Clinical Investigator Training Course, 60440-60441 [2012-24214]
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Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Notices
Organization name
Location
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Turtle Mountain Community College ................................................................................
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College of Menominee Nation ..........................................................................................
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Statutory Authority: Section 2008(a) of
Title XX of the Social Security Act, as
amended by Section 5507 of the Affordable
Care Act (Pub. L. 111–148).
Earl S. Johnson,
Director, Office of Family Assistance.
[FR Doc. 2012–24310 Filed 10–2–12; 8:45 am]
BILLING CODE 4184–48–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Clinical Investigator Training Course
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA) 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 13 and 14,
2012, from 8 a.m. to 5 p.m., and on
November 15, 2012, 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.
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Registration: Register by October 22,
2012. 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://evm.
auxserv.duke.edu/iebms/reg/
reg_p1_form.aspx?oc=10&ct=
DCRIINVEST&eventid=46475 or
download a full-size copy of the
registration form 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 at least 7 days in
advance. Persons attending the course
are advised that FDA is not responsible
for providing access to electrical outlets.
I. Background
Clinical trial investigators play a
critical role in the development of
medical products. They are responsible
for ensuring the safe and ethical
treatment of study subjects and for
collecting adequate and reliable data to
support regulatory decisions. This
course is intended to assist clinical
investigators in understanding what
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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 drug 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 comprised of approximately
26 lectures, each lasting between 30 and
E:\FR\FM\03OCN1.SGM
03OCN1
Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Notices
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 15, 2012, 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 at health care
professionals responsible for, or
involved in, the conduct and/or design
of clinical trials.
Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–24214 Filed 10–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0284]
Pediatric Studies of Sodium
Nitroprusside Conducted in
Accordance With Section 409I of the
Public Health Service Act;
Establishment of Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
opening of a public docket to make
available to the public a report of the
pediatric studies of sodium
nitroprusside that were conducted in
accordance with the Public Health
Service Act (the PHS Act) and
submitted to the Director of the National
Institutes of Health (NIH) and the
Commissioner of Food and Drugs.
DATES: Submit either electronic or
written comments by November 2, 2012.
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You may submit comments,
identified by FDA–2012–N–0284, by
any of the following methods.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Akilah Green, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6475,
Silver Spring, MD 20993–0002, email:
akilah.green@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 409I of the PHS Act (42 U.S.C.
284m), the Secretary of the Department
of Health and Human Services (the
Secretary) acting through the Director of
NIH, in consultation with FDA and
experts in pediatric research, must
develop, prioritize, and publish a list of
priority needs in pediatric therapeutics,
including drugs, biological products,
and indications that require study.1 For
drugs and biological products and
indications on this list, FDA, acting in
consultation with NIH, is authorized to
issue a written request to holders of a
new drug application (NDA) or
abbreviated new drug application
(ANDA) for a drug, or holders of a
biologics license application (BLA) for a
1 Prior to the 2007 reauthorization of the Best
Pharmaceuticals for Children Act (Pub. L. 107–109),
the priority list included specific drugs instead of
therapeutic areas.
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60441
biological product, for which pediatric
studies are needed to provide safety and
efficacy information for pediatric
labeling. If the sponsors receiving the
written request decline to conduct the
studies or if FDA does not receive a
response to the written request within
30 days of the date the written request
was issued, the Secretary, acting
through the Director of NIH and in
consultation with FDA, must publish a
request for proposals to conduct the
pediatric studies described in the
written request and award funds to an
entity with appropriate expertise for the
conduct of the pediatric studies
described in the written request. Upon
completion of the pediatric studies, a
study report that includes all data
generated in connection with the
studies must be submitted to FDA and
NIH and placed in a public docket
assigned by FDA.
Sodium nitroprusside, a hypotensive
agent, is labeled for the immediate
reduction of blood pressure of patients
in hypertensive crises, for producing
controlled hypotension in order to
reduce bleeding during surgery, and for
the treatment of acute congestive heart
failure. Off-label use of sodium
nitroprusside in pediatric patients is
significant, despite the lack of adequate
pharmacokinetic, dosing, tolerability,
and safety data for this age group.
On January 21, 2003, NIH published
a Federal Register notice (68 FR 2789)
announcing the addition of several
drugs, including sodium nitroprusside,
to the priority list of drugs most in need
of study for use by children to ensure
their safety and efficacy. A written
request for pediatric studies of sodium
nitroprusside was issued on July 8,
2002, to Abbott Laboratories, the holder
of the NDA for sodium nitroprusside.
FDA did not receive a response to the
written request. Accordingly, NIH
issued a request for proposals to
conduct the pediatric studies described
in the written request in July 2004, and
awarded funds to Duke University and
Stanford University in September 2004,
to complete the studies described in the
written request. Upon completion of the
pediatric studies, a report of the
pediatric studies of sodium
nitroprusside was submitted to NIH and
FDA. As required under section 409I of
the PHS act, FDA opened a public
docket and NIH placed in the docket the
report of pediatric studies of sodium
nitroprusside that was submitted to NIH
and FDA. The report includes all data
generated in connection with the study,
including the written request.
We invite interested parties to review
the report and submit comments to the
docket. The public docket is available
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Pages 60440-60441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24214]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Clinical Investigator Training Course
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) 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 13 and
14, 2012, from 8 a.m. to 5 p.m., and on November 15, 2012, 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 October 22, 2012. 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://evm.auxserv.duke.edu/iebms/reg/reg_p1_form.aspx?oc=10&ct=DCRIINVEST&eventid=46475 or download a full-size
copy of the registration form 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 at least 7 days in advance. Persons attending the
course are advised that FDA is not responsible for providing access to
electrical outlets.
I. Background
Clinical trial investigators play a critical role in the
development of medical products. They are responsible for ensuring the
safe and ethical treatment of study subjects and for collecting
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 drug 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 comprised of
approximately 26 lectures, each lasting between 30 and
[[Page 60441]]
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 15, 2012, 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 at health care professionals responsible
for, or involved in, the conduct and/or design of clinical trials.
Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24214 Filed 10-2-12; 8:45 am]
BILLING CODE 4160-01-P
