Clinical Investigator Training Course, 63988-63989 [2013-25127]
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
ANNUAL BURDEN: CURRENT REQUEST
Number of
responses
per
respondent
Annual
number of
respondents
Activity/respondent
Average
burden per
response
(hours)
Total annual
burden hours
Responsible Fatherhood Grantee Impact Evaluation
(19) RF Follow-up survey
Study participants .....................................................................................
1,600
1
0.75
1,200
Healthy Marriage Grantee Impact Evaluation
(20) HM Follow-up survey
Study participants .....................................................................................
3,200
1
0.75
2,400
Total ...................................................................................................
........................
........................
........................
3,600
Estimated Total Annual Burden
Hours (for instruments previously
approved and currently in use, and
those associated with this 30-Day
Notice): 16,716.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2013–25128 Filed 10–24–13; 8:45 am]
BILLING CODE 4184–37–P
emcdonald on DSK67QTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1214]
Clinical Investigator Training Course
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
17:55 Oct 24, 2013
Jkt 232001
The Food and Drug Administration’s
(FDA’s) Center for Drug Evaluation and
Research/Office of Medical Policy and
the Duke University Office of
Continuing Medical Education are
cosponsoring a 3-day training course for
clinical investigators on scientific,
ethical, and regulatory aspects of
clinical trials. This training course is
intended to provide clinical
investigators with expertise in the
design, conduct, and analysis of clinical
trials; improve the 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 12 and 13,
2013, from 8 a.m. to 5 p.m., and on
November 14, 2013, from 8 a.m. to 4
p.m.
Location: The course will be held at
the Holiday Inn College Park, 10000
Baltimore Ave., College Park, MD
20740.
Contact Person: Connie Wisner, Office
of Medical Policy, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6360,
Silver Spring, MD 20993, 301–796–
8509.
Registration: Register by November 1,
2013. 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 Web site: https://
continuingeducation.dcri.duke.edu/fdaclinical-investigators-training-courseregistration or download a full-size copy
of the registration form from the
registration site and mail a check and
completed form to: Duke University
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Conference and Event Services, FDA
Investigator Course, Box 90841, 101
Bryan Center, Durham, NC 27708. You
will receive an email that confirms your
registration. (FDA has verified the Web
site address, but FDA is not responsible
for subsequent changes to the Web site
after this document publishes in the
Federal Register.)
Attendees are responsible for their
own accommodations. A block of rooms
has been reserved under ‘‘FDA Clinical
Investigator Course’’ at the Holiday Inn
College Park at a reduced conference
rate. Reservations for these
accommodations can be made online
using the course registration Web site
mentioned previously. Click on
‘‘registration form.’’ You will see a
direct link to the hotel.
Registration materials, payment
procedures, accommodation
information, and a detailed description
of the course can be found at the
registration/information Web site
mentioned previously.
If you need special accommodations
due to a disability, please contact
Connie Wisner (see Contact Person) 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
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
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
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
accomplish 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.
emcdonald on DSK67QTVN1PROD with NOTICES
B. Proposed Agenda
The course will be conducted over 3
days and comprised of 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.
The course will address FDA’s role in
clinical studies, regulatory
considerations for clinical trials, and
review of the material 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. Presenters will
discuss the role of clinical
VerDate Mar<15>2010
17:55 Oct 24, 2013
Jkt 232001
pharmacology in early clinical studies
and how this information is used in the
design of subsequent studies. The
course will also include discussions of
scientific, statistical, ethical, and
regulatory aspects of clinical studies. On
November 14, 2013, participants will
choose among three breakout sessions
that will explain how to put together an
application to FDA for drugs, biologics,
or devices.
C. Target Audience
The course is targeted toward health
care professionals responsible for, or
involved in, the conduct and/or design
of clinical trials.
Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25127 Filed 10–24–13; 8:45 am]
BILLING CODE 4160–01–P
63989
member to represent the interests of the
tobacco manufacturing industry must
send a letter stating the interest to FDA
by November 25, 2013, for the vacancy
listed in this notice. Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
November 25, 2013.
All letters of interest and
nominations should be submitted in
writing to TPSAC@fda.hhs.gov, or by
mail to Caryn Cohen, Office of Science,
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,1–877–287–1373
(choose Option 5), FAX: 240–276–3655,
email: TPSAC@fda.hhs.gov.
The
Agency requests nominations for a
nonvoting industry representative on
the Tobacco Products Scientific
Advisory Committee to represent the
interests of the tobacco manufacturing
industry.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
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 the Tobacco
Products Scientific Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
industry organizations interested in
participating in the selection of a
nonvoting industry representative to
represent the interests of the tobacco
manufacturing industry on the Tobacco
Products Scientific Advisory Committee
for the Center for Tobacco Products,
notify FDA in writing. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
upcoming vacancy effective with this
notice. Elsewhere in this issue of the
Federal Register, FDA is publishing a
separate document announcing the
Request for Notification for Voting
Members on the Tobacco Products
Scientific Advisory Committee.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner or designee
in discharging responsibilities as they
relate to the regulation of tobacco
products. The Committee reviews and
evaluates safety, dependence, and
health issues relating to tobacco
products and provides appropriate
advice, information and
recommendations to the Commissioner
of Food and Drugs.
The Committee includes three
nonvoting members who represent
industry interests. These members
include one representative of the
tobacco manufacturing industry, one
representative of the interests of tobacco
growers, and one representative of the
interests of the small business tobacco
manufacturing industry. The
representative of the interests of the
small business tobacco manufacturing
industry may be filled on a rotating
basis by representatives of different
small business tobacco manufacturers
based on areas of expertise relevant to
the topics being considered by the
Committee.
With this notice, nominations are
sought for one representative of the
interests of the tobacco manufacturing
industry, and an alternate to this
representative.
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 63988-63989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25127]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1214]
Clinical Investigator Training Course
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research/Office of Medical Policy and the Duke
University Office of Continuing Medical Education are cosponsoring a 3-
day training course for clinical investigators on scientific, ethical,
and regulatory aspects of clinical trials. This training course is
intended to provide clinical investigators with expertise in the
design, conduct, and analysis of clinical trials; improve the 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 12 and
13, 2013, from 8 a.m. to 5 p.m., and on November 14, 2013, from 8 a.m.
to 4 p.m.
Location: The course will be held at the Holiday Inn College Park,
10000 Baltimore Ave., College Park, MD 20740.
Contact Person: Connie Wisner, Office of Medical Policy, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6360, Silver Spring, MD 20993, 301-796-
8509.
Registration: Register by November 1, 2013. 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 Web
site: https://continuingeducation.dcri.duke.edu/fda-clinical-investigators-training-course-registration or download a full-size copy
of the registration form from the registration site and mail a check
and completed form to: Duke University Conference and Event Services,
FDA Investigator Course, Box 90841, 101 Bryan Center, Durham, NC 27708.
You will receive an email that confirms your registration. (FDA has
verified the Web site address, but FDA is not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.)
Attendees are responsible for their own accommodations. A block of
rooms has been reserved under ``FDA Clinical Investigator Course'' at
the Holiday Inn College Park at a reduced conference rate. Reservations
for these accommodations can be made online using the course
registration Web site mentioned previously. Click on ``registration
form.'' You will see a direct link to the hotel.
Registration materials, payment procedures, accommodation
information, and a detailed description of the course can be found at
the registration/information Web site mentioned previously.
If you need special accommodations due to a disability, please
contact Connie Wisner (see Contact Person) 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 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
[[Page 63989]]
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 accomplish 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 comprised of
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.
The course will address FDA's role in clinical studies, regulatory
considerations for clinical trials, and review of the material
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. Presenters will discuss the role of clinical pharmacology in
early clinical studies and how this information is used in the design
of subsequent studies. The course will also include discussions of
scientific, statistical, ethical, and regulatory aspects of clinical
studies. On November 14, 2013, participants will choose among three
breakout sessions that will explain how to put together an application
to FDA for drugs, biologics, or devices.
C. Target Audience
The course is targeted toward health care professionals responsible
for, or involved in, the conduct and/or design of clinical trials.
Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25127 Filed 10-24-13; 8:45 am]
BILLING CODE 4160-01-P
