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 Institute on Aging (NIA), (http://www.nia.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)
National Library of Medicine (NLM), (http://www.nlm.nih.gov)

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

Announcement Type
This funding opportunity announcement is a reissue of RFA-GM-08-002.

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

Request for Applications (RFA) Number: RFA-GM-09-008   

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, 93.394, 93.395, 93.396, 93.399, 93,866, 93.273, 93,279, 93.121, 93.242, 93.853, 93.879.

Key Dates  
Release/Posted Date:  August 15, 2008
Opening Date:  September 29, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  September 29, 2008
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 28, 2008
Peer Review Date(s): March/April 2009
Council Review Date(s): May 2009
Earliest Anticipated Start Date(s): July 1, 2009   
Additional Information To Be Available Date (Activation Date): Not applicable  Frequently Asked Questions (FAQs) at ttp://www.nigms.nih.gov/Research/Application/EurekaFAQs.htm
Expiration Date:
October 29, 2008

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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
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 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. The participating Institutes for this FOA are the National Institute of General Medical Sciences (NIGMS), the National Cancer Institute (NCI), the National Institute on Aging (NIA), 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), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Library of Medicine (NLM).  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: NIGMS supports basic research that is the foundation for disease diagnosis, treatment, and prevention. The Institute's programs encompass the areas of cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biochemistry, chemistry, bioinformatics, computational biology, and selected cross-cutting clinical areas that affect multiple organ systems, including anesthesiology, trauma and burn injury, and wound healing. 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.

NIA: NIA’s mission is to improve the health and well-being of older Americans through research, and specifically through research focused on aging processes, age-related diseases, and on special problems and needs of the aged.  NIA welcomes EUREKA applications in all program areas of the Institute. Potential applicants should focus on any of the priority areas identified in the program division web sites: Division of Aging Biology; Division of Behavioral and Social Research; Division of Neuroscience; Division of Geriatrics and Clinical Gerontology. Potential applicants are also strongly encouraged to contact staff in these NIA program divisions to explore the mission-relevance of their proposed work.

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. 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.  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

NLM: The National Library of Medicine (NLM) supports research grants that advance the sciences of biomedical informatics and bioinformatics. Informatics is concerned with the optimal management of information, and in practice is usually located at the intersection of computer and information sciences with an application domain such as health care, public health, basic biomedical research or clinical translational research.

For the EUREKA program, NLM seeks innovative applications in the following two ‘discovery science’ areas:

1.       Integrated discovery mining for biology and medicine: employing two or more sources to generate a new and meaningful hypothesis in biomedical science, capable of being tested by bench or clinical research. One source must be full-text published biomedical literature; the other source should be either (1) a database storing primary data from basic biomedical research or (2) data drawn from the electronic health records used for routine clinical care or from the data accumulated for a clinical research project. The interface of an integrated discovery mining system should support easy use by the intended users (i.e., by biomedical researchers or clinicians). Mining techniques should involve minimal human intervention.

2.       Integrated hypothesis testing for biology and medicine: employing two or more sources to test rigorously in silico a new and meaningful scientific hypothesis in biomedicine, one which otherwise would require laboratory or clinical verification. One source must be full-text published biomedical literature; the other source should be either (1) a database storing primary data from basic biomedical research or (2) data drawn from the electronic health records used for routine clinical care or the from the data accumulated for a clinical research project.

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 proposal aspects, 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 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, if you are a U.S. organization, you must use the PHS398 Modular Budget component.

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

2. Funds Available

NIGMS ($6 million, 18-22 awards), NCI ($750,000, 2-3 awards), NIA ($1 million, 2-3 awards), NIAAA ($600,000, 2 awards), NIDCR ($750,000, 2-3 awards), NIDA ($1 million, 3-4 awards), NIMH ($3 million, 8-12 awards), NINDS ($2 million, 6 awards), and NLM ($985,000, 3 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 grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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

This FOA is for new applications. Applicants are not permitted to submit a resubmission application in response to this FOA. Competing renewals will not be allowed in response to this FOA or subsequent reissues of this FOA.

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

Section IV. Application and Submission Information


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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are 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., “Special Instructions,” 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 in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions 

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

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 29, 2008 (Earliest date an application may be submitted to Grants.gov)  
Letters of Intent Receipt Date(s): September 29, 2008
Application Due Date(s): October 28, 2008
Peer Review Date(s): March/April 2009
Council Review Date(s): May 2009
Earliest Anticipated Start Date(s): July 1, 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Laurie Tompkins, Ph.D.
Division of Genetics and Developmental Biology
Institute 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 (preferred method for submitting letters of intent) 

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. 

In order to expedite the review, applicants are requested to notify the NIGMS 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

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

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

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 or competing renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements and Information

Supplementary Instructions:

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

Biosketches: Key personnel other than PIs should submit standard Biosketches (as described in the SF424 instructions). PIs must submit EUREKA-specific biosketches. 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. 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 PI is proposing in this application. Following each cited publication, patent, or meeting abstract, the 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 research plan is limited to eight pages. It should be self-contained, since appendices and updates are not allowed for this FOA. Except in unusual circumstances, multiple aims are inappropriate, since the research plan should be focused on verifying a hypothesis or solving a problem.  Omit the Specific Aims, Background and Significance, and Preliminary Studies sections. In the Research Design and Methods section, the applicant should address the following six points, using headings that correspond to each point (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 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?

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 eight 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 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

Items 2-5 of the PHS398 Research Page component are limited to 8 pages. All attachments must be provided to NIH in PDF format, file names must be included with no spaces or special characters, and a .pdf extension must be used.   

All other application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.

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 must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, whether the results are positive or negative, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.) Highly innovative ideas, by their very nature, may often lead to negative results, which may not be publishable in the conventional sense. However, there can be great value in learning from negative results. Therefore, if the research demonstrates that the goal(s) of the proposal is (are) not feasible, then the full experimental details, results, and conclusions must still be archived and made publicly available.

 (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 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

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by 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:

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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Significance and innovation will be major determinants of the score. The approach will be evaluated for general feasibility. An applicationwill 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.     

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How important is the problem or hypothesis? If the effort is successful, how significant will the impact be and how broad a community will be affected?   

Innovation:  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? How innovative or novel is the hypothesis or methodology? Is it significantly different from conventional hypotheses or methodologies?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aim(s) of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aim(s) of the project and the expertise of each of the PDs/PIs? Is the experimental plan (including preliminary data if provided) logical and appropriate to the aim(s) of the project, such that there is at least some likelihood that the project will succeed?

Investigators: Are the PI(s)/PD(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator(s) and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Do past achievements suggest that the investigator(s) are exceptionally innovative and likely to make paradigm-shifting, high-impact discoveries? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)
 
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

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

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents 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 or that augment existing U.S. resources will be assessed. 

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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. Commonly asked questions and their responses may be found at http://www.nigms.nih.gov/Research/Application/EurekaFAQs.htm.   For staff contact, inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Ravi Basavappa, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
Fax: (301) 480-2004
Email: basavapr@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

Robin Barr, Ph.D.
Office of Extramural Activities
National Institute on Aging
Gateway Building, Room 2C218
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205 (use Bethesda, MD 20814 for express mailing)
Telephone: (301) 496-9322
Fax: (301) 402-2945
Email: BarrR@nia.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.
Deputy Director
Division of Extramural Activities
National Institute of Dental and
Craniofacial Research
6701 Democracy Blvd.
Room 660, MSC 4878
Bethesda, MD  20892
Telephone: (301) 594-4800
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

Dr. Valerie Florance  
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301 
Bethesda, MD 20892
Telephone: (301) 594-4882
Fax: (301) 402-2952
Email: florancev@mail.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

Ramesh Vemuri, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging
Gateway Building, Room 2C212
Bethesda, MD 20892-2292
Telephone: (301) 496-9666
Fax: (301) 402-0066
Email: VemuriR@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

Dr. Arthur Petrosian
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301 
Bethesda, MD 20892
Telephone: (301) 594-4933
Fax: (301) 402-2952
Email: petrosia@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

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 Daley
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

Dwight Mowery
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301 
Bethesda, MD 20892
Telephone: (301) 496-4221
Fax: (301) 402-0421
Email:moweryd@mail.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).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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/


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NIH Funding Opportunities and Notices


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