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, 45582-45583 [2011-19065]
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Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
TABLE 2—Continued
Contact person
Committee/panel
Bryan Emery, Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, Phone: 301–827–1277, Fax: 301–827–0294, E-mail:
bryan.emery@fda.hhs.gov.
Gail Dapolito, Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852–1448, Phone: 301–827–1289, Fax: 301–827–0294, E-mail:
gail.dapolito@fda.hhs.gov.
Donald Jehn, Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, Phone: 301–827–1293, Fax: 301–827–0294, E-mail:
donald.jehn@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, White Oak
Bldg. 66, rm. 1613, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, Phone: 301–796–
6639, E-mail: Shanika.Craig@fda.hhs.gov.
Blood Products and Transmissible
Spongiform Encephalopathies.
Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–19066 Filed 7–28–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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16:17 Jul 28, 2011
Jkt 223001
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:
Cicely.Reese@fda.hhs.gov.
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
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Cellular Tissue and Gene Therapy.
Vaccines and Related Biological Products.
Radiological Devices Panel.
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
E:\FR\FM\29JYN1.SGM
29JYN1
Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
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.
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.
J. Endocrinologic and Metabolic Drugs
Advisory Committee
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.
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.
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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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,
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[FR Doc. 2011–19065 Filed 7–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date and Time: September 1, 2011,
1 p.m. to 5 p.m. EDT, September 2,
2011, 9 a.m. to 12 p.m. EDT.
Place: Parklawn Building (and via
audio conference call), Conference
Room 10–65, 5600 Fishers Lane,
Rockville, MD 20857.
The ACCV will meet on Thursday,
September 1 from 1 pm to 5 pm (EDT)
and on Friday, September 2 from 9 a.m.
to 12 p.m. (EDT). The public can join
the meeting via audio conference call by
dialing 1–800–369–3104 on September
1 and 2 and providing the following
information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the
September meeting will include, but are
not limited to: updates from the
Division of Vaccine Injury
Compensation (DVIC), Department of
Justice (DOJ), National Vaccine Program
Office (NVPO), Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health) and
Center for Biologics, Evaluation and
Research (Food and Drug
Administration). A draft agenda and
additional meeting materials will be
posted on the ACCV Web site (https://
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]]>Agencies
[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45582-45583]
From the Federal Register Online via the Government Printing 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: Cicely.Reese@fda.hhs.gov.
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
