Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). Participating Institutes: Office of Strategic Coordination (Common Fund)
Funding Opportunity Title	NIH Director's Transformative Research Awards (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of RFA-RM-11-006
Related Notices	July 26, 2013 - This RFA has been reissued as RFA-RM-13-008.
Funding Opportunity Announcement (FOA) Number	RFA-RM-12-017
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310
Funding Opportunity Purpose	The NIH Director’s Transformative Research Awards complements NIH’s traditional, investigator-initiated grant programs by supporting individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original and/or unconventional research with the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies. Little or no preliminary data are expected. Projects must clearly demonstrate the potential to produce a major impact in a broad area of biomedical or behavioral research.

Posted Date	June 29, 2012
Open Date (Earliest Submission Date)	August 21, 2012
Letter of Intent Due Date	August 21, 2012
Application Due Date(s)	September 21, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February 2013
Advisory Council Review	May 2013
Earliest Start Date(s)	August 2013
Expiration Date	September 22, 2012
Due Dates for E.O. 12372	Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The goal of the NIH Director's Transformative Research Awards initiative is to provide support for collaborative investigative teams or individual scientists who propose transformative research projects, which, if successful, would have a major impact in a broad area of biomedical or behavioral research. To be considered transformative, projects must have the potential to create or overturn fundamental scientific paradigms through the use of novel approaches, to transform the way research is conducted through the development of novel tools or technologies, or to lead to major improvements in health through the development of highly innovative therapies, diagnostic tools, or preventive strategies. Consistent with this focus, applications supported under the Transformative Research Awards initiative will reflect ideas substantially different from mainstream concepts.

Several key features of this FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated research awards. The application format, through its page limitations for sub-topics and requirements for explicitly addressing specific issues, focuses attention on the importance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on experimental details. Reviewers will be instructed to emphasize significance and innovation in their evaluations, and these criteria will be the primary basis for funding decisions. These features are intended to steer applicants and reviewers, at each step of the process, toward the goal of this initiative, which is to solicit and fund unusually bold and potentially transformative research.

Projects in any area of NIH interest, including basic, clinical, translational and behavioral studies, are encouraged and will be considered responsive to this FOA. Though technical and conceptual risks are expected in highly innovative projects, clinical research also must contend with potential risk to human subjects. Clinical researchers should not be dissuaded from submitting applications as long as rigorous assessment of participant risk/benefit ratios compellingly indicates the ratio to be in favor of the potential benefit. Many of the advances in public health have been achieved through clinical trials, which necessarily involve some risk to participating human subjects. NIH acknowledges the presence of such risk and has established a set of clinical research ethics principles that provides guidance regarding the risk/benefit ratio in clinical research. Applicants proposing clinical research should contact Program staff at the appropriate component NIH Institute or Center (IC) to ensure that their applications conform to IC-specific policies for clinical research.

The NIH Director's Transformative Research Awards initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The NIH Director's Transformative Research Awards initiative is a component of the Common Fund High-Risk Research Program that also includes the NIH Director's Pioneer Awards, NIH Director's New Innovator Awards, and the NIH Director's Early Independence Awards.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIH Common Fund intends to commit $15 million dollars in FY 2013 for this initiative. Component Institutes and Centers of NIH may provide additional funds based on specific programmatic interests and availability of funds. The number of awards depends on the size and scope of the most meritorious applications, programmatic interest, and availability of funds.
Award Budget	There is no budget limit per application up to the funds made available for the entire initiative.
Award Project Period	The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government with the exception of NIH Intramural investigators
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ravi Basavappa, Ph.D.
Office of Strategic Coordination
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, Room 205
Bethesda, MD 20892-0189
Telephone: 301-435-7204
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Item 9. Bibliography and Literature Cited: Limited to one page.

Biographical Sketches:

Key personnel other than PD(s)/PI(s) should submit standard biosketches including the personal statement (as described in the SF424 instructions). PD(s)/PI(s) must submit FOA-specific biosketches. For this FOA, PD(s)/PI(s) must limit the number of publications, patents, and/or meeting abstracts cited to ten or fewer items. PD(s)/PI(s) 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 is being proposed in this application. Following each cited publication, patent, or meeting abstract, the PD(s)/PI(s) should very briefly summarize the findings or achievements described in the publication or other cited item that demonstrate relevance (familiarity with the field), exceptional innovation, and/or broad scientific impact, if that is not apparent from the title. Each such summary should not exceed 60 words and all summaries must be provided within the four page limit.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

In one page, address the following:

Challenge, Innovation and Impact Statement (up to 200 words): What is the fundamental paradigm or problem that will be addressed? How does your proposed research challenge the existing paradigm or seek to establish a new paradigm? Or, how will the technology or clinical strategy to be developed fundamentally change the way research is conducted or the way patients are diagnosed or treated? What is exceptionally novel or innovative about your perspective and/or approach? Why is testing the hypothesis or solving the problem important for the field and for the NIH scientific enterprise as a whole? What are the potential breadth and magnitude of the project’s impact on science and/or health?

Rationale: What is the underlying logic or rationale driving the proposed research? What is the specific gap in knowledge or technology that will be addressed and how will the outcome of this study dramatically propel the field forward? What innovations in technology or approach will be necessary to attack the problem? This and the previous section should provide a cogent overview of the entire application.

Research Strategy

The Research Strategy component is limited to 12 pages. Organize the Research Strategy as a single document in the specified order using the instructions provided below. Start each section with the appropriate section heading (i.e., Challenge, Innovation and Impact Statement; Rationale; Approach; Appropriateness for the Transformative Research Awards initiative; and Timeline).

Approach (limit, 10 pages): How will you attempt to test the novel paradigm, develop the technology, or attack the problem? How does your approach significantly differ from the current state of the art in the field? If it is your methodology that is novel, what is unconventional and exceptionally innovative about your approach? How will your rationale and/or approach overcome existing challenges or barriers in the field? Provide enough information for reviewers to clearly understand what you are proposing to do, but do not include a detailed experimental plan.

Appropriateness for the Transformative Research Awards initiative (limit, one page): Why is the proposed research uniquely suited to the goals of the Transformative Research Awards initiative, rather than a conventional research grant application? How does the proposed research significantly differ from mainstream science being done in your laboratory or in other laboratories?

Timeline (limit, one page): Provide a timeline for the proposed research indicating points where intermediate objectives will be assessed, the measurable outcomes that will be used to monitor progress, and the timing and process for reaching decisions regarding the course and direction of the continuing research effort. Given the high degree of risk involved in applications submitted under the Transformative Research Awards initiative, it is anticipated 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.

Preliminary data are not required but may be included. The presentation must be clear and particularly compelling. No detailed experimental plan should be provided.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Appendices are not allowed for applications submitted in response to this FOA.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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 only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and responsiveness by the Office of the Director, NIH. Applications that are incomplete and/or non-responsive will not be reviewed.

No supplemental/update/post-submission or other information will be accepted after the receipt date for applications submitted in response to this FOA.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The NIH Director's Transformative Research Awards initiative is designed to support research projects with the potential to have a profound effect on biomedical or behavioral research. Preliminary data are not required. Each project is expected to develop innovative methods, to employ standard methods in innovative ways, or to test exceptionally innovative ideas. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge, understanding, or capability.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the study have clear transformative potential? Is the proposed research exceptional in terms of its consequence for the field and size of the community affected? Is the paradigm being tested central to the field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the past achievements of the PD(s)/PI(s) suggest that the investigator(s) is/are exceptionally innovative and likely to make paradigm-shifting, high-impact discoveries? If the PD(s)/PI(s) do(es) 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? Is this project high priority for the PD(s)/PI(s), as indicated by the person-months of effort that the PD(s)/PI(s) will devote to it?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the hypothesis or proposed methodology highly unconventional and exceptionally innovative?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Will particularly risky aspects be managed well?

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

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 PD(s)/PI(s) 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? Is the requested duration of the award appropriate for the proposed research?

Environment

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

Not Applicable..

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact/priority score.
• Will receive a summary statement consisting of a description of the overall process used to evaluate the application and, for scored applications, a brief paragraph describing the main issues of discussion.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, 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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Ravi Basavappa, Ph.D.
Office of Strategic Coordination
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, Room 205
Bethesda, MD 20892-0189
Telephone: (301) 435-7204
Email: [email protected]

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: [email protected]

Michael G. Morse
Office of Strategic Coordination
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, room 203
Bethesda, MD 20892-0189
Telephone: (301) 435-5446
Fax: (301) 435-7268
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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.