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 2011 (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-HD-09-012

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-HD-10-022

Companion FOA

None

Number of Applications

An institution may submit only one application in response to this FOA. Section III. 3. Additional Information on Eligibility.

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

93.865

FOA Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications for Center Core Grants designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD). This Funding Opportunity Announcement (FOA) seeks applications from institutions that meet the qualifications for a program of IDD research. The grants fund core resources to support interdisciplinary research and research training. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations.

Key Dates
Posted Date
Letter of Intent Due Date

February 22, 2011

Application Due Date(s)

March 22, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 2011

Expiration Date

March 23, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Intellectual and Developmental Disabilities (IDD) Branch (formerly Mental Retardation and Developmental Disabilities Branch), Center for Developmental Biology and Perinatal Medicine (CDBPM), invites Center Core Grant (P30) applications to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities. This Funding Opportunity Announcement (FOA) seeks applications from institutions that meet the qualifications for a program of IDD research. The primary objective of the NICHD Intellectual and Developmental Disabilities Research Centers (IDDRC) Program is to provide core support and facilities for cohesive, interdisciplinary research and research training. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations.  

Background

For more than 40 years, NICHD has provided support for IDDRCs through Center Core (P30) grants that facilitate program coordination and support central research facilities, administration, and development of a limited number of new development projects.  The degree of impairment associated with IDD varies with the cause. Moderate and more severe IDD often results from problems that produce profound alterations in brain development and/or function. Defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, maternal conditions, and other factors causing brain damage may lead to diminished intellectual and adaptive capacity. A larger proportion of cases of IDD relate to environmental or social conditions and disorders of unknown etiology. Each IDD syndrome requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the affected children. Therefore, one of the missions of the IDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of IDD. Research conducted in the IDDRCs covers a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical and behavioral research that studies persons with IDD. Major solutions to the problems associated with IDD may emerge from multidisciplinary, collaborative, and integrated approaches involving biomedical, behavioral, and biobehavioral research conducted in the IDDRCs. Thus, NICHD encourages cooperation among the Centers, including their integration into a network that may facilitate infrastructure necessary for the conduct of larger research programs or clinical trials. NICHD encourages the Centers to apply for clinical trials grants (R34, R01, and U01). Administrative and scientific organization within a Center and across the network of IDDRCs should enhance opportunities for breakthroughs. Scientific knowledge achieved through research supported by this special program will help prevent, diagnose, and ameliorate or treat IDD. 

Objectives

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 IDDRC Center Core Grants is to bring together scientists from a variety of disciplines to work within a Center on the common problems of IDD. 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. Consequently, applications for IDDRC Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. NICHD encourages, but does not require, applicants to include both biomedical and behavioral/biobehavioral components among the topics addressed within their Center. Applications responding to this FOA must include at least five topics relevant to the research mission of IDD. Support of postdoctoral trainees, junior investigators, and investigators new to the IDD field is also encouraged, as one of the goals of the IDDRC program is to attract scientists to IDD research.

Examples of topics include, but are not limited to:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission of applications from RFA HD-09-012
Revision of applications from RFA HD-09-012
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount of funding that the NICHD expect(s) to award in FY 2011 is $6.79 million and the anticipated number of awards is five.

Future year amounts will depend on annual appropriations. An applicant for a new grant may request a budget for direct costs of $750,000 the first year..

Award Budget

A new application may request up to $750,000 in direct costs.

A Renewal application may request up to $750,000 or up to 1 percent above the direct costs awarded in the final noncompeting (Type 5) year.

Budget increments for subsequent years will have a three percent limit. Budgets for New and Renewal applications will undergo stringent review within these guidelines.

Applications with budgets that exceed these guidelines will be deemed by NICHD to be non-responsive to this FOA and will be returned without review.

The cost of a proposed Center will be a material consideration in the selection of applications for funding..

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed five 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

 The IDDRC Director should be a scientist or science administrator who can provide effective scientific and administrative leadership. The Director will be responsible for the organization and operation of the IDDRC and for communication with the NICHD on scientific and operational matters. She/he should be able to integrate and synthesize the proposed research and, thereby, serve as an example to other investigators.

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

An institution may submit only one application in response to this FOA.  

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Eligibility Requirements

For the purpose of this FOA, the NICHD will support no more than one IDDRC grant (P30) per institution. Applications for P30 IDDRC grants must propose a program consisting of cores to be accessed by grants that propose research addressing at least five topics relevant to the research mission of IDD. A list of examples is outlined above (in Section I.1. “Research Objectives”). This list of topics is not comprehensive, nor are the examples exhaustive.

The program should consist of at least 10 externally funded research projects grouped according to relevant topics. The specific research projects must be (1) relevant to the mission of NICHD's IDD Center programs; (2) of a quality acceptable to NICHD; and (3) funded when the P30 award (initial or renewal) begins. These projects must be of high quality and provide a multidisciplinary approach to the problem(s) under investigation. Projects funded under initiatives unrelated to this FOA (such as Fragile X Research Centers, Autism Centers of Excellence, Rare Disease Cooperative Research Centers, and traditional P01s) may be counted in the 10 externally funded research projects. (Individual research components of a P01 program project may be counted as separate projects to qualify a Center or core.)

An IDDRC must contain an Administrative Core and a minimum of two additional core units. A minimum of three federally funded research projects must utilize each core unit. These projects must relate to IDD and at least one must be funded by NICHD, exclusive of research contracts, training grants, interagency agreements, and supplemental projects funded by other agencies.

When determining core support, subprojects within a Program Project (P01) will be considered as individual projects comparable to an R01. Projects located at institutions that do not already have an IDDRC must receive NICHD prior approval to access core facilities.

Core units must fulfill the following requirements:

Scientific personnel and institutional resources capable of providing a strong research base in the field specified must be available. There also must be a strong institutional commitment. The commitment may take the form of faculty appointments 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 Center programs.

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 PHS398 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:

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

The letter of intent should be sent to:

Melissa A. Parisi, M.D., Ph.D.
Intellectual and Developmental Disabilities Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard
Room 4B09, MSC 7510
Bethesda, MD 20892
Rockville, MD  20852 (for express/courier service; non-USPS service)
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 all copies of the appendix files must be sent to:

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: 301-496-1485
FAX: 301-402-4104
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

 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 PHS398 Application Guide

In keeping with the goals of the IDDRC Program enunciated in the Guidelines and in Other

 Submission Requirements, above, the applicants should highlight potentially unique core

 resources and how they plan to share them with other IDDRCs. 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 (please note all format requirements) as described in the PHS398 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 PHS398 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.

Applications are submitted on Form PHS 398. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by the specific instructions described below:

The applicant must provide a detailed description of each Core unit proposed as part of the Center, with detailed budget and budget justification. The applicant must name a scientist to be responsible for each Core unit proposed. The description of each Core unit proposed should include a rationale, indicating how the Core will support the research effort in an efficient and cost-effective manner. Cores should integrate with or buy into existing institutional resources rather than duplicate them. Core support to individual investigators should not overlap with support already available to them from other sources.

The applicant institution and pertinent departments must show a strong commitment to the Center's support. Dedicated space and/or equipment, staff recruitment, investigators' salaries, or other financial support for the proposed Center exemplify such commitment. The facilities should require no more than modest alteration and/or renovation. NICHD provides no funds for new construction. Scientific personnel and institutional resources must be available to provide a strong research base in the specified fields.

As a major goal, the IDDRC Program promotes 1) interdisciplinary collaboration among Centers’ investigators, 2) data/information sharing and integration, 3) synthesis of knowledge about IDD, and 4) translational research that will lead to amelioration and prevention. Each Center application should present a specific plan for achieving this major goal.

A major goal of the NICHD is to promote active collaboration among IDDRCs. To accomplish this goal, successful applicants will participate in the collaborative efforts of established Centers' programs. In planning the program, applicants should consider potential collaborative studies and projects that they may propose for the IDDRC network. The Administrative Core should budget for the maintenance of the IDDRC Network Web-Portal and for the development of common protocols, databases, and communications and informatics technologies.

Allowable Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the National Institutes of Health Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated in the FOA and/or the Notice of Grant Award. Under these rules, the director of a P30 Center may exercise flexibility to meet unexpected Center requirements by rebudgeting or requesting approval to rebudget between cores, consistent with NIH policy.

Administrative Core Unit:

Research-Related Core Units:

New Program Development Projects:

A goal of the IDDRC Program is to attract scientists to IDD research. Where appropriate, the applicant may request up to five years' support for "New Program Development" for direct research support of one or more projects or investigators. This support should not exceed a total of $100,000 direct costs per year, or 10 percent of total direct costs, whichever is less. Applicants may use such funds to attract new investigators to the Center, to develop a new area or program of research, to facilitate the development of new research programs of newly trained investigators or investigators new to IDD research, or to facilitate use of a Core at one Center by investigators affiliated with another Center that lacks that kind of Core. Description of New Program Development projects should be comparable to R03 research grant applications in detail and development. Each New Program Development project may provide support for no more than two years to any one investigator. Other investigators may be supported in subsequent years with approval of program staff.  In addition, support for postdoctoral trainees engaged in IDD-related research is permissible within this category of support, after review by a Center’s advisory committee based on selection criteria to be described in the application, and after approval of such candidates by program staff. Access to Cores by trainees or junior investigators participating in IDD research who have not yet secured independent funding or do not have a mentor with affiliate status may be allowed upon formal request of the PI and with approval of program staff.

Other Costs:

Items not fundable under an NICHD P30 grant:

SECTION I - GENERAL INFORMATION

A.  FACE PAGE

B.  Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

C.  TABLE OF CONTENTS

D.  BUDGET ESTIMATES

1.  Composite Budget

2.  Individual Core and New Program Development Budgets

Budget Justifications:  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.  If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage.  However, current NIH practice limits escalation to three percent.  In addition, for Competing Continuation applications, justify any significant increases in any category over the current level of support.

E.  BIOGRAPHICAL SKETCH

F.  RESOURCES

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each core unit by title, and assign each core unit a capital letter (A,B,C) that reflects the order in which the core units are presented in the application research plan. For each core unit, provide the name of the Core Director and biographical sketches for personnel not identified previously.

A.    SPECIFIC AIMS FOR OVERALL P30 CENTER (1 Page) 

B.  OVERVIEW OF P30 CENTER

The Overview shall not exceed 12 pages in total.

C.  CORE DESCRIPTIONS

For each Core Unit, include a single cover page listing the title of the Core, the name of the Core Director, and names of any other investigators (with titles and affiliations).  Identify each proposed Core unit by a letter (A, B, C…) and a title (Administrative Core, Molecular/Cellular Core, etc.).

The description of each core is limited to 12 pages, with no more than 8 cores total per application. 

1.  Administrative Core Unit

2.  Research Core Units

D.  RESEARCH PROJECTS PROPOSED FOR CORE USAGE

Research projects proposed for Core usage will be evaluated with respect to the appropriateness of the projects' use of core services. 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). 

Do not exceed one page per project.

E.  NEW PROGRAM DEVELOPMENT PROJECTS (Optional) 

For each New Program Development Project, include a single cover page listing the title of the project and the name of the investigators (with titles and affiliations).  New Program Development Projects will be peer reviewed for scientific and technical merit, as well as for the appropriateness of the projects' use of Core services. These projects must be described in sufficient detail to permit evaluation through the competitive, peer-review process.

The description of each New Program Development project is limited to 6 pages, and should include the following information:  

F.  PROGRESS REPORT PUBLICATION LIST (For competing renewal applications only) 

G.  USE OF CORES IN PRIOR PROJECT PERIOD (For competing renewal applications only)

H.  LETTERS OF ASSURANCE/AGREEMENT

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115

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 P30 applications, peer review of scientific and technical merit focuses on:  (1) review of the individual Core units; (2)  review of the New Program Development Projects (if applicable);  and (3) review of the P30 program as an integrated collection of projects and Cores oriented around a set of research themes, and the overall merit of the program.  Review criteria for these elements are listed in the sections below.  

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the overall P30 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?   

Investigator(s)

Are the PD/PIs, 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?  

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 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?   

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?   

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

 Integration of the Overall P30 Center  

A major emphasis in evaluating the P30 Center is the integration or “centeredness” of the overall program.  The P30 Center will be evaluated as an integrated collection of cores and research projects oriented around a set of research themes.   The review will evaluate the following:

 The review will also evaluate the following:

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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/priority 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 Unit Components

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

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

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

Review Criteria for New Program Development Projects (if applicable)

Reviewers will assign an impact score based on the likelihood of each new program development project to develop new areas of research, or to facilitate the development of newly trained investigators or investigators new to IDD research.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the 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?   

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the 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 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 project? 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 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?   

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?   

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  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines 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:

NIH considers the following in evaluating Center grant applications:

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 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, CCR 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

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Melissa A. Parisi, M.D., Ph.D.
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, Ph.D.
Director, Division of Scientific Review
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

Financial/Grants Management Contact(s)

Bryan S. Clark, M.B.A.
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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