[Federal Register Volume 75, Number 125 (Wednesday, June 30, 2010)]
[Notices]
[Pages 37818-37819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15814]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Issues in the Design and Conduct of Clinical Trials for 
Antibacterial Drug Development; 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 the design and conduct of 
clinical trials for antibacterial drug development. The public workshop 
is intended to provide information for and gain perspectives from 
health care providers, researchers, academia, industry, and regulators 
on various aspects of design and conduct of clinical trials for 
antibacterial drugs. The workshop will focus on the design and conduct 
of non-inferiority (NI) clinical

[[Page 37819]]

trials, which are often used in the evaluation of the safety and 
efficacy of a new antibacterial drug. The input from this public 
workshop will help in developing topics for further discussion.
    Date and Time: The public workshop will be held on August 2, 2010, 
from 8:30 a.m. to 5:30 p.m. and on August 3, 2010, from 8 a.m. to 4 
p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited 
and available only on a first-come, first-served basis.
    Contact Persons: Chris Moser or Lori Benner, Center for Drug 
Evaluation and Research, Food and Drug Administration, Office of 
Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, 
Silver Spring, MD 20993-0002, 301-796-1300.
    Registration: Registration is free for the public workshop. 
Interested parties are encouraged to register early because space is 
limited. Seating will be available on a first-come, first-served basis. 
To register electronically, e-mail registration information (including 
name, title, firm name, address, telephone and fax numbers) to 
[email protected]. Persons without access to the Internet can 
call Chris Moser or Lori Benner at 301-796-1300 to register (see 
Contact Persons). Persons needing a sign language interpreter or other 
special accommodations should notify Christine Moser or Lori Benner at 
least 7 days in advance.

SUPPLEMENTARY INFORMATION:  FDA is announcing a public workshop 
regarding scientific issues in the design and conduct of clinical 
trials for antibacterial drug development.
    Over the past decade, there have been public discussions on NI 
clinical trial design and the types of infectious disease indications 
for which the NI clinical trial design is appropriate. This public 
workshop will provide information on NI trial design, approaches to the 
justification of NI margins, and the assessment and timing of efficacy 
endpoints. Challenges in the conduct of clinical trials will be 
discussed, including good clinical practice and quality system 
approaches.
    The workshop will include presentations and perspectives from FDA 
and from stakeholders involved in clinical research. The public 
workshop is intended to provide information for and gain perspective 
from health care providers, researchers, academia, industry, and 
regulators on various aspects of the design and conduct of clinical 
trials for antibacterial drug development. The input from this public 
workshop will help in developing topics for further discussion.
    The agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15814 Filed 6-29-10; 8:45 am]
BILLING CODE 4160-01-S