[Federal Register Volume 64, Number 123 (Monday, June 28, 1999)]
[Notices]
[Pages 34659-34660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16315]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Orthopaedic and Rehabilitation Devices Panel of the Medical 
Devices 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Orthopaedic and Rehabilitation 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 July 26, 1999, 10:30 
a.m. to 5 p.m., and July 27, 1999, 7:30 a.m. to 2:30 p.m.
    Location: Hilton Hotel, Salons B and C, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Hany W. Demian or Mark N. Melkerson, Center for 
Devices and Radiological Health (HFZ-410), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2036, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), code 12521. Please call the 
Information Line for up-to-date information on this meeting.

[[Page 34660]]

    Agenda: On July 27, 1999, the committee will discuss and make 
recommendations on the classification of bone dowel devices of human 
origin.
    Procedure: On July 27, 1999, from 7:30 a.m. to 2:30 p.m., the 
meeting is open to the public. 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 
July 16, 1999. Oral presentations from the public regarding the 
classification of bone dowel devices will be scheduled between 
approximately 8:45 a.m. and 9:45 a.m. on July 27, 1999. Near the end of 
committee deliberations, a 30-minute open public session will be 
conducted for interested persons to address issues specific to the 
submission before the committee. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person by July 16, 1999, 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.
    Closed Committee Deliberations: On July 26, 1999, from 10:30 a.m. 
to 5 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information on a product 
development protocol. This portion of the meeting will be closed to 
permit discussion of this information (5 U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 22, 1999.
 Linda A. Suydam,
 Senior Associate Commissioner.
[FR Doc. 99-16315 Filed 6-25-99; 8:45 am]
BILLING CODE 4160-01-F