Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)

Title:  Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) (R01)  

Announcement Type

This Funding Opportunity Announcement (FOA) is a reissue of RFA-GM-10-009.   

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

Request for Applications (RFA) Number: RFA-GM-11-003

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)
93.859, 93.213, 93.394, 93.395, 93.396, 93.399, 93.273, 93,279, 93.121, 93.242, 93.853

Key Dates  
Release/Posted Date:   August 17, 2010
Opening Date:  September 21, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): not required  
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):  October 21, 2010  
Peer Review Date(s): March 2011  
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July 1, 2011   
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: October 22, 2010 

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The purpose of the EUREKA (Exceptional Unconventional Research Enabling Knowledge Acceleration) initiative is to foster exceptionally innovative research that, if successful, will have an unusually high impact on the areas of science that are germane to the mission of one or more of the participating NIH Institutes. EUREKA is for new projects, not for continuation of existing projects. Nor is EUREKA for support of pilot projects, i.e., projects of limited scope that are designed primarily to generate data that will enable the PD/PI to seek other funding opportunities. Rather, it is anticipated that EUREKA projects will begin and be completed during the funding period.

Participating Institutes                                    

Before submitting an application, it is extremely important to verify that the proposed research is of interest to at least one of the NIH Institutes that is participating in the EUREKA FOA, since applications that are not germane to the mission of one or more of the participating Institutes will be withdrawn without review. In FY2011, the participating Institutes for this FOA are the National Institute of General Medical Sciences (NIGMS), the National Cancer Institute (NCI), the National Center for Complementary and Alternative Medicine (NCCAM), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Dental and Craniofacial Research (NIDCR), the National institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS). Each of these NIH Institutes has its own scientific purview and different program goals for the EUREKA initiative. Prior to preparing an application, applicants should read the following paragraphs describing the Institutes’ missions and goals for this initiative, and consult the appropriate Institute website (listed with each Institute's name at the beginning of this announcement) for details of research areas supported by that Institute.  Applicants should contact the appropriate Institute representative listed below in Section VII to ensure that the proposed research will be responsive to this FOA. In addition, responses to commonly asked questions may be found at http://www.nigms.nih.gov/Research/Application/EurekaFAQs.htm.  As indicated in the application instructions (Section IV, below) applicants are strongly advised to include a cover letter indicating the appropriate Institute.

NIGMS: The mission of the National Institute of General Medical Sciences (NIGMS) is to support research that increases understanding of life processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS-funded researchers seek to answer important scientific questions in fields such as cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, bioinformatics, computational biology,  selected aspects of the behavioral sciences, and specific cross-cutting clinical areas that affect multiple organ systems.  For more information on NIGMS research interests, including staff contact listings, see http://search.nigms.nih.gov/research/programs.htm. Note that NIGMS will not accept EUREKA applications to support clinical trials.

NCI: The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. NCI welcomes EUREKA applications for all program areas supported by the Institute. For more information on NCI research interests, priorities and strategic objectives, listed by Program Area (including staff contact listings), see http://www.cancer.gov/researchandfunding.

NCCAM: The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government's lead agency for scientific research on complementary and alternative medicine (CAM). Our Mission is to 1) explore complementary and alternative healing practices in the context of rigorous science, 2) train complementary and alternative medicine researchers, and 3) disseminate authoritative information to the public and professionals (http://nccam.nih.gov/grants/).

NIAAA: The mission of the National Institute on Alcohol Abuse and Alcoholism is to provide leadership in the national effort to reduce alcohol-related problems (http://www.niaaa.nih.gov). To help fulfill this mission, NIAAA is interested in supporting innovative research on the role of the brain and behavior in the development and maintenance of alcohol abuse. Areas of research interest include basic and clinical neuroscience, developmental studies, genetics, epidemiology, health risks and benefits of alcohol consumption, prevention and treatment. Applicants are encouraged to contact NIAAA Program staff to discuss their proposed research program and its relevance to the mission of NIAAA.

NIDCR: The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve oral, dental and craniofacial health.  To achieve this mission, NIDCR supports research that includes infectious diseases; health disparities; behavioral and social aspects of health and disease; temporomandibular joint dysfunction; developmental biology and mammalian genetics; epithelial cell regulation and transformation; pharmacogenetics; bone and tooth physiology and injury; molecular and cellular neuroscience; oral microbiology and microbial pathogenesis; immunology and immunotherapy; AIDS and oral manifestations of immunosuppression; biomaterials; and tissue engineering and regenerative medicine.  For more information on the research interests of the NIDCR see http://www.nidcr.nih.gov/Research/.

NIDA: NIDA's mission is to lead the nation in bringing the power of science to bear on drug abuse and addiction. NIDA is interested in fostering technologically innovative and conceptually creative research that advances our understanding of drug abuse and addiction: its genetic and environmental antecedents, its behavioral and physiological consequences and its neurobiological mechanisms; how to prevent it and how to treat it.  For the EUREKA program, NIDA is interested in supporting high-risk/high-impact innovative research that encompasses research in the areas of (1) basic and clinical neuroscience and (2) genetics research involving genetic model systems, or human molecular genetics.  Applicants are strongly encouraged to contact NIDA staff to discuss feasibility of their proposed research and relevance to NIDA’s mission. For more information on NIDA’s programs, priorities, and strategic plan please refer to: http://www.nida.nih.gov/about/organization/Organization.html and http://www.nida.nih.gov/StrategicPlan/Index.html

NIMH:  The NIMH mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure (http://www.nimh.nih.gov).  To fulfill its mission, the Institute conducts research on mental disorders and the underlying basic science of brain and behavior.  NIMH welcomes EUREKA applications for all program areas supported by the Institute.  Applicants should focus on one of the following NIMH Strategic Objectives:

NINDS: The mission of the NINDS is to reduce the burden of neurological disease.  In pursuit of this goal, NINDS supports research on the normal and diseased nervous system, including basic cellular/molecular biology and genetics, cognitive/behavioral and systems neuroscience, neuroplasticity, neurodevelopment, neurodegeneration, and studies aimed at detection, prevention, and treatment of neurological diseases.  For more information on NINDS research funding listed by Program Area (including staff contact listings), see http://www.ninds.nih.gov/funding/areas/index.htm.

The EUREKA Program

To encourage exceptionally innovative research, this FOA solicits applications from investigators who want to test novel, unconventional hypotheses or pursue major methodological or technical challenges. The potential impact of the proposed research must be substantial, in terms of both the size of the scientific community affected and the magnitude of its impact on that community. The investigator should anticipate starting and completing the project during the term of the award, since this FOA is not for support of ongoing research or for pilot projects, and awards are not renewable. If it is the hypothesis that is novel, the investigator should be able to prove or disprove that hypothesis by the end of the funding period. If it is the methodology or technology that is exceptionally innovative, the investigator should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible.

The rationale for EUREKA is that for science to move forward in leaps rather than in incremental steps, investigators must have opportunities to test unconventional, potentially paradigm-shifting hypotheses, and to attempt to use novel, innovative approaches to solve difficult technical and conceptual problems that severely impede progress in a field. However, applications proposing such research are difficult to evaluate in comparison to more typical investigator-initiated R01 research grant applications, in which the emphasis tends to be more on the feasibility of the proposed research than on its novelty.

Several key features of the EUREKA FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated R01s. The application format, through its page limitations and requirements for explicitly addressing specific issues, focuses attention on the importance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on experimental details. Reviewers will be instructed to emphasize significance and innovation in their evaluations, and these criteria will be the primary basis for funding decisions. It is axiomatic that risk is inherent in highly innovative research. Accordingly, although reviewers will be asked to assess the logic of the experimental plan to determine whether the project has some (non-zero) likelihood of success, they will be reminded that risk is a hallmark of exceptionally innovative research and, in most cases, should not detract from the merit of an application.  A PD/PI’s record of overcoming difficult scientific hurdles, appropriate to his/her career stage, may also be useful in assessing the likelihood of success, although the focus of this initiative is on the project rather than the investigator.  These features are intended to steer applicants and reviewers, at each step of the process, toward the goals of the EUREKA initiative, which are to solicit and fund unusually bold and potentially transformative research.  

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization must use the PHS398 Modular Budget component. Foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

NIGMS ($6 million, 18-22 awards), NCI ($3 million, 10-12 awards), NCCAM ($400,000, 1 award), NIAAA ($600,000, 2 awards), NIDCR ($800,000, 1-2 awards), NIDA ($1 million, 3-4 awards), NIMH ($2 million, 6-9 awards), and NINDS ($2 million, 6 awards) are participating in this initiative. Support may be requested for up to $800,000 in direct costs (excluding consortium Facilities and Administrative [F&A] costs) over a four year period, prorated for shorter terms ($600,000 for three years, $400,000 for two years). Regardless of the term of support, direct costs (excluding consortium Facilities and Administrative [F&A] costs) may not exceed $250,000 in any one year.

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

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. 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


 (R&R) forms 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.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral 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 Grants.gov 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 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.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov 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 Grants.gov registration, eRA Commons registration and the SF424 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 Grants.gov/Apply.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/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. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate
(See Section IV.6 regarding appropriate required budget component.)  

Optional Components:

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

Foreign Organizations (Non-Domestic [non-U.S.] Entities)

NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from Foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

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 on 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.

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

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions 

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

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

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

Opening Date: September 21, 2010 (Earliest date an application may be submitted to Grants.gov)  Application Due Date: October 21, 2010
Peer Review Date(s): March 2011
Council Review Date(s): May 2011  
Earliest Anticipated Start Date(s): July 1, 2011

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

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.  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.

In order to expedite the review, applicants are requested to notify the NIGMS Referral Office Referral Office by email (sheehyp@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

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

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov 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 Grants.gov, 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 IC. Incomplete and/or non-responsive applications will not be reviewed.

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

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on 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.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

Supplementary Instructions:

The following exceptions to the general R01 instructions will apply for this FOA:

Biosketches: Key personnel other than PD/PIs should submit standard Biosketches including the personal statement (as described in the SF424 instructions). PD/PIs must submit EUREKA-specific biosketches. PD/PIs’ biosketches are limited to four pages.  For this FOA, the number of publications, patents, and/or meeting abstracts cited in each PI’s biosketch is limited to ten or fewer items. PD/PIs should cite their most relevant publications and/or other items and those that illustrate their exceptional innovativeness and the significance of their past accomplishments. The publications and/or other items that demonstrate exceptional innovation and significance need not be related conceptually to what the PD/PI is proposing in this application. Following each cited publication, patent, or meeting abstract, the PD/PI should very briefly summarize the findings or achievements described in the publication or other item that demonstrate relevance (familiarity with the field), exceptional innovation, and/or broad scientific impact, if that is not apparent from the title. Summaries should not exceed 60 words each.  

Research Plan: The Specific Aims section, which must be uploaded separately, is limited to one page. Except in unusual circumstances, multiple aims are inappropriate, since the research plan should be focused on verifying a hypothesis or solving a problem. The Research Strategy section is limited to six pages. It should be self-contained, since appendices and updates are not allowed for this FOA. Omit the Significance, Innovation, and Approach sections. Instead, in the Research Strategy section, the applicant should address the following six points, using headings that correspond to each of the six points, as listed below (e.g., the heading for the response to point 1 should be “The Challenge”). Applications will be evaluated by review panels that represent a diversity of scientific interests and do not necessarily have expertise in the PD/PI’s specific field.  Therefore, jargon must be avoided. Explain the challenge, the potential impact, and the approach in language that scientists in other fields can understand. 

1. The Challenge: What is the hypothesis or problem that will be addressed? If you are testing an unconventional, exceptionally novel hypothesis, how does it challenge the standard paradigm? If you are addressing a technological or methodological problem, what makes the problem especially challenging?

2. The Potential Impact: Why is testing the hypothesis or solving the problem important? How broad is the potential impact? Which community will be affected? What is the size of that community? Will the potential impact on that community be major or incremental?

3. The Approach (limit, three pages): How will you attempt to verify the novel hypothesis, or solve the problem? Provide enough information so that reviewers can determine what, in general, you are proposing to do, but do not include a detailed experimental plan. If it is your methodology that is novel, what is unconventional and exceptionally innovative about your approach? How does your approach differ from what other investigators have attempted to do?

4. The Appropriateness of EUREKA: Why is the proposed research uniquely suited to the stated goals of the EUREKA initiative, rather than a conventional research grant application? How does the proposed research differ from what you are already funded to do?

5. The Likelihood of Success: Briefly describe the past achievements that best illustrate your exceptional innovativeness, your ability to make paradigm-shifting discoveries or solve very difficult problems, and the impact of your past discoveries or solutions. The achievements that you highlight need not be conceptually related to the hypothesis or problem that you are addressing in this application. If your previous research was not unusually innovative, and you have not yet made a paradigm-shifting discovery or solved a very difficult problem, which aspect of the logic of the experimental approach suggests that there is some probability that the proposed research will be successful?  

6. Timeline (limit, half a page): Provide a timeline for the proposed research. To facilitate evaluation of progress reports, indicate when you anticipate that essential components of the project (e.g., optimization of protocols, generation of reagents, critical experiments to verify the hypothesis, validation of novel tools or techniques) will be completed.  

Literature cited: limited to 20 references. Note that the seven page limit for the Research Plan does not include the Literature Cited section. 

Appendix: Not allowed.

Cover letter: Prior to preparing an application, applicants are strongly recommended to verify that the proposed research is of interest to one or more of the NIH Institutes that are participating in the EUREKA FOA. They should consult the appropriate Institute website (listed with each participating Institute's name at the beginning of this announcement) for details of research areas supported by that Institute, and contact the appropriate Institute representative listed below in Section VII to ensure that the proposed research will be responsive to this FOA.  Applicants should indicate the appropriate Institute assignment in a cover letter (PHS398 Cover Letter File), submitted as a component of the application. 

No updates of any kind will be accepted.

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

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

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

Budget Component

U.S. applicants must use the PHS398 Modular Budget component.

All foreign applicants must complete and submit budget requests using the Research & Related Budget component.

Appendix Materials

No appendix materials will be allowed for applications submitted to this FOA. 

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 should 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: Not Applicable

(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/.)

Foreign Applications (Non-Domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States. 

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

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 participating institutes and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. Significance and innovation will be the major determinants of the overall impact score. The approach will be evaluated for general feasibility. An application will score poorly if it is clear to the reviewers that the proposed methodology has no probability at all of being successful, either because it is inherently illogical or because the same approach has already been attempted and shown not to be feasible. Unavoidable risk, which is intrinsic to novel and innovative approaches, is expected for these applications, and reviewers will be instructed that the presence or absence of preliminary data should not be taken into account when determining the score.    

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.   

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  How important is it for the community to address the problem or test the hypothesis? If the effort is successful, how profound will the impact be and how broad a community will be affected?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How innovative or novel is the hypothesis or methodology? Is it significantly different from conventional hypotheses or methodologies?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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?  

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? 

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 http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. Resubmissions are not allowed for this FOA.

Renewal Applications. Renewals are not allowed for this FOA.

Revisions Applications. Revisions are not  allowed for this FOA. 

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.

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

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:  1) Data Sharing Plan: Not Applicable; 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period of 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:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”       

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

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.

Annual progress reports will be examined closely to determine whether progress in each year is reasonable, in comparison to what was proposed in the timeline that was included in the application. If it is clear from the information in a progress report that the hypothesis is invalid, the problem cannot be solved, or the investigator is not making a focused, good-faith effort to complete the project during the term of the award, the award may be terminated early. However, temporary setbacks that are beyond the investigator’s control, which are inherent to research and are especially likely to occur during the execution of an exceptionally innovative research project, will not be grounds for terminating a project early.

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

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Laurie Tompkins, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
Fax: (301) 480-2228
Email: tompkinL@nigms.nih.gov

Judy Mietz, Ph.D.
Division of Cancer Biology
National Cancer Institute
6130 Executive Blvd, EPN Room 5028, MSC 7391
Bethesda, MD 20892-7391
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 496-9326
Fax: (301) 496-1224
Email: mietzj@mail.nih.gov

John R. Glowa, Ph.D.
Program Officer, Division of Extramural Research
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475 (20817 for courier services)
Telephone: (301) 496-0527
Fax: (301) 480-1587
Email: glowaj@mail.nih.gov

Antonio Noronha, Ph.D.
Director, Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2061
Bethesda, MD 20892-9304
Telephone: (301) 443-7722
Fax: (301) 443-4704
Email: anoronha@mail.nih.gov

Alicia Dombroski, Ph.D.
Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd.
Room 660, MSC 4878
Bethesda, MD  20892
Telephone: (301) 594-4805
Email: adombroski@mail.nih.gov

David Shurtleff, Ph.D.
Director, Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 443-1887
Fax: (301) 433-1887
Email: dshurtle@mail.nih.gov

Susan Koester, Ph.D.
Deputy Director, DNBBS
National Institute of Mental Health
6001 Executive Blvd., Room 7205, MSC 9645
Bethesda, MD 20892-9645 (for overnight mail please use Rockville, MD 20852)
Telephone: (301) 443-3563
Fax: (301) 451-5615
Email: koesters@mail.nih.gov

Edmund Talley, Ph.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2132
Bethesda, MD 20892-9531
Telephone: (301) 496-1917
Fax: (301) 402-1501
Email: talleye@ninds.nih.gov

2. Peer Review Contact(s):

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Fax: (301) 480-8506
Email: sunshinh@nigms.nih.gov

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express mail/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncidearefof@mail.nih.gov

Dale Birkle Dreer, Ph.D.
Director of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for courier ervice use 20817)
Telephone: (301) 451-6570
Fax: (301) 480-2419
Email: birkled@mail.nih.gov

Abraham P. Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039
Bethesda, MD 20852
Telephone: (301) 443-9737
Fax: (301) 443-6077
Email: bautista@mail.nih.gov

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
1DEM, Room 662, MSC 4878
6701 Democracy Blvd.
Bethesda, MD  20892-4878
Telephone:  (301) 594-5006
Fax: (301) 480-8303
Email: lynn.king@nih.gov

Teresa Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Blvd., Room 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: tlevitin@nida.nih.gov

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
Fax: (301) 443-3534
Email armstrda@mail.nih.gov

Chief, Scientific Review Branch.
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Blvd 
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

3. Financial/Grants Management Contact(s):

Grace Olascoaga
Chief Grants Management Officer
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5520
Fax: (301) 480-1969
Email: olascoag@nigms.nih.gov

Crystal Wolfrey
National Cancer Institute
Office of Grants Administration
6120 Executive Blvd, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7391
Rockville, MD 20852 (express/courier service)
Telephone: (301) 496-8634
Fax: (301) 496-8601
Email: wolfreyc@mail.nih.gov

George Tucker, MBA
Grants Management Officer
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MA 20892-5475 (for courier service use 20817)
Telephone: (301) 594-8853
Fax: (301) 480-1552
Email: tuckerg@mail.nih.gov

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Fax: (301) 443-3891
Email: jfox@mail.nih.gov

Mary Greenwood
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
1DEM, Room 658, MSC 4878
6701 Democracy Blvd.
Bethesda, MD  20892-4878
Telephone:  (301) 594-4808
FAX:  (301) 480-3562
E-mail: daleym@mail.nih.gov

Pamela G. Fleming
Chief, Grants Management Officer
National Institute on Drug Abuse
6101 Executive Blvd., Suite 250, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
Fax: (301) 594-6849
Email: pfleming@nida.nih.gov

Rebecca D. Claycamp, CRA
Chief, Grants Management Branch
National Institute of Mental Health
6001 Executive Blvd., Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Fax: (301) 443-6885
Email: rclaycam@mail.nih.gov

Tijuanna Decoster
Chief, Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3258
6100 Executive Blvd., MSC 9537
Bethesda, MD 20892-9537
Telephone: (301) 496-9231
Fax: (301) 402-0219
Email: td18k@nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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).

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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of 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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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