Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)

The summary for the Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed): Drug development tools (DDTs) are methods, materials, or measures that can potentially facilitate drug development. To support DDT development efforts, FDA established qualification programs for animal models for use under the Animal Rule, biomarkers, and clinical outcome assessments. Examples of DDTs may include but are not limited to: a biomarker used for clinical trial enrichment, a clinical outcome assessment (COA) used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures under the regulations commonly referred to as the Animal Rule. Qualification is a conclusion that within the stated context of use, the DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review under the FD&C Act. Qualification does not encompass the use of a DDT outside the COU specified through the qualification process. Once qualified, a DDT may be used within the qualified Context of Use (COU) as part of any relevant drug or biologic Investigational New Drug Application (IND), New Drug Application (NDA) or Biologic Licensing Application (BLA) without submission of additional information to justify the use of the DDT. Qualification of a DDT is voluntary and the use of a qualified DDT is not required for drug or biologic development. However, having qualified DDTs that can be used by multiple sponsors helps optimize drug development and evaluation. Increased public availability of qualified DDTs for specific contexts of use is anticipated to benefit the public health through (1) increased availability of effective drugs, (2) earlier access to medical therapies and (3) an enhanced knowledge of the drug under development. The qualification process allows for greater efficiency of development of DDTs by promoting DDT development in the precompetitive arena through collaborative efforts such as public-private partnerships and consortia. These grants will be used to provide funding to developers of drug development tools that have an accepted letter of intent within CDER's Drug Development Tool Qualification Program and working towards their qualification plan or full qualification package as described here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm378219.htm . The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. Applicants should use the outline of the qualification plan or full qualification package of the respective DDT program they are in, to assist in developing their grant application. Funding will only support grantee's work towards either their qualification plan or full qualification package.
Federal Grant Title: Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)
Federal Agency Name: Food and Drug Administration (HHS-FDA)
Grant Categories: Agriculture Consumer Protection Food and Nutrition
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-19-028
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Information not provided
Current Application Deadline: August 5th, 2019
Original Application Deadline: August 5th, 2019
Posted Date: June 10th, 2019
Creation Date: June 10th, 2019
Archive Date: September 4th, 2019
Total Program Funding: $7,000,000
Maximum Federal Grant Award: $250,000
Minimum Federal Grant Award:
Expected Number of Awards: 30
Cost Sharing or Matching: No
Last Updated: June 10th, 2019
Applicants Eligible for this Grant
State governments - County governments - City or township governments - Special district governments - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses
Link to Full Grant Announcement
Funding Opportunity Announcement
Grant Announcement Contact
Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: shashi.malhotra@fda.hhs.gov
shashi.malhotra@fda.hhs.gov
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