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-05-028, which was previously released April 20, 2005.

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

• July 13, 2007 - This RFA has been reissued as (RFA-HD-07-009).

Request for Applications (RFA) Number: RFA-HD-06-009

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: July 17, 2006
Letters of Intent Receipt Date(s): November 21, 2006
Application Submission Date(s): December 21, 2006
Peer Review Date(s): March/April 2007
Council Review Date(s): June 2007
Earliest Anticipated Start Date(s): July 1, 2007
Additional Information to Be Available Date (URL Activation Date): May 31, 2006
Expiration Date: December 22, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• This RFA invites applications for infrastructure grants in support of population research relevant to the mission of the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), NICHD.
• The NICHD intends to commit approximately $2.1 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2007 to fund applications in response to this RFA.
• The NICHD anticipates funding four to seven new and/or competing continuation grants in response to this RFA.
• An applicant may request a project period of five years.
• This funding opportunity will use the NIH Research Resource (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.
• A table summarizing the differences between the Infrastructure Award (R24) and Developmental Infrastructure Award (R21) is available at http://www.nichd.nih.gov/RFA/HD-06-009/SupplementaryInformation.htm.
• 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

This RFA invites applications for infrastructure grants in support of population research relevant to the mission of the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), 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 announcement invites applications for Research Infrastructure Awards. A separate announcement (available at: http://grants.nih.gov/grants/guide/pa-files/PAR-06-362.html) invites applications for Developmental Infrastructure Awards, which are intended to support the development and demonstrate the feasibility of programs that have high potential for advancing population research, but have not yet fully developed the necessary resources and mechanisms to be competitive for a Research Infrastructure Award. A table summarizing the differences between the Infrastructure Award (R24) and Developmental Infrastructure Award (R21) is available at http://www.nichd.nih.gov/RFA/HD-06-009/SupplementaryInformation.htm.

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

Purpose

The primary purposes of the Population Research Infrastructure Program 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 Infrastructure Grant funds infrastructure to support a portfolio of population research housed in or coordinated by a center or other research unit (hereafter, "research unit" or "unit") at an institution. Through this support, the Infrastructure 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;
• 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;
• Where appropriate and cost-effective, support infrastructure and activities that broadly serve the field of population research by translating and/or disseminating research findings and research resources.

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 unit and its current and future contributions to population research.

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

Scope

The Population Research Infrastructure Program seeks to advance scientific knowledge in areas related to the mission of the Demographic and Behavioral Sciences Branch (DBSB). DBSB is one of three programs in the Center for Population Research of the NICHD. Its mission is to foster research on the processes that determine population size, growth, composition, and distribution, and on the determinants and consequences of those processes. This mission translates into a research portfolio that looks intensively at the demographic processes of fertility, mortality, and migration and at their broad interrelationships with larger social, economic, and cultural processes. Areas of supported research include fertility and family planning, sexually transmitted diseases, family and household demography, mortality and health, population movement, population and environment, and population composition and change. Research supported by the Branch uses a broad spectrum of scientific approaches in the clinical, behavioral, and social sciences.

A description of the DBSB mission is available at http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. 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 VII.1. Scientific/Research Contacts 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. 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. 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/cpr/dbs/dbsb_mission.htm for more information).

6. Behavioral research on the sexual transmission of HIV, including demographic and social studies of sexual behaviors related to HIV transmission; the interrelationships between social, institutional, economic, and cultural contexts and sexual behavior; the interrelationships among pregnancy, pregnancy prevention, and HIV prevention; theoretically grounded intervention studies within these areas; and related methodological studies (see http://www.nichd.nih.gov/cpr/dbs/hiv.htm).

Infrastructure Support

Applicants may request support in the following categories: (1) Research Support Cores; (2) Developmental Infrastructure; and (3) Public Infrastructure. Applicants need not request support in all of the categories; rather, they should request types and levels of support that best suit their needs and objectives. The NICHD expects that the amount and allocation of infrastructure support that applicants request will vary substantially.

The first two categories of infrastructure support are intended to advance the scientific program of the applicant research unit. 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 applicant's research program; (2) the potential contribution of requested infrastructure to advancing the research program; and (3) the cost-effectiveness of the requested support. Applicants are expected to define guidelines for determining the eligibility of researchers and research projects to access resources provided under this program, and guidelines and procedures for allocating such 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 core resources are consistent with the goal of effectively advancing the scientific program of the unit and the goals of this RFA. Similarly, the announcement imposes no restrictions on how applicants define membership in their unit. Applicants are encouraged to develop flexible guidelines for membership that permit the involvement of researchers from other relevant fields. Membership may be extended to individuals who do not meet the criteria used to define applicant eligibility and budget guidelines (see Sections II.2 Funds Available and Section III.3, Other- Special Eligibility Requirements).

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 program and colleagues in other institutions, and/or joint ventures with other institutions to provide research, developmental, or public infrastructure 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 need not be another funded applicant or 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 applicant's research program. Examples include:

• Administrative Core, providing for coordination of research, editorial services, and/or assistance with developing grant application 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., GIS, statistical methods, biomarkers, survey methodologies).

Research Support cores should be designed to advance the applicant's research program while providing essential, cost-effective services to support on-going research activities. Cores should be designed to facilitate and promote innovation in the science conducted by program researchers in addition to responding to researcher needs. Equipment and support services that are specific to individual research projects or researchers are not allowable.

2. Developmental Infrastructure refers to 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 activities include:

• Seed grant programs, providing funds for the development of new research projects. Institutions 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 may 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 core services. 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 primarily directed instead 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.

Applicants may propose to cooperate with other institutions in undertaking any of the above-mentioned infrastructure activities. Cooperative activities may include the development of research partnerships involving scientists in the applicant's program and colleagues in other institutions, and/or joint ventures with other institutions to provide research, developmental, or public infrastructure 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 need not be another funded applicant or Center. Applicants must clearly describe the rights and responsibilities of each proposed partner in the funding, administration, and use of shared resources.

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

• NICHD expects to commit approximately $2.1 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2007.
• NICHD expects to support between four and seven 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 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.3, Other- Special Eligibility Requirements, 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 Research Objectives, above). Applicants may discuss budget requests with program staff listed under VII.1. Scientific/Research Contacts, below, prior to submission.
• The anticipated start date for these awards is July 1, 2007. The anticipated period of performance is five years.

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 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(s) 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, revised, and competing continuation 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 Infrastructure Program is expected to enhance the unit's competitiveness for NIH funding, the institution and pertinent departments are expected to show a strong commitment to the unit by providing additional infrastructure support at a level appropriate to the resources of the institution and the scope of the proposed program activities. Such commitment may be demonstrated by the provision of dedicated space, faculty appointments in subject areas relevant to the goals of the unit's research program, salary support for investigators or core staff, dedicated equipment, or other financial support for the proposed program. Applicants may consult with program staff listed under VII.1. Scientific/Research Contacts 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

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 or other administrative unit (referred to as the "research unit" or "unit") that coordinates or serves as a focal point for population research across the institution. This unit must have a defined governance structure.
• The unit 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 unit 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.

Applications not meeting the above eligibility criteria will be returned without review. One application per institution is permitted.

Note that the criterion used for unit 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 Sections II.2 Funds Available and to define page limitations for the research activity of program scientists under the Application Guidelines at http://www.nichd.nih.gov/RFA/HD-06-009/SupplementaryInformation.htm.

An applicant institution may submit only one application in response to this RFA.

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: GrantsInfo@nih.gov.

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 available at http://www.nichd.nih.gov/RFA/HD-06-009/SupplementaryInformation.htm and from program staff listed under VII.1. Scientific/Research Contacts. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by these guidelines.

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): November 21, 2006
Application Receipt Date(s): December 21, 2006
Peer Review Date(s): March/April 2007
Council Review Date(s): June 2007
Earliest Anticipated Start Date(s): July 1, 2007

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 Project Director/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 NICHD 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: rclark@mail.nih.gov

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: stretchr@mail.nih.gov

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.

Information on the status of an application should be checked by the Project Director/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

Sharing Research Resources

NIH policy requires that grant awardee 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 of 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.

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 Components. The size and scope of applicant programs are not a review criterion. 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.

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.

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, public infrastructure activities, and infrastructure activities undertaken with another institution. These criteria are listed below.

Standard PRIP applications

Significance: Does this infrastructure program support a research program that addresses important problems?

Taking into account the program’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 program 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 program 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 program 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 program; 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?

Approach: 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?

Innovation: Does this infrastructure program support a research program that is original and innovative? For example: Does this infrastructure program support a research program that challenges existing paradigms or clinical 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?

Investigators: 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 and key personnel? Does the team bring complementary and integrated expertise to the project (if applicable)?

What is the research 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 research collaboration; the specific qualifications of core directors; and the scientific accomplishments of all participating investigators?

Environment: 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 program 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 research unit 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 program through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?

PRIP-Public Infrastructure Only (PIO) applications

Significance: Does this 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?

Approach: 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?

Innovation: Does this 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?

Investigators: 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 and other researchers? 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?

Environment: 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?

What is the level of institutional commitment as indicated by the nature and level of resource commitment from the institution in which the research unit 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 program through space, equipment, and the potential for interaction with public and policy audiences and/or with scientists from various departments, institutions or disciplines?

Research support cores

Approach: What is the potential or actual contribution of the proposed core to advancing research within the applicant unit, 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 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?

Innovation: Is the core likely to enhance the ability of the applicant unit to produce innovative research?

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?

Developmental infrastructure

Approach: 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?

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

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?

Public infrastructure activities

Significance: 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: 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?

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?

Infrastructure activities undertaken with another institution

Approach: 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?

2.A. Additional Review Criteria:

Not applicable

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

Not applicable

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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: rclark@mail.nih.gov

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: stretchr@mail.nih.gov

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: farriorl@mail.nih.gov

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 PA 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.

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