Opportunity ID: 314427

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-19-015
Funding Opportunity Title: Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Apr 01, 2019
Last Updated Date: Apr 01, 2019
Original Closing Date for Applications: Jun 03, 2019
Current Closing Date for Applications: Jun 03, 2019
Archive Date: Jul 03, 2019
Estimated Total Program Funding: $37,500,000
Award Ceiling: $37,500,000
Award Floor: $7,500,000

Eligibility

Eligible Applicants: Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: The following organization is eligible to apply:Duke University

Additional Information

Agency Name: Food and Drug Administration
Description: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) 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) to support the Clinical Trials Transformation Initiative (CTTI).     
Link to Additional Information: Full Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Shashi Malhotra

Grants Management Specialist

Phone 2404027592
Email:shashi.malhotra@fda.hhs.gov

Version History

Version Modification Description Updated Date
Apr 01, 2019
Apr 01, 2019

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-19-015
Funding Opportunity Title: Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Apr 01, 2019
Last Updated Date: Apr 01, 2019
Original Closing Date for Applications: Jun 03, 2019
Current Closing Date for Applications: Jun 03, 2019
Archive Date: Jul 03, 2019
Estimated Total Program Funding: $37,500,000
Award Ceiling: $37,500,000
Award Floor: $7,500,000

Eligibility

Eligible Applicants: Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: The following organization is eligible to apply:Duke University

Additional Information

Agency Name: Food and Drug Administration
Description: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) 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) to support the Clinical Trials Transformation Initiative (CTTI).     
Link to Additional Information: Full Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Shashi Malhotra

Grants Management Specialist

Phone 2404027592
Email:shashi.malhotra@fda.hhs.gov

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-19-015
Funding Opportunity Title: Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Apr 01, 2019
Last Updated Date: Apr 01, 2019
Original Closing Date for Applications:
Current Closing Date for Applications: Jun 03, 2019
Archive Date: Jul 03, 2019
Estimated Total Program Funding: $37,500,000
Award Ceiling: $37,500,000
Award Floor: $7,500,000

Eligibility

Eligible Applicants: Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Eligible Organizations

The following organization is eligible to apply:

Duke University

Additional Information

Agency Name: Food and Drug Administration
Description: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research
(CDER), Office of Medical Policy (OMP) 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) to support the
Clinical Trials Transformation Initiative (CTTI).     
Link to Additional Information: Full Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Shashi Malhotra

Grants Management Specialist

Phone 2404027592
Email:shashi.malhotra@fda.hhs.gov

Related Documents

Packages

Agency Contact Information: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
Email: shashi.malhotra@fda.hhs.gov
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
93.103 RFA-FD-19-015 FORM E PKG00249608 Apr 01, 2019 Jun 03, 2019 View

Package 1

Mandatory forms

314427 RR_SF424_2_0-2.0.pdf

314427 PHS398_CoverPageSupplement_4_0-4.0.pdf

314427 RR_OtherProjectInfo_1_4-1.4.pdf

314427 PerformanceSite_2_0-2.0.pdf

314427 RR_KeyPersonExpanded_2_0-2.0.pdf

314427 RR_Budget_1_4-1.4.pdf

314427 PHS398_ResearchPlan_4_0-4.0.pdf

Optional forms

314427 RR_SubawardBudget30_1_4-1.4.pdf

314427 PHS_AssignmentRequestForm_2_0-2.0.pdf

2025-07-09T13:52:11-05:00

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