RFA-HD-27-012-Revised-Full-Announcement.html
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- Opportunity number
- RFA-HD-27-012
About this file
This is a Notice of Funding Opportunity (NOFO) for a limited competition administered by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865). The NOFO solicits applications for Intellectual and Developmental Disabilities Research Centers (IDDRCs) designed to advance diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities through multidisciplinary research centers. Eligibility is limited to currently funded IDDRCs under previous RFAs (RFA-HD-20-016 or RFA-HD-21-009), making this a limited competition opportunity. The funding mechanism is the P50 activity code supporting specialized centers through multi-project grants.
Applicants must propose institutions with multidisciplinary IDD research programs containing 3-4 total cores that facilitate interdisciplinary and translational research and support IDD-related projects funded by external sources, plus 2-3 specific research projects aligned with identified areas of IDD research need. The centers should incorporate collaborative investigations combining expertise in translational science, biomarker assessment, outcome measure development, tool validation, bioinformatics, and therapeutic development. Centers must include plans for outreach, engagement, and dissemination to the community, including persons with lived experience of disabilities. The award period is 3 years in total. Applications will undergo standard NIH peer review processes evaluating significance, approach, innovation, investigators, and environment, with only meritorious applications considered for funding.
RFA-HD-27-012-Revised-Full-Announcement.html
Text of this file
Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Funding Opportunity Title
Limited Competition: Intellectual and Developmental Disabilities Research Centers 2027 (P50 Clinical Trial Optional)
Activity Code
P50 Specialized Center
Announcement Type
Reissue of
RFA-HD-21-009
Related Notices
| Check for any recent Notices of NIH Policy Changes that may impact application requirements. |
| January 23, 2026 - NIH Pause on New Submissions to the NIH Human Embryonic Stem Cell Registry and Request for Information on Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research |
Funding Opportunity Number (FON)
RFA-HD-27-012
Companion Notice of Funding Opportunity
None
Number of Applications
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Assistance Listing Number(s)
93.865
Notice of Funding Opportunity Purpose
This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. The purpose of this NOFO is to seek applications in a limited competition for the Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers (IDDRCs). This NOFO invites applications to undergo peer review for research center grants designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD) and is limited to IDDRCs funded under RFA-HD-20-016 or RFA-HD-21-009. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.This NOFO seeks applications from institutions that meet the qualifications for a multidisciplinary program of IDD research that will include: 1) 3-4 total Cores that facilitate interdisciplinary and translational research in IDD and its dissemination, and that support IDD-related projects funded by other sources; and 2) at least two and no more than three specific research projects related to one of several areas identified as areas of research need in IDD. Collaborative investigations combining expertise in translational science, biomarker assessment, outcome measure development, tool validation, bioinformatics, and therapeutic development will be encouraged. Funds for the majority of outside research projects using these core facilities come from independent sources including Federal, State, and private organizations. In addition, the Center should include plans for outreach, engagement, and dissemination to the community, including persons with lived experience (PWLE) of disabilities. The duration of these Centers will be 3 years in total.
Funding Opportunity Goal(s)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.
Key Dates
Posted Date
May 15, 2026
Open Date (Earliest Submission Date)
September 02, 2026
| Application Due Dates |
| Review and Award Cycles |
| New |
| Renewal / Resubmission / Revision (as allowed) |
| AIDS - New/Renewal/Resubmission/Revision, as allowed |
| Scientific Merit Review |
| Advisory Council Review |
| Earliest Start Date |
Not Applicable
October 02, 2026
Not Applicable
| March 2027 | |
| May 2027 |
July 2027
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Expiration Date
October 03, 2026
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
| There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity. | |
| Use the NIH ASSIST system to prepare, submit and track your application online. | |
| Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability. |
Table of Contents
Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Purpose This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. The purpose of this NOFO is to seek applications in a limited competition for the Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers (IDDRCs). This NOFO invites applications to undergo peer review for research center grants designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD) and is limited to IDDRCs funded under RFA-HD-20-016 or RFA-HD-21-009. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. This NOFO seeks applications from institutions that meet the qualifications for a multidisciplinary program of IDD research that will include: 1) 3-4 total Cores that facilitate interdisciplinary and translational research in IDD and its dissemination, and that support IDD-related projects funded by other sources; and 2) at least two and no more than three specific research projects related to one of several areas identified as areas of research need in IDD. Collaborative investigations combining expertise in translational science, biomarker assessment, outcome measure development, tool validation, bioinformatics, and therapeutic development will be encouraged. Funds for the majority of outside research projects using these core facilities will come from independent sources including Federal, State, and private organizations. In addition, the Center should include plans for outreach, engagement, and dissemination to the community, including persons with lived experience (PWLE) of disabilities. The duration of these Centers will be 3 years in total.
Background For 50 years, discoveries made by investigators within the IDDRCs have increased the basic understanding of many forms of IDD and moved the field forward appreciably. Historically, the IDDRC program was funded via Center Core (P30) grants that facilitated program coordination and supported central research facilities, administration, and a limited number of new development projects. Over the years, Core services have evolved to include state-of-the-art infrastructure in areas such as developmental neurobiology, genomics, proteomics, neuroimaging, epidemiology, biostatistics, behavioral science, and clinical translational research. The prior round of competitions, held in FY2020 and FY2021, has supported IDDRCs through the P50 (Specialized Center) mechanism. This mechanism allows the research community to continue to respond to emerging needs within the IDD field through a combination of Core services and Specific Research Project(s). NICHD has encouraged cooperation among the Centers, including their integration into a virtual network that has facilitated development of larger, cross-cutting research programs and advances in the field. This NOFO represents the next step in the evolution of the IDDRC program toward more project-focused and translational approaches to IDD research. Research focus areas have been identified in the realms of translational science, biomarker assessment, outcome measure development, tool validation, bioinformatics, artificial intelligence (AI), and therapeutic development that will inform the Specific Research Projects proposed in response to this NOFO.
It is the intent of the NICHD to support individual IDDRCs using the current P50 award format for a final cycle of competition in FY2027. The duration of each proposed IDDRC will be 3 years maximum. The program in its current format will be transitioned in FY2030 to emphasize clinical trial readiness needs that will move the field of IDD research into areas of translational research.
Consistent with the NIH unified strategy, this NOFO encourages:
| Support of graduate students, postdoctoral researchers, junior investigators, and investigators in the IDD field through access to Core services, thereby fostering the next generation of biomedical scientists. |
| Translation of basic research observations into subject oriented protocols whose ultimate aims are to validate the mechanistic basis of IDD in humans and to develop new approaches for prevention, diagnosis, and treatment. |
| The option to focus on rigorous replication and reproducibility research, aligning with NIH’s priority to expand support for replication studies and to ensure gold standard science. |
Specific Objectives of the Research Program A major goal of the NICHD IDDRC Program is to support research that leads to the prevention and/or amelioration of IDD. The intent of the IDDRC Specialized Center program is to bring together scientists from various disciplines to work within a Center on the most pressing issues related to IDD. Each IDDRC typically supports investigators studying a range of topics in basic and clinical or applied research. This NOFO also encourages support of graduate students, postdoctoral researchers, junior investigators, and investigators in the IDD field through their access to Core services, in order to attract scientists to IDD research. NICHD strongly encourages translation of basic research observations into subject-oriented protocols whose ultimate aims are to validate the mechanistic basis of IDD in humans and to develop new approaches for the prevention, diagnosis and treatment of IDD. In addition, for the purposes of this NOFO, it is essential that scientific personnel and institutional resources capable of providing a strong research base in the IDD field are available.
Minimal Structural Requirements Applications responding to this NOFO must propose a multi-disciplinary program of IDD research that includes Core Components and Specific Research Project Components. Requirements for these components are described in the following sections.
Cores Each P50 Center can propose a minimum of three and a maximum of four Cores, with a required Administrative Core and a required Clinical Translational Core as two of the required Cores. Core components must facilitate interdisciplinary and translational research in IDD, and support IDD-related projects funded by other sources.
Each Core must fulfill the following requirements:
| Provide essential facilities or services for at least five, "outside," federally-funded, peer-reviewed research projects in addition to the Specific Research Projects funded directly through this P50 award. |
| Have satisfactory quality-control systems documented for its services or facilities. |
| Be cost-effective, i.e., the centralization should result in a lower cost than would be incurred if the same facilities or services were supported by the individual research grant budgets. |
| Increase the quality and productivity of research projects receiving Core support. |
| In general, contract-supported projects may not be counted as qualifying a Core to meet its five research project minimum requirement. Use of Core facilities by projects funded by research and development contracts will be evaluated on an individual basis. Any use of Core facilities by contracts must be paid for in full from contract funds, not from NICHD Center funds. |
| Use of Core facilities by projects located at other institutions is allowable with prior NICHD approval. The sharing of unique Core resources among IDDRCs is permitted and encouraged, provided that an appropriate cost-recovery mechanism is developed. |
| Use of Core facilities by graduate students or postdoctoral researchers supported by Institutional National Research Service Awards (T32) or other fellowships or career development awards (such as F and K awards) is allowable and encouraged. |
Administrative Core The Administrative Core should provide for the integration and management of activities within the IDDRC. Each Center should form an External Advisory Committee (EAC) composed of at least five members, with scientific, clinical and patient advocate representation, to ensure the perspectives of persons with lived experience (PWLE) in intellectual disabilities. The EAC should meet in-person or virtually approximately once a year. Funded IDDRCs must utilize the Administrative Core to establish and maintain a website to communicate the Center missions and the availability of Core services. When multiple geographic sites are involved in the IDDRC, the Administrative Core should provide the leadership and communication needed to manage the multiple sites. Any educational elements should be organized and coordinated within the Administrative Core.
In addition, the Administrative Core will provide dissemination services in order to promulgate information and promote communication about the research supported by the Center to other scientists, educators, the government, and the public, including those with IDD conditions and their families (PWLE). The Center should serve as a communication liaison between investigators conducting state-of-the-art research and the public, and where appropriate, the information should be structured so that it can effectively reach a large segment of the population, including non-English-speaking people.
Clinical Translational Core The Clinical Translational Core must have a translational science focus that supports research allowing application of basic science discoveries to the clinical setting, treatment development, and/or clinical trials. Examples of activities that might be considered as part of a clinical translational core include but are not limited to:
| Services related to patient recruitment or natural history studies; |
| Clinical services in subject assessment, phenotyping, evaluation, or treatment; |
| Provision of clinical navigator services to assist investigators with translational resources available at the Center; |
| Utilization of biomarkers or validated outcome measures; |
| Bioinformatics/biostatistics expertise to design clinical trials or provide clinical trial information management; |
| Manufacturing services that incorporate Good Manufacturing Practices (GMP) for chemical or compound formulation for drug development; |
| High-throughput screening to enhance identification of compounds for treatment of IDD; |
| Collection of human samples from individuals with IDD for biobanking purposes. |
Specific Research Projects Applications must include at least two and no more than three Specific Research Projects that address one or more of the focus themes identified below. These are recognized as potentially exploratory, discovery-based, and/or high-risk projects, with the goal of yielding interpretable results that will either prove or disprove the proposed hypothesis within a 3-year time frame.
Each Specific Research Project must utilize at least two cores of the IDDRC, which may include the Administrative Core and/or the Clinical Translational Core. Primary funding must be through this P50 mechanism, but other sources of funding are allowed (federal grant, philanthropic, or foundational support). The project can address a broad array of intellectual disorders, including new, recently characterized, or under-researched areas such as comorbid mental health conditions in IDD. In addition, because of delays in completing the Specific Research Project by many of the currently funded IDDRCs due to the COVID pandemic, investigators are allowed to choose one of these Projects to be a completion, continuation, and/or extension of a currently supported Project. The focus areas include, but are not limited to:
| -Omics approaches (e.g., genomic, transcriptomic, epigenomic, proteomic, metabolomic) to increase our understanding of IDD conditions that will improve diagnosis, management, and potentially, treatment. |
| Development and/or validation of a biomarker, clinical outcome assessment, or measurement for one or more IDD conditions in one or more species. |
| Development of real-world data to inform real-world evidence. |
| Development of clinical outcome measures or biomarkers for the cognitive and/or behavioral phenotypes of IDD that could be used to demonstrate a change in response to intervention or treatment (“clinical trial readiness” approaches). |
| Development of bi- or multi-modal treatment approaches for a single IDD condition or a group of IDD conditions to demonstrate combinatorial effects to ameliorate a cognitive or behavioral symptom(s) of the condition(s). |
| Strategies or treatments to prevent and mitigate the impact of exposures that cause IDD, including many types of medications, substances of abuse, infectious agents, environmental exposures, toxins, or others. |
| Interventions and approaches to manage co-occurring mental health conditions, including depression, anxiety, aggression, suicidal ideation, attention deficit hyperactivity disorder (ADHD), bipolar disorder, or psychotic disorders, in those with IDD. |
| Innovative technologies to improve assessments, interventions, and outcomes for individuals with IDD, including wearable devices, communication aids, robotics, e-textiles, mobile device applications (apps), electrophysiological or other measures. |
| Applications of artificial intelligence (AI)/machine learning (ML) for diagnosis and management of IDD conditions based on ethical and unbiased approaches. |
| AI/ML for early detection, risk stratification, or predictive modeling of IDD. |
| Validation of tools and technologies that can be implemented in the IDD community and engage PWLE of IDD, such as digital phenotyping or eye tracking software using a mobile device. |
| Use of implementation science to improve outcomes for people with IDD and their caregivers. |
Leadership The Center Director(s) (PD(s)/PI(s)) are responsible for developing and maintaining a Center environment that fosters traditional and novel approaches to multi-disciplinary research collaborations and educational activities.
Educational Activities As national resources for IDD research, the IDDRCs play leadership roles in the education of new investigators for the IDD research field and in educating the patient and lay communities regarding educational and research activities. Each Center should establish and maintain a strong mentoring environment for predoctoral and postdoctoral investigators in IDD research, as well as new and early-stage investigators. The Center may include, as examples, education on manuscript writing and reviewing, grantsmanship, team science approaches and lab management, as well as the ethical conduct of research. Other features of the environment may include a seminar program, retreats for presentation of research, journal clubs, or other activities that contribute to the preparation and mentorship of new and junior investigators for careers in IDD research. Education and outreach activities for the lay public may include seminar series, newsletters, public presentations, town hall meetings, social media posts, or other events to disseminate the goals and accomplishments of the Center. Educational and dissemination activities should be organized within the Administrative Core.
Institutional Support Scientific personnel and institutional resources capable of providing a strong research base in the IDD field must be available. A strong institutional commitment is essential. For example, the commitment may take the form of faculty appointments and/or partial salary support for investigators, purchase of research equipment and/or service contracts, and/or assignment of research space to facilitate collaborative research and interdisciplinary interaction. Scientists may have access to the Center's centralized facilities and participate in its activities while retaining independent control of their respective outside research projects. However, all activities using IDDRC Center funds must be relevant to the mission of NICHD's IDDRC program.
Administrative and scientific organization within a Center and across the network of IDDRCs should enhance opportunities for major discoveries and acquisition of scientific knowledge that will help prevent, diagnose, and ameliorate or treat IDD. NICHD encourages investigators within the Centers to apply for a variety of other grants, including clinical trials grants (e.g., R34, R01, and U01).
The IDDRC Network Recipients of IDDRC awards will become part of a national program in IDD research and will be expected to participate in IDDRC network activities, including monthly leadership calls, shared and coordinated activities and projects when appropriate, and an annual meeting of the IDDRC Leadership Committee (composed of IDDRC Directors, NIH program staff, and other relevant parties), that is held in the Washington, DC area, rotated among the IDDRC sites, or held virtually.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
Renewal
The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.
Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards
NICHD intends to commit approximately $12.15 M (direct costs) or $18 M (total costs) in FY 2027 to fund up to 15 awards.
Award Budget
Application budgets need to reflect the actual needs of the proposed project. Direct costs are limited to $800,000 total for each year of the award.
Award Project Period
The scope of the proposed project should determine the project period. However, the maximum project period is a total of 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations
This competition is limited to applicants that are recipients of IDDRC P50 awards under RFA-HD-20-016 or RFA-HD-21-009. Please refer to Section 1. Notice of Funding Opportunity Information for more details.
Foreign Organizations/International Collaborations
Non-domestic (non-U.S.) Entities (Foreign Organization) 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.
Required Registrations
Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
| eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. |
| Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration. |
Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
The PD(s)/PI(s) (known as the IDDRC Center Director(s)) should be a scientist or science administrator who can provide effective scientific and administrative leadership. The PD(s)/PI(s) of the IDDRC should be a recognized scientific leader(s) experienced in the field of IDD research and must be able to coordinate, integrate, and provide guidance in the establishment of research programs. The Director(s) will be responsible for the organization and operation of the IDDRC and for communication with the NICHD on scientific and operational matters. The Director(s) should be able to integrate and synthesize the proposed research, and, thereby, serve as an example to other investigators. The Center Director(s) should have a minimum total combined commitment of 2.4 person-months to the IDDRC. The Center Director(s) may also serve as the Director(s) on a Specific Research Project component or a Core of the IDDRC, although their total level of effort will need to increase accordingly. The Center Director(s) cannot serve as a Specific Research Project PD/PI on another active IDDRC award.
Only recipients funded under RFA-HD-20-016 or RFA-HD-21-009 are eligible to apply.
2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
3. Additional Information on Eligibility Number of Applications
Only one application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
| A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. |
| A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. |
| An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications). |
Section IV. Application and Submission Information
1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component |
| Component Type for Submission |
| Page Limit |
| Required/Optional |
| Minimum |
| Maximum |
| Overall |
| Overall |
| 12 |
Required
| 1 |
| 1 |
| Admin Core |
| Admin Core |
| 6 |
Required
| Clinical Translational Core |
| Clin Transl Core |
| 6 |
Required
| Other Cores |
| Core |
| 6 |
Required
| Specific Research Projects |
| Project |
| 12 |
Required
Instructions for the Submission of Multi-Component Applications
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
Overall Component When preparing the application, use Component Type ‘Overall’.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
SF424(R&R) Cover (Overall) Complete entire form.
PHS 398 Cover Page Supplement (Overall) Follow standard instructions.
Research & Related Other Project Information (Overall) Follow standard instructions.
Facilities and Other Resources: Describe the institutional support and commitment to the IDDRC. A strong institutional commitment is essential. The commitment may include faculty appointments and/or partial salary support for investigators, purchase of research equipment, or assignment of research space to facilitate collaborative research and interdisciplinary interaction. Scientists may have access to the Center's centralized facilities and participate in its activities while retaining independent control of their respective research projects. However, all activities using IDDRC Center funds must be relevant to the mission of NICHD's IDDRC program.
Other Attachments:
Applicants must provide a table listing the outside research projects with other sources of funding that are proposed for core usage. Name the table "Research Projects Proposed for Core usage". Projects should be listed in alphabetical order by PD/PI surname. Research Projects must be either currently funded or pending award (status = to be paid in eRA Commons or IMPACII).
For each outside funded research project proposed to access the IDDRC Research Center, provide the following information in tabular format:
| PD/PI and level of effort (person-months) |
| Title of project |
| Source of support (including grant number and project designation, such as 5 R01 HG 12345 (P.I. - Smith), Project III (P.I.- Jones)) |
| Indication of funding status (funded or pending) |
| Period of support |
| Total first year or current 12-month budget |
| Total project period budget |
| Brief description of project (no more than 2 sentences) |
| Brief relevance of the project to the center mission and IDD research (no more than 2 sentences) |
| Brief justification for use of IDDRC core resources (no more than 2 sentences) |
Project/Performance Site Locations (Overall) Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Include Specific Aims for the overall Center.
| Research Strategy: Describe the major themes of the Center, its goals and objectives, background information and the overall importance of the research to advancing the diagnosis, prevention, treatment, and amelioration of IDD. Explain the strategy for achieving the goals defined for the overall program and how each Core and Specific Research Project relate to that strategy. Explain how the different aspects of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how combined resources create a Center that is more than the sum of its parts. Include all necessary tables, graphs, figures, diagrams and charts in this section. In addition, provide the following information: | ||
| Purpose and Objectives of the Center: Discuss the philosophy and objectives of the IDDRC and general plans for the proposed grant period. This section can emphasize information that demonstrates the Center’s past success in realizing its objectives. | ||
| Administration, Organization, and Operation of the Center: Include information on the authority of the Center Director(s), the dissemination and communication plan, the use of internal user or Executive Committees and External Advisory Committees, and the method of determining Core access and space assignment. Describe the organizational framework and provide an organizational chart. | ||
| Cost-Effectiveness and Quality Control: Describe procedures used to lower costs and assure quality of Center administrative and research activities. | ||
| Connections between the proposed Center and other organizations such as patient advocacy groups, industry partners, or other Centers or IDDRCs. | ||
| Accomplishments not previously cited: Describe any other experience the applicants have had with research centers/programs or core resources, which may include: | Use of center/program/core administrative funds for activities such as consultant services, scientific seminars, renovations, or travel; | |
| Educational activities for graduate students, postdoctoral fellows, junior investigators, or members of the lay public that contributed to the center/program/core environment; | ||
| Investigators attracted to the field by the center/program and its core facilities, including trainees, new investigators and visiting investigators; | ||
| Impact of the center/program/core on the institution and community, including documentation of past successes in advancing IDD knowledge and research as well as outreach and dissemination activities and engagement of PWLE; | ||
| Role of the center/program/core in facilitating IDD research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research; and | ||
| Other accomplishments. |
Letters of Support: Provide letters of support from institutional officials and letters of assurance/agreement for any collaborative and cooperative endeavors or subcontracts. Include letters of agreement from consultants. For projects to be conducted off-site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application. Please compile all letters of support for the entire Center together in one section.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.
Administrative Core When preparing your application, use Component Type ‘Admin Core.’
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Admin Core) Complete only the following fields:
| Applicant Information |
| Type of Applicant (optional) |
| Descriptive Title of Applicant’s Project |
| Proposed Project Start/Ending Dates |
PHS 398 Cover Page Supplement (Admin Core) Follow standard instructions.
Research & Related Other Project Information (Admin Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Admin Core) List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Admin Core)
| In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Admin Core Director’ and provide a valid eRA Commons ID in the Credential field. |
| In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. |
| Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. |
| If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. |
Budget (Admin Core) Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Describe the specific functions of key scientific and technical personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as equipment purchase or alterations and renovations. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. No recurring annual escalations in costs are allowed.
Allowable costs for the Administrative Core may include:
| Salaries for the Center Director(s) (PD(s)/PI(s)) specifying a minimum total combined commitment of 2.4 person-months (20 percent) effort to the IDDRC; |
| Salaries and support for a limited number of administrative and clerical personnel, such as a Center Administrator, secretaries, and clerical support staff; |
| Administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional F & A charges; |
| Costs related to dissemination and communication of research results to investigators, the scientific community and lay public; |
| Costs related to seminars or meetings designed to promote interdisciplinary interaction, education, or Center cohesiveness; |
| Costs related to External Advisory Committee meetings; |
| Costs of minor renovation for Cores may be included within the IDDRC budget; NICHD provides no funds for new construction; |
| Travel of Center investigators to other IDDRCs or other collaborative sites to exchange scientific ideas, to plan multi-Center research projects, or to learn specialized techniques; and |
| Travel for 2-4 IDDRC staff and trainees to annual meeting of the IDDRC Steering Committee (composed of IDDRC Directors, NIH program staff, and other relevant parties), to confer with other NICHD IDDRC Directors and program staff and promote scientific interaction among the Centers. This is held in the Washington, DC area, rotated among the IDDRC sites, or held virtually. |
PHS 398 Research Plan (Admin Core) Specific Aims: Include Specific Aims for the Administrative Core.
Research Strategy: The Administrative Core will be responsible for the management and administration of the overall IDDRC. This section of the application should describe the strategies and processes that will be used to manage the Center and achieve its goals. This Core, led by the Center Director(s), will provide oversight for the Cores and research project(s), and will promote coordination and collaboration within the Center and with investigators and organizations outside the Center. The Research Strategy should describe the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; the dissemination and communication plan; the plans to incorporate the experiences of persons with lived experience (PWLE) into its activities; and the maintenance of ongoing communication internally and externally. Indicate who will be responsible for each of these activities. To assure active collaboration with other Centers, the IDDRC Director(s) should participate in monthly leadership calls, develop shared and coordinated activities and projects when appropriate, help to refine and standardize operating procedures among the Centers, and attend an annual meeting of the IDDRC Network, contribute to the coordination of effort, and/or help to refine and standardize operating procedures among the Centers. The application should provide the following information about the Administrative Core:
| Objectives of the Core |
| Organizational Chart |
| Staffing: Description of administrative/business management staff and oversight mechanisms by the Center Director (PD/PI), Center Co-Director (if applicable), and a local Executive Committee. |
| Services Provided: Description of current and projected services to other Core and Research Projects, as well as the process for prioritizing requests for use of Core facilities by the various research projects. Include a description of past services provided by the Administrative Core personnel, new technologies developed, changes in protocols or Core administration, dissemination and community activities, and other significant accomplishments. The Administrative Core should establish and maintain a website to communicate the Center's mission and the availability of Core services. When multiple geographic sites are involved in the IDDRC, the Administrative Core should provide the leadership and communication needed to manage the multiple sites. |
| Education: Include plans to establish and maintain an educational environment for predoctoral and postdoctoral investigators in IDD research, as well as new and early-stage investigators, and to engage the patient and lay community in educational and research activities. Utilization and adaptation of existing training programs are expected. The educational activities for the center may include, as examples: manuscript writing and reviewing, grantsmanship, team science approaches and lab management, as well as the ethical conduct of research. Other features of the educational environment may include a seminar program, retreats for presentation of research, journal clubs, or other activities that contribute to the preparation and/or mentorship of new faculty members or junior investigators for careers in IDD research. |
| Dissemination and communication plan: Include a plan to promote communication about the research supported by the Center to other scientists, educators, the government, and the public, including those with IDD conditions and their families. The Center should serve as a communication liaison between investigators conducting state-of-the-art research and the public, and where appropriate, the information should be structured so that it can effectively reach representative populations. This Core should establish meaningful partnerships with the community, including PWLE of disabilities. The IDDRC should incorporate the experiences, perspectives, needs, and priorities of stakeholders, including those with IDD, into its decisions and activities. Education and outreach activities for the public may include websites, seminar series, newsletters, public presentations, social media postings, town hall meetings, or other events to disseminate the goals and accomplishments of the center. |
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