[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Notices]
[Page 36452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Technical Electronic Product Radiation Safety Standards 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). The meeting will 
be open to the public.
    Name of Committee: Technical Electronic Product Radiation Safety 
Standards Advisory Committee.
    General Function of the Committee: To provide advice on technical 
feasibility, reasonableness, and practicality of performance standards 
for electronic products to control the emission of radiation under 42 
U.S.C. 263f(f)(1)(A).
    Date and Time: The meeting will be held on June 21, 2000, 8:30 a.m. 
to 5 p.m., and June 22, 2000, 8:30 a.m. to 12 noon.
    Location: Quality Suites, Potomac II and III, 3 Research Ct., 
Rockville, MD.
    Contact Person: Orhan H. Suleiman, Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3332, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12399. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On June 21, 2000, the committee will discuss: (1) A 
reproposal for amendments to the performance standard for lasers (part 
1040 (21 CFR part 1040)), (2) amendments being considered for the 
sunlamps standard (part 1040), and hear (3) a presentation addressing 
nonmedical ionizing radiation security systems, (4) a presentation 
concerning computed tomography fluoroscopy (CT) and the Year 2000 
Nationwide Evaluation of X-Ray Trends Survey of CT. On June 22, 2000, 
the committee will hear: (1) An update on the reengineering of the 
radiological health program at the Center for Devices and Radiological 
Health, (2) a presentation on manufacturers' requirements and the 
medical device approval process, and (3) a presentation regarding how 
ultrasound diathermy (21 CFR part 1050) is regulated by FDA.
    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 June 16, 2000. 
Oral presentations from the public will be scheduled on June 21, 2000, 
between approximately 11 a.m. and 11:20 a.m., and between approximately 
1:45 p.m. and 2:05 p.m. Oral presentations from the public will be 
scheduled on June 22, 2000, between approximately 10:30 a.m. and 11 
a.m. Time allotted for each presentation may be limited. Those desiring 
to make formal oral presentations should notify the contact person 
before June 16, 2000, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the June 21, 2000, Technical Electronic Product Radiation Safety 
Standards Advisory Committee meeting. Because the agency believes there 
is some urgency to bring these issues to public discussion and 
qualified members of the Technical Electronic Product Radiation Safety 
Standards Advisory Committee were available at this time, the 
Commissioner of Food and Drugs 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: June 1, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-14369 Filed 6-7-00; 8:45 am]
BILLING CODE 4160-01-F