Meetings: Medical Devices Advisory Committee et al.,

[Federal Register: January 14, 1998 (Volume 63, Number 9)]

[Notices]

[Page 2248-2249]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr14ja98-79]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Hematology and Pathology 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: Hematology and Pathology 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 January 28, 1998, 9:30 a.m. to 5 p.m.

Location: Parklawn Conference Center, conference rooms G and H, 5600 Fishers Lane, Rockville, MD.

Contact Person: Veronica J. Calvin, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1243, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12515. Please call the Information Line for up-to-date information on this meeting.

Agenda: The committee will discuss a premarket approval (PMA) supplement for a computerized automated Papanicolaou (PAP) smear reader that is indicated for use as a primary screener to select a subpopulation of smears that will be designated for no further review.

Procedure: On January 28, 1998, from 10:30 a.m. to 11:30 a.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 January 21, 1998. Oral presentations from the public will be

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scheduled between approximately 10:30 a.m. and 11:30 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 21, 1998, 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 January 28, 1998, from 9:30 a.m. to 10 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). FDA staff will present to the committee confidential information regarding present or future issues.

FDA regrets that it was unable to publish this notice 15 days prior to the January 28, 1998, Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee meeting. Because the agency believes there is some urgency to bring this issue to public discussion and qualified members of the Hematology and Pathology 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: January 8, 1998. Michael A. Friedman, Deputy Commissioner for Operations.

[FR Doc. 98-882Filed1-9-98; 2:15 pm]

BILLING CODE 4160-01-F