicotine Replacement Therapies in
Smoking Cessation. Lancet 343:139–142.
OTC or Rx
(date approved; date
Rx→OTC)
Route
(doses)
Appendix A: Summary of FDAApproved Active New Drug
Applications (NDAs) of Nicotine
Replacement Therapies (September 18,
2017)
Indication
Labeled treatment duration
and schedule
12 weeks:
• Wk 1–6: 1 per 1–2 hr.
• Wk 7–9: 1 per 2–4 hr.
• Wk 10–12: 1 per 4–8
hr.
If smoke 1st cigarette within
30 min of waking up, use 4
mg; if more than 30 min,
use 2 mg.
10 weeks and 8 weeks:
If >10 cigarettes/day:
• Wk 1–6: one 21 mg/
day.
• Wk 7–8: one 14 mg/
day.
• Wk 9–10: one 7 mg/
day.
If ≤10 cigarettes/day:
• Wk 1–6: one 14 mg/
day.
• Wk 7–8: one 7 mg/
day.
8 weeks:
If >10 cigarettes/day:
• Wk 1–4: one 21 mg/
day.
• Wk 5–6: one 14 mg/
day.
• Wk 7–8: one 7 mg/
day.
If ≤10 cigarettes/day:
• Wk 1–6: one 14 mg/
day.
• Wk 7–8: one 7 mg/
day.
The label does not specify
the recommended duration
of treatment, but notes the
following in the Indications
and Usage section:
The safety and efficacy of
the continued use of
Nicotrol NS for periods
longer than 6 months have
not been adequately studied and such use is not
recommended.
The recommended duration
of treatment is 3 months,
after which patients may
be weaned from the inhaler by gradual reduction
of the daily dose over the
following 6 to 12 weeks.
The safety and efficacy of
the continued use of
Nicotrol Inhaler for periods
longer than 6 months have
not been studied and such
use is not recommended.
Approved as prescription on
1/13/84 for 2 mg; 6/8/92
for 4 mg; Rx→OTC for
both on 2/9/16.
Oral (2, 4 mg
gum).
Reduces withdrawal symptoms, including nicotine
craving, associated with
quitting smoking (under Directions: If you are under
18 years of age ask a doctor before use).
NicoDerm CQ (nicotine) (NDA
020165; GSK, Sanofi
Aventis).
Approved as prescription on
11/7/91; Rx→OTC on 8/2/
96.
Patch (7, 14, 21
mg).
Same use as above ..............
Habitrol (nicotine) (NDA
020076; Ciba-Geigy,
Novartis, Dr. Reddy’s).
Approved as prescription on
11/27/91; Rx→OTC on 11/
12/99.
Patch (7, 14, 21
mg).
Same use as above ..............
Nicotrol NS (nicotine) (NDA
020385; Pfizer).
Prescription (3/22/96; N/A) ...
Nasal spray ......
• Indicated as an aid to
smoking cessation for the
relief of nicotine withdrawal
symptoms.
• Should be used as a part
of a comprehensive behavioral smoking cessation
program.
Nicotrol Inhaler (nicotine)
(NDA 020714; Pharmacia
and Upjohn).
nshattuck on DSK9F9SC42PROD with PROPOSALS
Nicorette gum (nicotine
polacrilex) (NDA 018612 for
2 mg, NDA 020066 for 4
mg; GSK).
Prescription (5/2/97; N/A) .....
Inhalant .............
• Indicated as an aid to
smoking cessation for the
relief of nicotine withdrawal
symptoms.
• Recommended for use as
part of a comprehensive
behavioral smoking cessation program.
Jkt 244001
Fmt 4702
VerDate Sep<11>2014
15:27 Nov 29, 2017
PO 00000
Frm 00014
Sfmt 4702
E:\FR\FM\30NOP1.SGM
30NOP1
Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Proposed Rules
56763
OTC or Rx
(date approved; date
Rx→OTC)
Route
(doses)
Indication
Labeled treatment duration
and schedule
Commit lozenge (nicotine
polacrilex) (NDA 021330;
GSK).
OTC (10/3/02; N/A) ...............
Oral (2, 4 mg) ...
Reduces withdrawal symptoms, including nicotine
craving, associated with
quitting smoking (under Directions: If you are under
18 years of age ask a doctor before use).
Nicorette mini lozenge (nicotine polacrilex) (NDA
022366; GSK).
OTC (5/18/09; N/A) ...............
Oral (2, 4 mg) ...
Same use as above ..............
12 weeks:
• Wk 1–6: 1 per 1–2 hr.
• Wk 7–9: 1 per 2–4 hr.
• Wk 10–12: 1 per 4–8
hr.
If smoke 1st cigarette within
30 min of waking up, use 4
mg; if more than 30 min,
use 2 mg.
12 weeks; same schedule as
Commit lozenge.
Product name
(NDA #; holder)
Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
this proposed exemption, in accordance
with the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments by January 29, 2018.
ADDRESSES: You may submit comments
as follows:
[FR Doc. 2017–25671 Filed 11–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2017–N–4919]
Medical Devices; Exemption From
Premarket Notification: Class II
Devices; Surgical Apparel; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Proposed order; request for
comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing its intention to exempt
certain subtypes of surgical apparel
from premarket notification
requirements, subject to conditions and
limitations. FDA intends to limit the
proposed exemption to single-use,
disposable respiratory protective
devices (RPD) used in a healthcare
setting and worn by healthcare
personnel during procedures to protect
both the patient and the healthcare
personnel from the transfer of
microorganisms, body fluids, and
particulate material. These devices,
commonly referred to as N95 filtering
facepiece respirators (FFRs) and surgical
N95 respirators (herein collectively
referred to as N95s) are currently
regulated by FDA under product code
MSH. All other class II devices
classified under FDA’s surgical apparel
classification regulation would continue
to be subject to premarket notification
requirements. FDA is publishing this
document to obtain comments regarding
nshattuck on DSK9F9SC42PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
15:27 Nov 29, 2017
Jkt 244001
Electronic Submissions
Submit electronic comments in the
following way. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 29,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 29, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
• 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’’).
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
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–
2017–N–4919 for ‘‘Medical Devices;
Exemption From Premarket
Notification: Class II Devices; Surgical
Apparel; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
E:\FR\FM\30NOP1.SGM
30NOP1
]]>Agencies
[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Proposed Rules]
[Pages 56759-56763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25671]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2017-N-6529]
The Food and Drug Administration's Approach To Evaluating
Nicotine Replacement Therapies; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing on FDA's approach to evaluating the safety
and efficacy of nicotine replacement therapy (NRT) products, including
how they should be used and labeled.
DATES: The public hearing will be held on Friday, January 26, 2018,
from 9 a.m. to 5 p.m. The public hearing may be extended or may end
early depending on the level of public participation. Persons seeking
to attend or to present at the public hearing must register by Tuesday,
January 2, 2018. Section II provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until Thursday, February 15, 2018.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room A,
Silver Spring, MD 20993-0002. Entrance for public hearing participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before February 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 15, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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-2017-N-6529 for ``FDA's Approach to Evaluating Nicotine Replacement
Therapies''; Public Hearing; Request for Comments. 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 Division of Dockets Management 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
[[Page 56760]]
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.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the received electronic and written/paper comments, 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.
FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver
Spring, MD 20993, 301-796-9203, OMPTFeedback@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A majority (roughly 70%) of adult smokers in the United States
report that they want to quit, and nearly half of them make a quit
attempt each year. Many of those quit attempts involve the use of NRT
products, which are designed to help people quit smoking by supplying
controlled amounts of nicotine to ease their withdrawal symptoms. FDA
has approved two types of prescription \1\ NRT products--a nicotine
nasal spray and nicotine inhaler--and three types of over-the-counter
(OTC) NRT products--a nicotine gum, transdermal nicotine patch, and
nicotine lozenge (see Appendix A). Most of these products have been
approved for over 20 years.\2\ The use of approved prescription and OTC
NRT products is generally considered to double the likelihood of a
successful quit attempt, although there is variation in efficacy among
the types of products.
---------------------------------------------------------------------------
\1\ Non-nicotine prescription medications are also available to
aid in smoking cessation, but are beyond the scope of this document.
\2\ Only the lozenge formulation has been approved for less than
20 years; it was approved in 2002.
---------------------------------------------------------------------------
Although the formulations and routes of administration of currently
approved NRT products have remained relatively unchanged for decades,
there have been developments in research regarding NRT products and
corresponding changes in the regulatory landscape. For example, in
2013, FDA recommended changing the statements on concomitant use and
duration of use in the labeling for OTC NRT products because evidence
gathered since 1984--the year the first NRT product was approved--
suggested that the statements were no longer necessary to ensure the
safe use of OTC NRT products for smoking cessation.\3\ Specifically,
the Agency recommended that the statement in the labeling for OTC NRT
products warning consumers that they should not use an NRT product if
they are still smoking, or using any other product that contains
nicotine--including another NRT--be removed. FDA also recommended that
the directions in the labeling for OTC NRT products be modified to
remove the statement advising consumers to stop using the product at
the end of the labeled duration of use. Instead of this statement, FDA
recommended that consumers be advised to talk to their health care
provider if they feel the need to use the product for longer than the
labeled duration of use to keep from smoking. To facilitate these
labeling changes, FDA invited the submission of supplemental new drug
applications (labeling supplements).
---------------------------------------------------------------------------
\3\ See the Federal Register, available at https://www.federalregister.gov/documents/2013/04/02/2013-07528/modifications-to-labeling-of-nicotine-replacement-therapy-products-for-over-the-counter-human-use. Recommendations also included other
language revisions that were not related to dosing or duration.
---------------------------------------------------------------------------
On July 28, 2017, the FDA announced a new comprehensive plan that
places nicotine, and the issue of addiction, at the center of the
Agency's tobacco regulation efforts. This plan will serve as a multi-
year roadmap to better protect children and significantly reduce
tobacco-related disease and death in the United States. One of the
first actions of this comprehensive approach will be an advanced notice
of proposed rulemaking (ANPRM) to seek input on the potential impacts
of reducing nicotine levels in cigarettes to minimally or non-addictive
levels. A key piece of the FDA's comprehensive plan is a recognition
that nicotine--while highly addictive--is delivered through products
that represent a continuum of risk and is most harmful when delivered
through combustible tobacco products. Accordingly, the Agency is
committed to increasing access to and use of nicotine replacement
therapy, which could help more smokers quit. Therefore, the Agency is
seeking public input on its approach to evaluating the safety and
efficacy of NRT products.
As a part of its mission to protect and promote public health, FDA
is responsible for ensuring that approved drugs, including NRT
products, are safe and effective.\4\ For FDA to approve a new drug, it
must find that the applicant has submitted ``substantial evidence'' of
effectiveness based on adequate and well-controlled studies \5\ and
that the drug is safe for use under the conditions set forth in the
labeling.\6\ Generally, the safety of a product is assessed by
determining whether its benefits outweigh its risks. The benefit-risk
assessment takes into account the extensive evidence of safety and
effectiveness submitted by a sponsor in a marketing application as well
as many other factors.\7\
---------------------------------------------------------------------------
\4\ Section 1003(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), 21 U.S.C. 393(b).
\5\ Section 505(d) of the FD&C Act; 21 U.S.C. 355(d).
\6\ 21 U.S.C. 355(d). FDA also noted in the preamble to the
final rule on new drug approvals (NDA final rule) that the new drug
approval process and the supplemental application requirements ``are
intended to ensure that the drug is safe, that its benefits outweigh
its risks, and that it is effective.'' See 50 FR 7452, 7469
(February. 22, 1985).
\7\ See FDA's Structured Approach to Benefit-Risk Assessment in
Drug Regulatory Decision-Making, Draft PDUFA V Implementation Plan--
February 2013, Fiscal Years 2013-2017, available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.
---------------------------------------------------------------------------
II. Purpose and Scope of the Public Hearing
To enable a thorough assessment of its approach for evaluating the
safety and efficacy NRT products and how they should be used and
labeled, FDA is holding a public hearing to receive information and
comments from a broad group of stakeholders, including the public
health community, researchers, health care professionals,
manufacturers, interested industry and professional organizations, and
the public, on the appropriate study designs and methods for evaluating
the safety and efficacy of OTC NRT drug products. FDA is also seeking
input on the warnings and directions sections of the Drug Facts
labeling (among other
[[Page 56761]]
aspects) for approved OTC NRT products, specifically regarding the
possible impact of current warnings on likelihood of use. The Agency
has determined that a public hearing is the most appropriate way to
ensure public engagement on these important public health issues. FDA
believes it is critical to obtain input across the research and medical
fields, the tobacco and pharmaceutical industries, and among public
health stakeholders regarding how evolving science could influence
FDA's approach to evaluating the safety and effectiveness of NRT
products.
Questions for Commenters To Address
Although FDA welcomes all feedback on any public health,
scientific, regulatory or legal considerations relating to NRT products
and their use in tobacco use cessation, we encourage commenters to
consider the following questions as they prepare their comments or
statements. Responses to questions should include supporting scientific
justification.
1. Might there be ways to improve upon the currently available
delivery systems to yield new OTC NRT products that might be more
effective? If so, what evidence would be needed to support such
changes, and how should they be evaluated?
2. Are there additional indications or regimens for OTC NRT
products that could be explored? Concepts to consider could include
relapse prevention, craving reduction, maintenance, reduce to quit, use
of short- and long-acting products in combination, or cessation of non-
cigarette tobacco products. What evidence would be needed to support
each indication or regimen?
3. What data would be required to demonstrate health benefits of
reduction in consumption of combustible tobacco products?
4. Are there OTC NRT products that could be studied for use in
combination that might result in reduced tobacco-related health
impacts? What evidence would be needed to support the safety and
efficacy of these products when used in combination?
5. Is there other information that could be added to labeling for
currently approved or new dosage forms of OTC NRT products that would
maximize their ability to be used to support smoking cessation? Please
consider the various sections of the Drug Facts labeling, including the
Uses, Warnings, and Directions sections.
6. Generally, the labeling of OTC NRT products contains a dosing
schedule based on duration of use, and FDA has recommended the labeling
on OTC NRT products be modified to include the following: ``If you feel
you need to use [the NRT product] for a longer period to keep from
smoking, talk to your health care provider.'' What is the impact of
longer term NRT treatment? What is the impact on likelihood of
cessation or relapse prevention? What data would support an affirmative
recommendation to use approved OTC NRT products for durations that
exceed those currently included in the Drug Facts labeling of approved
OTC NRT products, or would support a chronic or maintenance drug
treatment indication for such products?
Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend (either in
person or by webcast (see Streaming Webcast of the Public Hearing))
and/or present at the hearing, please register for the hearing and/or
make a request for oral presentations or comments by email to
OMPTfeedback@fda.hhs.gov by Tuesday, January 2, 2018. The email should
contain complete contact information for each attendee (i.e., name,
title, affiliation, address, email address, and telephone number). For
those wishing to present at the hearing, the email should also include
a presentation title. Those without email access can register by
contacting Allison Hoffman at 301-796-9203 by Tuesday, January 2, 2018
(see FOR FURTHER INFORMATION CONTACT).
FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the specific question, or questions, they wish to address. This will
help FDA organize the presentations. Individuals and organizations with
common interests should consolidate or coordinate their presentations
and request time for a joint presentation. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Presenters are encouraged to submit an electronic copy of their
presentation to OMPTfeedback@fda.hhs.gov on or before Friday, January
19, 2018. Persons registered to make an oral presentation are
encouraged to arrive at the hearing room early and check in at the
onsite registration table to confirm their designated presentation
time. An agenda for the hearing and any other background materials will
be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm580561.htm.
If you need special accommodations because of a disability, please
contact OMPTFeedback@fda.hhs.gov (see FOR FURTHER INFORMATION CONTACT)
no later than Tuesday, January 2, 2018, at 12 noon Eastern Time.
Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/part15nicotine.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES).
III. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner, the Center
for Drug Evaluation and Research, and the Center for Tobacco Products.
Under Sec. 15.30(f), the hearing is informal and the rules of evidence
do not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under Sec.
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts). To the extent that the conditions for the
hearing, as described in this notice, conflict with any provisions set
out in part 15, this notice acts as a waiver of those provisions as
specified in Sec. 15.30(h).
IV. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal
[[Page 56762]]
Register, but Web sites are subject to change over time.
1. Babb S, Malarcher A, Schauer G, Asman K, and Jamal A. 2017.
Quitting Smoking Among Adults--United States, 2000-2015. Morbidity
and Mortality Weekly Report 65:1457-1464.
2. Etter J-F and Stapleton JA. 2006. Nicotine Replacement Therapy
for Long-Term Smoking Cessation: A Meta-Analysis. Tobacco Control
15:280-285.
3. Silagy C, Mant D, Fowler G, and Lodge M. 1994. Meta-Analysis on
Efficacy of Nicotine Replacement Therapies in Smoking Cessation.
Lancet 343:139-142.
Appendix A: Summary of FDA-Approved Active New Drug Applications (NDAs)
of Nicotine Replacement Therapies (September 18, 2017)
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC or Rx (date approved; Labeled treatment duration
Product name (NDA #; holder) date Rx[rarr]OTC) Route (doses) Indication and schedule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nicorette gum (nicotine polacrilex) Approved as prescription on Oral (2, 4 mg gum)......... Reduces withdrawal 12 weeks:
(NDA 018612 for 2 mg, NDA 020066 1/13/84 for 2 mg; 6/8/92 symptoms, including Wk 1-6: 1 per 1-2
for 4 mg; GSK). for 4 mg; Rx[rarr]OTC for nicotine craving, hr.
both on 2/9/16. associated with quitting Wk 7-9: 1 per 2-4
smoking (under Directions: hr.
If you are under 18 years Wk 10-12: 1 per 4-
of age ask a doctor before 8 hr.
use). If smoke 1st cigarette
within 30 min of waking
up, use 4 mg; if more than
30 min, use 2 mg.
NicoDerm CQ (nicotine) (NDA 020165; Approved as prescription on Patch (7, 14, 21 mg)....... Same use as above.......... 10 weeks and 8 weeks:
GSK, Sanofi Aventis). 11/7/91; Rx[rarr]OTC on 8/ If >10 cigarettes/day:
2/96. Wk 1-6: one 21 mg/
day.
Wk 7-8: one 14 mg/
day.
Wk 9-10: one 7 mg/
day.
If <=10 cigarettes/day:
Wk 1-6: one 14 mg/
day.
Wk 7-8: one 7 mg/
day.
Habitrol (nicotine) (NDA 020076; Approved as prescription on Patch (7, 14, 21 mg)....... Same use as above.......... 8 weeks:
Ciba-Geigy, Novartis, Dr. Reddy's). 11/27/91; Rx[rarr]OTC on If >10 cigarettes/day:
11/12/99. Wk 1-4: one 21 mg/
day.
Wk 5-6: one 14 mg/
day.
Wk 7-8: one 7 mg/
day.
If <=10 cigarettes/day:
Wk 1-6: one 14 mg/
day.
Wk 7-8: one 7 mg/
day.
Nicotrol NS (nicotine) (NDA 020385; Prescription (3/22/96; N/A) Nasal spray................ Indicated as an The label does not specify
Pfizer). aid to smoking cessation the recommended duration
for the relief of nicotine of treatment, but notes
withdrawal symptoms. the following in the
Should be used as Indications and Usage
a part of a comprehensive section:
behavioral smoking The safety and efficacy of
cessation program. the continued use of
Nicotrol NS for periods
longer than 6 months have
not been adequately
studied and such use is
not recommended.
Nicotrol Inhaler (nicotine) (NDA Prescription (5/2/97; N/A). Inhalant................... Indicated as an The recommended duration of
020714; Pharmacia and Upjohn). aid to smoking cessation treatment is 3 months,
for the relief of nicotine after which patients may
withdrawal symptoms. be weaned from the inhaler
Recommended for by gradual reduction of
use as part of a the daily dose over the
comprehensive behavioral following 6 to 12 weeks.
smoking cessation program. The safety and efficacy of
the continued use of
Nicotrol Inhaler for
periods longer than 6
months have not been
studied and such use is
not recommended.
[[Page 56763]]
Commit lozenge (nicotine polacrilex) OTC (10/3/02; N/A)......... Oral (2, 4 mg)............. Reduces withdrawal 12 weeks:
(NDA 021330; GSK). symptoms, including Wk 1-6: 1 per 1-2
nicotine craving, hr.
associated with quitting Wk 7-9: 1 per 2-4
smoking (under Directions: hr.
If you are under 18 years Wk 10-12: 1 per 4-
of age ask a doctor before 8 hr.
use). If smoke 1st cigarette
within 30 min of waking
up, use 4 mg; if more than
30 min, use 2 mg.
Nicorette mini lozenge (nicotine OTC (5/18/09; N/A)......... Oral (2, 4 mg)............. Same use as above.......... 12 weeks; same schedule as
polacrilex) (NDA 022366; GSK). Commit lozenge.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25671 Filed 11-29-17; 8:45 am]
BILLING CODE 4164-01-P
