[Federal Register Volume 68, Number 122 (Wednesday, June 25, 2003)]
[Notices]
[Page 37850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16232]


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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: [email protected]. 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: [email protected].
    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