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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)

Title: Population Research Infrastructure Program (PRIP) FY10 (R24)

Announcement Type
This is a reissue of RFA-HD-08-007

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

Request for Applications (RFA) Number: RFA-HD-09-004

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: July 31, 2009
Letters of Intent Receipt Date: October 24, 2009
Application Receipt Date: November 24, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information to Be Available Date (Url Activation Date): Not Applicable
Expiration Date: November 25, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
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. Resource Sharing Plan(s)
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 Funding Opportunity Announcement (FOA) issued by the NICHD, National Institutes of Health, solicits grant applications that propose 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 Population Infrastructure Program (PRIP) allows three types of research infrastructure support: Research Support Cores; Developmental Infrastructure Cores; and Public Infrastructure Cores. This FOA allows for two types of applications: (1) Standard PRIP Applications, which request funding for Research Support Cores and/or Developmental Infrastructure Cores, and may also request funding for Public Infrastructure Cores; and (2) Public Infrastructure Only Applications, which request funding only for Public Infrastructure Core(s).

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.

This is one of two FOAs inviting applications under the Program for Population Research Infrastructure. This FOA invites applications for the Population Research Infrastructure Program. A separate FOA, Population Research Infrastructure Program-Short-term Support for Rising Programs (SSRP; see PAR-07-401, http://grants.nih.gov/grants/guide/pa-files/PAR-07-401.html), 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. 

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; to facilitate interdisciplinary collaboration among investigators conducting population-related research and in allied fields; and to 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.

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.

The PRIP 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: 

Three types of research infrastructure support are allowable under this FOA: Research Support Cores; Developmental Infrastructure Cores; and Public Infrastructure Cores. These three types of infrastructure are explained below, in the “Definitions of Infrastructure Support Categories” category. This FOA allows for two types of applications: (1) Standard PRIP Applications, which request funding for Research Support Cores and/or Developmental Infrastructure Cores, and may also request funding for Public Infrastructure Core(s); and (2) Public Infrastructure Only Applications, which request funding only for Public Infrastructure Core(s). The review criteria for Standard PRIP Applications and Public Infrastructure Only (PIO) applications differ. 

Background

The Program for Population Research Infrastructure replaced NICHD’s Population Research Centers P30/P50 program in 2000. Before 2000, DBSB provided most of its centers through the Center Core Grant (P30) mechanism, which supported core services for existing research projects at individual institutions. The P30 program required that applicants propose at least three “cores,” each of which serves at least three NIH/National Science Foundation grants during each year of centers funding, as well as other research projects deemed to have scientific merit and relevance to the mission of DBSB. DBSB also provides center support through the Specialized Research Center Grant (P50), which provides funding for research projects as well as core services. Following an evaluation of the P30/P50 program, which recommended exploring new mechanisms for supporting a revitalized infrastructure program featuring increased flexibility, reduced administrative burdens, and broader access to and competition for infrastructure support. (see http://www.nichd.nih.gov/publications/pubs/upload/pop_center_review.pdf), DBSB phased out its P30/P50 program, replacing it with the R24 Resource-Related Research Projects. An evaluation of the new R24 program recommended its continuation (see http://www.nichd.nih.gov/publications/pubs/upload/PRIPreport.pdf), and specifically recommended that the PRIP continue its annual competition, allowing centers that compete unsuccessfully to reapply in subsequent years.

In the transition from the P30/P50 program to the R24 program, existing research centers seeking continuing infrastructure support were required to compete for PRIP R24 funding. The new R24 Program for Population Research Infrastructure has been far more competitive than the original P30/P50 program and allowed active, productive new centers to successfully compete for funding. The number of funded centers increased from 12 in FY1999 to 24 in FY2008.

Currently, the program provides two types of grants, the Population Research Infrastructure Program (PRIP), through this RFA, and Population Research Infrastructure Program-Short-term Support for Rising Programs (SSRP, see PAR-07-401, http://grants.nih.gov/grants/guide/pa-files/PAR-07-401.html). 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 FOA (referred to as “population research” throughout this FOA). Both PRIP and SSRP provide support to large and small centers and to 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 at least one center researcher has current or recent grant or contract support from DBSB (see Section III. Eligibility Information, 3. Other - Special Eligibility Criteria). 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. SSRP infrastructure support should allow the development of resources and mechanisms that will facilitate a leap in scientific productivity, scientific impact, and contributions to population research, making the programs 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.

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 supports demographic, behavioral, and social science 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. 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 United States, 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. 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:

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).

Applicants responding to this FOA 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 that promotes innovation in population research. Applicants 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.

Infrastructure Support

Applicants may request support for three categories: (1) Research Support Cores; (2) Developmental Infrastructure Cores; and (3) Public Infrastructure Cores. 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 FOA. However, applicants must demonstrate that their proposed guidelines and procedures for controlling access to resources provided through PRIP are consistent with the goal of effectively advancing the scientific program of the center and the goals of this FOA. Similarly, this FOA 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 colleagues at 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

Research Support Cores provide shared resources that support the research at the applicant’s population center. 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. Research Support Cores need not be innovative themselves, but should be designed to facilitate and promote innovation in the science conducted by population center researchers. Research Support Cores should be responsive to the needs of population center researchers. Equipment and support services that are specific to individual research projects or researchers are not allowable.

Examples of Research Support Cores include but are not limited to:

Developmental Infrastructure Cores promote the development of new research capabilities, for example, developing innovative projects and approaches, developing new interdisciplinary collaborations, advancing the scientific development of junior researchers, and integrating experienced researchers from other fields into population research.

Examples of Developmental Infrastructure Cores include but are not limited to:

Public Infrastructure Cores 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 at significant external audiences. These audiences may include, but are not limited to, the broad community of population researchers and communities concerned with public policy or health or social programs. Applicants are permitted to apply solely for public infrastructure support; this type of application will be referred to as PRIP-Public Infrastructure Only (PIO) applications. The scored review criteria for Standard PRIP Applications and Public Infrastructure Only (PIO) applications address similar categories, but are defined differently for the two types of application. Illustrative examples of activities benefiting the broader scientific community include:

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:

In addition, applicants requesting funds for public infrastructure activities must justify that:

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Resource-Related Research Project (R24) award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The NICHD intends to commit approximately $1.9 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2010 to fund applications in response to this FOA.

The NICHD anticipates funding three to five new and/or renewal (formerly competing continuation) grants in response to this FOA. New, resubmission, and renewal applications may be submitted in response to this FOA;

Direct costs are limited to no more than $750,000 per year (plus applicable F&A costs).

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 direct costs 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.

Applicants may request additional funds beyond the guideline of approximately $17,000 direct costs per active program research (1) to support programs with evidence of exceptionally high impact or productivity or special features; or (2) to support for Public Infrastructure Cores (see definition of Public Infrastructure Cores in Section I. Funding Opportunity Description, 1. Research Objectives, above.

The anticipated start date for these awards is July 1, 2010.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications are permitted in response to this FOA.

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

An applicant institution may submit only one application in response to this FOA. 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 not be reviewed.

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.

Applicants are strongly encouraged to consult with program staff listed under Section VII. Agency Contact(s) if they have questions about their center’s eligibility.

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) 435-0714, 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

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: October 24, 2009
Application Receipt Date: November 24, 2009
Peer Review Date(s): February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 in Section IV.3.A.

The letter of intent should be sent to:

Rebecca L. Clark, Ph.D.
Acting Chief, Demographic and Behavioral Sciences Branch
Center for Population Research
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07 MSC 7510
Bethesda, MD 20892
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 forms 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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretchr@mail.nih.gov 

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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.

Resubmission applications will be accepted, but such an application must include an Introduction addressing the critique from the previous review.

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 NIH Grants Policy Statement.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

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 FOA. Under Research Plan, Section A. should be titled “Program Overview,” Section B should be titled “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 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 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 26 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 Section III. Eligibility Information, 3. Other - Special Eligibility Criteria 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 the Principal Investigator and, if the center researcher was not the Principal Investigator of the project, the center researcher’s role on the project. Include a list of all active program researchers, listing the PI first, then following with the other researchers listed alphabetically.

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 no more than half a page, on average, per active researcher. The total number of pages used to describe the research activities of the program researchers should not exceed the number of program researchers divided by two, with an overall limit on this section of 26 pages. Describe the Principal Investigator's research activity first and that of all other researchers subsequently in alphabetical order.

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.

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.

Developmental Infrastructure Cores - Describe the objectives and administrative organization of each Developmental Infrastructure Activity 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.

The Infrastructure Support Core section allows for descriptions of three types of cores: Research Support Cores (for example, administrative core, computing core, information core, methodology support cores); Developmental Infrastructure Cores (for example, seed grant programs, developing new research support cores, and workshops, conferences, seminar series, and visiting scholar programs); and Public Infrastructure Cores (for example, supporting and disseminating databases, providing infrastructure for data sharing, developing tools and strategies to communicate population research). The Infrastructure Support Core section has no overall page limit. However, the page limit for each core description is 5 pages, with one additional page allowed per core if the core involves partnership with another institution.

Additional information is available in the PHS 398 grant application instructions.

Research Plan Page Limitations

The overall page limit for the scientific research plan is 125 pages. The scientific research plan has four major components.

The page limit for the Program Overview is 20 pages.

The page limit for the Progress Report is 5 pages.

The overall page limit for the Research Activities of Program Scientists is 26 pages and the average page length per program scientist should not exceed ½ page.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Although the scored review criteria for the two main types of PRIP applications, Standard PRIP Applications and Public Infrastructure Only (PIO) Applications, address the same categories, they are defined differently for the two application types. 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. In addition, there are review criteria for proposed Cores.

A. Standard PRIP applications

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does this center support research that addresses important issues 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, have the recent contributions of center scientists produced new knowledge and/or approaches that have significantly expanded or improved the content, methods, and direction of population research? Has the center contributed to population science through large-scale projects that benefit the field broadly, by creating interdisciplinary collaborations, by training and mentoring of junior researchers, by providing scientific leadership, and/or by providing translational activities to improve clinical practice, public intervention programs, and public policy formulation?

Based on the center’s current trajectory of research productivity and accomplishments, vision for the potential future contributions, plans for advancing its scientific program, and success in developing junior researchers, what are the center’s potential future contributions to population research? 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?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the Project Director/Principal Investigator have appropriate experience to maintain high standards of research collaboration?

Innovation. Does the population research center support a research program that challenges and seeks to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Do the projects supported by this population research center employ concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Do the projects supported by this population research center propose refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions?

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

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

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? What is the level of institutional commitment as indicated by the amounts and types of resources the applicant institution has committed to the population research center, 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?

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

B. PRIP-Public Infrastructure Only (PIO) applications

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

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

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

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

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? What is the level of institutional commitment as indicated by the amounts and types of resources the applicant institution has committed to the population research center, 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?

C. Infrastructure Support Components

Each individual proposed Core will be evaluated separately based on the criteria below.

All Cores:

Developmental Cores:

Public Infrastructure Cores:

Infrastructure Activities undertaken with another institution:

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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

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

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

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07 MSC 7510
Bethesda, MD 20892
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Cecilia E. Bruce
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17L, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-1304
Email: brucec@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA 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. 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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