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

Intellectual and Developmental Disabilities Research Centers 2016 (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-HD-15-033

Related Notices

  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)

Funding Opportunity Announcement (FOA) Number

RFA-HD-16-013

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in  Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865  

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to seek applications for the Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers (IDDRCs). This FOA invites applications for research center cooperative agreements designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD). This FOA seeks applications from institutions that meet the qualifications for a multi-disciplinary program of IDD research that will include: 1) Cores that facilitate interdisciplinary and translational research in IDD, and support IDD-related projects funded by other sources; and 2) at least one specific research project related to one of five focus themes identified as an area of research need in IDD. Funds for the majority of research projects using these core facilities come from independent sources including Federal, State, and private organizations.

Key Dates
Posted Date

December 9, 2015

Open Date (Earliest Submission Date)

January 18, 2016

Letter of Intent Due Date(s)

January 18, 2016

Application Due Date(s)

February 18, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2016

Advisory Council Review

August 2016

Earliest Start Date

September 2016

Expiration Date

February 19, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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. Funding Opportunity Description

The purpose of this Funding Opportunity Announcement (FOA) is to seek applications for the Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers (IDDRCs).  This Funding Opportunity Announcement (FOA) invites applications for research center cooperative agreements designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD). This FOA seeks applications from institutions that meet the qualifications for a multi-disciplinary program of IDD research that will include: 1) Cores that facilitate interdisciplinary and translational research in IDD, and support IDD-related projects funded by other sources; and 2) at least one specific research project related to one of five focus themes identified as an area of research need in IDD. Funds for the majority of research projects using these core facilities come from independent sources including Federal, State, and private organizations.

Background

For almost 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 has been funded via Center Core (P30) grants that facilitate program coordination and support 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. In the new round of IDDRC competition, the goal is to provide an opportunity to transition the IDDRC program into a functional network of integrated and collaborative research centers. This initiative will support IDDRCs through the U54 (Specialized Center-Cooperative Agreement) mechanism. The U54 mechanism will also allow the research community, in collaboration with the NICHD, to respond to emerging needs within the IDD field.

The goals of the IDDRC program include the promotion of collaborative, multidisciplinary and interdisciplinary research programs that will not only provide core facilities and support for research in IDD, but will also advance the development of therapeutics and interventions for these conditions.

The missions of the IDD Branch at NICHD are broad and include research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of IDD. The research conducted by the IDDRCs in the past has mirrored this breadth and has covered a wide spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical, biomedical, behavioral, and biobehavioral studies in persons with IDD. During the past 50 years, the IDDRCs have been highly productive, and solutions to some of the major challenges associated with IDD have emerged from multidisciplinary, collaborative, and integrated approaches.

On April 23-24, 2012, the NICHD held a workshop to identify key research areas, resources, and integration strategies needed to make advances in the field of IDD over the next 5 to 15 years. Participants in the meeting included scientific experts from the research, clinical, and pharmaceutical communities, along with representatives from advocacy groups, other relevant federal agencies, and interested NIH Institutes and Centers. The recommendations that arose from that meeting and priorities of the NICHD form the basis for the five focus themes that were identified as areas of research need and that will inform the specific research project proposed in response to this FOA. In addition, there was broad recognition of the need to promote coordination of IDD-related research endeavors and integration of clinical trial efforts.

NICHD seeks opportunities to advance research in IDD that take advantage of new technologies that have recently evolved and to encourage cooperation among the Centers, including their integration into a network that may facilitate development of the infrastructure necessary for the conduct of larger research programs or clinical trials. The U54 mechanism provides the opportunity for the Centers to be responsive to these emerging needs, and allows them to be strategically placed to promote future clinical and translational efforts including clinical trials. This FOA represents a step in the evolution of the IDDRC program toward more project-focused and translational approaches to IDD research.

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-Cooperative Agreement 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 FOA also encourages support of postdoctoral researchers, junior investigators, and investigators new to the IDD field through their access to Core services, as one of the goals of the IDDRC program is to attract scientists to IDD research. NICHD strongly encourages translation of basic research observations into patient-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.

For purposes of this FOA, it is essential that scientific personnel and institutional resources capable of providing a strong research base in the IDD field are available. There also must be a strong institutional commitment. The commitment may take the form of 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 NICHD Center funds must be relevant to the mission of NICHD's IDD Center program.

Minimal Structural Requirements

Applications responding to this FOA must propose a multi-disciplinary program of IDD research that includes Core Components and Research Components.  Requirements for these components are described in the following sections.

Cores

Each U54 can propose a minimum of three and a maximum of six 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 federally-funded, peer-reviewed research projects, at least one of which is NICHD-funded.
  • 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. In cases where the funding agency primarily uses the contract mechanism to support investigator-initiated projects rather than the grant/assistance mechanism, the aforementioned restriction may not apply. In these cases, NICHD staff should be consulted. 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 U54 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 composed of at least five members, with scientific, clinical and patient advocate representation, as well as NIH program staff. The EAC should meet in-person or electronically approximately once a year, beginning in the first or second year of the Center award. 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.

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;
  • Development 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.
Research Projects

U54 applications must include at least one specific Research Project that has not been previously funded and addresses one or more of the five focus themes identified as an area of research need in IDD by leaders in the field at the NICHD-sponsored workshop held in April 2012.

Each 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 U54 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. The five focus areas are as follows, in no order of priority:

(1) Comprehensive –omic Approaches

Comprehensive -omic approaches (e.g., genomic, transcriptomic, epigenomic, metabolomic) that will markedly increase our understanding of IDD conditions with no known etiology or IDD conditions with complex etiologies to improve diagnosis, and potentially, treatment.  Examples include, but are not limited to:

  •   Whole exome or whole genome sequencing of a well-defined cohort of subjects with IDD to identify genetic or genomic variants likely to cause the phenotype;
  •   Methylation or other studies on individuals with a shared IDD diagnosis but variable manifestations (such as range of cognitive function) to identify potential epigenetic contributors;
  •   Tandem mass spectrometry on biological samples such as saliva, blood or urine from a group of individuals with metabolic or other disorders associated with intellectual disability that might define distinctive biomarkers or metabolic signatures that would allow monitoring of outcomes or response to treatment.

(2) Outcome Measures for Interventions or Treatments

Development of preclinical or clinical outcome measures or biomarkers for the cognitive and/or behavioral phenotypes of IDD that have the potential to demonstrate a change in response to intervention or treatment.  Examples include, but are not limited to:

  •   Development of a measure for an animal model (e.g., mouse, rat, nonhuman primate) of an IDD disorder that reliably detects changes in behavior response to a drug treatment;
  •   Development of a measure of cognitive function in individuals with an IDD condition that is sensitive to an intervention;
  •   Demonstration of changes in an existing behavioral measure in individuals with an IDD condition in response to therapy.

(3) Multi-modal Treatment Approaches

Development of bi- or multi-modal treatment approaches for a single IDD condition or a group of IDD conditions or spectrum disorders to demonstrate combinatorial effects to ameliorate a cognitive or behavioral symptom(s) of the condition(s). The interventions may or may not be disease-specific, and the potential to broaden to multiple IDD disorders is encouraged.  Examples include, but are not limited to:

  •   Use of a drug and a training paradigm in an animal model of an IDD to demonstrate improvement in a behavioral measure;
  •   Use of a medication and behavioral treatment in combination for individuals with an IDD condition to demonstrate improved efficacy;
  •   Use of one well-established intervention plus 1-2 medications to improve general symptoms of a mood disorder in individuals with different IDD conditions who share that mood disorder.

(4) Shared Resources Across IDDRCs for Treatment or Assessment

Development of an assessment battery or clinical intervention for an IDD condition or group of IDD conditions that links more than one funded IDDRC into a network, with sharing of at least one unique core resource from each IDDRC.  Examples include, but are not limited to:

  •   Development of an assessment paradigm for an allelic series of animal models for an IDD condition that uses the genomics core of one IDDRC and the animal behavioral core of another IDDRC;
  •   Development of a testing paradigm for a specific IDD condition that uses the biostatistics core from one IDDRC and the human behavioral assessment core of another IDDRC;
  •   Creation of a clinical trial for an IDD condition that utilizes the patient recruitment core from one IDDRC and the trial design core from another IDDRC.

(5) Public Health Approaches

Public health approaches to IDD that identify potentially preventable, modifiable, or treatable targets that can yield a rich payoff in ameliorating or improving outcomes for large groups of individuals with IDD or that will reduce risk of developing an IDD. These may include pre-conceptional, prenatal, postnatal or childhood exposures or risk factors, and may involve the broader family or community.  Examples include, but are not limited to:

  •   A project that addresses the risk of developing an IDD due to preterm birth;
  •   A project that addresses maternal exposures to potential teratogens (alcohol, cocaine, cytomegalovirus, etc.) that predispose to IDD;
  •   Development of a measure that attempts to reduce environmental factors (such as lead) that can contribute to IDD.
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 educating the patient and lay communities regarding 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, and to engage the patient and lay community in educational and research activities. 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, or other events to disseminate the goals and accomplishments of the center.  Educational 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. 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.

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 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 an annual meeting in the Washington, DC area of the IDDRC Steering Committee (composed of IDDRC Directors, NIH program staff, and other relevant advisors), and an annual IDDRC meeting that rotates among the IDDRC sites.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to commit a total of $6.2 million in FY 2016 to fund up to 5 awards.

Award Budget

Award budgets are limited to $800,000 total direct costs per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

The IDDRC Center Director(s) (PD(s)/PI(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 commitment of 2.4 person-months to the IDDRC. The Center Director(s) may also serve as PD(s)/PI(s) on the Research Project Component of the IDDRC. The Center Director(s) cannot serve as a Project PD/PI on another active IDDRC award.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Melissa A. Parisi, MD, PhD
Telephone: 301-435-6880
Fax: 301-496-3791
Email: parisima@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core (use for Administrative Core)

12 pages

Clin Transl Core (use for Clinical Translational Core)

12 pages

Project (use for Research Project(s)

12 pages

Core (use for Other Cores)

12 pages

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required, 1 maximum
  • Clinical Translational Core: required, 1 maximum
  • Other Core(s): required, 4 maximum
  • Research Project(s): required, 2 maximum
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) 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)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

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 section on outside research projects with other sources of funding that are proposed for core usage. Name the attachment "Research Projects.pdf". This will be the name used for the bookmark accessible to reviewers. Projects should be listed in alphabetical order by PD/PI surname.  Research Projects must be currently funded or pending award (status = “to be paid” in eRA Commons or IMPACII).

For each funded research project proposed to access the IDDRC Research Center, provide the following information. Do not exceed one page per project; applications exceeding this limit will not be reviewed:

  • PD/PI and level of effort (person-months)
  • Title of project
  • Source of support (including grant number and project designation, such as 5 P01 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
  • Relevance of the project to U54 center mission and IDD research
  • Brief justification for use of IDDRC core resources.
Project/Performance Site Location(s) (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.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) 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 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 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 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:

1) Use of center/program/core administrative funds for activities such as consultant services, scientific seminars, renovations, or travel;

2) Educational activities for graduate students, postdoctoral fellows, junior investigators, or members of the lay public that contributed to the center/program/core environment.

3) Investigators attracted to the field by the center/program and its core facilities, including new investigators and visiting investigators;

4) Impact of the center/program/core on the institution and community, including documentation of past successes in advancing IDD knowledge and research;

5) Role of the center/program/core in facilitating IDD research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research;

6) 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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applications are expected to provide an overview for and describe the oversight of the resource sharing plan of the Center as a whole. 

Applications should highlight potentially unique core resources and plans to share them with other IDDRCs, consistent with achieving the goals of the IDDRC Program. A cost-sharing plan to allow other IDDRCs access to such unique resources is acceptable and encouraged, if appropriate.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative 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 (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative 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) (Administrative 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 (Administrative Core)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘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 (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

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 major equipment 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 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 the Center Director(s), 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 of research results to 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 to 1-2 IDDRC program meetings annually to confer with other NICHD IDDRC Directors and program staff to promote scientific interaction among the Centers: one meeting of the IDDRC Steering Committee (composed of IDDRC Directors, NIH program staff, and other relevant advisors) will be held in the Washington, DC area, and a second annual IDDRC meeting will rotate among the IDDRC sites.

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.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

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 U54 IDDRC. This section of the application should describe the strategies and processes that will be used to manage the Center and achieve the 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; and the maintenance of ongoing communication. Indicate who will be responsible for each of these activities. To assure active collaboration with other Centers, the IDDRC Director(s) should attend annual meetings 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. If this Core already exists, include a description of past services provided by the Administrative Core personnel, new technologies developed, changes in protocols or Core administration, and other significant accomplishments. The Administrative Core should 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.
  • 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.  Education and outreach activities for the lay public may include seminar series, newsletters, public presentations, town hall meetings, or other events to disseminate the goals and accomplishments of the center. 
  • Executive Committee and External Advisory Committee:  The Administrative Core should establish a local Executive Committee, composed of members of the Center, and an External Advisory Committee, composed of members outside the Center and relevant NIH program officers. Describe the general composition of the EAC, but do not name specific individuals in the application unless the EAC has already been constituted. Describe how the External Advisory Committee will contribute to oversight of the Core facilities and specific research projects, as well as the educational environment of the Center. The External Advisory Committee should meet approximately once a year virtually or in person, and brief reports of the proceedings of the meeting and recommendations of the committee should be included in the annual progress reports of the Center.
  • IDDRC Steering Committee: The Center Director(s) is expected to participate in a steering committee of the entire IDDRC network composed of IDDRC Directors, NIH program staff, and other relevant advisors. This committee will hold regular conference calls and 1-2 annual IDDRC face-to-face meetings.
  • Cost effectiveness and plans for quality control: Describe any cost structures such as fee-for-service, in-kind, charge-back systems, or other methods used to establish cost effectiveness of the Core services. Describe quality controls systems in place to measure the accuracy, reproducibility, and reliability of equipment, assays or services in order to ensure the quality and value of the Core services broadly and the center as a whole.
  • User satisfaction surveys: Describe frequency and content of user satisfaction surveys, evaluation of cost effectiveness, and other means to assess quality and value of services to investigators. 

Letters of Support: Include any letters of support or collaboration specific to this Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. If not covered under the Overall Component, applicants should provide a plan for sharing any resources specific to this Core.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Clinical Translational Core

When preparing your application in ASSIST, use Component Type ‘Clin/Transl Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Translational 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 (Clinical Translational Core )

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Translational 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) (Clinical Translational 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 (Clinical Translational Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘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 (Clinical Translational Core)

Budget forms appropriate for the specific component will be included in the application package.

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 major equipment 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 Clinical Translational Core may include:

  • Salaries and support for Core Director(s)/core staff
  • Supplies (including animals);
  • Scientific equipment;
  • Computer facilities and services;
  • Travel for technical or administrative staff for technical training or to maintain operation of the core unit;
  • Minor renovation or alteration of existing facilities;
  • Consultant services.

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.

PHS 398 Research Plan (Clinical Translational Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Include Specific Aims for the Clinical Translational Core.

Research Strategy: The Clinical Translational Core will be critical for supporting research that allows application of basic science discoveries to the clinical setting, treatment development, and/or clinical trials. This section of the application should describe the strategies and processes that will be used to promote the clinical and translational goals of the Center. This Core, led by the Core Director(s), will provide oversight for translational services provided by the Core. The Research Strategy should describe the planning and coordination of translational research activities; the integration of cross-disciplinary translational research supports; and the maintenance of ongoing communication between Core staff and investigators. The application should provide the following information about the Clinical Translational Core:

  • Objective of the Core
  • Staffing: Brief description of scientific, technical, and support staff functions.
  • Services Provided: Description of current and projected services available to Research Project(s) of the U54 and outside Projects Proposed for Core Use, as applicable, as well as the process for prioritizing requests for use of Core facilities by the various research projects. If this Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant accomplishments.
  • Administration: Description of overall management of the Core.
  • Justification: Description of services provided and their bearing on productivity and quality.  Describe how the service(s) provided will support research that allows application of basic science discoveries to the clinical setting, treatment development, and/or clinical trials. Explain how this Core will advance the diagnosis, prevention, treatment, and amelioration of IDD in individuals with these conditions.
  • Utilization of Core:  For Research Projects proposed to utilize the Core, provide a list or table of projected usage of Core services (e.g., assays performed, animals supplied, etc.).  Sort the list/table in alphabetical order by last name of PD/PI, and include the grant number for each relevant project.  Compile a summary of usage data across all projects for each category of services.
  • Cost effectiveness and plans for quality control: Describe any cost structures such as fee-for-service, in-kind, charge-back systems, or other methods used to establish cost effectiveness of the Core services. Describe quality controls systems in place to measure the accuracy, reproducibility, and reliability of equipment, assays or services, including service contracts, maintenance schedules, and technical monitoring of services provided in order to ensure the quality and value of the Core services.
  • User satisfaction surveys: Describe frequency and content of user satisfaction surveys, evaluation of cost effectiveness, and other means to assess quality and value of services to investigators.   

Letters of Support: Include any letters of support or collaboration specific to this Core. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. If not covered under the Overall Component, applicants should provide a plan for sharing any resources specific to this Core.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report (Clinical Translational Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Translational Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Other Core(s)

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Other 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 (Other Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Other 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) (Other 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 (Other Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘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 (Other Core)

Budget forms appropriate for the specific component will be included in the application package. For any Other Cores, 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 major equipment 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 Other Core(s) may include:

  • Salaries and support for Core Director(s)/core staff;
  • Supplies (including animals);
  • Scientific equipment;
  • Computer facilities and services;
  • Travel for technical or administrative staff for technical training or to maintain operation of the core unit;
  • Minor renovation or alteration of existing facilities;
  • Consultant services.

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.

PHS 398 Research Plan (Other Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Include Specific Aims for the Core.  

Research Strategy: Provide the following information:

  • Objective of the Core
  • Staffing: Brief description of scientific, technical, and support staff functions.
  • Services Provided: Description of current and projected services to Research Projects  and Projects Proposed for Core Use, as applicable, as well as the process for prioritizing requests for use of Core facilities by the various research projects. If this Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant accomplishments.
  • Administration: Description of overall management of the Core.
  • Justification: Description of services provided and their bearing on productivity and quality. Explain how this Core will advance the diagnosis, prevention, treatment, and amelioration of IDD in individuals with these conditions.
  • Utilization of Core: For Research Projects proposed to utilize the Core, provide a list or table of projected usage of Core services (e.g., assays performed, animals supplied, etc.).  Sort the list/table in alphabetical order by last name of PD/PI, and include the grant number for each relevant project.  Compile a summary of usage data across all projects for each category of services.
  • Cost effectiveness and plans for quality control: Describe any cost structures such as fee-for-service, in-kind, charge-back systems, or other methods used to establish cost effectiveness of the Core services. Describe quality controls systems in place to measure the accuracy, reproducibility, and reliability of equipment, assays or services, including service contracts, maintenance schedules, and technical monitoring of services provided in order to ensure the quality and value of the Core services broadly and the center as a whole.
  • User satisfaction surveys: Describe frequency and content of user satisfaction surveys, evaluation of cost effectiveness, and other means to assess quality and value of services to investigators. 

Letters of Support: Include any letters of support or collaboration specific to this Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. If not covered under the Overall Component, applicants should provide a plan for sharing any resources specific to this Core.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report (Other Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Other Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Research Project

When preparing your application in ASSIST, use Component Type ‘Project.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project )

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 (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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) (Research Project)

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 (Research Project)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 (Research Project)

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.

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Include Specific Aims for the Research Project, clearly stating the overall objective of the project and which of the five focus themes it addresses, as well as its relevance to the focus theme chosen.

Research Strategy: For any project that involves preclinical research, adequate rigor is expected with regard to experimental design, minimizing bias, interpretation of results, and transparency of reporting. There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, and analysis. NICHD urges applicants to the IDDRC program to consider the rationale for the chosen animal model(s) and endpoints, adequacy of controls, route and timing of therapeutic dosing, justification of sample size, statistical methods, blinding methods, strategies for randomization, and robustness and reproducibility of results when describing preclinical studies and designing the specific Research Project. Examples of the critical elements of a well-designed study are summarized in this document: http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf ).

A minimum of two Cores (which may include the Administrative and/or Clinical Translational Core) of the Center must be utilized by each Research Project and should be identified.

Organize the Research Strategy as described in the SF424 Application Guide and using the instructions provided below. Start each section with the appropriate section heading—Significance, Innovation, Approach. In the application, an explanation should be included describing how the project relates to and both complements and is enhanced by the research goals and Cores of the Center. Specify the overall biomedical significance of the work proposed and why the project is best suited to be carried out in the Center environment. As part of the Research Strategy, include information on preliminary studies, data, and/or prior experience pertinent to this application. Because the five focus themes represent difficult, challenging scientific questions that may require overcoming critical barriers in the field, NICHD recognizes that applications may include Research Projects that are exploratory, discovery-based and/or higher risk in nature. If external sources of funding are available for the project, these must be clearly stated, including source, amount, and duration of support.

Letters of Support: Include any letters of support or collaboration specific to this Research Project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. If not covered under the Overall Component, applicants should provide a plan for sharing any resources specific to this Research Project.

The following modifications apply to any specific Research Project responding to one of the five focus themes that addresses autism research:

  • The NIH National Database for Autism Research (NDAR) houses research data of all types (genetic, imaging, clinical assessment, etc.) from human subjects involved in autism spectrum disorder (ASD) studies, and is currently on track to receive data from tens of thousands of such subjects.  NDAR’s first data release occurred in November 2010, making mostly clinical assessment data from over 10,000 research subjects available to qualified investigators.  It is expected that in the next several years, ASD data from more than 90% of new investigations will be available in or through NDAR.
  • All autism-related projects will be expected to contribute data to NDAR, which will function as a data repository. NDAR will be involved to facilitate sharing activities.  Central clinical coordination and local data management for data cleaning and entry and bio-statistical consulting will be the responsibility of the autism project. For more information on NDAR, please visit http://ndar.nih.gov/ndarpublicweb/.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Research Project )

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research  Project )

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, the overall score for U54 applications will emphasize the following:

  • Overall effectiveness and adequacy of Core resources and facilities;
  • Scientific merit and potential to impact the IDD field of the specific Research Project(s) responding to one of the five focus themes;
  • Scientific merit and relevance to IDD of the research projects proposed for Core usage;
  • Ability of the Clinical Translational Core to successfully promote treatment development for IDD;
  • Qualifications of the Center Director(s);
  • Quality of the plans for management and oversight of the Center;
  • Institutional commitment;
  • Accomplishments of the Center if it already exists; and
  • Synergy among the components of the Center.

The review will evaluate the potential for the Center as a whole to have a significant impact on the field during the terms of the award, weighing the balance of more conventional approaches with highly innovative components or projects in which success is not guaranteed. The overall score for the center application may be higher or lower than the average of the individual components based on the assessment of whether the whole is greater than the sum of its parts.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the program, including the Clinical Translational Core, have the potential to advance treatment development for IDD? Does the specific Research Project proposed demonstrate synergy with the Center's goals, utilize the Center's resources appropriately, and have potential to make advances in its area of focus? Do the research projects proposed for Core usage have scientific merit and relevance to IDD and to the Center's mission and goals?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the Center Director(s) have leadership ability and scientific stature, an ability to meet the program's demands of time and effort, and an ability to promote the Center mission among participants? Does the program involve the participation of a suitable number of responsible, experienced investigators with adequate time commitment for the Core and Research Components as well as the overall Center to succeed?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the Core services provided cutting-edge or state-of-the-art? If the Core services are standard but fulfilling a critical need, are the projects accessing those services innovative and/or likely to advance the field?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  Are the arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, external review, and cooperation among the investigators in the program well delineated and appropriate? Is the administrative and organizational structure conducive to attaining the specific aims of the proposed program? For existing centers, is there a track record of success in advancing progress in IDD-related research? Do the research projects proposed for core usage have scientific merit and relevance to the objectives of the IDDRC as a whole?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the Center able to provide adequate infrastructure to support novel approaches to IDD research and has it anticipated current and future needs of the research community? Is the academic and physical environment as it bears on research subjects, space, and equipment, and on the potential for interaction with scientists from other departments and institutions sufficient and conducive for the specific Research Project and the Center as a whole? Is the institutional commitment to the requirements of the program adequate? Do the research projects proposed for core usage appropriately access core services and provide coherence with the goals of the IDDRC?

Additional Review Criteria - Overall

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Integration of the Overall U54 Center

A major emphasis in evaluating the IDDRC is the integration or “centeredness” of the overall program. The IDDRC will be evaluated as an integrated collection of Core and Research Components oriented around an IDD focus. The reviewers will evaluate the following:

  • Does the program function as a true “Center” rather than a collection of unrelated support services and research projects with the sum of the parts being greater than the individual components?
  • Do coordination and integration between the proposed Cores and specific Research Project reflect a cohesive research program?
  • Is value added by having the proposed Cores and specific Research Project comprise a Center that allows the Center to leverage additional resources that would not have been possible without an integrated Center structure?
  • Are the projects proposed for Core usage relevant to IDD and well integrated with the Center Overall? 
  • Is the Center multidisciplinary in scope and do the breadth and overall quality of the Center's program, the Core Components, the specific Research Project, and projects proposed for Core usage have the ability to catalyze significant research advances in IDD?
Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria for Core Components

Reviewers will assign an impact score based on the assessment of each Core Component in terms of the following review criteria. Separate criterion scores will not be assigned for Cores.

Other Cores

Reviewers will evaluate the following:

  • Qualifications, experience, and commitment of the Core Director(s) and other Core personnel;
  • Quality of the services provided;
  • Cost effectiveness and quality control of the Core;
  • If Core already exists, the effectiveness and relevance of provided services and development of new technologies or other significant advances;
  • Utility of the Core to the program.

Administrative Core

Reviewers will evaluate the following:

  • Core Director’s experience in research administration;
  • Appropriateness of administrative structures and day-to-day management of the program;
  • Decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;
  • Process for prioritizing use of Core facilities by the various research projects;
  • Process for evaluating research projects and investigators for membership in the Center and access to the Cores;
  • Mechanisms proposed for regular communication and coordination among investigators in the program;
  • Plan for program evaluation, including the use of an internal Executive Committee and External Advisory Committee.

Clinical Translational Core

Reviewers will evaluate the following:

  • Experience of the Core Director in directing translational science;
  • Likelihood that the service(s) provided will support translational science in IDD;
  • Promotion of projects that will lead to treatment development and/or clinical trials;
  • Responsiveness of the Core to Human Subjects issues that may arise.
  • Cost effectiveness and quality control of the Core.
Review Criteria for Research Project(s)

Reviewers will assign an impact score based on the likelihood of success for each specific Research Project responding to one of the five focus themes. Since the five focus themes represent difficult, challenging scientific questions that may require overcoming critical barriers in the field, NICHD recognizes that applications may include Research Projects that are exploratory, discovery-based and/or higher risk in nature. In evaluating higher risk components or exploratory projects with limited preliminary data, the reviewers will weigh the potential to achieve transformative, paradigm-shifting advances against the risks. The reviewers will evaluate the likelihood that interpretable results will be obtained from exploratory or high- risk studies. For example, if proposing a novel hypothesis, the investigators should be able to prove or disprove that hypothesis by the end of the funding period; if proposing an exceptionally innovative methodology or technology, the investigators should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible.

Overall Impact - Research Project(s)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria.

Scored Review Criteria - Research Project(s)

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Research Project that by its nature is not innovative may be essential to advance a field.

Significance

Does the Research Project address an important problem or a critical barrier to progress in the field? If the aims of the Research Project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the Center structure facilitate the Research Project's ability to make substantive advances in at least one of the five focus themes listed in Section I (Comprehensive -omic Approaches, Outcome Measures for Interventions or Treatments, Multimodal Treatment Approaches, Shared Resources Across IDDRCs for Treatment or Assessment, Public Health Approaches) ?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Research Project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the Research Project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Research Project? Are potential problems, alternative strategies, and benchmarks for success presented? If the Research Project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is adequate rigor incorporated into study design, analysis, interpretation, and reporting?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Research Project proposed? Will the Research Project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the Research Project well integrated into the Center as a whole?

Additional Review Criteria - Research Project(s)

As applicable for the Research Project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed Center as a whole or specific Research Project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Research Project(s)

As applicable for the Research Project, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable 

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NICHD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.  
  • Cost-effectiveness of the Core facilities.
  • Cost of the Center.
  • Compliance with resource sharing policies.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • The PD(s)/PI(s) will have the primary responsibility for defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The PD(s)/PI(s) will serve as Center Director(s) and will be responsible for the integration and management of activities within the IDDRC.
  • The Center Director(s) shall be responsible for organizing a local Executive Committee for day-to-day management of the IDDRC, and an External Advisory Committee, with scientific, clinical and patient advocate representation. The role of these Committees will include the oversight, review, and evaluation of the Center, and the selection and prioritization of projects that will use resources and services that are provided through the IDDRC.
  • The Center Director(s) of each IDDRC also serves as a member of the IDDRC Steering Committee and is required to participate in its activities, to include regular conference calls and 1-2 annual IDDRC face-to-face meetings.
  • Awardees agree to participate in the overall coordination of NIH research efforts in IDD. This participation may include collaboration and consultation with other NIH awardees, the appropriate sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection. Awardees with a clinical trial component in their IDDRC agree to review of associated data, abstracts, and other publications by the DSMB and the NIH prior to their release.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • An NIH Project Scientist will be responsible for: (1) overseeing the activities of the Center, including the Research Component project, along with the other entities delineated above, to ensure that studies are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the Center runs in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (3) serving as a point of contact for investigators with the NIH; and (4) disseminating information from the Institute and communicating with Institute leadership to ensure that the Center operates smoothly.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

  • The IDDRC Steering Committee for the entire IDDRC network will be composed of IDDRC Directors, NIH program staff, and other relevant advisors. This committee will hold regular conference calls and organize two annual IDDRC face-to-face meetings, one to be held in the Washington, DC area, and one to be held at an IDDRC site. The Steering Committee shall discuss the direction of IDD research, the development of a vision for integration of the Centers, and a plan for how they can best serve the overall goals of the program and promote development of therapies for IDD.
  • The NICHD Project Scientist and Program Official will work closely with the IDDRC Steering Committee, and the PD(s)/PI(s) of all Centers in order to ensure proper conduct of the program as a whole.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Melissa A. Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: parisima@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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