Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs Advisory Committee, 45578-45579 [2011-19067]
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Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
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quality of clinical trials; and enhance
the safety of trial participants. Senior
FDA staff will communicate directly
with clinical investigators on issues of
greatest importance for successful
clinical research.
Date and Time: The training course
will be held on November 7 and 8, 2011,
from 8 a.m. to 5 p.m., and on November
9, 2011, from 8 a.m. to 3:30 p.m.
Location: The course will be held at
the National Labor College, 10000 New
Hampshire Ave., Silver Spring, MD
20903–0002.
Contact Person: Leonard Sacks, Office
of Critical Path Programs, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4174,
Silver Spring, MD 20993, 301–796–
8502.
Registration: Register by October 21,
2011. The registration fee is $400 per
person. The fee includes course
materials and onsite lunch. Early
registration is recommended because
seating is limited. There will be no
onsite registration.
Register online for the training course
at the registration/information Web site
at https://www.trialstransformation.org/
fda-clinical-investigator-training-course
or by FAX to 919–660–1769. An e-mail
will be sent confirming your
registration.
Attendees are responsible for their
own accommodations. A block of rooms
has been reserved under ‘‘FDA Clinical
Investigator Course’’ at the National
Labor College at a reduced conference
rate. Reservations can be made at
https://www.supportnlc.org/
Room_Reservations.html or by calling
301–431–6400. FDA has verified the
Web site address, but is not responsible
for subsequent changes to the Web site
after this document publishes in the
Federal Register.
Registration materials, payment
procedures, accommodation
information, and a detailed description
of the course can be found at https://
www.trialstransformation.org/fdaclinical-investigator-training-course.
If you need special accommodations
due to a disability, please contact
Leonard Sacks at least 7 days in
advance. Persons attending the course
are advised that FDA is not responsible
for providing access to electrical outlets.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical trial investigators play a
critical role in the development of
medical products. They bear the
responsibility for ensuring the safe and
ethical treatment of study subjects and
for acquiring adequate and reliable data
to support regulatory decisions. This
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course is intended to assist clinical
investigators in understanding what
preclinical and clinical information is
needed to support the investigational
use of medical products, as well as the
scientific, regulatory, and ethical
considerations involved in the conduct
of clinical trials. The course will cover
a wide variety of key topics, including
material on novel safety concerns,
adverse event monitoring, compliance
with the legal and ethical obligations of
clinical research, and acceptable
scientific and analytic standards in the
design and conduct of clinical studies.
The faculty will include a diverse
representation of senior FDA staff,
enabling FDA to communicate directly
with clinical investigators on issues of
greatest importance for successful
clinical research.
II. Description of the Training Course
A. Purpose
The training course is designed to
provide clinical investigators with an
overview of the following information:
• The essential toxicological,
pharmacological, and manufacturing
data to support investigational use in
humans;
• Fundamental issues in the design
and conduct of clinical trials;
• Statistical and analytic
considerations in the interpretation of
trial data;
• Appropriate safety evaluation
during studies; and
• The ethical considerations and
regulatory requirements for clinical
trials.
In addition, the course should do the
following:
• Foster a cadre of clinical
investigators with knowledge,
experience, and commitment to
investigational medicine;
• Promote communication between
clinical investigators and FDA;
• Enhance investigators’
understanding of FDA’s role in
experimental medicine; and
• Improve the quality of data while
enhancing subject protection in the
performance of clinical trials.
B. Proposed Agenda
The course will be conducted over 3
days and will comprise approximately
26 lectures, each lasting between 30 and
45 minutes. The course will be
presented mainly by senior FDA staff,
with guest lecturers presenting selected
topics.
On November 7, 2011, the course will
address the role of FDA in clinical
studies, regulatory considerations for
clinical trials, and review of the material
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generally appearing in an ‘‘investigator’s
brochure,’’ i.e., the preclinical
information (toxicology, animal studies,
and chemistry/manufacturing
information) that supports initial
clinical trials in humans. Presentations
will also discuss the role of clinical
pharmacology in early clinical studies
and how this information is used in the
design of subsequent studies. On
November 8, 2011, the course will
include discussions of scientific,
statistical, ethical, and regulatory
aspects of clinical studies. On
November 9, 2011, participants will
choose among three breakout sessions
that explain how to put together an
application to FDA for drugs, biologics,
or devices.
C. Target Audience
The course is targeted at health care
professionals responsible for, or
involved in, the conduct and/or design
of clinical trials.
Dated: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–19149 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 Nominations for Members
on a Public Advisory Committee;
Medical Imaging Drugs Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for 12 members to serve on
the Medical Imaging Drugs Advisory
Committee in the Center for Drug
Evaluation and Research.
FDA has a special interest in ensuring
that women, minority groups, and
individuals with physical disabilities
are adequately represented on advisory
committees and, therefore, extends
particular encouragement to
nominations for appropriately qualified
female, minority, or physically
challenged candidates. Final selection
from each vacancy will be determined
by the expertise required to meet
specific Agency needs and in a manner
to ensure appropriate balance on
membership.
SUMMARY:
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Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
Nominations should be received
before September 27, 2011.
ADDRESSES: All nominations for
membership, except for consumernominated members and industry
representatives members, should be sent
to Minh Doan (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Minh Doan, Center for Drug Evaluation
and Research, Food and Drug
Administration, Bldg. 31, rm. 2417,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–
9001, Fax: 301–847–8533, E-mail:
MIDAC@fda.hhs.gov.
DATES:
FDA is
requesting nominations for voting
members on the Medical Imaging Drugs
Advisory Committee (the Committee).
(Elsewhere in this issue of the Federal
Register is 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
nonvoting industry representatives, and
a request for nominations of voting and
nonvoting consumer representatives.)
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Function
The Committee advises the
Commissioner of Food and Drugs or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
FDA has regulatory responsibility. The
Committee also 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.
II. Criteria for Members
Persons nominated for membership
on the Committee must have adequately
diversified research and/or clinical
experience appropriate to the work of
the committee in such fields as nuclear
medicine, radiology, epidemiology or
statistics, and related specialties.
The specialized training and
experience necessary to qualify the
nominee as an expert suitable for
appointment is subject to review, but
may include experience in medical
practice, teaching, research, and/or
public service relevant to the field of
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activity of the committee. The term of
office is up to 4 years.
III. Nomination Procedure
Any interested person may nominate
one or more qualified persons for
membership on the Committee. Selfnominations are also accepted.
Nominations must include a current,
complete resume or curriculum vitae for
each nominee, current business and/or
home address, telephone number, and email address if available. Nominations
must specify the advisory committee for
which the nominee is recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination, unless self-nominated.
Potential candidates will be required to
provide detailed information concerning
such matters as financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This document 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. 2011–19067 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
Consumer Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
and Request for Nominations for
Voting and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
SUMMARY:
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45579
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may either be selfnominated or may be nominated by a
consumer organization. Nominations
will be accepted for current vacancies
and for those that will or may occur
through June 2012.
Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
e-mail stating that interest to FDA (see
ADDRESSES) by August 29, 2011, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by August 29,
2011.
DATES:
All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be sent
electronically to CV@OC.FDA.GOV, by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, rm. 5129,
Silver Spring MD 20993–0002, or by fax
to 301–847–8640. Information about
becoming a member of an FDA advisory
committee can be obtained by visiting
FDA’s Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doreen Brandes, Advisory Committee
Oversight and Management Staff, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5122,
Silver Spring, MD 20993–0002, 301–
796–8858, or e-mail:
Doreen.Brandes@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the persons listed in table 2 in the
SUPPLEMENTARY INFORMATION section of
this document.
FDA is
requesting nominations for voting and/
or nonvoting consumer representatives
for the vacancies listed in table 1 of this
document:
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45578-45579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19067]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Request for Nominations for Members on a Public Advisory
Committee; Medical Imaging Drugs Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for 12 members to serve on the Medical Imaging Drugs
Advisory Committee in the Center for Drug Evaluation and Research.
FDA has a special interest in ensuring that women, minority groups,
and individuals with physical disabilities are adequately represented
on advisory committees and, therefore, extends particular encouragement
to nominations for appropriately qualified female, minority, or
physically challenged candidates. Final selection from each vacancy
will be determined by the expertise required to meet specific Agency
needs and in a manner to ensure appropriate balance on membership.
[[Page 45579]]
DATES: Nominations should be received before September 27, 2011.
ADDRESSES: All nominations for membership, except for consumer-
nominated members and industry representatives members, should be sent
to Minh Doan (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Minh Doan, Center for Drug Evaluation and Research, Food and Drug
Administration, Bldg. 31, rm. 2417, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, E-mail:
MIDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Medical Imaging Drugs Advisory Committee (the
Committee). (Elsewhere in this issue of the Federal Register is 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 nonvoting industry representatives, and a request
for nominations of voting and nonvoting consumer representatives.)
I. Function
The Committee advises the Commissioner of Food and Drugs or
designee in discharging responsibilities as they relate to helping to
ensure safe and effective drugs for human use and, as required, any
other product for which FDA has regulatory responsibility. The
Committee also 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.
II. Criteria for Members
Persons nominated for membership on the Committee must have
adequately diversified research and/or clinical experience appropriate
to the work of the committee in such fields as nuclear medicine,
radiology, epidemiology or statistics, and related specialties.
The specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment is subject to review, but
may include experience in medical practice, teaching, research, and/or
public service relevant to the field of activity of the committee. The
term of office is up to 4 years.
III. Nomination Procedure
Any interested person may nominate one or more qualified persons
for membership on the Committee. Self-nominations are also accepted.
Nominations must include a current, complete resume or curriculum vitae
for each nominee, current business and/or home address, telephone
number, and e-mail address if available. Nominations must specify the
advisory committee for which the nominee is recommended. Nominations
must also acknowledge that the nominee is aware of the nomination,
unless self-nominated. Potential candidates will be required to provide
detailed information concerning such matters as financial holdings,
employment, and research grants and/or contracts to permit evaluation
of possible sources of conflicts of interest.
This document 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. 2011-19067 Filed 7-28-11; 8:45 am]
BILLING CODE 4160-01-P
