Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices 43141 

prospective candidates should be sent to 

FDA by September 25, 2009. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to cv@oc.fda.gov, or by 

mail to Advisory Committee Oversight & 

Management Staff, 5600 Fishers Lane 

(HF–4), rm. 14C03, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: Erik 

P. Mettler, Office of Policy, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4324, Silver Spring, 

MD 20993, 301–796–4711, FAX: 301– 

847–3541, e-mail: 

erik.mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

agency requests nominations for 

nonvoting industry representatives on 

the Tobacco Products Scientific 

Advisory Committee. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing two separate documents 

announcing the establishment of the 

committee and the request for 

nomination of the Tobacco Products 

Scientific Advisory Committee. 

I. Center for Tobacco 

Tobacco Products Scientific Advisory 

Committee 

The Tobacco Products Scientific 

Advisory Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to the regulation of tobacco 

products. The Committee reviews and 

evaluates safety, dependence, and 

health issues relating to tobacco 

products and provides appropriate 

advice, information, and 

recommendations to the Commissioner 

of Food and Drugs. 

The Committee shall include three 

nonvoting members who are identified 

with industry interests. These members 

shall include one representative of the 

tobacco manufacturing industry, one 

representative of the interests of tobacco 

growers, and one representative of the 

interests of the small business tobacco 

manufacturing industry. This final 

position can be filled on a rotating, 

sequential basis by representatives of 

different small business tobacco 

manufacturers based on areas of 

expertise relevant to the topics being 

considered by the Committee. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document. Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the Tobacco Products 

Scientific Advisory Committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner of Food and Drugs will 

select the nonvoting member to 

represent industry interests. 

III. Application Procedure 

Individuals may self nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. A current 

curriculum vitae and the name of the 

committee of interest should be sent to 

the FDA contact person within the 30 

days. FDA will forward all nominations 

to the organizations expressing interest 

in participating in the selection process 

for the committee. (Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages, nominations 

for appropriately qualified candidates 

from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20483 Filed 8–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Industry Exchange Workshop on Food 

and Drug Administration Drug and 

Device Requirements; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Philadelphia 

District, in cosponsorship with the 

Society of Clinical Research Associates 

(SoCRA) is announcing a public 

workshop entitled: ‘‘FDA Clinical Trial 

Requirements, Regulations, Compliance 

and GCP.’’ This 2-day public workshop 

is intended to provide information 

about FDA clinical trial requirements to 

the regulated industry. 

Date and Time: The public workshop 

will be held on October 21, 2009, from 

8:30 a.m. to 5 p.m. and October 22, 

2009, from 8:30 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Hyatt Regency Pittsburgh 

International Airport, 1111 Airport 

Blvd., Pittsburgh, PA 15231, 724–899– 

1234 or 1–800–233–1234. 

Attendees are responsible for their 

own accommodations. To make 

reservations at the Hyatt Regency Hotel, 

contact the Hyatt Regency Hotel. 

Contact: Marie Falcone, Food and 

Drug Administration, U.S. 

Customhouse, 200 Chestnut St., rm. 900, 

Philadelphia, PA 19106, 215–717–3703, 

FAX: 215–597–4660, e-mail: 

marie.falcone@fda.hhs.gov. 

Registration: You are encouraged to 

register by October 19, 2009. The 

SoCRA registration fees cover the cost of 

facilities, materials, and breaks. Seats 

are limited; please submit your 

registration as soon as possible. Course 

space will be filled in order of receipt 

of registration. Those accepted in to the 

course will receive confirmation. 

Registration will close after the course is 

filled. Registration at the site is not 

guaranteed but may be possible on a 

space available basis on the day of the 

public workshop beginning at 8 a.m. 

The cost of registration is as follows: 

COST OF REGISTRATION

Affiliation Fee 

FDA Employee Fee Waived 

Government (Non-Member) $525.00 


jlentini on DSKJ8SOYB1PROD with NOTICES
43142 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices 

COST OF REGISTRATION—Continued 

Affiliation Fee 

Non-Government (SoCRA 

Member) 

$575.00 

Non-Government (Non 

SoCRA Member) 

$650.00 

If you need special accommodations 

due to a disability, please contact Marie 

Falcone (see Contact) at least 7 days in 

advance of the workshop. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and e-mail 

address, along with a check or money 

order payable to ‘‘Socra.’’ Mail to: 

SoCRA, 530 West Butler Ave., suite 109, 

Chalfont, PA 18914. To register via the 

Internet, go to http://www.socra.org/ 

html/FDA_Conference.htm. FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register).The 

registrar will also accept payment by 

major credit cards (VISA/MasterCard/ 

AMEX only). For more information on 

the public workshop, or for questions on 

registration, contact the Society of 

Clinical Research Associates at 800– 

762–7292 or 215–822–8644, FAX: 215– 

822–8633, or e-mail: 

SoCRAmail@aol.com. 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, institutional review board 

(IRB) inspections, electronic record 

requirements, and investigator initiated 

research. Topics for discussion include 

the following: 

• What FDA Expects in a 

Pharmaceutical Clinical Trial; 

• Adverse Event Reporting—Science, 

Regulation, Error, and Safety; 

• Part 11 Compliance—Electronic 

Signatures; 

• Informed Consent Regulations; 

• IRB Regulations and FDA 

Inspections; 

• Keeping Informed and Working 

Together; 

• FDA Conduct of Clinical 

Investigator Inspections; 

• Meetings With FDA: Why, When, 

and How; 

• Investigator Initiated Research; 

• Medical Device Aspects of Clinical 

Research; 

• Working With FDA’s Center for 

Biologics Evaluation and Research; and 

• The Inspection is Over—What 

Happens Next? Possible FDA 

Compliance Actions. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121), as outreach 

activities by Government agencies to 

small businesses. 

Dated: August 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20340 Filed 8–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Public Health 

Informatics (BSC, NCPHI) 

Correction: The notice was published 

in the Federal Register on August 18, 

2009 [Volume 74, Number 158] [page 

41712]. The ‘‘Matters To Be Discussed’’ 

has been revised: The board will discuss 

public health informatics issues related 

to the H1N1 virus; CDC public health 

informatics strategies and goals, 

including future program activities; and 

how the board can provide informatics 

scientific input to CDC. 

Contact Person for More Information: 

Dr. Scott McNabb, National Center for 

Public Health Informatics, CDC, 1600 

Clifton Road, NE., Mailstop E–78, 

Atlanta, Georgia 30333, Telephone (404) 

498–6427, Fax (404) 498–6235. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the CDC 

and the Agency for Toxic Substance and 

Disease Registry. 

Dated: August 18, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–20575 Filed 8–25–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary 

and Alternative Medicine 

Announcement of Wellness Workshop 

ACTION: Notice. 

SUMMARY: The National Center for 

Complementary and Alternative 

Medicine (NCCAM) invites the research 

community to participate in a workshop 

focused on wellness. 

The purpose of this workshop is to 

review several measures of wellness, 

identify their strengths and weaknesses, 

and make recommendations on how 

best to capture the construct. This 

information will help NCCAM guide 

development of questions for the 2012 

National Health Interview Survey. 

The Workshop will take place on 

September 25, 2009. Those interested in 

CAM research are particularly 

encouraged to attend. 

Background: The National Center for 

Complementary and Alternative 

Medicine (NCCAM) was established in 

1999 with the mission of exploring 

complementary and alternative healing 

practices in the context of rigorous 

science, training CAM researchers, and 

disseminating authoritative information 

to the public and professionals. NCCAM 

funds research grants that explore the 

science of CAM. For more information, 

see http://nccam.nih.gov/grants/ 

whatnccamfunds/. 

Participating: The public is invited to 

attend and observe this workshop. 

Those interested in attending are 

required to RSVP via e-mail to Edward 

Culhane Jr. at culhane@mail.nih.gov 

with their name, affiliation, e-mail and 

phone number. Space constraints limit 

the number of attendees at this 

workshop and participation will be on 

a first come, first served basis. For more 

information about what will be covered 

at the workshop, see http:// 

nccam.nih.gov/news/events/. 

FOR FURTHER INFORMATION CONTACT: To 

request more information, visit the 

NCCAM Web site at http:// 

nccam.nih.gov/news/events/, call 301– 

594–3391 (Edward Culhane Jr.) or email at culhanee@mail.nih.gov. 


jlentini on DSKJ8SOYB1PROD with NOTICES