[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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