[Federal Register: November 9, 2000 (Volume 65, Number 218)]
[Notices]
[Page 67389]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no00-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Radiological Health Reengineering; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA), Center for Devices and
Radiological Health (CDRH), is announcing a public workshop intended to
gather information regarding its radiological health programs. The
topic to be discussed is reengineering of electronic product radiation
control processes with attention to prioritization, information
exchange on new technology and public health issues, standards, and
product testing.
Date and Time: The public workshop will be held on November 15 and
16, 2000, 8:30 a.m. to 4:30 p.m.
Location: The public workshop will be held at the Holiday Inn, Two
Montgomery Village Ave., Gaithersburg, MD.
Contact: Joanne Barron, Center for Devices and Radiological Health
(HFZ-342), Food and Drug Administration, 2094 Gaither Rd., Rockville,
MD 20850, 301-594-4654, FAX 301-594-4672, e-mail: jxb@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION: At the workshop, FDA would like to hear
whether certain radiological health programs and processes would
benefit from changes and, if so, which changes would be most effective.
The purpose of reengineering the radiological health processes is to
make the best use of FDA expertise and resources in performing
activities that best fulfill FDA's role in radiation protection. While
reengineering provides opportunities to shift priorities, FDA also
would like to establish partnerships with others who have a role in
radiation protection from electronic products.
During the past 2 years, FDA obtained comments from stakeholders on
improvements needed in the radiological health program. Comments
received suggested four areas for improvement: (1) Prioritization, (2)
information exchange, (3) standards, and (4) product testing. Several
FDA teams considered the ideas and now would like public participation
in revising the processes. CDRH must prioritize the use of limited
resources to effectively and efficiently address these public health
concerns. To that end, FDA issues recommendations and guidance and
develops and enforces regulatory performance standards for radiation-
emitting electronic products to minimize exposures to unnecessary
radiation. FDA develops test methods and tests electronic products to
ensure conformance to standards, identify nationwide exposure trends,
and provide a basis for analyzing new technologies. FDA and
stakeholders need information on product emissions, exposures, use, and
health effects as a basis for decisions and actions. CDRH expects this
public workshop to benefit the radiological health reengineering effort
by developing practical solutions to the following questions:
1. How should CDRH choose and implement specific radiological
health activities and set priorities?
2. How can CDRH optimize and improve the development/administration
of electronic product radiation standards, recommendations, and
guidances?
3. How can CDRH optimize and improve the evaluation of radiation
emissions and exposures from electronic products?
4. How can CDRH better communicate and network with partners
(States, other Federal agencies, industry, health professionals,
standards organizations, etc.) regarding its radiological health
program?
FDA will conduct concurrent breakout sessions on each of the four
topics during this public workshop.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, fax
number, and e-mail address), and written material and requests to make
oral presentations to Diarra Hall at Laurel Consulting Group, 14504
Greenview Dr., suite 500, Laurel, MD 20708, 301-490-5500, FAX 301-490-
7260 by November 13, 2000; or complete the registration form that is
available at http://www.fda.gov/cdrh/reenging/radhlth/index.html.
If you need special accommodations due to a disability, please
contact Diarra Hall in advance.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page.
Dated: November 2, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-28694 Filed 11-8-00; 8:45 am]
BILLING CODE 4160-01-F