[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34022-34023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0313]


Dual Antiplatelet Therapy Trial: Research Project Grant (R01)

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 Office of Critical 
Path Programs (OCPP). The goal of the Dual Antiplatelet Therapy (DAPT) 
Trial is to solicit a sole source grant application from Harvard 
Clinical Research Institute (HCRI) that proposes to provide funding in 
support of a dual antiplatelet therapy clinical trial being conducted 
by HCRI.

DATES: Important dates are as follows:
    1. The application due date is August 12, 2009.
    2. The anticipated start date is in September 2009.
    3. The opening date is July 14, 2009.
    4. The expiration date is in May 2010.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
    Nancy Stanisic, Office of Critical Path Programs (HF-18), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
1660.
    Vieda Hubbard, Office of Acquisitions and Grants Services, (HFA-
500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 
20857, 301-827-7177.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://www.fda.gov/oc/initiatives/criticalpath/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Request for Applications (RFA) Number: RFA-FD-09-016
Catalog of Federal Domestic Assistance Number: 93.103

A. Background

    OCPP is soliciting a sole source grant application from HCRI that 
proposes to provide funding in support of a dual antiplatelet therapy 
clinical trial being conducted by HCRI.
    Given the lack of randomized data, there is considerable 
uncertainty in the medical community about the optimal duration of dual 
antiplatelet therapy following Percutaneous Cardiac Intervention. It is 
unclear as to whether the duration of dual antiplatelet therapy in 
patients receiving Drug Eluting Stents (DES) should be 3 to 6 months 
(as was prescribed in the pivotal DES randomized trials conducted for 
premarket approval), 12 months (as per the American College of 
Cardiology/American Heart Association/Society for Cardiac Angiography 
and Interventions guidelines), or even longer. It is also unknown 
whether the presumed benefit of extended dual antiplatelet therapy is 
specific to DES or whether non-Acute Coronary Syndrome patients treated 
with BMS (e.g. stable angina) may also benefit from extended dual 
antiplatelet therapy. With these considerations in

[[Page 34023]]

mind, it is imperative that the risks and benefits of continued 
clopidogrel use be evaluated to determine, with greater precision, the 
optimal duration of dual anti-platelet therapy. This trial will be 
conducted with the unprecedented cooperation of four device 
manufacturers and two drug manufacturers under the direction of HCRI.

B. Research Objectives

    The Research Project Grant (R01) is an award to support a discrete, 
specified, circumscribed project to be performed by HCRI in areas 
representing the investigators' specific interests and competencies 
based on the mission of FDA. The development of the DAPT trial 
represents an important and critical new paradigm for FDA and the 
medical product development community --having identified a critical 
public health issue in a combination product that impacts hundreds of 
thousands of American patients, the device and drug industries are 
collaborating together to address this question with a single trial. 
The advantages of this concerted effort are obvious--obtaining an 
answer more quickly and with fewer resources expended. The study is 
unprecedented in the level of cooperation, both internal and external, 
that is required.
    FDA awards R01 grants to institutions/organizations of all types. 
This mechanism allows the program directors/principal investigators 
(PDs/PIs) to define the scientific focus or objective of the research 
based on particular areas of interest and competence. Although the PDs/
PIs write the grant application and are responsible for conducting and 
supervising the research, the actual applicant is the research 
institution/organization.
    One of OCPP's mandates is to identify and promote the development 
of collaborative partnerships and support mechanisms of innovative 
trial design. Innovative clinical trial design may make it possible to 
develop accepted protocols for smaller but smarter trials or trials 
that can be conducted with collaboration of multiple device and drug 
manufacturers. The development of the DAPT trial represents an 
important and critical new paradigm for FDA. When a critical public 
health issue is identified in a combination product that impacts 
thousands of American patients, the concerted effort of multiple parts 
of the agency can bring the members of the regulated industry and 
clinical community to develop a clinical trial that will provide the 
answers needed by practicing physicians.

C. Eligibility Information

    This award will be made to HCRI.

II. Award Information/Funds Available

A. Award Amount

    The total amount of funding that the agency expects to award 
through this announcement is $1.5 million. There will be one award.

B. Length of Support

    The total project period for the application submitted in response 
to this funding opportunity may not exceed 2 years.

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/oc/initiatives/criticalpath/. Persons interested in 
applying for a grant may obtain an application form at http://grants.nih.gov/grants/forms.htm. For all paper submissions, the 
following steps are required:
    <bullet> Step 1: Obtain a Dun and Bradstreet (DUNS) Number
    <bullet> Step 2: Register With Central Contractor Registration
    <bullet> Step 3: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, 
submit paper applications to: Vieda Hubbard (see FOR FURTHER 
INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT).

    Dated: July 8, 2009.
 Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16695 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S