Part I Overview Information



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

Components of Participating Organizations
This Funding Opportunity Announcement (FOA) is developed as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act). NIH Institutes and Centers with funding authority listed below will participate with the NIH Office of the Director in this initiative.

National Cancer Institute (NCI/NIH), (http://www.cancer.gov/)
National Eye Institute (NEI/NIH), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov/)
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID/NIH), http://www3.niaid.nih.gov
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR/NIH), (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National Library of Medicine (NLM/NIH), (http://www.nlm.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD/NIH), (http://ncmhd.nih.gov/)Office of Research on Women’s Health (ORWH/OD/NIH) (http://orwh.od.nih.gov)
National Center for Research Resources (NCRR/NIH), (http://www.ncrr.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)

Title: Recovery Act Limited Competition: Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-OD-09-010

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)
93.701

Key Dates
Release/Posted Date: September 18, 2009
Opening Date: November 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 12, 2009
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): December 11, 2009
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 12, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information


Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The mission of the NIH is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. To that end, the NIH, through extramural grants programs of its Institutes and Centers (ICs), supports a broad range of health science research, including biomedical, public health and behavioral and social science. Previous research has enormously increased our understanding of the molecular, cellular, behavioral, and social bases of disease and identified targets and methods for improving health care. Recent advances in technology and science create numerous opportunities for the public and private sectors to accelerate discoveries for the prevention, diagnosis and treatment of disease.

Communities are key consumers of NIH-supported health science research. Communities are broadly defined to include neighborhoods, schools, and workplaces; public health departments, health care providers, and social service agencies; community coalitions; state, county, and local governments; business-community collaborations; campus-community partnerships; public-private partnerships; and other types of organizations and institutions that filter or translate research findings to the American public. However, NIH recognizes that in order to maximize the relevance, dissemination, and implementation of health science research for the public, communities must have the opportunity to be actively engaged in the research enterprise, including active participation in formulating research questions, designing, and conducting research; translation and application of research findings to community-based practice and public health initiatives; and using research-generated evidence to support public health policy decisions. Improving public health often entails moving beyond the conventional health care system to include integrated and innovative methods. Moreover, the development of transformative infrastructures that collect and integrate information/data and application of health knowledge can provide an interface for the various perspectives and interests of academic health centers and communities allowing for more effective communication and dissemination of locally-relevant research findings. The availability of Recovery Act funds provides a unique opportunity for NIH to support these goals by strengthening and transforming relationships between academic health centers and communities to sustain health research.

Applications are invited from domestic (United States) institutions/organizations proposing to develop or expand needed infrastructures that will fundamentally transform collaboration and communication between academic health centers and local communities. Such collaborative infrastructures are essential to advance the health science research enterprise while ensuring that important research findings are effectively disseminated and implemented to improve public health and advance health care delivery. This RFA is not intended to fund research or evaluation projects, clinical trials, or public health campaigns. Rather, the intent is to fund projects to develop infrastructure for productive and sustainable academic-community research partnerships that can be leveraged in the future for efficiently conducting research that includes and is relevant to affected communities, and through which research findings can be disseminated in a manner that maximizes impact on public health.

It is expected that each grantee will be able to leverage this Recovery Act funding into future research grants using the infrastructure partnership between itself and the participating community. The NIH strongly encourages applicants to propose infrastructures that may build upon or be linked to extant infrastructures supported by other Federal agencies (e.g., Administration on Aging [AoA], Agency for Healthcare Research and Quality [AHRQ], Centers for Disease Control and Prevention [CDC], Health Resources and Services Administration [HRSA], Indian Health Service [IHS], Substance Abuse and Mental Health Services Administration [SAMHSA], US Department of Agriculture [USDA], etc.) and thus heighten their potential for long-term sustainability.

2. Scope and Specific Requirements

Scope. The Community Infrastructure grants program will support the development, expansion, or reconfiguration of bi-directional relationships between academic health centers and community entities in the pursuit of improved public health through research. These transformative collaborative arrangements may influence the next generation of health science research. Projects could involve the development of public-private partnerships; connections between academic health centers and their constituent institutions (such as schools and departments, research institutes, health promotion centers or health science libraries) and community entities such as local neighborhoods, community clinics, health departments, schools, public libraries, community-based social services organizations, or workplaces; facilitate development of practice-based research; create needed information technology to support research; projects that build on existing HHS-supported programs or networks; and other organizational linkages. They should engage and empower communities in designing and conducting research projects and the dissemination of research findings in locally-relevant, practical ways. The intended partnerships and infrastructures sought through this initiative differ from traditional practice in that the fundamental purpose is to facilitate bi-directional communication, decision-making and participation in research to improve public health. The Academic Health Center (AHC), in order to facilitate this bi-directionality, may need to plan significant training of the community entities in the rationale and skills necessary to achieve equity in these partnerships. Community partnerships are not intended as simply a vehicle for recruiting participants into research (although this may be an important intermediate objective); rather, such partnerships should promote collaborative decision-making and, ultimately, facilitate and accelerate the translation of research findings to local practice. As an outgrowth of this initiative, academic centers should be positioned to leverage these partnerships to strengthen the design, feasibility, relevance, and dissemination of research. To maximize their potential, community infrastructure projects will ideally span scientific disciplines, diseases, and conditions, and will offer the potential for sustained collaboration and future research.

In this community research infrastructure program, NIH establishes the role of Community Research Associate (CRA), who will be a community representative and serve as a primary liaison facilitating communication and collaboration between the academic health center and the local community. Applicants must identify at least one CRA and include a biosketch. It must be demonstrated and documented in some manner that the CRA can represent the community’s needs and will. The NIH envisions that CRA’s will be respected community members such as local health officials, leaders of community-based organizations, or community health care providers, with a successful track record in community-based programs and projects. It is critical that this person be invested with the authority to bring the community’s views and opinions into negotiations and discussions with AHC program staff. The CRA will work closely with the PDs/PIs on the conceptualization and implementation of the transformative, sustainable infrastructure apparatus that the local award seeks to establish. The CRA is responsible for and accountable to the community and the collaboration as a whole for the proper conduct of the project or program, including sharing in decisions and appropriate distribution, sharing, and stewardship of resources. The identity and proposed role of the CRA in the project should be described in detail.

Illustrative examples of potential community-linked infrastructure projects include, but are not limited to:

To ensure efficient use of Recovery Act funds as well as maximize the likelihood of sustainability beyond the funding period, projects should build upon existing infrastructure and resources wherever feasible. Of particular interest are collaborative projects that build on activities currently supported by NIH or other HHS resources and networks (e.g., CDC, HRSA, AoA, AHRQ, SAMHSA, and IHS). The sustainability potential of projects may also be demonstrated through existing partnerships with local philanthropic organizations, foundations, or local and state governments. Organizational infrastructure may include, but need not be limited to, existing collaborative structures such as the National Network of Libraries of Medicine (NN/LM), Clinical and Translational Science Awards (CTSAs), Research Centers in Minority Institutions (RCMI), and Institutional Development Awards (IDeA) interuniversity consortia including shared library and information technology infrastructures, and existing academic/community outreach collaboratives such as the Cooperative Extension Service, among others.

Requirements. Recovery Act funding has unique and significant requirements for reporting and oversight to which established research centers are best equipped to respond. As such, NIH intends that AHCs will be the applicant organizations for this FOA. Proposed projects are expected to demonstrate the following in the context of the application’s Research Plan:

Timeline. Applicants should construct the project timeline to include critical milestones, measurable outcomes, and mid-term and end of project deliverables to be publicly shared as expeditiously as possible. Awards will be made for a three-year budget period.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the RC4 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).

2. Funds Available

This initiative is funded under the Recovery Act. NIH has designated up to $30 million in Fiscal Years 2009 - 2010 to fund 30 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Because the nature and scope of the proposed projects will vary amongst applications, it is anticipated that the size of each award will vary. However, applicants’ budget proposals are limited to a maximum of $1 million in total costs over the entire project period. The planned duration of the proposed projects issued under this FOA may not exceed three years. Grants will be awarded upfront and in full as a single budget period.

Applicants are strongly encouraged to build upon existing programs and networks of other HHS agencies. NIH may give funding priority within this FOA to applications that leverage existing infrastructures supported by other Federal agencies (e.g., Administration on Aging, Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Health Resources and Services Administration, Indian Health Service, Substance Abuse and Mental Health Services Administration, US Department of Agriculture, etc.) in order to heighten awarded projects’ potential for long-term sustainability.

To further sustain the economic growth and progress in health science, awardees are encouraged to explore the development of Public-Private Partnerships (PPPs) during the course of the award. Information on developing PPPs can be found at http://ppp.od.nih.gov/. Note that the development plan is not part of the Community Infrastructure grant program application.

The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component may not exceed 10% of the total requested direct costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less.

NIH grants policies as described in the 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.

Working with the PDs/PIs should be one or more persons designated as Community Research Associate (CRA), who will be a community representative. This person will serve as a primary link between the PD/PI from the academic health center and the local community. The CRA may be, but is not required to be, named as a PD/PI on this application; this decision is left to the discretion of the applicant organizations.

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. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


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:

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

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.

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

Several 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 301-435-0714; 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 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 necessary for processing (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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. 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
Research & Related Budget, as appropriate

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 15 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” [Section 14 of the Research Plan Component in the SF424 (R&R)], 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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: November 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 12, 2009
Application Due Date(s): December 11, 2009
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 2010

3.A.1. Letter of Intent

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

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

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:

NIDALetterofIntent@mail.nih.gov.

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538

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.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed. An application that does not comply with the required page limitations is considered non-responsive and 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 the application status in the Commons.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, as indicated in the NIH Grants Policy Statement.

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 the NIH Grants Policy Statement).

6. Other Submission Requirements

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.”

Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)

Research Plan: The Research Plan is limited to a total of 12 pages.

PHS398 Research Plan Component Sections

Item Number and Title

Instructions

1. Introduction to Application

Omit (N/A: Resubmissions and Revisions not allowable)

2. Specific Aims

One page maximum. Separate PDF attachment

3. Background and Significance

Combined in a single PDF in item 5

4. Preliminary Studies/Progress Report

Combined in a single PDF in item 5

5. Research Design and Methods

Item 5 consists of Items 3-5 and is limited to 12 pages. Attach the 12-page Research Plan encompassing items 3-5 as a single PDF document. Figures and illustrations may be included but must fit within the specified page limit. Do not include links to Web sites for further information. Do not include animations. An application that does not comply with these page limitations is considered non-responsive and will not be reviewed.

Excluded from the 12-page Research Plan limitation are the following items:

Note the 12-page limit also excludes the Project Summary/Abstract; Bibliography and Literature Cited; and Biographical Sketches (separate PDFs).

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.

Organize the Research Plan in the specified order using the instructions provided below. Start each section with the appropriate section heading (i.e. Background/Preliminary Studies, Opportunity and Potential Impact, The Approach, Timeline, Milestones and Expected Measurable Outcomes and Deliverables.)

Preliminary data are not required but may be included, if necessary to demonstrate the feasibility of the proposed studies. The presentation must be clear and particularly compelling. No detailed scientific plan should be provided, but timelines must be presented.

Special Instructions for Other Project Information (Section 4.4 of SF424 (R&R) Application)

Item 6. Project Summary/Abstract: Follow instructions in the SF424 (R&R) Application Guide.

Item 8. Bibliography and Literature Cited: Limited to one page.

Continue with the instructions in the SF424 (R&R) Application Guide.

Special Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of SF424 (R&R) Application)

Biographical Sketches: Each biographical sketch is limited to two pages. The number of publications cited in each biosketch is limited to ten or fewer items. An application that does not comply with the required page limitations is considered non-responsive and will not be reviewed.

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). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations is considered non-responsive and will not be reviewed.

No supplemental/update information will be accepted before review.

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, applicants under this FOA are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

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

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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.

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review groups convened by CSR 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:

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.

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, technological advances, technical capability, clinical practice, and/or health be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Innovation. Does 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, technological developments, 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?

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

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

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

2.A. 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.

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.

2.B. Additional Review Considerations

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

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

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

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

Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

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.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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

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.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

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


This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application[1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

(i) the communication is purely logistical;

(ii) the communication is made at a widely attended gathering;

(iii) the communication is to or from a Federal agency official and another Federal Government employee;

(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency

official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

(v) the communication is initiated by the Federal agency official.

For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

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):

For general inquiries about scientific/research issues please contact:

Dr. Suzanne Heurtin-Roberts
Office of the Director
The National Institutes of Health
1 Center Dr., Rm B3-11
Bethesda, MD 20892
301-402-2277
sheurtin@mail.nih.gov

For IC-specific inquiries, please contact the appropriate person below.

Awarding Component

Scientific/Research Contact

Financial/Grants Mgmt. Contact

National Institute on Aging http://www.nia.nih.gov

Chyren Hunter, Ph.D.
Division of Extramural Activities
National Institute on Aging
7201 Wisconsin Avenue, Room 2C218
Bethesda, MD 20892-9205
Telephone: (301) 496-9322
FAX: (301) 402-0528
Email: Hunterc@nia.nih.gov

Deborah Stauffer
Supv. Grants Management Specialist
Grants and Contracts Management Branch
National Institute on Aging
Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892
301-402-7734
301-402-3672 (fax)
Email- debbie.stauffer@nih.gov

National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov

Vivian B. Faden, Ph.D.
Acting Director, Office of Science Policy and Communications
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3097
Bethesda, MD 20892
Telephone: (301) 594-6232
FAX: (301) 480-1726
Email:
vfaden@mail.nih.gov

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
[For express mail use: Rockville, MD 20852-1705]
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: jfox@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/

Shahnaz Khan, MPH
Clinical Coordinator, Extramural Program
NIH/NIAMS
One Democracy Plaza
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892
Phone: 301-451-9893
Fax: 301-480-4543
Email: khanshah@mail.nih.gov

Andrew Jones
Acting Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
One Democracy Plaza
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892
Email: jonesan@mail.nih.gov
Phone: (301) 435-0610
FAX: (301) 480-5450

National Institute of Biomedical Imaging and Bioengineering http://www.nibib.nih.gov/

Belinda Seto, Ph.D.
Deputy Director
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., Suite 202
Bethesda, MD 20892
Phone: (301) 451-0705
Fax: (301) 480-4515
Email: setob@mail.nih.gov

Angelos Bacas
Grants Management Specialist
Office of Grants Management
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd. MCS 5469
Suite 900, Democracy 2
Bethesda, MD 20892-5469 (Regular Mail)
Bethesda, MD 20817 (Fedex and Courier Services)
Phone: 301-451-4782
Fax: 301-451-5735
Email: bacasa@mail.nih.gov

National Cancer Institute
http://www.nci.nih.gov or http://www.cancer.gov

Shobha Srinivasan, Ph.D.
Health Disparities Research Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPS Room 6126, MSC 7338
Bethesda, MD 20892-7338 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-435-6614
Fax: 301-594.-6787
Email:
ss688k@nih.gov

Ms. Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7340 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
Fax: (301)496-8601
E-mail: crystal.wolfrey@nih.gov

National Institute of Child Health and Human Development
http://www.nichd.nih.gov

Tonse N. K. Raju, MD, DCH
Program Scientist/Medical Officer Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development,
6100 Executive Blvd,
Bethesda, MD 20892-MS7510
(For FedEx: use Rockville, MD 20852)
Phone: 301-402-1872
Email: rajut@mail.nih.gov

Bryan Clark, M.B.A.
Grants Management (GM) Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, Room 8A01
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-UPS service)
Telephone: (301) 435-6975
Email: clarkb1@mail.nih.gov

National Institute on Drug Abuse http://www.nida.nih.gov

Lori J. Ducharme, Ph.D.
Health Scientist Administrator Services Research Branch / DESPR
National Institute on Drug Abuse
6001 Executive Blvd., Rm 5180 MSC 9589
Bethesda MD 20892-9589
Phone: (301) 443-2279
Fax: (301) 443 6815
Email: ducharmel@nida.nih.gov

Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse
6101 Executive Blvd., MSC 8403
Bethesda, MD 20892-8403
Phone: (301) 443-6701
FAX: (301) 594-6849
Email: pfleming@nida.nih.gov

National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov

Donald J. DeNucci, D.D.S., M.S.
Program Specialist-Practice Based Research Networks
NIDCR/NIH
6701 Democracy Blvd.
Room 632, Mail Stop 4878
Bethesda, MD 20892-4878
Tel: (301) 451-5096
Email: denuccid@nidcr.nih.gov

Ms. Mary Greenwood
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research,
NIH, HHS
6701 Democracy Blvd.
Room 658, MSC 4878
Bethesda, MD 20892-4878 (Courier 20817)
Phone: 301-594-4808
Fax: 301-480-3562
Email: md74u@nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov

Robert J. Kuczmarski, Dr.P.H.
Director, Obesity Prevention and Treatment Program
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 673
Bethesda, MD 20892-5450 (20817 for express mail)
Phone: 301-451-8354
Fax: 301-480-8300
Email: kuczmarskir@niddk.nih.gov

Marilyn F. Rosendorf
Grants Management Specialist, NIDDK
6707 Democracy Boulevard, Room 742, MSC 5456
Bethesda, MD 20892-5456 (use 20817 for express mail)
Phone: 301-402-4625
Fax: 301-594-9523
Email: rosendorfm@mail.nih.gov

National Institute of Environmental Health Sciences
http://www.niehs.nih.gov

Liam R. O'Fallon
Program Analyst
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
U.S. Department of Health and Human Services
P.O. Box 12233 (MD K3-13)
Research Triangle Park, NC 27709
Phone: 919.541.7733
Fax: 919.316.4606
Email: ofallon@niehs.nih.gov

Ms. Dorothy Duke
Chief, Grants Management Branch
National Institute of Environmental Health Sciences, NIH
MSC KS-11
530 Davis Drive
Keystone Building, Room 3044
Research Triangle Park, NC 27709
Phone: 919-541-2749
Fax: 919-541-2860
Email: Duke3@niehs.nih.gov

National Eye Institute http://www.nei.nih.gov

Tom Greenwell, PhD
Program Director
Division of Extramural Research
National Eye Institute
Suite 1300 / MSC 9300
5635 Fishers Lane
Bethesda, MD 20892-9300

For FedEx use: Rockville, MD 20852
Phone: 301-451-2020
Fax: 301-402-0528
Email: Greenwellt@nei.nih.gov

William Darby
Chief, Grants Management Branch
Division of Extramural Research
National Eye Institute
Suite 1300 / MSC 9300
5635 Fishers Lane
Bethesda, MD 20892-9300

For FedEx use: Rockville, MD 20852
Phone: 301-451-2020
Fax: 301-402-0528
Email: Darbyw@nei.nih.gov

National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov

Peter G. Kaufmann PhD
Deputy Chief, Clinical Applications and Prevention Branch
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive msc 7936
Bethesda, MD 20892-7936
Phone: 301-435-2467
Fax: 301-443-0945
Email: kaufmannp@nhlbi.nih.gov

Robert L. Tarwater
Lead Grants Management Specialist
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7150
Bethesda, Maryland 20892-7926
Phone: 301 402-6090
Fax: 301 451-5462
Email: tarwater@nih.gov

National Human Genome Research Institute
http://www.genome.gov

Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Phone: (301) 496-7531
Fax: (301) 402-1950
Email: jean.mcewen@nih.hhs.gov

Ken Ow
Sr. Budget Analyst
National Human Genome Research Institute, NIH
31 Center Drive, Room B1B55 MSC 2070
Bethesda, MD 20892-2070
Telephone: 301-594-0629
Email: ow@nih.gov

National Institute of Mental Health http://www.nimh.nih.gov

David Chambers, D.Phil.
Associate Director, Dissemination and Implementation Research,
NIMH Chief, Services Research and Clinical Epidemiology Branch
Chief, Dissemination and Implementation Research Program
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Blvd., Room 7133
Bethesda, MD 20892-9631
Phone: 301-443-3747
Email: dchamber@mail.nih.gov

Ms. Rebecca Claycamp
Chief Grants Management Officer
National Institute of Mental Health, NIH
6001 Executive Boulevard
Room 6122
Bethesda, Maryland 20892-9605
Phone: 301-443-2811
Fax: 301-443-6885
Email: rclaycam@mail.nih.gov

National Institute of Nursing Research
http://www.ninr.nih.gov

Paul A. Cotton,PhD,RD
Program Director, Health Behavior & Minority Health
Division of Extramural Activities
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
6701 Democracy Blvd, Ste. 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier zip: 20817)
www.nih.gov/ninr
Phone: 301.402.6423
Fax: 301.451.5647
cottonp@mail.nih.gov

Randi Freundlich, R.D.
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Blvd., Rm 710
One Democracy Plaza
Bethesda , MD 20892-4870
Phone: 301-594-5974
Fax: 301-402-4502
Email: freundlichr@mail.nih.gov

National Center for Research Resources
http://www.ncrr.nih.gov

Donna Jo McCloskey, PHD, RN
Program Officer
National Center for Research Resources
Division for Clinical Research Resources
Democracy 1, Room 921
Bethesda MD, 20892
Phone: 301-451-4216
Cell: 301-312-3426
Fax: 301-451-5378
Email: mccloskd@mail.nih.gov

National Center on Minority Health and Health Disparities
http://www.ncmhd.nih.gov

Francisco S. Sy, MD, DrPH
Division of Extramural Activities & Scientific Programs
National Center on Minority Health & Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-402-1366
FAX: 301-480-4049
Email: syf@mail.nih.gov

Priscilla Grant, J.D., C.R.A.
Office of Grants Management
Division of Extramural Activities & Scientific Programs
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800
Bethesda, Maryland 20892-5465
Phone: (301) 594-8412
Fax: (301) 480-4049
Email: grantp@mail.nih.gov

National Library of Medicine
http://www.nlm.nih.gov

Dr. Hua-Chuan Sim
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4882
Fax: (301) 402-2952
Email: simh@mail.nih.gov

Ms. Arnita Miles
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4221
Fax: (301) 402-0421
Email: milesar@mail.nih.gov

Office of Research on Women’s Health, National Institutes of Health,

http://orwh.od.nih.gov

Eleanor Z. Hanna, Ph.D.
Associate Director for Special Projects and Centers
Office of Research on Women's Health
Office of The Director
National Institutes of Health
EPS 150A
6120 Executive Boulevard
Bethesda, MD. 20892
Phone: 301-435-1573
Fax: 301-402-0005
Email: hannae@od.nih.gov

Office of Behavioral and Social Sciences Research

http://obssr.od.nih.gov

Dana M. Sampson, MS, MBA
Office of Behavioral and Social Sciences Research (OBSSR)
National Institutes of Health
31 Center Drive
Building 31, Room B1C19
Bethesda, MD 20892
Phone: 301-451-9514
Fax: 301-402-1150
Email: Sampsond@od.nih.gov

Inquiries related to existing community infrastructures supported by other Department of Health and Human Services agencies may be directed to the following contacts as appropriate:

Administration on Aging
John Wren
Deputy Assistant Secretary for Policy & Management
US Department of Health and Human Services
Phone: (202) 357-3460

Agency for Healthcare Research and Quality
Gregg Taliaferro, PhD
Senior Service Fellow
Center for Primary Care Prevention and Clinical Partnerships
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1668
Email: gregg.taliaferro@ahrq.hhs.gov

Centers for Disease Control & Prevention
Juliana Cyril, Ph.D., MPH
Associate Director
Office of Public Health Research
Office of the Chief Science Officer
Atlanta, GA
Phone: (404) 639-4639
Fax: (404) 639-4903
Email: JCyril@cdc.gov

Health Resources and Services Administration
Kaytura L. Felix, MD
Chief Medical Officer
Bureau of Primary Health Care
5600 Fishers Lane, 17-105
Rockville, MD 20857
Phone: (301) 594-4306
Fax: (301) 594-4072
Email: kfelix@hrsa.gov

Indian Health Service
Alan Trachtenberg, MD, MPH
Research Director (acting)
United States Public Health Service
801 Thompson Ave., TMP 450
Rockville, MD 20852
Phone: (301) 443-0578
Fax: (301) 443-0114

Substance Abuse and Mental Health Services Administration
Christine Hager, Ph.D.
Social Science Analyst
Office of Applied Studies
1 Choke Cherry Road
Rockville, MD 20857
Phone: (240) 276-1287
Email: Christine.Hager@SAMHSA.hhs.gov

2. Peer Review Contact(s):

Katherine N. Bent, RN, PhD, CNS
Chief, Healthcare Delivery and Methodologies Integrated Review Group
National Institutes of Health
6701 Rockledge Drive , Room 3160, MSC 7770
Bethesda , MD 20892 (20817 for overnight/courier delivery)
phone: 301-435-0695
fax: 301-480-1056
Email: bentkn@csr.nih.gov

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

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

Human Subjects Protection:
Federal regulations (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 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 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) 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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access 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 Medicine’s 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 Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 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/.


[1] Formal Application includes the preliminary application and letter of intent phases of the program.


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