Opportunity Information: Apply for RFA DK 13 011

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Continuation of ChiLDReN, the Childhood Liver Disease Research Network (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 $6,500,000.00 to eligible and selected applicants.
  • Eligible applicants include: Independent school districts Native American tribal governments (Federally recognized) City or township governments State governments Public and State controlled institutions of higher education For profit organizations other than small businesses County governments Private institutions of higher education Special district governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification).
  • 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

This grant opportunity, RFA-DK-13-011, is a National Institutes of Health (NIH) funding announcement aimed at continuing and strengthening the Childhood Liver Disease Research Network (ChiLDReN) through cooperative agreement awards (U01). The core purpose is to maintain an organized, multi-site research network made up of a central Data Coordination Center (DCC) and multiple Clinical Centers. Together, these components are intended to support coordinated clinical and translational research efforts focused on rare pediatric liver diseases, with an emphasis on generating high-quality, comparable data across sites and accelerating discoveries that can improve diagnosis, management, and outcomes for affected children.

The scientific scope of ChiLDReN under this FOA is centered on rare and often life-altering liver conditions in infants, children, and adolescents. The diseases explicitly highlighted include biliary atresia, Alagille syndrome, alpha-1 antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC) syndromes, bile acid synthesis defects, mitochondrial hepatopathies, idiopathic neonatal hepatitis, and cystic fibrosis-associated liver disease. The network structure is designed to enable studies that are difficult to conduct at a single institution because patient populations are small, geographically dispersed, and clinically heterogeneous. By pooling patients and standardizing data and biospecimen approaches across centers, the program supports more robust natural history studies, improved phenotyping, and the development of evidence needed to guide clinical care and future therapeutic trials.

From an administrative and operational standpoint, the announcement supports two main functional pillars. The Data Coordination Center is positioned as the hub for network-wide data management and coordination, typically encompassing responsibilities such as protocol support, database development and maintenance, data quality control, statistical support, and facilitation of consistent reporting across studies and sites. The Clinical Centers serve as the places where patient recruitment, clinical data collection, follow-up, and study-specific procedures occur, helping the network enroll enough participants to make meaningful conclusions despite the rarity of these disorders. Because the funding mechanism is a cooperative agreement (U01), NIH is expected to have substantial programmatic involvement, meaning awardees generally work collaboratively with NIH staff on planning, oversight, and network governance rather than operating in a completely independent investigator-initiated mode.

The opportunity is categorized as discretionary funding, with the funding activity aligned to health research within the NIH portfolio, specifically under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). The estimated total funding amount listed is $6,500,000. No cost sharing or matching is required, which can reduce barriers to participation for institutions that might otherwise struggle to contribute non-federal funds to cover part of the project costs.

Eligibility is broad and includes many types of organizations that can support clinical research infrastructure and multi-site collaboration. Eligible applicants include state and local governments (including cities, counties, townships, special districts), public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status, with some distinctions noted), public housing authorities/Indian housing authorities, and for-profit organizations (other than small businesses), as well as small businesses. The FOA also explicitly extends eligibility to a wide range of institution types and community-focused entities, including faith-based and community-based organizations, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions (AANAPISIs). Importantly, non-U.S. entities are eligible, including foreign organizations and foreign institutions, and the FOA allows foreign components as defined in the NIH Grants Policy Statement, reflecting a willingness to include international expertise and patient populations when appropriate.

Key dates show the posting and creation date as July 18, 2013, with an original and current closing date of November 20, 2013, and an archive date of December 21, 2013. These dates indicate the opportunity is historical and archived, but the description still provides a clear snapshot of NIH priorities for pediatric hepatology network research during that period, particularly the emphasis on coordinated infrastructure (DCC plus Clinical Centers) to address rare disease research challenges.

For applicants or stakeholders seeking more details, the full announcement was hosted through the NIH grants guide, and the listing provides troubleshooting contacts via the NIH Office of Extramural Research (OER) webmaster for access or linking issues. Overall, the FOA is best understood as an infrastructure-and-research continuation award intended to sustain a mature collaborative network that can carry out complex, multi-center studies in rare pediatric liver diseases, leveraging centralized coordination and standardized methods to produce clinically actionable evidence and a stronger translational pipeline.

Frequently Asked Questions (FAQs) - NIH RFA-DK-13-011 (ChiLDReN U01)

What is RFA-DK-13-011?

RFA-DK-13-011 is a National Institutes of Health (NIH) funding announcement to continue and strengthen the Childhood Liver Disease Research Network (ChiLDReN) through cooperative agreement awards using the U01 mechanism.

What is the main purpose of this funding opportunity?

The purpose is to maintain an organized, multi-site research network that supports coordinated clinical and translational research on rare pediatric liver diseases. A central goal is to generate high-quality, comparable data across sites and accelerate discoveries that improve diagnosis, management, and outcomes for affected children.

What kind of network structure does ChiLDReN use under this FOA?

The network is structured around two main components: a central Data Coordination Center (DCC) and multiple Clinical Centers. These components work together to run coordinated, multi-site studies and support standardized data and (as described) biospecimen approaches across participating sites.

Which pediatric liver diseases are specifically highlighted in the announcement?

The FOA explicitly highlights rare and often life-altering pediatric liver conditions, including biliary atresia, Alagille syndrome, alpha-1 antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC) syndromes, bile acid synthesis defects, mitochondrial hepatopathies, idiopathic neonatal hepatitis, and cystic fibrosis-associated liver disease.

Why does this program emphasize a multi-site approach?

The announcement emphasizes multi-site research because many of these disorders are rare. Patient populations can be small, geographically dispersed, and clinically heterogeneous, making single-institution studies difficult. Pooling participants across centers and standardizing methods helps produce more robust, comparable findings.

What types of research does the FOA aim to support?

It is designed to support coordinated clinical and translational research efforts, including activities such as natural history studies, improved phenotyping, and generating evidence to guide clinical care and inform future therapeutic trials.

What is the role of the Data Coordination Center (DCC) in this network?

The DCC is positioned as the hub for network-wide data management and coordination. The announcement describes typical responsibilities such as protocol support, database development and maintenance, data quality control, statistical support, and facilitating consistent reporting across studies and sites.

What is the role of the Clinical Centers?

Clinical Centers are the sites where patient recruitment, clinical data collection, follow-up, and study-specific procedures occur. They help the network enroll enough participants to reach meaningful conclusions despite the rarity of the conditions being studied.

What funding mechanism is used, and what does it imply about NIH involvement?

The mechanism is a cooperative agreement (U01). This implies substantial NIH programmatic involvement, meaning awardees generally collaborate with NIH staff on planning, oversight, and network governance rather than operating entirely independently.

What is the estimated total funding amount listed for this opportunity?

The listing provides an estimated total funding amount of $6,500,000.

Is cost sharing or matching required?

No. The opportunity states that no cost sharing or matching is required.

What federal program area or CFDA listing is associated with this announcement?

The funding activity is aligned to health research within the NIH portfolio and is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

What types of organizations are eligible to apply?

Eligibility is broad and includes state and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status, with distinctions noted in the announcement); public housing authorities/Indian housing authorities; for-profit organizations (other than small businesses); and small businesses.

Are community-focused or special-designation institutions included in eligibility?

Yes. The FOA explicitly extends eligibility to faith-based and community-based organizations and includes Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions (AANAPISIs).

Are non-U.S. organizations eligible to apply?

Yes. The FOA states that non-U.S. entities are eligible, including foreign organizations and foreign institutions. It also allows foreign components as defined in the NIH Grants Policy Statement.

What are the key dates shown for this funding announcement?

The posting/creation date is July 18, 2013. The original and current closing date is November 20, 2013. The archive date is December 21, 2013.

Is this opportunity still open?

No. Based on the dates provided, the closing date was November 20, 2013, and the announcement was archived on December 21, 2013, indicating it is a historical (archived) opportunity.

How is this opportunity best characterized based on the description?

It is best described as an infrastructure-and-research continuation effort intended to sustain a mature, collaborative pediatric liver disease network using centralized coordination (DCC) and standardized multi-site methods to produce clinically actionable evidence and strengthen the translational pipeline.

Where was the full announcement hosted, and what support contact is mentioned?

The full announcement was hosted through the NIH grants guide. For access or linking issues, the listing references troubleshooting contacts via the NIH Office of Extramural Research (OER) webmaster.

What is meant by producing "high-quality, comparable data across sites" in this context?

In the context of this FOA, it refers to coordinated network operations (through the DCC and Clinical Centers) that support consistent data collection, quality control, and reporting across multiple sites, helping results be compared and combined across the network.

Why is standardization across centers important for rare pediatric liver disease research?

The description emphasizes that standardizing data (and biospecimen approaches) across centers helps overcome challenges posed by rare, heterogeneous conditions by enabling pooled analyses, improved characterization of disease, and stronger evidence to guide care and future studies.

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