Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Funding Opportunity Title	Research Infrastructure for Demographic and Behavioral Population Science (R24)
Activity Code	R24 Resource-Related Research Projects
Announcement Type	Reissue of RFA-HD-09-004
Related Notices	September 16, 2011 - This RFA has been reissued as RFA-HD-12-186.
Funding Opportunity Announcement (FOA) Number	RFA-HD-10-020
Companion FOA	None
Number of Applications	An applicant institution may submit only one application in response to this FOA. Institutions may not hold more than one NICHD population infrastructure award at a time. See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	This FOA issued by the NICHD, National Institutes of Health, solicits grant applications from institutions to provide research infrastructure support that will enhance the research capabilities of established population science centers doing research in areas within the mission of the NICHD Demographic and Behavioral Sciences Branch. This FOA allows for three types of research infrastructure support: (1) Research Support Cores; (2) Developmental Infrastructure Cores; and (3) Public Infrastructure Cores through three types of applications: (1) General Research Infrastructure applications, for population science research centers with accomplishments, capabilities, and plans in diverse areas of population science three or more signature research themes; (2) Specialized Research Infrastructure applications, for population science research centers with accomplishments, capabilities, and plans in only a few areas of population science one or two signature research themes; or (3) Public Infrastructure Only applications, for population science centers that request funding only for Public Infrastructure Core(s).

Posted Date	December 17, 2010
Letter of Intent Due Date	January 28, 2011
Application Due Date(s)	February 28, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May/June 2011
Advisory Council Review	August 2011
Earliest Start Date(s)	September 2011
Expiration Date	March 1, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

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

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

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

• Research in demography, the scientific study of human populations, including their size, composition, distribution, density, and growth and decline, as well as the causes and consequences of changes in these factors. Major areas of focus include fertility, mortality and morbidity, migration, nuptiality, and family demography.
• Behavioral and social science research on HIV/AIDS and other sexually transmitted diseases and reproductive health.
• Research on other scientific areas related to the health and well-being of populations that applies the methods and perspectives of demography and social science, including the use of population representative samples and methods that address causal inference, such as selectivity, and endogeneity. A population is defined as an aggregate collection of individuals in a defined geographic or socio-demographic group, such as residents of New York City, married people in the United States, African American children younger than 5 years of age, or teenage mothers. DBSB emphasizes research examining policy and non-medical interventions affecting population health.

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

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

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

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

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

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

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

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

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

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

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

Funding Instrument	Grant
Application Types Allowed	New Renewal Applications funded under prior issuance of this FOA are permitted in response to this FOA. Resubmission Applicants may submit a resubmission of an application originally submitted under a prior issuance of this FOA, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Revision The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NICHD intends to commit approximately $3.1 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2011. The NICHD anticipates funding five new and/or renewal (formerly competing continuation) grants in response to this FOA. Direct cost requests should be made on the basis of the number of active population scientists in the center, the center’s impact and productivity, and the center's external funding for population science research within the DBSB mission. As a general rule, NICHD expects budget requests for R24 applications to average approximately $17,000 direct costs annually for each active population scientist (see additional guidelines below). An individual who is counted as an active population scientist must hold a permanent (tenured or non-tenured) appointment with the applicant institution; trainees, post-doctoral fellows and visiting professors are excluded. Active population scientists must be engaged in population science research within the DBSB mission and this engagement must be demonstrated by the scientist satisfying at least two of the following three criteria: 1) Externally-funded research grants or contracts within the three most recently completed federal fiscal years 2008, 2009, and 2010, which ends September 30; 2) Publications in peer-reviewed journals during the three most recently completed federal fiscal years; and Papers in preparation and plans for future population science research. 3) Qualifying grants or contracts must be from a source outside the applicant institution. Centers requesting higher levels of support than the general rule outlined above should justify their funding request by providing evidence that the center has produced and will continue to produce population science research or public infrastructure of exceptionally high impact to population science overall. Renewal applications may request no more than a 20% increase over the direct costs awarded in the last non-competing (Type 5) year. All applicants from centers with prior DBSB research infrastructure support renewals and recipients of developmental infrastructure grants must justify increases in the requested funding level over the direct costs awarded in the last non-competing (Type 5) budget year by demonstrating that prior DBSB research infrastructure support increased the impact and pace of the center’s population science research. As a general rule, for General and Specialized Research Infrastructure R24 applications, NICHD expects that the first year direct cost budget request will not exceed the annual direct costs from grants and contracts for population science research within the DBSB mission that the center has received in the last year. For Public Infrastructure Only R24 applications, applicants should justify their funding requests by providing evidence that the public infrastructure provided will increase the impact of population science research within DBSB’s mission.
Award Budget	NICHD expects requested direct costs to range from $100,000 to $750,000. Requests for Specialized Research Infrastructure Support or for Public Infrastructure Only Support should not exceed $150,000 direct costs. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed five years.

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

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

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)
• Eligible Agencies of the Federal Government
• 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 Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

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

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

• Established research center. Applicant institutions must have an established research center that coordinates or is the focus of population science research across the institution and this center must be the center for which the application requests research instructure funding. Funds from this FOA may not be used to establish a new population science research center at the applicant institution. The Principal Investigator must be the director of the center when the application is submitted and/or the award is issued.
• Three or more qualifying population scientists. The center must include at least three scientists who satisfy all three of the following criteria: (1) externally-funded research grants or contracts within the three most recently completed federal fiscal years 2008, 2009, and 2010, which ends September 30; (2) publications in peer-reviewed journals during the three most recently completed federal fiscal years; and (3) papers in preparation and plans for future population science research. To satisfy the first criterion, the qualifying scientist must be the Project Direct/Principal Investigator or other senior/key personnel on the qualifying grant or contract; and must have received the qualifying grant or contract from a source outside the applicant institution. The qualifying population scientists must hold permanent (tenured or non-tenured) appointments with the applicant institution. Trainees, post-doctoral fellows, and visiting professors are ineligible to be qualifying population scientists. Both active and qualifying population scientists should be used as a basis for requesting direct costs. For Public Infrastructure Only applications, only one qualifying population scientist is required.
• Funding by DBSB. The center must include at least one active population scientist who has been funded by DBSB within the three most recently completed federal fiscal years. This scientist must have served as the Project Director/Principal Investigator or other senior/key personnel on a research project grant (e.g., R01, R03, R15, R21, R37, R00, P01, U01, RC1, RC2, RC3, RC4); a resource-related research project grant (R24, U24); an individual research career award (K01, K08, K18, K23, K24, K99); a small business innovation research or small business technology transfer grant (R41, R42, R43, R44); an institutional training grant (T32), an education project grant (R25), or a research contract that was funded or administered by DBSB. Grants considered to be funded or administered by DBSB have a grant number including the Institute/Center designation of HD and a program official who is a member of DBSB staff. Researchers who have held only individual pre-doctoral and/or post-doctoral fellowships (e.g. F31, F32) and/or conference grants (e.g., R13, U13) do not satisfy this eligibility requirement. These eligibility criteria do not apply to Public Infrastructure Only applications.
• One application per institution. An applicant institution may submit only one application in response to this FOA. Institutions may not hold more than one NICHD Research Infrastructure for Demographic and Behavioral Population Science award (e.g., RFA-HD-09-004 or PAR-07-401) at a time.

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

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

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

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

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

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

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

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

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

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

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

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

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

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

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

The letter of intent should be sent to:

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

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

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

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

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

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

• Center Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 30 pages.
• Research Infrastructure Cores is limited to 15 pages.

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

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

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

• 3.1 Center Research Strategy (30 pages)
• 3.1.1 Program Overview (20 pages)
• 3.1.2 Preliminary Studies/Progress Report (5 pages)
• 3.1.3 Summary of Research Support (5 pages)
• 3.2 Research Infrastructure Cores (15 pages total, 3 pages each for each core)

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

Detailed Budget for Initial Budget Period:

• Prepare a composite detailed budget table for the overall infrastructure grant and separate detailed budget tables for each infrastructure core (e.g., administrative core, computer core, and seed grant program). Applicants are advised to include in their budget funds for one annual R24 grantee meeting. This meeting is usually held in conjunction with the annual meeting of the Population Association of America.

Budget for Entire Proposed Project Period:

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

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

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

Center Research Strategy

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

Program Overview:

• The page limit for the program overview is 20 pages, comprising two parts: an overall description of the center and its governance; and the center’s signature research themes.
• Provide an overall description of the center and its governance.
• Describe the center’s governance and organizational structure, providing an organizational chart. Explain the center’s administrative position within the larger institution, the authority of the Center Director (Principal Investigator), and the role of advisory or user committees.
• Explain why the center’s governance, organizational, and advisory structure are appropriate for advancing the center’s aims in population science. Describe the qualifications of the PI and other key personnel with responsibility for directing the center, including their relevant experiences, accomplishments, and expertise.
• Elucidate the principles and procedures used to determine membership in or affiliation with the center. Explain the selection criteria, privileges, and responsibilities of center membership and, if applicable, how they vary for different levels of membership. Explain how membership rules advance the center’s mission in population science. Note that center members may include individuals who do not meet the active population scientist criteria described in this FOA’s Funds Available section. Indicate which individuals are (1) active population scientists; (2) qualifying population scientists; (3) other center affiliates; or (4) a technical/administrative contributors. These four categories are mutually exclusive (see Funds Available and Other-Special Eligibility Criteria sections above for definitions of these categories). Identify at least one individual who has received DBSB funding in the last three years as required in the Other-Special Eligibility Criteria section.
• Explain how the NICHD research infrastructure support has and will be leveraged with all other forms of support to advance the center s mission in population science.
• Describe the center’s signature research themes. Signature research themes are the scientific areas that exemplify the applicant center s most significant current and/or anticipated contributions to DBSB’s mission in population science.
• For each signature research theme, explain the potential significance and innovation that will be achieved if the center’s vision for the signature research theme is realized. In describing the significance, explain the critical problems or critical barriers in population science will be addressed; explain how scientific knowledge and/or technical capabilities will be improved; and/or explain how important theories, concepts, or methods in population science will be changed. In describing the innovation, explain how the novel concepts, approaches, or methods that will be introduced. Explain why the center’s scientists are well suited to advancing scientific achievement in the signature research theme.
• For signature research themes overall, explain how the applicant institution’s scientific and institutional environment will contribute to the center’s achieving scientific progress in its signature research themes. Describe the level of institutional commitment as indicated by the amounts and types of resources the applicant institution has committed to the center.

Preliminary Studies/Progress Report:

• The page limit for the preliminary studies/progress report as outlined in the PHS 398 instructions is 5 pages.
• Follow the directions in the PHS 398 instructions. Include a description of the center’s scientific contributions within its signature research themes and elucidate the significance and innovation of the center s scientists recent contributions. Information in the biographical sketches may be referenced and does not need to be repeated.

Active Research Support:

• The page limit for the center’s active research support is 5 pages.
• Summarize the center’s active research support for FY2010. For the center as a whole, list the support (in direct costs) from grants and contracts (hereafter, grants ) for research and training in population science. For grants that have duration of more than a year, estimate the support available to the center in FY2010. Provide the support received in major categories such as the following: Infrastructure support from DBSB, other funding from DBSB, other NICHD funding; other NIH funding, NSF funding, funding from foundations; funding from the parent institution. Do not include all grants for all center scientists; report only grants that are related to population science within the mission of DBSB. This information may be presented in tabular form.
• List the center’s grants that were active in FY 2010. Include only those grants that provided research or research infrastructure support related to population science within the mission of DBSB; do not report all grants for all center scientists. Include the following information: the Principal Investigator of the grant; the subcontract Principal Investigator at the applicant center (if applicable), the project number (e.g., 5R01HD123456-07), the project title, the funding source (e.g., NICHD or NIA), the current project period (e.g. 04/01/2007-03/31/2012), the total direct costs for the current project period, and whether the grant is in a no-cost extension. This information may be presented in tabular form. If the list includes institutional training, center grants, or research infrastructure support from sources other than DBSB, briefly explain how these grants are related to the mission of DBSB. Provide the aggregated direct costs, estimated if necessary, available to the center in FY2010; this should equal the active research support available to the center in FY2010, excluding funding from the parent institution, as described in the previous paragraph.
• List other funds and in-kind support that the center received in FY2010, such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure core personnel, and dedicated equipment. Include support for research faculty salaries only if support is provided for a research infrastructure-related function such as directing a center, managing a core, and similar activities. This information may be presented in tabular form.

• The overall page limit for the research infrastructure cores section is 15 pages and the page limit for each research support core is 3 pages.
• Centers may request support for three categories of research infrastructure: (1) Research Support Cores; (2) Developmental Infrastructure Cores; and (3) Public Infrastructure Cores. Centers should request the types and levels of core support that best suit their mission in population science; centers are not obligated to request support in all categories. The NICHD expects that the types of infrastructure support cores requested and the amount of funding requested for each type of infrastructure will vary.
• Describe proposed infrastructure activities in the order listed in the previous paragraph. If more than one core is proposed under a given category, assign letters to distinguish the cores (e.g., 1.a, 1.b; 2.a, 2.b, 2.c).
• For each core, provide the name of the core director and other key personnel. Describe the core’s objective and the current and planned support and services to be provided. Describe the core’s governance and organizational structure, providing an organizational chart, and whether the activity involves collaboration with another institution. Describe the space and physical resources available to the core.
• Describe the qualifications of the core director and other key core personnel, including their relevant experiences, accomplishments, and expertise related to the objectives of the core. Explain the steps taken to ensure that the cores are cost-efficient and do not duplicate existing services. Explain any cost-sharing arrangements.
• For research support and developmental infrastructure cores, explain the core services that will be provided that are over and above those supported by the applicant organization, other funders, or individual grants and contracts. Describe how the core activities supported through this FOA will increase the impact and pace of population science research conducted by center scientists. Explain how the core activities supported through this FOA will advance the center’s population science by (1) encouraging collaborations among population scientists and between population scientists and scientists in other disciplines, within and across institutions; (2) developing new approaches and methods that advance population science research; (3) fostering the development of junior population scientists and providing opportunities for junior, mid-level, and senior scientists both within and outside of population science to engage in interdisciplinary population science; and/or (4) promoting the application of the methods and perspectives of population science to new topics in the area of the health and well-being of populations.
• For research support and developmental infrastructure cores, explain eligibility for and allocation of services. Briefly list the research activities that are currently using core services and resources, and the research activities expected to use them in the future. Elucidate explicit strategies for ensuring that junior scientists and scientists working on interdisciplinary research have access to core services.
• In describing the eligibility for and allocation of services for seed grant programs, describe (1) priorities for allocating funds; (2) eligible applicants, (3) procedures for reviewing applications; (4) requirements for leveraging funds or preparing research applications to continue or expand the research project; (5) size of awards; (6) length of award periods; (7) number of awards permitted to an individual researcher; (8) mentoring arrangements; and (9) support for the program from the parent institution or other funding sources; and (10) procedures for developing junior researchers and fostering interdisciplinary research projects.
• For public infrastructure cores, explain the services that will be provided that are over and above those supported by the applicant organization, other funders, or individual grants and contracts. Describe the target audience and the methods for disseminating the resource to that audience. Describe how the activities will advance population science. For public infrastructure cores aimed at scientific audiences, explain how the activities will increase the impact and pace of population science research and/or promote the application of the methods and perspectives of population science to new topics in the area of the health and well-being of populations.
• For infrastructure activities involving collaborations outside the applicant institution, explain why including the additional institution(s) adds to the value of the infrastructure activity. Describe plans for staffing and for sharing the administration, decision-making, and resources.

Resource Sharing Plan

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

Appendix

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

Part I. Overview Information contains information about Key Dates.

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

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

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

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

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

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

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

Significance

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

• Are the center’s signature research themes addressing an important problem or critical barrier in population science?
• If the center’s plans for providing research infrastructure are successful, how will scientific knowledge, approaches, and methods of population science, or access to population science data sets, methods, and/or significant research findings be improved?
• How will successful implementation of the proposed research infrastructure change the application of methods and perspectives of population science to new topics in the area of the health and well-being of populations?

Investigator(s)

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

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

Innovation

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

• Do the center’s accomplishments and planned accomplishments in their signature research themes challenge and seek to shift current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, or instrumentation? Are the center’s accomplishments and planned accomplishments in their signature research themes novel?
• In addition, for applications with public infrastructure cores, are the resources to be shared and/or the methods for sharing the resources novel?

Approach

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

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

• Are the proposed types of research infrastructure support and the proposed methods for providing this support feasible?
• For General and Specialized Research Infrastructure Support applications, are the proposed types of research infrastructure support cores, and the methods for providing infrastructure support through these cores, appropriate for (1) encouraging collaborations among population scientists and between population scientists and scientists in other disciplines, within and across institutions; (2) developing new approaches and methods that advance population science research; (3) fostering the development of junior population scientists and providing opportunities for junior, mid-level, and senior scientists both within and outside of population science to engage in interdisciplinary population science; and/or (4) promoting the application of the methods and perspectives of population science to new topics in the area of the health and well-being of populations?
• For General and Specialized Research Infrastructure Support applications, are the proposed types of research infrastructure support cores, and the methods for providing infrastructure support through these cores, likely to be cost effective and to increase the productivity of center scientists? Are appropriate strategies in place to assure access to core services for junior scientists and scientists working on interdisciplinary research?
• For General and Specialized Research Infrastructure Support applications from centers that have received DBSB research infrastructure funding in the past, has the center demonstrated that the past research infrastructure funding has advanced science in the center’s signature research themes or in population science overall? Has the center demonstrated that the past research infrastructure funding has been cost-effective, has contributed to increased productivity among center scientists, and has fostered the center s success in developing funded research projects relevant to the mission of DBSB?
• In addition, for applications with seed grant program cores, are the program’s procedures appropriate for advancing population science research within the centers signature research themes and in population science overall, in terms of (1) priorities for allocating funds; (2) eligible applicants, (3) procedures for reviewing applications; (4) requirements for leveraging funds or preparing research applications to continue or expand the research project; (5) size of awards; (6) length of award periods; (7) number of awards permitted to an individual researcher; (8) mentoring arrangements; (9) support for the program from the parent institution or other funding sources; and (10) procedures for developing junior researchers and fostering interdisciplinary research projects?
• In addition, for applications with public infrastructure cores, are the methods for providing this support appropriate for supporting the dissemination of population science data sets, methods, and/or significant research findings? Is the targeted audience appropriate? Are the services cost-effective?
• In addition, for applications with infrastructure activities involving collaborations outside the applicant institution, does the inclusion of the additional institution add to the value of the infrastructure activity? Are the plans for staffing and for sharing the administration, decision-making, and resources appropriate and feasible?

Environment

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

• What is the level of institutional commitment as indicated by the amounts and types of resources the applicant institution has committed to the center, taking into account the institutional context? Does the academic and physical environment contribute to the likelihood of success of the center through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines? Do the center’s structure and membership rules contribute to the likelihood of success of the center? Do the cores have appropriate cost-sharing arrangements with the institution, relevant departments, and other research infrastructure support grants?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

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

Renewals

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

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

Revisions

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

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• 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/priority score.
• Will receive a written critique.

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

• 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 business official.

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

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

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.

Not Applicable

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

Progress reports should be submitted electronically, through eRA Commons.

• In A. Specific Aims, grantees should report any changes in the center’s signature research themes or cores.
• In B. Studies and Results, grantees should describe their progress in the last year in (1) encouraging collaborations among population scientists and between population scientists and scientists in other disciplines, within and across institutions; (2) developing new approaches and methods that advance population science research; (3) fostering the development of junior population scientists and providing opportunities for scientists to engage in interdisciplinary population science; (4) promoting the application of the methods and perspectives of population science to new topics in the area of the health and well-being of populations; (5) supporting the dissemination of population science data sets, methods, and significant research findings; (6) summarize the activities of each research infrastructure cores, providing evidence of cost-effectiveness; and (7) document the increasing efficiency of the center’s population scientists by providing an integrated list of population science publications that received infrastructure support, directly or indirectly, from the grant, and a summary of the center’s continuing, new, and pending population science research support (direct costs), by source.
• In C. Significance, grantees should describe the most important scientific activities and accomplishments in population science during the last year, emphasizing the significance of findings and their potential impact on population science.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

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

Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

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

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 Parts 74 and 92.