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Innovation Award: COVID-19 and Health Equity in the US

Deadline: 6-Dec-22

The U.S. Food and Drug Administration (FDA) has announced the Innovation Award: COVID-19 and Health Equity to fund COVID research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making.

The FDA Office of Minority Health and Health Equity (OMHHE) is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography.

 Research Objectives
  • These efforts focus on advancing innovative research that will strengthen and advance COVID-19 health equity research.
  • OMHHE is interested in research proposals that will contribute to advancing understanding of COVID-19 and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19.  These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography.
  • The following studies are encouraged under this FOA:
    • Studies that leverage real world data to support evaluation of outcomes of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19 by demographic data including, but not limited to, ethnicity, race, age, disability and geography.
    • Studies that advance understanding of how to mitigate spread of COVID-19 misinformation and disinformation about science and medicine.
    • Studies that leverage big data, novel data sources and artificial intelligence/machine learning options that contribute to the continued evaluation of the safety and efficacy of COVID-19 FDA-approved products (therapeutics, diagnostics, and vaccines) by demographic data including, but not limited to, ethnicity, race, age, disability, and geography.
    • Studies that continue to advance understanding of long COVID by demographic data including, but not limited to, ethnicity, race, age, disability and geography.
Funding Information
  • FDA’s Office of Minority Health and Health Equity OMHHE intends to fund up to $2,000,000 for fiscal year 2023 in support of this cooperative agreement program.
  • It is anticipated that up to FOUR (4) awards will be made, not to exceed $500,000 in total costs (direct plus indirect) per award.
  • Duration: The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support.
Eligibility Criteria
  • 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:
    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • 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)
  • Local 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
  • Foreign Institutions
  • Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
  • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
  • Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
Applicant Organizations
  • Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.
  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process.  The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons – Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one
  • Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
  • Program Directors/Principal Investigators (PD(s)/PI(s))
  • All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

For more information, visit https://www.grants.gov/web/grants/view-opportunity.html?oppId=341830