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 using ASSIST or an institutional system-to-system solution; 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.

It is critical that applicants follow the Multi-Project (M) 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.

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

The goal of this funding opportunity announcement (FOA) is to advance the field of population dynamics research by increasing research impact, innovation, and productivity; developing junior scientists; and maximizing the efficiency of research support.

The objectives of this initiative are to:

• Increase the scientific impact, innovation, and productivity of population dynamics research;
• Increase competitiveness for peer-reviewed external funding in population dynamics research;
• Support experiences for junior population dynamics scientists that will contribute to their research independence; and
• Maximize the efficiency of funding for population dynamics research by minimizing the financial and time burdens of providing administrative and other research support services associated with research projects.

This initiative will provide funding for population dynamics infrastructure cores at already productive population research centers. Applicant centers are expected to have a recent record of high impact, innovative scientific publications and competitiveness for peer-reviewed external funding for research within the scientific mission of the NICHD Population Dynamics Branch (PDB).

Cores

Applications must include a minimum of two research infrastructure cores, a mandatory Administrative Core plus a Development Core and/or one or more Scientific/Technical Cores. The Development Core is meant to develop junior scientists and advance new scientific research within the center. A Scientific/Technical Core is meant to provide scientific and/or technical services and/or resources to center researchers in order to enhance their research capabilities.

With the exception of the Development Core, which should focus on new projects, the cores should provide support for both existing projects and the development of new projects. The proposed cores should be effective in promoting scientific impact, innovation, productivity, and competitiveness, but need not be innovative themselves. This FOA encourages core activities promoting interdisciplinary collaborations and collaborations within and across institutions.

History, size, and institutional context of centers

This initiative invites applications from both recently- and long-established population dynamics research centers. This initiative is not limited to population dynamics research centers that have received previous funding from the NICHD Population Dynamics Research Infrastructure Program. Funds issued through this initiative are meant to foster scientific impact, innovation, productivity, and competitiveness for peer-reviewed external funding for research within the scientific mission of PDB in the next five-year project period, not to simply reward past performance. Competitiveness for external funding includes external funding for research within the PDB scientific mission from all sources, not solely funding from PDB. This initiative invites applications from population research centers of any size, from small to large. A center's productivity, impact, and innovation will be assessed relative to the number of center scientists; a highly productive small center may have greater impact than a moderately productive medium-sized center, even if the latter has numerically more grants and publications. Because this initiative is expected to enhance competitiveness for funding from NIH and other external sources, the applicant institution is expected to show a strong commitment to the center by providing support to the center.

Resources provided through this initiative are meant to augment existing administrative, scientific, and technical services and resources that are already available to the centers; these resources 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. Resources provided through this initiative are not meant to be a substitute for research projects, training, or conference grant funding; centers wishing to conduct those types of activities should submit separate applications for support through the appropriate mechanism.

Specific Areas of Research Interest

To be responsive to this initiative, the primary research areas (PRAs) identified must be within the scientific mission of NICHD Population Dynamics Branch (PDB). The PDB scientific mission is to support research, research training, and data collection in three areas:

• Demography: The scientific study of human populations, including fertility, mortality and morbidity, migration, population distribution, nuptiality, family demography, population growth and decline, and the causes and consequences of demographic change.
• Population health: Research on human health, productivity, behavior, and development at the population level, using population representative samples or policy or natural experiments.
• Reproductive health: Behavioral and social science research on family planning, infertility, sexually transmitted infections and HIV/AIDS.

Research focusing primarily on elderly populations and individuals is not responsive to this initiative.

For the purposes of this initiative, "population dynamics research" and "population research" refer to research within the three areas described above. "Population" is defined as the aggregate collection of individuals in a defined geographic area, social, economic, and/or demographic group. Examples include the residents of New York City, married people in the United States, and African American children under age five. Aggregates defined by their participation in a study, program, or service or by having a diagnosis of a specific medical condition are not considered populations under this definition.

For the purposes of this announcement, the "NICHD Population Dynamics Research Infrastructure Program" refers to all grants and activities supported by RFA-HD-12-186, RFA-HD-13-007, RFA-HD-15-009, RFA-HD-16-017, RFA-HD-17-007, RFA-HD-18-013, and predecessor announcements.

See Section VIII. Other Information for award authorities and regulations.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are noteligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are noteligible to apply.

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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.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.

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.

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

Established Research Center. The applicant institution must have an established administrative unit (for example, center or institute) that administers or coordinates population dynamics research across the applicant institution, hereafter referred to as the "population research center." Funds from this FOA must be for this population research center and may not be used to establish a new population research center at the applicant institution. The PD/PI must be the director of the center when the application is submitted and/or the award is issued. As used in this FOA, an "established unit" has the following characteristics: the applicant institution has formally created the administrative unit; the unit has an administrative position and reporting structure within the applicant institution; the unit has dedicated space; the unit has a governance and organizational structure; the unit's director has defined responsibilities and authority; and the unit has rules or guidelines for selecting or recruiting members/affiliates.

Active Scientists. Applicants must have at least five active scientists working in population dynamics research, that is, research within the scientific mission of NICHD Population Dynamics Branch. Active population scientists must hold their primary affiliation with the applicant institution and this position (tenured or non-tenured) must be permanent; trainees, post-doctoral fellows, visiting professors, and scientists with primary appointments at other institutions are excluded. Active population dynamics scientists must meet both of the following criteria:

• Externally-funded population dynamics research grants or contracts within the three most recently completed Federal fiscal years, 2015, 2016 and 2017; grants awarded in FY 2018 may also be included. Federal fiscal years run from October 1 to September 30; for example, Federal fiscal year 2016 runs from October 1, 2015 to September 30, 2016. The active scientist must be the PD/PI, a Multiple Program/Director/Principal Investigator (MPD/MPI), Key/Senior Personnel on the qualifying grant or contract and must have received the grant or contract from a source outside the applicant institution. The Project Leads of subprojects on P01 grants also qualify.
• Population dynamics research publications in peer-reviewed journals during the three most recently completed Federal fiscal years.

Funding by the NICHD Population Dynamics Branch. Applicants must have at least one active scientist, as defined above, who has received a research grant or other significant funding from the Population Dynamics Branch within the three most recently completed Federal fiscal years. The mechanisms that qualify are research project grants (e.g., R01, R03, R15, R21, R37, R00, U01, UH2/UH3); research program projects (P01); resource-related research project grants (R24, U24), excluding R24 grants funded through the Population Dynamics Centers program; individual career development awards for faculty (K01, K08, K23); institutional training grants (T32); education project grants (R25); and research contracts (N01, N02, N03, N44, Y01, Y02, Y03) that were funded or administered by the Population Dynamics Branch. Mechanisms that do not qualify are individual pre-doctoral and/or post-doctoral fellowships (e.g., F31, F32, K99), conference grants (e.g., R13, U13) and R24 or P2C grants funded through the Population Dynamics Centers program. Grants considered to be funded or administered by the Population Dynamics Branch have a grant number that includes the Institute/Center designation of "HD" and a program official who is a member of the Population Dynamics Branch staff.

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

Only one application per institution is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Institutions may not hold more than one NICHD Population Dynamics Centers Research Infrastructure Program P2C or R24 award at a time (for example, awards from this FOA, RFA-HD-12-186, RFA-HD-13-007, RFA-HD-14-016, RFA-HD-15-009, RFA-HD-16-017, RFA-HD-17-007, or RFA-HD-18-013.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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.

It is critical that applicants follow the Multi-Project (M) 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.

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Rosalind B. King, Ph.D.
Telephone: 301-435-6986
Fax: 301-496-0962
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	6
Development Core	12
Sci Tech Core (Use for Scientific/Technical Core)	6

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: Required, minimum 1; maximum 1
• At least one of the following:
• Development Core: Optional, minimum 0; maximum 1
• Scientific/Technical Core: Optional, minimum 0; maximum 3

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.

Complete entire form.

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

Follow standard instructions.

Facilities & Other Resources: Explain the center's administrative position within the larger institution, including formal departments and other scientifically related centers. Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for achieving the specific aims described in this application. Describe the organizational resources available to the center. Identify the facilities to be used, including, but not limited to, dedicated space, computer facilities and resources, laboratories, and other facilities. If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Relative proximity of resources and size and shape of dedicated space may be presented in either graphic or narrative form. Describe only those resources that are directly related to achieving the specific aims described in this application or that complement the proposed research support cores. Provide any information describing the Other Resources available to the project (e.g., secure data room) and the extent to which they would be available to the project.

Describe institutional investment in the success of the center's Early Stage Investigators (ESI), e.g., resources for classes, travel, and training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESI's projects, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support and coverage of supplies, equipment and technical personnel.

List types and amount of committed funding the center receives from the applicant institution. Examples include but are not limited to dedicated equipment, dedicated space, salary support for investigators or core staff, faculty appointments in subject areas relevant to the goals of the program, operating budgets, financial support for new space or equipment, and arrangements the center has to recover indirect costs. Include salaries only if the support is provided for a center-related function such as directing a center, managing a core, or similar activities. Institutional support for center and 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. The information presented in this section constitutes the center's "externally funded annual support for population dynamics research and training" (see Award Budget in Section II).

Provide information about the center's external funding for population dynamics research, research training, and data collection that is within the mission of PDB and was received in either FY 2016 or FY 2017; select one fiscal year, do not present information for both. This information may be presented in tabular form. Comparable grants awarded in FY 2018 may be listed in a separate table. Report only direct costs; do not report total costs. Report only on funding for activities that are within the PDB mission; do not report all funding to all center affiliates.

List the following:

• NICHD Population Dynamics Research Infrastructure Program funding.
• Funding that the center received directly from PDB for which the applicant institution is the grantee and the PD/PI(s) has an appointment at the applicant institution.
• Subcontracts that the center received indirectly from PDB, via PDB grants made to other institutions.
• Funding that the center received directly from National Institutes of Health (NIH), but not from PDB. Because most NIH grant applications that address scientific areas within the mission of PDB are assigned to PDB, it is expected that the list of grants from other NIH sources will be short. Grants with a secondary assignment to NICHD linked to a program official who is a member of the Population Dynamics Branch staff are included here, noting the existence of the secondary assignment. If no secondary assignment exists, the applicant must explain how the grant fits in the PDB mission.
• Subcontracts that the center received indirectly from NIH, but not PDB, via NIH grants made to other institutions. Because most NIH grant applications that address scientific areas within the mission of PDB are assigned to PDB, it is expected that the list of grants from other NIH sources will be short. Subcontracts to grants with a secondary assignment to NICHD linked to a program official who is a member of the Population Dynamics Branch staff are included here, noting the existence of the secondary assignment. If no secondary assignment exists, the applicant must explain how the grant fits in the PDB mission.
• Funding that the center received directly from non-NIH sources. Do not include funding unless it is within the PDB mission.
• Subcontracts that the center received indirectly from non-NIH sources. Do not include funding unless it is within the PDB mission.

For all funding, provide the funder and grant/contract number (e.g., NICHD R01HD012345, NIA R03AG543210), the PD/PIs, the grant title, the direct costs for FY 2016 or FY 2017, and whether the grant is in a no-cost extension. If the center receives no funding in a category, state "None." For multiyear grants, estimate the amount that was spent or received in FY 2016 or FY 2017. For subcontracts, also provide the grantee institution and the PD/PI of the subcontract at the applicant institution.

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.

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.

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.

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

Specific Aims: The specific aims must address how the center plans to use the funding available through this FOA to achieve the primary objectives of this initiative. Applicants are required to identify their center's primary research areas (PRAs) to be supported through this program, the areas in which the center expects to make its most significant contributions to population dynamics in the next five years. In terms of the first objective, on increasing the scientific impact, innovation, and productivity of population dynamics research, centers should focus primarily but not necessarily entirely on increasing scientific impact, innovation, and productivity within the center's primary research areas. Applicant centers are required to provide evidence that the support they request through this initiative will contribute to the center achieving its specific aims.

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

1. Program Overview

The Program Overview should describe the applicant's specific aims, including the progress it plans to make in these primary research areas, how the applicant plans to achieve these aims, and how the resources provided through this initiative enhance the applicant's ability to achieve these aims, over and above what the applicant would have been able to achieve without the funding from the initiative. Information provided elsewhere in the application for instance, in the cores, biographical sketches, and Research & Related Other Project Information section should not be repeated in this section.

• Center affiliates. List the center's affiliates in alphabetical order, indicating whether they are active population dynamics scientists; other center affiliates; or technical/administrative contributors. Identify one or more active population dynamics scientists who have been funded by the PDB as defined in Other Eligibility Criteria. Other pertinent information, such as discipline (e.g., demography, economics, sociology, public health, anthropology), academic department, or institutional affiliation (for collaborations across institutions) may be included but is not required. Information may be presented in tabular form. Include biographical sketches for all center affiliates in the appropriate component of the application.
• Primary Research Areas. Describe the research areas in which the center expects to make its most significant contributions to population dynamics in the next five years. (It is not expected that all research done at the center will fall within the primary research areas, nor is it expected that all active center affiliates will be doing research in these primary research areas.) Describe the significance and innovation of each primary research area. Describe how support from this FOA will be leveraged to increase the center's ability to make major contributions in the primary research areas over and above what could be done without this support. Describe how the experience, training, and ongoing record of accomplishments of the center's leadership and affiliates will contribute to the center's ability to make major contributions in the primary research areas. For renewal applications, explain how the primary research areas have changed since the prior competing application, if applicable. Information in the core descriptions, biographical sketches, and preliminary studies/progress report may be referenced and must not be repeated.
• Center description. Briefly describe the applicant center's governance and organizational structure, providing an organizational chart; the responsibilities and authority of the Center Director (PD/PI); the role of advisory or user committees, if applicable; membership recruitment or selection; and the privileges, and responsibilities of center membership and how they vary for different levels of membership. Describe how the applicant center defines "junior scientist." Discuss how the institutional context enhances the center's ability to achieve its specific aims. If applicable, discuss circumstances that limit or enhance the applicant institution's ability to provide support. Explain how the center's structure and procedures contribute to advancing the center's primary research areas and specific aims.

New applications should not identify or contact potential advisory committee members; renewal applications should identify current advisory committee members. If the center plans to change the Center Director during the project period, explain how the next Center Director will be selected.

Describe how the center assesses the following: the scientific impact and innovation of the research produced by center affiliates; the productivity of center affiliates; the competitiveness for peer-reviewed external funding of affiliates; success in ensuring that junior scientists achieve research independence; and the cost-effectiveness of research infrastructure. Example assessment metrics include, but are not limited to: number of peer-reviewed publications overall, in major demography or social science journals, or in scientific journals with high impact scores; citation counts; number and/or size of grants and/or contracts; number of grant applications submitted; success rates of grant applications submitted; number of new investigator applications submitted and funded; and collection, compilation, and/or dissemination of widely used data sets or other resources. Publications and funding are important metrics of impact, innovation, productivity, and competitiveness, but, for the purposes of this initiative, evidence of the overall scientific impact on the field of population dynamics of a center's recent research is more important than mechanical counts of articles and grants.

2. Preliminary Studies/Progress Report

Applicants who have not received prior support from the NICHD Population Dynamics Research Infrastructure Program should include preliminary studies related to the center's primary research areas and specific aims and describe existing research infrastructure activities related to the proposed cores. For renewal applications, include a progress report. If applicable, explain how the research emphasis of the center has changed since the prior competing application and why previously supported cores are being dropped or changed. Information provided elsewhere should not be repeated here.

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 as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. Do not include biographical sketches in the Appendix.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. 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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

Annual direct costs for the Administrative Core may not exceed $160,000. Applicants should budget funds for the PD/PI to attend one annual NICHD Population Dynamics Research Infrastructure Program Principal Investigator meeting. This meeting is usually held in conjunction with the annual meeting of the Population Association of America.

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.

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

Specific Aims: Describe the Administrative Core's objectives and the administrative services to be supported through this initiative.

Research Strategy: The administrative core has two major functions. The first function is overseeing and coordinating the activities funded through the other cores supported through this FOA. The second function is maximizing the efficiency of funding for population dynamics research by minimizing the financial and time burdens of providing administrative support services associated with research projects. Activities may include 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 dynamics centers. The Administrative Core is mandatory.

Provide the following information for the Administrative Core:

• Describe how the support from this FOA will be used to provide administrative core services over and above the services provided by the applicant institution and center. Describe how the administrative services provided by this FOA complement and/or leverage administrative services provided by other sources. If administrative services are to be supported both by this FOA and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.
• Explain how the types of administrative services to be provided through support from this FOA advance the overall application's specific aims.
• Explain how the applicant plans to assess whether the administrative support services supported by this FOA are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of administrative services supported by this FOA.
• If applicable, explain why the applicant is continuing, modifying, or dropping administrative activities supported by this FOA and its predecessors. Information in the progress report may be referenced and should not be repeated here.
• Explain eligibility and priorities for accessing core services supported by this FOA and the procedures to be used to ensure that junior scientists have access to core services.
• Describe the core's governance and organizational structure.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

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:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

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.

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.

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)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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 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. The specific aims for the Development Core should explicitly address how the core will increase the scientific impact, innovation, productivity of population dynamics research conducted in the applicant center; increase the center scientists' competitiveness for peer-reviewed external funding in population dynamics research; and support experiences for junior scientists that will contribute to their research independence.

Research Strategy: The research strategy should address how the applicant plans to use support from this FOA to provide development activities and services above and beyond services and activities provided by the applicant institution and center.

All applicants requesting support for a Development Core must propose a seed grant (or pilot) program supporting small-scale and innovative research projects, especially those that will provide preliminary data leading to larger research efforts in population dynamics research. Seed grant programs may provide funding, but may also, in addition to or instead of, 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 internal workshops and conferences.

Provide the following information for the Development Core:

• Describe how the support from this FOA will be used to provide development services and activities above and beyond services and activities provided by the applicant institution and center, including those from NIH-funded T, F, K, or R25 programs, if applicable to the applicant center and/or its affiliates. Describe how these services and activities will be provided. Describe how the development services and activities provided by this FOA complement and/or leverage development services and activities provided by other sources. If development services and activities are to be supported both by this FOA and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.
• Explain how the types of development services and activities to be provided through support from this FOA advance the overall application's specific aims. Explain how the applicant plans to assess whether the development services and activities supported by this FOA are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of development services and activities supported by this FOA.
• Explain eligibility and priorities for accessing core services supported by this FOA and the procedures to be used to ensure that junior scientists have access to core services.
• Describe procedures for soliciting, reviewing, and selecting applications or proposed activities, including who will be involved in the review.
• If applicable, explain why the applicant is continuing, modifying, or dropping development services and activities supported by this FOA and its predecessors. Information in the progress report may be referenced and should not be repeated here.
• Describe the core's governance and organizational structure.

For seed grant programs, address all the items above and, in addition, include the following:

• Procedures for soliciting and reviewing seed grant applications from junior researchers.
• How the core will prioritize the funding of applications from junior researchers.
• Requirements for preparing research applications to continue or expand the research project.
• Size of awards.
• Length of award periods.
• Number of awards permitted to an individual researcher.
• Mentoring arrangements.
• If applicable and not reported elsewhere, the number of applications submitted during the prior competitive segment, the number of awards made, the size of the awards, the number of applications for external funding that arose from seed grants, and the success rate for these applications. Report for the seed grant program overall and for junior scientists.
• For each seed grant, please provide (may be presented in tabular form): name of lead investigator; rank of lead investigator at time of seed grant initial award; and title, recipient organization, and funding outcome of external application(s), if any, that are a direct result of the seed grant.
• Explain the institutional plans and procedures that assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects. Information in other sections may be referenced and not repeated.

Renewal applications requesting an increase in funding over the prior competitive award must justify the need for additional funding. This justification should include evidence demonstrating the demand within the center for the new or expanded activity; an explanation of why, if the budget were held at the level of the most recent competitive segment, the new or expanded activities could not be supported through re-budgeting; a discussion of why existing NIH competitive funding mechanisms cannot be used to support the proposed or expanded activity; and a description of the metrics that will be used to assess whether the additional funding has resulted in enhancing the center's ability to achieve the objectives of this FOA.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The Data Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program. It is expected that the results of NICHD-funded research will be shared with the wider scientific community in a timely manner.

Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype "dbGaP" (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub "DASH" (https://dash.nichd.nih.gov/) or other equivalent broad-sharing data and/or biospecimen repositories."

The following resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing: https://www.nlm.nih.gov/cde/.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Development Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

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

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 Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific/Technical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific/Technical 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.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific/Technical 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 Core)

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

Specific Aims: Describe the Scientific/Technical Core's objectives and the current and planned support and services to be provided. The specific aims should explicitly address how the core will increase the scientific impact, innovation, and productivity of population dynamics research conducted in the applicant center. Specific aims may also address how the core will increase the center scientists' competitiveness for peer-reviewed external funding in population dynamics research; and how it will support experiences for junior scientists that will contribute to their research independence.

Research Strategy: The research strategy should address how the applicant plans to use support from this FOA to provide scientific and technical services and resources above and beyond services and activities provided by the applicant institution and center. The services and resources to be provided should be designed to enhance the scientific innovation and technical sophistication of new projects by providing access to advanced scientific/technical expertise at the project development phase and should advance informal scientific education by exposing scientists to advanced methodologies. Examples of the areas for which scientific/technical services and resources may be offered include, but are not limited to, biodemography, support for accessing data and associated documentation, methodology, programming, spatial analysis, and statistical services including personnel and computer time. In order to exploit economies of scale, applicants are strongly urged to consolidate all scientific/technical services and resources under a single core. Applicants proposing more than one Scientific/Technical Core must justify the use of multiple cores by providing evidence that, compared with use of a single core, use of multiple cores will provide costs savings and/or demonstrably better provision of services and resources. Plans for the scientific and technical services and resources to be provided over the project period should reflect any planned innovations in the Primary research areas.

Provide the following information for the Scientific/Technical Core:

• Describe how the support from this FOA will be used to provide scientific and technical services and resources above and beyond services and resources provided by the applicant institution and center as well as existing NIH grants (other than a current P2C through the Population Dynamics Branch). Describe how these services and resources will be provided. Describe how the development services and activities provided by this FOA complement and/or leverage development services and activities provided by other sources. If development services and activities are to be supported both by this FOA and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.
• Explain how the types of scientific and technical services and resources to be provided through support from this FOA advance the overall application's specific aims. Explain how the applicant plans to assess whether the scientific and technical services and resources supported by this FOA are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of scientific and technical services and resources supported by this FOA.
• Explain eligibility and priorities for accessing core services supported by this FOA and the procedures to be used to ensure that junior scientists have access to core services.
• If applicable, explain why the applicant is continuing, modifying, or dropping scientific and technical services and resources supported by this FOA and its predecessors. Information in the progress report may be referenced and should not be repeated here.
• Describe the core's governance and organizational structure.
• If the applicant is proposing more than one Scientific/Technical Core, for each Scientific/Technical Core, explain the benefits of having a stand-alone core rather than a single core offering multiple types of services or resources.
• Briefly list the scientific research projects that are expected to use scientific and technical services and resources supported by this FOA, and, if applicable, the research activities that are currently or recently using services or resources supported by predecessor FOAs. Information from progress reports, the overall component section, and biographical sketches may be referenced and should not be repeated here.

Renewal applications requesting an increase in funding over the prior competitive award must justify the need for additional funding. This justification should include evidence demonstrating the demand within the center for the new or expanded activity; an explanation of why, if the budget were held at the level of the most recent competitive segment, the new or expanded activities could not be supported through re-budgeting; a discussion of why existing NIH competitive funding mechanisms cannot be used to support the proposed or expanded activity; and a description of the metrics that will be used to assess whether the additional funding has resulted in enhancing the center's ability to achieve the objectives of this FOA.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The Data Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program. It is expected that the results of NICHD-funded research will be shared with the wider scientific community in a timely manner.

Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype "dbGaP" (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub "DASH" (https://dash.nichd.nih.gov/) or other equivalent broad-sharing data and/or biospecimen repositories."

The following resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing: https://www.nlm.nih.gov/cde/.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Scientific/Technical Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the infrastructure program 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 infrastructure program proposed).

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, an infrastructure program that by its nature is not innovative may be essential to advance a field.

Does the infrastructure program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the infrastructure program 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 primary research areas proposed in this application address important problems or critical barriers in population dynamics research?

If the overall plans for providing research infrastructure are successful, will scientific knowledge, approaches, and methods of research in population dynamics improve?

Will successful implementation of the overall plans for providing research infrastructure change the application of methods and perspectives of research in population dynamics to new topics with relevance to the scientific understanding of the health and well-being of populations? Will successful implementation of this infrastructure program serve to catalyze methods and perspectives in population dynamics over and above what the applicant could do without this infrastructure support?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the infrastructure project? If Early Stage Investigators or those 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?

In the primary research areas and population dynamics overall, are the center affiliates productive, influential, and competitive for extramural funding?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the infrastructure program? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the infrastructure program 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?

Do governance and organizational structure, responsibilities of center leadership and advisors, and the membership policies and practices of this infrastructure program contribute to the likelihood of success?

Are the proposed types of research infrastructure support cores and the methods for providing core services appropriate for advancing the application's overall specific aims and primary 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 core services likely to be cost effective and to increase the impact and innovation of the research done by center scientists and the productivity and competitiveness of center scientists in terms of extramural funding and publications?

For applications that propose supporting pilot projects or seed grants, are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects? Are the plans proposed for soliciting, reviewing, and selecting projects to fund appropriate?

For applications that promote interdisciplinary collaborations and collaborations within and across institutions, do the proposed core activities contribute to the likelihood of success?

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 adequate for the proposed infrastructure activities, taking into account the institutional context? Does the academic and physical environment contribute to the likelihood of success through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?

Do the eligibility and priorities for access to infrastructure activities, services, and resources contribute to the likelihood of success?

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.

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.

When the proposed infrastructure program 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period. For applicants with past support from the NICHD Population Dynamics Research Infrastructure Program, has this support advanced the center's primary research areas in population dynamics?

Not applicable

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 score.

Not applicable

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Administrative Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.

• Will the services provided by the core enable the infrastructure program to achieve its specific aims and make advances in the primary research areas?
• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the Core's governance and organizational structure appropriate?
• Is the core cost-effective, and are there appropriate quality control measures? If core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate?
• Are the procedures for ensuring that junior scientists have access to Core services appropriate?
• Are the eligibility and priorities for access to Core services appropriate?

Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Development Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.

• Will the services and activities proposed enhance the applicant's ability to achieve its specific aims and make advances in the primary research areas over what could be achieved without these services and activities?
• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the Core's governance and organizational structure appropriate?
• Is the core cost-effective, and are there appropriate quality control measures? If core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate?
• Do the services enhance and go beyond the development opportunities provided through Ts, Fs, Ks, and R25s, if applicable to the applicant center and/or its affiliates?
• Are procedures for prioritizing the funding of seed grants to junior researchers adequate?
• Are the eligibility and priorities for access to services and activities appropriate?
• Are procedures for soliciting, reviewing, and selecting applications and proposed activities appropriate?
• For the seed grant program, are the requirements for preparing research applications, size of awards, length of award periods, number of awards permitted to an individual researcher, and mentoring arrangements appropriate? For centers with existing programs, is the success rate for seed grants adequate? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Scientific/Technical Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.

• Will the services and resources proposed enhance the applicant's ability to achieve its specific aims and make advances in the primary research areas over what could be achieved without these services and resources?
• If more than one Scientific/Technical Core is proposed, is there adequate justification for proposing a stand-alone core rather than a single core offering multiple types of services or resources?
• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the Core's governance and organizational structure appropriate?
• Is the core cost-effective, and are there appropriate quality control measures? If core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate?
• Are the procedures for ensuring that junior scientists have access to Core services appropriate?
• Are the eligibility and priorities for access to services and activities appropriate, including access for affiliates both within and outside of the host institution, as applicable?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH's Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Rosalind B. King, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6986
Email: [email protected]

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

Maggie Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

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.

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 Part 75.