Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections; Notice of Public Workshop, 52969 [E9-24828]
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Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices
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
Food and Drug Administration.
ACTION: Notice.
AGENCY:
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 Respdiagmtg@fda.hhs.gov
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
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Nov<24>2008
19:13 Oct 14, 2009
Jkt 220001
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 https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm181140.htm.
52969
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
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
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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SECURITY
Coast Guard
[USCG–2009–0362]
Collection of Information Under
Review by Office of Management and
Budget: OMB Control Numbers: 1625–
0014, 1625–0038, and 1625–0069
Coast Guard, DHS.
Thirty-day notice requesting
comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, this
request for comments announces that
the U.S. Coast Guard is forwarding three
Information Collection Requests (ICRs),
abstracted below, to the Office of
Information and Regulatory Affairs
(OIRA), Office of Management and
Budget (OMB) requesting an extension
of its approval for the following
collections of information: (1) 1625–
0014, Request for Designation and
Exemption of Oceanographic Research
Vessels; (2) 1625–0038, Plan Approval
and Records for Tank, Passenger, Cargo
and Miscellaneous Vessels, Mobile
Offshore Drilling Units, Nautical School
Vessels and Oceanographic Research
Vessels—46 CFR Subchapters D, H, I,
I–A, R and U; and (3) 1625–0069, Ballast
Water Management for Vessels with
Ballast Tanks Entering U.S. Waters.
Review and comments by OIRA ensure
we only impose paperwork burdens
commensurate with our performance of
duties.
DATES: Please submit comments on or
before November 16, 2009.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2009–0362] to the
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(DOT) or to OIRA. To avoid duplication,
please submit your comments by only
one of the following means:
(1) Electronic submission. (a) To Coast
Guard docket at https://
www.regulation.gov. (b) To OIRA by email via: oira_submission@omb.eop.gov.
(2) Mail or Hand delivery. (a) DMF
(M–30), DOT, West Building Ground
Floor, Room W12–140, 1200 New Jersey
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Notices]
[Page 52969]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 Respdiagmtg@fda.hhs.gov 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 https://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 https://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
