[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57975-57977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16216]


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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.
------------------------------------------------------------------------
             Contact Person                      Committee/Panel
------------------------------------------------------------------------
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:
 [email protected]
------------------------------------------------------------------------
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: [email protected]
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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,
 [email protected]                 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:
 [email protected]
------------------------------------------------------------------------


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 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and 
nonvoting consumer representatives for the vacancies listed in table 2 
of this document.

                                Table 2.
------------------------------------------------------------------------
                                              Current and
     Committee/Panel Expertise Needed          Upcoming      Approximate
                                               Vacancies    Date  Needed
------------------------------------------------------------------------
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
========================================================================

[[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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
Gastroenterology-Urology Devices Panel--    1--Nonvoting    January 1,
 gastroenterologists, urologists, and        Consumer        2007
 nephrologists                               Representativ
                                             e
------------------------------------------------------------------------
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