[Federal Register Volume 68, Number 108 (Thursday, June 5, 2003)]
[Notices]
[Pages 33718-33719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14215]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Notification From Industry Organizations Interested 
in Participating in Selection Process for Nonvoting Industry 
Representatives on Public Advisory Committees and Request for 
Nominations for Nonvoting Industry Representatives 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 that any 
industry organizations interested in participating in the selection of 
nonvoting industry representatives to serve on its public advisory 
committees for the Center for Drug Evaluation and Research (CDER) 
notify FDA in writing. FDA is also requesting nominations for nonvoting 
industry representatives to serve on CDER's public advisory committees. 
A nominee may either be self-nominated or nominated by an organization 
to serve as a nonvoting industry representative. Nominations will be 
accepted for current vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to the FDA by July 
7, 2003 for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by July 7, 
2003.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Igor Cerny (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Igor Cerny, 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 of 
1997 (FDAMA) (21 U.S.C. 355) requires that newly formed FDA advisory 
committees include representatives from the 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 CDER advisory committees identified in 
the following paragraphs.

I. CDER Advisory Committees

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.

[[Page 33719]]

4. Anti-Infective 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 infectious diseases and disorders.

5. Anti-Viral 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 and 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 of dermatologic and 
ophthalmic disorders.

9. Drug Safety and Risk Management Advisory Committee (formerly 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 the regard 
to safety, efficacy, and abuse potential, risk management, risk 
communication and quantitative evaluation of spontaneous reports, 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. Nonprescription Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of the over-the-counter (nonprescription) human drug 
products for use in the treatment of a broad spectrum of human symptoms 
and diseases.

13. Oncologic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
the use in the treatment of cancer.

14. 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.

15. Psychopharmacologic Drug 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.

16. 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. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document. Within the subsequent 15 days, FDA will send a letter to 
each organization that has expressed an interest, attaching a complete 
list of all such organizations; and a list of all nominees along with 
their current resumes. The letter will also state that it is the 
responsibility of the interested organizations to confer with one 
another and to select a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for a particular committee. The interested organizations are 
not bound by the list of nominees in selecting a candidate. However, if 
no individual is selected within 60 days, the Commissioner of Food and 
Drugs will select the nonvoting member to represent industry interests.

III. Application Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. A current curriculum vitae and the name of the 
committee of interest should be sent to the FDA contact person. FDA 
will forward all nominations to the organizations expressing interest 
in participating in the selection process for that committee. (Persons 
who nominate themselves as nonvoting industry representatives will not 
participate in the selection process.)
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its 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 drug 
manufacturing industry.
    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: May 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-14215 Filed 6-4-03; 8:45 am]
BILLING CODE 4160-01-S