[Federal Register: October 29, 2002 (Volume 67, Number 209)]
[Notices]
[Page 65990]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc02-79]
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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.
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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: powersjoh@cder.fda.gov, 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: chanl@cder.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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