This department is offering a grant to support research projects focusing on real-world data (RWD), real-world evidence (RWE), and related topics like data analytics, digital health tools, and innovative trial designs in healthcare settings.
Opportunity ID: 324928
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-20-007 |
| Funding Opportunity Title: | Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional |
| 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: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 25, 2021 |
| Last Updated Date: | May 25, 2021 |
| Original Closing Date for Applications: | – Archiving forecast |
| Current Closing Date for Applications: | – Archiving forecast |
| Archive Date: | May 26, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Native American tribal governments (Federally recognized) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Small businesses City or township governments |
| Additional Information on Eligibility: | Higher Education Institutions• Public/State Controlled Institutions of Higher Education • Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Governments• State Governments • County Governments• City or Township Governments• Special District Governments• Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized)• U.S. Territory or PossessionOther• Independent School Districts• Public Housing Authorities/Indian Housing Authorities• Native American Tribal Organizations (other than Federally recognized tribal governments)• Faith-based or Community-based Organizations• Regional Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
To support research projects that examine real-world data (RWD), real-world evidence (RWE), and related issues such as data analytics, the use of digital health tools, and innovative trial designs utilizing healthcare settings |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Officer Phone 301-796-8020 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
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