Document ID: FDA-2014-N-0610-0001
Agency: fda
Document Type: Notice
Title: Increasing the Quality and Efficiency of Clinical Trials
Posted Date: 2014-05-23T04:00Z

[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29780-29781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0610]

Increasing the Quality and Efficiency of Clinical Trials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the efforts of the 
Center for Drug Evaluation and Research/Office of Medical Policy to 
increase the quality and efficiency of clinical trials. The Food and 
Drug Administration (FDA), Center for Drug Evaluation and Research 
(CDER), Office of Medical Policy is announcing its intent to accept and 
consider a single-source application for the award of a grant to the 
Duke University's Duke Translational Medicine Institute (DTMI).

DATES: The application due date is June 30, 2014, by 11:59 p.m. Eastern 
Time. The expiration date is July 1, 2014.

ADDRESSES: Submit electronic applications to: http://www.grants.gov. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: Mark Lauda, Office of Medical Policy, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10990 New Hampshire Ave., Bldg. 51, Rm. 2212, Silver Spring, MD 20993, 
301-796-0381, email: Mark.Lauda@fda.hhs.gov; or Lisa Ko, Office of 
Acquisition & Grants Services, Food and Drug Administration, 5630 
Fishers Lane, Rockville, MD, 240-402-7592, email: Lisa.Ko@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://www.grants.gov. Search by Funding Opportunity Number: 
RFA-FD-14-017.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-14-017
93.103

A. Background

    It has long been recognized that the clinical trial enterprise will 
need to evolve in order to meet the demand to provide data to support 
evidence-based decisionmaking. A memorandum of understanding (MOU) 
between FDA and Duke University published in the Federal Register on 
November 23, 2007, served as the basis for the establishment of the 
Clinical Trials Transformation Initiative (CTTI). CTTI is a public-
private partnership whose mission is to identify and promote practices 
that will increase the quality and efficiency of clinical trials. This 
award will be made to DTMI within Duke University to identify and 
implement projects and disseminate resulting findings that will 
increase the quality and efficiency of clinical trials, CTTI's mission.
    CTTI membership is broad and includes stakeholders from government, 
industry, patient advocacy and consumer groups, professional societies, 
clinical research organizations, and academia. CTTI helps to effect 
change through the conduct of projects that identify existing 
inefficiencies, elucidate superior practices, and/or provide innovative 
approaches to evidence generation and medical product development. CTTI 
conducts projects that are either: (1) Proposed by its member 
organizations, including FDA, developed during review by its Steering 
Committee, and endorsed by its Executive Committee or (2) responsive to 
urgent needs of FDA.
    The opportunity for meaningful interaction with a broad set of 
stakeholders committed to improving the clinical trial enterprise and 
also the ability to rapidly gather data to address emerging issues 
offer significant value to the clinical trial enterprise. Since its 
inception, CTTI has undertaken many projects that have direct relevance 
to FDA's mission, including investigational new drug (IND) safety 
reporting, clinical trial monitoring, use of central investigational 
review boards, and antibacterial drug development.

B. Research Objectives

    The goals of this program are to develop and maintain an 
administrative and scientific infrastructure to support the creation 
and execution of a series of projects under the auspices of CTTI that 
will increase the quality and efficiency of clinical trials. The 
following are examples of activities that could be supported by this 
grant:
     Maintaining an adequate administrative and scientific 
infrastructure to implement all related projects under this 
collaborative effort.
     Identifying and/or hiring a sufficient number of qualified 
personnel to conduct activities, including project management, such as 
review of project milestones for degree of completion, preparation/
reporting of project findings, periodic and final reports, and for 
subsequent distribution in the public domain.
     Developing plans for the conduct of identified projects.
     Identifying, securing, and/or building, and effectively 
leveraging other resources for the conduct of identified projects.
     Upon completion of a given project, generating project 
results and recommendations and proposing related studies/projects, if 
needed, to build on the findings of the project and continuing to 
leverage established resources and personnel.

C. Eligibility Information

    The following organization is eligible to apply: DTMI located 
within Duke University.

II. Award Information/Funds Available

A. Award Amount

    This is a multiyear grant. FDA/CDER intends to fund up to 
$7,500,000 in total costs (direct and indirect) in Fiscal Year 2014. 
Awards are contingent upon the availability of funds.
    Subject to the availability of Federal funds and successful 
performance of the FOA's stated goals and objectives, four additional 
years of support may be

[[Page 29781]]

available. Funding beyond the first year will be noncompetitive and 
will depend on: (1) Satisfactory performance during the preceding year 
and (2) the availability of Federal fiscal year funds.
    Application budgets need to reflect the actual needs of the 
proposed project and should not exceed the following in total costs 
(direct and indirect):

Year 01: $7,500,000
Year 02: $7,500,000
Year 03: $7,500,000
Year 04: $7,500,000
Year 05: $7,500,000

B. Length of Support

    The scope of the proposed project should determine the project 
period. The maximum project period is 5 years.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an 
electronic application in response to this FOA, applicants should first 
review the full announcement located at http://www.grants.gov. Search 
by Funding Opportunity Number: RFA-FD-14-017. (FDA has verified the Web 
site addresses throughout this document, but FDA is not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register.) For all electronically submitted 
applications, the following steps are required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM)
 Step 3: Obtain Username & Password
 Step 4: Authorized Organization Representative (AOR) 
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration 
(eRA) Commons

    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: May 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11924 Filed 5-22-14; 8:45 am]
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