Request for Nomination for Industry Representatives and Participation From Industry Organizations on Public Advisory Committees, 20233-20235 [2015-08620]
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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
Dated: March 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
www.aaps.org/Meetings_and_
Professional_Development/Conference_
Mini_Sites/AAPS_WS_Transporters15/
Register/. The cost of registration is as
follows:
[FR Doc. 2015–08618 Filed 4–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Workshop on Drug Transporters
in Absorption, Distribution,
Metabolism, and Excretion: From the
Bench to the Bedside
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Drug Transporters in
Absorption, Distribution, Metabolism,
and Excretion (ADME): From the Bench
to the Bedside.’’ The public workshop is
an American Association of
Pharmaceutical Scientists/International
Transporter Consortium (AAPS/ITC)
Joint Workshop, cosponsored with
AAPS, the American Society for Clinical
Pharmacology and Therapeutics, and
the European Federation for
Pharmaceutical Sciences. The goals of
this public workshop are to provide an
opportunity for scientists in academia,
industry, and regulatory agencies to
exchange ideas about the cutting edge
science in transporters, and to facilitate
and enhance translational applications
of new development in transporter
research in drug development and
regulatory review of new therapeutics.
Date and Time: The public workshop
will be held on April 20, 2015, from
8:15 a.m. to 7 p.m.; April 21, 2015, from
8 a.m. to 6:30 p.m.; and April 22, 2015,
from 8 a.m. to 3:45 p.m.
Location: The public workshop will
be held at the Renaissance Baltimore
Harborplace Hotel, 202 East Pratt St.,
Baltimore, MD 21202. The hotel’s phone
number is 410–547–1200.
Contacts: FDA: Lei Zhang, Food and
Drug Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3196,
Silver Spring, MD 20993, 301–796–
1635, email: leik.zhang@fda.hhs.gov.
AAPS: For questions related to this
event, please contact AAPS at
registration@aaps.org.
Registration: Workshop information
and the registration link are posted at
the AAPS meetings and professional
development conference site. To register
for the workshop, please visit https://
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discussion of cutting edge science in
transporters among scientists from
academia, industry, and regulatory
agencies.
• To develop a mutual understanding
on what needs to be done in transporter
AAPS Member ..........................
$1,815 research and how to translate
Nonmember ..............................
2,190 knowledge obtained from the bench to
Government ..............................
675 bedside.
Academic ..................................
880
• To facilitate and enhance
Student .....................................
110 translational applications of new
development in transporter research in
The registration fee will be waived for drug development and regulatory
50 FDA employees. If you need special
review of new therapeutics.
accommodations because of a disability,
Dated: April 8, 2015.
please contact AAPS at registration@
Leslie Kux,
aaps.org. Onsite registration on the day
Associate Commissioner for Policy.
of the workshop will be available.
Additional Information About the
[FR Doc. 2015–08614 Filed 4–14–15; 8:45 am]
Workshop: The workshop agenda and
BILLING CODE 4164–01–P
additional background materials will be
accessible at https://www.fda.gov/Drugs/
DEPARTMENT OF HEALTH AND
NewsEvents/ucm439157.htm to all
HUMAN SERVICES
registrants.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
[Docket No. FDA–2015–N–0001]
Transporters serve an important role
in the ADME of drugs, and in turn could
affect their safety or efficacy. The
AAPS/ITC joint transporter workshop in
2015 aims to continue on the success of
preceding AAPS workshops on Drug
Transporters meetings (2003, 2005,
2007, 2009, 2011, 2013) and ITC
transporter workshops (2008 and 2012)
to provide an opportunity for scientists
in academia, industry, and regulatory
agencies to exchange ideas about the
cutting-edge science. Key areas of focus
will include the following:
• Transporter tools of the future (e.g.,
organs-on-a-chip, humanized mouse
models, and transporter imaging);
• Interplay of drug metabolism and
transporters;
• ‘‘State of the art’’ sessions on:
Æ Emerging transporters,
Æ Endogenous biomarkers to assess
transporter-mediated drug efficacy and
toxicity or to predict drug-drug
interactions, and
Æ Quantitative transporter proteomics
in translational drug metabolism and
pharmacokinetics;
• ‘‘Hot Topics’’ in the translation of
transporter data to the clinic;
• Prospective transporter substrate
modeling; and
• Review of comments related to
transporters following recent guidances
issued from the regulatory agencies,
including FDA, European Medicines
Agency, and Pharmaceuticals and
Medical Devices Agency (Japan).
II. Goals and Objectives
• To provide a forum for open
interchange, dissemination, and
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Request for Nomination for Industry
Representatives and Participation
From Industry Organizations 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
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
SUMMARY:
E:\FR\FM\15APN1.SGM
15APN1
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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
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 https://
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:
Cicely.Reese@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative to the following
advisory committees:
tkelley on DSK3SPTVN1PROD with NOTICES
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
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17:29 Apr 14, 2015
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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
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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
E:\FR\FM\15APN1.SGM
15APN1
Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
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.
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Patrick Archdeacon, Food and Drug
Administration, Bldg. 51 Rm.6314,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–3952;
or Vieda Hubbard, Division of
Acquisition Support and Grants (HFA–
500), Food and Drug Administration,
5630 Fishers Lane, Rockville, MD
20857, 240–402–7588.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at: https://
www.grants.gov/.
SUPPLEMENTARY INFORMATION:
Dated: April 9, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
I. Funding Opportunity Description
[FR Doc. 2015–08620 Filed 4–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1083]
Innovations in Medical Evidence
Development and SurveillanceMethods Research Agenda
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of Center for Drug Evaluation
and Research (CDER). The goal of the
CDER is to support the development of
appropriate methodologies to conduct
medical product safety surveillance in
large electronic databases. Innovations
in Medical Evidence Development and
Surveillance (IMEDS)-Methods is a
program within the Reagan-Udall
Foundation that supports FDA’s
scientific mission of serving public
health needs by initiating and
facilitating research into the methods of
safety evaluation in large databases.
DATES: 1. The application due date is
June 15, 2015.
2. The anticipated start date is July 15,
2015.
3. The opening date is April 13, 2015.
4. The expiration date is June 16,
2015.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Submit the electronic
application to: https://www.grants.gov.
For more information, see section III of
ADDRESSES:
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RFA–FD–15–010 93.103
A. Background
Section 905 of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) mandates FDA to
develop an enhanced ability to monitor
the safety of drugs after these products
reach the market. In response to this
mandate, FDA launched its Sentinel
Initiative, a long-term program designed
to build and implement an electronic
system for monitoring the safety of
medical products in the post market
setting. FDA has already created
significant infrastructure on which to
operate such a system: Through its
Mini-Sentinel pilot, a distributed
database with access to more than 150
million patient records has been created
(the Sentinel Distributed Database). In
order to optimally leverage these data,
however, new analytic methodologies
will be required. IMEDS-Methods is a
program within the Reagan-Udall
Foundation that supports FDA’s
scientific mission of serving public
health needs by initiating and
facilitating research into the methods of
safety evaluation in large databases.
IMEDS-Methods aims to improve the
tools for conducting post-marketing
safety surveillance using automated
healthcare data and to foster their
adoption.
B. Research Objectives
IMEDS plans to conduct methods
research in five core areas: (1)
Addressing bias in estimates from
observational studies; (2) better
understanding uses and limitations of
the data; (3) applying lessons learned
from earlier IMEDS projects to FDA
surveillance activities; (4) expanding the
surveillance question to continuous
risk/benefit assessment; and (5)
continuing to support qualified
investigators in industry, government,
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20235
and academic settings by providing
access to de-identified electronic
healthcare data and computing
resources through the IMEDS Research
Laboratory.
C. Eligibility Information
Eligibility is limited to the ReaganUdall Foundation. The Reagan-Udall
Foundation has established the IMEDSMethods program, which is uniquely
positioned to develop the new
methodologies required for FDA to
conduct effective active post market
safety surveillance of medical products
using large electronic health care data.
The IMEDS organization has developed
a network of statisticians,
epidemiologists, data scientists, and
clinicians who have experience
operating in both the IMEDS research
laboratory and also familiarity with the
Sentinel Distributed Database. In
addition, through the Reagan-Udall
Foundation public-private partnership,
the IMEDS-Methods program has a
unique ability to convene FDA, patients,
academics, government, and industry so
that the findings and tools developed
through its research agenda will be
promulgated and adopted.
II. Award Information/Funds Available
A. Award Amount
FDA/CDER intends to fund up to
$1,000,000 in fiscal year 2015 in
support of this program project. It is
anticipated that only one award will be
made, not to exceed $1,000,000 (direct
plus indirect) for total costs.
B. Length of Support
There is a one year period of
performance beginning on June 15, 2015
or the date of award.
III. Electronic Application,
Registration, and Submission
Only one electronic application will
be accepted. To submit an electronic
application in response to this FOA, the
applicant should first review the full
announcement located at https://
www.grants.gov/. (FDA has verified the
Web site addresses throughout this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
For the electronically submitted
application, the following steps are
required.
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Obtain Username &
Password
E:\FR\FM\15APN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20233-20235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08620]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 20234]]
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 https://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: Cicely.Reese@fda.hhs.gov.
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
[[Page 20235]]
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]
BILLING CODE 4164-01-P
