Opportunity Information: Apply for RFA DK 13 503
Apply for RFA DK 13 503
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)(U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Jul 18, 2013 and posted on Jul 18, 2013.
- Applicants must submit their applications by Nov 20, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities County governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments Public and State controlled institutions of higher education For profit organizations other than small businesses Private institutions of higher education State governments Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government 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 funding opportunity RFA-DK-13-503, titled "Limited Competition Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) (U01)," is a National Institutes of Health (NIH) cooperative agreement designed to keep the long-running NASH Clinical Research Network operating while it finishes key ongoing work. This is a limited competition announcement, meaning it is intended for a restricted pool of applicants rather than the broader research community, and it uses the U01 mechanism, which reflects an active partnership model where NIH staff have substantial involvement in oversight and coordination compared with standard investigator-initiated grants.
The core purpose is continuity: maintaining support for both the Network's Data Coordinating Center and its clinical sites so they can complete two clinical treatment trials already underway, one focused on adults and one focused on children. In parallel, the network is expected to continue its longitudinal observational research by collecting and maintaining biospecimens and detailed clinical data from both pediatric and adult participants with nonalcoholic fatty liver disease (NAFLD). That NAFLD spectrum explicitly includes simple steatosis, nonalcoholic steatohepatitis (NASH), and progression to cirrhosis, emphasizing that the network is not only interested in treatment effects but also in the natural history of disease over time and the biological samples needed to understand mechanisms and identify predictors of progression.
The NASH CRN itself has a well-established history, having been sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) since 2002 and previously renewed in 2009. The FOA frames the network's broader scientific mission as understanding the etiology and contributing factors of NASH, mapping its natural history and complications, and developing and testing therapies. In practice, this kind of network structure is meant to enable consistent protocols across multiple sites, improve statistical power through pooled enrollment, support standardized data and specimen handling, and produce clinically useful evidence that is harder to generate through single-center studies.
Administratively, the opportunity was posted July 18, 2013, with an application due date of November 20, 2013, and an archive date of December 21, 2013. The estimated total funding level is $5.5 million, and there is no cost-sharing or matching requirement. The activity category is listed under Food and Nutrition/Health, and the CFDA number provided is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), aligning the program with NIDDK's digestives and liver disease portfolio.
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, state and local governments, U.S. territories or possessions, public housing authorities, and tribal governments and tribal organizations. It also explicitly includes a range of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, as well as faith-based and community-based organizations and eligible federal agencies. At the same time, it clearly excludes non-U.S. entities: foreign institutions are not eligible, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed, reinforcing that the network and its coordinating infrastructure must remain U.S.-based.
Overall, this FOA is best understood as a continuation award opportunity aimed at protecting momentum in a mature, multi-site clinical research network. It prioritizes completing two ongoing interventional trials and sustaining a long-term NAFLD/NASH observational database with associated biospecimens, ensuring that the infrastructure, participant follow-up, and standardized data collection needed for robust conclusions remain in place through the end of the planned studies. For full details, NIH pointed applicants to the official announcement page at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-503.html, with NIH Office of Extramural Research (OER) webmaster contacts provided for access or linking issues.
Frequently Asked Questions (FAQs)
What is the funding opportunity number and title?
The funding opportunity is RFA-DK-13-503, titled "Limited Competition Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) (U01)."
What type of award mechanism is being used?
This opportunity uses the NIH U01 cooperative agreement mechanism. A U01 reflects an active partnership model where NIH staff have substantial involvement in oversight and coordination compared with standard investigator-initiated grants.
Is this a competitive opportunity open to all applicants?
No. This is a limited competition announcement, meaning it is intended for a restricted pool of applicants rather than the broader research community.
Which NIH institute is sponsoring this opportunity?
The opportunity is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH).
What is the main goal of this continuation opportunity?
The core purpose is continuity: maintaining support for the NASH Clinical Research Network so it can finish key ongoing work while keeping the network operating.
What network components are expected to be supported?
The FOA is designed to maintain support for both the Network's Data Coordinating Center and its clinical sites.
What major studies is the network expected to complete?
The network is expected to complete two clinical treatment trials that are already underway: one focused on adults and one focused on children.
Does the FOA include observational research as well as treatment trials?
Yes. In parallel with completing the ongoing treatment trials, the network is expected to continue longitudinal observational research.
What kinds of samples and data will be maintained under the observational work?
The network is expected to collect and maintain biospecimens and detailed clinical data from both pediatric and adult participants with nonalcoholic fatty liver disease (NAFLD).
Which conditions are included under the NAFLD spectrum for this program?
The NAFLD spectrum explicitly includes simple steatosis, nonalcoholic steatohepatitis (NASH), and progression to cirrhosis.
Is the focus only on treatment effects?
No. The FOA emphasizes both treatment research and the natural history of disease over time, including the biological samples and clinical data needed to understand mechanisms and identify predictors of progression.
How long has the NASH Clinical Research Network been supported?
The NASH CRN has been sponsored by NIDDK since 2002 and was previously renewed in 2009.
What broader scientific mission does the FOA describe for the network?
The network's mission is described as understanding the etiology and contributing factors of NASH, mapping its natural history and complications, and developing and testing therapies.
Why use a multi-site clinical research network structure?
The FOA frames the network approach as a way to enable consistent protocols across multiple sites, improve statistical power through pooled enrollment, support standardized data and specimen handling, and generate clinically useful evidence that can be difficult to produce through single-center studies.
When was this opportunity posted?
The opportunity was posted on July 18, 2013.
What was the application due date?
The application due date was November 20, 2013.
When was this FOA archived?
The archive date was December 21, 2013.
How much total funding is estimated for this opportunity?
The estimated total funding level is $5.5 million.
Is cost-sharing or matching required?
No. There is no cost-sharing or matching requirement listed for this opportunity.
What activity category is this opportunity listed under?
The activity category is listed under Food and Nutrition/Health.
What CFDA number is associated with this program?
The CFDA number provided is 93.847, "Diabetes, Digestive, and Kidney Diseases Extramural Research."
What types of U.S. organizations are eligible to apply?
Eligibility includes many U.S.-based organization types, including public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, state and local governments, U.S. territories or possessions, public housing authorities, and tribal governments and tribal organizations.
Are minority-serving institutions specifically included as eligible?
Yes. The FOA explicitly includes institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions.
Are faith-based and community-based organizations eligible?
Yes. Faith-based and community-based organizations are explicitly included among eligible applicants.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included in the eligibility list.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible.
Can a U.S. organization include a non-U.S. (non-domestic) component on the application?
No. Non-domestic components of U.S. organizations are not eligible under this FOA.
Are foreign components (as NIH defines them) allowed?
No. Foreign components are not allowed.
What does the FOA suggest about where the network infrastructure must be based?
Based on the eligibility restrictions, the network and its coordinating infrastructure must remain U.S.-based.
Where can applicants find the official NIH announcement page?
NIH directed applicants to the official announcement page at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-503.html.
Who is listed for help with access or linking issues?
NIH Office of Extramural Research (OER) webmaster contacts are provided in the announcement for access or linking issues.
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