# Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed)

Source: https://welltoldgrants.com/grants/rfa-fd-22-022-deconstruction-of-data-and-standards-to-support/  
Official notice: https://www.grants.gov/search-results-detail/336599

> Food and Drug Administration offered grants of up to $350,000 (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make one award worth $350,000 in total. Applications closed on March 31, 2022.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-22-022 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 31, 2022 |
| Award ceiling | $350,000 |
| Award floor | $50,000 |
| Expected awards | 1 |
| Total funding | $350,000 |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- 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

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe 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 EducationNonprofits 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 OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsForeign InstitutionsNon-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.

## What the grant funds

Data concepts (not just the information but the underlying definition of its meaning) between many different sources of real-world data (RWD) (e.g., EHRs, Claims, and digital health technologies) as well as those used in clinical research and regulatory submissions are almost always similar but not identical. This difference requires mapping and transforming data between RWD and clinical research use to rely heavily on human interpretation and is an obstacle to developing a fully reliable computer-driven approach. This request for applications is aimed at defining the elemental components of RWD in a way that may support future computable approaches to defining what is currently only implied by definitions of data elements or business practices to facilitate standardization for regulatory submissions.

## Questions people ask

### Is RFA-FD-22-022 still open?

No. It closed on March 31, 2022. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed)?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed)?

Closed March 31, 2022. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $350,000 each. About $350,000 in total for one award.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.