83 FR 63658 - The Tobacco Products Scientific Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 237 (December 11, 2018)

Page Range		63658-63659
FR Document		2018-26721

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (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.

Federal Register, Volume 83 Issue 237 (Tuesday, December 11, 2018)

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63658-63659]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4162]


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 (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 6, 2019, from 8:30 a.m. to 
5 p.m. and on February 7, 2019 from 8 a.m. to 1 p.m.

ADDRESSES: FDA White Oak Conference Center, Bldg. 31, Rm. 1503 (the 
Great Room), 10903 New Hampshire Ave., 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.

[[Page 63659]]


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], 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 6-7, 2019, the Committee will convene for two 
sessions. The first session will convene on February 6, 2019, during 
which the Committee will discuss an amendment to the modified risk 
tobacco product applications (MRTPAs), submitted by Swedish Match North 
America for the following snus smokeless tobacco products:
     MR0000020: General Loose;
     MR0000021: General Dry Mint Portion Original Mini;
     MR0000022: General Portion Original Large;
     MR0000024: General Classic Blend Portion White Large-12ct;
     MR0000025: General Mint Portion White Large;
     MR0000027: General Nordic Mint Portion White Large-12ct;
     MR0000028: General Portion White Large; and
     MR0000029: General Wintergreen Portion White Large.
    The second session will convene, after the first session has 
concluded, on February 6, 2019, and continue on February 7, 2019. 
During the second session the Committee will discuss the MRTPA, 
submitted by Altria Client Services LLC on behalf of U.S. Smokeless 
Tobacco Company LLC for the following smokeless tobacco product:
     MR0000108: Copenhagen Snuff Fine Cut.
    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 
January 22, 2019. Oral presentations from the public for the first 
session will be scheduled between approximately 10 a.m. and 10:30 a.m. 
on February 6, 2019, and for the second session between approximately 8 
a.m. and 8:30 a.m. on February 7, 2019. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement describing the general nature of the evidence 
or arguments they wish to present, the names and email addresses of 
proposed participants, and the session during which they would like to 
speak, on or before January 14, 2019. 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 15, 2019.
    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 (see: FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the meeting.
    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 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26721 Filed 12-10-18; 8:45 am]
 BILLING CODE 4164-01-P

63658 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices

request a hearing constitutes a waiver of application. The proposal was based on money penalties (section 307(a)(7) of the
his right to a hearing concerning this a finding under section 306(b)(2)(B)(i)(I) FD&C Act). In addition, FDA will not
action. of the FD&C Act that Dr. Fishman was accept or review any abbreviated new
DATES: This order is applicable convicted of a misdemeanor under drug applications submitted by or with
December 11, 2018. Federal law for conduct relating to the the assistance of Dr. Fishman during his
regulation of drug products under the period of debarment (section
ADDRESSES: Submit applications for
FD&C Act, and that the type of conduct 306(c)(1)(B) of the FD&C Act).
termination of debarment to the Dockets
that served as the basis for the Any application by Dr. Fishman for
Management Staff (HFA–305), Food and
conviction undermines the process for termination of debarment under section
Drug Administration, 5630 Fishers
the regulation of drugs. 306(d)(1) of the FD&C Act should be
Lane, Rm. 1061, Rockville, MD 20852. The proposal offered Dr. Fishman an identified with Docket No. FDA–2018–
FOR FURTHER INFORMATION CONTACT: opportunity to request a hearing, N–1994 and sent to the Dockets
Kenny Shade, Division of Enforcement, providing him 30 days from the date of Management Staff (see ADDRESSES). All
Food and Drug Administration, 12420 receipt of the letter in which to file the such submissions are to be filed in four
Parklawn Dr., Rockville, MD 20857, request, and advised him that failure to copies. The public availability of
301–796–4640. request a hearing constituted a waiver of information in these submissions is
SUPPLEMENTARY INFORMATION: the opportunity for a hearing and of any governed by 21 CFR 10.20(j).
I. Background contentions concerning this action. Dr. Publicly available submissions will be
Fishman received the proposal on placed in the docket and will be
Section 306(b)(2)(B)(i)(I) of the FD&C August 2, 2018. Dr. Fishman did not viewable at https://www.regulations.gov
Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) request a hearing within the timeframe or at the Dockets Management Staff (see
permits debarment of an individual if prescribed by regulation and has, ADDRESSES) between 9 a.m. and 4 p.m.,
FDA finds that the individual has been therefore, waived his opportunity for a Monday through Friday.
convicted of a misdemeanor under hearing and has waived any contentions
Federal law for conduct relating to the Dated: December 4, 2018.
concerning his debarment (21 CFR part
regulation of drug products under the 12). Leslie Kux,
FD&C Act, and if FDA finds that the Associate Commissioner for Policy.
type of conduct that served as the basis II. Findings and Order [FR Doc. 2018–26722 Filed 12–10–18; 8:45 am]
for the conviction undermines the Therefore, the Director, Office of BILLING CODE 4164–01–P
process for the regulation of drugs. Enforcement and Import Operations,
On November 19, 2013, in the United Office of Regulatory Affairs, under
States District Court for the Northern section 306(b)(2)(B)(i)(I) of the FD&C DEPARTMENT OF HEALTH AND
District of Ohio, judgment was entered Act, under authority delegated to the HUMAN SERVICES
against Dr. Fishman after he entered a Director (Staff Manual Guide 1410.35),
plea of guilty to one count of finds that Dr. David J. Fishman has been Food and Drug Administration
misbranding, in violation of section convicted of a misdemeanor under [Docket No. FDA–2018–N–4162]
301(a) of the FD&C Act (21 U.S.C. Federal law for conduct relating to the
331(a)), which is a misdemeanor offense regulation of drug products under the The Tobacco Products Scientific
under section 303(a)(1) of the FD&C Act FD&C Act, and that the type of conduct Advisory Committee; Notice of Meeting
(21 U.S.C. 333(a)(1)). that served as the basis for the
FDA’s finding that debarment is conviction undermines the process for AGENCY: Food and Drug Administration,
appropriate is based on the the regulation of drugs. HHS.
misdemeanor conviction referenced As a result of the foregoing findings ACTION: Notice.
herein. The factual basis for this and in consideration of the factors
conviction is as follows: Between described in section 306(c)(3) of the SUMMARY: The Food and Drug
January 10, 2006, and March 12, 2009, FD&C Act, Dr. David J. Fishman is Administration (FDA) announces a
Dr. Fishman was a physician debarred for 3 years from providing forthcoming public advisory committee
(oncologist) in Ohio. During this time, services in any capacity to a person with meeting of the Tobacco Products
Dr. Fishman purchased and received an approved or pending drug product Scientific Advisory Committee (the
oncology drugs, including TAXOTERE application under sections 505, 512, or Committee). The general function of the
(docetaxel) and NOVANTRONE 802 of the FD&C Act (21 U.S.C. 355, Committee is to provide advice and
(mitoxantrone), from a drug distributor 360b, or 382), or under section 351 of recommendations to the Agency on
located in Canada. These new drugs the Public Health Service Act (42 U.S.C. FDA’s regulatory issues. The meeting
originated outside the United States and 262), effective (see DATES) (see sections will be open to the public.
were not approved by FDA for 306(c)(1)(B), (c)(3), and 201(dd) (21 DATES: The meeting will be held on
introduction or delivery for introduction U.S.C. 321(dd)) of the FD&C Act). Any February 6, 2019, from 8:30 a.m. to 5
into interstate commerce in the United person with an approved or pending p.m. and on February 7, 2019 from 8
States. Thus, Dr. Fishman caused the drug product application who a.m. to 1 p.m.
introduction or delivery for introduction knowingly employs or retains as a ADDRESSES: FDA White Oak Conference
into interstate commerce of prescription consultant or contractor, or otherwise Center, Bldg. 31, Rm. 1503 (the Great
drugs that were misbranded for lacking uses the services of Dr. Fishman in any Room), 10903 New Hampshire Ave.,
adequate directions for use in their capacity during his debarment, will be Silver Spring, MD 20993–0002. Answers
amozie on DSK3GDR082PROD with NOTICES1

labeling. subject to civil money penalties (section to commonly asked questions including
As a result of this conviction, on July 307(a)(6) of the FD&C Act (21 U.S.C. information regarding special
27, 2018, FDA sent Dr. Fishman a notice 335b(a)(6)). If Dr. Fishman provides accommodations due to a disability,
by certified mail proposing to debar him services in any capacity to a person with visitor parking, and transportation may
for 3 years from providing services in an approved or pending drug product be accessed at: https://www.fda.gov/
any capacity to a person that has an application during his period of AdvisoryCommittees/AboutAdvisory
approved or pending drug product debarment, he will be subject to civil Committees/ucm408555.htm.

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Document Created: 2018-12-11 01:06:32
Document Modified: 2018-12-11 01:06:32

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 February 6, 2019, from 8:30 a.m. to 5 p.m. and on February 7, 2019 from 8 a.m. to 1 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], 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.
FR Citation		83 FR 63658

83 FR 63658 - The Tobacco Products Scientific Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 237 (December 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration