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Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional - Federal Grants

Funding Opportunity Overview

Opportunity NumberRFA-FD-20-030
Opportunity TitleExploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional
Opportunity CategoryDiscretionary
Funding Instrument TypeCooperative Agreement
Post DateMarch 16, 2020 (Monday)
Last Updated DateMarch 16, 2020 (Monday)
Close DateMay 11, 2020 (Monday)
Award Amount$1,000,000 - $12,000,000

Funding Detail Description

The purpose of this Funding Opportunity Announcement (FOA) is 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.

Funding Additional Information

Agency NameFood and Drug Administration
Important Dates
Post DateMarch 16, 2020 (Monday)
Close DateMay 11, 2020 (Monday)
Last Updated DateMarch 16, 2020 (Monday)
Archive DateJune 10, 2020 (Wednesday)
Awards Detail
Award Floor$1,000,000
Award Ceiling$12,000,000
Expected Number Of Awards2
Cost Sharing or Matching RequirementNo
Additional InformationFull Announcement
Additional Information URLhttps://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-030.html

CFDA Numbers

Next CFDA (Catalog of Federal Domestic Assistance) numbers are associated to this grant.
  • 93.103 - Food and Drug Administration_Research

Categories of Funding Activities

Categories of Funding Activities

  • Agriculture
  • Consumer Protection
  • Food and Nutrition

Category Explanation

  • No Additional Explanation Reported

Funding Eligibility

Eligible Applicants

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • 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
  • Others

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 Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o 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 Possession Other 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

Grantor Contact Information

Grantor ContactShashi Malhotra
Grants Management Specialist
Phone 2404027592
Emailshashi.malhotra@fda.hhs.gov
(work email)