[Federal Register Volume 67, Number 209 (Tuesday, October 29, 2002)]
[Notices]
[Page 65990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27438]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0461]


Antimicrobial Drug Development; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public 
workshop, cosponsored with the Infectious Diseases Society of America 
(IDSA) and the Pharmaceutical Research and Manufacturers of America 
(PhRMA), regarding antimicrobial drug development. The public workshop 
is intended to provide information for and gain perspective from 
advocacy groups, interested health care providers, academia, and 
industry organizations on various aspects of antimicrobial drug 
development, including the selection of delta in noninferiority 
(equivalence) clinical trials, the need for newer antimicrobial agents 
for the treatment of resistant pathogens, and clinical trial design. 
The input from this public workshop will help in developing topics for 
further exploration.
    Date and Time: The public workshop will be held on November 19 and 
20, 2002, from 9 a.m. to 5 p.m.
    Location: The public workshop will be held in the Center for Drug 
Evaluation and Research Advisory Committee Conference Room, rm. 1066, 
5630 Fishers Lane, Rockville, MD. Seating is limited and available only 
on a first-come, first-served basis. Please note there is very limited 
parking in the vicinity of 5630 Fishers Lane, but it is near the 
Twinbrook Metro station. Please bring picture identification in order 
to clear building security.
    Contact Person: John H. Powers, Center for Drug Evaluation and 
Research (HFD-104), Food and Drug Administration, 9201 Corporate Blvd., 
Rockville, MD 20850, 301-827-2350, e-mail: [email protected], or 
Leo Chan, Center for Drug Evaluation and Research (HFD-104), Food and 
Drug Administration, 9201 Corporate Blvd., Rockville, MD 20850, 301-
827-2350, e-mail: [email protected].
    Registration: Preregistration is required. Send registration 
information (including name, title, firm name, address, telephone, and 
fax number) to Leo Chan (see the Contact Person section of this 
document) by November 12, 2002. There is no registration fee for the 
public workshop. Space is limited; therefore, interested parties are 
encouraged to register early.
    Persons needing a sign language interpreter or other special 
accommodations should notify the contact person at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, 
cosponsored with IDSA and PhRMA, regarding antimicrobial drug 
development. On February 19 and 20, 2002, a public meeting of FDA's 
Anti-Infective Drugs Advisory Committee was held to discuss issues 
related to the selection of delta in noninferiority (equivalence) 
clinical trials and the development of antimicrobial agents for the 
treatment of resistant pathogens (67 FR 3726, January 25, 2002). This 
public workshop will further expand the discussion of both issues as 
well as focus on general considerations in designing clinical trials 
for antimicrobial products. Additional discussion topics include drug 
development for acute bacterial meningitis, acute exacerbation of 
chronic bronchitis, and hospital-acquired pneumonia. The input from 
this public workshop will help in developing topics for further 
exploration.
    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 will be available 
for review at the Dockets Management Branch Public Reading Room, Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852 and on the Internet at http://www.fda.gov/ohrms/dockets/dockets/dockets.htm or you may request a transcript of the public workshop from 
the Freedom of Information Staff (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 20 working days after the public workshop, at a cost of 
10 cents per page.

    Dated: October 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27438 Filed 10-28-02; 8:45 am]
BILLING CODE 4160-01-S