Federal Register / Vol. 75, No. 96 / Wednesday, May 19, 2010 / Notices 28027 

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. 

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), email: 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 lowmenthol 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
28028 Federal Register / Vol. 75, No. 96 / Wednesday, May 19, 2010 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Cancer Institute Clinical Trials 

and Translational Research Advisory 

Committee. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Cancer 

Institute Clinical Trials and Translational 

Research Advisory Committee. 

Date: July 14, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: Update on the progress of the 

implementation of the Clinical Trials 

Working Group and the Translational 

Research Working Group reports. 

Place: National Institutes of Health, 

Building 31, 6th Floor, C–Wing, Room 10, 31 

Center Drive, Bethesda, MD 20892. 

Contact Person: Sheila A. Prindiville, MD, 

MPH, Director, Coordinating Center for 

Clinical Trials, Office of the Director, 

National Cancer Institute, National Institutes 

of Health, 6120 Executive Blvd., 3rd Floor 

Suite, Bethesda, MD 20892, 301–451–5048, 

prindivs@mail.nih.gov. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: May 17, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–12006 Filed 5–18–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; PAR DE–09–182. 

Date: June 15, 2010. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Lynn M. King, PhD, Chief, 

Scientific Review Branch, National Institute 

of Dental and Craniofacial Research/NIH, 

6701 Democracy Blvd., Bethesda, MD 20892– 

6402, 301–594–5006, lynn.king@nih.gov. 


jlentini on DSKJ8SOYB1PROD with NOTICES