Office of the Director Notice of Establishment, 8887 [2012-3572]
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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices
Location: The public workshop will
be held at the Marriott Ann Arbor
Ypsilanti at Eagle Crest, 1275 S. Huron
St., Ypsilanti, MI 48197, 800–606–7044.
Contact: Society of Clinical Research
Associates (SoCRA), 530 West Butler
Ave., Suite 109, Chalfont, PA 18914,
1–800–762–7292 or 215–822–8644,
FAX: 215–822–8633, email:
SoCRAmail@aol.com, Web site: https://
www.SoCRA.org. (FDA has verified the
Web site addresses throughout this
document, but we are not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.); or Nancy
Bellamy, Food and Drug
Administration, Detroit District Office,
300 River Pl., Suite 5900, Detroit, MI
48207, 313–393–8143, Fax: 313–393–
8139, email:
nancy.bellamy@fda.hhs.gov.
Accommodations: Attendees are
responsible for their own
accommodations. Please mention
SoCRA to receive the hotel room rate of
$119 plus applicable taxes (available
until April 17, 2012 or until the SoCRA
room block is filled).
COST OF REGISTRATION
SoCRA member .......................
SoCRA nonmember (includes
membership) .........................
Federal Government member ..
Federal Government nonmember .................................
FDA Employee .........................
$575
650
450
525
*
sroberts on DSK5SPTVN1PROD with NOTICES
* (Free) Fee Waived.
If you need special accommodations
due to a disability, please contact
SoCRA (see Contact) at least 21 days in
advance. Extended periods of question
and answer and discussion have been
included in the program schedule.
SoCRA designates this educational
activity for a maximum of 13.3
Continuing Education Credits for
SoCRA CE and Nurse CNE. SoCRA
designates this live activity for a
maximum of 13.3 AMA PRA Category 1
Credit(s) TM. Physicians should claim
only the credit commensurate with the
extent of their participation. CME for
Physicians: SoCRA is accredited by the
Accreditation Council for Continuing
Medical Education to provide
continuing medical education for
physicians. CNE for Nurses: SoCRA is
an approved provider of continuing
nursing education by the Pennsylvania
State Nurses Association (PSNA), an
accredited approver by the American
Nurses Credentialing Center’s
Commission on Accreditation (ANCC).
ANCC/PSNA Provider Reference
Number: 205–3–A–09.
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Registration Instructions: To register,
please submit a registration form with
your name, affiliation, mailing address,
telephone, fax number, and email, along
with a check or money order payable to
‘‘SoCRA’’. Mail to: SoCRA (see Contact
for address). To register via the Internet,
go to https://www.socra.org/html/
FDA_Conference.htm. Payment by
major credit card is accepted (Visa/
MasterCard/AMEX only). For more
information on the meeting registration,
or for questions on the workshop,
contact SoCRA (see Contact).
Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, IRB inspections,
electronic record requirements, and
investigator initiated research. Topics
for discussion include the following: (1)
What FDA Expects in a Pharmaceutical
Clinical Trial; (2) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (3) Part 11 Compliance—
Electronic Signatures; (4) Informed
Consent Regulations; (5) IRB
Regulations and FDA Inspections; (6)
Keeping Informed and Working
Together; (7) FDA Conduct of Clinical
Investigator Inspections; (8) Meetings
With FDA: Why, When, and How; (9)
Investigator Initiated Research; (10)
Medical Device Aspects of Clinical
Research; (11) Working With FDA’s
Center for Biologics Evaluation and
Research; (12) The Inspection is Over—
What Happens Next? Possible FDA
Compliance Actions; (13) Ethical Issues
in Subject Enrollment; (14) Medical
Device Aspects of Clinical Research;
(15) Are We There Yet? An Overview of
the FDA GCP Program.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393) which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121) as outreach
activities by Government Agencies to
small businesses.
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
App), the Director, National Institutes of
Health (NIH), announces the
establishment of the National Center for
Advancing Translational Sciences
Advisory Council (Council) and the
Cures Acceleration Network Review
Board (Board), in the National Center for
Advancing Translation Sciences
(NCATS).
The Council will advise, assist,
consult with, and make
recommendations to the Secretary of
Health and Human Services (Secretary),
the Director, National Institutes of
Health (NIH) and the Director, National
Center for Advancing Translational
Sciences (NCATS, also referred to as
Center) on matters related to the
activities carried out by and through the
Center and the policies respecting these
activities.
The Board will advise, and provide
recommendation to, the Director,
NCATS, with respect to (1) policies,
programs, and procedures for carrying
out the duties of the Director, NCATS,
under section 480 of the PHS Act; and
(2) significant barriers to successful
translation of basic science into clinical
application (including issues under the
purview of other agencies and
departments).
Duration of each committee is two
years from the date the Charter is filed.
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director Notice of
Establishment
Dated: February 7, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012–3572 Filed 2–14–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Page 8887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director Notice of Establishment
Pursuant to the Federal Advisory Committee Act, as amended (5
U.S.C. App), the Director, National Institutes of Health (NIH),
announces the establishment of the National Center for Advancing
Translational Sciences Advisory Council (Council) and the Cures
Acceleration Network Review Board (Board), in the National Center for
Advancing Translation Sciences (NCATS).
The Council will advise, assist, consult with, and make
recommendations to the Secretary of Health and Human Services
(Secretary), the Director, National Institutes of Health (NIH) and the
Director, National Center for Advancing Translational Sciences (NCATS,
also referred to as Center) on matters related to the activities
carried out by and through the Center and the policies respecting these
activities.
The Board will advise, and provide recommendation to, the Director,
NCATS, with respect to (1) policies, programs, and procedures for
carrying out the duties of the Director, NCATS, under section 480 of
the PHS Act; and (2) significant barriers to successful translation of
basic science into clinical application (including issues under the
purview of other agencies and departments).
Duration of each committee is two years from the date the Charter
is filed.
Dated: February 7, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012-3572 Filed 2-14-12; 8:45 am]
BILLING CODE 4140-01-P
