[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Notices]
[Page 48427]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Consumer Representative
Members on Public Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting consumer representatives to serve on the
National Mammography Quality Assurance Advisory Committee (NMQAAC) in
the Center for Devices and Radiological Health (CDRH). FDA has a
special interest in ensuring that women, minority groups, and
individuals with disabilities are adequately represented on advisory
committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: Nominations will be accepted through January 31, 2006.
ADDRESSES: All nominations should be sent to the contact person listed
in the FOR FURTHER INFORMATION CONTACT section of this document.
FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Advisory Committee
Oversight and Management Staff (HF-4), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, e-mail:
Michael.Ortwerth@fda.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
consumer representatives to serve on the NMQAAC.
I. Functions of NMQAAC
The functions of the committee are to advise FDA on the following
topics: (1) Developing appropriate quality standards and regulations
for mammography facilities; (2) developing appropriate standards and
regulations for bodies accrediting mammography facilities under this
program; (3) developing regulations with respect to sanctions; (4)
developing procedures for monitoring compliance with standards; (5)
establishing a mechanism to investigate consumer complaints; (6)
reporting new developments concerning breast imaging which should be
considered in the oversight of mammography facilities; (7) determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas;
(8) determining whether there will exist a sufficient number of medical
physicists after October 1, 1999; and (9) determining the costs and
benefits of compliance with these requirements.
II. Criteria for Members
Persons nominated for membership on the committee as a consumer
representative must meet the following criteria: (1) Must be from among
national breast cancer or consumer health organization with expertise
in mammography, (2) be able to analyze technical data, (3) understand
research design, (4) discuss benefits and risks, and (5) evaluate the
safety and efficacy of products under review. The consumer
representative must be able to represent the consumer perspective on
issues and actions before the advisory committee; serve as a liaison
between the committee and interested consumers, associations,
coalitions, and consumer organizations; and facilitate dialogue with
the advisory committees on scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include use of organizations representing the
public interest and consumer advocacy groups. The organizations have
the responsibility of recommending candidates of the agency's
selection.
IV. Nomination Procedures
All nominations must include a cover letter, a curriculum vita or
resume (which should include nominee's office address, telephone
number, and e-mail address), and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
Any interested person or organization may nominate one or more
qualified persons for membership on the NMQAAC to represent consumer
interests. Self-nominations are also accepted. Nominations shall
include complete curriculum vitae of each nominee, current business
address and telephone number, and shall state that the nominee is aware
of the nomination, is willing to serve as a member, and appears to have
no conflict of interest that would preclude membership. FDA will ask
the potential candidates to provide detailed information concerning
such matters as financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflict
of interest. The term of office is up to 4 years, depending on the
appointment date.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: August 10, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16330 Filed 8-16-05; 8:45 am]
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