Part I Overview Information


Department of Health and Human Services

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

Title: Developmental Infrastructure For Population Research (R21)

Announcement Type
This is a reissue of PAR-04-138, which was previously released August 11, 2004.

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-362

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.866

Key Dates
Release/Posted Date:  April 19, 2006
Opening Date:  May 2, 2006  (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 22, 2006
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).  
Application Submission/Receipt Date(s): November 22, 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): Not Applicable
Expiration/Closing Date: November 23, 2006

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

The National Institute of Child Health and Human Development (NICHD), through the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), invites applications for developmental infrastructure grants in support of population research relevant to the DBSB mission. Applicants may request funds under this Funding Opportunity Announcement (FOA) to support infrastructure development 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.

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Institute of Child Health and Human Development (NICHD), through the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), invites applications for developmental infrastructure grants in support of population research relevant to the DBSB mission. Applicants may request funds under this Funding Opportunity Announcement (FOA) to support infrastructure development designed to: (1) enhance the quality and quantity of population research conducted at an institution; and (2) develop new research capabilities to advance population research through innovative approaches. A central goal of this program is to facilitate interdisciplinary collaboration and innovation in population research while providing essential and cost-effective core services in support of the development, conduct, and translation of population research based in centers or comparable administrative units.

This is one of two announcements inviting applications under the Population Research Infrastructure Program. This announcement invites applications for Developmental Infrastructure Awards. A separate announcement, RFA-HD-04-022, invites applications for Research Infrastructure Awards. A table summarizing the differences between the Research Infrastructure Award and the Developmental Infrastructure Award is available at http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm.

Developmental Infrastructure Awards 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 full-fledged Research Infrastructure Award.

Background

The Demographic and Behavioral Sciences Branch (DBSB) is one of three programs in the Center for Population Research of the NICHD. The mission of the Branch 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 disease, 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.

During the years 1972-2000, NICHD provided infrastructure support for population research through the Center Core Grant (P30) and Specialized Research Center Grant (P50) mechanisms. In 1999, DBSB undertook a comprehensive review of this program to determine whether its structure and guidelines best served the future needs of population research. A report summarizing the results of this review is available at http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf and from the program contact named under Section VII. Agency Contacts. As a result of the review, DBSB is phasing out the P30 and P50 mechanisms in favor of the R24 and R21 mechanisms.  This announcement uses the R21 mechanism.  A corresponding announcement (RFA-HD-04-022) uses the R24 mechanism.

Objectives and Scope

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 promote innovative approaches to population research questions. An additional goal is to facilitate interaction among scientists in locations throughout the United States that contributes to the integration and coordination of population research.

The Infrastructure Grant retains some of the characteristics of traditional P30 and P50 grants. It 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. However, it is designed to move beyond the traditional center grant mechanism to allow institutions to aggressively pursue scientific opportunities appearing at the boundaries between traditional population research and allied fields, and to facilitate partnerships among diverse scientists and institutions. The Infrastructure Grant allows units to use funds to address not only the core support needs of existing projects, but to develop new directions and approaches to population research. It asks applicants to design and propose infrastructure programs that will advance the interdisciplinary reach, innovation, and impact of their research programs, in addition to serving the existing needs of researchers.

The Developmental Infrastructure Award is intended to support the development of research units that have high potential for advancing population research. The award provides such units the opportunity to further develop the mechanisms and resources required to support and facilitate significant new contributions to the field, continue to build a substantial interdisciplinary portfolio of population research, and demonstrate their feasibility as full-fledged population research units. Applicants for Developmental Awards are expected to demonstrate the potential for becoming competitive for a Population Research Infrastructure Program Award (R24) within three to five years.

Applicants must 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.

Population Research Topics

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 Section VII. Agency Contacts to discuss the relevance of other topics to the DBSB mission.

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. Fertility research, including research on individual, social, economic, and cultural determinants and consequences of fertility and fertility trends, on the interrelationship between fertility patterns and education, work, union formation and dissolution, family structure, and health; and on 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 aspects of health, morbidity, disability, and mortality, including research on infant mortality and low birth weight; health disparities; research that relates demographic and social processes to mortality and health across the life course; and 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 studies of sexual behaviors related to HIV transmission; studies of the interrelationships between social, institutional, economic, and cultural contexts and sexual behavior; studies of the interrelationships among pregnancy, pregnancy prevention, and HIV prevention; theoretically grounded intervention studies within these areas; and related methodological studies (see http://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html).

Infrastructure Support

Applicants for the Developmental Infrastructure Award may request support in two categories: (1) Research Support Cores and (2) Developmental Infrastructure. Applicants are not required to request support in both 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.

For both categories of support, 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 of the requested infrastructure to develop the resources and mechanisms required to build a substantial interdisciplinary portfolio of population research and facilitate significant new contributions to the field; 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 announcement.

Definitions of Infrastructure Support Categories

1. Research Support Cores provide shared resources that support the applicant's research program.

Examples include:

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:

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 research partnerships must be justified in terms of the scientific advances to be gained through collaboration across institutions relative to those likely to emerge from within-institution partnerships. Examples of allowable activities include travel for project development and coordination and use of research support core, seed project, and research project funds. Applicants also may propose cooperative research support or developmental services in which the applicant and a Population Center or similar unit in another institution participate in joint funding and administration of a common service or resource. Examples might include a shared library, data archive or outreach effort. 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.

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 Exploratory/Developmental Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.  

2. Funds Available

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

An application in response to this funding opportunity may request a project period of up to five years and a budget for direct costs of up to $150,000 per year.  NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.      

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:

Foreign institutions/organizations are not eligible to apply. However, consortium arrangements between foreign and domestic institutions/organizations are permitted.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her 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 PD/PI should be a scientist or science administrator who can provide effective administrative and scientific leadership.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.  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 NICHD program staff listed under Section VII., “Agency Contacts,” to discuss this expectation.

3. Other-Special Eligibility Criteria

Additional eligibility criteria for this FOA include:

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

The research conducted at the unit should reflect scientific benefits and cost-efficiencies resulting from cooperation and interaction among a pool of scientists with shared interests in population research. Applicants 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.

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 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; (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 Principal Investigator or contributed substantially to the scientific design and/or conduct of the research.

Applications not meeting the above eligibility criteria by the time of the application deadline will be returned without review.  One application per institution is permitted.  Applications for supplementation of existing projects are not eligible to compete with applications for new awards.

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 Section II.2., “Funds Available,” and to define page limitations under the Application Guidelines at http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm.

If your institution has held a P30, P50, or R24 grant from NICHD related to population research in the three years prior to the application date, you may not apply for a Developmental Infrastructure Award. Developmental awards are nonrenewable and institutions may not simultaneously hold a Developmental Award and a Population Research Infrastructure Program Award.

Potential applicants may contact staff listed under Section VII., “Agency Contacts,” to discuss eligibility prior to submission of an application.

Section IV. Application and Submission Information


Registration and Instructions for Submission via Grants.gov


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations. 

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date:   May 2, 2006  (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 22, 2006
Application Submission/Receipt Date(s): November 22, 2006  
Peer Review Date(s): March/April 2007
Council Review Date(s): June 2007
Earliest Anticipated Start Date: July 1, 2007

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 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) 496-1174
Email: rclark@mail.nih.gov

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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

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 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 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 the NIH Grants Policy Statement

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications submitted under this FOA:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

Plan for Sharing Research Data

Not Applicable.

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

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.

Overall Program

One primary criterion will be used to evaluate the overall scientific merit of an application for a Developmental Infrastructure Award.

The potential future contributions of the applicant program to population research:  Reviewers will base their assessment of potential on such factors as the current level and trajectory of research productivity, innovation, quality, and significance; the significance of the applicant's central scientific objectives and signature population-related themes and the plan for advancing them; the program's plan for encouraging synergy and interaction among population researchers; and the applicant's success in contributing to the development of junior researchers. Applicants rated favorably on this criterion will have high potential for becoming competitive for a Research Infrastructure Award within three to five years.

Three secondary criteria will also be used to assess the overall scientific merit of applications:

Infrastructure Support Components

Each individual element of the proposed infrastructure program will be evaluated separately based on the criteria below.

Research Support Cores

Developmental Infrastructure

Collaborations

Applications proposing to undertake any infrastructure activity in cooperation with another institution will be evaluated for the value added by the involvement of other institutions and the appropriateness and adequacy of plans for the sharing of rights and responsibilities among proposed partners with respect to the funding, administration, and use of shared resources.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research:
The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

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 NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.

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

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), 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 NIH 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.

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 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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually 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 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) 496-1174
Email: rclark@mail.nih.gov

2. Peer Review Contact:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
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
Telephone: (301) 435-7010
Fax: (301) 452-5510
Email: farriorl@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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).

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 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.

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 SF424 (R&R); 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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