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
This Funding Opportunity Announcement (FOA) is developed as an NIH Roadmap Initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate with the NIH Office of the Director in Roadmap initiatives. This FOA will be administered by the Office of Policy and Strategic Initiatives in the Office of the Director of the NIH (OPASI-OD-NIH) on behalf of the NIH (http://www.nih.gov).

Title:  Roadmap Transformative R01 Program (R01)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-RM-08-029

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)
93.310

Key Dates
Release/Posted Date: September 9, 2008  
Opening Date:  December 29, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 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):  January 29, 2009
Peer Review Date(s): May/June 2009 
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 1, 2009
Additional Information To Be Available Date (Activation Date): September 1, 2008 – Frequently Asked Questions (FAQs) at http://nihroadmap.nih.gov/
Expiration Date: January 30, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
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

A major goal of the NIH is to foster bold and creative investigator-initiated research. While R01 grants support the bulk of mainstream NIH investigator-initiated efforts, the Transformative Research Projects Program (T-R01) is designed to provide a more flexible and engaging avenue for support of investigators testing novel concepts and truly transformative ideas.  The primary objective of the T-R01 initiative is to create a program that is specifically designed to support exceptionally innovative, high risk, original and/or unconventional research with the potential to create new or challenge existing scientific paradigms. The T-R01 program is a High Risk/High Reward Demonstration Project supported by the NIH Common Fund, in which novel approaches to peer review and program management will also be piloted. Applicants to this Funding Opportunity Announcement (FOA) must clearly articulate (1) the fundamental issue to be addressed and its overarching importance to the biomedical/behavioral research enterprise, (2) how the studies will either establish new or disrupt existing paradigms, and (3) how the proposed rationale and/or approaches significantly differ from state of the art in the field.

2. Research Topics

The goal of the Transformative Research Projects Program is to provide support for individual scientists or collaborative investigative teams who propose transformative approaches to major contemporary challenges. To be considered transformative, projects must have the potential to create or overturn fundamental scientific paradigms through the use of new and novel approaches. Successful projects will be expected to have a major impact in a broad area of biomedical or behavioral research. Consistent with this highly transformative focus, projects supported under the T-R01 program will reflect ideas substantially different from mainstream concepts being pursued in the investigator’s laboratory or elsewhere.

Projects in any area of NIH interest that meet the transformative criteria above are encouraged and will be considered responsive to this FOA. Areas of highlighted need that have been identified through an NIH strategic planning process include:

Understanding and Facilitating Human Behavior Change

Behavior change is critical to the prevention, management, and treatment of many important health conditions. However, the initiation and maintenance of behavior change can be very difficult, and even those interventions that succeed in controlled clinical trials do not always scale well. Transformative advances in the science of behavior change, especially those that can unify disease-specific efforts, are urgently needed. In response to this challenge, the T-R01 program invites proposals from investigators and interdisciplinary teams working to understand basic mechanisms of behavior change at the biological, behavioral and social levels and developing innovative approaches to intervention. Questions of particular interest include how the interaction between neural, biological, behavioral, psychological, and social factors result in initial and sustained behavior change (possibly best understood via transdisciplinary approaches including neuro- and behavioral economics, affective neuroscience, and approaches that focus on “will power” or behavior regulation). Highly responsive applications may also propose the use of new technologies and/or consider the broader context in which individuals live to understand basic mechanisms of behavior change common to multiple health conditions. 

Complex 3-Dimensional Tissue Models

Although tissues and organs are 3-dimensional structures, their physiology and pathophysiology are currently studied in vitro with 2-dimensional techniques, in which key phenotypic and functional characteristics are often lost. Development of complex 3-dimensional tissue models would revolutionize the study of human responses by bridging the knowledge gap between describing basic cellular processes and understanding the aggregate, intricate responses of intact organisms. Human tissue models to be supported under the T-R01 program should integrate features such as multiple cell types, cell-instructive scaffolds with appropriate spatial organization, vascularization/microchannels for tissue perfusion and maintenance, components of the immune system, innervation, tunable microenvironments, and real time monitoring. The resultant platforms should yield quantitative, biologically relevant information while driving rapid and iterative design flexibility.  It is anticipated that these human tissue models might ultimately be adapted to high throughput screening platforms to conduct studies of environmental stressors or for pre-clinical drug discovery.

Functional Variation in Mitochondria in Disease

Mitochondria are one of the most complex and important organelles found in eukaryotic cells.  In addition to their central role in energy metabolism, mitochondria are involved in many key cellular processes such as the formation of reactive oxygen species and apoptosis.  Mutations in mitochondrial DNA lead to a diverse collection of diseases that are challenging to diagnose and treat, and where precise mechanisms of disease pathogenesis remain elusive. Mitochondrial dysfunction has also been implicated in aging and in many chronic disease states including cancer, Parkinson’s, diabetes mellitus, Alzheimer’s, hepatic and cardiovascular diseases. Given the central importance of mitochondrial function in human biology, the ability to identify, measure and track the structural and functional basis of mitochondrial heterogeneity in human cells and tissues over the lifespan would transform our understanding of the role of this critical organelle in human health and disease. For this reason, the T-R01 program is soliciting proposals that propose innovative approaches to overcoming major roadblocks in human mitochondrial research. Significant challenges to be addressed under the T-R01 program include defining variability in human mitochondrial structure and function within and between cells and tissues in health and disease, developing tools and technologies to identify, study and manipulate human mitochondrial function in vivo at an organelle level, and elucidating the complexity of human mitochondrial function through the use of integrative, systems-biology based approaches.

Transitions from Acute to Chronic Pain

More than 30 million Americans suffer from unrelieved chronic pain. Management strategies often fail, in part because an individual’s susceptibility to chronic pain is highly variable, the identification of those destined to transition from acute to chronic pain is difficult, and, once pain has become chronic, changes may have occurred that cannot be easily reversed. The lack of well defined phenotypes that reflect the cellular, molecular, genetic, psychological, cognitive, and behavioral changes that occur as individuals transition to chronic pain has been a major barrier to development of personalized approaches to pain intervention. For these reasons, T-R01 proposals are sought that will transform how we view the pain state of individuals and that will revolutionize the current empirically-based analgesic treatment approaches to ones based upon objective and predictive measures of an individual’s pain phenotype. It is anticipated that responsive studies will involve formation of innovative partnerships including interdisciplinary and multidisciplinary teams to adequately address the topic and experimental aims.

Formulation of Novel Protein Capture Reagents

A comprehensive analysis of the human proteome will be essential for gaining deeper insights into the biological basis of human health and disease. Reaching this goal depends upon the development of protein capture tools that will reliably detect over a broad range of concentrations and that can characterize the structure, function and interactions of multiple proteins in human samples. The limited availability of suitable capture reagents and immobilization chemistries is a major bottleneck to high throughput analysis of the human proteome. In response to this challenge, a number of technologies are emerging that involve the insertion of combinatorial binding sites in alternate (non-antibody) protein scaffolds, synthesis of oligomers (RNA and DNA aptamers, oligo- and polypeptides of either natural or unnatural amino acids, and hybrids of these forms), and small organic molecules whether natural (biotin, tetrodotoxin, resiniferatoxin, lectin binding carbohydrate side chains) or entirely synthetic (substrate-based enzyme inhibitors). These novel technologies and the new and validated reagent sets that result will have the potential to transform methods and paradigms in both basic and clinical research. Given this transformative potential, T-R01 proposals are sought that will develop innovative approaches and enabling technologies for providing diverse libraries of protein capture reagents that are adaptable to high throughput platforms. Particularly needed are comprehensive reagent sets that can specifically or selectively recognize, bind and “capture” a broad universe of human proteins, or that can distinguish among the natural variants of a single protein such as splice variants, co- and post-translational modifications including but not limited to glycosylation, phosphorylation, acylation, and oxidation. Inherent in the development of this technology would be the development of array-based and other high throughput technologies for the validation and analysis of these reagent sets.

Providing an Evidence Base for Pharmacogenomics

In the future, prescribing decisions will be increasingly guided by genetic tests that can predict risk and effectiveness of treatments for individual patients. However, few evidence-based guidelines have been established linking individual genetic variations to medication response profiles. Proposals are sought under this T-R01 initiative that will establish and validate the predictive value of genetic profiling for creating clinical practice guidelines. Pilot studies that will broaden the pharmacogenomics evidence base in unique populations through the use of innovative clinical study designs, methods, and algorithms for use in clinical decision making are of primary interest. It is anticipated that responsive studies may involve formation of innovative partnerships including interdisciplinary and multidisciplinary teams to adequately address the topic and experimental aims.

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 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 submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all Foreign applicants must complete and submit budget requests using the Research & Related Budget component.

The NIH intends to issue solicitations for additional T-R01 awards in future years, contingent upon the availability of funds.

2. Funds Available

This initiative is part of the NIH Roadmap for Biomedical Research (http://nihroadmap.nih.gov/). The NIH common fund intends to commit up to $25 million (total costs) in FY2009 to fund up to 60 applications, contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. There is no budget limit per application up to the amount of funding provided for the program as a whole.

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 NIH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

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. Renewal applications and resubmissions will not be accepted.

Applicants may submit more than one application, provided that 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: December 29, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 29, 2008
Application Due Date(s): January 29, 2009
Peer Review Date(s): May/June 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 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:

Kristin M. Abraham, Ph.D. 
Division of Strategic Coordination -OPASI
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, Room 255
Bethesda, MD 20892-0189
Telephone: (301) 594-8190
Fax: (301) 435-7268
Email: T_R01@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

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

3.C. Application Processing

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

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

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by Office of Policy and Strategic Initiatives staff (OPASI-OD). 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 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 and Information

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

The Research Plan is limited to 8 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.   

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

Appendix Materials

Appendix materials are not allowed under this FOA.

Supplementary Instructions:

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

Biosketches: Each biosketch is limited to two pages. The number of publications cited in the PI’s biosketch is limited to ten or fewer items. PIs should cite their most relevant publications and those that illustrate exceptional innovativeness and significance of past accomplishments. Publications demonstrating exceptional innovation and significance need not be related conceptually to what the PI is proposing in the application. 

Research Plan: The research plan is limited to 8 pages. It should be self-contained, since appendices and updates are not allowed. Except in unusual circumstances, multiple aims are inappropriate, since the research plan should be focused on establishing or disrupting a scientific paradigm. Omit the Specific Aims, Background and Significance, and Preliminary Studies sections. In the Research Design and Methods section, the applicant should address the five points listed below in order and with appropriate subheadings. The challenge and potential impact are of primary importance, and must be clear and particularly compelling. Applications will be evaluated by review panels that represent a diversity of scientific interests and expertise. Therefore, jargon must be avoided. Explain the challenge, the potential impact, and the approach in language that scientists with broad expertise can understand. No detailed scientific plan should be provided, but timelines must be presented.

1. The Challenge & Potential Impact (limit, one page): What is the paradigm or problem that will be addressed? If you are testing an unconventional, exceptionally novel hypothesis, how does it challenge the existing paradigm? 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?

2. The Approach (limit, five pages): How will you attempt to test the novel paradigm or solve the problem? How does your rationale and/or approach significantly differ from the state of the art in the field? If it is your methodology that is novel, what is unconventional and exceptionally innovative about your approach? Provide enough information for reviewers to determine what you are proposing to do, but do not include a detailed experimental plan.

3. The Appropriateness of the T-R01 Mechanism (limit, one page): Why is the proposed research uniquely suited to the stated goals of the Transformative R01 initiative, rather than a conventional research grant application? How does the proposed research significantly differ from the mainstream science being done in your and other laboratories?

4. Timeline (limit, one page): Provide a timeline for the proposed research indicating points where intermediate objectives will be assessed and decisions will be made regarding the course and direction of the continuing research effort. Given the high degree of risk involved in T-R01 proposals, it is expected that investigators will need to continually reassess approaches based on experimental outcomes and potentially alter course to meet project goals. Possible alternative paths that may be followed at critical junctures in the project plan should be described and indicated on the timeline.

Bibliography & References Cited: limited to one page. Note that the eight page limit for the Research Plan does not include the Literature Cited section (separate Pdf).

Appendix: not allowed

No updates will be accepted.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see 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, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

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

As part of the Roadmap for Biomedical Research, NIH expects that not only data, but also resources generated during the period of T-R01 support should be made rapidly available to the research community and that sharing plans should follow the same principles and spirit as the proposed data release policy. The applicant should provide specific plans for resource sharing and distribution in the application. The reasonableness of the sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed resources sharing plan into the determination of scientific merit. The adequacy of the resources sharing plans will be considered by the funding organization when making recommendations about funding applications. The presence of a resources sharing plan will be part of the terms and conditions of the award. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm. See Section VI.3. Award Administration Information, “Reporting.”

Technology and Data Sharing Overview

This initiative is part of the NIH Roadmap for Biomedical Research. In order to fulfill requirements for oversight of the Roadmap T-R01 Program as a whole, NIH staff may have to present status reports outside of the annual reporting cycles. Thus, in addition to the annual Non-Competing Grant Process Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm), awardees may be required to submit progress reports more frequently than annually.. Program staff will use information from reports, site visits, etc. to evaluate each grantee’s progress. The success of the overall program will also be evaluated with the assistance of external advisors (see “Management and Evaluation” below).

Management and Evaluation

The project management team will evaluate the grants through annual progress reports and through annual T-R01 Program meetings starting in year 1 of the award. PIs of funded projects will be required to attend one grantee meeting per year for project evaluation. The annual meeting will include program staff, external advisors, and PIs from all funded awards in the Roadmap T-R01 Program.

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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).  

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 an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

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. Reviewers will be asked to evaluate 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 the primary determinants of overall scientific merit. The approach will be evaluated for technical merit. Reviewers will be instructed that an application should score poorly if it is clear that the proposed methodology has no probability of success, either because it is inherently illogical or because the same approach has been attempted and shown not to be feasible. Neither unavoidable risk that is intrinsic to novel and innovative approaches, nor lack of significant preliminary data will preclude an application receiving a favorable review.

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?  Does the study have clear transformative potential? Is the proposed research exceptional, in terms of the magnitude of the potential impact and size of the community affected? Is the paradigm being tested central to the field?

Innovation:  Is the project highly 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?  Is the hypothesis and/or proposed methodology unconventional and exceptionally innovative? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims 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 aims of the project and the expertise of each of the PDs/PIs? Is the logic of the approach significantly compelling despite the lack of experimental details? Has this methodology or hypothesis been tested before? Does the information in the timeline inspire confidence that the PI will be able to assess progress in each year of the award and either complete the project or demonstrate conclusively that it cannot be completed, despite good-faith efforts, during the term of the award?

Investigators: Are the PD(s)/PI(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 and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Do the past achievements of the PI(s) suggest that the investigator(s) is/are exceptionally innovative and likely to make paradigm-shifting, high-impact discoveries? If the PI does not have a history of doing exceptionally innovative, high-impact research, does the logic of the experimental plan suggest that there is at least some likelihood of success?

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

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

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.

The resource sharing plan will become part of the terms and conditions of the award.

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

A Program Official from one or more of the participating NIH Institutes and Centers will be assigned to each funded application and will assume responsibility for normal stewardship of the awards. Program Officials responsible for managing individual applications funded under this initiative will work in concert with one another and with the NIH Office of Policy and Strategic Initiatives to assist with convening regular meetings of the funded PIs, and to promote data sharing and collaboration across funded projects.

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 for completion of milestones 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.

This initiative is part of the NIH Roadmap for Biomedical Research. In order to fulfill requirements for oversight of the Roadmap T-R01 Program as a whole, NIH staff may have to present status reports outside of the annual reporting cycles. Thus, in addition to the annual Non-Competing Grant Process Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm), awardees may be required to submit progress reports more frequently than annually.. Program staff will use information from reports, site visits, etc. to evaluate each grantee’s progress. The success of the overall program will also be evaluated with the assistance of external advisors (see “Management and Evaluation” below).

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):

Kristin M. Abraham, Ph.D. 
Division of Strategic Coordination -OPASI
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, Room 255
Bethesda, MD 20892-0189
Telephone: (301) 594-8190
Fax: (301) 435-7268
Email: T_R01@mail.nih.gov

2. Peer Review Contact(s):

John L. Bowers, Ph.D.
Biological Chemistry & Macromolecular Biophysics IRG
Center for Scientific Review
6701 Rockledge Drive
Room 4170, MSC 7806
Bethesda, MD 20892-7806
Telephone: (301) 435-1725
Fax: (301) 480-2327
Email: bowersj@csr.nih.gov

3. Financial/Grants Management Contact(s):

Scott Jackson, M.P.A.
Division of Strategic Coordination, OPASI
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, Room 203
Bethesda, MD 20892-0189
Telephone: (301) 402-2277
Fax: (301) 435-7268
Email: jacksonsc@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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.