Opportunity Information: Apply for RFA OD 16 002
Apply for RFA OD 16 002
- The HHS-NIH11 in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Data Coordinating and Operations Center for the IDeA States Pediatric Clinical Trials Network (U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.310, 93.313, 93.350, 93.361, 93.393, 93.395, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879,.
- This funding opportunity was created on Dec 07, 2015 and posted on Dec 07, 2015.
- Applicants must submit their applications by Apr 15, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIH funding opportunity RFA-OD-16-002 supports the creation of a single Data Coordinating and Operations Center (DCOC) for the IDeA States Pediatric Clinical Trials Network (ISPCTN) through a U24 cooperative agreement mechanism. The ISPCTN is a multicenter pediatric clinical research program intended to strengthen and coordinate the ability of participating sites to run high-quality clinical studies involving children. In practical terms, this award is meant to fund the central hub that makes a large, multi-site pediatric trials network function day to day, including the operational coordination, trial support infrastructure, and the data systems needed to conduct studies consistently across locations.
The Network is broadly intended to enable research on diseases and conditions relevant to pediatric populations, but it places particular emphasis on priority topic areas aligned with the Environmental influences on Child Health Outcomes (ECHO) Program. Those four focus areas are: (1) upper and lower airway disease, (2) obesity, (3) pre-, peri-, and postnatal outcomes, and (4) neurodevelopment. While the opportunity leaves room for a wide range of pediatric clinical research, applicants are expected to design DCOC capabilities that can readily support studies in these priority domains, meaning the coordinating center should anticipate common protocol needs, outcomes, and data elements that come up in these kinds of pediatric investigations.
As a cooperative agreement (rather than a standard grant), the U24 structure signals that NIH will have substantial programmatic involvement in the work. The DCOC is not simply a passive fund recipient; it is expected to collaborate closely with NIH and the broader ISPCTN leadership and participating clinical sites. Typically, this kind of center serves as the backbone for network governance and study execution: coordinating communications and meetings, standardizing procedures, supporting protocol development and implementation, ensuring consistent data collection across sites, overseeing data quality and management, assisting with regulatory and compliance processes, tracking study progress, and producing reports and analyses that allow the Network to monitor performance and scientific output. The DCOC is also generally responsible for the operational mechanics that keep multicenter studies aligned, such as training and documentation, centralized tools, timelines, and troubleshooting across sites when issues arise.
Eligibility for this opportunity is broad and includes many organization types that can credibly operate a national-level coordinating center. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various governmental entities (state, county, city/township, special districts), as well as eligible Native American tribal governments and tribal organizations, and public housing authorities/Indian housing authorities. The breadth of eligibility reflects that a DCOC can be housed in a range of organizations as long as it has the expertise, systems, staffing, and institutional capacity to coordinate complex clinical research operations across multiple sites.
Administratively, the opportunity was posted December 7, 2015, created the same day, and closed April 15, 2016. NIH anticipated making one award (ExpectedAwards: 1), indicating an intent to fund a single centralized DCOC to serve the entire ISPCTN. The funding opportunity sits within HHS/NIH (listed as HHS-NIH11) and references multiple CFDA numbers, reflecting that NIH support for this type of networked clinical research infrastructure can intersect with several NIH programs and institutes. The award ceiling was not specified in the provided notice, but the single-award structure and the scope of responsibilities imply a substantial, centrally managed effort focused on building and operating the core coordinating infrastructure for pediatric clinical trials and related clinical research within the ISPCTN.
Frequently Asked Questions (FAQs) - NIH RFA-OD-16-002 (ISPCTN DCOC, U24)
What is RFA-OD-16-002 funding?
RFA-OD-16-002 is an NIH funding opportunity to create and support a single Data Coordinating and Operations Center (DCOC) for the IDeA States Pediatric Clinical Trials Network (ISPCTN) using a U24 cooperative agreement mechanism.
What is the purpose of the DCOC?
The DCOC is intended to function as the central hub that makes a large, multi-site pediatric clinical research network operate day to day. It supports operational coordination, trial support infrastructure, and the data systems needed to run studies consistently across multiple participating locations.
How many awards did NIH expect to make under this opportunity?
NIH anticipated making one award (ExpectedAwards: 1), meaning a single DCOC was expected to serve the entire ISPCTN.
What is the ISPCTN?
The IDeA States Pediatric Clinical Trials Network (ISPCTN) is a multicenter pediatric clinical research program designed to strengthen and coordinate the ability of participating sites to conduct high-quality clinical studies involving children.
What kinds of studies is the Network meant to support?
The Network is broadly intended to enable research on diseases and conditions relevant to pediatric populations. While it allows for a wide range of pediatric clinical research, it places particular emphasis on priority topic areas aligned with the Environmental influences on Child Health Outcomes (ECHO) Program.
What are the four ECHO-aligned priority focus areas mentioned in the opportunity?
The four priority focus areas are: (1) upper and lower airway disease, (2) obesity, (3) pre-, peri-, and postnatal outcomes, and (4) neurodevelopment.
Does the funding opportunity restrict research only to those four priority areas?
The opportunity leaves room for a wide range of pediatric clinical research, but applicants are expected to design DCOC capabilities that can readily support studies in those priority domains. In practice, that means the coordinating center should be built to handle common protocol needs, outcomes, and data elements typical of those pediatric investigation areas.
What does it mean that this award uses a U24 cooperative agreement mechanism?
A U24 cooperative agreement indicates that NIH will have substantial programmatic involvement. The DCOC is expected to work collaboratively with NIH, ISPCTN leadership, and participating clinical sites rather than operating as a fully independent, hands-off grant recipient.
What kinds of responsibilities would the DCOC typically handle for the Network?
Based on the description provided, the DCOC typically serves as the backbone for network governance and study execution. Responsibilities can include coordinating communications and meetings, standardizing procedures, supporting protocol development and implementation, ensuring consistent data collection across sites, overseeing data quality and management, assisting with regulatory and compliance processes, tracking study progress, and producing reports and analyses to monitor performance and scientific output.
What operational tasks are implied for keeping multi-site studies aligned?
The DCOC is described as responsible for operational mechanics such as training and documentation, centralized tools, timelines, and troubleshooting across sites when issues arise, all aimed at keeping multicenter studies aligned and running consistently.
Is the DCOC mainly a data center, an operations center, or both?
It is both. The opportunity describes the DCOC as supporting operational coordination and trial support infrastructure, as well as the data systems and data management practices needed to conduct studies consistently across multiple locations.
Who is eligible to apply for this opportunity?
Eligibility is broad. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and governmental entities (state, county, city/township, special districts). Eligible Native American tribal governments and tribal organizations are also included, as well as public housing authorities and Indian housing authorities.
Why is eligibility so broad for this NIH opportunity?
The description suggests eligibility is broad because a national-level coordinating center can be housed in many types of organizations, as long as the organization has the expertise, systems, staffing, and institutional capacity to coordinate complex clinical research operations across multiple sites.
Which federal agency is associated with this opportunity?
The opportunity is within HHS/NIH (listed as HHS-NIH11).
Were specific funding limits or a maximum award ceiling provided?
No award ceiling was specified in the provided notice information. The description notes that the single-award structure and the scope of responsibilities imply a substantial, centrally managed effort.
When was the funding opportunity posted, and when did it close?
It was posted on December 7, 2015, created the same day, and it closed on April 15, 2016.
What does it mean that the DCOC is a "single" center for the Network?
It means NIH intended to fund one centralized coordinating and operations hub to support the entire ISPCTN, rather than funding multiple separate coordinating centers.
How is the DCOC expected to interact with NIH and participating sites?
Because this is a cooperative agreement with substantial NIH involvement, the DCOC is expected to collaborate closely with NIH and work with ISPCTN leadership and participating clinical sites to coordinate network governance and study execution.
What is meant by building "coordinating infrastructure" for pediatric clinical trials?
In this context, coordinating infrastructure refers to the centralized operational and data capabilities needed to support consistent multi-site study execution, such as standardized procedures, shared tools and documentation, training approaches, data collection consistency, data quality oversight, and regular reporting and analyses across the Network.
Why does the opportunity reference multiple CFDA numbers?
The notice references multiple CFDA numbers, reflecting that NIH support for networked clinical research infrastructure can intersect with several NIH programs and institutes.
What is the practical "day-to-day" role of the DCOC described in the opportunity?
Practically, the DCOC is described as the operational and data backbone that keeps a multi-site pediatric trials network functioning. This includes coordinating communications, supporting study setup and implementation, keeping timelines on track, maintaining consistent data practices across sites, and resolving cross-site operational issues as they occur.
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| Environmental Influences on Child Health Outcomes: Patient Reported Outcomes Research Resource Center Core (ECHO PRO Core) (U24) Apply for RFA OD 16 003 Funding Number: RFA OD 16 003 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Clinical Sites for the IDeA States Pediatric Clinical Trials Network (UG1) Apply for RFA OD 16 001 Funding Number: RFA OD 16 001 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $315,000 |
| Administrative Supplements for Research on Sex/Gender Differences (Admin Supp) Apply for PA 16 066 Funding Number: PA 16 066 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $100,000 |
| NIH Pathway to Independence Award (Parent K99/R00) Apply for PA 16 077 Funding Number: PA 16 077 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32) Apply for PA 16 152 Funding Number: PA 16 152 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Research Project Grant (Parent R01) Apply for PA 16 160 Funding Number: PA 16 160 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Exploratory/Developmental Research Grant Program (Parent R21) Apply for PA 16 161 Funding Number: PA 16 161 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Patient-Oriented Research Career Development Award (Parent K23) Apply for PA 16 198 Funding Number: PA 16 198 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award (Parent K08) Apply for PA 16 191 Funding Number: PA 16 191 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Pathway to Independence Award (Parent K99/R00) Apply for PA 16 193 Funding Number: PA 16 193 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Lasker Clinical Research Scholars Program (Si2/R00) Apply for PAR 16 203 Funding Number: PAR 16 203 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Academic Research Enhancement Award (Parent R15) Apply for PA 16 200 Funding Number: PA 16 200 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $300,000 |
| Mentored Quantitative Research Development Award (Parent K25) Apply for PA 16 194 Funding Number: PA 16 194 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BD2K Mentored Career Development Award in Biomedical Big Data Science for Intramural Investigators (K22) Apply for RFA ES 16 003 Funding Number: RFA ES 16 003 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BD2K Mentored Career Development Award in Biomedical Big Data Science for Clinicians and Doctorally Prepared Scientists (K01) Apply for RFA ES 16 002 Funding Number: RFA ES 16 002 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BD2K Predoctoral Training in Biomedical Big Data Science (T32) Apply for RFA LM 16 002 Funding Number: RFA LM 16 002 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BD2K Open Educational Resources for Skills Development in Biomedical Big Data Science (R25) Apply for RFA HG 16 016 Funding Number: RFA HG 16 016 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $200,000 |
| Change of Grantee Organization (Type 7 Parent) Apply for PA 16 285 Funding Number: PA 16 285 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Successor-in-Interest (Type 6 Parent) Apply for PA 16 286 Funding Number: PA 16 286 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research Supplements to Promote Diversity in Health-Related Research (Admin Supp) Apply for PA 16 288 Funding Number: PA 16 288 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
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