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)
Office of Dietary Supplements (ODS)

Funding Opportunity Title

Developmental Mechanisms of Human Structural Birth Defects (P01)

Activity Code

P01 Research Program Project Grants

Announcement Type

Reissue of PAR-12-034

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-13-285  

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages innovative, multidisciplinary, interactive, and synergistic program project (P01) grant applications from institutes/organizations that propose to integrate basic, translational, and clinical approaches to understanding the developmental biology and genetic basis of congenital structural human malformations.  To contain costs, each P01 will consist of only three projects, associated cores, and a smaller optional developmental/pilot project.  At least one project must propose basic research in an animal model system and at least one project must be clinical or translational in nature.  The projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that is genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans. 

Key Dates
Posted Date

July 25, 2013

Open Date (Earliest Submission Date)

August 25, 2013  

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply  

Earliest Start Date

Standard dates apply  

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

This Funding Opportunity Announcement encourages innovative, multidisciplinary, interactive, and synergistic program project (P01) grant applications from institutes/organizations that propose to integrate basic, translational, and clinical approaches to understanding the developmental biology and genetic basis of congenital structural human malformations. The projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that is genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans.

Background

Annually, almost five percent of all live births in the United States (more than 180,000 babies) involve babies born with birth defects, as broadly defined to include both structural and functional/metabolic abnormalities.  Next to accidents, birth defects are the leading cause of death in children; they account for half of all pediatric hospitalizations.  In terms of economic costs, billions of dollars are spent over the lifetimes of children born with any of 17 major, severe, nonfatal birth defects.  In sum, structural birth defects have a great impact on public health, socioeconomics, and family life.  A high priority goal of NICHD’s Scientific Vision for the Next Decade is to address the problem of structural birth defects.

The Developmental Biology and Structural Variation Branch at NICHD has supported a Birth Defects Initiative since 2000 by funding a number of research grants and program project grants focused on the use of molecular genetic approaches for the study of the genetic susceptibility, genetic epidemiology, and developmental biology of human congenital structural malformations.  These grants established the basis for the Birth Defects Working Group whose investigators meet annually to present research updates, share ideas and technical advances, establish new collaborations, and provide input and advice to NICHD staff.  The objective is to capitalize on the rapid and revolutionary discoveries occurring as a result of the Human Genome Project with the ultimate goal of enhancing the translation of basic knowledge and insights from functional genomic studies into development of new, innovative, and efficacious strategies for the molecular diagnosis, treatment, and prevention of human structural birth defects.  Investigators funded through this FOA will become part of NICHD’s Birth Defects Working Group comprised of investigators funded through prior FOAs under NICHD’s Birth Defects Initiative. 

This FOA encourages P01 applications in order to broaden the base of basic scientists and clinicians involved in the Birth Defects Working Group, to enhance this research effort, and to promote the translation of advances from the bench to bedside.

Essential Features of a Program Project: 

The Program Project size should be planned carefully.  The program must be comprised of three meritorious R01-type Research Projects to permit an effective collaborative effort among the participating investigators.  Research efforts should not be so diverse and diffuse in scope as to hinder productive collaboration.  In such instances of diverse and diffuse scope, consideration should be given to submitting individual R01 research project grant applications.  In addition, P01s that are too large may inhibit communication and interaction among collaborators and, as a result, become less effective.  For the purposes of this FOA, in order to contain costs, each P01 will consist of only three R01-type Research Projects, an optional developmental/pilot project, and associated cores. 

P01 Program Projects supported by NICHD may only be renewed for one additional 5-year period.  At the end of that time, the Projects within the program should be sufficiently developed to warrant independent support as R01 grants.  Applications for support beyond the first renewal period must be submitted as "New" applications and must include significant changes in scope and direction and, when appropriate, changes in individual project leadership. Exceptions to this policy may be approved by NICHD staff, but such exceptions will be rare and granted only with extraordinary justification. 

Research Scope

This FOA encourages research on developmental defects of generalized body patterning and localized dysmorphic anomalies across a variety of organ systems, such as the skeletal, nervous, gut, cardiac, and lymphatic systems, that lead to clinically significant and major congenital structural malformations.  In particular, studies that focus on modifier genes and the role of quantitative aspects of development, such as gene dosage or copy number variation, as well as imaging of developmental processes are encouraged.  While applications that focus on developmental disorders that result in intellectual disabilities and related neurobehavioral disabilities are of interest to the NICHD, they are outside the scope of this FOA.  However, studies that address syndromes of which intellectual disabilities are a part of the phenotype will be considered as long as the project focuses only on the structural defects associated with the phenotype.

Proposed projects must be innovative, multidisciplinary, interactive, and synergistic while integrating basic, translational, and clinical approaches.  To contain costs, each P01 will consist of only three R01-type Research Projects, an optional developmental/pilot project, and associated cores.  At least one research project must use basic research in an animal model system and at least one project must be clinical or translational in nature.  The R01-type Research Projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that are genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans.  If included, an R03/R21-like project must also be related to the overall theme of the P01.

The basic science project(s) may include but are not limited to studies to: 1) identify and characterize the genes, gene modifiers, gene products, mutations, polymorphisms, or multigene and gene/environment interactions that play a role in normal and abnormal embryonic patterning and organogenesis; 2) elucidate the developmental biological processes and pathways, the biochemical, biophysical, cellular, molecular, genetic mechanisms, or spatial and temporal gene expression patterns which are involved in dysmorphogenesis; and/or 3) examine how teratogens and nutritional deficiencies disrupt or modify gene expression and basic developmental processes.

The translational/clinical project(s) may include but are not limited to studies to: 1) characterize and classify genotypes and phenotypes of human malformations that are comparable in the animal models being examined; 2) develop physical, genetic, and comparative maps for genes involved in human malformations; 3) identify the developmental genetic processes and molecular pathogenesis of human malformations utilizing animal models; and 4) develop innovative molecular genetic methods, technologies, and strategies to enhance the diagnosis of human malformations or aid in the intervention to ameliorate the formation of the birth defects.

Applicants are encouraged to collaborate with existing population-based birth defects registries, databases, and surveillance programs at the private, state, and Federal levels, especially the Centers for Disease Control and Prevention (CDC) Centers of Excellence for Birth Defects.  Applicants are encouraged to initiate collaborations with the CDC Centers to avail themselves of these valuable resources.

Applicants are encouraged to apply recent technological advances in developmental biology and genetics in their projects and to utilize the many existing research resources, bioinformatic databases, and biotechnological tools in their research cores. The research cores should be structured to share work effort and research resources (e.g., biotechnology, high-throughput instrumentation, microarrays, oligonucleotide chips, animal model development, and technical assistance) among the research projects. The aim of a core is to provide support and enhance the progress, productivity, cost-effectiveness, and outcome of the research projects.

Applications may include, but are not limited to, new and innovative approaches to investigate: 1) genetic and epigenetic defects, nutritional deficiencies, and teratogens that perturb, modify, or alter gene expression during early development; 2) the identity and function of transcription and growth factors in normal and abnormal gastrulation, embryogenesis, organogenesis, and patterning, as well as their modification by environmental agents; and 3) defective embryonic developmental processes and pathways that ultimately lead to malformations.

Areas of research appropriate for this FOA include, but are not limited to:

The topics listed above are only examples, are not in priority order, and are not intended to be all-inclusive. Investigators are encouraged to explore and develop new, innovative projects and research cores that are consistent with the overall objectives of this FOA.

Research Cores

The aim of a core is to provide support and enhance the progress, productivity, cost-effectiveness, and outcome of the research projects. Applicants are encouraged to make use of recent technological advances in developmental biology, genetics, and genomics in their projects and, when applicable, to utilize resources via research cores. The research cores should be structured to share work effort and research resources (e.g., biotechnology, high-throughput instrumentation, microarrays, oligonucleotide chips, animal model development, and technical assistance) among the research projects in the most cost-effective manner.  A core must be utilized by at least two of the three component projects, preferably by all three.

Participation in NICHD’s Structural Birth Defects Meetings

The PD(s)/PI(s) for the overall grant and the Project Lead for each component project should plan to attend an NICHD-sponsored three-day meeting generally held on an annual basis in the Washington, D.C. metropolitan area. Funds to pay for this travel should be included in the budget request. The meeting will provide an opportunity for all investigators funded through NICHD’s Birth Defects Initiative to communicate, discuss the progress of their research, exchange ideas and information, troubleshoot technical issues, share resources, foster collaborations that are relevant to the research goals of the Birth Defects Initiative, and provide input and advice to NICHD staff. This requirement is designed to establish an interactive group of investigators who are interested in multidisciplinary approaches to enhancing our understanding of the genetic epidemiology, etiology, pathogenesis, developmental biology, and genetics of structural birth defects.    

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. 

Application Types Allowed

New
Renewals (As described in NOT-HD-13-002, there is a 10-year limit to NICHD P01 grants, so only one 5-year renewal is allowed.)   
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

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

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed Program Project.

Award Project Period

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

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) 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(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI of the overall P01 Program Project should be an established scientist with demonstrated administrative capabilities.  Research Projects should be led by investigators (Project Leads) with appropriate background in the relevant discipline(s). The Administrative Core and any other Cores should be led by investigators (Core Leads) with appropriate scientific and technical expertise.  The PD/PI and other Senior/Key Personnel should be able to collaborate productively so that new scientific information may be exchanged freely and effectively applied by others in the program.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

The simultaneous submission of an R01 and a P01 application for support of the same Research Project is allowed.  If both applications receive a fundable score, however, the Lead of the Research Project must decline the R01 award and keep the Research Project in the P01.

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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

2. Content and Form of Application Submission

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

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

Page Limitations


Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

  6 pages

Core

  6 pages

Project

12 pages

Pilot Projects (Component includes all Pilot Projects)

  6 pages


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Follow the instructions in the SF424 Application Guide.  The Project Narrative is only required for the Overall Component, not for any other components of the application. 

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

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

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Applications requesting more than $1 million direct costs per year or $5 million direct costs over 5 years or that request inflationary increases for the noncompeting years for renewals will require compelling budget justifications.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:  Include Specific Aims for the overall program project.

Research Strategy:  Describe the major themes of the overall Program Project, its goals and objectives, background information and the overall importance of the research to the theme of this program.  Explain the strategy for achieving the goals defined for the overall program and how each Research Project and Core relate to that strategy. Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, and how the combined resources create an overall program that is more than the sum of its parts. Include all necessary tables, graphs, figures, diagrams and charts in this section.  In addition, provide the following information:

Letters of Support:  Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants.  Letters of support for the Program Project overall should be included with the Overall Component. Letters of support for individual Research Projects or Cores should be included with those components of the application. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

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

The PD(s)/PI(s) for the overall grant and the Project Leads and Core Leads should plan to attend an NICHD-sponsored three-day meeting generally held on an annual basis in the Washington, D.C. metropolitan area. Funds to pay for this travel should be included in the budget request.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administrative Core)

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

Specific Aims:  Include a brief list of Specific Aims outlining the objectives and functions of the Administrative Core.

Research Strategy: For the Administrative Core, provide the following information:

Include tables or organizational charts, if appropriate.

For new applications, include information on past activities or accomplishments relevant to the Admin Core.   For renewal/revision applications, provide a Progress Report. 

Letters of Support:   Include Letters of Support specific to the Administrative 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 SF424 (R&R) Application Guide, with the following modifications:

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

Cores

When preparing your application in ASSIST, use Component Type ‘Core’ for any additional Cores.

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

SF424 (R&R) Cover (Cores)

Complete only the following fields:

PHS 398 Cover Page Supplement (Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cores)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Cores)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Cores)

Budget (Cores)

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

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Cores)

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

Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Core.

Research Strategy: Provide the following information:

Letters of Support: Provide letters of support specific to the 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 SF424 (R&R) Application Guide, with the following modifications:

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

Research Project

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

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

Budget (Research Project)

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

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Note:  Potential overlap of P01 Research Projects with other current projects will be assessed for applications that are selected to receive grant awards.  NIH staff will request complete and up-to-date “Other Support” information after peer review as part of the "Just-in-Time" request. This information will be used to check that the proposed research is not already funded through other sources.

PHS 398 Research Plan          (Research Project)

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

Specific Aims:  Provide Specific Aims for the Research Project.

Research Strategy:  Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading—Significance, Innovation, Approach. Clearly describe the project's objectives and explain its relevance to the overall program's theme.  Specify the biomedical significance of the work proposed. As part of the Research Strategy, include information on preliminary studies, data, and/or prior experience pertinent to this application. For renewal/revision applications, provide a Progress Report.  Describe the Research Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the Project.

Letters of Support:  Provide letters of support specific to the Research Project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Pilot Project Component (optional component)

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

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

The Pilot Project Component may include one or more Pilot Projects to generate preliminary data or to develop new technologies that further enhance the research efforts of the Program Project.  All proposed Pilot Projects must be described together within the designated page limit for the Research Strategy of the Pilot Project Component of the application.  If additional Pilot Projects are to be supported after the onset of the P01 award, the application must describe the process for reviewing and selecting those projects.

SF424 (R&R) Cover (Pilot Project Component)

Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot Project Component)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project Component)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Pilot Project Component)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot Project Component)

Budget (Pilot Project Component)

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

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Pilot Project Component)

One or more Pilot Projects may be proposed to generate preliminary data for submission of an R01 or other applications or to develop new technologies that further enhance the research efforts of the Program Project. The proposed Research Plan must be described in sufficient detail to permit evaluation of the Pilot Project(s) using the review criteria listed under Section V “Application Review Information”, with the exception that little or no preliminary data are required. 

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

Specific Aims:  Describe Specific Aims for Pilot Projects included in this Component.

Research Strategy:  Following the instructions in the SF424 (R&R) Application Guide, describe each of the proposed Pilot Projects using the appropriate headings—Significance, Innovation, Approach. Each Pilot Project description should clearly relate the project's objectives to the Program Project's overall theme.  Specify the biomedical significance of the work proposed. Although little or no preliminary data are required for a Pilot Project, any relevant studies or data that establish the feasibility and rationale for the project may be included.  Describe the Pilot Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the project.  If additional Pilot Projects are to be supported after the onset of the P01 award, the application must describe the process for reviewing and selecting those projects.  

Letters of Support: Provide letters of support specific to any of the proposed Pilot Projects.

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 SF424 (R&R) Application Guide, with the following modifications:

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.  

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 12 weeks before submitting the application (6 weeks for the September 2013 due date) and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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 this particular announcement, note the following:  peer review of NICHD Program Project applications focuses on three areas: (1) review of the individual Research Projects and any optional Pilot Projects; (2) review of the individual Cores; (3) review of the P01 program as an integrated collection of Projects and Cores oriented around a central theme, and the overall merit of the program.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Program 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 Program 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 Program Project that by its nature is not innovative may be essential to advance a field.

Significance

Does the Program Project address an important problem or a critical barrier to progress in the field? If the aims of the Program 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 Program 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 Program 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 Program 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 Program Project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Program Project as an Integrated Effort

The overall Program Project will be evaluated as an integrated research effort focused on one or more research areas listed under Research Scope.  The relationship and contributions of each Research Project and Core to the central theme will be discussed and evaluated. The assessment will take into consideration all proposed Research Projects and Cores, including any with poor ratings. The review of the Program Project as an integrated effort will include the following criteria:

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 Program 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 Program 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 recommended for 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 Program 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 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 Research Projects


Overall Impact - Research Projects 

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Projects 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 proposed Program Project).

Scored Review Criteria- Research Projects

Reviewers will also 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 Research 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 Research Project? If Early Stage Investigators, New Investigators, or investigators in early stages of independent careers will serve as Project Leads, 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 Research Project? Are potential problems, alternative strategies, and benchmarks for success presented? If the Research Project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the 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 Research Project proposed? Will the Project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the Project well-integrated into the Program Project as a whole?

Additional Review Criteria-Research Projects

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Research 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 following: 

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 recommended for 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 - Research Projects

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

Applications from Foreign Organizations  

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers of Research Projects need not comment on Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, Genome Wide Association Studies).   Resources to be developed through any Core, Research Project, or Pilot Project must be described in the Resource Sharing Plan for the P01 Overall Component and reviewed for that section of the application only.

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 Pilot Project(s)

For any optional Pilot Projects, note the following:

Optional Pilot Projects are all included within the Pilot Project Component.  Pilot Projects are discrete, well-defined projects that can be completed in a relatively short time frame with limited funding. For this reason, the Pilot Project Components of an application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem.  Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, though they may be included if available. 

Review of the Pilot Project Component must include consideration of any and all Pilot Projects proposed in the application, as well as the process for selecting additional Pilot Projects during the course of the award.

Overall Impact - Pilot Project Component

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Pilot Project(s) to make an important contribution to the overall Program Project, in consideration of the following scored review criteria and additional review criteria.

Scored Review Criteria- Pilot Project Component

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 Pilot Project Component have potential for addressing an important problem or a critical barrier to progress in the field? If the aims of the Pilot Project(s) 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 Pilot Project(s)? If Early Stage Investigators, New Investigators, or investigators in early stages of independent careers will serve as Project Leads, 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 Pilot Project(s)? Are potential problems, alternative strategies, and benchmarks for success presented?  Will the strategy establish feasibility and will particularly risky aspects be managed? If the Pilot Project(s) involve 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?

Is there an effective process for reviewing and selecting new Pilot Projects after any initial Pilot Projects have been completed?  Are there adequate institutional plans and procedures to assure that any new Pilot Projects comply with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

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 Pilot Project(s) proposed? Will the Project(s) benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Are the Pilot Projects well-integrated into the Program Project as a whole?

Additional Review Criteria- Pilot Project Component

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Pilot Project(s) involve 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 that include a Pilot Project Component, the committee will consider the following: 

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 recommended for 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- Pilot Project Component

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers of Pilot Projects need not comment on Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, Genome Wide Association Studies).   Resources to be developed through any Core, Research Project, or Pilot Project must be described in the Resource Sharing Plan for the P01 Overall Component and reviewed for that section of the application only.

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 Cores


Overall Impact - Cores

Reviewers will assign an Impact Score for the Administrative Core and any other Cores in terms of the following review criteria.

Additional Review Criteria-Cores

Reviewers will evaluate the following items while determining scientific and technical merit, and in providing an Impact Score, but will not give separate scores for these items.

Administrative Core and Other Cores

For Administrative Core and all other Cores, the review will evaluate the following:

Administrative Core

In addition to the above criteria for all Cores, reviewers will evaluate the following for the Administrative Core:

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 Cores involve 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 following: 

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 recommended for 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-Cores

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers of Cores need not comment on Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, Genome Wide Association Studies).   Resources to be developed through any Core or Research Project must be described in the Resource Sharing Plan for the P01 Overall Component and reviewed for that section of the application only.

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 Core functions.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

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 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. 

For Program Projects proposing awardee-selected Pilot Projects, progress reports should briefly describe status of Pilot Projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Lorette C. Javois, PhD
Program Director
Developmental Biology and Structural Variation Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-5541
Email: javoisl@mail.nih.gov

Peer Review Contact(s)

Sherry L. Dupere, PhD
Chief, Scientific Review Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email:  duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Chief Grants Management Officer
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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NIH Funding Opportunities and Notices



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