82 FR 11226 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 33 (February 21, 2017)

Page Range		11226-11227
FR Document		2017-03364

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

Federal Register, Volume 82 Issue 33 (Tuesday, February 21, 2017)

[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11226-11227]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Tobacco Products Scientific Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Tobacco Products Scientific 
Advisory Committee. The general function of the committee is to provide 
advice and recommendations to the Agency on FDA's regulatory issues. 
The meeting will be open to the public.

DATES: The meeting will be held on April 6, 2017, from 8:30 a.m. to 
4:30 p.m.

ADDRESSES: Tommy Douglas Conference Center, 10000 New Hampshire Ave., 
Silver Spring, Maryland 20903. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002, 1-877-287-1373, email: [email protected]. A notice in the 
Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: Under section 910(b)(2) (21 U.S.C. 387j(b)(2)) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA may refer 
applications for premarket review of new tobacco products (PMTA) to the 
Tobacco Products Scientific Advisory Committee (Committee). The FD&C 
Act also provides for mandatory referral of modified risk tobacco 
product applications (MRTPA) to the Committee under section 911(f)(1) 
(21 U.S.C. 387k (f)(1)). On April 6, 2017, FDA will present information 
to the Committee on the processes used in review of tobacco product 
applications, including premarket tobacco, substantial equivalence, and 
modified risk tobacco product applications. Topics will include the 
statutory standards applicable to the different types of applications, 
the scientific basis for review decisions, with a focus on PMTA and 
MRTPA, and the role of the Committee in the review process.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material

[[Page 11227]]

will be posted on FDA's Web site after the meeting. Background material 
is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
March 23, 2017. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before March 15, 2017. Time allotted for 
each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by March 16, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Caryn Cohen at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 15, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03364 Filed 2-17-17; 8:45 am]
BILLING CODE 4164-01-P

11226 Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices

SUPPLEMENTARY INFORMATION: and Manufacture of Drug Substances’’ ADDRESSES: Tommy Douglas Conference
published November 20, 2012 (77 FR Center, 10000 New Hampshire Ave.,
I. Background
69634), and available online at http:// Silver Spring, Maryland 20903. Answers
In recent years, many important www.fda.gov/downloads/Drugs/ to commonly asked questions including
initiatives have been undertaken by GuidanceComplianceRegulatory information regarding special
regulatory authorities and industry Information/Guidances/ accommodations due to a disability,
associations to promote international UCM261078.pdf. The draft guidance visitor parking, and transportation may
harmonization of regulatory provides guidance on selecting and be accessed at: http://www.fda.gov/
requirements. FDA has participated in justifying starting materials, in AdvisoryCommittees/
many meetings designed to enhance particular for the synthesis of chemical AboutAdvisoryCommittees/
harmonization, and is committed to entity drug substances. Comments about ucm408555.htm.
seeking scientifically based harmonized this draft will be considered by FDA FOR FURTHER INFORMATION CONTACT:
technical procedures for pharmaceutical and the Quality Implementation Caryn Cohen, Office of Science, Center
development. One of the goals of Working Group. for Tobacco Products, Food and Drug
harmonization is to identify and then This draft guidance is being issued Administration, Document Control
reduce differences in technical consistent with FDA’s good guidance Center, Bldg. 71, Rm. G335, 10903 New
requirements for drug development practices regulation (21 CFR 10.115). Hampshire Ave., Silver Spring, MD
among regulatory agencies. The draft guidance, when finalized, will
ICH was organized to provide an 20993–0002, 1–877–287–1373, email:
represent the current thinking of FDA TPSAC@fda.hhs.gov. A notice in the
opportunity for harmonization on this topic. It does not establish any
initiatives to be developed with input Federal Register about last minute
rights for any person and is not binding modifications that impact a previously
from both regulatory and industry on FDA or the public. You can use an
representatives. FDA also seeks input announced advisory committee meeting
alternative approach if it satisfies the cannot always be published quickly
from consumer representatives and
requirements of the applicable statutes enough to provide timely notice.
others. ICH is concerned with
and regulations. Therefore, you should always check the
harmonization of technical
requirements for the registration of II. Electronic Access Agency’s Web site at http://
pharmaceutical products for human use www.fda.gov/AdvisoryCommittees/
Persons with access to the Internet default.htm and scroll down to the
among regulators around the world. The may obtain the document at https://
six founding members of the ICH are the appropriate advisory committee meeting
www.regulations.gov, http:// link, or call the advisory committee
European Commission; the European www.fda.gov/Drugs/Guidance
Federation of Pharmaceutical Industries information line to learn about possible
ComplianceRegulatoryInformation/ modifications before coming to the
Associations; the Japanese Ministry of
Guidances/default.htm, or http:// meeting.
Health, Labour, and Welfare; the
www.fda.gov/BiologicsBloodVaccines/
Japanese Pharmaceutical Manufacturers SUPPLEMENTARY INFORMATION:
GuidanceComplianceRegulatory Agenda: Under section 910(b)(2) (21
Association; CDER and CBER, FDA; and
Information/Guidances/default.htm. U.S.C. 387j(b)(2)) of the Federal Food,
the Pharmaceutical Research and
Manufacturers of America. The Dated: February 14, 2017. Drug, and Cosmetic Act (the FD&C Act),
Standing Members of the ICH Leslie Kux, FDA may refer applications for
Association include Health Canada and Associate Commissioner for Policy. premarket review of new tobacco
Swissmedic. Any party eligible as a [FR Doc. 2017–03309 Filed 2–17–17; 8:45 am] products (PMTA) to the Tobacco
Member in accordance with the ICH BILLING CODE 4164–01–P
Products Scientific Advisory Committee
Articles of Association can apply for (Committee). The FD&C Act also
membership in writing to the ICH provides for mandatory referral of
Secretariat. The ICH Secretariat, which DEPARTMENT OF HEALTH AND modified risk tobacco product
coordinates the preparation of HUMAN SERVICES applications (MRTPA) to the Committee
documentation, operates as an under section 911(f)(1) (21 U.S.C. 387k
international nonprofit organization and Food and Drug Administration (f)(1)). On April 6, 2017, FDA will
is funded by the Members of the ICH [Docket No. FDA–2017–N–0001] present information to the Committee
Association. on the processes used in review of
The ICH Assembly is the overarching Tobacco Products Scientific Advisory tobacco product applications, including
body of the Association and includes Committee; Notice of Meeting premarket tobacco, substantial
representatives from each of the ICH equivalence, and modified risk tobacco
members and observers. AGENCY: Food and Drug Administration, product applications. Topics will
In November 2016, the ICH Assembly HHS. include the statutory standards
endorsed the draft guidance entitled ACTION: Notice. applicable to the different types of
‘‘Q11 Development and Manufacture of applications, the scientific basis for
Drug Substances—Questions and SUMMARY: The Food and Drug review decisions, with a focus on PMTA
Answers (regarding the selection and Administration (FDA) announces a and MRTPA, and the role of the
justification of starting materials)’’ and forthcoming public advisory committee Committee in the review process.
agreed that the guidance should be meeting of the Tobacco Products FDA intends to make background
made available for public comment. The Scientific Advisory Committee. The material available to the public no later
sradovich on DSK3GMQ082PROD with NOTICES

draft guidance is the product of the Q11 general function of the committee is to than 2 business days before the meeting.
Quality Implementation Working Group provide advice and recommendations to If FDA is unable to post the background
of the ICH. The guidance consists of the Agency on FDA’s regulatory issues. material on its Web site prior to the
questions and answers that were The meeting will be open to the public. meeting, the background material will
developed to clarify the principles for DATES: The meeting will be held on be made publicly available at the
selecting starting materials described in April 6, 2017, from 8:30 a.m. to 4:30 location of the advisory committee
the ICH guidance ‘‘Q11 Development p.m. meeting, and the background material

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Document Created: 2018-02-01 15:04:27
Document Modified: 2018-02-01 15:04:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on April 6, 2017, from 8:30 a.m. to 4:30 p.m.
Contact		Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email: [email protected] A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation		82 FR 11226

82 FR 11226 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 33 (February 21, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration