[Federal Register Volume 65, Number 60 (Tuesday, March 28, 2000)]
[Notices]
[Page 16401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 4, 2000, 8 a.m. to 
6 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: John E. Stuhlmuller, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8243, ext. 157, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12625. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: There will be a brief FDA presentation on the least 
burdensome provisions of the FDA Modernization Act of 1997. 
Subsequently, the committee is being asked to provide input to the 
agency regarding the design of clinical trials for the following: (1) 
Devices using spinal cord stimulation in the treatment of angina 
pectoris; (2) rate-responsive pacemakers, specifically, the evaluation 
of rate-adaptive features; and (3) devices used in the treatment of 
atrial fibrillation. Background information, questions for the panel, 
and a bibliography for each topic to be discussed by the committee are 
available to the public on the Internet at http://www.fda.gov/cdrh/upadvmtg.html.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by March 28, 
2000. Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 9 a.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before March 28, 2000, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the April 4, 2000, Circulatory System Devices Panel of the Medical 
Device Advisory Committee meeting. Because the agency believes there is 
some urgency to bring these issues to public discussion and qualified 
members of the Circulatory System Devices Panel were available at this 
time, the Commissioner of Food and Drugs concluded that it was in the 
public interest to hold this meeting even if there was not sufficient 
time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 20, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-7543 Filed 3-27-00; 8:45 am]
BILLING CODE 4160-01-F