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 2014 (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-HD-13-002 

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-14-012

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 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.       

Key Dates
Posted Date

March 7, 2014

Letter of Intent Due Date(s)

April 6, 2014

Application Due Date(s)

May 6, 2014, by 5:00 PM local time of applicant organization.  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2014    

Advisory Council Review

August 2014   

Earliest Start Date

September 2014 

Expiration Date

May 7, 2014 

Due Dates for E.O. 12372
 

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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


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 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 trainees, 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.

Core Components

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:

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.  Any training 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:

Research Component Projects

U54 applications must include at least one specific Research Component 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 Component 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 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:

(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:

(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:

(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:

(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:

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 training.

Training and Education

As national resources for IDD research, the IDDRCs play leadership roles in training of new, early stage, postdoctoral, and predoctoral investigators  for the IDD research field and in educating the patient and lay communities regarding research activities. Training areas and activities may include, for example, grant and manuscript writing and review, team science approaches and management, and seminars, retreats, and mentorship.  Training 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. The facilities should require no more than modest alteration and/or renovation. NICHD provides no funds for new construction but minor renovation for Cores may be included within the IDDRC budget. 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 staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to commit a total of $5.2 million in FY 2015 to fund up to 4 awards.

Award Budget

Support for the entire IDDRC should not exceed $1.3 million in total 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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 PHS 398 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.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 PHS 398 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/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 Component Project 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..

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

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:

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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and 5 copies of the Appendix files on CD-ROM must be sent to:

Sherry Dupere, PhD
Director, Scientific Review Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service;  non-USPS service)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.   

Modify Form Page 3 to enable reviewers to find each component of the application easily.  The Table of Contents should be prepared listing all of the major sections described below and numbered consecutively.  Include page numbers for Human Subject and Vertebrate Animal sections for each Core and Research Project Component and for the Overall Center.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed.

For the U54 Center application, prepare a series of Composite budget tables as requested below.

Composite Budgets

Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 398 to present a composite budget, including totals for each component, for all requested support for the first year. In the header for each page, indicate that this is a COMPOSITE budget. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the totals for each Core and Research Component Project and the category subtotals. If consortium arrangements have been made involving other institutions or organizations, include total costs (direct and Facilities and Administrative (F & A)) associated with such third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category. Costs for purchased services should be itemized under "OTHER EXPENSES."

Items not fundable under this FOA:

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.  

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS 398 to prepare a composite budget that summarizes total costs for each  component for each year of requested support.  In the header for each page, indicate that this is a COMPOSITE budget. Include totals of Consortium/Contractual Costs by year for the project.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketches are required for all Senior/Key scientific personnel participating in the U54 Center, including those associated with specific Cores or Projects.  Beginning with the PD/PI (Center Director), and following in alphabetical order, submit biographical sketches as described in the PHS398 Application Guide. 

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed. In addition to resources described in the instructions, applicants must provide a section on research projects proposed for core usage as below.

Research Projects Proposed for Core Usage:

Research projects with other sources of funding that are proposed for Core usage will be evaluated with respect to the appropriateness of their use of Core services and relevance to IDD. These projects should be listed in numerical order. The following information is to be given for each research project that is currently funded or pending award (status = “to be paid” in eRA Commons or IMPACII).

For each funded research project proposed for Core usage, provide the following information (do not exceed one page per project):

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

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 Component 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:

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

2) Training activities that contributed to the center/program/core environment, and documentation of previous trainees, preceptors, present positions; current trainees, preceptors, research topics;

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;

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.

Protection of Human Subjects: Provide an overview of the human subjects considerations for the Center as a whole. List the components of the application that involve human subjects and page numbers for the relevant human subjects sections. 

Vertebrate Animals:  Provide an overview of the vertebrate animal considerations for the Center as a whole. List the components of the application that involve live vertebrate animals and page numbers for the relevant sections.

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Administrative Core)

Do not complete a Table of Contents for the Administrative Core.

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, i.e., ADMIN CORE. Consortium Budgets (if applicable) should be presented as described in Composite Budgets for the Overall Component. Total Direct and F & A costs of sub-awardees are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual Component budgets, and a detailed Consortium budget is to be inserted following the appropriate Component budget.

Budget Justifications: For the Administrative Core, 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. Identify such significant increases with asterisks against the appropriate amounts. No recurring annual escalations in costs are allowed.

Allowable costs for the Administrative Core may include:

Budget for Entire Proposed Period of Support (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, i.e., ADMIN CORE.

Biographical Sketch (Administrative Core)

Do not include this section.  All Biographical Sketches should be included together with the Overall component of the Center application.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.   Describe space and physical resources dedicated to the Administrative Core.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

 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:

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.

Protection of Human Subjects:  If the Administrative Core services involve human subjects, (e.g., recruitment, screening, evaluation, biobanking), discuss the Human Subjects protections following the PHS 398 Instructions.  If all of the individual projects accessing the Core have their own Human Subjects sections, this should be clearly stated in this section.

Inclusion of Women, Minorities and Children.  If appropriate for this Core Component, describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children. Follow PHS 398 Instructions in preparing this section.

Vertebrate Animals: If the Administrative Core services involve live vertebrate animals, Follow PHS 398 Instructions in preparing this section. . If all of the individual projects accessing the Core have their own vertebrate animal assurances, this should be clearly stated in this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Clinical Translational Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Clinical Translational Core)

All instructions in the PHS 398 Application Guide must be followed.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Clinical Translational Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Clinical Translational Core)

Do not complete a Table of Contents for the Clinical Translational Core.

Detailed Budget for Initial Budget Period (Clinical Translational Core)

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, i.e., Clinical Translational Core.

Budget Justifications: For the Clinical Translational Core, 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. Identify such significant increases with asterisks against the appropriate amounts. No recurring annual escalations in costs are allowed.

Allowable costs for the Clinical Translational Core may include:

Budget for Entire Proposed Period of Support (Clinical Translational Core)

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, i.e., Clinical Translational Core.

Biographical Sketch (Clinical Translational Core)

Do not include this section.  All Biographical Sketches should be included together with the Overall component of the Center application.

Resources (Clinical Translational Core)

All instructions in the PHS 398 Application Guide must be followed.  Describe space and other resources dedicated to the Clinical Translational Core.

Research Plan (Clinical Translational Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

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:

Protection of Human Subjects:  If Core services involve human subjects, (e.g., recruitment, screening, evaluation, biobanking), discuss the Human Subjects protections following the PHS 398 instructions.  If all of the individual projects accessing the Core have their own Human Subjects sections, this should be clearly stated in this section.

Inclusion of Women, Minorities and Children.  If appropriate for this Core Component, describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children. Follow PHS 398 Instructions in preparing this section.

Vertebrate Animals: If Core services involve live vertebrate animals, follow PHS 398 Application Instructions in preparing this section. If all of the individual projects accessing the Core have their own vertebrate animal assurances, this should be clearly stated in this section.

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Other Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Other Core)

All instructions in the PHS 398 Application Guide must be followed.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Other Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Other Core)

Do not complete a Table of Contents for Other Cores.

Detailed Budget for Initial Budget Period (Other Core)

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, e.g., CORE COMPONENT A, B, etc.

Budget Justifications: 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. Identify such significant increases with asterisks against the appropriate amounts. No recurring annual escalations in costs are allowed.

Allowable costs for Other Core(s) may include:

Budget for Entire Proposed Period of Support (Other Core)

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, e.g., OTHER CORE A, B, etc.

Biographical Sketch (Other Core)

Do not include this section.  All Biographical Sketches should be included together with the Overall component of the Center application.

Resources (Other Core)

All instructions in the PHS 398 Application Guide must be followed.  Describe space and other resources dedicated to the other Cores.

Research Plan (Other Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

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

Specific Aims:  Include Specific Aims for any other Cores. 

Research Strategy:  For any other Core(s), provide the following information:

Protection of Human Subjects:  If Core services involve human subjects, (e.g., recruitment, screening, evaluation, biobanking), discuss the Human Subjects protections following PHS 398 Instructions.  If all of the individual projects accessing the Core have their own Human Subjects sections, this should be clearly stated in this section.

Inclusion of Women, Minorities and Children.  If appropriate for this Core Component, describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children. Follow PHS 398 Instructions in preparing this section.

Vertebrate Animals: If Core services involve live vertebrate animals, follow PHS 398 Application Instructions in preparing this section. If all of the individual projects accessing the Core have their own vertebrate animal assurances, this should be clearly stated in this section.

Letters of Support:  Include any letters of support or collaboration specific to any Other Cores. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Research Project(s)

All instructions in the PHS398 Application Guide must be followed for each Research Component Project, with the following additional instructions, as noted.

Face Page (Research Project(s))

All instructions in the PHS 398 Application Guide must be followed.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Research Project(s))

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Research Project(s))

Do not complete a Table of Contents for the Research Project(s).

Detailed Budget for Initial Budget Period (Research Project(s))

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, e.g., RESEARCH PROJECT A, B, etc.

Budget Justifications: For any Research Project(s), 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. Identify such significant increases with asterisks against the appropriate amounts. No recurring annual escalations in costs are allowed.

Budget for Entire Proposed Period of Support (Research Project(s))

All instructions in the PHS 398 Application Guide must be followed.

In the header for each page, indicate which Component the budget represents, e.g., RESEARCH PROJECT A, B, etc.

Biographical Sketch (Research Project(s))

Do not include this section.  All Biographical Sketches should be included together with the Overall component of the Center application.

Resources (Research Project(s))

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Research Project(s))

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

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

Specific Aims:  Include Specific Aims for the Research Component Project.  

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. 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). NICHD urges applicants to the IDDRC program to consider these elements when describing preclinical studies and designing the specific Research Component project.

Organize the Research Strategy as described in the PHS 398 Application Guide and using the instructions provided below. Start each section with the appropriate section heading—Significance, Innovation, Approach. Each Research Project should clearly state its overall objective and explain its relevance to the focus theme chosen. 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. 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.

Protection of Human Subjects:  If the Research Project(s) involve human subjects, (e.g., recruitment, screening, evaluation, biobanking), discuss the Human Subjects protections and inclusion of women, minorities and their subgroups, and children as research subjects, following PHS 398 Instructions.

Inclusion of Women, Minorities and Children.  If appropriate for this Research Project, describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children. Follow PHS 398 Instructions in preparing this section.

Vertebrate Animals: If the Research Project involves live vertebrate animals, follow PHS 398 Application Instructions in preparing this section.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

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

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Pre-Application Information Call and On-Line Information

The NIH will hold a pre-application informational conference call to which all interested prospective applicants are invited. Program and review staff will make presentations to explain the goals and objectives of the FOA and will answer questions from call participants.

To obtain the call-in information, please contact Dr. Melissa Parisi in the Intellectual and Developmental Disabilities Branch (parisima@mail.nih.gov).

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 reflect the following:

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?  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 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?   

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 Research Component Project(s) 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 review 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 Research Component Project(s) reflect a cohesive research program?

Is value added by having the proposed Cores and research project(s) 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 Research Component Project(s), 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 or one of the Cores or Research Project(s) 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) Genome Wide Association Studies (GWAS).

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.

For each individual Core Component, the review will evaluate the following:

For the Administrative Core, the review will also evaluate the following:

For the Clinical Translational Core, the review will also evaluate the following:

Review Criteria for Research Project(s)

Reviewers will assign an impact score based on the likelihood of success for each Research Component 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.  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.  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 Component Project 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 - 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 Component 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? Is the Research Project related to one of the five focus themes responsive to the articulated goals of the program, consistent with the focus of the Center, and the IDDRC program as a whole? Will the Center facilitate the Research Project's ability to make substantive advances in IDD research?

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? If the Research Project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? If the Research Project involves preclinical studies, are the vertebrate animal sections adequately described, and 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 for Research Project(s)

As applicable for the Research Component 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 or one of the Cores or Research Component(s) 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 for Research Project(s)

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) Genome Wide Association Studies (GWAS).

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 the 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:

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

Applications will be assigned  to the appropriate NIH Institute or Center and 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:

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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:

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

Areas of Joint Responsibility include:

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 the following three members will be convened: a designee of the IDDRC 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

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 Parts 74 and 92.


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