
[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]


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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: 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 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


