Opportunity Information: Apply for RFA RM 13 004
Apply for RFA RM 13 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Sites for an Undiagnosed Diseases Network (UDN) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
- This funding opportunity was created on Jan 29, 2013 and posted on Jan 29, 2013.
- Applicants must submit their applications by Jun 19, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Public and State controlled institutions of higher education Small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession 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 NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NIH funding opportunity RFA-RM-13-004, titled "Clinical Sites for an Undiagnosed Diseases Network (UDN) (U01)," was a discretionary federal grant competition that used the cooperative agreement mechanism (U01). In plain terms, NIH was looking to fund clinical sites that would become part of a broader Undiagnosed Diseases Network (UDN), explicitly designed to extend and build on the NIH Intramural Research Program's existing Undiagnosed Diseases Program (IRP UDP). The core idea behind the announcement was to create a coordinated set of clinical centers capable of evaluating patients who have serious, often multi-system conditions that have remained undiagnosed despite extensive medical workups, and to connect those sites into a networked model that can share expertise, data, and research resources.
Because the award type is a cooperative agreement, the opportunity implied an unusually active partnership between NIH and the awardees compared to a standard research grant. Under a U01, NIH typically expects substantial programmatic involvement, meaning the funded clinical sites would not operate as isolated projects but would work closely with NIH and with other network components to meet shared goals, follow common protocols, and contribute to network-wide deliverables. The activity category for the announcement was health, and it was listed under CFDA 93.310 (Trans-NIH Research Support), signaling that it was meant to serve broad NIH priorities across multiple institutes and disease areas rather than focusing on a single condition.
The main purpose was the establishment of "Clinical Sites" within the UDN. A clinical site in this context generally means a specialized center capable of receiving referrals, conducting deep phenotyping (detailed clinical characterization), coordinating advanced diagnostic testing, and integrating research approaches when standard clinical pathways fail. These sites are typically expected to bring together multidisciplinary teams (for example, medical genetics, neurology, immunology, metabolism, radiology, pathology, bioinformatics, and other specialties as needed) and to be able to manage complex cases over time. In a network like UDN, the clinical sites also usually serve as the front door for patient evaluation and as a critical point of integration between clinical care and research, including the generation of high-quality clinical data and biospecimens that can be used to identify new diseases, new gene-disease relationships, or new mechanisms of disease.
From an administrative standpoint, the opportunity did not require cost sharing or matching, which reduces barriers for applicants and means NIH planned to support the proposed work without requiring the applicant to contribute a defined portion of the project cost. The funding instrument type was a cooperative agreement rather than a contract, which generally indicates NIH sought investigator-driven scientific and clinical leadership within a framework of NIH coordination, rather than purchasing a predefined service.
Eligibility was broad across U.S.-based organizations and government entities. Eligible applicants included state, county, city or township, special district, and tribal governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding higher education in those categories where specified); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly noted additional eligible applicants such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and tribal governments that are not federally recognized. At the same time, it was clear that non-U.S. entities could not apply: foreign institutions were not eligible, non-domestic components of U.S. organizations were not eligible, and foreign components (as NIH defines them) were not allowed. In practice, that means the clinical infrastructure and the key project activities needed to be based in the United States and carried out by U.S.-eligible organizations.
The timeline shows this was a time-limited, archived opportunity from 2013. It was posted on January 29, 2013, with an original and current closing date of June 19, 2013, and an archive date of July 20, 2013. That combination indicates NIH solicited applications during that window, made awards afterward, and then closed the solicitation, which is typical for a network-building RFA where NIH wants to stand up a cohort of sites at the same time. The listing also included an NIH Office of Extramural Research (OER) contact for technical difficulties accessing the announcement online, pointing applicants to the OER Webmaster.
In short, this RFA was aimed at building a national, coordinated set of clinical hubs for diagnosing the hardest-to-diagnose patients by combining intensive clinical evaluation with research-grade methods and by linking those hubs into a shared NIH-supported network that expanded the reach of the original NIH intramural Undiagnosed Diseases Program.
FAQs: NIH RFA-RM-13-004 - Clinical Sites for an Undiagnosed Diseases Network (UDN) (U01)
What is the funding opportunity RFA-RM-13-004?
RFA-RM-13-004 was an NIH discretionary federal grant competition to fund clinical sites as part of an Undiagnosed Diseases Network (UDN). The goal was to stand up a coordinated set of clinical centers that could evaluate patients with serious, often multi-system conditions that remained undiagnosed after extensive medical workups.
What does UDN stand for, and what was the network intended to do?
UDN stands for Undiagnosed Diseases Network. It was intended to connect specialized clinical sites into a shared network model so they could share expertise, data, and research resources while working to diagnose complex, unresolved patient cases and expand knowledge about diseases and mechanisms.
How did this opportunity relate to the NIH Intramural Undiagnosed Diseases Program (IRP UDP)?
The UDN clinical sites were explicitly designed to extend and build on the NIH Intramural Research Program's existing Undiagnosed Diseases Program (IRP UDP). In other words, NIH was scaling a successful intramural effort into a broader, multi-site national network.
What type of award mechanism was used?
This opportunity used the cooperative agreement mechanism (U01). That is a type of grant in which NIH expects substantial programmatic involvement compared to a standard research grant.
What does it mean that this was a cooperative agreement (U01)?
Because it was a U01 cooperative agreement, funded clinical sites were expected to work closely with NIH and other UDN components rather than operate as isolated projects. The structure implied coordinated network goals, common protocols, shared deliverables, and active NIH involvement in programmatic aspects of the work.
What was the main purpose of this RFA?
The main purpose was to establish "Clinical Sites" within the UDN. These sites would serve as specialized centers for referral intake, intensive clinical characterization (deep phenotyping), advanced diagnostic testing coordination, and integration of research approaches when conventional clinical evaluation does not yield a diagnosis.
What is a "Clinical Site" in the context of the UDN?
A clinical site in this context refers to a specialized center capable of evaluating difficult, unresolved patient cases using multidisciplinary expertise and research-grade methods. The site would typically function as a hub for patient evaluation and for generating high-quality clinical data and biospecimens that support discovery and diagnosis efforts across the network.
What kinds of patients were these clinical sites meant to evaluate?
The sites were intended to evaluate patients with serious conditions, often affecting multiple body systems, who remained undiagnosed despite extensive prior medical workups.
What is "deep phenotyping" as described in the opportunity?
Deep phenotyping was described as detailed clinical characterization. In practice, within this network context, it meant capturing comprehensive and high-quality clinical information to support advanced diagnostic and research approaches for undiagnosed conditions.
What types of specialties were expected to be involved at a clinical site?
The opportunity indicated that clinical sites typically bring together multidisciplinary teams. Examples mentioned include medical genetics, neurology, immunology, metabolism, radiology, pathology, bioinformatics, and other specialties as needed to handle complex cases.
How were clinical care and research expected to connect in this network model?
The clinical sites were expected to be a key integration point between patient evaluation and research, including generating high-quality clinical data and biospecimens that could help identify new diseases, new gene-disease relationships, or new mechanisms of disease.
What was the activity category for this funding opportunity?
The activity category was health.
What CFDA number was associated with this opportunity, and what does it signal?
The opportunity was listed under CFDA 93.310 (Trans-NIH Research Support). This signaled that it was meant to support broad NIH priorities across multiple institutes and disease areas rather than focusing on a single condition.
Was cost sharing or matching required?
No. The opportunity stated that cost sharing or matching was not required, meaning NIH planned to support the proposed work without requiring a defined applicant contribution to project costs.
Was this award more like a contract or a grant?
It was a cooperative agreement, which is a type of grant mechanism rather than a contract. The description emphasized investigator-driven scientific and clinical leadership within a framework of NIH coordination, as opposed to NIH purchasing a predefined service.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations and government entities. Eligible applicants included state, county, city or township, special district, and tribal governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding higher education in those categories where specified); for-profit organizations other than small businesses; and small businesses.
Were there specific types of institutions explicitly noted as eligible?
Yes. The opportunity explicitly noted additional eligible applicants such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and tribal governments that are not federally recognized.
Were foreign institutions allowed to apply?
No. The opportunity stated that foreign institutions were not eligible.
Could a U.S. organization apply if the work would be done outside the United States?
No. Non-domestic components of U.S. organizations were not eligible, and foreign components (as NIH defines them) were not allowed. The clinical infrastructure and key project activities needed to be based in the United States and carried out by U.S.-eligible organizations.
When was this opportunity open, and is it still active?
This was a time-limited opportunity from 2013. It was posted on January 29, 2013, had a closing date of June 19, 2013 (original and current), and was archived on July 20, 2013. The archive status indicates the solicitation is closed.
Why would NIH use a time-limited RFA for building a network?
The timeline and archived status are consistent with a network-building RFA where NIH aims to select and launch a cohort of sites within the same general timeframe so the network can be established and coordinated as a unified program.
Who was listed as a contact for technical problems accessing the announcement online?
The listing included an NIH Office of Extramural Research (OER) contact for technical difficulties accessing the announcement online, directing applicants to the OER Webmaster.
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