[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
