41734 Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 

4. Organizes, plans, and directs the 

Center for research support in the areas 

of Tobacco. 

Directs the development methods 

used to extrapolate test results from 

animals to humans. 

5. Coordinates research in Center 

program areas with leading scientists in 

other segments of FDA and the scientific 

community at large and promotes and 

coordinates the Center’s technology 

transfer under the provisions of the 

Federal Technology Transfer Act. 

6. Coordinates with other Center and 

agency components and top level 

officials of other agencies to provide 

input for long-term research planning in 

responsible program areas. 

7. Insures that programs implemented 

are responsive to the Center’s portion of 

the agency’s integrated research plan. 

8. Provides scientific oversight of 

Center research contracts and 

agreements. 

9. Advises and assists the Center 

Director, Deputy Director, and other key 

officials on scientific issues that have an 

impact on policy, direction, and longrange goals. 

10. Coordinates and provides 

guidance on special and overall science 

policy in program areas that cross major 

agency component lines and scientific 

aspects that are critical or controversial, 

including agency risk assessment 

policies. 

11. Represents the Center with other 

government agencies, state and local 

governments, industry, academia, 

consumer organizations, Congress, 

national and international 

organizations, and the scientific 

community on tobacco science policy 

and tobacco science issues. 

12. Serves as the focal point for 

overall management of Center activities 

related to science priorities, resources, 

and leveraging efforts, as well as peer 

review of scientists and scientific 

programs. 

13. Advises the Commissioner, 

Deputy Commissioner, and other key 

officials on scientific facilities and 

participates with other agency 

components in planning such facilities. 

14. Administers the Tobacco Advisory 

Committee that advises the Center 

Director, Deputy Director, and other key 

officials regarding the quality and 

direction of tobacco science and 

scientific issues. 

II. Delegation of Authority. Pending 

further delegation, directives or orders 

by the Commissioner of the Food and 

Drugs, all delegations and redelegations 

of authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

Dated: August 7, 2009. 

Kathleen Sebelius, 

Secretary of Health and Human Services. 

[FR Doc. E9–19680 Filed 8–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Development of Antiviral Products for 

Treatment of Smallpox and Related 

Poxvirus Infections; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop regarding scientific 

issues in clinical development of 

antiviral drug products for treatment of 

smallpox and related poxvirus 

infections. This public workshop is 

intended to provide information for and 

gain perspective from health care 

providers, academia, and industry on 

various aspects of antiviral product 

development for smallpox and related 

poxvirus infections, including the status 

of clinical understanding of smallpox 

from pre-eradication experience, current 

epidemiology of naturally occurring 

poxvirus infections, potential effect of 

antiviral treatment for smallpox and 

related poxvirus infections, and issues 

pertaining to animal models for 

smallpox and related poxvirus 

infections. The input from this public 

workshop will help in developing topics 

for further discussion. 

Dates and Times: The public 

workshop will be held on September 1, 

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

September 2, 2009, from 8 a.m. to 4 p.m. 

Location: The public workshop will 

be held at the Crowne Plaza Silver 

Spring, 8777 Georgia Ave., Silver 

Spring, MD 20910. 

Contact Person: Chris Moser or Lori 

Benner, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, Office of Antimicrobial 

Products, New Hampshire Ave., Bldg. 

22, rm. 6209, Silver Spring, MD 20993– 

0002, 301–796–1300. 

Registration: To register 

electronically, e-mail registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) to 

SmallpoxWkshp@fda.hhs.gov by August 

24, 2009. Persons without access to the 

Internet can call 301–796–1300 to 

register. Registration is free for the 

public workshop, but interested parties 

are encouraged to register early because 

spaced is limited. Seating will be 

available on a first-come, first-served 

basis. Persons needing a sign language 

interpreter or other special 

accommodations should notify 

Christine Moser or Lori Benner (see 

Contact Person) at least 7 days in 

advance. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public workshop 

regarding antiviral drug development 

for smallpox and related poxvirus 

infections. This public workshop will 

focus on scientific considerations in the 

clinical development of products for 

treatment of smallpox and related 

poxvirus infections. This public 

workshop is intended to provide 

information regarding historical 

perspectives on smallpox and current 

perspectives on related poxvirus 

infections in humans. The workshop 

will explore approaches to assessing the 

potential effect of antiviral treatment for 

smallpox and related poxvirus 

infections. Issues pertaining to animal 

models for smallpox and related 

poxvirus infection and their 

relationship to disease in humans will 

be discussed at the workshop. In 

addition, the workshop will include 

perspectives of public health 

organizations on possible uses of an 

antiviral product for poxvirus 

infections. 

The agency encourages individuals, 

patient advocates, industry, consumer 

groups, health care professionals, 

researchers, and other interested 

persons to attend this public workshop. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 20 working days after the 

public workshop, at a cost of 10 cents 

per page. Transcripts will also be 

available on the Internet at http:// 

www.fda.gov/Drugs/NewsEvents/ 

ucm169065.htm approximately 45 days 

after the workshop. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19781 Filed 8–17–09; 8:45 am] 

BILLING CODE 4160–01–S 


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