Opportunity Information: Apply for RFA HD 21 029
The funding opportunity titled "Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)" (RFA HD 21 029) is a discretionary National Institutes of Health (NIH) grant announcement issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It supports participation as a Clinical Center within the long-running Maternal-Fetal Medicine Units (MFMU) Network, a multi-center research network that conducts coordinated studies in pregnancy and perinatal care. The overall purpose is to improve maternal, fetal, and neonatal health by running high-quality observational and interventional clinical research using standardized, network-wide protocols so results are comparable and can be combined across sites.
This announcement uses the UG1 cooperative agreement mechanism, which is important because it reflects a partnership model rather than a typical stand-alone research grant. Under a cooperative agreement, the funded Clinical Centers do not operate independently in the way an R01-style investigator-initiated project might. Instead, they work closely with NICHD and other MFMU Network sites on shared scientific goals, common study designs, consistent data collection methods, and coordinated trial operations. In practice, that means the awardee is expected to integrate into an existing network infrastructure and help execute ongoing protocols rather than proposing an entirely new, site-specific research agenda. The phrase "Clinical Trial Optional" indicates that applications may involve clinical trials or may focus on observational clinical studies, depending on the specific ongoing protocols being completed within the network.
The emphasis on "limited competition" signals that this is not a broadly open call for any applicant with a general interest in maternal-fetal research. Limited competitions are typically restricted in eligibility or intent, often to support continuity of an established research network and ensure the network can complete already-approved and active studies. In this case, the FOA is specifically framed around completing ongoing MFMU Network protocols, which implies that the funded Clinical Centers are expected to have the clinical volume, operational readiness, research staffing, and institutional capacity needed to immediately contribute to recruitment, intervention delivery (if applicable), participant follow-up, data entry, and adherence to network standards such as Good Clinical Practice, human subjects protections, and uniform reporting procedures.
Eligible applicants, as listed in the source data, include a range of U.S.-based government and tribal entities: county governments, city or township governments, special district governments, independent school districts, and Native American tribal governments and tribal organizations (including those other than federally recognized tribal governments). While the NIH commonly funds academic medical centers and universities under many FOAs, this specific eligibility listing highlights governmental and tribal organizational eligibility in the provided dataset. Regardless of the applicant type, the applying organization would need to function as a capable clinical research site able to enroll and manage pregnant participants and/or newborns as required by MFMU protocols, and to collaborate effectively with the network.
The announcement is explicit about restrictions on foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible to apply, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In other words, the work supported under this FOA must be carried out entirely within allowable U.S.-based organizational structures, without foreign components performing substantive portions of the project.
Administratively, the FOA was created on July 30, 2020, and the original closing date for applications was September 4, 2020. The listing references CFDA number 93.865, which corresponds to NICHD funding streams. The opportunity category is discretionary, and the activity category is listed as Health, Income Security and Social Services, reflecting the public health and clinical care impact of maternal-fetal and neonatal research. While an award ceiling and expected number of awards are not provided in the source excerpt, the network-based structure and cooperative agreement mechanism typically mean budgets and award numbers are driven by the operational needs of the network and the number of sites required to complete the planned protocols.
At a practical level, a successful applicant under this FOA would be proposing to serve as a MFMU Network Clinical Center that can reliably implement network protocols across multiple studies, including participant identification and recruitment, informed consent, intervention delivery when relevant, standardized clinical assessments, outcome ascertainment for mothers and infants, and timely, high-quality data submission. Because MFMU research often targets clinically meaningful outcomes in pregnancy and birth, the Clinical Center role generally demands strong coordination between obstetrics, maternal-fetal medicine, neonatology, nursing, pharmacy (if interventions are involved), research coordinators, and data/quality staff, along with the institutional ability to comply with NIH and NICHD oversight requirements typical of cooperative agreements.Apply for RFA HD 21 029
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)" 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 2020-07-30.
- Applicants must submit their applications by 2020-09-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments, City or township governments, Special district governments, Independent school districts, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments).
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The funding opportunity is titled "Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)" (RFA HD 21 029).
Which agency and institute are issuing this announcement?
This is a discretionary National Institutes of Health (NIH) grant announcement issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
What is the purpose of this opportunity?
The purpose is to support participation as a Clinical Center within the Maternal-Fetal Medicine Units (MFMU) Network to help complete ongoing network protocols. The overall goal is to improve maternal, fetal, and neonatal health through high-quality, coordinated observational and interventional clinical research using standardized, network-wide protocols.
What is the MFMU Network?
The Maternal-Fetal Medicine Units (MFMU) Network is a long-running, multi-center research network that conducts coordinated studies in pregnancy and perinatal care. It relies on common study designs and standardized data collection so results are comparable across sites and can be combined.
What does "limited competition" mean in this context?
"Limited competition" indicates the opportunity is not broadly open to any applicant proposing any maternal-fetal research topic. It is framed to support continuity of an established research network and to ensure the network can complete already-approved and active studies (ongoing MFMU Network protocols).
What grant mechanism is used for this opportunity?
This opportunity uses the UG1 cooperative agreement mechanism.
What does a UG1 cooperative agreement imply for how the project is run?
A UG1 cooperative agreement reflects a partnership model rather than a fully independent, stand-alone research grant. Funded Clinical Centers are expected to work closely with NICHD and other MFMU Network sites on shared scientific goals, common study designs, consistent data collection methods, and coordinated trial operations, integrating into the existing network infrastructure.
Does the application need to include a clinical trial?
No. The announcement is labeled "Clinical Trial Optional," meaning the work may involve clinical trials or may focus on observational clinical studies, depending on the specific ongoing protocols being completed within the network.
What is the Clinical Center expected to do under this award?
A funded Clinical Center is expected to help execute ongoing MFMU Network protocols rather than propose an entirely new, site-specific research agenda. Practical responsibilities typically include participant identification and recruitment, informed consent, intervention delivery when relevant, participant follow-up, standardized clinical assessments, outcome ascertainment for mothers and infants, timely and high-quality data entry/submission, and adherence to network standards and procedures.
What kinds of studies does this support (observational vs. interventional)?
The MFMU Network conducts coordinated observational and interventional clinical research in pregnancy and perinatal care. This specific opportunity supports completing ongoing protocols, which may include clinical trials or observational studies.
What capabilities should an applicant organization have to be successful?
Based on the description, an applicant should be able to function as a capable clinical research site with the clinical volume, operational readiness, research staffing, and institutional capacity to immediately contribute to ongoing network studies. That includes the ability to recruit and manage pregnant participants and/or newborns (as required by protocols), deliver interventions if applicable, ensure follow-up, and maintain consistent, standardized data collection and reporting.
What compliance and quality standards are emphasized?
The opportunity emphasizes adherence to network standards and expectations such as Good Clinical Practice, human subjects protections, and uniform reporting procedures, along with the ability to meet NIH and NICHD cooperative agreement oversight expectations.
Which types of applicants are listed as eligible in the provided information?
The provided eligibility listing includes U.S.-based government and tribal entities, including county governments, city or township governments, special district governments, independent school districts, Native American tribal governments, and Native American tribal organizations (including those other than federally recognized tribal governments).
Are foreign organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Can a U.S. organization include a non-U.S. component or foreign component in the project?
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 under this FOA must be carried out entirely within allowable U.S.-based organizational structures.
When was the funding opportunity created and when was it originally due?
The FOA was created on July 30, 2020, and the original closing date for applications was September 4, 2020.
What is the CFDA number referenced for this opportunity?
The listing references CFDA number 93.865, corresponding to NICHD funding streams.
What is the opportunity category and activity category?
The opportunity category is discretionary. The activity category is listed as Health, Income Security and Social Services.
Is an award ceiling or expected number of awards provided in the information?
No. The provided excerpt does not include an award ceiling or the expected number of awards.
What kind of coordination across clinical departments might be needed at the Clinical Center?
The description indicates that a Clinical Center role generally requires strong coordination among obstetrics, maternal-fetal medicine, neonatology, nursing, pharmacy (if interventions are involved), research coordinators, and data/quality staff to implement network protocols and comply with oversight requirements.
Is this opportunity focused on starting new studies or completing existing ones?
It is focused on completing existing, ongoing MFMU Network protocols. The Clinical Center is expected to integrate into the network and help carry out active studies using network-wide standardized procedures.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA HD 21 029) also looked into and applied for these:
| Funding Opportunity |
|---|
| Development of the Fetal Immune System (R01 Clinical Trial Not Allowed) Apply for PAR 20 298 Funding Number: PAR 20 298 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $300,000 |
| Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional) Apply for PAR 20 300 Funding Number: PAR 20 300 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional) Apply for PAR 20 299 Funding Number: PAR 20 299 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 Clinical Trial Not Allowed) Apply for RFA HD 21 030 Funding Number: RFA HD 21 030 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Contraceptive Development Research Centers Program (P50 Clinical Trial Optional) Apply for RFA HD 22 003 Funding Number: RFA HD 22 003 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24 Clinical Trial Required) Apply for RFA HD 21 032 Funding Number: RFA HD 21 032 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| 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 |
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