[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Notices]
[Page 52969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24828]



[[Page 52969]]

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DEPARTMENT OF HEALTH AND HUMAN SERIVCES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Advancing Clinical Development of Molecular and Other Diagnostic 
Tests for Respiratory Tract Infections; Notice of Public Workshop

AGENCY:  Food and Drug Administration.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
workshop, co-sponsored with the Infectious Diseases Society of America 
(IDSA), regarding scientific issues in the development of molecular and 
other tests for the diagnosis of respiratory infections, entitled 
``Advancing Clinical Development of Molecular and Other Diagnostic 
Tests for Respiratory Tract Infections.'' The purpose of the public 
workshop is to provide an opportunity to share information and 
perspectives with health care providers, academia, and industry on 
various aspects of diagnostic test development for respiratory 
infections. Topics for discussion will include the role of emerging 
diagnostic tests in promoting appropriate use of antibiotics by 
physicians, the use of novel diagnostic tests in the study of new drugs 
for respiratory infections, and the possible contribution of biomarkers 
in the approach to treatment of respiratory infections.
    Date and Time: The public workshop will be held on November 12, 
2009, from 8 a.m. to 6 p.m. and on November 13, 2009, from 8 a.m. to 
4:30 p.m.
    Location: The public workshop will be held at the Hilton Washington 
DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD 
20877. Seating is limited and available only on a first-come, first-
served basis.
    Contact Person: Christine Kellerman, Center for Devices and 
Radiological Health, Food and Drug Administration, Office of In Vitro 
Diagnostic Devices, 10903 New Hampshire Ave., Building 66, rm. 5677, 
Silver Spring, MD 20993-0002, 301-796-5711.
    Registration: To register electronically, e-mail registration 
information (including: Name, title, firm name, address, telephone, and 
fax numbers) to [email protected] by November 8, 2009. Persons 
without access to the Internet can call 301-796-5711 to register. 
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. Persons needing a sign 
language interpreter or other special accommodations should notify 
Christine Kellerman (see Contact Person) at least 7 days in advance. 
Additional information is also available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm181140.htm.

SUPPLEMENTARY INFORMATION:

I. Background

    New diagnostic technologies offer opportunities to guide the 
appropriate clinical use of anti-infective agents, facilitate the study 
of new anti-infective agents, and aid in tracking the spread of 
infectious diseases. To explore issues regarding the development and 
adoption of emerging diagnostic tests, FDA is announcing a public 
workshop, co-sponsored with IDSA to address scientific issues in the 
development of in vitro diagnostic tests for respiratory infections.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the workshop include:
     Principles of clinical trial design and their application 
to studies of new diagnostics, or studies where new diagnostics and new 
drugs are investigated simultaneously;
     Test characteristics for emerging tests that would promote 
clinical adoption and improve antibiotic stewardship;
     Principles for including specific viral or bacterial 
pathogens in multiplex diagnostic test panels;
     Discussion of approaches to developing a new molecular 
method when there is no ``gold standard'' reference method; and
     The use of biomarkers in respiratory infections.
    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: 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. A link to the transcripts will also be available on the 
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm approximately 45 days after the 
workshop.

    Dated: October 7, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24828 Filed 10-14-09; 8:45 am]
BILLING CODE 4160-01-S