FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Request for Comments, 70955-70958 [2012-28835]
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Dated: November 16, 2012.
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[FR Doc. 2012–28396 Filed 11–23–12; 11:15 am]
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DEPARTMENT OF HEALTH AND
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21 CFR Part 15
[Docket No. FDA–2012–N–1148]
FDA Actions Related to Nicotine
Replacement Therapies and SmokingCessation Products; Report to
Congress on Innovative Products and
Treatments for Tobacco Dependence;
Public Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
1-day public hearing to obtain input on
certain questions related to the
implementation of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Family Smoking
Prevention and Tobacco Control Act
SUMMARY:
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(Tobacco Control Act). This public
hearing is being held to obtain
comments from the public on FDA
consideration of applicable approval
mechanisms and additional indications
for nicotine replacement therapies
(NRTs), and to request input on a report
to Congress examining the regulation
and development of innovative products
and treatments for tobacco dependence.
DATES: The public hearing will be held
on December 17, 2012, 8 a.m. to 5 p.m.
Individuals who wish to present at the
public hearing must register by
December 6, 2012. Section III of this
document provides attendance and
registration information. Electronic or
written comments will be accepted after
the public hearing until January 2, 2013.
ADDRESSES: The public hearing will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
rm. 1503, Silver Spring, MD 20993.
Individuals who wish to present at the
public hearing must register by
December 6, 2012, and provide
complete contact information, including
name, title, affiliation, address, email,
and phone number (see section III of
this document for further information).
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
Transcripts of the public hearing will
be available for review at the Division
of Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the public
hearing (see section VI of this
document).
A live Web cast of this public hearing
may be seen at https://
collaboration.fda.gov/Section918 on the
day of the public hearing. A video
record of the public hearing will be
available at the same Web address for 1
year.
FOR FURTHER INFORMATION CONTACT:
Ayanna Augustus, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3219,
Silver Spring, MD 20993, 301–796–
3980, FAX: 301–796–2310, email:
Section918PublicMeeting@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a 1-day public
hearing to obtain input on certain
questions related to the implementation
of section 918 of the FD&C Act (21
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U.S.C. 387r), as amended by the
Tobacco Control Act (Pub. L. 111–31).
Section 918 has two parts. Under
Section 918(a), which is primarily
focused on NRTs, the Secretary of the
Department of Health and Human
Services (the Secretary of HHS) is
required to consider certain new
approval mechanisms and additional
indications for NRTs. Several NRTs,
including nicotine-containing gums,
patches, and lozenges, are already
marketed for smoking cessation. Under
section 918(b), a broader range of
products is implicated. Section 918(b)
requires that the Secretary of HHS, after
consultation with recognized scientific,
medical, and public health experts,
submit a report to Congress examining
how best to regulate, promote, and
encourage the development of
‘‘innovative products and treatments
(including nicotine-based and nonnicotine-based products and
treatments)’’ to better achieve the
following three goals: (1) Total
abstinence from tobacco use, (2)
reductions in consumption of tobacco,
and (3) reductions in the harm
associated with continued tobacco use.
The purpose of this public hearing is to
create a forum for interested
stakeholders to provide input regarding
FDA’s fulfillment of the requirements
set forth in section 918, including on the
following issues, among others: (1) The
use of fast-track and accelerated
approval authorities for smokingcessation products, including NRTs; (2)
the potential for extended use of NRTs
(beyond currently approved durations of
use) for the treatment of tobacco
dependence; (3) the potential for
additional indications for NRTs,
including for craving relief or relapse
prevention; and (4) how best to regulate
‘‘innovative products and treatments’’
targeted at tobacco users in order to
achieve abstinence from tobacco use,
reductions in consumption of tobacco,
and reductions in the harm associated
with continued tobacco use. FDA will
consider the information it obtains from
the public hearing in its implementation
of the requirements of section 918,
including in drafting the report to
Congress required by section 918(b).
II. Purpose and Scope of the Public
Hearing
The purpose of this 21 CFR part 15
hearing is to receive information and
comments from a broad group of
stakeholders, including manufacturers,
interested industry and professional
organizations, the public health
community, individuals affected by
tobacco dependence, researchers, health
care professionals, and the public,
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regarding implementation of section 918
of the FD&C Act. FDA is also consulting
directly with other Federal agencies and
third parties, as contemplated by section
918.
FDA is particularly interested in
obtaining information and public
comment on the issues listed in sections
II.A and II.B of this document, although
comments related to any issues
regarding implementation of section 918
are welcome.
A. Section 918(a): FDA Actions Related
to NRTs and Smoking-Cessation
Products
Fast-Track Status for SmokingCessation Products, Including NRTs.
Section 918(a)(1) of the FD&C Act
provides that the Secretary of HHS
must, ‘‘at the request of the applicant,
consider designating products for
smoking cessation, including nicotine
replacement products as fast track
research and approval products within
the meaning of section 506’’ of the
FD&C Act (21 U.S.C. 356).
Accelerated approval and fast track
designation are available under section
506 of the FD&C Act and FDA
regulations,1 and these provisions have
been used on a case-by-case basis for
drug candidates that are intended to
treat ‘‘a serious or life-threatening
condition’’ and that have the potential
to fill an unmet medical need. The Food
and Drug Administration Safety and
Innovation Act (FDASIA), which was
enacted in July 2012, amends section
506 to define ‘‘breakthrough therapy’’ 2
and provide that certain expedited
review processes may be available to
any drug candidate intended to treat a
serious or life-threatening disease or
condition, whether alone or in
combination with other drugs, provided
that the drug candidate has the potential
to fill an unmet medical need.
FDA seeks comment on the following
issues related to section 918(a)(1) of the
FD&C Act:
1.1. How can FDA best use its
authorities under section 506 of the
FD&C Act, as amended by FDASIA
(including the designation of products
as ‘‘fast track products’’ and as
‘‘breakthrough therapies’’), to facilitate
expedited review and accelerated
1 See 21 CFR part 314, subpart H, and 21 CFR part
601, subpart E.
2 A ‘‘breakthrough therapy’’ is a drug intended,
alone or in combination with one or more other
drugs, to treat a serious or life-threatening disease
or condition, where ‘‘preliminary clinical evidence
indicates that the drug may demonstrate substantial
improvement over existing therapies on 1 or more
clinically significant endpoints, such as substantial
treatment effects observed early in clinical
development.’’ 21 U.S.C. 356(a)(1).
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approval for smoking-cessation
products?
1.2. Under what circumstances should
a smoking-cessation product candidate
be considered to fill an unmet medical
need under section 506, in light of the
existing products for smoking cessation?
1.3. What kind of preliminary clinical
evidence might support the designation
of a smoking-cessation product
candidate as a ‘‘breakthrough therapy’’
under section 506?
Extended use of NRTs for treatment of
tobacco dependence. Section 918(a)(2)
of the FD&C Act provides that the
Secretary of HHS must ‘‘consider
approving the extended use of nicotine
replacement products (such as nicotine
patches, nicotine gum, and nicotine
lozenges) for the treatment of tobacco
dependence.’’ The NRTs referenced in
this provision are currently labeled as
aids to smoking cessation with a course
of treatment generally lasting 10–12
weeks, depending on the product.
FDA’s understanding is that ‘‘extended
use’’ as used in section 918(a)(2) refers
to use beyond that period of time, for
the treatment of tobacco dependence.
On October 26 and 27, 2010, FDA
held a public workshop entitled ‘‘Risks
and Benefits of Long-Term Use of
Nicotine Replacement Therapy
Products.’’ The questions explored in
that workshop overlap with the issues
raised in section 918(a)(2) of the FD&C
Act. Although FDA does not seek to
duplicate the discussion held at the
October 2010 workshop, FDA is
interested in receiving any new or
additional information that might be
relevant to the extended use of NRTs for
tobacco dependence.
FDA seeks comment on the following
issues related to section 918(a)(2) of the
FD&C Act:
2.1. What evidence is available to
support the approval of NRTs for
extended use to maintain abstinence in
individuals who have quit?
2.2. What evidence is available to
support the approval of NRTs for
extended use to achieve cessation
(quitting)?
2.3. With regard to both of the above
indications, does the evidence implicate
specific populations?
Additional indications for NRTs, such
as craving relief and relapse prevention.
Section 918(a)(3) of the FD&C Act
provides that the Secretary of HHS must
‘‘review and consider the evidence for
additional indications for nicotine
replacement products, such as for
craving relief or relapse prevention.’’ As
noted previously, the NRTs referenced
in this provision are currently indicated
as aids to smoking cessation. In the
studies that were carried out to
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demonstrate efficacy, the endpoint was
smoking cessation. These products aid
cessation by relieving withdrawal
symptoms, including cravings, that
smokers may experience in the process
of quitting. However, no currently
approved NRT is indicated for craving
relief outside of the context of quitting;
nor is any currently approved NRT
indicated for relapse prevention.
FDA seeks comment on the following
issues related to section 918(a)(3) of the
FD&C Act:
3.1. If an additional indication is
sought for an approved NRT in which
craving relief itself is the endpoint of
efficacy studies:
a. How can the concept of ‘‘craving’’
be adequately characterized to support a
potential indication for craving relief?
b. Craving can occur in the context of
acute withdrawal or long after a former
smoker has quit (the latter may be
described as ‘‘provoked’’ or ‘‘cueinduced’’ craving). Have both types of
craving been adequately characterized
to support a potential indication for
craving relief?
c. Are there scientifically acceptable
study designs for establishing efficacy
for craving relief that use:
i. Established instruments to measure
patient-reported outcomes?
ii. Analytical methods that address
the degree of craving relief that should
be considered clinically significant?
3.2. If an additional indication is
sought for an approved NRT for relapse
prevention:
a. How should ‘‘relapse’’ be defined
and measured?
b. How should the population of
individuals at risk of relapse be defined?
3.3. Are there other additional
indications that might be sought for
approved NRT products?
B. Report to Congress on How Best To
Regulate Innovative Products and
Treatments To Achieve Abstinence
From Tobacco Use, Reductions in the
Consumption of Tobacco, and
Reductions in the Harm Associated
With Continued Tobacco Use
Section 918(b) of the FD&C Act
requires that the Secretary of HHS, after
consultation with recognized scientific,
medical, and public health experts,
submit to Congress a report that
examines how best to regulate, promote,
and encourage the development of
‘‘innovative products and treatments
(including nicotine-based and nonnicotine-based products and treatments)
to better achieve, in a manner that best
protects and promotes the public
health—(A) total abstinence from
tobacco use; (B) reductions in
consumption of tobacco; and (C)
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reductions in the harm associated with
continued tobacco use.’’ The report to
Congress must include the
recommendations of the Secretary of
HHS on how FDA should coordinate
and facilitate the exchange of
information on these ‘‘innovative
products and treatments’’ among
relevant offices and Centers within FDA
and within the National Institutes of
Health, the Centers for Disease Control
and Prevention, and other relevant
Agencies such as the Substance Abuse
and Mental Health Services
Administration.
One question raised by section 918(b)
of the FD&C Act is how FDA should
regulate specific ‘‘innovative products
and treatments’’ that make claims in the
three categories identified. ‘‘Abstinence
from tobacco use’’ may be understood to
include non-initiation of tobacco use
(never starting to use) as well as
cessation of tobacco use (a user
successfully quitting). Product claims in
this category might therefore include
claims to prevent or inhibit initiation as
well as claims to bring about cessation.
A claim to reduce consumption of
tobacco might, for example, suggest that
the product would cause users to smoke
fewer cigarettes or otherwise consume
less tobacco. A claim to reduce the
harms associated with continued
tobacco use might, for example, suggest
that the user could continue consuming
tobacco as desired without experiencing
one or more of the harmful effects of
tobacco use.
Section 918(b) also raises a question
as to how FDA and other HHS Agencies
can implement regulation and policy
with regard to the ‘‘innovative products
and treatments’’ referenced in the
statute to bring about the three effects
identified—abstinence, reductions in
consumption, and reductions in the
harm associated with continued use—as
broader outcomes, in a manner that best
protects and promotes the public health.
FDA seeks comment on the following
issues related to these provisions of
section 918(b):
4.1. What kinds of innovative
products and treatments designed to
achieve any of the above three
purposes—abstinence from tobacco use,
reduction in tobacco consumption, and
reduction in the harm associated with
continued use—might be developed to
meet the criteria for marketing under
applicable legal authorities?
4.2. With regard to the ‘‘abstinence’’
category, what innovative products and
treatments might be developed to better
achieve either cessation or noninitiation? What are the established
methods for measuring the prevention
or inhibition of initiation?
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4.3. With regard to innovative
products and treatments for ‘‘reduction
in consumption of tobacco,’’
a. How can the reduction best be
measured?
b. If the reduction is associated with
a certain goal or benefit:
i. What evidence is available to
indicate that the reduction in
consumption will bring about that goal
or achieve that benefit?
ii. What degree and duration of
reduction are necessary to achieve that
goal or benefit?
4.4. With regard to innovative
products and treatments for ‘‘reduction
in the harm associated with continued
tobacco use’’:
a. How should the ‘‘harm’’ be
identified and measured?
b. Is there a range of harms that might
be addressed, and if so, which are the
most important to address?
4.5. With regard to innovative
products and treatments making claims
in any of the three categories identified
in section 918(b), what barriers exist to
development and marketing approval?
4.6 In regulating the innovative
products and treatments referenced in
section 918(b), how can FDA and other
HHS Agencies act to ensure that the
three effects mentioned in section
918(b)—total abstinence from tobacco
use, reductions in consumption of
tobacco, and reductions in the harm
associated with continued tobacco use—
are achieved as broader outcomes, in a
manner that best protects and promotes
the public health?
4.7. How can these broader outcomes
be taken into account in FDA’s
premarket evaluation of new product
candidates?
III. Attendance and Registration
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
seating. Attendance is free and will be
on a first-come, first-served basis.
Individuals who wish to present at the
public hearing must register by
December 6, 2012, and provide
complete contact information, including
name, title, affiliation, address, email,
and phone number. Those without
email access may register by contacting
Ayanna Augustus (see FOR FURTHER
INFORMATION CONTACT). FDA has
included questions for comment in
section II of this document. You should
identify the number of each question
you wish to address in your
presentation, so that FDA can consider
that in organizing the presentations.
Individuals and organizations with
common interests should consolidate or
coordinate their presentations and
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request time for a joint presentation.
FDA will do its best to accommodate
requests to speak and will determine the
amount of time allotted for each oral
presentation, and the approximate time
that each oral presentation is scheduled
to begin. FDA will notify registered
presenters of their scheduled times, and
make available an agenda at https://
www.fda.gov/Drugs/NewsEvents/
ucm324938.htm approximately 1 week
prior to the public hearing. Once FDA
notifies registered presenters of their
scheduled times, presenters should
submit to FDA an electronic copy of
their presentation to
Section918PublicMeeting@fda.hhs.gov
by December 10, 2012.
If you need special accommodations
because of a disability, please contact
Ayanna Augustus (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
A live Web cast of this public hearing
may be seen at https://
collaboration.fda.gov/Section918 on the
day of the public hearing. A video
record of the public hearing will be
available at the same Web address for 1
year.
IV. 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 part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by senior
management and technical experts from
various offices within FDA.
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 may 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 (part 10 (21 CFR part 10,
subpart C)). Under § 10.205,
representatives of the electronic 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 section VI of this
document). To the extent that the
conditions for the hearing, as described
in this document, conflict with any
provisions set out in part 15, this
document acts as a waiver of those
provisions as specified in § 15.30(h).
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V. Request for Comments
Regardless of attendance at the public
hearing, interested persons may submit
either electronic or written comments to
the Division of Dockets Management
(see ADDRESSES). It is no longer
necessary to send two copies of mailed
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VI. Transcripts
Transcripts of the public hearing will
be available for review at the Division
of Dockets Management (see ADDRESSES)
and on the Internet at https://
www.regulations.gov approximately 30
days after the public hearing. A
transcript will also be made available in
either hard copy or on CD–ROM, upon
submission of a Freedom of Information
request. Written requests should be sent
to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28835 Filed 11–27–12; 8:45 am]
BILLING CODE 4160–01–P
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22 CFR Part 121
RIN 1400–AD25
[Public Notice: 8091]
Amendment to the International Traffic
in Arms Regulations: Revision of U.S.
Munitions List Category XI and
Definition for ‘‘Equipment’’
Department of State.
Proposed rule.
AGENCY:
ACTION:
As part of the President’s
Export Control Reform effort, the
Department of State proposes to amend
the International Traffic in Arms
Regulations (ITAR) to revise Category XI
(military electronics) of the U.S.
Munitions List (USML) to describe more
precisely the articles warranting control
on the USML and to provide a
definition for ‘‘equipment.’’ The
revisions contained in this rule are part
of the Department of State’s
retrospective plan under E.O. 13563
completed on August 17, 2011. The
Department of State’s full plan can be
accessed at https://www.state.gov/
documents/organization/181028.pdf.
SUMMARY:
E:\FR\FM\28NOP1.SGM
28NOP1
]]>Agencies
[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Proposed Rules]
[Pages 70955-70958]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28835]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2012-N-1148]
FDA Actions Related to Nicotine Replacement Therapies and
Smoking-Cessation Products; Report to Congress on Innovative Products
and Treatments for Tobacco Dependence; Public Hearing; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day
public hearing to obtain input on certain questions related to the
implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Family Smoking Prevention and Tobacco Control
Act
[[Page 70956]]
(Tobacco Control Act). This public hearing is being held to obtain
comments from the public on FDA consideration of applicable approval
mechanisms and additional indications for nicotine replacement
therapies (NRTs), and to request input on a report to Congress
examining the regulation and development of innovative products and
treatments for tobacco dependence.
DATES: The public hearing will be held on December 17, 2012, 8 a.m. to
5 p.m. Individuals who wish to present at the public hearing must
register by December 6, 2012. Section III of this document provides
attendance and registration information. Electronic or written comments
will be accepted after the public hearing until January 2, 2013.
ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993.
Individuals who wish to present at the public hearing must register by
December 6, 2012, and provide complete contact information, including
name, title, affiliation, address, email, and phone number (see section
III of this document for further information).
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify comments with the docket number found in brackets in
the heading of this document.
Transcripts of the public hearing will be available for review at
the Division of Dockets Management and on the Internet at https://www.regulations.gov approximately 30 days after the public hearing (see
section VI of this document).
A live Web cast of this public hearing may be seen at https://collaboration.fda.gov/Section918 on the day of the public hearing. A
video record of the public hearing will be available at the same Web
address for 1 year.
FOR FURTHER INFORMATION CONTACT: Ayanna Augustus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3219, Silver Spring, MD 20993, 301-796-
3980, FAX: 301-796-2310, email: Section918PublicMeeting@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a 1-day public hearing to obtain input on certain
questions related to the implementation of section 918 of the FD&C Act
(21 U.S.C. 387r), as amended by the Tobacco Control Act (Pub. L. 111-
31). Section 918 has two parts. Under Section 918(a), which is
primarily focused on NRTs, the Secretary of the Department of Health
and Human Services (the Secretary of HHS) is required to consider
certain new approval mechanisms and additional indications for NRTs.
Several NRTs, including nicotine-containing gums, patches, and
lozenges, are already marketed for smoking cessation. Under section
918(b), a broader range of products is implicated. Section 918(b)
requires that the Secretary of HHS, after consultation with recognized
scientific, medical, and public health experts, submit a report to
Congress examining how best to regulate, promote, and encourage the
development of ``innovative products and treatments (including
nicotine-based and non-nicotine-based products and treatments)'' to
better achieve the following three goals: (1) Total abstinence from
tobacco use, (2) reductions in consumption of tobacco, and (3)
reductions in the harm associated with continued tobacco use. The
purpose of this public hearing is to create a forum for interested
stakeholders to provide input regarding FDA's fulfillment of the
requirements set forth in section 918, including on the following
issues, among others: (1) The use of fast-track and accelerated
approval authorities for smoking-cessation products, including NRTs;
(2) the potential for extended use of NRTs (beyond currently approved
durations of use) for the treatment of tobacco dependence; (3) the
potential for additional indications for NRTs, including for craving
relief or relapse prevention; and (4) how best to regulate ``innovative
products and treatments'' targeted at tobacco users in order to achieve
abstinence from tobacco use, reductions in consumption of tobacco, and
reductions in the harm associated with continued tobacco use. FDA will
consider the information it obtains from the public hearing in its
implementation of the requirements of section 918, including in
drafting the report to Congress required by section 918(b).
II. Purpose and Scope of the Public Hearing
The purpose of this 21 CFR part 15 hearing is to receive
information and comments from a broad group of stakeholders, including
manufacturers, interested industry and professional organizations, the
public health community, individuals affected by tobacco dependence,
researchers, health care professionals, and the public, regarding
implementation of section 918 of the FD&C Act. FDA is also consulting
directly with other Federal agencies and third parties, as contemplated
by section 918.
FDA is particularly interested in obtaining information and public
comment on the issues listed in sections II.A and II.B of this
document, although comments related to any issues regarding
implementation of section 918 are welcome.
A. Section 918(a): FDA Actions Related to NRTs and Smoking-Cessation
Products
Fast-Track Status for Smoking-Cessation Products, Including NRTs.
Section 918(a)(1) of the FD&C Act provides that the Secretary of
HHS must, ``at the request of the applicant, consider designating
products for smoking cessation, including nicotine replacement products
as fast track research and approval products within the meaning of
section 506'' of the FD&C Act (21 U.S.C. 356).
Accelerated approval and fast track designation are available under
section 506 of the FD&C Act and FDA regulations,\1\ and these
provisions have been used on a case-by-case basis for drug candidates
that are intended to treat ``a serious or life-threatening condition''
and that have the potential to fill an unmet medical need. The Food and
Drug Administration Safety and Innovation Act (FDASIA), which was
enacted in July 2012, amends section 506 to define ``breakthrough
therapy'' \2\ and provide that certain expedited review processes may
be available to any drug candidate intended to treat a serious or life-
threatening disease or condition, whether alone or in combination with
other drugs, provided that the drug candidate has the potential to fill
an unmet medical need.
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\1\ See 21 CFR part 314, subpart H, and 21 CFR part 601, subpart
E.
\2\ A ``breakthrough therapy'' is a drug intended, alone or in
combination with one or more other drugs, to treat a serious or
life-threatening disease or condition, where ``preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on 1 or more clinically
significant endpoints, such as substantial treatment effects
observed early in clinical development.'' 21 U.S.C. 356(a)(1).
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FDA seeks comment on the following issues related to section
918(a)(1) of the FD&C Act:
1.1. How can FDA best use its authorities under section 506 of the
FD&C Act, as amended by FDASIA (including the designation of products
as ``fast track products'' and as ``breakthrough therapies''), to
facilitate expedited review and accelerated
[[Page 70957]]
approval for smoking-cessation products?
1.2. Under what circumstances should a smoking-cessation product
candidate be considered to fill an unmet medical need under section
506, in light of the existing products for smoking cessation?
1.3. What kind of preliminary clinical evidence might support the
designation of a smoking-cessation product candidate as a
``breakthrough therapy'' under section 506?
Extended use of NRTs for treatment of tobacco dependence. Section
918(a)(2) of the FD&C Act provides that the Secretary of HHS must
``consider approving the extended use of nicotine replacement products
(such as nicotine patches, nicotine gum, and nicotine lozenges) for the
treatment of tobacco dependence.'' The NRTs referenced in this
provision are currently labeled as aids to smoking cessation with a
course of treatment generally lasting 10-12 weeks, depending on the
product. FDA's understanding is that ``extended use'' as used in
section 918(a)(2) refers to use beyond that period of time, for the
treatment of tobacco dependence.
On October 26 and 27, 2010, FDA held a public workshop entitled
``Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy
Products.'' The questions explored in that workshop overlap with the
issues raised in section 918(a)(2) of the FD&C Act. Although FDA does
not seek to duplicate the discussion held at the October 2010 workshop,
FDA is interested in receiving any new or additional information that
might be relevant to the extended use of NRTs for tobacco dependence.
FDA seeks comment on the following issues related to section
918(a)(2) of the FD&C Act:
2.1. What evidence is available to support the approval of NRTs for
extended use to maintain abstinence in individuals who have quit?
2.2. What evidence is available to support the approval of NRTs for
extended use to achieve cessation (quitting)?
2.3. With regard to both of the above indications, does the
evidence implicate specific populations?
Additional indications for NRTs, such as craving relief and relapse
prevention. Section 918(a)(3) of the FD&C Act provides that the
Secretary of HHS must ``review and consider the evidence for additional
indications for nicotine replacement products, such as for craving
relief or relapse prevention.'' As noted previously, the NRTs
referenced in this provision are currently indicated as aids to smoking
cessation. In the studies that were carried out to demonstrate
efficacy, the endpoint was smoking cessation. These products aid
cessation by relieving withdrawal symptoms, including cravings, that
smokers may experience in the process of quitting. However, no
currently approved NRT is indicated for craving relief outside of the
context of quitting; nor is any currently approved NRT indicated for
relapse prevention.
FDA seeks comment on the following issues related to section
918(a)(3) of the FD&C Act:
3.1. If an additional indication is sought for an approved NRT in
which craving relief itself is the endpoint of efficacy studies:
a. How can the concept of ``craving'' be adequately characterized
to support a potential indication for craving relief?
b. Craving can occur in the context of acute withdrawal or long
after a former smoker has quit (the latter may be described as
``provoked'' or ``cue-induced'' craving). Have both types of craving
been adequately characterized to support a potential indication for
craving relief?
c. Are there scientifically acceptable study designs for
establishing efficacy for craving relief that use:
i. Established instruments to measure patient-reported outcomes?
ii. Analytical methods that address the degree of craving relief
that should be considered clinically significant?
3.2. If an additional indication is sought for an approved NRT for
relapse prevention:
a. How should ``relapse'' be defined and measured?
b. How should the population of individuals at risk of relapse be
defined?
3.3. Are there other additional indications that might be sought
for approved NRT products?
B. Report to Congress on How Best To Regulate Innovative Products and
Treatments To Achieve Abstinence From Tobacco Use, Reductions in the
Consumption of Tobacco, and Reductions in the Harm Associated With
Continued Tobacco Use
Section 918(b) of the FD&C Act requires that the Secretary of HHS,
after consultation with recognized scientific, medical, and public
health experts, submit to Congress a report that examines how best to
regulate, promote, and encourage the development of ``innovative
products and treatments (including nicotine-based and non-nicotine-
based products and treatments) to better achieve, in a manner that best
protects and promotes the public health--(A) total abstinence from
tobacco use; (B) reductions in consumption of tobacco; and (C)
reductions in the harm associated with continued tobacco use.'' The
report to Congress must include the recommendations of the Secretary of
HHS on how FDA should coordinate and facilitate the exchange of
information on these ``innovative products and treatments'' among
relevant offices and Centers within FDA and within the National
Institutes of Health, the Centers for Disease Control and Prevention,
and other relevant Agencies such as the Substance Abuse and Mental
Health Services Administration.
One question raised by section 918(b) of the FD&C Act is how FDA
should regulate specific ``innovative products and treatments'' that
make claims in the three categories identified. ``Abstinence from
tobacco use'' may be understood to include non-initiation of tobacco
use (never starting to use) as well as cessation of tobacco use (a user
successfully quitting). Product claims in this category might therefore
include claims to prevent or inhibit initiation as well as claims to
bring about cessation.
A claim to reduce consumption of tobacco might, for example,
suggest that the product would cause users to smoke fewer cigarettes or
otherwise consume less tobacco. A claim to reduce the harms associated
with continued tobacco use might, for example, suggest that the user
could continue consuming tobacco as desired without experiencing one or
more of the harmful effects of tobacco use.
Section 918(b) also raises a question as to how FDA and other HHS
Agencies can implement regulation and policy with regard to the
``innovative products and treatments'' referenced in the statute to
bring about the three effects identified--abstinence, reductions in
consumption, and reductions in the harm associated with continued use--
as broader outcomes, in a manner that best protects and promotes the
public health.
FDA seeks comment on the following issues related to these
provisions of section 918(b):
4.1. What kinds of innovative products and treatments designed to
achieve any of the above three purposes--abstinence from tobacco use,
reduction in tobacco consumption, and reduction in the harm associated
with continued use--might be developed to meet the criteria for
marketing under applicable legal authorities?
4.2. With regard to the ``abstinence'' category, what innovative
products and treatments might be developed to better achieve either
cessation or non-initiation? What are the established methods for
measuring the prevention or inhibition of initiation?
[[Page 70958]]
4.3. With regard to innovative products and treatments for
``reduction in consumption of tobacco,''
a. How can the reduction best be measured?
b. If the reduction is associated with a certain goal or benefit:
i. What evidence is available to indicate that the reduction in
consumption will bring about that goal or achieve that benefit?
ii. What degree and duration of reduction are necessary to achieve
that goal or benefit?
4.4. With regard to innovative products and treatments for
``reduction in the harm associated with continued tobacco use'':
a. How should the ``harm'' be identified and measured?
b. Is there a range of harms that might be addressed, and if so,
which are the most important to address?
4.5. With regard to innovative products and treatments making
claims in any of the three categories identified in section 918(b),
what barriers exist to development and marketing approval?
4.6 In regulating the innovative products and treatments referenced
in section 918(b), how can FDA and other HHS Agencies act to ensure
that the three effects mentioned in section 918(b)--total abstinence
from tobacco use, reductions in consumption of tobacco, and reductions
in the harm associated with continued tobacco use--are achieved as
broader outcomes, in a manner that best protects and promotes the
public health?
4.7. How can these broader outcomes be taken into account in FDA's
premarket evaluation of new product candidates?
III. Attendance and Registration
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and will be on a first-come, first-served basis. Individuals who
wish to present at the public hearing must register by December 6,
2012, and provide complete contact information, including name, title,
affiliation, address, email, and phone number. Those without email
access may register by contacting Ayanna Augustus (see FOR FURTHER
INFORMATION CONTACT). FDA has included questions for comment in section
II of this document. You should identify the number of each question
you wish to address in your presentation, so that FDA can consider that
in organizing the presentations. Individuals and organizations with
common interests should consolidate or coordinate their presentations
and request time for a joint presentation. FDA will do its best to
accommodate requests to speak and will determine the amount of time
allotted for each oral presentation, and the approximate time that each
oral presentation is scheduled to begin. FDA will notify registered
presenters of their scheduled times, and make available an agenda at
https://www.fda.gov/Drugs/NewsEvents/ucm324938.htm approximately 1 week
prior to the public hearing. Once FDA notifies registered presenters of
their scheduled times, presenters should submit to FDA an electronic
copy of their presentation to Section918PublicMeeting@fda.hhs.gov by
December 10, 2012.
If you need special accommodations because of a disability, please
contact Ayanna Augustus (see FOR FURTHER INFORMATION CONTACT) at least
7 days before the meeting.
A live Web cast of this public hearing may be seen at https://collaboration.fda.gov/Section918 on the day of the public hearing. A
video record of the public hearing will be available at the same Web
address for 1 year.
IV. 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 part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by senior management and technical experts from various
offices within FDA.
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 may
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 (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic 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 section VI of this document). To the extent that the
conditions for the hearing, as described in this document, conflict
with any provisions set out in part 15, this document acts as a waiver
of those provisions as specified in Sec. 15.30(h).
V. Request for Comments
Regardless of attendance at the public hearing, interested persons
may submit either electronic or written comments to the Division of
Dockets Management (see ADDRESSES). It is no longer necessary to send
two copies of mailed comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
VI. Transcripts
Transcripts of the public hearing will be available for review at
the Division of Dockets Management (see ADDRESSES) and on the Internet
at https://www.regulations.gov approximately 30 days after the public
hearing. A transcript will also be made available in either hard copy
or on CD-ROM, upon submission of a Freedom of Information request.
Written requests should be sent to the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28835 Filed 11-27-12; 8:45 am]
BILLING CODE 4160-01-P
