[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45582-45583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representatives 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 August 
29, 2011, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by August 
29, 2011.

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

FOR FURTHER INFORMATION CONTACT: Cicely Reese, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002. 301-
796-9001, 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

A. Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology

    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.

B. 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.

C. 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.

D. 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.

E. 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.

F. 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.

G. 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.

H. 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.

I. 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

[[Page 45583]]

Department of Health and Human Services and the Department of Justice 
with regard to safety, efficacy, and abuse potential, and 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.

J. 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.

K. 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.

L. Medical Imaging Drugs Advisory Committee

    The Committee reviews and evaluates 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. 
Elsewhere in this issue of the Federal Register, FDA is issuing a final 
rule adding the Medical Imaging Drugs Advisory Committee to the list of 
FDA standing advisory committees in 21 CFR 14.100, as well as a request 
for nominations of voting members and a request for nominations of 
voting and nonvoting consumer representative members.

M. 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.

N. 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.

O. 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.

P. 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.

Q. 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 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 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 the 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: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19065 Filed 7-28-11; 8:45 am]
BILLING CODE 4160-01-P