[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55909-55910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19077]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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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: [email protected].
SUPPLEMENTARY INFORMATION:
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://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
needs,
(2) Expand focus on patient and consumer protection,
(3) Allow for a more targeted approach to FDA's programs and
activities,
[[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://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
ADDRESSES).
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]
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