42316 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 

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 selfdetermination 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 

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 

http://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 http:// 

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 http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the assessment. 


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