Opportunity Information: Apply for RFA RM 17 019

The grant opportunity titled "Clinical Sites for the Undiagnosed Diseases Network (UDN) Phase II (U01)" (Funding Opportunity Number RFA-RM-17-019) is a National Institutes of Health (NIH) funding announcement aimed at supporting clinical sites that will participate in Phase II of the Undiagnosed Diseases Network. The UDN is designed to help patients with complex, rare, or unusual conditions who have not received a definitive diagnosis despite extensive prior medical evaluation. Under this announcement, NIH is seeking organizations that can serve as clinical hubs within the network, contributing specialized clinical expertise, advanced diagnostic evaluation, and coordinated patient-focused efforts that align with the broader goals of the UDN.

This opportunity uses the Cooperative Agreement mechanism (U01), which typically indicates a more hands-on partnership between NIH and the award recipients than a standard grant. In practice, that usually means NIH expects substantial programmatic involvement, coordination across multiple sites, and active participation in network-wide activities rather than isolated, independent projects. The activity category is Health, and the CFDA number listed is 93.310, which corresponds to NIH programs associated with research and related health activities.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; and Native American tribal organizations that are not federally recognized tribal governments. The announcement also allows nonprofit organizations (both with and without 501(c)(3) status, as long as they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses. In addition to these categories, the FOA explicitly calls out several other eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible agencies of the federal government, regional organizations, Indian/Native American tribal governments other than federally recognized tribes, and U.S. territories or possessions.

At the same time, there are important restrictions regarding foreign participation. Non-domestic (non-U.S.) entities, described as foreign organizations and foreign institutions, are not eligible to apply as the main applicant. Similarly, non-domestic components of U.S. organizations are not eligible to apply. However, the FOA states that foreign components are allowed, as defined in the NIH Grants Policy Statement. That distinction usually means a U.S.-based applicant can include certain types of foreign collaborations or elements in the project if they fit NIH policy definitions and are justified, but the primary awardee organization must be domestic and eligible under the announcement rules.

Key administrative details included in the listing are that the sponsoring agency is the National Institutes of Health, the opportunity category is discretionary, and the original closing date for applications was 2017-11-02, with a creation date of 2017-08-15. The award ceiling and the expected number of awards are not specified in the provided source data, which suggests that applicants would have needed to consult the full FOA text or NIH guidance for budgetary limits, anticipated award counts, and other programmatic requirements. Overall, the opportunity is structured to expand or sustain a coordinated national network of clinical sites capable of tackling difficult-to-diagnose conditions through collaborative, high-level clinical evaluation and network participation under NIH’s cooperative agreement framework.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Sites for the Undiagnosed Diseases Network (UDN) Phase II (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
  • This funding opportunity was created on 2017-08-15.
  • Applicants must submit their applications by 2017-11-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: 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.
Apply for RFA RM 17 019

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FAQs: Clinical Sites for the Undiagnosed Diseases Network (UDN) Phase II (U01)

What is the title of this grant opportunity?

The opportunity is titled "Clinical Sites for the Undiagnosed Diseases Network (UDN) Phase II (U01)."

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-RM-17-019.

Which federal agency is sponsoring this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What is the purpose of this funding opportunity?

This NIH funding announcement is intended to support clinical sites that will participate in Phase II of the Undiagnosed Diseases Network (UDN). The UDN focuses on helping patients who have complex, rare, or unusual conditions and who have not received a definitive diagnosis despite extensive prior medical evaluation.

What is the Undiagnosed Diseases Network (UDN)?

The UDN is a coordinated network designed to evaluate patients with difficult-to-diagnose conditions. It aims to bring together specialized clinical expertise, advanced diagnostic evaluation, and coordinated patient-focused efforts to help reach diagnoses for individuals who remain undiagnosed after significant prior workups.

What kind of organizations is NIH looking for under this announcement?

NIH is seeking organizations that can serve as clinical hubs within the UDN. These clinical sites are expected to contribute specialized clinical expertise, advanced diagnostic evaluation, and coordinated efforts that align with the broader goals of the network.

What funding mechanism is used for this program?

This opportunity uses the Cooperative Agreement mechanism (U01).

What does it mean that this is a Cooperative Agreement (U01) rather than a standard grant?

A U01 cooperative agreement typically reflects a more substantial partnership between NIH and award recipients than a standard grant. In practice, this usually implies NIH expects substantial programmatic involvement, coordination across multiple sites, and active participation in network-wide activities, rather than isolated or fully independent projects.

What is the activity category for this opportunity?

The activity category is Health.

What is the CFDA number associated with this opportunity?

The CFDA number listed is 93.310, which corresponds to NIH programs associated with research and related health activities.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include:

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Federally recognized Native American tribal governments
  • Public housing authorities and Indian housing authorities
  • Native American tribal organizations (other than federally recognized tribal governments)
  • Nonprofit organizations (with or without 501(c)(3) status, as long as they are not institutions of higher education)
  • For-profit organizations (other than small businesses)
  • Small businesses

Are any specific institution types explicitly called out as eligible?

Yes. The announcement explicitly identifies additional eligible applicant types, including:

  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Faith-based or community-based organizations
  • Eligible agencies of the federal government
  • Regional organizations
  • Indian/Native American tribal governments other than federally recognized tribes
  • U.S. territories or possessions

Are foreign organizations eligible to apply as the primary applicant?

No. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the main applicant.

Are non-domestic components of U.S. organizations eligible to apply?

No. Non-domestic components of U.S. organizations are not eligible to apply.

Are foreign components allowed in a project if the applicant is U.S.-based?

Yes. The FOA states that foreign components are allowed, as defined in the NIH Grants Policy Statement. This generally means a U.S.-based applicant may include certain foreign collaborations or elements if they fit NIH policy definitions and are appropriately justified, but the primary awardee organization must be domestic and otherwise eligible under the announcement.

What is the opportunity category?

The opportunity category is discretionary.

When was the opportunity created?

The creation date listed is 2017-08-15.

What was the original closing date for applications?

The original closing date for applications was 2017-11-02.

Is the award ceiling provided?

No. The award ceiling is not specified in the provided source information.

Is the expected number of awards provided?

No. The expected number of awards is not specified in the provided source information.

What would applicants have needed to consult for budget limits or award counts?

Because the award ceiling and expected number of awards are not included in the provided listing, applicants would have needed to consult the full FOA text or NIH guidance for details such as budgetary limits, anticipated award counts, and other programmatic requirements.

How does this opportunity fit into the broader goals of the UDN?

Overall, the opportunity is structured to expand or sustain a coordinated national network of clinical sites capable of addressing difficult-to-diagnose conditions through collaborative, high-level clinical evaluation and active participation in network-wide efforts under NIH's cooperative agreement framework.

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