Clinical Investigator Training Course, 45577-45578 [2011-19149]
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45577
Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
LIHEAP Quarterly Allocation Estimate, ACF–535 ...........................................
55
1
0.25
13.75
Estimated Total Annual Burden
Hours: 13.75.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@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:
implement an adoption and foster care
reporting system. Federal regulations at
45 CFR 1355.40 sets forth the
requirements of section 479 of the
Social Security Act for the collection of
uniform, reliable information on
children who are under the
responsibility of the State title IV–B/IV–
E agency for placement, care, and
adoption. The respondents are child
welfare agencies in the 50 States, the
District of Columbia, and Puerto Rico.
The data collected will inform State/
Federal policy decisions, program
management, and responses to
Congressional and Departmental
inquiries. Specifically, the data are used
for short/long-term budget projections,
trend analysis, child and family service
reviews, and to target areas for
improved technical assistance. The data
will provide information about foster
care placements, adoptive parents,
length of time in care, delays in
termination of parental rights and
placement for adoption.
Respondents:
Office of Management and Budget,
Paperwork Reduction Project, Fax:
202–395–7285, E-mail:
oira_submission@omb.eop.gov, Attn:
Desk Officer for the Administration
for Children and Families.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 2011–19229 Filed 7–28–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Adoption and Foster Care
Analysis and Reporting System
(AFCARS), Title IV–B & IV–E.
OMB No.: 0980–0267.
Description: Section 479 of title IV–E
of the Social Security Act (the Act)
directs States to establish and
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
AFCARS ..........................................................................................
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Instrument
52
2
2,581
268,424
Estimated Total Annual Burden
Hours: 268,424.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@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
VerDate Mar<15>2010
18:53 Jul 28, 2011
Jkt 223001
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
ACTION:
[FR Doc. 2011–19192 Filed 7–28–11; 8:45 am]
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. FDA–2011–N–0523]
Clinical Investigator Training Course
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA), Office of Critical
Path Programs and the Clinical Trials
Transformation Initiative (CTTI) 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 investigators with
expertise in the design, conduct, and
analysis of clinical trials; improve the
SUMMARY:
E:\FR\FM\29JYN1.SGM
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45578
Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
16:17 Jul 28, 2011
Jkt 223001
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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\29JYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45577-45578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19149]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0523]
Clinical Investigator Training Course
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Office of Critical
Path Programs and the Clinical Trials Transformation Initiative (CTTI)
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 investigators with expertise in
the design, conduct, and analysis of clinical trials; improve the
[[Page 45578]]
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/fda-clinical-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 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 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
