
[Federal Register: May 19, 2010 (Volume 75, Number 96)]
[Notices]               
[Page 28027-28028]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my10-65]                         


[[Page 28027]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Tobacco Products Scientific Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Tobacco Products Scientific Advisory Committee.
    Function of the Committee: To provide advice and recommendations to 
the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 15, 2010, from 8:30 
a.m. to 5 p.m. and on July 16, 2010, from 8 a.m. to 5 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, 9751 
Washingtonian Blvd., Gaithersburg, MD. The hotel phone number is 301-
590-0044.
    Contact Person: Cristi Stark, Office of Science, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373 (choose Option 4), e-mail: 
TPSAC@fda.hhs.gov or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 8732110002. 
Please call the Information Line for up-to-date information on this 
meeting. A notice in the Federal Register about last minute 
modifications that affect a previously announced advisory committee 
meeting cannot always be published quickly enough to provide timely 
notice to the public. Therefore, you should always check the agency's 
Web site and call the advisory committee information line to learn 
about possible modifications of this meeting's schedule before coming 
to the meeting.
    Agenda: On July 15, 2010, the committee will (1) hear and discuss a 
presentation on dissolvable tobacco products in order to prepare for 
the Tobacco Products Scientific Advisory Committee's required report to 
the Secretary of Health and Human Services regarding the impact of the 
use of dissolvable tobacco products on the public health; (2) receive 
updates on upcoming committee business related to menthol, including 
agency requests for information from industry on menthol cigarettes in 
order to prepare for the Tobacco Products Scientific Advisory 
Committee's required report to the Secretary of Health and Human 
Services regarding the impact of use of menthol in cigarettes on the 
public health; and (3) hear and discuss industry presentations on 
menthol in cigarettes as they relate to five topics: Characterization 
of menthol, clinical effects of menthol, biomarkers of disease risk, 
marketing data, and population effects. Specific areas of interest 
identified by the committee for industry presentations include the 
following:
Characterization of menthol
    1. Trends in quantities of menthol present in the cigarette rod and 
smoke over time for various brands/subbrands of menthol and nonmenthol 
products as determined by the Cambridge Filter/ISO test method using 
standard parameters as well as the intense smoking conditions set forth 
in Canadian regulations.
    2. Information regarding the manufacturing of menthol and 
nonmenthol cigarettes, including (a) the source and type of menthol 
used, (b) the presence or use of any menthol analogs, and (c) the types 
of manufacturing processes through which menthol is introduced into the 
tobacco product, as well as the considerations in selecting a 
particular method.
    3. The threshold (menthol content) at which a product is identified 
and marketed as a menthol cigarette and how that threshold is 
established.
    4. The rationale for adding menthol to cigarettes not marketed as 
menthol cigarettes, and the criteria for determining the quantity of 
menthol to be added.
    5. For international brands of menthol cigarettes, the quantities 
of menthol in both menthol and nonmenthol cigarettes sold 
internationally, and the factors considered in determining the quantity 
of menthol to be added.
Clinical effects of menthol
    6. Studies of dose-response relationships for the physiologic 
effects of mentholated tobacco smoke.
    7. Mechanistic studies of menthol effects including (a) 
chemosensory effects of menthol compounds in tobacco smoke, including 
effects at thermal and trigeminal receptors; (b) the effect of menthol 
on the neurobiology of tobacco dependence; and (c) the effect of 
menthol on clinical and behavioral measures.
    8. Studies addressing the dosing relationship and the metabolic 
interactions between nicotine and menthol, including resulting 
perceptions of nicotine strength and the interaction between menthol 
delivery and nicotine/tar levels, for both low-menthol and high-menthol 
products.
    9. Information on correlations between menthol content and consumer 
perceptions regarding (a) taste, (b) nicotine strength, and (c) product 
harm.
Biomarkers
    10. Analyses of laboratory and populations studies using biomarkers 
to assess the effect of menthol content on disease risk for cigarette 
smokers, based on cigarette consumption (e.g., cigarettes per day), 
including data related to menthol among population subgroups.
Marketing data
    11. Data on consumer preferences for menthol cigarettes.
    12. Consumer perception studies of advertising, packaging, and 
labeling of menthol cigarettes.
    13. Marketing strategies for various brands/subbrands of menthol 
cigarettes, including strategies targeted to particular demographic 
groups.
    14. Marketing strategies for various brands/subbrands of menthol 
cigarettes sold internationally.
Population effects
    15. Among cigarette smokers, rates of switching from menthol to 
nonmenthol cigarettes and vice versa.
    16. Comparative rates of initiation by youth and young adults with 
menthol and nonmenthol cigarettes.
    17. Comparative rates of cessation for users of menthol and 
nonmenthol cigarettes.
    Information regarding menthol derived from both natural and 
synthetic sources, as well as menthol analogs and functional 
equivalents will be important to the committee in evaluating the impact 
of the use of menthol in cigarettes on the public health. Furthermore, 
FDA asks that to the extent possible and where relevant, data prepared 
for the presentations be stratified by gender, race/ethnicity, and age.
    On July 16, 2010, the committee will continue discussion on topic 
3.
    The FDA will work with representatives of the tobacco industry who 
wish to make presentations to ensure that adequate time, separate from 
the time slots for the general Open Public Hearing, is provided. 
Companies interested in making formal presentations to the Committee 
should respond by June 10, 2010, to TPSAC@fda.hhs.gov with the 
following information: (1) Confirmation of your availability to present 
at the July 15 and 16, 2010, TPSAC meeting, (2) specific topics for 
which you have relevant information and which you intend to present 
during the July 15 and 16, 2010, TPSAC meeting, and (3) whether you

[[Page 28028]]

are planning to provide background materials for the committee before 
the meeting. Each of the five broad categories listed in the Agenda 
portion of this notice will be allotted approximately 1 hour of 
presentation time during the meeting. Companies with common interest 
are urged to coordinate their oral presentations.
    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 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 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 June 
30, 2010. Oral presentations from the public (excluding the tobacco 
industry) will be scheduled between approximately 9 a.m. and 9:15 a.m. 
on July 15, 2010, for dissolvable tobacco products, and 12:30 p.m. and 
1:30 p.m. on July 16, 2010, for menthol. Those desiring to make 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 June 21, 2010. 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 June 23, 
2010.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Cristi Stark 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: May 13, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-11907 Filed 5-18-10; 8:45 am]
BILLING CODE 4160-01-S

