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-10-020

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-HD-12-186

Companion FOA

None

Number of Applications

An applicant institution may submit only one application in response to this FOA. An Institution may hold no more than one NICHD population infrastructure award at a time. Section III. 3. Additional Information on Eligibility.

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

93.865

FOA Purpose

The purpose of this FOA is to promote science within the mission of the NICHD Demographic and Behavioral Sciences Branch by providing research infrastructure to population science research centers. Types of research infrastructure provided include administrative and technical research support, developmental infrastructure, and public infrastructure. This FOA supports three types of applications: (1) General Research Infrastructure, for centers with three to six signature population science research themes; (2) Specialized Research Infrastructure, for centers with one or two signature research themes; and (3) Public Infrastructure Only applications, for centers that request funding only for public infrastructure.

Key Dates
Posted Date

September 16, 2011

Letter of Intent Due Date

October 21, 2011

Application Due Date(s)

November 22, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

November 23, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The 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 population science centers.

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

Areas of research within the DBSB scientific mission are hereafter referred to as “population science research.” Research primarily focusing on elderly populations is not within the DBSB mission.

Background

Because of the range of scientific disciplines involved and the types of data required, research infrastucture has been crucial in promoting research in demography and other population sciences.

Demography is an intrinsically interdisciplinary field, drawing from the academic disciplines of sociology and economics, as well as geography, anthropology, and other social, behavioral, and biomedical sciences. These academic disciplines are housed in a variety of academic departments and, often, across several schools or divisions within a university. Research infrastructure support has been instrumental in developing and advancing demography and other population science across these disciplinary and institutional barriers.

The scientific process for the population sciences frequently involves the collection or compilation of large, complex data sets by one research team, followed by analyses of these data by myriad and diverse research teams, many not associated with the original data collection. Population science addresses scientific questions that rely heavily on observational research and natural experiments. To ensure generalizability in these types of studies, population science requires population-representative data based on either probability samples or censuses. To address causal inference in these types of studies, population science requires detailed data on the factors affecting human health—often at multiple levels and drawing multiple scientific disciplines—and often requires longitudinal data. Support for collecting and disseminating population science data has been shared by private foundations and Federal agencies, including the National Institutes of Health, the National Science Foundation, the U.S. Bureau of the Census, and the U.S. Department of Labor. 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. Continuing research infrastructure support in population science has made this model of scientific discovery possible and productive.

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

Signature Research Themes

This FOA requires that applicants identify one or more signature research themes. Signature research themes are the unifying research areas that exemplify the applicant center’s most significant contributions to population science. Each signature research theme constitutes a specific aim.

Types of Applications

This FOA supports three types of applications: (1) General Research Infrastructure applications, for population science research centers with three to six 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.

Types of Research Infrastructure

This FOA supports three types of research infrastructure: Research Support Cores; Developmental Infrastructure Cores; and Public Infrastructure Cores. All cores supported through this FOA must enhance the center's capacity to engage in population science research. Centers are not obligated to request support in all categories and may request support for up to six research infrastructure cores. Resources provided through this FOA may not be used to offset any 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. Each research infrastructure core constitutes a specific aim.

Research Support Cores provide administrative and technical support. Examples include, but are not limited to: administrative cores, providing support for developing grant applications and managing grants; computing cores, providing equipment and/or services; and methodology support cores.

Developmental Infrastructure Cores increase the scientific scope and productivity of the center's research and researchers. Examples include, but are not limited to: seed grant programs; support to enhance interdisciplinary research capacity; development of new measures or methodology; and support for the expansion of the center’s scientific scope and/or scientists into novel areas of scientific inquiry.

Public Infrastructure Cores are primarily directed at external audiences, although core activities may also benefit the applicant center. 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. See http://www.nichd.nih.gov/about/org/cpr/dbs/ for detailed descriptions of DBSB program areas.

Section II. Award Information
Funding Instrument

Grant 

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS398 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.

The NICHD intends to fund between 4 and 6 new and/or renewal awards, corresponding to a total of $2.4 million in total costs in FY 2012. Future year amounts will depend on annual appropriations.

Award Budget

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

Requested direct cost for Specialized Research Infrastructure and Public Infrastructure Only applications may not exceed $150,000 first year direct costs.

Requested direct costs have upper limits based on the total number of active and qualifying population scientists in the center. The maximum allowable first year direct costs for a center with 6 or fewer active/qualifying population scientists is $100,000; for 7 to 10 scientists is $160,000;  for 11 to 20 scientists is $310,000; for 21 to 30 scientists is $450,000; for 31 to 40 scientists is $580,000; for more than 40 scientists is $700,000. This limit does not apply to Public Infrastructure Only applications.

Direct cost requests have upper limits based on the center's level of externally funded research. Requested first year direct costs may not exceed the center's externally funded research in population science, based on the direct costs of grants, contracts, and cooperative agreements in FY 2011 or FY 2010, whichever is greater. This limit does not apply to Public Infrastructure Only applications.

Direct cost requests have upper limits based on prior population science research infrastructure support from the NICHD Demographic and Behavioral Sciences Branch, RFA-HD-10-020 and predecessor FOAs. For applicants with prior DBSB research infrastructure support—renewals and recipients of developmental infrastructure grants—requested first year direct costs may not exceed 120% of direct costs during the recent (penultimate or last) non-competing (Type 5) budget year. Applicants requesting an increase in annual direct costs compared with the recent non-competing (Type 5) direct costs must provide persuasive evidence that prior DBSB research infrastructure support increased the impact and pace of the center’s population science research.

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

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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

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

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

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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

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.

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

An Institution may hold no more than one NICHD population infrastructure award at a time.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

The letter of intent should be sent to:

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 must be followed, with the following exceptions or additional requirements:

Senior/Key Personnel

Senior/Key Personnel should include, at a minimum, the PD(s)/PI(s) and Core Directors; do not list all center affiliates in this section.

Other Significant Contributors

Other Significant Contributors should include all qualifying and active population scientists, other center affiliates, and technical and administrative significant contributors not listed in the Senior/Key Personnel section.

Detailed Budget for Initial Budget Period

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

Prepare a composite detailed budget table for the overall infrastructure grant and separate detailed budget tables and justifications for each research infrastructure core. Applicants are advised to budget funds for one annual R24 grantee meeting. This meeting is usually held in conjunction with the annual meeting of the Population Association of America.

Budget for Entire Proposed Period of Support

Prepare a composite budget table for the overall infrastructure grant and separate budget tables for each infrastructure core.

Resources

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.

Research Plan

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

Center Research Strategy

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

Modify the Table of Contents illustrated on the PHS 398 Form Page 3.  Under “3. Research Strategy,” include the following headings and subheadings:

3.1 Center Research Strategy (30 pages)

3.1.1    Program Overview (20 pages)

3.1.2    Preliminary Studies/Progress Report (5 pages)

3.1.3    Summary of Research Support (5 pages)

Program Overview:

Preliminary Studies/Progress Report:

The page limit for the preliminary studies/progress report as outlined in the PHS 398 instructions is 5 pages.

Active Research Support:

The page limit for the center’s active research support is 5 pages.

Research Infrastructure Cores

Identify each proposed core unit by a letter (A, B, C...) and a title (e.g., Research Support Core, Developmental Infrastructure Core, Other Cores).  Provide a full description of each core unit. A Center may propose up to six research infrastructure cores. The overall page limit for each research infrastructure core is 6 pages.

Resource Sharing Plan

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

Appendix

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

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

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

Are the center’s signature research themes addressing an important problem or critical barrier in population science?

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

Are the core directors and other 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 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 signature research themes 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 signature research themes novel?

For applications with public infrastructure cores, are the resources to be shared and/or the methods for sharing the resources novel?

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?

Are the proposed types of research infrastructure support and the proposed methods for providing this support feasible?

For General and Specialized Research Infrastructure Support applications, are the proposed types of research infrastructure support cores, and the methods for providing infrastructure support through these cores, appropriate for (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; and/or (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?

For General and Specialized Research Infrastructure Support applications, 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? Are appropriate strategies in place to assure access to core services for junior scientists and scientists working on interdisciplinary research?

For General and Specialized Research Infrastructure Support applications from centers that have received DBSB research infrastructure funding in the past, has the center demonstrated that the past research infrastructure funding has advanced science in the center’s signature research themes or in population science overall? Has the center demonstrated that the past research infrastructure funding has been cost-effective, has contributed to increased productivity among center scientists, and has fostered the center’s success in developing funded research projects relevant to the mission of DBSB?

For applications with seed grant program cores, are the program’s procedures appropriate for advancing population science research within the centers signature research themes and in population science overall, in terms of (1) priorities for allocating funds; (2) eligible applicants, (3) procedures for reviewing applications; (4) requirements for leveraging funds or preparing research applications to continue or expand the research project; (5) size of awards; (6) length of award periods; (7) number of awards permitted to an individual researcher; (8) mentoring arrangements; (9) support for the program from the parent institution or other funding sources; and (10) procedures for developing junior researchers and fostering interdisciplinary research projects?

For applications with public infrastructure cores, are the methods for providing this support appropriate for supporting the dissemination of population science data sets, methods, and/or significant research findings? Is the targeted audience appropriate? Are the services cost-effective?

For applications with infrastructure activities involving collaborations outside the applicant institution, 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?  

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?

What is the level of institutional commitment as indicated by the amounts and types of resources the applicant institution has committed to the center, taking into account the institutional context? 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? Do the cores have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?  

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

Not applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

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

Not Applicable.

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications  will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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: 301-451-3415

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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