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

Learning Disabilities Innovation Hubs (R24)

Activity Code

R24 Resource-Related Research Projects   

Announcement Type

New

Related Notices

  • March 29, 2012 - See Notice NOT-HD-12-016. This Notice serves to clarify items in the FOA in the following sections: Background, Developmental Infrastructure Core (optional), Administrative Core (required) and Core Unit Descriptions.

Funding Opportunity Announcement (FOA) Number

RFA-HD-12-203

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865 

FOA Purpose

This funding opportunity announcement (FOA) invites resource-related research project applications, hereafter referred to as the Learning Disabilities Research Hubs or LDR Hubs, addressing the etiology, manifestation, prevention and remediation of reading, writing or mathematics learning disabilities (LDs). The constitution of an LDR Hub includes a single research project and one or two corresponding core(s) that support the goals and aims of the LDR Hub. The FOA seeks to tackle under-researched topics and populations as well as topics that have been some of the most challenging in the area of learning disabilities impacting reading, writing, and mathematics. Applicants must focus one of two possible research foci to be responsive to this FOA: 1) research topics that include a primary focus on historically under-represented populations who are at-risk for or diagnosed with one or more learning disabilities impacting reading, writing, or mathematics; or 2) research topics considered nascent, understudied, or highly innovative and potentially high risk, involving one or more of these LDs, which may or may not be wholly focused on at-risk or understudied populations with LDs.  This FOA integrates research topics that are of relevance to four research programs at the NICHD: the Language, Bilingualism, and Biliteracy Program; the Early Learning and School Readiness Program; the Mathematics and Science Cognition and Learning: Development and Disorders Program; and the Reading, Writing, and Related Learning Disabilities Program.  Trans-disciplinary and crosscutting scientific topics are specifically invited through this funding opportunity announcement (FOA). In an effort to build research personnel resources, applicants are required to develop cogent plans for direct involvement and mentoring of early career researchers, defined as pre-doctoral or medical students, post-doctoral, and other investigators that have recently finished their pre-doctoral, medical, or post-doctoral training and are pursuing research careers.

Key Dates
Posted Date

January 25, 2012

Letter of Intent Due Date

March 11, 2012

Application Due Date(s)

April 11, 2012              

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 2012

Expiration Date

April 12, 2012

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 Child Development and Behavior Branch (CDBB), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), invites resource-related research project applications, hereafter referred to as the LDR Hubs, to address nascent or understudied research topics or highly innovative and potentially higher risk approaches related to learning disabilities impacting reading, writing, and mathematics, with a special focus on the study of or inclusion of understudied populations. Given the higher tolerance for risk with this announcement, topics related to some of the most recalcitrant research questions in the field (e.g., addressing the needs of learners with multiple learning disabilities and those with particularly complex constellations of comorbidities) are relevant and encouraged. This FOA integrates research topics that are of relevance to four research programs at the NICHD: the Language, Bilingualism, and Biliteracy Program; the Early Learning and School Readiness Program; the Mathematics and Science Cognition and Learning: Development and Disorders Program; and the Reading, Writing, and Related Learning Disabilities Program. Trans-disciplinary and crosscutting scientific topics are of particular interest as are both basic and translational research investigations. In an effort to build research personnel resources, applicants are required to develop cogent plans for direct involvement and mentoring of early career researchers (defined as pre-doctoral or medical students, post-doctoral, and other investigators that have recently finished their pre-doctoral, medical, or post-doctoral training and are pursuing research careers).

Background

NICHD has had a long-standing interest in learning disabilities. This funding announcement is intended to complement the Learning Disabilities Research Centers (LDRCs) that are focused on learning disabilities impacting reading and writing. Historically, the LDRCs have been primarily focused on reading disabilities with an enhanced focus in the most recent FOA (HD-12-202) on writing, reading comprehension, and the role of executive function skills in supporting literacy development. This announcement intends to complement the scientific scope of the LDRCs and to align with cross-programmatic efforts within the NICHD to examine topics related to learning disabilities. The purpose of the LDR Hubs initiative is to provide an integrated research funding opportunity for addressing nascent or understudied research topics, or highly innovative and potentially higher risk approaches related to learning disabilities impacting reading, writing, and mathematics. Additionally, this FOA intends to encourage research involving historically underserved populations that are significantly at-risk for or diagnosed with learning disabilities impacting reading, writing, and mathematics.

This FOA recognizes that areas of high programmatic relevance (e.g., topics focused on math learning disabilities, writing disabilities, and multiple learning disabilities) continue to be understudied. This FOA is specifically designed to encourage tackling these topics and more generally some of the most challenging and historically recalcitrant topics in the learning disabilities research fields with the goal of more broadly addressing the needs of these learners at risk for or diagnosed with LDs impacting reading, writing, and mathematics. This FOA recognizes that for many such topics there is only a limited research base to build on that is directly relevant to the research topic. Also, for some research foci it is expected that there may be difficulties in identification, recruitment and retention of particular populations of interest as well as methodological challenges inherent in investigating some of these topics. To help mitigate these challenges, this FOA encourages projects to leverage the existing scientific base on better specified and studied learning disabilities and comorbidities to begin to more systematically study and address the needs of understudied populations of learners. The recognition of the import of addressing these under-researched topics and populations is reflected in the increasingly cross-disciplinary focus of recent workshops that the NICHD has led, including workshops focused on the cognition and learning needs of incarcerated youth (pre-adolescent and adolescent), the intersection of mathematics and reading disabilities, and writing development, disabilities, and instruction. Note, this FOA is not limited to or framed by topics covered by these workshops but rather reflects the broader cross-programmatic and trans-disciplinary topics relevant to informing our understanding of learning disabilities that impact mathematics, reading, and writing and comorbid conditions. This FOA seeks to build a conceptual and research capacity bridge to help meet programmatic, practice, and policy goals.

Given the strong focus historically on reading in the LDRCs program, applicants responding to the present FOA would need to provide a very strong justification for why a focus on reading disabilities in isolation or in conjunction with ADHD alone could qualify as a nascent or understudied topic. Applicants may pose research projects focused on reading related topics if these involve the intersection of reading with other learning disabilities expressly mentioned in this FOA such as mathematics or writing or if they involve significantly understudied populations and those individuals with complex comorbidities. The intent of this FOA is to develop the research base on understudied topics and populations with learning disabilities in the areas of mathematics, reading and writing and to help these fields move toward building a research base mature enough to gain support through parent funding announcements from the NIH including the LDRC competition. Additionally, the research supported by this FOA should help develop a sufficient research base to better inform practice and policy to benefit children, adolescents and adults.

LDR Hubs must meaningfully interact, in consortium, with the existing LDRCs throughout the LDR Hubs funding period of up to four years. LDR Hubs should be designed to seed the research field such that nascent or understudied topics and populations can begin to mature into richer areas of pursuit; the LDR Hubs are additionally tasked with working to build a cohort of researchers capable of pursuing these lines of inquiry. The integration of early career researchers throughout the work of the LDR Hubs will help ensure the sustained pursuit of these emerging and maturing topics and is a structural requirement of these projects.

Scope

This announcement encourages foundational and translational (e.g., intervention-based) research approaches related to learning disabilities that impact the acquisition and mastery of mathematics, reading, and writing. The constitution of an LDR Hub must include a single research project and one or two corresponding core(s) that support the goals and aims of the LDR Hub. These research investigations developed and conducted within the scope of LDR HUB are intended to inform the understanding of underlying etiology, manifestation, and prevention and remediation of these LDs and related comorbidities. Applicants must include a behavioral sciences component as part of any project and are encouraged to integrate this approach with other approaches (e.g., neurobiological and/or genetic) as appropriate to the research question proposed. Specifically, NICHD is interested in questions that are significantly understudied as they relate to these LDs and/or questions that involve significantly understudied populations at high risk for or diagnosed with LDs in mathematics, reading, and/or writing.

Critically, applicants should articulate scientific research questions that are most appropriate for the developmental period that is being examined and pursue these questions in diverse learners; all developmental periods through early adulthood are acceptable. In early adulthood, we are primarily interested in learners that show performance levels similar to adult basic and adult secondary education as well as for those seeking remedial skill development in post-secondary or workplace programs in mathematics, reading, and writing; choice of other adult populations must be strongly justified. NICHD particularly encourages a strong match between the research questions posed and the methods used to investigate these questions. It is assumed that projects will take advantage of mixed methods as appropriate.

In addition to the focus on nascent, understudied, or high innovation and higher risk topics, this FOA requires significant involvement of mentored, early career researchers in the planning and execution of the research endeavor. Each submission must include an Administrative Core to facilitate overall administrative responsibilities of the project and to oversee and ensure the successful execution of the mentoring and early career involvement. Additionally, applicants have the option of incorporating a second core (Developmental Infrastructure Core) to develop and oversee infrastructure and support allocation, that would assist (1) early-career investigators who are developing pilot projects that are within scientific scope of the parent application but not specifically outlined as projects within the application sent in response to this FOA; or (2) non-LDR Hub affiliated mid-senior level staff whose expertise complements that of the existing center in developing projects. Specifically, a portion of the funds from the LDR Hub can be used to support pilot projects of early career staff in an effort to support their career development and support the broader goals of the LDR Hub. Alternatively, funds can be used to develop new interdisciplinary collaborations with mid- and senior-level scientists not currently involved in the LDR Hub, to facilitate new or untapped opportunities that could not otherwise be accomplished due to expertise of existing LDR Hub staff. For such a core, a formal application process must be articulated that includes opportunities for LDR Hub and non-Hub researchers to apply for the pilot funds.

An Advisory Committee composed of five or more members including at least two external scientists not formally part of the LDR Hub is required to review pilot research proposals developed by early career investigators that are involved with the LDR Hub. The Advisory Committee should be described in the application according to the area of expertise required. Specific individuals should not be named or contacted until after the competition has ended. The goal of this effort is to provide opportunities for a new cohort of investigators to leverage the larger LDR Hub activities such that they can develop their own identifiable line of research and facilitate broader career transitioning goals. Up to $15,000 in direct costs per year may be requested for any one pilot project, with a total limit of $30,000 direct costs per year per LDR Hub for all pilot projects. This limit applies for the full duration of the LDR Hub. The Advisory Committee will be tasked with reviewing and recommending pilot concepts for consideration. However, all recommended concepts must also be submitted to NICHD program staff for review and approval before these pilot awards can be made. Recommended concepts should include all necessary human subject assurances (e.g., Institutional Research Board approvals) at the time of submission to the NICHD program staff.

Required and Optional Components of LDR Hubs

Research Project (required)

LDR Hub applications must contain a single research project proposal in the Research Strategy section.  Research projects may be composed of multiple aims and/or experiments. The application must include research and mentorship opportunities that, at minimum, include a behavioral sciences component and optimally will include trans-disciplinary approaches to the research topic. Applicants must clearly indicate whether they are addressing (1) a nascent or significantly understudied research topic or a higher risk, high innovation approach to examining learning difficulties or learning disabilities impacting mathematics, reading, and/or writing; OR (2) significantly underserved populations that are at high risk for or diagnosed with learning disabilities in these areas. Given the potential novelty of some of the scientific topics and approaches to examining LDs, preliminary data is not required for this FOA. All applicants must provide a cogent argument for the choices of aims/topics, and address the following:

Administrative Core (required)

In the description of the Administrative Core, applicants must clearly describe the meaningful integration of early career researchers, defined as pre-doctoral or medical students, post-doctoral individuals, and investigators who have recently finished their pre-doctoral, medical, or post-doctoral training and are pursuing research careers (e.g., assistant professor level faculty). These individuals should be involved in the planning and execution of a research project as appropriate to their level of training and experience and recruitment schedule.

Specifically, as part of the Administrative Core, the applicant must provide:

Developmental Infrastructure Core (optional)

For applicants proposing an optional Developmental Infrastructure core, applicants must clearly address the following in the core description:

Examples of Research Topics

Listed below are possible suggestions of the types of research topics that could be within scope for this FOA. This list is not intended to be comprehensive and applicants should not feel confined by the examples listed below. Appropriate topics include but are not limited to those listed below. 

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to commit up to $2,000,000 in total costs for FY 2012 to fund approximately two to three new awards.

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $450,000 in directs costs per year. Budget requests must reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period for an application submitted in response to this FOA, which may not exceed four 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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 (Program Director(s)/Principal Investigator(s)

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.     

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.  

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:

The letter of intent should be sent to:

Brett Miller, PhD
Program Director
Reading, Writing, & Related Learning Disabilities Research Program
Child Development & Behavior Branch (CDBB)
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-9849
Email: millerbre@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)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-3415
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, with the following exceptions or additional requirements:

Research Project Description

Core Description(s) (page allocation is per core) 

Budget Instructions for R24 Applications

This FOA uses non-modular formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). Applicants should prepare a series of composite budget tables for the R24 grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.

A.  Composite Budget for R24 Applications

Use PHS-398 Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD" to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment", etc., give the amount requested for the Research Project component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.

B.  Budgets for the R24 Individual Research Project Component and Core Components

Detailed Budget for Initial Budget Period (use PHS-398 Form Page 4 for each)

Budget for Entire Proposed Project (use PHS-398 Form Page 5 for each)

Budget Justifications and Explanations: Describe the specific functions of all key 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 or decreases in any category over the first 12-month budget period. Identify such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%.

Please Note: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardee are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate Research Project or Core budget. 

Research Plan

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

Research Strategy

Research Project Description (1 Research Project Only)

A full description of the research project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of the Research Project component on a separate page, and include the following: 

A.  Research Project Cover Page (1 page, not the PHS398 Face Page)

B.  Research Project Summary (1 page;  use PHS-398 Form Page 2) 

C.  Content of Research Plan (Begin each section with a section header)

Core Unit Descriptions

Identify each proposed Core unit by a letter (A, B, C...) and a title (e.g., Administrative Core, Developmental Infrastructure Core, Other Cores).  Provide a full description of each Core unit.  Begin the presentation of each Core unit on a separate page.   Include the following:

A.  Core Unit Cover Page (1 page, not the PHS398 Face Page)

B.  Core Project Summary (1 page; use PHS-398 Form Page 2)

C.  Core unit Structure, Administration, and Services (6 pages for each 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 PHS398 Application Guide, with the following modification:

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.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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.  

Annual Meetings for Investigators

Program Director(s)/Principal Investigator(s) (PD(s)/PIs) of the Centers funded through this FOA will be required to attend the annual investigators' meeting to share common concerns, common research opportunities, and measurement and research design strategies, as well as methods and approaches to data collection and analysis. The first meeting is expected to take place in spring 2013. Funds for travel to these meetings, which will be held in the Washington, D.C. area, should be included in the application budget request. Applicants are strongly encouraged, but not required, to plan and budget for other key LDR Hub staff to attend the yearly PD(s)/PI(s) meeting in addition to the PD(s)/PI(s).

Advisory Boards

Because of the nature of the scientific topics and populations under study, LDR Hub (R24) grants require guidance and interaction with senior members of the scientific community not directly involved in the conduct of the proposed research activities and operations.  Applicants should propose an External Advisory Board to provide objective outside counsel and periodic review of the LDR Hub's activities and progress. Applicants are not to contact or select Advisory Board members at this time, and should not list specific names of candidates in the application. Details of the operation of the Board, including size, structure, function, and frequency of meetings should be specified, as well as the scientific or other expertise and level of seniority of Board members to be recruited. Members of the Advisory Board are to be selected and confirmed, and notification sent to program staff at NICHD, within three months of the award date. Provisions for costs of the Advisory Board are to be included in the application budget request and justification.   

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.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the 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 project 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 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(s)/PI(s), 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(s)/PI(s), 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?        

Additional Review Criteria - Overall

As applicable for the project 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.

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project 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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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(s)/PI(s) 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, 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 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.

Applicants are encouraged to contact the listed program official regarding specific questions about scientific scope.  

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)

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
Email: millerbre@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
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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