Expired RFA-HD-07-009: Population Research Infrastructure Program (R24)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) ( http://www.nih.gov)

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD) ( http://www.nichd.nih.gov)

Title: Population Research Infrastructure Program (R24)

Announcement Type
This is a reissue of RFA-HD-06-009, which was previously released July 17, 2006.

Update: The following update relating to this announcement has been issued:

June 2, 2008 - This RFA has been reissued as (RFA-HD-08-007).

Request for Applications (RFA) Number: RFA-HD-07-009

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: July 13, 2007
Letters of Intent Receipt Date(s): August 20, 2007
Application Receipt Date(s): September 19, 2007
Peer Review Date(s): March/April 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): July 1, 2008
Additional Information to Be Available Date (URL Activation Date): Not applicable
Expiration Date: September 20, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The purpose of this RFA is to provide infrastructure support in order to foster and enhance the research capabilities of established population research centers that are highly productive and influential in the areas of research within the mission of the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research, NICHD.
The NICHD intends to commit approximately $1.061 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2008 to fund applications in response to this RFA.
The NICHD anticipates funding one to four new and/or renewal (formerly competing continuation) grants in response to this RFA. New, resubmission, and renewal applications may be submitted in response to this RFA.
An applicant may request a project period of five years.
This funding opportunity will use the NIH Resource-Related Research Project (R24) award mechanism.
Eligible organizations include for-profit or non-profit organizations, public or private institutions, such as universities, colleges, hospitals, and laboratories, units of state and local governments, eligible agencies of the Federal government..
Eligible Project Directors/Principal Investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research. The Project Director/Principal Investigator should be a scientist or science administrator who can provide effective scientific and administrative leadership. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
One application per institution is permitted.
See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of this RFA is to provide infrastructure support in order to enhance the research capabilities of established population research centers that are highly productive and influential in the areas of research within the mission of the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research, NICHD.
Applicants may request funds to support infrastructure development and/or research designed to: (1) enhance the quality and quantity of population research conducted at an institution; and (2) develop new research capabilities to advance population research through innovative approaches.
A central goal of this program is to facilitate interdisciplinary collaboration and innovation in population research while providing essential and cost-effective core services in support of the development, conduct, and translation of population research based in centers or comparable administrative units.
This is one of two announcements inviting applications under the Program for Population Research Infrastructure. This announcement invites applications for the Population Research Infrastructure Program. A separate announcement, Population Research Infrastructure Program-Short-term Support for Rising Programs (SSRP, see PAR-07-401, is aimed at up-and-coming established population research centers that would benefit from short-term infrastructure support to prepare for applying for the PRIP program within three to five years.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Purpose

The primary purposes of the Program for Population Research Infrastructure are to provide resources to support and advance research that will improve understanding of the antecedents and consequences of population structure and change, facilitate interdisciplinary collaboration among investigators conducting population-related research and in allied fields, and promote innovative approaches to population research questions. An additional goal is to facilitate interactions among scientists in locations throughout the United States that contribute to the integration and coordination of population research.

The Program for Population Research Infrastructure provides two types of grants, the Population Research Infrastructure Program (PRIP) and the Population Research Infrastructure Program Short-term Support for Rising Programs (SSRP). The SSRP replaces the Developmental Infrastructure for Population Research (DIPR) Program (see PAR06-362). Both the PRIP and the SSRP use the R24 mechanism to provide infrastructure support to established population research centers doing research in areas within the mission of DBSB as described on the DBSB website (http://www.nichd.nih.gov/about/org/cpr/dbs/) and in this RFA (referred to as population research throughout this RFA). Both PRIP and SSRP provide support to both large and small centers and to both broad-based and specialized centers. Both PRIP and SSRP require that applicant centers include at least three active researchers doing research in areas within the mission of DBSB and that least one center researcher has current or recent grant or contract support from DBSB (see eligibility criteria for details). No institution may have more than one PRIP, DIPR, or SSRP award at a time.

Major differences between the PRIP and SSRP programs are the following: The PRIP provides infrastructure support to established population research centers that are highly influential, highly productive, and make substantial contributions to advancing population research. The SSRP provides infrastructure support to established population research centers that are becoming increasingly productive and influential, but have not yet developed to the point at which they are competitive for a PRIP award. The goal of SSRP is to provide infrastructure support that will allow the development of resources and mechanism that will facilitate a leap in scientific productivity, scientific impact, and contributions to population research. SSRP centers are expected to be competitive for a PRIP award within three to five years of receiving the award.

In addition to the differences described in the previous paragraph, the PRIP and SSRP grant programs also differ in the following ways.

Length of award: PRIP awards are for five years; SSRP awards are for three to five years.
Maximum direct costs requests: While the size of both PRIP and SSRP awards will vary by the number of researchers associated with the center (see Funds Available section), SSRP awards are limited to no more than $150,000 per year in direct costs. PRIP awards do not have a limit for direct cost requests.
Previous infrastructure support: SSRP applicants may not have received infrastructure support from this program (PRIP, DIPR, SSRP) in the previous three years; no restriction on previous infrastructure support applies to the PRIP.
Renewal awards: PRIP awards are renewable; SSRP awards are not renewable.
Public infrastructure: PRIP applications may request support for public infrastructure; SSRP may not request support for public infrastructure.
Progress reports: PRIP requires a progress report for competitive renewals (Type 2) and for applications for new awards (Type 1) from centers that previously held an SSRP or DIPR award; SSRP requires no progress report.

The PRIP grant funds infrastructure to support a portfolio of population research housed in or coordinated by a center or other research unit (hereafter, research center or center ) at an institution. Through this support, the PRIP grant is intended to:

Produce scientific benefits and cost-efficiencies resulting from cooperation and interaction among a pool of scientists with shared interests in population research and shared infrastructure needs; and
Advance the interdisciplinary reach, innovation, and impact of population research through encouraging the development of new directions and approaches to population research and the aggressive pursuit of scientific opportunities appearing at the boundaries between traditional population research and allied fields.

Applicants responding to this RFA should have in place (or propose in their applications) effective mechanisms for fostering the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in population research. They must also articulate a clear vision for their research center and its current and future contributions to population research.

Applicants must identify the signature population-related themes of the center. These themes must be relevant to the DBSB mission. Signature themes are defined as research topics that exemplify the applicant center’s most significant current and/or anticipated contributions to population research. The themes should reflect the major strengths of the center, but do not need to encompass all research topics covered by the center’s researchers. Applicants must also articulate a vision for the potential future contributions of the center.

Scope

The Program for Population Research Infrastructure seeks to advance scientific knowledge in areas related to the mission of the Demographic and Behavioral Sciences Branch. DBSB is one of three branches of the Center for Population Research of the NICHD. DBSB s mission is to improve the health and well-being of individuals, families, and populations by adding to knowledge about human population dynamics and their causes and consequences. DBSB funds demographic, behavioral and social sciences research on fertility, families, population movement, health and mortality, HIV/AIDS, and population composition. Research on population diversity and change, studies of the consequences of population diversity and change for health and well-being, and research on the interrelationships among individual, family, group, community, and population processes are all central to this mission. To achieve these goals, DBSB fosters innovative and multi-disciplinary research by providing awards to individual investigators and research teams as well as supporting research training and infrastructure in the population sciences. Further information about DBSB’s mission can be found on DBSB’s website, http://www.nichd.nih.gov/about/org/cpr/dbs/. Illustrative examples of population research topics that fall within the DBSB mission include, but are not limited to, the list that follows. Applicants may consult with program staff listed under Section VII. Agency Contact(s) to discuss the relevance to the DBSB mission of specific topics.

1. Research on the antecedents and consequences of changes in population size, structure, and composition, including the documentation, analysis, and/or projection of population composition with respect to demographic, economic, social, and geographic characteristics; economic and social mobility; the relationship of economic, social, and cultural factors to population change; and the interrelationship between population and the physical environment.

2. Demographic, social science, and behavioral science research on families and households, including studies of the determinants of trends in marriage, divorce, and cohabitation; the formation of and changes in household structures, fatherhood, patterns of child support and visitation with absent parents; the use of child care services; the relationship between changing fertility and family patterns and the well-being of children; intergenerational demography; and the implications of welfare and health policies on families.

3. Demographic, social science, and behavioral science research on fertility, including studies of individual, social, economic, and cultural determinants and consequences of fertility and fertility trends; the interrelationship between fertility patterns and education, work, union formation and dissolution, family structure, and health; and contraceptive use, abortion, and sexual behavior.

4. Research on population movement and distribution, including studies of the determinants and consequences of international and internal migration and residential mobility; assimilation and adaptation of migrants; migrant selectivity; residential segregation; and spatial demography.

5. Demographic and social science research on health, morbidity, disability, health disparities, and mortality, including research on infant mortality and low birth weight; and research that relates demographic and social processes to mortality and health across the life course and to the health and well being of children (see http://www.nichd.nih.gov/about/org/cpr/dbs/prog_mort/index.cfm for more information).

6. Demographic, social science, and behavioral science research on the sexual transmission of HIV and other sexually transmitted diseases, including studies of sexual behaviors related to HIV and other STD transmission; the interrelationships between social, institutional, economic, and cultural contexts and sexual behavior; the interrelationships among pregnancy, pregnancy prevention, and HIV and other STD prevention; theoretically grounded intervention studies within these areas; and related methodological studies (see http://www.nichd.nih.gov/about/org/cpr/dbs/prog_HIVSTD/index.cfm ).

7. For other specific diseases and conditions not mentioned above, research that primarily focuses on the social, cultural, familial, and economic determinants and consequences of these diseases and conditions.

DBSB defines "population" as the aggregate collection of individuals in a defined geographic area and/or social or demographic group. Examples include the residents of New York City, married people in the U.S., and African American children under age five. Aggregates defined by their participation in a study, program, or service are not considered populations under this definition

Centers with strong research programs in areas within the mission of DBSB are encouraged to develop research projects with researchers outside the traditional areas of population research (for instance, anthropology, geography, biological sciences, epidemiology, public health, and medicine) in order to develop innovative interdisciplinary science that addresses important issues in the population research.

Potential applicants seeking information on establishing a new population research center or in refocusing the research activities of currently ineligible research centers so that they become eligible for PRIP support may consult with program staff listed under Section VII. Agency Contact(s).

Infrastructure Support

Applicants may request support for three categories: (1) Research Support Cores; (2) Developmental Infrastructure; and (3) Public Infrastructure. Applicants should request the types and levels of support that best suit their needs and objectives; they are not obligated to request support in all categories. The NICHD expects that the types of infrastructure support requested and the amount of funding requested for each type of infrastructure will vary.

The first two categories of infrastructure support are intended to advance the scientific program of the applicant research center. For these categories, applicants must justify the types and amounts of support requested in terms of: (1) the scope, objectives, and current and potential impact of the current and planned research at the applicant's population center; (2) the potential contribution of requested infrastructure to advancing the current and planned research at the applicant s population center; and (3) the cost-effectiveness of the requested support. Applicants are expected to provide guidelines for determining the eligibility of researchers and research projects to access resources provided through the PRIP program, and guidelines and procedures for allocating these resources. No restrictions on access (e.g., by students, investigators lacking research support, investigators in fields other than population research) are imposed under this announcement. However, applicants must demonstrate that their proposed guidelines and procedures for controlling access to resources provided through the PRIP program are consistent with the goal of effectively advancing the scientific program of the center and the goals of this RFA. Similarly, the announcement imposes no restrictions on how applicants define membership in their center. Applicants are encouraged to develop flexible guidelines for membership that permit the involvement of researchers from all fields relevant for the goals of their research center. Membership in the center and access to resources provided through the PRIP program may be extended to individuals who do not meet the criteria used to define applicant eligibility (see Section III. Eligibility Information: 3. Other - Special Eligibility Criteria).

In undertaking any of the infrastructure activities, applicants may propose cooperating with other institutions. Cooperative activities may include the development of research partnerships involving scientists in the applicant's population research center and colleagues in other institutions, and/or joint ventures with other institutions to provide research and/or developmental services. Proposed partnerships must be justified in terms of the advances to be gained through collaboration across institutions relative to those likely to emerge from within-institution partnerships. Partners in a cooperative venture do not need to be from another funded SSRP, DIPR, or PRIP center. Applicants must clearly describe the rights and responsibilities of each proposed partner in the funding, administration, and use of shared resources.

Definitions of Infrastructure Support Categories

1. Research Support Cores provide shared resources that support the research at the applicant’s population center. Examples include:

Administrative Core, providing for coordination of research, editorial services, and/or assistance with developing grant applications and fiscal management of grants.
Computing Core, providing equipment and/or services supporting shared computing needs.
Information Core, providing support for retrieving information, materials, and data commonly used in population research.
Methodology Support Cores, providing support for specific methodologies employed in population research (e.g., geographic information systems (GIS), statistical methods, biomarkers, survey methodologies).

Research Support Cores should be designed to advance the research at the applicant’s population center by providing essential, cost-effective services to support on-going and proposed research activities. Cores should be designed to facilitate and promote innovation in the science conducted by population center researchers and should be responsive to researchers needs. Equipment and support services that are specific to individual research projects or researchers are not allowable.

2. Developmental Infrastructure Cores provide activities that promote the development of new research capabilities. Such activities may lead to outcomes such as innovative projects and approaches, new interdisciplinary collaborations, the scientific development of junior researchers, or the integration of experienced researchers from other fields into population research. Examples of potential developmental infrastructure activity cores include:

Seed grant programs, providing funds for the development of new research projects. Centers proposing seed grant programs must develop guidelines and eligibility requirements appropriate to the goals of this RFA, and procedures and policies for administration of the program. Issues that should be addressed include, but need not be limited to: (1) priorities for allocating funds (e.g., junior researchers, specified areas of research, interdisciplinary work, etc.); (2) procedures for reviewing applications; (3) requirements for leveraging funds or preparing research proposals to continue or expand the research project; (4) size of awards; (5) length of award periods; (6) number of awards permitted to an individual researcher; (7) mentoring arrangements; and (8) support for the program from the parent institution or other funding sources.
Activities that foster the development of new Research Support Cores. For example, applicants may propose to hire consultants to assist with the design of GIS services, or conduct pilot studies to evaluate the cost-effectiveness of alternative modes of core service delivery.
Workshops, conferences, seminar series, and visiting scholar programs that lay the groundwork for new substantive work or foster new research collaborations.

3. Public Infrastructure activities differ from the first two categories of infrastructure support because they are not solely intended to advance the research program at the applicant institution, but are instead primarily directed at significant external audiences. These audiences may include (but are not limited to) the broad community of population researchers or communities concerned with public policy or health or social programs. Applicants may apply for limited infrastructure support that supports only public infrastructure; this type of application will be referred to as PRIP-Public Infrastructure Only (PIO) applications.

Illustrative examples of activities benefiting the broader scientific community include: supporting and disseminating databases of high relevance to population research; and providing infrastructure for data sharing.

Illustrative examples of activities benefiting policy or program audiences include the development of tools for effectively communicating population research findings to relevant audiences and innovative strategies for translating research findings for application to programs designed to improve health and well-being.

Applicants are encouraged to request funds for public infrastructure activities only when they can justify that: (1) these activities will significantly advance the field of population research; and/or (2) these activities will improve the accessibility of population research to the policy and practice communities and enhance the appropriate application of research findings to activities that improve health and well-being. In addition, applicants requesting funds for public infrastructure activities must justify that: (3) the proposed activity does not duplicate existing resources or services at that or at other institutions; and (4) the proposed activity is cost-effective. Applicants should also address the time frame during which the resource(s) or service(s) will be needed and provided, and the short- and long-term plans for supporting the proposed resources and/or services. As applicable, this plan should address expectations for future NICHD support, support from the applicant institution, and other sources of support, and plans for charging users and managing program income.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Resource-Related Research Project (R24) award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NICHD intends to commit approximately $1.061 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2008 to fund applications in response to this RFA.
The NICHD anticipates funding one to four new and/or competing continuation grants in response to this RFA.
Applicants should request a project period of five years and should request support appropriate to the size and impact of their scientific portfolio and to the goals of their infrastructure program.
As a general rule, NICHD expects direct cost budget requests for R24 applications to average approximately $17,000 for each active program researcher who can provide evidence of research activity directly relevant to the DBSB mission in two or more of the following categories: (1) externally funded research grants or contracts in the past three years; (2) publications in peer-reviewed journals during the past three years; and (3) papers in preparation and future plans for research. See Section III. Eligibility Information: 3. Other - Special Eligibility Criteria, below, for further information on these categories of research activity. Count only researchers holding permanent (tenured or non-tenured) appointments; do not count trainees, post-doctoral fellows, or visiting professors.
Requests may vary from the guideline provided above as justified by evidence of exceptionally high impact or productivity or special features of the proposed infrastructure program.
Applicants may request additional funds beyond those suggested by the guideline to support for Public Infrastructure activities (see definition of Public Infrastructure in Section I. Funding Opportunity Description: 1. Research Objectives, above). Applicants may discuss budget requests with program staff listed under Section VII. Agency Contact(s), below, prior to submission.
The anticipated period of performance is five years.
The anticipated start date for these awards is July 1, 2008.

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 NICHD 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:

For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Units of State government
Units of local government
Eligible agencies of the Federal government
Domestic Institutions

Although foreign institutions are not eligible to submit applications in response to this RFA, consortium arrangements between foreign and domestic institutions are permitted. New, resubmission, and renewal applications may be submitted in response to this RFA.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

The Project Director/Principal Investigator should be a scientist or science administrator who can provide effective scientific and administrative leadership.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing. However, because the PRIP support is expected to enhance the center s competitiveness for NIH funding, the institution and pertinent departments are expected to show a strong commitment to the center by providing additional infrastructure support at a level appropriate to the resources of the institution and the scope of the activities that the center proposes to be supported by the PRIP. Institutional and departmental commitment may be demonstrated by the provision of dedicated space, faculty appointments in subject areas relevant to the goals of the center’s population research program, salary support for investigators or core staff, dedicated equipment, or other financial support for the population center, its population research activities, and/or infrastructure that supports its population research activities. Applicants may consult with program staff listed under Section VII. Agency Contact(s) to discuss this expectation.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Additional eligibility criteria for applications responding to this RFA include the following:

Applicant institutions must have an established research center, program, or other administrative unit (referred to as the "research center" or "center") that coordinates or serves as a focal point for population research across the institution. This center must have a defined governance structure. The center that coordinates or serves as a focal point for population research across the institution must be the center for which the application requests infrastructure support. Funds from the PRIP program may not be used to establish a new population research center at the applicant institution.
The center must have at least three researchers who hold permanent (tenured or non-tenured) appointments with the applicant institution and can present evidence of research activity directly related to the mission of DBSB in all three of the following categories: (1) externally funded research grants or contracts in the past three years; (2) publications in peer-reviewed journals during the past three years; and (3) papers in preparation and future plans for research. Because their association with the center can be expected to be temporary, trainees, post-doctoral fellows, and visiting professors should not be counted toward this requirement. The "past three years" refers to the 36-month period preceding the application submission date for this RFA. "Externally funded" means funding is received from sources outside the institution; it may include funding from NIH, NSF, other federal agencies, state and local governments, and private foundations. Include only projects on which the individual has served as Project Director/Principal Investigator or contributed substantially to designing and/or conducting the scientific research. For PRIP-Public Infrastructure Only (PIO) applications, only one permanent researcher must meet these criteria.
The center must include at least one researcher who holds a permanent (tenured or non-tenured) appointment with the applicant institution and who has at least one research project grant (e.g., R01, R21, R03, U01, P01, R37, R41, R42, R43, R44), individual career development grant (e.g., K01, K23), institutional training program grant (e.g., T32, D43), educational project grant (i.e., R25) or research contract that was funded or administered by the NICHD’s Demographic and Behavioral Sciences Branch in past five years. 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 satisfying this eligibility requirement. For a researcher to qualify for this eligibility requirement, he or she must have been the principal investigator, co-principal investigator, program director, or other senior/key personnel who contributed to the scientific development or execution of the project in a substantive, measurable way or must have played the equivalent role on a contract. Grants are considered to be funded or administered by DBSB if the grant number includes the Institute/Center designation of HD and if the program official assigned to the grant is a member of DBSB staff. Because their association with the center can be expected to be temporary, trainees, post-doctoral fellows, and visiting professors should not be used to satisfy this requirement. The "past five years" refers to the 60-month period preceding the application submission date for this RFA. These eligibility criteria do not apply to PRIP-Public Infrastructure Only (PIO) applications.
An applicant institution may submit only one application in response to this RFA. Institutions may not hold more than one NICHD population infrastructure award (e.g., PRIP, DIPR, or SSRP) at a time.

Applications not meeting the above eligibility criteria will be returned without review.

Note that the second set of criteria used for center eligibility above (at least three researchers with evidence of research activity in all three categories) differs from the criteria used to define guidelines for requested budgets under Section II. Award Information: 2. Funds Available and to define page limitations for the research activity of program scientists in Section IV. Application and Submission Information: 2. Content and Form of Application Submission.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Applications for Research Infrastructure Awards (R24) should be prepared according to the Application Guidelines below. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by these guidelines.

SECTION I. GENERAL INFORMATION

B. DESCRIPTION AND PERSONNEL

Under Key Personnel, list key scientific and technical personnel participating in the grant. Do not list all researchers affiliated with the applicant program. List only those individuals who contribute significantly to the leadership and guidance of the proposed program and infrastructure components. At a minimum, the Principal Investigator and Core Directors must be listed.

C. TABLE OF CONTENTS

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a table of contents should be prepared listing major sections and paginated to enable reviewers to find specific information readily. The general form on Form Page 3 of the PHS 398 should be used, but should be modified to reflect the application sections required by this RFA. Under Research Plan, Section A. should be titled Program Overview, Section B should be title Progress Report, Section C should be titled Research Activities of Program Scientists, and Section D should be titled Infrastructure Core Descriptions.

D. DETAILED BUDGET FOR INITIAL BUDGET PERIOD

Prepare a composite detailed budget table for the Infrastructure Grant and separate detailed budget tables for each infrastructure component (e.g., Administrative Core, Computer Core, Seed Grant Program).

E. BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

Prepare a composite budget table for the Infrastructure Grant and separate budget tables for each infrastructure component.

F. BIOGRAPHICAL SKETCH

A biographical sketch is required for all key scientific and technical personnel named on Form Page 2 (see Description and Personnel, above), as well as for all active center researchers, as defined in Section II. Award Information , 2. Funds Available. Include active program researchers first, beginning with the Principal Investigator, with others following in alphabetical order. Then provide biographical sketches for all technical personnel involved in infrastructure components of the application in alphabetical order.

G. SUMMARY OF RESEARCH SUPPORT

Present a summary of the research and research support the center receives, by source. For the applicant center as a whole, provide the total funds supporting research and infrastructure in the center for the most recent 12-month period for which the information is available. Indicate the 12-month period for which the data are being provided. Provide the amount of funding received in major categories such as the following: Infrastructure support from NICHD (e.g., a prior NICHD R24 or R21 infrastructure award); other NICHD funding; other NIH funding, NSF funding, funding from foundations; funding from the parent institution. This information may be presented in tabular form.

For the same 12-month reporting period, provide a list of the grants and contracts that provide research or infrastructure support to the center's research program. Include the following information: the principal investigator at the applicant center, the project number, the project title, the funding source, the project start and end dates, the total award amount, the award amount for the 12-month reporting period. If the grant or contract is a subcontract to another organization, indicate the principal investigator and institution for the overall grant. This information may be presented in tabular form.

For the same 12-month reporting period, list other funds and in-kind support received by the center 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 the center, managing a core, and similar activities. This information may be presented in tabular form.

H. RESOURCES

Provide the information required by the PHS 398. 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 floor plans for the space available to the applicant center, including the location of spaces that are not physically continuous, as continuation pages.

SECTION II - RESEARCH PLAN

Page limitations: The length of the sections devoted to the overall description of the population research center, progress report, research activity, and proposed infrastructure components must not exceed those specified below.

Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted in the appropriate section below. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate component.

A. PROGRAM OVERVIEW

Use no more than 20 pages for this section. Summarize the center's research program, identifying signature population-related themes that exemplify the center's most significant current and/or anticipated contributions to population research within the mission of DBSB. Address the scientific and practical significance of each research theme. Describe the current and recent research activity in the center that has contributed to the theme, identifying relevant scientific accomplishments and describing their impact. Highlight activities that have produced significant innovation and/or interdisciplinary collaboration. Describe the vision of program scientists for advancing research related to the theme.

Also describe other major contributions the center's active researchers have made to population research related to the mission of DBSB within the last five years. Examples of such contributions include large-scale projects that benefit the field broadly, creation of interdisciplinary collaborations, training and mentoring of junior scientists, scientific leadership of program personnel, and translational activities to improve clinical practice, public intervention programs, and public policy formulation. Do not repeat contributions discussed in the context of signature population-related themes.

Summarize the vision of center researchers for the center's future scientific advances and contributions. Describe strategies the center employs for advancing the quality and innovation of its population research program over the short and long run. Describe how the center fosters the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in population research. Describe how the center develops and implements its goals. Describe how the center assures the development and success of junior scientists.

Describe the configuration and governance of the center and provide an organizational chart. Include information on the administrative position of the center within the larger institution, the authority of the Center Director (Principal Investigator), and the role of advisory or user committees. Outline the principles and procedures the center uses to determine membership in or affiliation with the center, to allocate resources, and to allow access to core services. If the center employs more than one category of membership or affiliation, explain the selection criteria, privileges and responsibilities associated with each. Describe how the NICHD support would leverage and interact with all other forms of support contributing to the research activities of the program.

Summarize the key features of the proposed infrastructure program and explain how each element will advance the quality, productivity, and innovation of the center's research activities. For Public Infrastructure activities, explain the value and significance of the activities.

B. PROGRESS REPORT

Applicants currently funded under the Population Research Infrastructure Program (R24) or Developmental Infrastructure for Population Research Program (R21) should prepare a progress report as required in the PHS 398.

Do not exceed five pages.

C. RESEARCH ACTIVITY OF PROGRAM SCIENTISTS

Use no more than 50 pages for this section. At the beginning of this section, identify three program researchers who satisfy the second set of criteria in the Other-Special Eligibility Criteria Section. Each of these individuals must have a permanent appointment at the applicant institution and must present evidence of research activities directly related to the mission of DBSB in all three categories (see Other-Special Eligibility Criteria Section for complete details). After that, indicate the center researcher who has the history of NICHD DBSB grant or contract support as defined in the third set of eligibility criteria in the Other-Special Eligibility Criteria Section. For the grant or contract that satisfies the third set of eligibility criteria, provide the grant or contract number, grant or contract title, the name of principal investigator and, if the center researcher was not the principal investigator of the project, the center researcher’s role on the project.

Next, briefly summarize the recent and current research activity of each active program scientist with respect to each of the five points listed below. Use one page, on average, per active researcher. The total number of pages used for describe the research activities of the program researchers should not exceed the number of program researchers, with an overall limit on this section of 50 pages. Describe the Principal Investigator's research activity first and that of all other researchers subsequently in alphabetical order.

Summarize the most important scientific accomplishments of the researcher during the 36 months prior to the receipt date for this RFA. Discuss these accomplishments with respect to their significance, innovation, and actual or potential impact on population research
Identify externally funded research projects in which the researcher participated as key personnel during the 36 months prior to the receipt date for this RFA, the amount, source, and period of funding, and the role and time commitment of the individual on the project. Information provided in the BIOGRAPHICAL SKETCH may be referenced as appropriate to avoid repetition.
Briefly summarize relevant working papers and future research plans (e.g., pending and planned research grant applications).
Describe how the researcher contributes to the center's research activities, how his or her expertise, disciplinary training, substantive interests, and technical skills help to advance the central scientific objectives and signature population-related themes of the center. Identify recent, active, or planned collaborations involving this researcher. If the researcher holds an appointment in another institution or center, describe the degree to which the researcher is involved in the applicant center's program, providing specific and quantitative measures of involvement.
Describe how the researcher uses (or would use) the proposed infrastructure cores or activities.

D. INFRASTRUCTURE CORE DESCRIPTIONS

Describe proposed infrastructure cores, as applicable, in the order listed below. If more than one core is proposed under a given category, assign letters to distinguish the cores (e.g., 1.a; 2.c). For each core, provide the name of the Director and describe procedures used to assure cost-efficiency and high quality administrative and research activities.

Do not exceed five pages in describing each component (core or activity). If any component is described as a collaborative activity (i.e., involving partnership with another institution), applicants may use one additional page to describe how each partner will contribute (e.g., in terms of administration, staffing, and other resources); how each partner will benefit (e.g., in terms of access to services or research productivity); and how decision-making will be shared.

1. Research Support Cores - Describe the objectives, administrative organization (use organizational chart), staffing (including a Core Director and any professional or technical personnel and their duties), space and physical resources, current and projected services, eligibility for and allocation of services, and cost-sharing arrangements. Briefly describe current or planned research activities that will utilize the core services.

Explain how the proposed research support cores will contribute to advancing the center’s research program and its signature population-related themes and to fostering innovation in the program's research. Describe strategies for assuring that research support services effectively respond to and anticipate the evolving needs of science conducted in the center. Justify the core in terms of scientific impact and cost-effectiveness. Explain what the proposed core services will provide over and above research support that the applicant's institution and specific research projects already provide and why they are essential to meet the needs and goals of the research program.

2. Developmental Infrastructure Cores - Describe the objectives and administrative organization of each developmental infrastructure core. Describe the impact of the infrastructure core on population research within the center. In describing seed grant programs, provide details on program procedures and policies, including review procedures; priorities for allocating funds; requirements for leveraging funds or preparing research proposals to extend or continue the project; size of awards; length of award periods; number of awards permitted to an individual researcher; mentorship arrangements; and cost-sharing arrangements with the parent institution.

3. Public Infrastructure Cores - Describe the objective of each core activity and the target audience (e.g., population researchers, program managers, policy makers). Explain the significance of the activity. Discuss the potential of the activity for advancing population research, stimulating innovative or interdisciplinary research, and/or enhancing the effective dissemination and translation of research findings. Describe the unique contribution of the activity compared with other similar activities that already exist. Describe the administrative organization (use organizational chart), staffing, space and physical resources and current or projected services and activities. Describe the plan for disseminating the resources, services, or products to the target audience. Justify the core in terms of cost-effectiveness and describe short- and long-range plans for supporting the activity.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): August 20, 2007
Application Receipt Date(s): September 19, 2007
Peer Review Date(s): March/April 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): July 1, 2008

3.A.1. Letter of Intent

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 Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1175
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review
Availability of funds
Relevance to program priorities

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Advisory Child Health and Human Development Council.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance
Approach
Innovation
Investigators
Environment

Peer reviewers will evaluate each application for overall scientific merit according to the criteria provided below. Reviewers will also evaluate the merit of proposed infrastructure support cores, the developmental infrastructure cores, and, if applicable, the infrastructure activities undertaken with another institution using the criteria provided below. The size and scope of applicant programs are not review criteria. NICHD believes that investments of infrastructure resources in small centers of excellence with focused scientific programs may be highly cost-efficient for the field. Reviewers are encouraged to take the number of researchers involved in a program into account in applying the review criteria below, particularly when evaluating current and potential program impact. While both larger and smaller programs are expected to demonstrate research activity of high quality, programs with fewer researchers would not be expected to demonstrate the same quantity of research productivity and program impact as programs with a greater number of researchers

There are separate and distinct review criteria for the two main types of PRIP applications, standard PRIP applications and PRIP-Public Infrastructure Only (PIO) applications. In addition, there are also separate and distinct review criteria for research support cores, developmental infrastructure cores, public infrastructure cores, and infrastructure activities undertaken with another institution. These criteria are listed below.

Significance

Standard PRIP Applications:

Does this population research center support a research program that addresses important problems in population research?

Taking into account the center’s size and scope as measured by the number of researchers and/or the breadth of the science covered, what is the quality of the existing research program and its impact on the field? What are the significance, innovation, and quality of current and recent contributions of center scientists? Considering both the applicant's signature population-related themes and other relevant research, have these contributions produced new knowledge and/or new approaches to research that have significantly expanded, improved or altered the content, methods, and direction of population research? To what extent has the research center contributed to population science through large-scale projects that benefit the field broadly, creation of interdisciplinary collaborations, training and mentoring of junior researchers, scientific leadership by program personnel, and translational activities to improve clinical practice, public intervention programs, and public policy formulation?

What are the potential future contributions of the applicant's research center to population research, as based on the current trajectory of research productivity, innovation, and accomplishments; the applicant's vision for the potential future contributions of the center; the plan for advancing the scientific program; and the applicant's success in contributing to the development of junior researchers?

As secondary review criteria: What is the quality and potential impact of proposed infrastructure program based on the overall quality, scientific merit, and innovation of the activities to be supported? Based on existing capabilities and proposed activities, what is the likelihood that the proposed program will enhance population research, promote new research directions, facilitate interactions across disciplines and substantive areas of study, or advance theoretical or technical approaches?

PRIP-Public Infrastructure Only (PIO) Applications:

Does this center’s public infrastructure program disseminate information, materials and/or services that address important problems?

What is the quality and potential impact of the proposed infrastructure program based on the overall quality, scientific merit, and innovation of the activities to be supported?

Research Support Cores and Developmental Infrastructure Cores:

Does this core increase or have the potential to increase the center’s ability to addresses important problems in population research?

Public Infrastructure Activities:

Does this core increase or have the potential to increase the center’s ability to addresses important problems in population research?

For public infrastructure activities that are intended to benefit the research community: What is the value and significance of the proposed activity for population researchers and what is its potential for promoting interdisciplinary and/or innovative population research?

For public infrastructure activities directed to policy, program, or other audiences: What is the significance of the proposed activity and its potential for improving the accessibility of population research to significant audiences and enhancing the appropriate application of research findings to activities that improve health and well-being?

Approach

Standard PRIP Applications and PRIP-Public Infrastructure Only (PIO) Applications:

Are the framework, design, and methods adequately developed, well integrated, well reasoned, and appropriate to the aims of the infrastructure program? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Research Support Cores:

What is the potential or actual contribution of the proposed research support core to advancing research within the applicant population research center by: enhancing the productivity of the existing scientific program; fostering new scientific advances; facilitating interactions across disciplines and substantive areas of study; and/or advancing theoretical or technical approaches?

Given the size and characteristics of the applicant s existing research program and the applicant’s vision for potential future contributions, is the research support core appropriate?

Are the services and/or activities cost-effective, and are cost -sharing arrangements with the institution, relevant departments, and other external infrastructure support programs appropriate?

Developmental Infrastructure Cores:

Given the size and characteristics of the applicant's existing research program and the vision for the potential future contributions, is the developmental infrastructure activity appropriate?

Are the services or activities cost-effective and are the appropriateness of cost-sharing arrangements with the institution, relevant departments, and other external infrastructure support programs appropriate?

For seed grant programs, are the procedures and policies for administering the program such as guidelines for reviewing applications, priorities for allocating funds, requirements for leveraging funds, and size and length of awards, and other program guidelines appropriate and of high quality? For competing continuation applications, have seed grant programs succeeded in developing funded research projects relevant to the mission of DBSB?

Public Infrastructure Activities:

Are the targeted audiences and the adequacy of the plans for disseminating the proposed activities, resources, or services to these audiences appropriate?

Are the services or activities cost effective and are the short- and long-term plans for supporting them (including cost-sharing arrangements) appropriate?

Infrastructure Activities Undertaken with Another Institution:

What value is added by the involvement of other institutions, are plans for the sharing of rights and responsibilities among proposed partners with respect to the funding, administration, and use of shared resources appropriate and adequate?

Innovation

Standard PRIP Applications:

Does this population research center support a research program that is original and innovative? For example: Does this population research center support a research program that challenges existing paradigms or practice; address an innovative hypothesis or critical barrier to progress in the field? Does this infrastructure program support a research program that develops or employs novel concepts, approaches, methodologies, tools, or technologies for this area?

PRIP-Public Infrastructure Only (PIO) Applications:

Does this center’s public infrastructure program disseminate information, materials and/or services that are original and innovative or that can be used to perform original and innovative research? For example: Does this public infrastructure program disseminate data sets or methodologies that challenge (or could be used to challenge) existing paradigms or clinical practice; or address (or could be used to address) an innovative hypothesis or critical barrier to progress in the field? Does this public infrastructure program disseminate information, materials and/or services that have developed or employed (or could be used to develop or employ) novel concepts, approaches, methodologies, tools, or technologies for this area?

Research Support Cores:

Is the core likely to enhance the ability of the applicant population research center to produce innovative research?

Developmental Infrastructure Cores:

What is the potential of the proposed activity to advance research within the applicant population research center by stimulating innovation in population research and/or fostering the development of junior researchers?

Investigators

Standard PRIP Applications:

Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Director/Principal Investigator, key personnel, and other center members? Does the team bring complementary and integrated expertise to the project (if applicable)?

What is the research competence of key personnel and other center members, taking into consideration the capability and scientific credentials of the Project Director/ Principal Investigator to direct the program and maintain high standards of research collaboration; the specific qualifications of core directors; and the scientific accomplishments of all participating investigators?

PRIP-Public Infrastructure Only (PIO) Applications:

Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Director/Principal Investigator, key personnel, and other center members? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

What is the competence of key personnel, taking into consideration the capability and scientific credentials of the Project Director/ Principal Investigator to direct the program and maintain high standards of collaboration; the specific qualifications of core directors; and the accomplishments of all participating investigators?

Research Support Cores, Developmental Infrastructure Cores, and Public Infrastructure Activities:

Investigators: Do the investigators responsible for the cores/activities have appropriate qualifications, experience, and commitment to the program and do they have the ability to devote the required time and effort to the program?

Environment

Standard PRIP Applications:

Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed activities benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

How successful has the applicant research center been in creating an active intellectual community that encourages synergy and intellectual exchange among population researchers and advances innovative and/or interdisciplinary research?

What is the level of institutional commitment as indicated by the nature and level of resource commitment from the institution in which the population research center is housed and any cooperating institutions, taking into account the institutional context? Does the academic and physical environment contribute to the likelihood of success of the research center through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?

PRIP-Public Infrastructure Only (PIO) Applications:

What is the level of institutional commitment as indicated by the nature and level of resource commitment from the institution in which the population research center is housed and any cooperating institutions, taking into account the institutional context? Does the academic and physical environment contribute to the likelihood of success of the research center through space, equipment, and the potential for interaction with public and policy audiences and/or with scientists from various departments, institutions or disciplines?

2.A. Additional Review Criteria:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1175
Email: [email protected]

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: [email protected]

3. Financial or Grants Management Contacts:

Rashawn Farrior
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-7010
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.