Clinical Trials Transformation Initiative (U19), 29216-29217 [E9-14436]

Download as PDF 29216 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Form name Number of respondents State Education Agency Contacts .................. School District Contacts ................................. School Administrators ..................................... Teachers ......................................................... Students .......................................................... State Recruitment Script ................................ District Recruitment Script .............................. School Recruitment Script .............................. Data Collection Checklist and Make-up Form NYPANS Questionnaire ................................. Height and Weight Record Form ................... Student Contact Form .................................... 24–Hour Dietary Recall Interview Script ........ Dated: June 15, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–14411 Filed 6–18–09; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P Proposed Information Collection Activity; Comment Request Administration for Children and Families Proposed Projects Title: Head Start Eligibility Verification. OMB No.: New Collection. Description: The requirements for establishing proof of eligibility for the Average burden per response (in hours) Number of responses per respondent 17 80 133 400 8,000 8,000 1,200 750 1 1 1 1 1 1 1 3 30/60 30/60 30/60 15/60 45/60 3/60 2/60 30/60 enrollment of children in Head Start programs are documented in 45 CFR 1305.4(e). Each child’s record must include a signed document by an employee identifying those documents which were reviewed to determine eligibility. Presently there is no uniform document which the employee must sign. This form will be used to facilitate an efficient and accurate determination of childrens’ eligibility for Head Start enrollment. Respondents: Head Start grantees. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Head Start Eligibility Verification ...................................................................... mstockstill on PROD1PC66 with NOTICES Instrument 1,600 750 0.08 96,000 Estimated Total Annual Burden Hours: 96,000. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the VerDate Nov<24>2008 16:25 Jun 18, 2009 Jkt 217001 proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: June 16, 2009. Janean Chambers, Reports Clearance Officer. [FR Doc. E9–14482 Filed 6–18–09; 8:45 am] BILLING CODE 4184–01–P PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0262] Clinical Trials Transformation Initiative (U19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of grant funds to support the Clinical Trials Transformation Initiative (CTTI). The goal of CTTI is to support modernization of the clinical trial enterprise by identifying practices that will enhance human subject protection, boost the quality of information derived from clinical trials, and make the research process more efficient. DATES: Important dates are as follows: 1. The application is due by: July 6, 2009. 2. The anticipated start date is in: September 2009. E:\FR\FM\19JNN1.SGM 19JNN1 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Notices 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 mstockstill on PROD1PC66 with NOTICES 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 VerDate Nov<24>2008 16:25 Jun 18, 2009 Jkt 217001 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 https://www.fda.gov/ ScienceResearch/SpecialTopics/ CriticalPathInitiative/ SpotlightonCPIProjects/ ucm083241.htm. Persons interested in applying for a grant may obtain PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 29217 application forms and instructions at https://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 https:// 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. E:\FR\FM\19JNN1.SGM 19JNN1

Agencies

[Federal Register Volume 74, Number 117 (Friday, June 19, 2009)]
[Notices]
[Pages 29216-29217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14436]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0262]


Clinical Trials Transformation Initiative (U19)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds to support the Clinical Trials 
Transformation Initiative (CTTI). The goal of CTTI is to support 
modernization of the clinical trial enterprise by identifying practices 
that will enhance human subject protection, boost the quality of 
information derived from clinical trials, and make the research process 
more efficient.

DATES: Important dates are as follows:
    1. The application is due by: July 6, 2009.
    2. The anticipated start date is in: September 2009.

[[Page 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 https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm083241.htm. Persons interested in applying 
for a grant may obtain application forms and instructions at https://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 
https://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
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