Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Notices 29217 

FOR FURTHER INFORMATION CONTACT: 

Programmatic/Review Contact: 

Melissa Robb, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

rm. 14B–45, Rockville, MD 20857, 

301–827–1516, 

Melissa.robb@fda.hhs.gov 

Grants Management Contact: Gladys 

M. Bohler, OAGS, Food and Drug 

Administration, 5630 Fishers Lane, 

rm. 2105, Rockville, MD 20857, 

301–827–7168, 

gmbohler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

Funding Opportunity Number: RFA– 

FD–09–011 

Catalog of Federal Domestic 

Assistance Number: 93.103 

A. Background 

The Critical Path Initiative, launched 

by FDA in 2004, has the objective of 

helping modernize the development, 

evaluation, manufacture, and use of 

FDA-regulated products. Through 

nationwide collaboration with other 

Federal, academic, scientific, and 

industry organizations, the initiative 

seeks to develop new tools to facilitate 

innovation in FDA-regulated product 

development. Examples of tools include 

novel biomarkers, laboratory assays, 

genetic tests, and state-of-the art 

information technologies, etc. In this 

initiative, FDA plays the role of a 

facilitator in the creation of partnerships 

and collaborations to support specific 

scientific projects. 

FDA and Duke University’s 

Department of Translational Medicine 

Institute (DTMI) co-founded CTTI. 

CTTI’s goal is to systematically 

modernize the clinical trial process, a 

goal shared by FDA’s Critical Path 

Initiative. CTTI is made up of a broad 

representation of member organizations 

including government, industry, patient 

advocacy groups, professional societies, 

and academia. The participants are 

working together to identify practices 

that through broad adoption will 

increase the quality and efficiency of 

clinical trials. 

CTTI is generating evidence about 

how to improve the design and 

execution of clinical trials. Projects 

about design will address principles 

generally applicable to clinical trials to 

ensure that they are fit to accomplish 

their intended purpose. 

B. Research Objectives 

The goals of this program are to 

develop an administrative and scientific 

infrastructure to support the creation 

and execution of a series of projects 

under the auspices of CTTI, to 

complement the goals of FDA’s Critical 

Path Initiative. 

This funding opportunity will use a 

cooperative agreement award 

mechanism (U19). In the cooperative 

agreement mechanism, the Project 

Director/Principal Investigator (PD/PI) 

retains the primary responsibility and 

dominant role for planning, directing, 

and executing the proposed project, 

with FDA staff being substantially 

involved as a partner with the PD/PI. 

Substantive involvement includes, but 

is not limited to, the following: (1) FDA 

will work closely with the DTMI 

throughout the lifetime of this program 

and throughout all phases of planning, 

implementation, conduct and reporting 

of this program and all related projects; 

(2) FDA will appoint project officer (s) 

for the task(s) associated with this 

program and related projects; (3) FDA 

will identify appropriate staff to provide 

strategic and scientific input, as needed, 

throughout the life of this program and 

related projects. 

C. Eligibility Information 

This is a sole source award to DTMI 

located within Duke University to 

support the CTTI. Only one award will 

be made to the DTMI to support the 

CTTI. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing up to $1.5 

million (direct and indirect costs 

combined) during fiscal year 2009 to 

support research and related efforts of 

identified projects that are part of the 

Critical Path Initiative. 

B. Length of Support 

Subject to the availability of Federal 

funds and successful performance of the 

funding opportunity announcement 

(FOA) stated goals and objectives, 4 

additional years of support may be 

available depending on annual 

appropriations. This award will be 

funded based on the quality of the 

application received and is subject to 

availability of Federal funds to support 

the program. 

III. How to Submit a Paper Application 

To submit a paper application in 

response to this FOA, applicants should 

first review the full announcement 

located at http://www.fda.gov/ 

ScienceResearch/SpecialTopics/ 

CriticalPathInitiative/ 

SpotlightonCPIProjects/ 

ucm083241.htm. Persons interested in 

applying for a grant may obtain 

application forms and instructions at 

http://grants.nih.gov/grants/forms.htm. 

For paper submissions, the following 

steps are required: 

• Step 1: Obtain a Dun and Bradstreet 

Data Universal Numbering System 

(DUNS) Number 

• Step 2: Register with Central 

Contractor Registration (CCR) 

Instructions on how to complete these 

steps can be found at http:// 

www07.grants.gov/applicants/ 

organization_registration.jsp 

Submit paper applications to: Gladys 

M. Bohler, OAGS/GAAT, Food and 

Drug Administration, 5630 Fishers Lane 

(HFA–500), rm. 2105, Rockville, MD 

20874. 

Dated: June 15, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14436 Filed 6–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Child Support Enforcement 

AGENCY: Office of Child Support 

Enforcement (OCSE), Administration for 

Children and Families (ACF), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice to administratively 

impose a matching requirement. 

CFDA Number: 93.564. 

Legislative Authority 

Section 1115 of the Social Security 

Act [42 U.S.C. 1315] provides funds for 

experimental, pilot or demonstration 

projects that are likely to assist in 

promoting the objectives of Part D of the 

Title IV. The projects must be designed 

to improve the financial well-being of 

children or otherwise improve the 

operation of the child support program. 

Projects may not permit modifications 

in the child support program that would 

have the effect of disadvantaging 

children in need of support. 

SUMMARY: The Office of Child Support 

Enforcement (OCSE) in the 

Administration for Children and 

Families (ACF) hereby gives notice to 

the public that a matching requirement 

of five percent (5%) will be 

administratively imposed upon awards 

made under competitions governed by 

the following ‘‘Section 1115’’ funding 

opportunities in Fiscal Year 2009. 

mstockstill on PROD1PC66 with NOTICES

29218 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Notices 

Funding opportunity No. Funding opportunity title CFDA No. 

HHS–2009–ACF–OCSE–FD–0093 .............................................. Partnership to Strengthen Families—Child Support Enforcement/Temporary Assistance for Needy Families—University 

Partnership Demonstration Project.

93 .654 

HHS–2009–ACF–OCSE–FD–0095 .............................................. Projects to Address the Sudden and Prolonged Effect of the 

Economic Downturn on the IV–D Caseload and Program 

Operations.

93 .654 

HHS–2009–ACF–OCSE–FD–0098 .............................................. Health Care/Medical Support in Child Support Enforcement: 

Reform Strategy Grants.

93 .654 

Historically, the imposition of a 

matching requirement on awards under 

this program resulted in an increased 

level of commitment to the project and 

its success and sustainability, without 

creating an undue financial burden on 

the grantee. 

Section 1115 funds awarded to each 

project will represent 29 percent (29%) 

of the total project costs. The total 

approved project cost is the sum of the 

ACF grant award under Section 1115, 

regular Federal Financial Participation 

(FFP), and the State share. For the 

purposes of the demonstration projects, 

the total expenditures will be treated as 

State expenditures under Title IV–D that 

will be reimbursed by the regular Title 

IV–D FFP match of 66 percent (66%). 

Applicants must prepare a formal 

budget on the required standard forms, 

as listed in Section IV.2, Content and 

Form of Application Submission of the 

funding opportunity announcements. 

Grantees must provide at least five 

percent (5%) of the total approved 

project cost. This non-Federal, i.e., State 

share, may be met by cash, incentive 

funds (awarded under section 458 of the 

Social Security Act), or in-kind 

contributions. The five percent (5%) 

match may be provided through in-kind 

contributions, as allowed by section 

1115(a)(2)(A) of the Social Security Act. 

For example, if an applicant’s total 

project budget is $150,000, this would 

be made up of three funding sources: 

Section 1115 funds (29% = $43,500), 

cost sharing (5% = $7,500) and regular 

Title IV–D Federal Financial 

Participation/FFP (66% = $99,000). 

Title IV–D applicants that anticipate 

satisfying the matching requirement 

through in-kind contributions, or the 

use of incentive funds awarded under 

section 458 of the Social Security Act, 

must request prior approval as part of 

the required budget justification (see 

Section IV.2. Budget and Budget 

Justification in the published funding 

opportunity announcements) in 

accordance with section 1115(a)(2)(A) of 

the Social Security Act. Costs borne by 

matching contributions are subject to 

the regulations governing allowability 

found under and 45 CFR 92.24. 

Eligible applicants for these Section 

1115 demonstration project grants are 

State (including the District of 

Columbia, Guam, Puerto Rico, and the 

Virgin Islands) Title IV–D agencies or 

the umbrella agencies of the IV–D 

program. 

Planned ACF funding opportunity 

announcements may be found at the 

HHS Grants Forecast Web site at 

http://www.hhs.gov/grantsforecast/. The 

HHS’s Grants Forecast is a database of 

planned funding opportunities 

proposed by its operating divisions, 

including ACF. Each Forecast record 

contains actual or estimated dates and 

funding levels for awards that an 

operating division intends to award 

during the fiscal year. ACF’s publicly 

published funding opportunity 

announcements are available on http:// 

www.Grants.gov, where applicants may 

also apply for funding electronically, 

and on the ACF Grant Opportunities 

Web page at http://www.acf.hhs.gov/ 

grants/. 

FOR FURTHER INFORMATION CONTACT: 

Myles Schlank, Office of Child Support 

Enforcement, 370 L’Enfant Promenade, 

SW., Washington, DC 20047. Telephone: 

202–401–9329, e-mail: 

myles.schlank@acf.hhs.gov. 

Dated: June 15, 2009. 

Robert Cohen, 

Acting Commissioner, Program Office: Child 

Support Enforcement. 

[FR Doc. E9–14363 Filed 6–18–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Reimbursement of Travel and 

Subsistence Expenses toward Living 

Organ Donation Eligibility Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Response to solicitation of 

comments on amendment to program 

follow-up period and publication of 

amended Program Eligibility 

Guidelines. 

SUMMARY: This notice finalizes an 

amendment to the eligibility guidelines 

proposed on March 4, 2009 in the 

Federal Register (74 FR 9407). The 

purpose of this notice was to solicit 

comments on the amendment to the 

Program Eligibility Guidelines proposed 

by HRSA concerning the 

Reimbursement of Travel and 

Subsistence Expenses Program followup period. 

FOR FURTHER INFORMATION CONTACT: 

Richard Durbin, Director, Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, Parklawn Building, 

Room 12C–06, 5600 Fishers Lane, 

Rockville, Maryland 20857; telephone 

(301) 443–7577; fax (301) 594–6095; or 

E-mail: rdurbin@hrsa.gov. 

SUPPLEMENTARY INFORMATION: In the 

existing Program eligibility guidelines, 

under the Qualifying Expenses Section, 

the first paragraph states: 

‘‘For the purposes of the Reimbursement of 

Travel and Subsistence Expenses toward 

Living Organ Donation Program, qualifying 

expenses presently include only travel, 

lodging, and meals and incidental expenses 

incurred by the donor and/or his/her 

accompanying person(s) as part of: 

(1) Donor evaluation, clinic visit or 

hospitalization, 

(2) Hospitalization for the living donor 

surgical procedure, and/or 

(3) Medical or surgical follow-up clinic 

visit or hospitalization within 90 days 

following the living donation procedure.’’ 

HRSA proposed amending the first 

bullet of this paragraph to read: ‘‘(1) 

Donor evaluation, and/or’’. In addition, 

HRSA proposed amending the third 

bullet of this paragraph to read: ‘‘(3) 

Medical or surgical follow-up clinic 

visit or hospitalization within two 

calendar years or beyond—if 

exceptional circumstances exist— 

following the living donation 

procedure.’’ The purpose of this 

proposed change was to bring the 

NLDAC follow-up period in line with 

the OPTN policies of a 2-year follow-up 

of living organ donors. 

HRSA received six public comments 

on this request. All the respondents 

mstockstill on PROD1PC66 with NOTICES