Organization, Functions, and Delegations of Authority, 42316 [E9-20056]
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Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20814
(Telephone Conference Call).
Contact Person: Jeannette L. Johnson,
Ph.D., Scientific Review Officer, National
Institutes on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7705,
JOHNSONJ9@NIA.NIH.GOV.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 17, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20156 Filed 8–20–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Organization, Functions, and
Delegations of Authority
srobinson on DSKHWCL6B1PROD with NOTICES
Part G, Indian Health Service, Proposed
Functional Statement
Office of Direct Service and Contracting
Tribes (ODSCT) (GABI)
(1) Provides Agency leadership and
advocacy for Direct Service Tribes (DST)
in the development of health policy,
program management, budget
formulation and resource allocation and
advises the IHS Director and senior
management on DST issues and
concerns; (2) provides Agency
leadership concerning policy
development and Agency functions and
responsibilities associated with selfdetermination contracting (Title I of the
Indian Self-Determination and
Education Assistance Act, Public Law
93–638, as amended), monitors Agency
compliance with self-determination
policies, administrative procedures and
guidelines, and advises the Director,
IHS, and senior management on
activities and issues related to selfdetermination contracting; (3) provides
Agency leadership in the development
of contract support cost (CSC) policy,
and fulfills national operational
responsibilities, with respect to the CSC
program administered by IHS; (4)
provides Agency leadership with
respect to policy development and
issues concerning new Federally
recognized/restored Tribes; (5)
administers a national statutorily
mandated grant program designed to
assist Tribes and Tribal organizations in
beginning and/or expanding self-
VerDate Nov<24>2008
16:22 Aug 20, 2009
Jkt 217001
determination activities; (6) serves as
the principal liaison with DST Tribal
leaders, the Direct Service Tribes
Advisory Committee (DSTAC), national
Indian or Tribal organizations, interTribal consortiums, Area health boards,
and Service Unit health boards; (7)
coordinates quarterly DSTAC and
annual DST meetings to provide a forum
for DST Tribal leaders to express their
concerns and primary issues relating to
direct health care delivery by the IHS;
(8) coordinates and facilitates meetings
between Direct Service and Title I
contracting Tribal delegations and the
Office of the Director at Headquarters,
during national meetings and at other
locations as required; (9) maintains a
central database of contact information
for Tribal leaders, health directors,
health programs, etc.; (10) assures that
Indian Tribes and Tribal organizations
are informed regarding pertinent health
policy and program management issues
and that consultation, with participation
by Indian Tribes and Tribal
organizations, occurs during the
development of IHS policies and
Agency decision making; (11) provides
technical assistance and support to IHS
Area Offices and to Tribes in
administering health programs; and (12)
participates in cross-cutting issues and
processes including but not limited to
emergency preparedness/security,
budget formulation, self-determination
issues, Tribal shares computations, and
resolution of audit findings as needed.
This reorganization shall be effective
on August 14, 2009.
Dated: August 13, 2009.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. E9–20056 Filed 8–20–09; 8:45 am]
BILLING CODE 4165–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0352]
Prescription Drug User Fee Act IV
Information Technology Assessment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: In the last decade, the Food
and Drug Adminstration (FDA) has
achieved great success in reforming and
modernizing its regulatory processes
and responsibilities as a result of
changes and improvements driven by
the requirements of the Prescription
Drug User Fee Act (PDUFA), the 1997
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
FDA Modernization Act (FDAMA), and
other legislation. PDUFA was
reauthorized by the Food and Drug
Administration Amendments Act of
2007, Title I, Prescription Drug User Fee
Amendments of 2007 (PDUFA IV). FDA
plans to make even greater progress
during the PDUFA IV timeframe (Fiscal
Years 2008 through 2012), building on
the foundation established in previous
years. The additional resources
provided by user fees, when combined
with appropriations, have enabled the
FDA to modernize its information
technology infrastructure and begin a
monumental transformation from a
paper-based to an electronic work
environment.
As part of the PDUFA IV
commitment, FDA published the
PDUFA IV Information Technology (IT)
Plan for comment to allow the public to
provide feedback as FDA moves towards
a fully electronic standards-based
submission and review environment.
FDA reviewed the comments, updated
the plan, and published the updated
version in June 2008 (73 FR 36880; June
30, 2008).
Under the PDUFA IV IT Plan an
assessment of progress against the plan
is conducted on an annual basis. The
most recent report, which is available at
https://www.fda.gov/oc/pdufa/, reflects
the current assessment of the PDUFA IV
IT Plan. The report contains four
columns. The first three columns were
previously published as part of the
original plan. The last column, labeled
‘‘Current Status’’ provides details of the
activities for each project assessed. The
next assessment will be published in
November 2009.
More information on the PDUFA
program is available at https://
www.fda.gov/oc/pdufa/.
DATES: Submit written or electronic
comments on the assessment at any
time. These comments will be
considered as the agency makes annual
updates to the plan each fiscal year.
ADDRESSES: Submit written requests for
single copies of the IT Assessment to the
Office of the Chief Information Officer
(HFA–080), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the IT
Assessment to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the assessment.
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Notices]
[Page 42316]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20056]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Organization, Functions, and Delegations of Authority
Part G, Indian Health Service, Proposed Functional Statement
Office of Direct Service and Contracting Tribes (ODSCT) (GABI)
(1) Provides Agency leadership and advocacy for Direct Service
Tribes (DST) in the development of health policy, program management,
budget formulation and resource allocation and advises the IHS Director
and senior management on DST issues and concerns; (2) provides Agency
leadership concerning policy development and Agency functions and
responsibilities associated with self-determination contracting (Title
I of the Indian Self-Determination and Education Assistance Act, Public
Law 93-638, as amended), monitors Agency compliance with self-
determination policies, administrative procedures and guidelines, and
advises the Director, IHS, and senior management on activities and
issues related to self-determination contracting; (3) provides Agency
leadership in the development of contract support cost (CSC) policy,
and fulfills national operational responsibilities, with respect to the
CSC program administered by IHS; (4) provides Agency leadership with
respect to policy development and issues concerning new Federally
recognized/restored Tribes; (5) administers a national statutorily
mandated grant program designed to assist Tribes and Tribal
organizations in beginning and/or expanding self-determination
activities; (6) serves as the principal liaison with DST Tribal
leaders, the Direct Service Tribes Advisory Committee (DSTAC), national
Indian or Tribal organizations, inter-Tribal consortiums, Area health
boards, and Service Unit health boards; (7) coordinates quarterly DSTAC
and annual DST meetings to provide a forum for DST Tribal leaders to
express their concerns and primary issues relating to direct health
care delivery by the IHS; (8) coordinates and facilitates meetings
between Direct Service and Title I contracting Tribal delegations and
the Office of the Director at Headquarters, during national meetings
and at other locations as required; (9) maintains a central database of
contact information for Tribal leaders, health directors, health
programs, etc.; (10) assures that Indian Tribes and Tribal
organizations are informed regarding pertinent health policy and
program management issues and that consultation, with participation by
Indian Tribes and Tribal organizations, occurs during the development
of IHS policies and Agency decision making; (11) provides technical
assistance and support to IHS Area Offices and to Tribes in
administering health programs; and (12) participates in cross-cutting
issues and processes including but not limited to emergency
preparedness/security, budget formulation, self-determination issues,
Tribal shares computations, and resolution of audit findings as needed.
This reorganization shall be effective on August 14, 2009.
Dated: August 13, 2009.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. E9-20056 Filed 8-20-09; 8:45 am]
BILLING CODE 4165-16-M
