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

Required Application Instructions

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

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; develop junior scientists; and maximize the efficiency of research support.

The primary objectives of this initiative are to:

• Increase the scientific impact, innovation, 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.

A secondary objective is to:

• Support the broad dissemination of data, methods, and materials in the field of population dynamics research.

This initiative will provide funding for research infrastructure cores at already productive population research centers. Applicants are required to describe the scientific areas in which they expect to make their most significant contributions to population dynamics research in the next five years. Applicant Centers are expected to have a recent record of high impact, innovative scientific publications and competitiveness for peer-reviewed external funding. Other activities demonstrating productivity include dissemination of innovative data, methods, or materials related to population dynamics.

Cores

Applicants must request support for a minimum of two research infrastructure cores, a mandatory Administrative Core and at least one the following types of other cores: a Development Core; Scientific/Technical Core(s); and a Public Core. The Development Core is meant to develop junior scientists and advance scientific research within the Center; Scientific/Technical Cores are meant to provide scientific and/or technical services and/or resources to Center researchers in order to enhance their research capabilities. The Public Core is meant to provide scientific and/or technical services and/or resources primarily to scientists outside the applicant Center.

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. Core activities promoting interdisciplinary collaborations and collaborations within and across institutions are encouraged.

History, size, and institutional context of centers

This initiative invites applications from both recently- and long-established population research centers. The initiative is not limited to population 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 in the next five year project period, not to simply reward past performance. This initiative invites applications from small, medium, and large population research centers. A center's productivity, impact, and innovation are meant to 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 somewhat more grants and publications. Because this initiative is expected to enhance population research centers' 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 as a substitute for research grant funding.

The scientific areas that applicants designate as those in which they expect to make their most significant contributions to population dynamics research in the next five years 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.
• Reproductive health: Behavioral and social science research on family planning, infertility, sexually transmitted diseases and HIV/AIDS.
• Population health: Research on human health, productivity, behavior, and development at the population level, using such methods as inferential statistics, natural experiments, policy experiments, statistical modeling, and gene/environment interaction studies.

Research focusing primarily on elderly populations and individuals is not within the scope of this initiative. For the purposes of this initiative, "population dynamics research" and "population research" refer to research within the three areas described above. For the purposes of this announcement, the "NICHD Population Dynamics Research Infrastructure Program" refers to all grants and activities supported by RFA-HD-08-007, RFA-HD-09-004, RFA-HD-10-020, RFA-HD-12-186, RFA-HD-13-007, RFA-HD-15-009, PAR-07-401 and predecessor announcements.

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

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

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 four additional eligibility criteria for applications responding to this FOA:

• Established Research Center. Applicant must have an established administrative unit (for example, center or institute) that administers or coordinates population research across the institution, hereafter referred to as a "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 Population Scientists. Applicants must have at least five active population dynamics scientists. Active population dynamics 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 2013, 2014 and 2015. Federal fiscal years run from October 1 to September 30; for example, Federal fiscal year 2015 runs from October 1, 2014 to September 30, 2015. The active scientist must be the PD/PI or a Multiple Program/Director/Principal Investigator (MPD/MPI) on the grant or contract, and must have received the grant or contract from a source outside the applicant institution.
• 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 population dynamics scientist who has been funded by the Population Dynamics Branch within the three most recently completed Federal fiscal years. This scientist must have served as the PD/PI or a MPD/MPI or other significant contributor on a research project grant (e.g., R01, R03, R15, R21, R37, R00, U01, RC1, RC2, RC3, RC4); a Research Program Project (P01); a resource-related research project grant (R24, U24), excluding R24 grants funded through the Population Dynamics Centers program; an individual research career award for faculty (K01, K08, K18, K23, K24); an institutional training grant (T32); an education project grant (R25); or a research contract that was funded or administered by the Population Dynamics Branch. The PDs/PIs and MPDs/PIs of subprojects on P01 projects also qualify. Researchers who have held only individual pre-doctoral and/or post-doctoral fellowships (e.g., F31, F32, K99), conference grants (e.g., R13, U13) and/or R24 or P2C grants funded through the Population Dynamics Centers program do not satisfy this eligibility requirement. 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 (normally identified by having a unique DUNS number or NIH IPF number) 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-08-007, RFA-HD-09-004, RFA-HD-10-020, RFA-HD-12-186, RFA-HD-13-007, RFA-HD-14-016, RFA-HD-15-009, PAR-07-401.)

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

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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:

Rebecca L. Clark, Ph.D.
Telephone: 301-480-1475
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
Public 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 Component: Required
• Administrative Core: Required, maximum 1
• At least one of the following:
• Development Core: Optional, maximum 1
• Scientific/Technical Core(s): Optional, maximum 3
• Public Core: Optional, maximum 1

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. Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for the center achieving its specific aims. 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 applicable to achieving the center’s specific aims 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, 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.

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, arrangements the center has to recover indirect costs, and salary support. 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." 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 2014 or FY 2015; select one fiscal year, do not present information for both. This information may be presented in tabular form. 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 virtually all 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. Explain how each grant fits in the PDB mission.
• Subcontracts that the center received indirectly from NIH, but not PDB, via NIH grants made to other institutions. Explain how each subcontract fits in the PDB mission.
• Funding that the center received directly from non-NIH sources. Omit funding for areas that are not within the PDB mission.
• Subcontracts that the center received indirectly from non-NIH sources. Omit funding for areas that are not 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 2014 or FY 2015, 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 2014 or FY 2015. For subcontracts, provide, in addition, the grantee institution and 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. In terms of the first objective, on increasing the scientific impact, innovation, 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. Specific aim(s) may also address how the center plans to achieve the secondary objective, on disseminating data, methods, and materials. 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 center's overall objectives, including the progress it plans to make in its primary research areas, and how the center plans to achieve these aims. Explain how the resources provided through this initiative enhance the center's ability to achieve its specific aims, over and above what the center 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 Section III. 3. Additional Information on Eligibility section. Other pertinent information, such as discipline (e.g., demography, economics, sociology, public health, anthropology, etc.) or academic department may be included but is not required. Information may be presented in tabular form. 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 areas. Describe the significance and innovation of each primary research area. Describe how the support received through this initiative will contribute to the center's ability to make major contributions in these areas. 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 these areas.

For renewal applications, explain how the Primary Research Areas have changed, if applicable. Information in the core descriptions, biographical sketches, and preliminary studies/progress report may be referenced and need not be repeated here.

Center description. Briefly describe the center s governance and organizational structure, providing an organizational chart; the responsibilities and authority of the Center Director (PD/PI); the synergies across the Center Director and other key personnel; the role of advisory or user committees, if applicable; membership recruitment or selection; the privileges, and responsibilities of center membership and how they vary for different levels of membership. . 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 committee members; renewal applications should identify current committee members. If the center plans to change the Center Director during the grant period, explain how the next Center Director will be selected

Explain how support from this FOA will be leveraged to advance the primary research areas and specific aims. 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.

Describe how the center assesses the following: the scientific impact, innovation of the research produced by center affiliates; the productivity of center affiliates; the competitiveness for peer-reviewed external funding of affiliates; the success of efforts to help 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 of a center's recent research is more important than mechanical counts of articles and grants.

2. Preliminary Studies/Progress Report

For applicants that have not received prior support from the NICHD Population Dynamics Research Infrastructure Program, 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 and applications from other past recipients of support from the NICHD Population Dynamics Research Infrastructure Program, include a progress report. If applicable, explain how the research emphasis of the center has changed 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 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 forms appropriate for the specific component will be included in the application package. Applicants are advised to budget funds for one annual NICHD Population Dynamics Research Infrastructure Program grantee 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 purpose of the Administrative Core is to manage and coordinate the center's activities and provide administrative support for research activities such as assisting in the development and submission of grant applications, and aiding in compliance with the administrative and fiscal requirements of funding agencies, managing working paper series and other dissemination of the center's research findings, providing editing services, and managing coordination and communications with other population dynamics centers. The Administrative Core is mandatory.

Provide the following information for the Administrative Core:

• Describe the types of services that the Administrative Core will provide and how they will be provided.
• Describe the Administrative Core's governance and organizational structure, providing an organizational chart.
• Discuss how the synergies across personnel help the Core achieve its specific aims. If support for administrative activities is or is to be provided by sources other than the Population Dynamics Centers program, describe which administrative activities will be supported by this initiative and how they complement those supported by other sources. Describe the steps taken to ensure that the core does not duplicate existing activities. If core functions are, or are to be, supported by both this program and other sources, explain the financial arrangements.
• Explain how the types of services provided and the methods of service provision advance the overall application's specific aims. Explain how the center assesses the Administrative Core. If applicable, explain why the center is continuing to support, modifying, or dropping activities within the Administrative Core. Information in the progress report may be referenced and should not be repeated here.
• Explain the procedures the center uses, if any, to maximize the efficiency of the Administrative Core.
• Explain the procedures the center uses, if any, to ensure that junior scientists have access to Administrative Core services.
• Explain eligibility and priorities for access to Administrative Core services.

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

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

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

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.

If human subjects research is anticipated within the period of the award but plans for involvement of human subjects cannot be described in the application as allowed by the DHHS regulations (45 CFR part 46.118), designate Yes in response to Are Human Subjects Involved? . In the section on Protection of Human Subjects in the Research Plan, include either an explanation of anticipated protections for human subjects or an explanation of why protections cannot be described. For further instructions, see Scenario D. Delayed-Onset Human Subjects Research in Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan http://grants.nih.gov/grants/guide/url_redirect.htm?id=82216.

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.

Research Strategy: The purpose of the Development Core is to increase the scientific scope and productivity of the center's research and researchers. All applicants 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 the 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 workshops and conferences.

Provide the following information:

• Describe the types of services that the Development Core will provide and how they will be provided.
• Describe the Development Core's governance and organizational structure, providing an organizational chart.
• Discuss how the synergies across personnel help the Core achieve its specific aims.

If support for developmental activities is or is to be provided by sources other than the Population Dynamics Centers program, describe which developmental activities will be supported by this initiative and how they complement those supported by other sources. Describe the steps taken to ensure that the core does not duplicate existing services. If core functions are, or are to be, supported by both this program and other sources, explain the financial arrangements.

• Explain how the types of services provided and the methods of service provision advance the overall application's specific aims. Explain how the center assesses the Development Core. If applicable, explain why the center is continuing to support, modifying, or dropping activities within the developmental core. Information in the progress report may be referenced and should not be repeated here.
• Explain the procedures the center uses, if any, to maximize the efficiency of the developmental core.
• Explain the procedures the center uses, if any, to ensure that junior scientists have access to Development Core services.
• Explain eligibility and priorities for funding or services.
• Describe procedures for reviewing applications or proposed activities including who will be involved in the review.

For seed grant programs, include in addition the following:

• 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; and
• Mentoring arrangements.
• If applicable and not reported elsewhere, report the success rate for seed grant during the prior funding period.
• 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.

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

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

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

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

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.

If human subjects research is anticipated within the period of the award but plans for involvement of human subjects cannot be described in the application as allowed by the DHHS regulations (45 CFR part 46.118), designate Yes in response to Are Human Subjects Involved? . In the section on Protection of Human Subjects in the Research Plan, include either an explanation of anticipated protections for human subjects or an explanation of why protections cannot be described. For further instructions, see Scenario D. Delayed-Onset Human Subjects Research in Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan http://grants.nih.gov/grants/guide/url_redirect.htm?id=82216.

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.

Research Strategy: The purpose of Scientific/Technical Core(s) is to provide scientific and technical services and resources to advance the center's research in population dynamics. Cores 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 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, data support, methodology, programming, spatial analysis, and statistics. In order to exploit economies of scale, applicants are strongly urged to consolidate all center-focus scientific/technical services and resources under a single core. Centers 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.

Provide the following information:

• Describe the types of services and resources that the Scientific/Technical Core will provide and how they will be provided.
• Describe the Scientific/Technical Core’s governance and organizational structure, providing an organizational chart.
• Discuss how the synergies across personnel help the Core achieve its specific aims.
• If support for Scientific/Technical Core activities are or are to be provided by sources other than the Population Dynamics Centers program, describe which activities will be supported by this initiative and how they complement those supported by other sources. Describe the steps taken to ensure that the core does not duplicate existing services.
  If core functions are, or are to be, supported by both this program and other sources, explain the financial arrangements.
• Explain how the types of services provided and the methods of service provision advance the overall application's specific aims. Explain how the center assesses the Scientific/Technical Core. If applicable, explain why the center is continuing to support, modifying, or dropping activities within the Scientific/Technical Core. Information in the progress report may be referenced and should not be repeated here.
• Explain the procedures the center uses, if any, to maximize the efficiency of the Scientific/Technical Core.
• Explain the procedures the center uses, if any, to ensure that junior scientists have access to Scientific/Technical Core services.
• Explain eligibility and priorities for Scientific/Technical Core services.
• If the applicant center is proposing more than one Scientific/Technical Core, for each Scientific/Technical Core explain how the center benefits from 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 services or resources provided by the Scientific/Technical Core, and, if applicable, the research activities that are currently or recently using core services or resources. Information from progress reports, the overall component section, and biographical sketches may be referenced and should not be repeated here.

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

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

Planned Enrollment Report (Scientific/Technical Core)

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

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

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

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

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Public Core)

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

If human subjects research is anticipated within the period of the award but plans for involvement of human subjects cannot be described in the application as allowed by the DHHS regulations (45 CFR part 46.118), designate Yes in response to Are Human Subjects Involved? . In the section on Protection of Human Subjects in the Research Plan, include either an explanation of anticipated protections for human subjects or an explanation of why protections cannot be described. For further instructions, see Scenario D. Delayed-Onset Human Subjects Research in Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan http://grants.nih.gov/grants/guide/url_redirect.htm?id=82216.

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) (Public Core)

List all performance sites that apply to the specific component.

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

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

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

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

PHS 398 Research Plan (Public Core)

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

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

Research Strategy: The purpose of the Public Core is to provide scientific and/or technical services and/or resources primarily to scientists outside the applicant center with the aim of benefiting population dynamics research overall. Examples include, but are not limited to, archiving and disseminating population dynamics data sets, providing efficient processes for sharing complex data sets while preserving confidentiality, and disseminating population dynamics methods. The Public Core may not be used to disseminate research findings, since this activity is under the purview of the required Administrative Core. The Public Core is optional.

Provide the following information:

• Describe the types of services and resources that the Public Core will provide. Describe the target audience and how the services and resources will be disseminated to this audience. Explain why dissemination of these types of services and resources to this particular audience will benefit the field of population dynamics research overall.
• Describe the Public Core’s governance and organizational structure, providing an organizational chart. If a core involves collaborations outside the applicant institution, explain how the partnership adds to the value of the infrastructure activity. Describe plans for staffing and for sharing the administration, decision-making, and resources. Information included in the Consortium/Contractual Arrangements section may be referenced and should not be repeated.
• If support for Public Core activities are or are to be provided by sources other than the Population Dynamics Centers program, describe which activities will be supported by this initiative and how they complement those supported by other sources. Describe the steps taken to ensure that the core does not duplicate existing services. If core functions are, or are to be, supported by both this program and other sources, explain the financial arrangements.
• Discuss how the breadth of skills and experiences of the core director and other staff, and synergies across personnel help the Core achieve its specific aims.
• Explain how the types of services provided and the methods of service provision will advance the overall application's specific aims. Explain how the center assesses the Public Core. If applicable, explain why the center is continuing to support, modifying, or dropping activities within the Public Core. Information in the progress report may be referenced and should not be repeated here.
• Explain the procedures the center uses, if any, to maximize the efficiency of the Public Core.
• Explain eligibility and priorities for access to Public Core services.

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

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

Planned Enrollment Report (Public Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Public Core)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

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.

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 NICHD and responsiveness by NICHD, 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 NOT-OD-13-030.

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

For this particular announcement, note the following: The scored review criteria refer to the application overall, not solely the "Overall Component" of the application.

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

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

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

• Do the center’s primary research areas address important problems or critical barriers in population dynamics research? Do the center’s accomplishments and planned accomplishments in their primary research areas challenge and seek to shift current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, or instrumentation? Are the center’s accomplishments and planned accomplishments in their primary research areas novel?
• If the center’s overall plans for providing research infrastructure are successful, will scientific knowledge, approaches, and methods of population dynamics improve?
• Will successful implementation of the center’s overall plans for providing research infrastructure change the application of methods and perspectives of population dynamics to new topics in the area of the health and well-being of populations?

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

• 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 center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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

• Do the center's governance and organizational structure, responsibilities of center leadership and advisors, and the membership policies and practices 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 center’s overall specific aims and primary research areas? For centers with past support from the NICHD Population Dynamics Research Infrastructure Program, has this support advanced the center's 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?

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 center activities, taking into account the institutional context? Does the academic and physical environment contribute to the likelihood of success of the center through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?
• Do the structure and the eligibility and priorities for access to center and core services contribute to the likelihood of success?

Overall, if core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate? support grants?

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

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

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.

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 .

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 and will provide a single impact score for the Administrative Core, but will not give separate scores for the individual items.

• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the Core’s governance and organizational structure appropriate?
• Will the services provided by the core enable the center to achieve its specific aims and make advances in the primary research areas?
• 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?

If a Development Core is proposed, reviewers will evaluate the following items in determining scientific and technical merit and will provide a single impact score for the Development Core, but will not give separate scores for the individual items.

• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the Core’s governance and organizational structure appropriate?
• Will the services provided by the core enable the center to achieve its specific aims and make advances in the primary research areas?
• 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 Development Core services appropriate?
• Are the eligibility and priorities for access to Core services appropriate?
• Are procedures for reviewing 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?

If one or more Scientific/Technical Cores are proposed, reviewers will evaluate the following items in determining scientific and technical merit and will prove a single impact score for each Scientific/Technical Core, but will not give separate scores for the individual items.

• 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?
• Will the services provided by the core enable the center to achieve its specific aims and make advances in the primary research areas?
• 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?

If a Public Core is proposed, reviewers will evaluate the following items in determining scientific and technical merit and will provide a single impact score for the Public Core, but will not give separate scores for the individual items.

• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the Core’s governance and organizational structure appropriate?
• Will the services provided and the target audience advance the overall application s specific aims and the field of population dynamics research overall?
• 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?
• If the Public Core involves collaboration with an entity outside the applicant institution, does the partnership add to the value of the core and are appropriate procedures in place to guide the collaboration?

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

As part of the scientific peer review, all applications:

• 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.
• Program balance.

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

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

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 clinical trials or 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.

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. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Rebecca L. Clark, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1174
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: [email protected]

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