[Federal Register Volume 69, Number 89 (Friday, May 7, 2004)]
[Notices]
[Pages 25595-25596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10460]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Strategies for Developing Therapeutics That Directly Target 
Anthrax and Its Toxins; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Strategies for Developing Therapeutics That 
Directly Target Anthrax and Its Toxins.'' The goals of the public 
workshop are to provide a forum for sharing information and discussing 
strategies for safety and efficacy testing of therapeutics that target 
anthrax and its toxins in order to expedite the development of these 
FDA-regulated products; and to address the optimal studies for product 
characterization, proof of concept, and demonstration of safety and 
efficacy in postexposure prophylaxis and/or in the treatment of 
established disease. The workshop will cover therapies that

[[Page 25596]]

involve monoclonal antibodies, other recombinant proteins, polyclonal 
immune globulin (human or animal) and small molecules that inhibit 
toxins. The workshop will not cover the use of vaccines and 
antimicrobial drugs targeting anthrax and its toxins.
    Date and Time: This 2-day public workshop will be held on June 10, 
2004, from 8:30 a.m. to 5 p.m., and June 11, 2004, from 8:30 a.m. to 3 
p.m.
    Location: The public workshop will be held at the National 
Institutes of Health (NIH), Natcher Auditorium, Bldg. 45, 45 Center 
Dr., Bethesda, MD 20894.
    The NIH campus is accessible via the Washington, DC Metro Transit 
System, Red Line, at the Medical Center Station. The Natcher Conference 
Center is a short walk from the metro station, or you may take a 
shuttle bus that runs from the metro station to the various buildings 
on the campus. Because of security measures, visitors' parking is 
extremely limited and use of private vehicles may cause significant 
delays in entering the campus. Additionally, you will be required to 
show a photo ID upon entry to the campus and the Natcher Conference 
Center.
    Contact Person: Melanie Whelan, Center for Biologics Evaluation and 
Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-3841, FAX: 301-827-3079, 
e-mail: [email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone number, e-mail address, and FAX number) 
to the contact person by Friday, May 21, 2004. There is no registration 
fee for the public workshop. Because seating is limited, we recommend 
early registration. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Melanie Whelan (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA, Center for Biologics Evaluation and 
Research and Center for Drug Evaluation and Research; the National 
Institutes of Health, National Institute of Allergy and Infectious 
Diseases; the Centers for Disease Control and Prevention; and the 
Department of Health and Human Services, Office of Research and 
Development Coordination are cosponsoring a public workshop. The public 
workshop will provide a forum for sharing information and discussing 
strategies for safety and efficacy testing of therapeutics, including 
monoclonal antibody-based therapies, other recombinant proteins, 
polyclonal immune globulins (human and animal derived), and small 
molecules, that target anthrax and its toxins in order to expedite the 
development of these FDA-regulated products. The use of vaccines and 
antimicrobial drugs targeting anthrax and its toxins will not be 
covered. The public workshop is intended to address the optimal studies 
for product characterization, proof of concept, and demonstration of 
safety and efficacy in postexposure prophylaxis and/or in the treatment 
of established disease.
    Mail or fax your issues and questions to Melanie Whelan (see 
Contact Person) by Friday, May 28, 2004. (There will be an opportunity 
to raise additional questions and issues for discussion at the public 
workshop.) The agenda for this public workshop, when finalized, will be 
posted on the Center for Biologics Evaluation and Research's Web site 
at http://www.fda.gov/cber/scireg.htm.
    Transcripts: Transcripts of the workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. In addition, the transcript will be placed on FDA's 
Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: April 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10460 Filed 5-6-04; 8:45 am]
BILLING CODE 4160-01-S