00-28694. 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 [phone], e-mail: [e-mail].

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 [phone] 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.