National Center for Research Resources; Notice of Closed Meeting, 306 [E8-31388]
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Federal Register / Vol. 74, No. 2 / Monday, January 5, 2009 / Notices
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) First hand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations.
The overall benefit to regulatory
project managers will be exposure to
project management, team techniques,
and processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Firms
interested in offering a site tour or
learning more about this training
opportunity should respond by (see
DATES) by submitting a proposed agenda
to Beth Duvall-Miller (see FOR FURTHER
INFORMATION).
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Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–31320 Filed 1–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Part C Early Intervention Services
Grant
Health Resources and Services
Administration, HHS.
ACTION: Notice of Non-competitive
Program Expansion Supplemental
Award.
FOR FURTHER INFORMATION CONTACT:
Kathleen Treat, through e-mail
ktreat@hrsa.gov, or via telephone, 301–
443–0493.
Dated: December 19, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–31373 Filed 1–2–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
AGENCY:
SUMMARY: HRSA will be providing
temporary critical HIV medical care and
treatment services through the Medical
Center of Louisiana at New Orleans to
avoid a disruption of HIV clinical care
to clients in Orleans Parish in
Louisiana.
SUPPLEMENTARY INFORMATION:
Intended recipient of the award:
Medical Center of Louisiana at New
Orleans, New Orleans, Louisiana.
Amount of the award: $186,664 to
ensure ongoing clinical services to the
target population.
Authority: Section 2651 of the Public
Health Service Act, 42 U.S.C. 300ff–51.
CFDA Number: 93.918.
Project period: July 1, 2006 to June 30,
2011. The period of supplemental
support is from November 1, 2008, to
June 30, 2009.
Justification for the Exception to
Competition: Critical funding for HIV
medical care and treatment services to
clients in Orleans Parish in Louisiana
will be continued through a noncompetitive program expansion
supplement to an existing grant award
to Medical Center of Louisiana at New
Orleans, New Orleans, Louisiana. This
is a temporary award because the
previous grant recipient serving this
population notified HRSA that it would
not be able to continue participating in
the program after the fiscal year (FY)
2008 award was made. Medical Center
of Louisiana at New Orleans is the best
qualified grantee for this supplement
since it serves many of the former
grantee’s patients and is the closest Part
C Program to the former grantee. Further
funding beyond June 30, 2009, for this
service area will be competitively
awarded during the Part C HIV Early
Intervention Service (EIS) competing
application process for FY 2009.
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National Center for Research
Resources; Notice of Closed Meeting
Pursuant to Section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Research Resources Special Emphasis Panel;
SBIR Contracts.
Date: February 26, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hilton Hotel Gaithersburg, 620 Perry
Parkway, Gaithersburg, MD 20877.
Contact Person: Guo Zhang, Ph.D., MD,
Scientific Review Officer, National Center for
Research Resources; or, National Institutes of
Health, 6701 Democracy Blvd., 1 Democracy
Plaza, Room 1064, MSC 4874, Bethesda, MD
20892–4874, 301–435–0812,
zhanggu@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333, National Institutes of Health,
HHS)
Dated: December 24, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–31388 Filed 1–2–09; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Notices]
[Page 306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31388]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Research Resources; Notice of Closed Meeting
Pursuant to Section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meeting.
The meeting 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Center for Research Resources
Special Emphasis Panel; SBIR Contracts.
Date: February 26, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: Hilton Hotel Gaithersburg, 620 Perry Parkway,
Gaithersburg, MD 20877.
Contact Person: Guo Zhang, Ph.D., MD, Scientific Review Officer,
National Center for Research Resources; or, National Institutes of
Health, 6701 Democracy Blvd., 1 Democracy Plaza, Room 1064, MSC
4874, Bethesda, MD 20892-4874, 301-435-0812, zhanggu@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure, 93.306, 93.333,
National Institutes of Health, HHS)
Dated: December 24, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-31388 Filed 1-2-09; 8:45 am]
BILLING CODE 4140-01-P
