Center for Scientific Review; Notice of Closed Meetings, 56771 [2011-23530]
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Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
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publishes in the Federal Register.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, e-mail, and
payment information for the fee to
Xavier University, Attention: Sue
Bensman, 3800 Victory Pkwy.,
Cincinnati, OH 45207. An e-mail will be
sent confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarter hotel is the Downtown
Cincinnati Hilton Netherlands Plaza, 35
West Fifth Street, Cincinnati, OH 45202,
513–421–9100. To make reservations
online, please visit the ‘‘Venue &
Logistics’’ link at https://
www.XavierGOC.com. The hotel is
expected to sell-out during this
timeframe; so, early reservation in the
conference room-block is encouraged.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see Contact Persons) at least 7
days in advance of the conference.
SUPPLEMENTARY INFORMATION: The
public conference helps fulfill the
Department of Health and Human
Services and FDA’s important mission
to protect the public health. The
conference will provide those engaged
in FDA-regulated outsourcing with
information on the following topics:
• Regulatory Expectations for
Outsourcing Roles and Responsibilities,
Supply Chain Quality, and Challenges
Observed,
• Price Versus Total Cost of
Ownership,
• Strategic Procurement,
• Development and Commercial
Contracts,
• Functional Quality Agreements,
• Meaningful Metrics,
• FDA and the Medicines and
Healthcare Products Regulatory Agency
Inspection Trends and Enforcement,
• McNeil Case Study and Living
Under Consent Decree,
• Practical Risk Management and
Case Studies of Litigation,
• Supplier Qualification Program,
• Third Party Initiatives and Impact,
• Operationalizing Quality-by-Design,
• Audit Panel to Cover Focus Areas
for Due Diligence Audits, Ongoing
Audit/Oversight, and Supply Chain
Audits,
• The Power of Integrated Supply
Chains—By Design. Drive to the Source
of the Frustrations,
• End-to-End Planning for Successful
Launch,
• Pharma Case Study on How to
Manage a Global Complex Supply
Chain,
• USP <1079>: Good Storage and
Distribution Practices, and USP <1083>
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Pedigree and Track and Trace Presented
By the Author, and
• Next Steps for the Industry.
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 conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
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
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23482 Filed 9–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Gastrointestinal/Kidney Pathophysiology,
Toxicology/Pharmacology AREA Grant
Applications.
Date: October 5, 2011.
Time: 3 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, 1 Metro
Center, Bethesda, MD 20814.
Contact Person: Patricia Greenwel, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178,
MSC 7818, Bethesda, MD 20892, 301–435–
1169, greenwep@csr.nih.gov.
PO 00000
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56771
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Special
Topic: Enabling Bioanalytical and Imaging
Technologies.
Date: October 6–7, 2011.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Four Points by Sheraton Washington
DC Downtown, 1201 K Street, NW.,
Washington, DC 20005.
Contact Person: Ross D Shonat, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6172,
MSC 7892, Bethesda, MD 20892, 301–435–
2786, ross.shonat@nih.hhs.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Molecular
Neuroscience.
Date: October 6, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Carol Hamelink, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4192,
MSC 7850, Bethesda, MD 20892, (301) 213–
9887, hamelinc@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–23530 Filed 9–13–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review;
Cancellation of Meeting
Notice is hereby given of the
cancellation of the Center for Scientific
Review Special Emphasis Panel,
October 5, 2011, 3:30 p.m. to October 5,
2011, 6:30 p.m., Hyatt Regency
Bethesda, One Bethesda Metro Center,
Bethesda, MD 20814 which was
published in the Federal Register on
September 6, 2011, 76 FR 55076–55077.
The meeting is cancelled due to the
reassignment of applications.
Dated: September 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–23536 Filed 9–13–11; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Page 56771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Gastrointestinal/Kidney Pathophysiology, Toxicology/
Pharmacology AREA Grant Applications.
Date: October 5, 2011.
Time: 3 p.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, 1 Metro Center, Bethesda, MD
20814.
Contact Person: Patricia Greenwel, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD
20892, 301-435-1169, greenwep@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Special Topic: Enabling Bioanalytical and Imaging
Technologies.
Date: October 6-7, 2011.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Four Points by Sheraton Washington DC Downtown, 1201 K
Street, NW., Washington, DC 20005.
Contact Person: Ross D Shonat, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6172, MSC 7892, Bethesda, MD 20892, 301-435-
2786, ross.shonat@nih.hhs.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Molecular Neuroscience.
Date: October 6, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Carol Hamelink, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4192, MSC 7850, Bethesda, MD 20892, (301) 213-
9887, hamelinc@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: September 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-23530 Filed 9-13-11; 8:45 am]
BILLING CODE 4140-01-P
