[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]
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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.
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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 (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