[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20233-20235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08620]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Request for Nomination for Industry Representatives and
Participation From Industry Organizations 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 FDA by May 15,
2015, (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by May 15, 2015.
ADDRESSES: All statements of interest from interested industry
organizations interested in participating in the selection process of
nonvoting industry representative nominations should be
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sent to Cicely Reese (see FOR FURTHER INFORMATION CONTACT). All
nominations for nonvoting industry representatives may be submitted
electronically by accessing the FDA Advisory Committee Membership
Nomination Portal at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.
Information about becoming a member of an FDA advisory committee can
also be obtained by visiting FDA's Web site http://www.fda.gov/AdvisoryCommittees/default.htm.
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, email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative to the following advisory committees:
I. CDER Advisory Committees
A. Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology: Reviews and evaluates scientific, clinical, and technical
issues related to the safety and effectiveness of drug products for use
in the treatment of a broad spectrum of human diseases.
B. Anesthetic and Analgesic Drug Products Advisory Committee
(formerly 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.
C. 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.
D. 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. (Terminated February
15, 2015).
E. 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.
F. Bone, Reproductive, and Urologic Drugs Advisory Committee
(formerly Advisory Committee for Reproductive Health Drugs): Reviews
and evaluates available data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of
osteoporosis and metabolic bone disease, obstetrics, gynecology,
urology, and related specialties.
G. Cardiovascular and Renal Drugs Advisory Committee: Reviews and
evaluates available data on 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: Reviews and
evaluates information on risk management, risk communication, and
quantitative evaluation of spontaneous reports for drugs for human use.
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 diseases.
L. 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.
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. Pharmacy Compounding Advisory Committee: Provides advice on
scientific, technical, and medical issues concerning drug compounding.
Q. 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.
R. 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 the 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. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this
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document (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 seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
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: April 9, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-08620 Filed 4-14-15; 8:45 am]
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