[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Notices]
[Page 37850]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0281]
Severe Acute Respiratory Syndrome Diagnostics: Scientific and
Regulatory Challenges Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to discuss methods for evaluating new diagnostic tests for
severe acute respiratory syndrome (SARS). The purpose of this workshop
is to serve as a public forum for interested stakeholders and FDA to
consider resources and methods to evaluate SARS diagnostic tests. In
addition, the workshop serves as an opportunity to provide mechanisms
for public-private partnerships and sharing of both information and
resources to facilitate evaluation and safe use of new diagnostic
tests.
Date and Time: The public workshop will be held on July 14, 2003,
from 8 a.m. to 5 p.m.
Addresses: The public workshop will be held at the DoubleTree
Rockville Hotel and Executive Meeting Center (http://www.doubletreerockville.com
), 1750 Rockville Pike, Rockville, MD 20852,
301-468-1100, FAX: 301-468-0163. The hotel may be reached by Metro
using the Twinbrook station on the red line. Submit written or
electronic comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, e-mail: FDADockets@oc.fda.gov. Online registration,
additional information about the meeting, and directions to the
facility are available on the Internet at: http://www.fda.gov/cdrh/meetings/071403.html
.
Contact Person: Cynthia Benson, Center for Devices and Radiological
Health (HFZ-3), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-827-7989, e-mail: cmh@cdrh.fda.gov. Agenda: At the workshop, FDA will receive questions and comments
from stakeholders likely to be affected by FDA policies or procedures
regarding SARS diagnostic tests. Stakeholders include, but are not
limited to, medical device product manufacturers, members of the
academic and clinical communities, and consumer and patient advocacy
groups.
Registration: Preregistration is required by July 7, 2003, and will
be accepted on a first-come, first-served basis; however,
notwithstanding attendance at the workshop, interested persons are
encouraged to provide comments (see the Request for Comments section of
this document). Please register online at http://www.fda.gov/cdrh/meetings/071403.html.
Persons without Internet access may call 1-888-
203-6161 to register. To accommodate overnight attendees, a limited
number of reserved rooms are available by calling the DoubleTree
Rockville Hotel and Conference Center (see the Addresses section of
this document). Please register with the hotel by June 30, 2003. FDA is
pleased to provide the opportunity for interested persons to listen
from a remote location to the live proceedings of the workshop. In
order to ensure that a sufficient number of call-in lines are
available, please register to listen to the meeting at http://www.fda.gov/cdrh/meetings/071403.html.
Persons without Internet access
may call 1-888-203-6161 to register. Please register by July 7, 2003.
FDA will provide audio conference participants the opportunity for
comments and questions by fax (fax number to be provided at the
workshop).
If you need special accommodations due to a disability, please
contact Shirley Meeks at 301-594-1283 at least 7 days in advance.
Request for Comments: Regardless of attendance at the workshop,
interested persons may submit written or electronic comments to the
Division of Dockets Management (see the Addresses section of this
document). Submit two paper copies of any mailed comments. Individuals
may submit one paper copy. Identify comments with the docket number
found in brackets in the heading of this document. The comments that
FDA receives will be made available at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Transcripts: Following the workshop, transcripts will be available
for review at the Division of Dockets Management (see the Addresses
section of this document).
SUPPLEMENTARY INFORMATION: The objectives of the workshop are to
discuss methods for evaluating new SARS assays for clinical and public
health use and to develop information on availability and access to
control materials, reagents, and specimens needed for development and
qualification of SARS diagnostic assays. FDA hopes to address unique
issues related to the evaluation of nucleic acid amplification, direct
antigen, and serologic assays. FDA also wishes to promote partnerships
among government, industry, health care providers, and the clinical
laboratory community that would facilitate the development of new SARS
diagnostic assays through sharing of information and resources.
Dated: June 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16232 Filed 6-23-03; 3:07 pm]
BILLING CODE 4160-01-S