[Federal Register Volume 64, Number 183 (Wednesday, September 22, 1999)]
[Notices]
[Page 51327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Obstetrics and Gynecology 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). At least one 
portion of the meeting will be closed to the public.
    Name of the Committee: Obstetrics and Gynecology 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 October 4, 1999, 8 a.m. 
to 5 p.m.
    Location: Parklawn Bldg., conference rooms D and E, 5600 Fishers 
Lane, Rockville, MD.
    Contact Person: Elisa D. Harvey, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180 or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12524. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On October 4, 1999, in the morning session, the committee 
will discuss issues for new barrier contraceptive devices such as 
premarket study design, prescription versus over-the-counter 
availability, and premarket versus postmarket studies. The following 
current guidance documents are available as references: (1) ``Testing 
Guidance for Male Condoms Made from New Material,'' (2) ``Guidance for 
Industry: Uniform Contraceptive Labeling,'' and (3) ``Premarket Testing 
Guidelines for Female Barrier Contraceptive Devices Also Intended to 
Prevent Sexually Transmitted Diseases.'' Single copies of these 
guidance documents are available to the public by contacting the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 1-800-638-2041 or by faxing your 
request to 301-443-8818 and requesting the document by shelf numbers 
455, 1251, and 384, respectively. They are also available on the 
Internet using the World Wide Web at http://www.fda.gov/cdrh/ode/
oderp455.html, http://www.fda.gov/cdrh/ode/contrlab.html, and http://
www.fda.gov/cdrh/ode/384.pdf.
    In the afternoon session, the committee will discuss clinical study 
requirements for new nonextirpative methods of treating uterine 
fibroids.
    Procedure: On October 4, 1999, from 9 a.m. to 5 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 
September 27, 1999. Oral presentations from the public will be 
scheduled between approximately 9:30 a.m. and 10 a.m. and between 
approximately 1:30 p.m. and 2 p.m. Time allotted for each presentation 
may be limited. Those desiring to make formal presentations should 
notify the contact person before September 27, 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 October 4, 1999, from 8 a.m. to 
9 a.m., the meeting will be closed to permit the committee to hear and 
review trade secret and/or confidential commercial information 
regarding pending and future device issues. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the October 4, 1999, Obstetrics and Gynecology Devices Panel of the 
Medical Devices Advisory Committee meeting. Because the agency believes 
there is some urgency to bring these issues to public discussion and 
qualified members of the Obstetrics and Gynecology Devices Panel of the 
Medical Devices Advisory Committee were available at this time, the 
Commissioner 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: September 17, 1999.
 Linda A. Suydam,
 Senior Associate Commissioner.
[FR Doc. 99-24711 Filed 9-17-99; 3:37 pm]
BILLING CODE 4160-01-F