[Federal Register Volume 65, Number 218 (Thursday, November 9, 2000)]
[Notices]
[Page 67389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28694]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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: [email protected].

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