E9-19781. 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 [e-mail] 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.