[Federal Register Volume 65, Number 159 (Wednesday, August 16, 2000)]
[Notices]
[Pages 49990-49991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Nonvoting Members of Industry 
Interests 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 nonvoting representatives of industry interests to 
serve on public advisory committees under the purview of the Center for 
Biologics Evaluation and Research (CBER) and the Center for Drug 
Evaluation and Research (CDER). Elsewhere in this issue of the Federal 
Register, FDA is publishing a notice announcing its intention of adding 
nonvoting industry representatives to certain public advisory 
committees.
    FDA has a special interest in ensuring that women, minority groups, 
individuals with disabilities, and small businesses are adequately 
represented on advisory committees, and therefore, encourages 
nominations for appropriately qualified candidates from these groups. 
Specifically, in this document, nominations for nonvoting 
representatives of industry interests are encouraged from the biologics 
and/or drug manufacturing industry.

DATES: Nominations should be received by September 15, 2000.

ADDRESSES: All nominations for membership should be submitted to 
William Freas or John M. Treacy (addresses below).

FOR FURTHER INFORMATION CONTACT:
    Regarding representatives of industry interests for CBER advisory 
committees: William Freas, Scientific Advisors and Consultants Staff 
(HFM-71), Food and Drug Administration, 5515 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-0314.
    Regarding representatives of industry interests for CDER advisory 
committees: John M. Treacy, Advisors and Consultants Staff (HFD-21), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7001.

SUPPLEMENTARY INFORMATION: Section 120 of the FDA Modernization Act 
(FDAMA) of 1997 (21 U.S.C. 355) requires that newly formed FDA advisory 
committees include representatives from the biologics and/or drug 
manufacturing industries. Although not required for existing 
committees, to keep within the spirit of FDAMA, the agency intends to 
add nonvoting industry representatives to all its CBER and CDER 
advisory committees identified below.

I. Functions

A. Advisory Committees Under the Purview of CBER

1. Allergenic Products Advisory Committee
    Reviews and evaluates available data concerning the safety, 
effectiveness, and adequacy of labeling of allergenic biological 
products or materials that are administered to humans for the 
diagnosis, prevention, or treatment of allergies and allergic disease.
2. Biological Response Modifiers Advisory Committee
    Reviews and evaluates available data relating to the safety, 
effectiveness, and appropriate use of biological response modifiers 
which are intended for use in the prevention and treatment of a broad 
spectrum of human diseases.
3. Blood Products Advisory Committee \1\
    Reviews and evaluates available data concerning the safety, 
effectiveness, and appropriate use of blood and products derived from 
blood and serum which are intended for use in the diagnosis, 
prevention, or treatment of human diseases.
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    \1\ Currently, there is a standing representative of industry 
interests on this advisory committee.
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4. Transmissible Spongiform Encephalopathies Advisory Committee
    Reviews and evaluates available data concerning the safety of 
products which may be at risk for transmission of spongiform 
encephalopathies having an impact on the public health.
5. Vaccines and Related Biological Products Advisory Committee
    Reviews and evaluates available data concerning the safety, 
effectiveness, and appropriate use of vaccines and related biological 
products intended for use in the diagnosis, prevention, or treatment of 
human diseases.

B. Advisory Committees Under the Purview of CDER

1. Advisory Committee for Pharmaceutical Science
    Advises on scientific and technical issues concerning the safety 
and effectiveness of human generic drug products for use in the 
treatment of a broad spectrum of human diseases.
2. Advisory Committee for Reproductive Health Drugs
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in obstetrics, gynecology, and contraception.
3. Anesthetic and Life Support Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in anesthesiology and surgery.
4. Anti-Infective Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness

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of marketed and investigational human drug products for use in the 
treatment of infectious diseases and disorders.
5. Antiviral Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of acquired immune deficiency syndrome (AIDS), 
HIV-related illnesses, and other viral, fungal, and mycobacterial 
infections.
6. Arthritis Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of arthritis, rheumatism, and related diseases.
7. Cardiovascular and Renal Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cardiovascular and renal disorders.
8. Dermatologic and Ophthalmic Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of dermatologic and ophthalmic disorders.
9. Drug Abuse Advisory Committee
    Advises the Commissioner of Food and Drugs regarding the scientific 
and medical evaluation of all information gathered by the Department of 
Health and Human Services and the Department of Justice with regard to 
safety, efficacy, and abuse potential of drugs or other substances and 
recommends actions to be taken by the Food and Drug Administration with 
regard to marketing, investigation, and control of such drugs or other 
substances.
10. Endocrinologic and Metabolic Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of endocrine and metabolic disorders.
11. Gastrointestinal Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of gastrointestinal disorders.
12. Medical Imaging Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in diagnostic and therapeutic procedures using radioactive 
pharmaceuticals and contrast media used in diagnostic radiology.
13. Nonprescription Drugs Advisory Committee \1\
    Reviews and evaluates available data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug products 
for use in the treatment of a broad spectrum of human symptoms and 
diseases.
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    \1\ Currently, there is a standing representative of industry 
interests on this advisory committee.
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14. Oncologic Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cancer.
15. Peripheral and Central Nervous System Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of neurologic disease.
16. Pharmacy Compounding Advisory Committee \1\
    Provides advice on scientific, technical, and medical issues 
concerning drug compounding by licensed practitioners.
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    \1\ Currently, there is a standing representative of industry 
interests on this advisory committee.
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17. Psychopharmacologic Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the practice of psychiatry and related fields.
18. Pulmonary-Allergy Drugs Advisory Committee
    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of pulmonary disease and diseases with allergic 
and/or immunologic mechanisms.

II. Nomination Procedure

    Any organization in the biologics and/or drug manufacturing 
industry wishing to participate in the selection of an appropriate 
industry representative of a particular advisory committee identified 
above, may nominate one or more qualified persons. Persons who nominate 
themselves as representatives of industry interests for a certain 
advisory committee may not participate in the overall selection 
process.
    Nominees should be full-time employees of firms that manufacture 
products regulated by the agency or of consulting firms that represent 
biologics and/or drug manufacturers. Nomination packages should include 
a cover letter indicating the committee of interest and complete 
curriculum vitae of each nominee. The term of office is up to 4 years.

III. Selection Procedure

    A letter will be sent to each party that has sent a nomination 
package to FDA for a particular advisory committee. The letter will 
provide the complete list of all nominees. It is the responsibility of 
each nominating organization to consult with one another to select a 
single member to represent the industry interests for the respective 
advisory committee. This must be completed within 60 calendar days upon 
receipt of the letter. If no individual is selected within the 60 
calendar days, the Commissioner of Food and Drugs will select a 
nonvoting member to represent the industry interests for the respective 
advisory committee.
    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 7, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-20721 Filed 8-15-00; 8:45 am]
BILLING CODE 4160-01-F