[Federal Register: September 23, 2005 (Volume 70, Number 184)]
[Page 55909-55910]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0375]

Stakeholder Meeting on the Implementation of A New Direction for 
the Food and Drug Administration's Radiological Health Program; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: A New Direction for FDA's Radiological Health 
Program. The topics of discussion are the agency's activities to 
implement its radiological health program (the program).

DATES: The public meeting will be held on October 31 and November 1, 
2005, from 8:30 a.m. to 5 p.m. The agency is requiring registration by 
October 17, 2005.
    All parties wishing to make a presentation or to speak on an issue 
specific to the topics of the meeting should indicate their intent, the 
topics to be addressed, and provide an abstract of their comments to be 
presented by October 17, 2005. FDA will limit the time for 
presentations to the public comment periods; the number of parties 
requesting to participate will determine the amount of time allotted to 
each presentation.

ADDRESSES: The public meeting will be held at the Hilton Washington DC 
North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Submit written requests to make an oral presentation to Kaye 
Chesemore (see FOR FURTHER INFORMATION CONTACT). Include your name, 
title, firm or organization name (if representing such), address, 
telephone, and fax number with your request. All requests and 
presentation materials should include the docket number found in 
brackets in the heading of this document. Submit all requests for 
suggestions and recommendations to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kaye Chesemore, Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3309, FAX: 301-594-3306, e-
mail: kfc@cdrh.fda.gov.


I. Background

    In May 2004, FDA's Center for Devices and Radiological Health 
(CDRH) began an effort to examine how the program could best adapt to 
current public health needs. This effort culminated in a report that 
outlines key elements of the program and states how the new direction 
will impact the most pressing public health problems in the 
radiological health area. A copy of the report is available on CDRH's 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/radhlth/initiative.html.

    The agency has determined that it must shift the focus of resources 
to the products and procedures with the highest risks to the public, 
including those that affect the greatest number of people or present 
the potential for the greatest harm.
    The benefits that FDA expects from this focus are that the new 
program will:
    (1) Align CDRH efforts with current and evolving public health 
    (2) Expand focus on patient and consumer protection,
    (3) Allow for a more targeted approach to FDA's programs and 

[[Page 55910]]

    (4) Increase information dissemination and training, and
    (5) Improve coordination across the radiological health community.

II. Agenda

    On October 31, 2005, FDA is providing the opportunity for a number 
of stakeholder organizations to discuss how they can assist FDA in 
implementing the program and in addressing important public health 
problems. FDA and its stakeholders will discuss the following aspects 
of the radiological health plan overview:
     Standards--Discussion will consider the following topics: 
Increased reliance by FDA on consensus radiation safety performance 
standards, the role of national and international standards, and the 
role of State regulations in assuring product safety and proper use.
     Monitoring the Use of Radiation--Discussion will consider 
the following topics: The shift of CDRH's focus from products to users, 
patients, and consumers; adverse event reporting; State program roles 
in ensuring appropriate use of radiation; facility quality assurance 
programs; and the establishment of a voluntary patient radiation dose 
reporting system for diagnostic imaging procedures that use ionizing 
radiation. This system could be used to monitor national exposure 
trends and provide a basis for establishing diagnostic reference levels 
of patient dose for use in facility quality improvement programs.
     Monitoring the Industry--Discussion will consider the 
following topics: The shift of FDA emphasis from testing products, to 
inspecting manufacturers to assure quality manufacturing and products; 
the reduction of reporting requirements; and the development of 
electronic reporting methods.
     Education--Discussion will consider education and training 
for manufacturers, regulators, and users.
    On November 1, 2005, FDA will hold concurrent discussion sessions 
throughout the day on the Standards, Monitoring, and Education topics 
to provide further opportunity for stakeholder comment and discussion.
    FDA will provide an opportunity for comment during the public 
comment period for individuals and/or organizations on October 31, 
2005. In addition, the agency will provide an opportunity to present 
individual viewpoints during the concurrent discussion sessions on 
November 1, 2005. FDA reserves the right to limit the time of speakers 
during the public comment periods.

III. Registration

    Participants must register for the meeting by October 17, 2005. 
Acceptance will be on a first-come, first-served basis. There will be 
no onsite registration and unregistered participants will not be added 
to the program. Please register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/120303.html.
 Persons without Internet access may register for 

the onsite meeting by calling 301-594-3309 by October 17, 2005.
    If you need special accommodations due to a disability, please fax 
information regarding those needs to Kaye Chesemore at 301-594-3306, at 
least 7 days in advance of the meeting.

IV. Request for Suggestions, Recommendations, and Materials

    FDA is particularly interested in receiving suggestions from 
stakeholders related to the topics listed previously in this document. 
Send suggestions or recommendations to the Division of Dockets 
Management (see ADDRESSES).
    FDA will place an additional copy of any material it receives in 
the docket for this document (2005N-0375). Suggestions, 
recommendations, and materials may be seen at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday (see 

V. Transcripts

    Following the meeting, transcripts will be available for review at 
the Division of Dockets Management (see ADDRESSES).

    Dated: September 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19077 Filed 9-20-05; 3:31 pm]