[Federal Register: May 2, 2002 (Volume 67, Number 85)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Technical Electronic Products Radiation Safety Standards
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
SUMMARY: 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 Products Radiation Safety
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 21
Date and Time: The meeting will be held on May 22, 2002, from 8:30
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A and B,
620 Perry Pkwy., Gaithersburg, 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: The committee will hear an informal review of ongoing
activities associated with electronic products. Following the overview,
FDA will discuss its concern about radiation doses associated with x-
ray computed tomography (CT), and its current thinking about amending
the U.S. performance standard for x-ray CT imaging procedures.
Specifically FDA will address possible requirements for: (1) Definition
and standardization of CT terminology; (2) display of an index of
patient radiation dose that could be automatically recorded within a
facility quality assurance program; (3) automatic exposure control
through modulation of x-ray tube output according to patient
dimensions; and (4) limitation of the x-ray field size to that needed
for image formation. In the afternoon, FDA will discuss proposed
amendments to the U.S. performance standard for sunlamp products and
certain initiatives of international standards organizations concerning
sunlamp products. In the final session, FDA will be considering
mandatory standards for x-ray security screening systems; FDA will
discuss public health considerations regarding these systems that use
Background information on the discussion topics will be posted
under the Technical Electronic Products Radiation Safety Standards
Committee (TEPRSSC) Dockets Management Branch Web site at http://
www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2002 and
scroll down to TEPRSSC.)
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 May 10, 2002.
On May 22, 2002, oral presentations from the public will be scheduled
between approximately 9:45 a.m. and 10:15 a.m., and between 3:15 p.m.
and 4 p.m. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before May 10, 2002, 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.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, 301-594-1283, ext. 113, at least 7 days in
advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 24, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent
[FR Doc. 02-10797 Filed 5-1-02; 8:45 am]
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