[Federal Register: October 2, 2006 (Volume 71, Number 190)]
[Notices]
[Page 57975-57977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc06-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting and Nonvoting Consumer
Representative Members on Public Advisory Committees and Panels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting and nonvoting consumer representatives to serve
on its advisory committees/panels that are under the purview of the
Office of the Commissioner, the Center for Drug Evaluation and
Research, the Center for Devices and Radiological Health, and the
National Center for Toxicological and Research (NCTR).
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on its
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: Nominations will be accepted for current vacancies and for those
that will or may occur through December 31, 2006. Because vacancies
occur on various dates throughout the year, there is no cutoff date for
the receipt of nominations.
ADDRESSES: Send all nominations and curricula vitae to the following
contact persons listed in table 1 of this document:
Table 1.
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Contact Person Committee/Panel
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Jan Johannessen, Office of the Pediatric Advisory Committee
Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane, rm.
14B-08, Rockville, MD 20857, 301-827-
6687, e-mail:
jan.johannessen@fda.hhs.gov
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Igor Cerny, Center for Drug Evaluation Arthritis Advisory Committee
and Research (HFD-21), Food and Drug
Administration, 5630 Fishers Lane,
Rockville, MD 20857, 301-827-6763, e-
mail: igor.cerny@fda.hhs.gov
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Collin L. Figueroa, Center for Devices Device Good Manufacturing
and Radiological Health (HFZ-342), Practice Advisory Committee
Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850
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Geretta Wood, Center for Devices and General Hospital and Personal
Radiological Health (HFZ-400), Food Use Devices Panel,
and Drug Administration, 9200 Gastroenterology-Urology
Corporate Blvd., rm. 110D, Rockville, Devices Panel, General and
MD 20850, 301-594-2022, x 133, e-mail: Plastic Surgery Devices Panel,
geretta.wood@fda.hhs.gov and the Anesthesiology and
Respiratory Therapy Devices
Panel of the Medical Devices
Advisory Committee
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Leonard M. Schechtman, National Center Science Advisory Board to NCTR
for Toxicological Research (HFT-10),
Food and Drug Administration, 5600
Fishers Lane, rm. 16-85, Rockville, MD
20857, 301-827-6696, e-mail:
leonard.schechtman@fda.hhs.gov
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FOR FURTHER GENERAL INFORMATION CONTACT: Doreen Brandes, Office of the
Commissioner (HF-4), Food and Drug Administration, 5600 Fishers Lane,
rm. 15A-12, Rockville, MD 20853, 301-827-1220, e-mail
doreen.brandes@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and
nonvoting consumer representatives for the vacancies listed in table 2
of this document.
Table 2.
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Current and
Committee/Panel Expertise Needed Upcoming Approximate
Vacancies Date Needed
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Pediatric Advisory Committee-- 1--Voting Immediately
knowledgeable in pediatric research, Consumer
pediatric subspecialties, statistics, and/ Representative
or biomedical ethics
========================================================================
Arthritis Advisory Committee-- 1--Voting Immediately
knowledgeable in the fields of arthritis, Consumer
rheumatology, orthopedics, epidemiology Representative
or statistics, analgesics, and related
specialties
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[[Page 57976]]
Certain Panels of the Medical Devices Advisory Committee
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Anesthesiology and Respiratory Therapy 1--Nonvoting Immediately
Devices Panel--anesthesiologists, Consumer
pulmonary medicine specialists, or other Representativ
experts who have specialized interests in e
ventilator support, pharmacology,
physiology, or the effects and
complications of anesthesia
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General Hospital and Personal Use Devices 1--Nonvoting Immediately
Panel--internists, pediatricians, Consumer
neonatologists, endocrinologists, Representativ
gerontologists, nurses, bio-medical e
engineers, or microbiologists/infection
control practioners or experts
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Gastroenterology-Urology Devices Panel-- 1--Nonvoting January 1,
gastroenterologists, urologists, and Consumer 2007
nephrologists Representativ
e
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General and Plastic Surgery Devices Panel-- 1--Nonvoting Immediately
surgeons (general, plastic, Consumer
reconstructive, pediatric, thoracic, Representativ
abdominal, pelvic, and endoscopic); e
dermatologists; experts in biomaterials,
lasers, wound healing, and quality of
life; and biostatisticians
========================================================================
Science Advisory Board to NCTR-- 1--Voting July 1, 2007
toxicologists, chemists, or public health Consumer
background as it relates to foods, drugs, Representative
etc.
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I. Functions
A. Pediatric Advisory Committee
The Committee advises and makes recommendations to the Commissioner
of Food and Drugs (the Commissioner) regarding the following topics:
(1) Pediatric research conducted under sections 351, 409I, and 499 of
the Public Health Service Act (42 U.S.C. 262, 284m, and 290b) and
sections 501, 502, 505, 505A, and 505B of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351, 352, 355, 355a, and 355c); (2)
identification of research priorities related to pediatric therapeutics
and the need for additional treatments of specific pediatric diseases
or conditions; (3) the ethics, design, and analysis of clinical trials
related to pediatric therapeutics; (4) pediatric labeling disputes as
specified in section 3 of the Best Pharmaceuticals for Children Act
(BPCA) (Public Law 107-109); (5) pediatric labeling changes as
specified in section 5 of the BPCA; (6) adverse event reports for drugs
granted pediatric exclusivity and any safety issues that may occur as
specified in section 17 of the BPCA; (7) any other pediatric issue or
pediatric labeling dispute involving FDA regulated products; (8)
research involving children as subjects as specified in 21 CFR 50.54;
and (9) any other matter involving pediatrics for which FDA has
regulatory responsibility.
B. Arthritis Advisory Committee
The committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of arthritis, rheumatism, and related diseases and
makes appropriate recommendations to the Commissioner.
C. Certain Panels of the Medical Devices Advisory Committee
The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the act envisions for device
advisory panels. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
the Commissioner regarding recommended classification or
reclassification of devices into one of three regulatory categories,
advises on any possible risks to health associated with the use of
devices, advises on formulation of product development protocols,
reviews premarket approval applications for medical devices, reviews
guidelines and guidance documents, recommends exemption of certain
devices from application of portions of the act, advises on the
necessity to ban a device, and responds to requests from the agency to
review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices. With the exception
of the Medical Devices Dispute Resolution Panel, each panel, according
to its specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
D. NCTR
The Science Advisory Board to the committee is responsible for
examining the biological effects of potentially toxic substances found
in the environment through fundamental investigations aimed at
understanding the mechanisms of actions of those substances in animals
and developing a better understanding of what these data in animals
mean for man.
II. Criteria for Members
Persons nominated for membership as consumer representatives on the
committees/panels must meet the following criteria: (1) Demonstrate
ties to consumer and community-based organizations, (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 representatives must be able to
represent the consumer perspective on issues and actions before the
advisory committee, serve as liaisons 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 the use of organizations representing
the public interest and consumer advocacy groups. The organizations
have the responsibility of recommending candidates of the agency's
selection.
[[Page 57977]]
IV. Nomination Procedures
All nominations must include a cover letter, a curriculum vitae or
resume (that includes the 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. Nominations will specify the advisory panel(s) or
committee(s) for which the nominee is recommended. Nominations will
include confirmation that the nominee is aware of the nomination, is
willing to serve as a member of the advisory committee if selected, and
appears to have no conflict of interest that would preclude membership.
Any interested person or organization may nominate one or more
qualified persons for membership as consumer representatives on one or
more of the advisory committees/panels. Self-nominations are also
accepted. Potential candidates will be required to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of a conflict of interest. The nomination should specify the
committee(s)/panel(s) 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: September 25, 2006.
Randall Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16216 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S