Part I Overview Information

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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: Academic-Community Partnership Conference Series (U13)

Announcement Type
This is a reissue of PAR-08-106.

Update: The following updates relating to this announcement have been issued:

• February 10, 2012 - This PAR has been reissued as PAR-12-102.
• August 25, 2011 - See Notice NOT-HD-11-023. The purpose of this Notice is to clarify eligibility for PAR-11-241.
• March 5, 2010 - See Notice NOT-HD-10-009 Clarification of Budget Form.
• December 21, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

Program Announcement (PA) Number: PAR-09-092

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 the 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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release/Posted Date: January 30, 2009
Opening Date: March 1, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 1, 2009, February 2, 2010, February 2, 2011
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 Due Date(s): March 31, 2009, March 2, 2010, March 2, 2011
Peer Review Date(s): June/July 2009, June/July 2010, June/July 2011
Council Review Date(s): October 2009, October 2010, October 2011
Earliest Anticipated Start Date(s): December 2009, December 2010, December 2011
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: March 3, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This announcement solicits NICHD Cooperative Agreement Conference (U13) applications to conduct health disparities-related meetings, workshops, and symposia. The objectives of these meetings will be to establish academic-community partnerships, identify community-research priorities, and develop long-term collaborative agendas. Areas of focus for these partnerships may include one or more of the following community-health issues infant mortality; sudden infant death syndrome (SIDS); violence prevention; techniques for outreach and information dissemination; childhood, adolescent, and/or adult obesity; health literacy; uterine fibroid tumors; and pediatric and maternal HIV/AIDS prevention.
• Mechanism of Support. This FOA will utilize the NIH Cooperative Agreement Conference (U13) grant award mechanism.
• Funds Available and Anticipated Number of Awards. Since 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 vary. The total amount awarded and the number of awards will depend upon the number of mechanisms, quality, duration, and costs of the applications received. Although the financial plans of the NICHD provide support for this program, awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. An applicant may request a project period of up to three years and a budget for direct costs of up to $30,000 per year. F&A costs are not allowed costs.
• Application Research Strategy Length: The NIH Cooperative Agreement Conference Grant Award Mechanism (U13) application Research Plan component of the PHS398 (Item 3) may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm. The Introduction (required for a resubmission application) is limited to ONE page.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Applicants must have an established Office of Research Development at their institution or an equivalent to handle government grants.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Include Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications. Each institution may submit only one application in response to this solicitation.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Applicants may not submit a renewal application.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm.
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/.
  • Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

Table of Contents

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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. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contacts
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

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Section I. Funding Opportunity Description

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1. Research Objectives

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of Special Populations, invites applications from eligible institutions to conduct health disparities-related workshops, meetings, and symposia with community organizations. The purpose of this project is for NICHD to assess the benefit of bringing community organizations and academic institutions/organizations together to identify opportunities for Community-Based Participatory Research (CBPR). The terms community organizations is defined, for the purposes of this award, as organizations that 1) have a documented (e.g. mission statement) interest in improving the health of the relevant community and 2) have a history (3 years or more) of serving the health needs and interests of the relevant community. They may include (but are not limited to) public schools, community-based organizations, faith-based organizations, and/or advocacy groups. The purposes of these partnerships (e.g. workshops/symposia/meetings) are to identify important community partners, establish community research priorities, and to develop a long-term CBPR agenda. It is expected that the academic-community partnerships developed through this initiative will lead to grant applications for the support of CBPR projects designed to meet identified community needs. These projects can focus on one or more of the following areas: infant mortality; SIDS; techniques for outreach and information dissemination; pediatric and maternal HIV/AIDS prevention, childhood, adolescent, and/or adult obesity; health literacy; uterine fibroid tumors; and violence prevention.

Background

The NIH recognizes the value of supporting academic and community partnerships which are relevant to achieving the health promotion and disease prevention goals of Healthy People 2010" to increase the quality and years of healthy life and to eliminate health disparities. The program described in this solicitation builds on NICHDs mission of conducting research to understand the biological, behavioral, and social processes that dictate physical, emotional, and cognitive growth. NICHD creates the knowledge to understand the complex interplay of processes that transform cells into healthy functioning individuals, free of disease and disabilities. When this is not achieved, or is achieved unequally by different segments of the population, (health disparities), NICHD's mission seeks to understand specific causes and works to develop remedies.

NICHD also aims to build bridges for communities by employing the principles of Community-Based Participatory Research (CBPR) so that research priorities are met for the communitys health needs. CBPR is a collaborative process of research involving researchers and community representatives that (1) engages community members; (2) employs local knowledge in the understanding of health problems and the design of interventions; and (3) invests community members in the processes and products of research. Construction of these bridges must be thoroughly and carefully designed with foundations rooted in science, but firmly grounded in the communities to be served. Health disparities do not merely occur, they develop over time as natural biological and behavioral forces interacting with such factors as poverty and unequal opportunities, and are modified by a variety of community, social, educational, and economic influences. Closing the health disparities gap requires an in-depth understanding of these processes and mechanisms as they interact over time. Finally, it requires the conscientious design of educational and behavioral interventions, rooted in science, but first conceived through careful partnerships with communities by relevant academic institutions/organizations with an interest in improving the health of the individuals residing in these communities.

Scope

The major goals of this program are to:

(1) Establish partnerships between academic institutions/organizations and relevant community organizations;

(2) Identify, document and highlight local health disparity conditions and the communitys view of its own health problems; and

(3) Form an alignment between community organizations and the applicant institution/organizations research priorities for the ultimate conduct of Community-Based Participatory Research (CBPR).

Activities relating to these goals will be accomplished through an ongoing series of conferences, meetings, seminars, and workshops, where institution/organization and community partners work together to develop a strong working relationship and a set of research goals focused on community priorities in one or more of the following areas:

• Infant mortality
• SIDS
• Uterine fibroid tumors
• Childhood, adolescent, and/or adult obesity
• Health literacy
• Outreach and Information Dissemination
• Pediatric and maternal HIV/AIDS prevention
• Violence prevention

Special emphasis should be placed on:

• Dissemination of relevant health promotion information that stems from current research findings and initiatives (if applicable);
• Jointly sponsored symposia/workshops/meetings addressing the local health status and health disparities of a relevant community of interest;
• Activities to heighten the communitys awareness of state and local health disparities problems and NIHs commitment to the elimination of these health disparities; and
• Opportunities for the community to inform the grantee organization/institution(s) of the research priorities it has identified.

Applications should propose a comprehensive, coordinated, and integrated plan of activities organized around defined program goals.

Please note: Partnerships with community organizations/leaders do not have to be in place to qualify an institution to apply for these cooperative agreement awards. Applicants that seek to strengthen existing relationships with community stakeholders are encouraged to apply. When appropriate, the cooperative agreement award should be used to support the formative stages of such partnerships.

Specific examples of collaborative activities within each of the required categories include, but are not limited to, the following:

Partnerships between the Grantee Institution and Community Organizations

• Planning and outreach sessions to identify key stakeholders from a variety of community organizations (e.g., public schools, community-based organizations, faith-based organizations, advocacy groups);
• Working meetings to identify and develop common goals and objectives that will guide the work of the partnerships;
• Meetings to strengthen and enhance the collaborative/multidisciplinary research efforts between grantee institution/organizations and communities of interest:
• Identification of Health Disparities Conditions and Community Health Needs;
• Working sessions among researchers, advocates, and community leaders using current research to identify the resource needs of the community;
• Seminars led by community and institutional/organizational researchers highlighting research findings on the prevalence and incidence of health disparities in the community; and
• Ongoing working sessions to develop collaborative plans that will endure after the duration of the conference grant.

Additionally, consideration for support will be given to relevant topics where research is lacking or nascent and where stimulation of such research will meet the expressed needs of the community.

Expected Timeline

Awards through this U13 program will provide support for up to three years at a maximum of $30,000 direct costs per year for:

Year 1

• Convene three to six opportunities (e.g. meetings, presentations) to introduce community partnership plans to relevant, various Community Organizations;
• Identify members of the Advisory Board for the Academic-Community Partnership Series award. This Advisory Board should consist of representatives from both the grantee institution/organization and the community of interest;
• Convene at least two (2) Advisory Board meetings with the goal of planning community partnership activities; and
• Hold two to four open community forums to disseminate information on community, regional and/or state relevant health disparities.

Year 2

• Convene two to three meetings to introduce grantee institutions/organizations interest in community partnership plans to relevant community stakeholders;
• Hold two to four open community forums to disseminate information on regional and/or state relevant health disparities;
• Hold quarterly (4) Advisory Board meetings to discuss details related to the progress of the Academic-Community Partnership Series.
• Develop at least one partnership, as evidenced through the development of a specific Memorandum of Understanding (MOU), with an institution or organization (e.g. academic, community-based organization) that has successfully implemented a CBPR project in the applicants region or state. CBPR is a collaborative process of research involving researchers and community representatives that:

(1) engages community members,

(2) employs local knowledge in the understanding of health problems and the design of interventions, and

(3) invests community members in the processes and products of research.

This MOU should describe details related to the exact nature of the relationship, number of meetings per year, and clear outcomes that will benefit both partners. At least one representative from the organization/institution with CBPR experience should be named to the Advisory Board;

Year 3

• Convene quarterly (4) Advisory Board meetings to discuss details related to the progress of the Academic-Community Partnership Series;
• Organize during the first quarter of the year, representatives from a select group of Community Organization representatives that have been actively working with the grantee organization/institution during the first two years of the award;
• Develop at least one partnership, as evidenced through the specific development of a MOU, with this group of representatives of Community Representatives. This MOU should describe details related to the exact nature of a relationship between the grantee institution/organization and the group of Community Organization representatives, which may include (but not limited to):

(1) purpose of the partnership,

(2) frequency of meetings,

(3) designation of leadership roles, and

(4) bylaws or governing policies;

• Develop through a series of meetings, a Collaborative Plan with the aforementioned Community Representative group that identifies:

(1) short-term and long-term CBPR intervention development goals and

(2) intended post Academic-Community Partnership Series awardoutcomes/benefits for the community of interest.

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

Section II. Award Information

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Mechanism of Support

This FOA will use the NIH Cooperative Agreement Conference Grant (U13) award mechanism. 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 (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.

This FOA also will use the NIH U13 cooperative agreement award mechanism. Under the U13 mechanism, the Project Directors/Principal Investigators (PDs/PIs) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PD/PI, as described in Section VI.2.Administrative Requirements, Cooperative Agreement Terms and Conditions of Award.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Applicants must complete and submit a detailed categorical budget using the Research & Related Budget component

2. Funds Available

An applicant may request a project period of up to three years and a budget for direct costs of up to $30,000 per year. F&A costs are not allowed costs.

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

Facilities and Administrative (F&A) 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

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)
• Eligible Agencies of the Federal Government
• Faith-based or Community-based Organizations

Foreign institutions are not eligible to apply for conference grant support.

1.B. Eligible Individuals

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

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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. Each institution may submit only one application in response to this solicitation.

Community organizations are, for the purposes of this award, organizations that 1) have a documented (e.g. mission statement) interest in improving the health of the relevant community and 2) have a history (3 years or more) of serving the health needs and interests of the relevant community.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction 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 addressing the previous peer review critique (Summary Statement). 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. Applicants may not submit a renewal application.

Section IV. Application and Submission Information

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To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or 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:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

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

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

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

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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 organization/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 the 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 301-710-0267, Email: [email protected].
  
• 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 for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 1, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 1, 2009, February 2, 2010, February 2, 2011
Application Due Date(s): March 31, 2009, March 2, 2010, March 2, 2011
Peer Review Date(s): June/July 2009, June/July 2010, June/July 2011
Council Review Date(s): October 2009, October 2010, October 2011
Earliest Anticipated Start Date(s): December 2009, December 2010, December 2011

3.A.1. Letter of Intent

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

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Regina Smith James, M.D.
Acting Director, Division of Special Populations
Director, Extramural Associates Program
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2692
Fax: (301) 480-0393
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due 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 weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

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. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements and Information.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) 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.

Organizational DUNS

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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

This U13 is limited to 6 pages.

• The Introduction (required for a resubmission application) is limited to ONE page.

Special Requirements

• Applicants must identify specific plans to organize an Advisory Board as a part of the activities to be performed under this award. The purpose, function, and expectations of this Board should be described. Representatives from the community must be included on the Board. If members of the Board have not been identified at the time of application, applicants should identify the types of members that will be recruited for the Board.
• Objectives must be focused. Anticipated outcomes of the Academic-Community Partnership Conference Series grant award include, but are not limited to: (1) providing a forum for the development of a community partnership structure that will support the conduct of an eventual CBPR project in one of the identified areas of emphasis and (2) facilitating cultural centered community partnership with a focus on addressing and eliminating health disparities.
• One of the specific aims must address the development of a MOU between the applicant organization/institution and one or more organizations within the community of interest for the purpose of carrying out a CBPR project in one of the areas of interest for the initiative. Guidance that can inform the development of an Academic-Community Partnership MOU can be found in several places, including but not limited to the University of Kansas Community Tool Box (http://ctb.ku.edu/en/).
• At least one of the specific aims should address outreach to the community and how this grant will be used to identify the communitys perceived areas of interest regarding addressing disparities in health. Use the sub-aims to describe how such an assessment will be conducted. (It is important to show how the programs areas of emphasis compare with the communitys perceptions of their experiences in regard to health disparities.)
• At least one aim should address how the applicant plans to use the conference grant to provide health education in the areas identified by the community as their areas of concern.
• In the Research, Design and Methods section, applicants should describe the processes/methodologies for carrying out each of the specific aims noted in sufficient detail such that the reviewers clearly understand and can assess the merits of the design/methods in accomplishing each specific aim and ultimately the goal of the project.
• A critical part of the application for NIH support of conferences is documentation of appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science. These individuals must be included in all aspects of planning, organization/institution, and implementation of NIH-sponsored and/or supported meetings. Appropriate representation means representation based on the availability of individuals from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff members are assured of concerted recruitment efforts. Organizers of scientific meetings must document compliance with the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in Scientific Meetings Supported by the NIH (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-066.html).

Community Partnership Plan

Use this section of the application to describe the objectives, specific programs, and logistical arrangements for the proposed meetings to support the development of community partnerships. When documenting activities by year for each of the three years, describe meeting formats (seminar, workshop, colloquia, town hall meeting, etc.), including the principal topics to be covered (e.g. introduction of applicant organization/institution, relevant health disparities) and developments or contributions the meeting might stimulate. Describe the types of participants (e.g. Community Organizations, University staff) and how the meetings will relate to partnering with the community of interest.

Provide a detailed justification for the meetings, including the need, timeliness, and usefulness of the meeting to the community partnership process. Describe the role of the advisory committee, and if applicable, provide the names and credentials of advisory board members, including the basis for their selection and documentation of their agreement to participate. If this information is not yet available, describe the types of individuals that will be recruited for the Board.

Describe the process of identifying a seasoned CBPR partner for the Academic-Community Partnership Series award. This seasoned CBPR partner should be an organization or institution that has successfully implemented a CBPR project in the applicants region or state. Describe the role of the seasoned CBPR partner, and if applicable, provide the names and credentials of the CBPR partner, including the basis for their selection and documentation of their agreement to participate. If this information is not yet available, describe the type of seasoned CBPR partner that will be recruited.

Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of the proposed meetings. Describe plans for publicizing the meetings/symposia/conferences/workshops. Identify related meetings held in the relevant community during the past three years. Describe plans for routinely assessing whether the format, time, and location of meetings are effective for representatives from Community Organizations.

The following instructions are to be used in conjunction with the SF424 (R&R) Application Guide accompanying the SF424 (R&R) application form.

SF424 (R&R) Cover Component: Enter the title of the conference or scientific meeting on line Item 9.

Project/Performance Site Locations: Enter the site(s) of the conference or meeting as the Performance Site.

Senior/Key Person: Personnel are defined as the PD/PI and those responsible for the planning of the organizational/institutional meetings. Attach a biographical sketch for the PD/PI, Co-Chair, key personnel, and confirmed key speakers.

Budget: The appropriate NICHD conference award program contact should be consulted for guidance regarding any specific budget requirements (see Section VII. 1.). Enter the direct costs requested. Provide a narrative justification for each proposed personnel position, including their role and proposed level of effort. Include information regarding efforts to obtain funding for this conference/meeting from other sources. Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: meeting topic(s); tentative dates; locations; participants; and contingency plans for future meetings dependent upon, for example, the outcome of the first years meeting or developments in the field.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference/meeting); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the meeting (only if received for use during the budget period); conference services; publication costs; registration fees; and/or speakers fees. Please also refer to the NIH Grants Policy Statement for additional information regarding costs.

Non-allowable costs: Purchase of equipment; transportation costs exceeding U.S. carrier coach-class fares; Visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs. Please also refer to the NIH Grants Policy Statement for additional information regarding costs.

PHS 398 Checklist Component: This checklist is required; however, no information regarding F&A should be included as this is not an allowable cost for this mechanism.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

The appendix is limited to announcements and reports of previous meetings under the same sponsorship. No other information or material should be submitted as appendices.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

• Data Sharing Plan. Not Applicable
• Sharing Model Organisms. Not Applicable
• Genome Wide Association Studies (GWAS). Not Applicable

Section V. Application Review Information

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1. Criteria

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

2. Review and Selection Process

Applications that are complete 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:

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

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

The following criteria will be addressed and considered in the determination of scientific merit and rating.

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? Do these meeting plans promote academic-community partnership around a relevant health problem? If the aims of the application are achieved, will academic-community partnership be advanced? What will be the effect of these endeavors on the eventual conduct of CBPR in the community of interest?)

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? Is the PD/PI well suited for organizing and fulfilling the goals of this conference grant? Are the qualifications of the PD/PI appropriate and past performance adequate? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference grant?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed Do the meetings employ novel community partnership approaches or methods to fulfill its purpose?

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) Protections for Human Subjectss, 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? Is the format of these meetings appropriate for achieving successful community partnership? Will the Advisory Board and seasoned CBPR partner be selected appropriately? Are the meetings timely for the subject matter? How well do the plans for inclusion of women, minorities, and persons with disabilities provide for their appropriate representation in the planning, organization/institution, and implementation of the proposed meetings?

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? Has the applicant identified a community in need of community partnership and ultimately CBPR? How appropriate are the meeting sites? Does the applicant have the ability to contribute to the probability of success in partnering with organizations that represent the community of interest? Do the proposed meetings take advantage of unique features of the community or employ useful partnership arrangements? Is there strong evidence of institutional/organizational support?

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.

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

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.

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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 Agents 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).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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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.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), ad other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for:

• Defining objectives and approaches of the conference series and for planning and conducting planned meetings and activities.
• Leading the Advisory Board and serving as the main point of contact for the seasoned CBPR partner.
• Identifying specific milestones for conferences that will be supported during the project period, when multi-year conferences are supported.

Applicants for this U13 program are expected to propose a series of meetings/workshops/symposia designed to: (1) define the targeted community; (2) establish and strengthen partnerships between applicant institutions and relevant Community Organizations; (3) identify the communitys views of its own health problems to establish research priorities; and (4) develop a long-term Community Based Participatory Research (CBPR) agenda aligning the communitys identified health problems and the applicant institution/organizations research priorities.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist [or Project Coordinator, or Project Collaborator, or Intramural Scientist] will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Substantial involvement as a partner would include, for example, assisting in such activities as planning the agenda, selecting speakers, organizing a symposium, determining the content of the meeting, or determining the acceptability of submitted papers. Substantial involvement would not include serving as an invited speaker or providing limited advice.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

PD/PIs will participate in periodic meetings or conference calls to share progress and experiences with other Academic-Community Partnership programs.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Jean Flagg-Newton, Ph.D.
Assistant to Director, Extramural Associates Program
Division of Special Populations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2736
Fax: (301) 480-0393
Email: [email protected]

Carl V. Hill, Ph.D. M.P.H.
Program Director, Extramural Associates Program
Division of Special Populations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2736
Fax: (301) 480-0393
Email: [email protected]

2. Peer Review Contact(s):

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: [email protected]

3. Financial/Grants Management Contact(s):

Bonnie Jackson
Grants Management Specialist
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-5482
Email: [email protected]

Section VIII. Other Information

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Required Federal Citations

Vertebrate Animals:
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 (45 CFR 46) 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 institutional review board (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 impact/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/

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

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, Minorities, and Children:
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) application; 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-09-116.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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Part 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 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/.