The Tobacco Products Scientific Advisory Committee; Notice of Meeting, 70979 [2019-27774]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
provisions in 21 CFR part 601 are
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/combination-productsguidance-documents or https://
www.regulations.gov.
Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27799 Filed 12–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
The 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 (TPSAC,
the 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
February 14, 2020, from 8:30 a.m. to 5
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. 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/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
For those unable to attend in person,
the meeting will also be webcast and
will be available at the following link:
https://collaboration.fda.gov/
tpsac021420/.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products,
Food and Drug Administration,
Document Control Center, Bldg. 71, Rm.
G335, 10903 New Hampshire Ave.,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:53 Dec 23, 2019
Jkt 250001
Silver Spring, MD 20993–0002, 1–877–
287–1373, email: TPSAC@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). 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
website 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: On February 14, 2020, the
Center for Tobacco Product’s TPSAC
will convene for one open session,
during which the Committee will
discuss the modified risk tobacco
product applications, submitted by
22nd Century Group Inc. for the
following combusted filtered cigarette
tobacco products:
• MR0000159: VLNTM King
• MR0000160: VLNTM Menthol King
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 website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website 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 February 7, 2020.
Oral presentations from the public will
be scheduled between
approximately10:45 a.m. and 11:45 a.m.
on February 14, 2020. Those individuals
interested in making formal oral
presentations should notify the contact
person (see FOR FURTHER INFORMATION
CONTACT) and submit a brief statement
describing the general nature of the
evidence or arguments they wish to
present and the names and email
addresses of proposed participants on or
before January 30, 2020, by 5 p.m.
Eastern Time. Time allotted for each
presentation may be limited. If the
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
70979
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 January 31, 2020.
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 Serina HunterThomas at least 7 days in advance of the
meeting (see FOR FURTHER INFORMATION
CONTACT).
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/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: December 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27774 Filed 12–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0579]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Deviations in Manufacturing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 27,
2020.
SUMMARY:
E:\FR\FM\26DEN1.SGM
26DEN1
]]>Agencies
[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Page 70979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27774]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0001]
The 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 (TPSAC, the 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 February 14, 2020, from 8:30 a.m. to
5 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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 those unable to attend in person, the meeting will also be
webcast and will be available at the following link: https://collaboration.fda.gov/tpsac021420/.
FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, 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],
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). 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
website 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: On February 14, 2020, the Center for Tobacco Product's
TPSAC will convene for one open session, during which the Committee
will discuss the modified risk tobacco product applications, submitted
by 22nd Century Group Inc. for the following combusted filtered
cigarette tobacco products:
MR0000159: VLN\TM\ King
MR0000160: VLN\TM\ Menthol King
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 website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website 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
February 7, 2020. Oral presentations from the public will be scheduled
between approximately10:45 a.m. and 11:45 a.m. on February 14, 2020.
Those individuals interested in making formal oral presentations should
notify the contact person (see FOR FURTHER INFORMATION CONTACT) and
submit a brief statement describing the general nature of the evidence
or arguments they wish to present and the names and email addresses of
proposed participants on or before January 30, 2020, by 5 p.m. Eastern
Time. 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 January 31, 2020.
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 Serina Hunter-Thomas at least 7 days in advance of the meeting
(see FOR FURTHER INFORMATION CONTACT).
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website 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: December 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27774 Filed 12-23-19; 8:45 am]
BILLING CODE 4164-01-P
