Tobacco Products Scientific Advisory Committee; Notice of Meeting, 11226-11227 [2017-03364]
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Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices
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SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization, and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products for human use
among regulators around the world. The
six founding members of the ICH are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and
the Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
Swissmedic. Any party eligible as a
Member in accordance with the ICH
Articles of Association can apply for
membership in writing to the ICH
Secretariat. The ICH Secretariat, which
coordinates the preparation of
documentation, operates as an
international nonprofit organization and
is funded by the Members of the ICH
Association.
The ICH Assembly is the overarching
body of the Association and includes
representatives from each of the ICH
members and observers.
In November 2016, the ICH Assembly
endorsed the draft guidance entitled
‘‘Q11 Development and Manufacture of
Drug Substances—Questions and
Answers (regarding the selection and
justification of starting materials)’’ and
agreed that the guidance should be
made available for public comment. The
draft guidance is the product of the Q11
Quality Implementation Working Group
of the ICH. The guidance consists of
questions and answers that were
developed to clarify the principles for
selecting starting materials described in
the ICH guidance ‘‘Q11 Development
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and Manufacture of Drug Substances’’
published November 20, 2012 (77 FR
69634), and available online at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM261078.pdf. The draft guidance
provides guidance on selecting and
justifying starting materials, in
particular for the synthesis of chemical
entity drug substances. Comments about
this draft will be considered by FDA
and the Quality Implementation
Working Group.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: February 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03309 Filed 2–17–17; 8:45 am]
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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.
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.
SUMMARY:
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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: https://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:
TPSAC@fda.hhs.gov. 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 https://
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
ADDRESSES:
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://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
https://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]
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11227
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
Written/Paper Submissions
Submit written/paper submission as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–0595 for ‘‘Pediatric
Postmarketing Pharmacovigilance and
Drug Utilization Reviews’’ that have
been posted on the FDA Web site at
https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm between September 17,
2016, and February 24, 2017, but will
not be presented at the March 6–7, 2017
PAC meeting (82 FR 1345, January 5,
2017). 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
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 Division of Dockets
Management. 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’’
[Docket No. FDA–2017–N–0595]
Pediatric Postmarketing
Pharmacovigilance and Drug
Utilization Reviews; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments related to the pediatric
postmarketing pharmacovigilance and
drug utilization reviews of products
posted between September 17, 2016,
and February 24, 2017, on the FDA Web
site, but will not be presented at the
March 6–7, 2017, Pediatric Advisory
Committee (PAC) meeting. These
reviews are intended to be available for
review and comment by members of the
PAC, interested parties (such as
academic researchers, regulated
industries, consortia, and patient
groups), and the general public.
DATES: Submit either electronic or
written comments by March 10, 2017.
The docket will open on February 27,
2017, and remain open until March 10,
2017.
ADDRESSES: You may submit your
comments as follows:
SUMMARY:
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, you 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
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Agencies
[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11226-11227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03364]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
https://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: TPSAC@fda.hhs.gov. 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 https://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 https://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 https://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