Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

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

Title:  Recovery Act Limited Competition: NIH Director’s Opportunity for Research in Five Thematic Areas (RC4)

Announcement Type

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

Request for Applications (RFA) Number: RFA-OD-10-005 

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


This FOA must be read in conjunction with the application guidelines included with this announcement in for Grants (hereafter called

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)

Key Dates
Release/Posted Date: December 28, 2009
Opening Date:   February 15, 2010 (Earliest date an application may be submitted to
Letters of Intent Receipt Date: February 15, 2010
NOTE: On-time submission requires that applications be successfully submitted to no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date:  March 15, 2010
AIDS Application Due Date: Not applicable
Peer Review Date(s): June/July 2010 
Council Review Date(s): August 2010
Earliest Anticipated Start Date: August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 16, 2010

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The NIH has received new funds for Fiscal Years (FYs) 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”). This is one of a number of NIH initiatives related to the Recovery Act. These are listed at the following site:

Under the Recovery Act, the NIH has established a program entitled “NIH Director’s Opportunity for Research in Five Thematic Areas”. This program will support projects that address research endeavors in specific areas that will benefit from significant three-year funds without the expectation of continued NIH funding beyond this period. The research supported by the program should have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery.

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, supports a broad range of biomedical research. Previous research has enormously increased our understanding of the molecular, cellular and behavioral bases of disease and our approaches to health care. The most 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. The high complexity of the technologies and data systems required for this type of research, and the requirements for large interdisciplinary teams significantly limit progress and prevent private sector investments and expansions.

Through investments of ARRA funds in FY2009, the NIH has the unprecedented opportunity to expand, accelerate and jumpstart research programs in meeting emerging biomedical and behavioral research needs.  In FY2010, we continue to extend this opportunity to fuel additional research in addressing new challenges.  The purpose of this program is to support high impact ideas in five broad thematic areas that lend themselves to short-term funding, and may lay the foundation for new fields of investigation. Applicants may propose to address either a specific disease- or technology-related research question relevant to one or more of the participating Institutes and Centers, or propose the creation of a unique infrastructure/resource designed to accelerate scientific progress in the future. This FOA is designed to provide investigators and institutions with the opportunity to address these unique challenges by engaging in new avenues of research where progress would produce a significant impact on growth and investment on biomedical or behavioral science and/or health research.

Note: Applicants to the Program must clearly specify the thematic area that their research addresses in the Project Summary/Abstract Component of the application. Applicants must also clearly articulate how the proposed studies would significantly extend our understanding of biomedical or behavioral science and/or health as it relates to the thematic area.

2. Scope and Specific Requirements

Scope. This grants program is aimed at research endeavors that address one or more of the following five thematic areas:

  1. Applying Genomics and Other High Throughput Technologies:  In the past, many basic biomedical science projects were limited in scope to some aspect of genetics, cell biology, or physiology.  The revolution now sweeping the field is the ability to be comprehensive – for example, to define all of the genes of the human, model organisms or the human microbiota, all of the human proteins and their structures, or all of the major pathways for signal transduction in the cell. Technologies contributing to these advances, many of which became practical at scale only in the last few years, include DNA sequencing, microarray technology, nanotechnology, small molecule screening capabilities, new imaging modalities, and computational biology.  These comprehensive approaches coupled with systems-level integration, analysis and mining of large datasets now hold the promise of major advances in the understanding of the mechanisms of diseases. 

  2. Translating Basic Science Discoveries into New and Better Treatments:  Armed with a wealth of basic science discoveries and an understanding of the pathophysiology of various diseases, we are embarking on the next frontier in designing new diagnostic and therapeutic strategies.  Molecular and cellular insights into a disease can be developed into screening assays on hundreds of thousands of compounds, and tested in disease models to identify the most promising leads that can sustain the drug development pipeline and attract public-private partnerships for further pursuits. Additional pathways to therapeutics from gene therapy, biologics, and stem cells (including iPS cells) are also showing great promise. The opportunity is here for translational science to develop small molecule-based, gene-based, protein/peptide-based and cell-based therapies for common as well as rare diseases. 

  3. Using Science to Enable Health Care Reform:  Quality, affordable health care for all Americans cannot occur without significant advances in the underlying science that will enable effective and efficient disease prevention and diagnosis, as well as better and cheaper treatments to be identified.  Clinical research targeted toward health disparities, social and behavioral factors, large-scale prospective population cohort analysis, comparative effectiveness, cost-effective prevention and personalized medicine, and pharmacogenomics will allow us to assess and mitigate disease risks, predict outcome and optimize treatment.  Health services research that includes health information technology and health research economics will enhance the safety, quality and efficiency of the health care delivery system, as well as facilitate health promotion.

  4. Focusing on Global Health:  The NIH has a long tradition of supporting the discovery phase of solutions to major global health challenges, and recent scientific advances in genomics, small molecule screening technologies, and vaccine development portend the possibility of further major impacts on some of the most challenging and harmful diseases worldwide.  This theme encourages a greater focus on global health and new emphasis on formulating prevention and intervention strategies to tackle a number of infectious and parasitic diseases, chronic non-communicable diseases and injuries, and other neglected diseases striking the developing world, with the goal to reduce morbidity and mortality associated with these diseases worldwide.

  5. Reinvigorating the Biomedical Research Community:  The lifeblood of biomedical research in the United States rests upon the talent and dedication of its scientists and the support of innovative research.  This theme encourages investigators to cultivate new collaborations and to assemble multidisciplinary or interdisciplinary teams in conducting innovative research on the most challenging biomedical and behavioral areas.   The goal is to strengthen our research capacity, to broaden our research base and to enhance cross-fertilization of disciplines by recruiting new investigators and new expertise into the research community, and by developing and retaining these talents in a collaborative environment that fosters creativity and exploration. 

Note:  For the purpose of this FOA the definition of comparative effectiveness research (CER) will adhere to that adopted by the Federal Coordinating Council given at (see in particular pages 5 and 16).  The term “comparative” refers to comparisons of interventions and strategies to prevent, diagnose, treat, and monitor health conditions.  The term “effectiveness” refers to applicability “to real-world needs and decisions faced by patients, clinicians, and other decision makers” within “real-world settings,” i.e. not the ideal settings created in efficacy investigations.  CER investigations compare two or more interventions and strategies that are currently available to practicing clinicians (i.e., not innovative or experimental drugs, devices, or approaches that might more typically be part of an FDA-regulated efficacy study).  These interventions and strategies can include “medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.”  As examples, CER investigations could:

For examples of CER topics and approaches a 2009 Institute of Medicine Panel consider to be of high national priority, applicants are also encouraged to consult the Panel’s report at

Requirements. Projects submitted in response to this FOA are expected to demonstrate the following:

A detailed statement addressing the scope and the requirements should be included as part of the application Research Plan and in summary form in the Letter of Intent.

Only projects with a scientific scope that requires an annual budget greater than $500,000 in total costs are expected to be considered.

The award provides three years of support to applicant organizations that can demonstrate the need for a significant short-term stimulus investment on a well defined project that is ready for deployment and implementation and that meets the goals of the Recovery Act.

Key resources and data acquired with the support of this FOA will be expected to be shared rapidly with the public and the scientific community as described under the NIH Policy for Sharing of Data and the NIH Policy for Sharing Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (

Timeline. Applicants should construct the project timeline to include critical milestones, measurable outcomes, and mid-term and end of project results 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 supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. Contingent upon the submission of a sufficient number of scientifically meritorious applications, approximately $80 million of ARRA funds will be obligated by September 30, 2010 to support requests submitted in response to this FOA.   

Only applications for projects that require $500,000 or more in total costs per year are expected to be considered for funding. The total cost amount for individual awards will vary and should be commensurate with the scope and complexity of the project. However, the duration of the awards issued under this FOA will be limited to three years.

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, with the exception of projects submitted to address topics identified as included in the Focusing on Global Health theme, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.  Projects in response to the Focusing on Global Health theme could propose a larger foreign component. NIH will consider these requests in the context of the research being proposed and its potential for critically advancing research in global health.

NIH grants policies as described in the for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs 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

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 current 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 and follow the directions provided on that Web site.


Appropriate registrations with and eRA Commons must be completed on or before the due date in order to successfully submit an application.  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 with both and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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 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.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through

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:

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

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 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

Optional Components:

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


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, the Research Plan section and 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. 

3. Submission Dates and Times

See Section IV.3.A. for details.

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

Opening Date: February 15, 2010 (Earliest date an application may be submitted to
Letters of Intent Receipt Date: February 15, 2010
Application Due Date: March 15, 2010
AIDS Application Due Date: Not applicable
Peer Review Date(s):
June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: August 31, 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:

Cathleen Cooper, Ph.D.
Chief, Oncology 1: Basic Translational (OBT) IRG
NIH/Center for Scientific Review
6701 Rockledge Drive, Rm 6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone: 301-443-4512
Fax: 301-480-0287

3.B. Submitting an Application Electronically to the NIH

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

3.C. Application Processing

3.C.1 Submitting On-Time

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

All applications must meet the following criteria to be considered “on-time”:

Please visit for detailed information on what to do if or eRA system issues threaten your ability to submit on time.

Submission to is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through,

NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the OD consistent with the intent of this FOA. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from and the Commons. The submitting AOR/SO receives the 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, or previously solicited through ARRA-related opportunities, is to be submitted in response to this funding opportunity, it is to be prepared as a NEW application. That is, the application for this 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. In addition, ARRA awards are subject to Standard Terms and Conditions for ARRA Awards consistent with NOT-OD-09-080, NOT-OD-09-120, and NOT-OD-10-003.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 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 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 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 Strategy Page Limitation: The Research Strategy is limited to a total of 12 pages

PHS398 Research Plan Component Sections

Item Number and Title


1. Introduction to Application

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

2. Specific Aims

One page maximum. Separate PDF attachment

3. Research Strategy

Limited to 12 pages. Attach the 12- page Research Strategy as a single PDF document. Figures and illustrations may be included but must fit within the 12-page limit. Do not include links to Web sites for further information. Do not include animations.

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

Organize the Research Strategy in the specified order using the instructions provided below. Start each section with the appropriate section heading (i.e. Research Area, Opportunity and Potential Impact, Approach, Timeline, Milestones, Expected Measurable Outcomes and Deliverables, and Long Term Sustainability Plan.)

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 7. Project Summary/Abstract: Follow instructions in the SF424 (R&R) Application Guide. Begin this section by stating the thematic area that this application addresses.

Item 9. Bibliography and Literature Cited: Limited to one page.  Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication.  When citing articles that fall under the Public Access Policy, provide the NIH Manuscript Submission reference number or the PubMed Central (PMC) reference number for each article. If the PMCID is not yet available, indicate "PMC Journal - In Process."

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. Individuals should cite their most relevant publications and those that highlight the significance of past accomplishments.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See Also see

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.  

No supplemental/update information will be accepted.

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

(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

(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

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

Review 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 the Center for Scientific Review and in accordance with NIH peer review procedures (, 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). 

Scored 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, 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?

Are the milestones set appropriately and could they be reached reasonably over the timeline?  Are the expected measurable outcomes and results well described, and will they meaningfully fulfill the research opportunities in one or more of the five research themes?

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?  Have the physical facilities, services and institutional requirements been carefully considered? Is there evidence of strong, institutional support and commitment to the rapid and efficient deployment of the new proposed infrastructure?

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. For additional information, see

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.

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).

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:

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.

Selection Process

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. In addition, as part of “just-in-time” information for those Recovery Act awards, for any modular budget application, a detailed budget will be required prior to award.

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.  Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

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[1] . 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

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:

Awarding Component

Scientific/Research Contact(s):

Financial/Grants Management Contact(s):

National Institute on Aging (NIA)
Chyren Hunter, Ph.D.
Deputy Director, Division of Extramural Activities
Gateway Building, Room 2C218
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Phone: 301-496-9322
Fax: 301-402-2945
Linda Whipp
Grants Management Officer
Gateway Building, Suite 2N212
Bethesda, MD 20892-2292
Phone:  301-496-1472
Fax:  301-402-3672
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Abraham P. Bautista, Ph.D.
Director, Office of Extramural Activities
5635 Fishers Lane, Room 2089
Bethesda MD 20892-9304
Phone: 301-443-9737
Fax: 301-443-6077
Judy Fox
Chief, Grants Management Branch
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Phone:  301-443-4704
Fax:  301-443-3891
National Institute of Allergy and Infectious Diseases (NIAID)
Dr. Patricia Haggerty
Associate Director, Division of Extramural Activities
6700B Rockledge Dr. Rm 2139
Bethesda, MD 20892
Phone:  301-451-2615
Mary Kirker
Chief, Grants Management Branch
6700-B Rockledge Drive, Rm
Bethesda, MD 20892-7614
Phone:  301-402-6400
Fax:  301-493-0597
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Hung Tseng PhD
Extracellular Matrix Biology and Disease Program
One Democracy Plaza, Room 886
6701 Democracy Boulevard
Bethesda, MD 20892-4872
Phone: 301-496-0810
Gail B. Hamilton
Senior Grants Management Officer
6701 Democracy Blvd., Suite 800, Room 844
Bethesda, MD 20892-4872
Phone:  301-594-3506
Fax:  301-480-5450
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Grace C.Y. Peng, Ph.D.
Program Director
6707 Democracy Blvd., Suite 200, MSC 5469
Bethesda, MD 20892
Phone:  301-451-4778
Chris A. Darby
Grants Management Specialist
6707 Democracy Blvd., MSC 5469
Suite 900, Democracy II
Bethesda, MD  20892-5469
Phone:  301-451-4786
Fax:  301-451-5735
National Cancer Institute (NCI) or
Jerry S. H. Lee, Ph.D.
Special Assistant and Program Director
Office of the Deputy Director

31 Center Drive, Room 11A30C,
MSC 2590
Bethesda, MD 20892-2590
Phone:  301-496-1045
FAX:  301-480-2889
Ms. Crystal Wolfrey
Office of Grants Administration
6120 Executive Boulevard, EPS
Suite 243, MSC 7150
Bethesda, MD 20892-7340
Phone: 301-496-8634
Fax:  301-496-8601
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Dennis A. Twombly, Ph.D.
Extramural Training Officer
Acting Deputy Director, Office of Extramural Policy
6100 Executive Boulevard, Room 2C01
Bethesda, Maryland 20892-7510
Phone:  301-451-3371
FAX:  301-480-2400
Bryan S. Clark, M.B.A.
Chief Grants Management Officer

6100 Executive Boulevard
Room 8A01, MSC 7510

Bethesda, MD 20892

Phone: 301-435-6975
Fax: 301-402-0915
National Institute on Drug Abuse (NIDA)
Christine Colvis, PhD
Director, Program Integration
Neuroscience Center, Rm 5261
6001 Executive Blvd.
Bethesda, MD 20892
Phone: 301-443-6480
Carol Alderson
Office of Management
Grants Management Branch
6001 Executive Boulevard, 5th Floor, MSC 9560
Bethesda, MD 20892-9560
Phone: 301-933-6196
Fax: 301-594-6869
National Institute on Deafness and Other Communication Disorders (NIDCD)
Gordon B. Hughes, M.D.
Program Director, Clinical Trials
Division of Scientific Programs
6120 Executive Blvd., EPS-400C MSC 7180
Bethesda, MD 20892-7180
Phone: 301-435-4085
Fax: 301-402-6251
Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities
Executive Plaza South, Room 400B
6120 Executive Blvd., MSC 7180
Bethesda, MD  20892-7180  
Phone: 301-435-0713
Fax: 301-451-5365
National Institute of Dental and Craniofacial Research (NIDCR)
Lillian Shum, PhD
Chief, Integrative Biology and Infectious Diseases Branch
Division of Extramural Research
6701 Democracy Blvd., Rm. 624
Bethesda, MD 20892-4878
Phone: 301-594-0618
Fax: 301-480-8319
Ms. Mary Greenwood
Chief Grants Management Officer
6701 Democracy Blvd.
Room 658, MSC 4878
Bethesda, MD 20892-4878
Phone: 301-594-4808
Fax: 301-480-3562
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Philip F. Smith, Ph.D.
Deputy Director
Division of Diabetes, Endocrinology, and Metabolic Diseases
Co-Director, Office of Obesity Research
6707 Democracy Blvd., Rm 689 MSC 5460
Bethesda, MD 20892-5460
Phone: 301.594.8816
Fax: 301.480.3503
Elizabeth Gutierrez
Grants Specialist
Grants Management Branch
Division of Extramural Activities
6707 Democracy Blvd, Room 712B
Bethesda, MD 20817
Phone: 301-594-8844
National Institute of Environmental Health Sciences (NIEHS)
NIEHS Scientific Program Contacts
Dorothy Duke
Chief, Grants Management
Division of Extramural Research and Training
111 TW Alexander Drive, Mail Drop K3-13
Keystone Building, Room 3044
Research Triangle Park, NC  27709-2233
Phone:  919-541-2749
Fax:  919-541-2860
National Eye Institute (NEI)
Lisa A.Neuhold, Ph.D.
Division of Extramural Research
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892
Phone:  301-451-2020
Fax:  301-402-0528
Mr. William W. Darby
Division of Extramural Research
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Phone:  301-451-2020
Fax:  301-496-9997
National Institute of General Medical Sciences (NIGMS)
Peter C. Preusch, Ph.D.
Biophysics Branch Chief
Division of Cell Biology and Biophysics
45 Center Drive, MSC 6200
Bethesda, MD  0892-6200
Phone:  301-594-1158
FAX:  301-480-2004
Grace Olascoaga
Chief Grants Management Officer
45 Center Drive MSC 6200
Room 2AN.32
Bethesda, MD 20892-6200
Phone: 301-594-5520
Fax: 301-480-1969
National Heart, Lung, and Blood Institute (NHLBI)
Division of Cardiovascular Sciences
Stephen S. Goldman, Ph.D.
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone: 301-435-0560

Division of Lung Diseases
James Kiley, Ph.D.
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone: 301-435-0233

Division of Blood Diseases and Resources
Henry Chang, M.D.
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone: 301-435-0067
Tony Agresti
Grants Management Specialist
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20982
Phone: 301-435-0186
National Human Genome Research Institute (NHGRI)
Joseph Campbell
5635 Fishers Lane Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Phone: 301-443-6811
Fax: 301-480-2770
Cheryl Chick
Chief Grants Management Officer
Grants Administration Branch
5635 Fishers Lane, Ste. 3058
Bethesda, MD  20892-9307
Phone: 301-435-7858
Fax: 301-451-5434
National Institute of Mental Health (NIMH)
Jean G. Noronha, Ph.D.
Division of Extramural Activities
6001 Executive Blvd, Room 6147, MSC 9609,
Bethesda, MD 20892-9609
Phone: 301-443-3367
Fax: 301-443-4720
Ms. Rebecca Claycamp
Chief Grants Management Officer
6001 Executive Boulevard
Room 6122
Bethesda, MD 20892-9605
Phone: 301-443-2811
Fax: 301-443-6885
National Institute of Neurological Disorders and Stroke (NINDS)
Emmeline Edwards, Ph.D.
Deputy Director for Extramural Research
NSC 3305
6001 Executive Boulevard
Bethesda, MD 20892-9531
Phone: 301-496-9248
Tijuana Decoster, MPA
Chief Grants Management Officer
NSC 3258
6001 Executive Blvd
Bethesda, MD 20892-9537
Phone: 301-496-9231
National Institute of Nursing Research (NINR)
Linda S. Weglicki, PhD, RN
Health Scientist Administrator
Division of Extramural Activities
6701 Democracy Blvd, Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870
Phone: 301-594-6908
Ron Wertz
Grants Management Specialist
6701 Democracy Blvd, Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870
Phone: 301-594-2807
Fax: 301-402-4502
National Center for Complementary and Alternative Medicine (NCCAM)
Craig Hopp
Program Officer
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
Phone: 301-496-5825
Fax: 301-480-1587
George A. Tucker, M.B.A.
Director, Office of Grants Management
Chief Grants Management Officer
Phone: 301-594-9102
Fax:  301-480-1552
National Center on Minority Health and Health Disparities (NCMHD)
Francisco S. Sy, MD, DrPH
Division of Extramural Activities & Scientific Programs
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-402-1366
FAX: 301-480-4049
Priscilla Grant, J.D., C.R.A.
Chief Grants Management Officer
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892-5465
Phone: 301-594-8412
Fax:  301-480-4049
National Center for Research Resources (NCRR)
Heng Xie, M.D., M.P.H., Ph.D.
Supervisory Medical Officer
Division for Clinical Research Resources
6701 Democracy Blvd., Democracy I, Rm. 908
Bethesda MD 20892-4874
Phone: 301-443-8063
Fax: 301-480-3661
Molly Puente, Ph.D.
Grants Management Specialist
6701 Democracy Blvd.,
Room 1035
Phone: 301-402-6737
Fax: 301-480-3777
National Library of Medicine (NLM)
Dr. Valerie Florance
NLM Extramural Programs, NIH
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Phone: 301-496-4621
Fax: 301-402-2952
Dwight Mowery
NLM Extramural Programs, NIH
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Phone: 301-496-4221
Fax: 301-402-0421
John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC)
Kenneth Bridbord, M.D.
Division of International Training & Research
31 Center Drive, Room B2C39
Bethesda, MD 20892-2220
Phone: 301-496-1653
Fax: 301-402-0779
Bruce R. Butrum
Chief Grants Management Officer    
Office of the Director                                       
Building 31, Room B2C29
31 Center Drive
Bethesda, MD 20892-2220
Phone: 301-496-1670
Fax: 301-594-1211

Peer Review Contact(s):

Cathleen Cooper, Ph.D.
Chief, Oncology 1: Basic Translational (OBT) IRG
NIH/Center for Scientific Review
6701 Rockledge Drive, Rm 6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone: 301-443-4512
Fax: 301-480-0287

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5):

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:

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 ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( 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 (

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,

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 ( 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.

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

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 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 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” (; a complete copy of the updated Guidelines is available at 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 (

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

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( 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, 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 ( For more information, see the Public Access webpage at

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 ( 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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at 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:

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

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NIH Funding Opportunities and Notices

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