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

Population Dynamics Centers Research Infrastructure FY 2014 (P2C)

Activity Code

P2C Resource-Related Research Multi-Component Projects and Centers

Announcement Type

Reissue of RFA-HD-13-007

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-14-016

Companion Funding Opportunity

None   

Number of Applications

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

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

93.865

Funding Opportunity Purpose

The purpose of this FOA is to increase the pace and impact of research within the scientific mission of the NICHD Population Dynamics Branch (PDB) by providing research infrastructure support to population science research centers.

Key Dates
Posted Date

March 7, 2014

Open Date (Earliest Submission Date)

April 6, 2014

Letter of Intent Due Date(s)

April 6, 2014

Application Due Date(s)

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

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2014

Advisory Council Review

August 2014

Earliest Start Date

September 2014

Expiration Date

May 7, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of this FOA is to increase the pace and impact of research within the scientific mission of the NICHD Population Dynamics Branch (PDB) by providing research infrastructure support to population science research centers.

Objectives

By providing support for cost-effective high quality research infrastructure, this FOA is aimed at achieving the following objectives:

Scope

This FOA calls for centers to advance research within the PDB scientific mission, which has three components.

In this FOA, "population science" refers to areas of research within the stated scope of the PDB scientific mission. Research primarily focusing on elderly populations is not within the PDB mission.

Primary Research Areas (formerly Signature Research Themes)
Applicants are to identify between one and six primary research areas in which the Center expects to make its most significant contributions to population science in the next five years. Each primary research area must fall within one of the three components of the PDB scientific mission.

Research infrastructure cores

Applicants may request support for research infrastructure cores in order to advance their specific aims and research in their primary research areas and population science overall.

There are four types of research infrastructure cores:

Resources provided through this FOA may not be used to offset or replace research infrastructure already provided by the applicant institution. Access to research infrastructure supported by this FOA may not be limited to a single research project or research team. Centers are not obligated to request support in all categories.

Types of Applications

This FOA supports three mutually exclusive types of applications:

Centers must include both an Administrative Core and a Development Core.  Centers may also request support for up to three Scientific/Technical Research Support Cores,  and one Public Infrastructure Core that provide scientific and technical resources to audiences outside the applicant center.

Research Topics

The applicant’s primary research areas must fall within the PDB scientific mission described above in the Scope section of this announcement: demography, behavioral and social science research on reproductive health; and population health. See http://www.nichd.nih.gov/about/org/der/branches/pdb/Pages/overview.aspx for detailed descriptions of PDB program areas. 

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 of awards to RFA-HD-08-007, RFA-HD-09-004, RFA-HD-13-007, and PAR-07-401.
Revisions to awards from RFA-HD-10-020, RFA-HD-12-186, and RFA-HD-13-007.

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.

NICHD intends to commit $1,459,000 in FY 2014 to fund 2-5 awards.

Award Budget

NICHD expects requested direct costs to range from $100,000 to $700,000 per year.

For Specialized Centers, requested first-year direct costs may not exceed $160,000.

For General Center awards, requested first-year direct costs have upper limits based on research project funding and the number of active population scientists in the Center, whichever is lower.

Research project funding: Requested first year direct costs may not exceed the direct costs of the Center's annual externally funded research projects in population science; Centers may select any fiscal year between 2009 and 2013 as the base.

First year direct cost limits are based on number of active population scientists in the Center, as follows:

Active Population

Scientists in

Applicant Center

Maximum

requested first

year direct costs

5 to 6

$100,000

7 to 10

$160,000

11 to 20

$310,000

21 to 30

$450,000

31 to 40

$580,000

40 or more

$700,000

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five years.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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

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

Other Special Eligibility Criteria

There are four additional eligibility criteria for applications responding to this FOA:

Applications not meeting these four eligibility criteria will not be reviewed. 

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. An Institution may hold no more than one NICHD Population Dynamics Centers Research Infrastructure award at a time. 

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

Section IV. Application and Submission Information


1. 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.

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:

Rebecca L. Clark, Ph.D.
Chief, Population Dynamics Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1174
Email: rclark@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/

Program Plan Page Limits

Overall

12

Admin Core

12

Development Core

12

Scientific/Technical

6

Public Core

12


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

Instructions for the Submission of Multi-Component Applications

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

Applications 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 with the additional instructions.

Facilities & Other Resources

Explain the Center’s administrative position within the larger institution. Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for research in the Center's primary research areas. Describe any unique features of the scientific environment at the applicant institution that will benefit the Center's scientific research. Describe the level of institutional commitment as indicated by the amounts and types of resources the applicant institution has committed to the Center.

List funding and in-kind support the Center receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure core personnel, and dedicated equipment. Include support for research faculty salaries only if support is provided for a research infrastructure-related function such as directing a center, managing a core, and similar activities. Institutional support for infrastructure core personnel and research faculty should be reflected in the budget request. This information may be presented in tabular form.

Other Attachments. Include an attachment titled "Active Research Support." Describe the support the Center received in Federal fiscal year 2013 for research and research training that is within the mission of PDB as defined in the Funding Opportunity Description section of this announcement. Report direct costs only. Include only awards to the applicant institution; for awards to other institutions, report only consortium agreements or subcontracts to the applicant institution. For grants with duration of more than a year, estimate the support available to the Center in Federal fiscal year 2013. Information may be presented in tabular form. Report the Center's active funding using the following categories: PDB population science research infrastructure, PDB institutional research training, other PDB funding, other NICHD funding, other NIH funding, NSF funding, other Federal funding, and funding from foundations. For the Center's active funding from external sources, provide PD(s)/PI(s); subcontract PD(s)/PI(s) at applicant center (if applicable); project number; project title; funding source; current project period; direct costs (or direct subcontract costs) for current project period; and whether funding is in a no-cost extension. For each category, describe how the research falls within one of the three components of the PDB scientific mission as defined in the Funding Opportunity Description section: demography, behavioral and social science research on reproductive health, and population health.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan          (Overall)

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

Specific Aims:  The specific aims should address the objectives of this FOA.

Research Strategy:  The Research Strategy section includes the Program Overview and the Preliminary Studies/Progress Report.

1. Program Overview

Center affiliates

List the Center's affiliates, indicating whether they are active population scientists; other center affiliates; or technical/administrative contributors. Identify one or more active population scientists as defined in Section III. 3. Additional Information on Eligibility section. Other pertinent information, such as discipline (e.g., demography, economics, sociology, public health, anthropology, etc.) or academic department may be included but is not required. Information may be presented in tabular form.

Center type

State the type of center support the Center is requesting: General or Specialized. For renewals and revisions, indicate whether the  request differs from the type of PDB P2C or R24 population research infrastructure received in the most recent funding period—for example, whether a Specialized Center is now requesting General Center support.

Primary research areas (formerly signature research areas)

Identify between one and six primary research areas; these are the areas in which the Center expects to make its most significant contributions to population science in the next five years. Each primary research area must fall within one or more of the three components of the PDB scientific mission as defined in the Funding Opportunity Description section of this announcement: demography, behavioral and social science research on reproductive health; and population health. The primary research areas need not encompass all research conducted within the Center. Describe the significance and innovation of each primary research area. Describe briefly the Center's other significant research that is not within the primary research areas. For a renewal or revision, if the Center's primary research areas have changed since the previous Center application, explain why. Information from the progress report may be referenced and need not be repeated.

Center description

Describe the Center’s governance and organizational structure, providing an organizational chart. Describe the authority of the Center Director (PD/PI) and, if applicable, the role of advisory or user committees. If applicable, describe the qualifications of the incoming center director or explain how the next center director will be selected. Describe the selection criteria, privileges, and responsibilities of center membership and, if applicable, how they vary for different levels of membership. Explain how membership rules advance specific aims and research in population science overall. Explain how the NICHD research infrastructure support has been or will be leveraged with other forms of support to advance the specific aims and research in the primary research areas and population science overall.

2. Preliminary Studies/Progress Report

For applicants who have not received prior population science research infrastructure support from PDB, include preliminary studies related to the proposed primary research areas and existing activities related to the research infrastructure cores. For renewal applications and applicants who have received developmental infrastructure support from PDB, include a progress report. The specific aims for the previous project include the primary research areas and the research infrastructure cores. Information in the biographical sketches or in research strategies for Cores may be referenced and does not need to be repeated.

Letters of Support:  Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. 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.

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.

Facilities & Other Resources. Describe the space and physical resources available to the core.

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.

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: Describe the Administrative Core's objectives and the current and planned support and services to be provided.

Research Strategy:  The purpose of the Administrative Core is to manage and coordinate the Center's activities and provide administrative support for research activities such as assisting in the development and submission of grant applications, and aiding in compliance with the administrative and fiscal requirements of funding agencies, managing working paper series and other dissemination of  the Center's research findings, providing editing services, and managing coordination and communications with other population science centers. The Administrative Core is mandatory.

Provide the following information for 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

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

Planned Enrollment Report  (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

Development Core

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

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

SF424 (R&R) Cover (Development Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Development Core)

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

If human subjects research is anticipated within the period of the award but plans for involvement of human subjects cannot be described in the application as allowed by the DHHS regulations (45 CFR part 46.118), designate Yes in response to “Are Human Subjects Involved?”. In the section on Protection of Human Subjects in the Research Plan either include an explanation of anticipated protections for human subjects or an explanation of why protections cannot be described. For further instructions, see Scenario D. Delayed-Onset Human Subjects Research in Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf#Part_II .

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

Project Narrative:  Do not complete.

Facilities & Other Resources. Describe the space and physical resources available to the core.

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

Budget (Development Core)

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          (Development Core)

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

Specific Aims:  Describe the Development Core's objectives and the current and planned support and services to be provided.

Research Strategy:  The purpose of the Development Core is to increase the scientific scope and productivity of the Center's research and researchers. All applicants must propose a seed grant (or pilot) program, supporting small-scale and innovative research projects, especially those that will provide the preliminary data leading to larger research efforts on population science. Seed grant programs may provide funding, but may also, in addition to or instead, provide other types of support, such as research assistant(s), or dedicated consulting or mentorship. The Development Core may also support other types of development activities, including but not limited to application preparation workshops/boot camp; seminar or brown bag series; working groups; and other workshops and conferences. The Development Core is mandatory.

Provide the following information for the Development Core:

For seed grant programs, also address the following:

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

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

Planned Enrollment Report  (Development Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Development Core)

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

Scientific/Technical Research Support Core

When preparing your application in ASSIST, use Component Type ‘Scientific/Technical.’

Centers may request support for up to three Scientific/Technical Research Support Cores; these cores are optional.

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

SF424 (R&R) Cover (Scientific/Technical Research Support Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Scientific/Technical Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific/ Technical Research Support Core)

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

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

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Facilities & Other Resources. Describe the space and physical resources available to the core.

Project /Performance Site Location(s) (Scientific/ Technical Research Support 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 (Scientific/ Technical Research Support Core)

Budget (Scientific/ Technical Research Support Core)

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          (Scientific/Technical Research Support Core)

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

Specific Aims: Describe the Core's objectives and the current and planned services and resources to be provided.

Research Strategy: The purpose of Scientific/Technical Research Support Cores is to provide scientific and technical services and resources to advance the applicant Center's research in population science. Cores should be designed to allow the applicant center to realize cost savings through economies of scale; enhance the scientific innovation and technical sophistication of new projects by providing access to advanced scientific/technical expertise at the project development phase; and advance informal scientific training by exposing scientists to advanced methodologies. 

Examples of Scientific/Technical Research Support Core include, but are not limited to, biodemography, information computing, data support, methodology, programming, spatial analysis, and statistics cores.

For each Scientific/Technical Research Support Core, provide the following information:

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.

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

Planned Enrollment Report  (Scientific/Technical Research Support Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Scientific/Technical Research Support Core)

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

Public Infrastructure Core

Centers may request support for a Public Infrastructure Core; this core is optional.

When preparing your application in ASSIST, use Component Type 'Public Core'.

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

SF424 (R&R) Cover (Public Infrastructure Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Public Infrastructure Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Public Infrastructure 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.

Facilities & Other Resources. Describe the space and physical resources available to the core.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Public Infrastructure 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 (Public Infrastructure Core)

Budget (Public Infrastructure Core)

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          (Public Infrastructure Core)

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

Specific Aims:  For the Public Infrastructure Core, describe the core's objectives and the current and planned services and resources to be provided.

Research Strategy: The purpose of the Public Infrastructure core is to provide scientific and technical services, support, and/or information, primarily for scientific audiences outside the applicant institution. Examples include, but are not limited to, archiving and disseminating population science data sets, providing efficient processes for sharing complex data sets while preserving confidentiality, and disseminating population science methods.

Provide the following information for the Public Infrastructure 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.

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

Planned Enrollment Report  (Public Infrastructure Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Public Infrastructure Core)

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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 NICHD Scientific Review Branch and responsiveness by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at ehayunga@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Do the Center’s major research areas address important problems or critical barriers in population science?

If the Center’s overall plans for providing research infrastructure are successful, how will the following improve: scientific knowledge, approaches, and methods of population science, or access to population science data sets, methods, and/or significant research findings?

How will successful implementation of the Center’s overall plans for providing proposed research infrastructure change the application of methods and perspectives of population science to new topics in the area of the health and well-being of populations?

Investigator(s)

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

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?

Do the Center’s accomplishments and planned accomplishments in their primary research areas challenge and seek to shift current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, or instrumentation? Are the Center’s accomplishments and planned accomplishments in their primary research areas novel?

Approach

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

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Are the proposed types of research infrastructure support cores and the methods for providing infrastructure support through these cores appropriate for advancing the Center’s overall specific aims and research within the Center’s major research areas? For Centers that have received PDB research infrastructure support in the past, has this support advanced the Center’s research within the Center’s major research areas?

Based on the plans presented in this application and, for renewals, past performance, overall, are the proposed types of research infrastructure support cores and the methods for providing infrastructure support through these cores, likely to be cost effective and to increase the productivity of center scientists?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  

Is the level of institutional commitment, as indicated by the amounts and types of resources the applicant institution has committed to the Center and taking into account the institutional context, adequate for the proposed Center activities?

Does the academic and physical environment contribute to the likelihood of success of the Center through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?

Do the Center’s structure and membership rules contribute to the likelihood of success of the Center?

Overall, does the Center have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?  

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Review Criteria for Administrative Core


Overall Impact - Administrative Core

Reviewers will provide an overall impact score for the Administrative Core, in consideration of the following review criteria.

Scored Review Criteria – Administrative Core

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.

Investigator(s)

Are the Director of the Administrative Core and other Administrative Core staff well suited for the core? Have the core directors demonstrated an ongoing record of accomplishments related to the objectives of the core?

Approach

Has the applicant provided a well-reasoned and appropriate strategy for managing and coordinating the Center's activities and providing administrative support for research activities such as assisting with grant applications, compliance with funding requirements, dissemination of research findings, and managing inter-center activities?

Based on the plans presented in this application and, for renewals, past performance, will the Administrative Core promote the efficiency, productivity and impact of population science and/or reduce the costs of population science research? Based on the plans and, for  renewals, past performance, given the administrative support provided, is the Core cost-efficient?

Are plans for evaluating the Administrative Core appropriate? For renewals, has the Center appropriately evaluated the Core and responded appropriately to the evaluation?

Environment

Will the Administrative Core benefit from unique features of the scientific or administrative environment or collaborative arrangements?

Does the Administrative Core have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?

Review Criteria for Development Core


Overall Impact - Development Core

Reviewers will provide an overall impact score for the Development Core, in consideration of the following review criteria and additional review criteria.

Scored Review Criteria – Development Core

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.

Investigator(s)

Are the Director of the Development Core and other Development Core staff well suited for the core? Have the core directors demonstrated an ongoing record of accomplishments related to the objectives of the core?

Innovation

Does the Development Core enhance the ability of Center scientists and research projects to challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the types of scientific and/or technical research support novel to one field of research or novel in a broad sense?

Approach

Has the applicant provided a well-reasoned and appropriate strategy for increasing the scientific scope and productivity of the Center's research and researchers? Are eligibility and priorities for funding and/or services appropriate for advancing the scientific aims of the Center? Arappropriate strategies in place to ensure that junior scientists and scientists working on interdisciplinary research have access to Development Core services? Are procedures for reviewing applications or proposed activities appropriate? For seed grant programs, has the applicant provided well-reasoned and appropriate  requirements for leveraging funds or preparing research applications, size of awards, length of award periods, number of awards to individual researchers, and mentoring arrangements?

Based on the plans presented in this application and, for renewals, past performance, will the Development Core promote the efficiency, productivity and impact of population science and/or reduce the costs of population science research? Based on the plans and, for renewals, past performance, given the proposed number of seed grant awards and other development activities, is the Core cost-efficient?

Are plans for evaluating the Development Core appropriate? For renewals with Development Cores, has the Center appropriately evaluated the Core and responded appropriately to the evaluation?


If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? If the applicant has claimed Scenarios D, Delayed-Onset Human Subjects Research, has the applicant provided an adequate explanation about why it is not possible to present definite plans in the application?

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 Development Core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the Development Core have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?   

Additional Review Criteria - Development Core

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Review Criteria - Scientific/Technical Research Support Core


Overall Impact - Scientific/Technical Research Support Core

Reviewers will provide an overall impact score for the Scientific/Technical Research Support Core, in consideration of the following review criteria.

Scored Review Criteria – Scientific/Technical Research Support Core

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.

Investigator(s)

Are the Director of the Scientific/Technical Research Support Core and other Scientific/Technical Research Support Core staff well suited for the core? Have the core directors demonstrated an ongoing record of accomplishments related to the objectives of the core?

Innovation

Does the Scientific/Technical Research Support Core enhance the ability of Center scientists and research projects to challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the types of scientific and/or technical research support novel to one field of research or novel in a broad sense?

Approach

Has the applicant provided a well-reasoned and appropriate strategy for providing scientific and technical services and resources to advance the applicant Center's research in population science? If more than one Scientific/Technical Research Support Core does the applicant provide a well-reasoned explanation for offering multiple cores rather than a single core offering multiple services or resources? Are eligibility and priorities for services/resources appropriate for advancing the scientific aims of the Center? Are there appropriate strategies in place to ensure that junior scientists and scientists working on interdisciplinary research have access to Scientific/Technical Research Support Core services and resources?

Based on the plans presented in this application and, for renewals, past performance, will the Scientific/Technical Research Support Core promote the efficiency, productivity and impact of population science and/or reduce the costs of population science research?  Based on the plans and, for renewals, past performance, given the number of scientific research projects using Core services or resources, is the Core cost-efficient?

Are plans for evaluating the Scientific/Technical Research Support Core appropriate? For renewals with Scientific/Technical Research Support Cores, has the Center appropriately evaluated the Core(s) and responded appropriately to the evaluation?

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?

Does the Scientific/Technical Research Support Core have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?

Review Criteria - Public Infrastructure Core


Overall Impact - Public Infrastructure Core

Reviewers will provide an overall impact score for the Public Infrastructure Core, in consideration of the following review criteria.

Scored Review Criteria – Public Infrastructure Core

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.

Investigator(s)

Are the Director of the Scientific/Technical Research Support Core and other Scientific/Technical Research Support Core staff well suited for the core? Have the core directors demonstrated an ongoing record of accomplishments related to the objectives of the core?

Innovation

Are the methods or materials to be disseminated novel and/or are the techniques for disseminating the methods or materials innovative?   

Approach

Has the applicant provided a well-reasoned and appropriate strategy for providing services, support, and/or information primarily for audiences outside the applicant institution?

Is the targeted audience appropriate?

If the Public Infrastructure Core includes collaborations with outside institutions, does the inclusion of the additional institution add to the value of the infrastructure activity? Are the plans for staffing and for sharing the administration, decision-making, and resources appropriate and feasible?

Based on the plans presented in this application and, for renewals, past performance, will the Public Infrastructure Core promote the efficiency, productivity and impact of population science and/or reduce the costs of population science research?  Based on the plans and, for renewals, past performance, given the number of scientific research projects using Core services or resources and/or the scope of the target audience, is the Core cost-efficient?

Are plans for evaluating the Public Infrastructure Core appropriate? For renewals with Public Infrastructure Cores, has the Center appropriately evaluated the Core(s) and responded appropriately to the evaluation?

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?

Does the Core have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?

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 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 & 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.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Rebecca L. Clark, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1174
Email: rclark@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, Ph.D.
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)

Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6996
Email: williate@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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.