[Federal Register Volume 62, Number 161 (Wednesday, August 20, 1997)]
[Notices]
[Page 44283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22089]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    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 regulatory issues.
    Date and Time: The meeting will be held on September 15, 1997, 9:30 
a.m. to 6 p.m., and September 16, 1997, 8:30 a.m. to 3 p.m.
    Location: Gaithersburg Hilton, Salons A, B, and C of the Ballroom, 
620 Perry Pkwy., 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: On September 15, 1997, the committee will hear a 
presentation of the basic concepts of FDA's Product Development 
Process. The committee will discuss and make recommendations on two 
premarket approval (PMA) applications for prosthetic heart valves. On 
September 16, 1997, the committee will discuss and make recommendations 
on a PMA for a prosthetic heart valve.
    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 September 5, 
1997. Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 10:30 a.m. on September 15, 1997, and 
between approximately 8:30 a.m. and 9:30 a.m. on September 16, 1997. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
September 5, 1997, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 14, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-22089 Filed 8-19-97; 8:45 am]
BILLING CODE 4160-01-F