Food and Drug Administration, HHS.
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.
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.
Send all nominations and curricula vitae to the following contact persons listed in table 1 of this document:
|Jan Johannessen, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, rm. 14B-08, Rockville, MD 20857, 301-827-6687, e-mail: firstname.lastname@example.org||Pediatric Advisory Committee|
|Igor Cerny, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-827-6763, e-mail: email@example.com||Arthritis Advisory Committee|
|Collin L. Figueroa, Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850||Device Good Manufacturing Practice Advisory Committee|
|Geretta Wood, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., rm. 110D, Rockville, MD 20850, 301-594-2022, x 133, e-mail: firstname.lastname@example.org||General Hospital and Personal Use Devices Panel, Gastroenterology-Urology Devices Panel, General and Plastic Surgery Devices Panel, and the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee|
|Leonard M. Schechtman, National Center for Toxicological Research (HFT-10), Food and Drug Administration, 5600 Fishers Lane, rm. 16-85, Rockville, MD 20857, 301-827-6696, e-mail: email@example.com||Science Advisory Board to NCTR|
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 firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
FDA is requesting nominations for voting and nonvoting consumer representatives for the vacancies listed in table 2 of this document.
|Committee/Panel Expertise Needed||Current and Upcoming Vacancies||Approximate Date Needed|
|Pediatric Advisory Committee—knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics||1—Voting Consumer Representative||Immediately|
|Arthritis Advisory Committee—knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties||1—Voting Consumer Representative||Immediately|
|Start Printed Page 57976|
|Certain Panels of the Medical Devices Advisory Committee|
|Anesthesiology and Respiratory Therapy Devices Panel—anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia||1—Nonvoting Consumer Representative||Immediately|
|General Hospital and Personal Use Devices Panel—internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, bio-medical engineers, or microbiologists/infection control practioners or experts||1—Nonvoting Consumer Representative||Immediately|
|Gastroenterology-Urology Devices Panel—gastroenterologists, urologists, and nephrologists||1—Nonvoting Consumer Representative||January 1, 2007|
|General and Plastic Surgery Devices Panel—surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians||1—Nonvoting Consumer Representative||Immediately|
|Science Advisory Board to NCTR—toxicologists, chemists, or public health background as it relates to foods, drugs, etc.||1—Voting Consumer Representative||July 1, 2007|
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.
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.Start Printed 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.Start Signature
Dated: September 25, 2006.
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16216 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S