[Federal Register Volume 72, Number 110 (Friday, June 8, 2007)]
[Notices]
[Pages 31841-31842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11065]


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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 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 FDA by July 9, 
2007, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by July 9, 
2007.

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

FOR FURTHER INFORMATION CONTACT: Jayne Peterson, Advisors and 
Consultants Staff (HFD-21), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
[email protected].

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 committees existing prior to the 
passage of FDAMA, to keep within the spirit of FDAMA, the agency has 
added nonvoting industry representatives to CDER advisory committees 
identified in the following paragraphs.

I. CDER Advisory Committees

1. Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology (Formerly 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 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

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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 Safety and Risk Management Advisory Committee

    Advises the Commissioner of Food and Drugs (the Commissioner) 
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 FDA 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 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 
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 diseases.

15. 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.

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 (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed and 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 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 (see FOR 
FURTHER INFORMATION CONTACT) within 30 days (see DATES). 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 the 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 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-11065 Filed 6-7-07; 8:45 am]
BILLING CODE 4160-01-S