Opportunity Information: Apply for RFA HD 21 032
The National Institutes of Health (NIH) released this funding opportunity under the HEAL (Helping to End Addiction Long-term) Initiative to support a Data Coordinating Center (DCC) that will lead the design and implementation of a multi-center, comparative effectiveness randomized controlled trial focused on Neonatal Opioid Withdrawal Syndrome (NOWS). The core purpose is to rigorously compare pharmacological treatment approaches for infants with NOWS and determine which medication strategy is most effective, using a standardized, well-powered trial structure across multiple clinical sites. The award mechanism is a U24 cooperative agreement, which typically means the funded team will not only carry out the work but will do so in close collaboration with NIH program staff, with substantial federal involvement in scientific or operational coordination.
The DCC is expected to function as the central hub for trial coordination and data operations. In practical terms, this kind of center usually develops and manages key trial infrastructure: the study protocol and operations manuals, randomization and data management systems, common data elements, site training and monitoring processes, statistical analysis planning, and consistent reporting across participating locations. Because the FOA explicitly requires a clinical trial, the DCC is positioned to take responsibility for the full data lifecycle and trial governance support needed for a large, multi-site RCT, including establishing methods that allow meaningful head-to-head comparisons among pharmacologic treatments used to manage NOWS. The emphasis on "comparative effectiveness" signals that the trial is intended to generate real-world, actionable evidence to guide clinical decision-making rather than simply testing an intervention under narrow conditions.
Eligibility is broad and includes many types of U.S.-based organizations. Eligible applicants listed include state, county, and local 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories as specified); for-profit organizations other than small businesses; small businesses; and other organizations that meet NIH requirements. The FOA also calls out additional eligible groups such as 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 federal agencies, regional organizations, and U.S. territories or possessions.
At the same time, the opportunity is clear about foreign participation restrictions. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. In other words, the applicant organization and the work supported by this award are intended to be fully domestic in structure and performance location, consistent with NIH policy language in the announcement.
Administratively, the program is categorized as a discretionary funding opportunity and uses a cooperative agreement funding instrument. The activity category is listed under Health, Income Security and Social Services, and the CFDA number provided is 93.865. The opportunity number is RFA HD 21 032, and it was created on 2021-01-11 with an original closing date of 2021-03-30. The funding notice does not provide an award ceiling or expected number of awards in the text supplied, but it frames the effort as a significant, centralized coordinating role for a major multi-center trial within the HEAL Initiative portfolio.Apply for RFA HD 21 032
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on 2021-01-11.
- Applicants must submit their applications by 2021-03-30. (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.
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Frequently Asked Questions (FAQs)
What is this NIH funding opportunity about?
This opportunity supports a Data Coordinating Center (DCC) under the NIH HEAL (Helping to End Addiction Long-term) Initiative. The DCC will lead the design and implementation of a multi-center, comparative effectiveness randomized controlled trial (RCT) focused on Neonatal Opioid Withdrawal Syndrome (NOWS), with the goal of rigorously comparing pharmacological treatment approaches for infants with NOWS.
What is the main goal of the trial supported by this award?
The main goal is to determine which medication strategy is most effective for treating infants with NOWS by using a standardized, well-powered trial structure across multiple clinical sites. The emphasis is on head-to-head comparison of pharmacologic strategies in a way that produces actionable evidence for clinical decision-making.
What does "comparative effectiveness" mean in this context?
Based on the language provided, "comparative effectiveness" indicates the trial is intended to compare existing pharmacological treatment approaches directly and generate real-world, clinically useful evidence to guide practice, rather than testing an intervention only under narrow or highly controlled conditions.
What is Neonatal Opioid Withdrawal Syndrome (NOWS) in this funding notice?
In this notice, NOWS is the clinical condition being studied in infants, and the trial will focus specifically on pharmacological approaches used to manage NOWS. The DCC will support infrastructure and coordination to compare medication strategies used for NOWS treatment.
What type of award mechanism is used?
The award mechanism is a U24 cooperative agreement.
What does a U24 cooperative agreement imply for how the project will be run?
A U24 cooperative agreement generally means the funded team carries out the work in close collaboration with NIH program staff, with substantial federal involvement in scientific or operational coordination. The DCC is expected to work closely with NIH rather than operating fully independently.
What is the role of the Data Coordinating Center (DCC)?
The DCC is expected to function as the central hub for trial coordination and data operations for a large, multi-site RCT. It supports trial-wide infrastructure and consistent processes across participating locations so the study can produce meaningful, comparable results.
What kinds of responsibilities is the DCC expected to handle?
As described, the DCC typically develops and manages core trial infrastructure such as:
- Study protocol and operations manuals
- Randomization systems
- Data management systems
- Common data elements
- Site training and monitoring processes
- Statistical analysis planning
- Consistent reporting across participating sites
The DCC is positioned to support the full data lifecycle and trial governance needs for a multi-center RCT.
Does this funding opportunity require a clinical trial?
Yes. The information provided states that the FOA explicitly requires a clinical trial.
What does "multi-center" mean for this project?
It means the randomized controlled trial will be conducted across multiple clinical sites. The DCC is intended to coordinate trial operations and data standards across these sites so outcomes can be compared reliably.
Why is a centralized coordinating center important for this kind of RCT?
The notice frames the effort as a standardized, well-powered, multi-site RCT. A centralized DCC helps ensure consistent trial implementation, unified data standards, and coordinated analysis and reporting, all of which are important for rigorous head-to-head comparisons of pharmacological treatments.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations. The eligible applicants listed include:
- State, county, and local 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
- Tribal organizations that are not federally recognized
- Public housing authorities/Indian housing authorities
- Nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories as specified)
- For-profit organizations other than small businesses
- Small businesses
- Other organizations that meet NIH requirements
Are any additional eligible groups specifically called out?
Yes. The notice also calls out additional eligible groups such as:
- 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 federal agencies
- Regional organizations
- U.S. territories or possessions
Can a non-U.S. (foreign) organization apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply based on the restrictions described.
Can a U.S. organization include a non-U.S. component of work?
No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. The work supported by this award is intended to be fully domestic in structure and performance location.
What is the opportunity number for this funding notice?
The opportunity number is RFA HD 21 032.
Which NIH initiative is this associated with?
This opportunity is released under the NIH HEAL (Helping to End Addiction Long-term) Initiative.
How is this opportunity categorized administratively?
It is categorized as a discretionary funding opportunity and uses a cooperative agreement funding instrument.
What is the activity category listed for this opportunity?
The activity category is listed under Health, Income Security and Social Services.
What CFDA number is associated with this opportunity?
The CFDA number provided is 93.865.
When was this opportunity created?
The opportunity was created on 2021-01-11.
What was the original closing date listed?
The original closing date was 2021-03-30.
Does the provided notice include an award ceiling or the expected number of awards?
No. The text supplied does not provide an award ceiling or an expected number of awards.
Is this award focused on building trial infrastructure, running the study, or both?
Based on the description, the DCC is expected to lead design and implementation of the multi-center RCT and to provide central trial coordination and data operations. The responsibilities listed suggest both infrastructure development (systems, common data elements, manuals) and operational support (training, monitoring, reporting, analysis planning) for the trial.
What is the core deliverable implied by this DCC award?
The core deliverable implied is a rigorously designed and implemented, standardized, well-powered, multi-center comparative effectiveness RCT in NOWS, supported by coordinated trial governance, consistent data collection, and a planned statistical analysis approach that enables meaningful comparison of pharmacological treatment strategies.
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Applicants who have applied for this opportunity (RFA HD 21 032) also looked into and applied for these:
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|---|
| HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required) Apply for RFA HD 21 031 Funding Number: RFA HD 21 031 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $150,000 |
| Natural History of Disorders Screenable in the Newborn Period (R01 Clinical Trial Optional) Apply for PAR 21 115 Funding Number: PAR 21 115 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed) Apply for RFA NS 21 015 Funding Number: RFA NS 21 015 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $15,000,000 |
| HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed) Apply for RFA NS 21 016 Funding Number: RFA NS 21 016 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $500,000 |
| User-Based Design to Aid in Contraceptive Development by Small Business (R43 Clinical Trial Not Allowed) Apply for RFA HD 22 019 Funding Number: RFA HD 22 019 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $250,000 |
| Technologies to Advance Precision Medicine for Reproductive Health and Infertility (R43, R44 Clinical Trial Optional) Apply for RFA HD 22 010 Funding Number: RFA HD 22 010 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Community Engaged Research on Pregnancy Related and Associated Infections and Sepsis Morbidity and Mortality (UG3/UH3 Clinical Trial Optional) Apply for RFA HD 21 033 Funding Number: RFA HD 21 033 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Coordinating Center for the NICHD Population Dynamics Centers Research Infrastructure Program FY 2022 (R24 Clinical Trial Not Allowed) Apply for RFA HD 22 014 Funding Number: RFA HD 22 014 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Population Dynamics Centers Research Infrastructure Program FY 2022 (P2C Clinical Trial Not Allowed) Apply for RFA HD 22 013 Funding Number: RFA HD 22 013 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Biomarker Research to Support Fertility Regulation Development by Small Business (R43 Clinical Trial Optional) Apply for RFA HD 22 018 Funding Number: RFA HD 22 018 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $259,613 |
| NICHD Small Research Grant Program (R03 Clinical Trial Required) Apply for PA 21 221 Funding Number: PA 21 221 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required) Apply for PA 21 231 Funding Number: PA 21 231 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Human Milk as a Biological System (R01 Clinical Trial Optional) Apply for RFA HD 22 020 Funding Number: RFA HD 22 020 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $499,999 |
| Screening and Functional Validation of Human Birth Defects Genomic Variants (R01 Clinical Trial Not Allowed) Apply for PAR 21 229 Funding Number: PAR 21 229 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $499,999 |
| HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed) Apply for RFA NS 21 029 Funding Number: RFA NS 21 029 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Pediatric Immune System Ontogeny and Development (INTEND) (R01 Clinical Trial Not Allowed) Apply for PAR 21 248 Funding Number: PAR 21 248 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Impact of Technology and Digital Media (TDM) Exposure/Usage on Child and Adolescent Development (P01 Clinical Trial Optional) Apply for RFA HD 22 009 Funding Number: RFA HD 22 009 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Learning Disabilities Innovation Hubs (P20 Clinical Trial Optional) Apply for RFA HD 22 005 Funding Number: RFA HD 22 005 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $390,000 |
| Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R41/R42 Clinical Trial Not Allowed) Apply for PAR 21 298 Funding Number: PAR 21 298 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R43/R44 Clinical Trial Not Allowed) Apply for PAR 21 297 Funding Number: PAR 21 297 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
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