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

Research Infrastructure for Demographic and Behavioral Population Science  (R24)

Activity Code

R24 Resource-Related Research Projects

Announcement Type

Reissue of RFA-HD-09-004

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-HD-10-020

Companion FOA

None

Number of Applications

An applicant institution may submit only one application in response to this FOA. Institutions may not hold more than one NICHD population infrastructure award at a time.  See Section III. 3. Additional Information on Eligibility.

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

 93.865   

FOA Purpose

This FOA issued by the NICHD, National Institutes of Health, solicits grant applications from institutions to provide research infrastructure support that will enhance the research capabilities of established population science centers doing research in areas within the mission of the NICHD Demographic and Behavioral Sciences Branch.  This FOA allows for three types of research infrastructure support: (1) Research Support Cores; (2) Developmental Infrastructure Cores; and (3) Public Infrastructure Cores through three types of applications: (1) General Research Infrastructure applications, for population science research centers with accomplishments, capabilities, and plans in diverse areas of population science —three or more signature research themes; (2) Specialized Research Infrastructure applications, for population science research centers with accomplishments, capabilities, and plans in only a few areas of population science—one or two signature research themes; or (3) Public Infrastructure Only applications, for population science centers that request funding only for Public Infrastructure Core(s).   

Key Dates
Posted Date
Letter of Intent Due Date

January 28, 2011                

Application Due Date(s)

February 28, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 2011 

Expiration Date

March 1, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to increase the pace and impact of research within the scientific mission of the NICHD Demographic and Behavioral Sciences Branch (DBSB) by providing research infrastructure support to existing population science centers that have the scientific expertise, experience, capacity, and vision necessary to advance demographic and behavioral population science research.

Scientific knowledge to be gained

This FOA will advance research within the DBSB scientific mission. The DBSB mission has three components. 

Areas of research within DBSB’s mission are hereafter referred to as “population science research.”

Background

Research infrastructure support to sustain and advance population science research is necessary for two reasons.  First, demography is an intrinsically interdisciplinary field, historically drawing primarily from the academic disciplines of sociology and economics, and, to a lesser extent, from geography and anthropology, and other social, behavioral, and biomedical disciplines. Because these academic disciplines involved in population sciences are housed in a variety of academic departments and, often, across several schools or divisions within a university, research infrastructure support has been crucial for fostering the development and impact of population science. Second, population science research is primarily based on the analysis of large, often longitudinal, population representative data bases, which require continued research infrastructure support to maintain, disseminate, and access. Collecting and disseminating these data bases requires substantial investments, which have come from Federal agencies, including the National Institutes of Health, the National Science Foundation, the U.S. Bureau of the Census, the U.S. Department of Labor, and private foundations. These large scale data collection and dissemination projects are cost effective because they allow myriad and diverse researchers beyond the original research team to produce cutting-edge, high impact research at relatively low costs. Examples of these fundamental population science data bases include the National Longitudinal Survey of Adolescent Health, the Panel Study of Income Dynamics, the National Longitudinal Survey of Youth, the Integrated Public Use Microdata Series, the Los Angeles Family and Neighborhood Study, Welfare, Children, and Families: A Three-City Study,  the National Survey of Family Growth, and the National Survey of Families and Households.

DBSB has used the R24 to support research infrastructure support to population science centers since FY 2000. The R24 has proven more effective in fostering high-impact population science than the predecessor P30/P50 program because it has shifted the focus of infrastructure support from scientific process to scientific outcomes, and has allowed population science centers the flexibility to develop and implement the types of research infrastructure support that best advances their scientific research and to take advantage of new scientific questions as they emerge. The adoption of the R24 mechanism has also resulted in a more competitive review process and increased cost-effectiveness through a doubling of the number of centers supported with only minor increases in NICHD funding levels.  The R24 mechanism has supported the emergence of several new high impact population science centers and contributed to an increased focus on cutting-edge interdisciplinary research, especially in the areas of gene-environment interactions, population-environment research, and family, contextual, and policy factors affecting child and adolescent development.

Objectives

The first objective of this FOA is to increase the impact of population science research by (1) encouraging collaborations among population scientists and between population scientists and scientists in other disciplines, within and across institutions; (2) developing new approaches and methods that advance population science research; (3) fostering the development of junior population scientists and providing opportunities for junior, mid-level, and senior scientists both within and outside of population science to engage in interdisciplinary population science; (4) promoting the application of the methods and perspectives of population science to new topics in the area of the health and well-being of populations; and (5) supporting the dissemination of population science data sets, methods, and significant research findings.

The second objective of this FOA is to decrease the costs of population science research and increase the efficiency of population scientists by supporting cost-effective research infrastructure.

Approaches

This FOA requires that applicants identify one or more signature research themes that exemplify the applicant center’s most significant current and/or anticipated contributions to population science. Applicants may request three types of research infrastructure support, Research Support Cores; Developmental Infrastructure Cores; and Public Infrastructure Cores and must demonstrate how this research infrastructure support will benefit research in the signature research theme(s) and in population science overall. Resources provided through this FOA may not be used to offset any research infrastructure already provided by the applicant institution.

This FOA supports three types of applications: (1) General Research Infrastructure applications, for population science research centers with three or more signature research themes; (2) Specialized Research Infrastructure applications, for population science research centers with one or two signature research themes, and (3) Public Infrastructure Only applications, for population science centers that request funding only for Public Infrastructure Core(s)   

Research Support Cores provide resources and services that will increase the pace and impact of population science research at the center. Access to resources and services may not be limited to a single research project or research team. Examples of Research Support Cores include but are not limited to: administrative cores; computing cores; information cores; and methodology support cores.

Developmental Infrastructure Cores also provide resources and services that will increase the pace and impact of population science research at the center. Developmental Infrastructure Cores promote the development of new research capabilities, developing innovative projects and approaches, developing new interdisciplinary collaborations, advancing the scientific development of junior researchers, and integrating experienced researchers from other fields into population science research at the applicant institution. Examples of developmental infrastructure cores include but are not limited to seed grant programs, and networks, workshops, conferences, seminar series, and visiting scholar programs that foster high impact population science research and/or new research collaborations.

Public Infrastructure Cores, unlike the other two types of cores, provide resources and services that will primarily benefit audiences outside the applicant institution. Public Infrastructure Cores provide resources and services that will either increase the pace and impact of population science research to scientists outside the applicant institution, or facilitate the translation and dissemination of population science research findings. Public Intrastructure Cores may target either scientists or non-scientists such as policy makers, program directors, and practitioners. Examples of activities benefiting scientists include, but are not limited to, archiving and disseminating population science data sets, providing efficient processes for sharing complex data sets while maintaining respondent confidentiality, and disseminating population science methods. Examples of activities benefiting non-scientists include translating, disseminating, and integrating significant population science research findings using language and techniques that are appropriate for non-scientific audiences.

Research topics

The applicant’s signature research themes must fall within the DBSB scientific mission described above.  The seven major program areas supported by DBSB are: Family, Children, and Intergenerational Research; Fertility, Infertility, and Reproductive Health; HIV and Sexually Transmitted Diseases (STDs); Health, Health Disparities, and Mortality; Immigrants, Migration, and Population Distribution; Race, Ethnicity, Population Composition, and Change; and Research Methodologies. See http://www.nichd.nih.gov/about/org/cpr/dbs/ for detailed descriptions of these program areas.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal Applications funded under prior issuance of this FOA are permitted in response to this FOA.
Resubmission Applicants may submit a resubmission of an application originally submitted under a prior issuance of this FOA, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).
Revision
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NICHD intends to commit approximately $3.1 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2011.  The NICHD anticipates funding five new and/or renewal (formerly competing continuation) grants in response to this FOA.

Direct cost requests should be made on the basis of the number of active population scientists in the center, the center’s impact and productivity, and the center's external funding for population science research within the DBSB mission. As a general rule, NICHD expects budget requests for R24 applications to average approximately $17,000 direct costs annually for each active population scientist (see additional guidelines below). An individual who is counted as an active population scientist must hold a permanent (tenured or non-tenured) appointment with the applicant institution; trainees, post-doctoral fellows and visiting professors are excluded.  Active population scientists must be engaged in population science research within the DBSB mission and this engagement must be demonstrated by the scientist satisfying at least two of the following three criteria:

1) Externally-funded research grants or contracts within the three most recently completed federal fiscal years 2008, 2009, and 2010, which ends September 30;

2) Publications in peer-reviewed journals during the three most recently completed federal fiscal years; and

Papers in preparation and plans for future population science research.

3) Qualifying grants or contracts must be from a source outside the applicant institution. Centers requesting higher levels of support than the general rule outlined above should justify their funding request by providing evidence that the center has produced and will continue to produce population science research or public infrastructure of exceptionally high impact to population science overall.

Renewal applications may request no more than a 20% increase over the direct costs awarded in the last non-competing (Type 5) year. All applicants from centers with prior DBSB research infrastructure support—renewals and recipients of developmental infrastructure grants—must justify  increases in the requested funding level over the direct costs awarded in the last non-competing (Type 5) budget year by demonstrating that prior DBSB research infrastructure support increased the impact and pace of the center’s population science research.

As a general rule, for General and Specialized Research Infrastructure R24 applications, NICHD expects that the first year direct cost budget request will not exceed the annual direct costs from grants and contracts for population science research within the DBSB mission that the center has received in the last year. For Public Infrastructure Only R24 applications, applicants should justify their funding requests by providing evidence that the public infrastructure provided will increase the impact of population science research within DBSB’s mission.

Award Budget

NICHD expects requested direct costs to range from  $100,000 to $750,000. Requests for Specialized Research Infrastructure Support or for Public Infrastructure Only Support should not exceed $150,000 direct costs.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

 Although foreign institutions are not eligible to submit applications in response to this FOA, consortium arrangements between foreign and domestic institutions are permitted.  

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.

Required Registrations

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

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

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

Eligible Individuals (Project Director/Principal Investigator)

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

Number of PDs/PIs. Only one PD/PI may be designated on the application.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

An applicant institution may submit only one application in response to this FOA. Institutions may not hold more than one NICHD population infrastructure award at a time.  .

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

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Rebecca L. Clark, Ph.D.
Chief, Demographic and Behavioral Sciences Branch
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B07 MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service;  non-USPS service)
Telephone: 301-496-1175
Email: rclark@mail.nih.gov

Application Submission

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

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

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

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

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Research Plan

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

Senior/Key Personnel and Other Significant Contributors

Senior/Key Personnel should include, at a minimum, the Principal Investigator and Core Directors; do not list all center affiliates in this section. Other Significant Contributors should include all other active population scientists (using the definition of “active population scientists” provided in the “Funds Available” section), other center affiliates, and technical and administrative significant contributors not listed in the Senior/Key Personnel section. 

Table of Contents

Modify as follows the Table of Contents illustrated on the PHS 398 Form Page 3. Replace “3. Research Strategy” with the following headings and subheadings.  The page limits are shown in parentheses:

Budget Instructions

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Detailed Budget for Initial Budget Period:

Budget for Entire Proposed Project Period:

Resources Format Page

In responding to the PHS 398 instructions on capacities, pertinent capabilities, relative proximity, and extent of availability to the project, it is permissible, although not required, for applicants to provide, as continuation pages, floor plans for the space available to the applicant center, including the location of spaces that are not physically continuous.

Specific Aims

The page limit for this section is one page. Applications submitted for this FOA have two types of specific aims, the signature research themes and the research infrastructure cores. Follow the guidance in the PHS 398 instructions for completing this section.

Center Research Strategy

The total page limit for the Research Strategy section is 30 pages, which includes the following subsections: Program Overview, Preliminary Studies/Progress Report, and Summary of Research Support .  

Program Overview:

Preliminary Studies/Progress Report:

Active Research Support:

Research Infrastructure Cores

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide,

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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 6 weeks before submitting the application 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 PHS398 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.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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.

The resubmission of applications submitted under prior issuances of this FOA will be accepted, but such an application must include an Introduction addressing the critique from the previous review.

Renewals

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

Renewal applications funded under prior issuance of this FOA are permitted in response to this FOA.

Revisions

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

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the the National Advisory Child Health and Human Development 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 business official.

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

Progress reports should be submitted electronically, through eRA Commons.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Rebecca L. Clark, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1175
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


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