Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Common Fund (Roadmap). This FOA is developed as an NIH Common Fund initiative (http://commonfund.nih.gov) through the Office of Strategic Coordination, Division of Program Coordination, Planning and Strategic Initiatives, Office of the NIH Director (http://dpcpsi.nih.gov/osc). All NIH Institutes and Centers participate in Common Fund initiatives. This FOA is being administered by the Office of Strategic Coordination on behalf of the NIH.
Funding Opportunity Title	2013 NIH Director's New Innovator Award Program (DP2)
Activity Code	DP2 NIH Director’s New Innovator Award
Announcement Type	Reissue of RFA-RM-11-005
Related Notices	August 8, 2013 - This RFA has been reissued as RFA-RM-13-007.
Funding Opportunity Announcement (FOA) Number	RFA-RM-12-016
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 New Innovator (DP2) Award initiative was created in 2007 to support a small number of early stage investigators of exceptional creativity who propose bold and highly innovative new research approaches that have the potential to produce a major impact on broad, important problems in biomedical and behavioral research. The New Innovator Awards complement ongoing efforts by NIH and its Institutes and Centers to fund early stage investigators through R01 grants, which continue to be the major sources of NIH support for early stage investigators. The NIH Director’s New Innovator Award initiative is a component of the High Risk - High Reward Research Program of the NIH Common Fund.

Posted Date	August 7, 2012
Open Date (Earliest Submission Date)	September 17, 2012
Letter of Intent Due Date	Not Applicable.
Application Due Date(s)	October 17, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	April 2013
Advisory Council Review	May 2013
Earliest Start Date(s)	September 2013
Expiration Date	October 18, 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 NIH Director's New Innovator Award addresses two important goals: stimulating highly innovative research and supporting promising new investigators. New investigators may have exceptionally innovative research ideas, but not the preliminary data required to fare well in the traditional NIH peer review system. As part of NIH's commitment to increasing opportunities for new scientists, it has created the NIH Director's New Innovator Award to support exceptionally creative new investigators who propose highly innovative research projects that have the potential for unusually high impact. This award complements ongoing efforts by NIH and its institutes and centers to fund new investigators through R01 grants and other mechanisms.

The NIH Director's New Innovator Award program is different from traditional NIH grants in several ways. It is designed specifically to support unusually creative investigators with highly innovative research ideas at an early stage of their career when they may lack the preliminary data required for an R01 grant. The emphasis is on innovation and creativity; preliminary data are not required, but may be included. No detailed, annual budget is requested in the application. The review process emphasizes the individual’s creativity, the innovativeness of the research approaches, and the potential of the project, if successful, to have a significant impact on an important biomedical or behavioral research problem.

The research proposed for a New Innovator Award may be in any scientific area relevant to the mission of NIH (biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences). Investigators who were not selected for an award in prior years may submit applications this year as long as they retain their ESI (early stage investigator) eligibility; however, all applications must be submitted as new applications regardless of any previous submission to the program.

The NIH Director's New Innovator Award initiative is part of the NIH Common Fund (formerly known as the NIH Roadmap), 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 Pioneer Awards initiative is a component of the Common Fund High-Risk Research Program that also includes the NIH Director's New Innovator Awards, the NIH Director's Transformative Research 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	The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. NIH intends to commit approximately $80 million for approximately 33 awards in FY 2013. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Awards will be for up to $300,000 in direct costs each year for five years, plus applicable Facilities and Administrative (F&A) costs to be determined at the time of award.
Award Project Period	The maximum project period is 5 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
• 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/Principal Investigator (PD/PI) 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 the purpose of this FOA, multiple PD(s)/PI(s) are not allowed.

Applicants must meet the definition of an Early Stage Investigator (ESI). An ESI is a new investigator (defined as a PD/PI who has not competed successfully for a significant NIH independent research award) who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). A complete list of NIH grants that do not disqualify a PD/PI as a new investigator can be found at: http://grants.nih.gov/grants/new_investigators/. Frequently Asked Questions about the NIH Early Stage Investigator (ESI) Policy can be found at http://grants.nih.gov/grants/new_investigators/.

An extension to the 10-year period may be granted under special circumstances (e.g., family care responsibilities, extended periods of clinical training, disability or illness, etc). To request an extension, an applicant MUST complete the Form for Requesting an Extension in the Early Stage Investigator (ESI) Period (http://grants.nih.gov/grants/new_investigators/esi_extension_add.htm). A request for extension must be approved at the time the New Innovator Award application is submitted. It may take up to several weeks for the approval process, so applicants should plan accordingly.

Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion. Applicants should allow several weeks for an extension request to be processed. NOTE: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed.

Applicants also must hold an independent research position at a domestic (U.S.) institution as of September 1, 2013. For the purpose of this FOA, independent research position means a position that automatically confers eligibility, by the applicant’s institutional policy, for an investigator to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the propose research. Investigators still in training or mentored status (postdoctoral fellows) are not eligible to apply unless they have a written commitment of an independent faculty position as of September 1, 2013 that is certified by submission of the application from that institution.

Applicants may submit or have an R01 (or other equivalent) grant application pending concurrently with their New Innovator Award application. However, if that pending grant is awarded in Fiscal Year 2013 with a start date of September 30, 2013 or earlier, then the applicant is no longer eligible to receive the New Innovator Award.

Awardees are required to commit at least 25% of their research effort each year to activities supported by the New Innovator Award.

For more details regarding eligibility requirements, see FAQs on the New Innovator website at http://commonfund.nih.gov/newinnovator/index.aspx.

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. Only one application per PD/PI is permitted in response to this FOA.

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.

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.

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.

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

Item Number 4.b: Agency Routing Identifier: Enter Science Area Designation. Designate one scientific area from the list below by entering the one-digit code and name of scientific area (e.g., 1 Behavioral and Social Sciences). Choose the one area that best describes your proposed research.

1 Behavioral and Social Science

2 Chemical Biology

3 Clinical and Translational Research

4 Immunology

5 Instrumentation and Engineering

6 Molecular and Cellular Biology

7 Neuroscience

8 High Throughput and Integrative Biology

9 Quantitative and Computational Biology

The areas of science listed above are very broad and frequently overlapping. New Innovator Award reviewers are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Choose the one science area that is most appropriate for your proposed project.

IMPORTANT: Enter only the one-digit code followed by one space and then the name of the science area (exactly as shown above); do not use quotation marks, dashes, or other characters.

Correct: 1 Behavioral and Social Sciences
Incorrect: 1 Behavioral and Social Sciences ; 1 Behavioral and Social Sciences; 1: Behavioral and Social Sciences

The selection of scientific area by applicants is solely to aid in selection of the most appropriate group of peer reviewers and does not in itself affect an application’s funding potential. The application requirements and instructions are identical for all the science areas. All nine scientific areas are considered as a single competition, are reviewed in the same time period and by the same panel, and compete for a single source of funds. Note: The science area designation (one digit code and name of science area) must also be included at the beginning of the Essay.

Field 8. Type of Application: Must be New .

Field 12. Proposed Project: Enter start date: 09/30/2013; Enter end date: 7/31/2018.

Field 15a. Total Federal Funds Requested: Enter $1,500,000.
Field 15b. Total Non-Federal Funds: Enter $0.
Field 15c. Total Federal & Non-Federal Funds: Enter $1,500,000.
Field 15d. Estimated Program Income: Enter $0.

Note: The Budget Request is entered only on Lines 15a and c, as described above. Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total $1.5 million -- should be entered on Lines 15a and c. Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

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

Field 9: Bibliography & References Cited: DO NOT USE. Reference citations are not required, but may be included in the essay and are included in the ten-page limit

Field 10. Facilities & Other Resources: Upload a brief statement (1 page maximum) of the facilities to be used for the conduct of the research.

Field 11: Equipment: DO NOT USE.

Field 12: Other Attachments: DO NOT USE.

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

Profile PD/PI Attach Biographical Sketch: Attach PD/PI s biographical sketch, two pages maximum, using the sample format on the Biographical Sketch Format Page shown in the Application Guide, Section 4.5. omitting Section A (Personal Statement) and Section D (Research Support).No biographical sketches of potential collaborators or other key personnel are to be submitted and will not be accepted. Information on potential collaborators is not required but may be included in the Essay.

Profile PD/PI Attach Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. Use the format for "Other Support" as shown in Section III.1.8 of the Application Guide. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 25% of his/her research effort to the project supported by the New Innovator Award.

Profile Senior Key Person 1: DO NOT USE. Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay.

Cover letters should be included to provide names and affiliations of significant collaborators for the New Innovator Award project. Letters of collaboration are NOT permitted.

Not Applicable.

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

Research Plan Attachments

Field 2.1. Introduction to Application: DO NOT USE

Field 2.2. Specific Aims: DO NOT USE

Field 2.3. Research Strategy: Upload Essay here. Submit an essay of no more than 10 pages that addresses (1) the significance and potential impact of the project, (2) what makes the approaches exceptionally innovative and how the applicant will address risks and challenges, and (3) the applicant s qualifications for this award. The description of the scientific plan should be written with a level of detail appropriate for reviewers who are broadly knowledgeable but who may not be directly involved in the proposed area of research. To focus the essay on the goals of the New Innovator Award program and the review criteria for applications, presentation of the proposed research as a series of specific aims is discouraged. Preliminary data are allowed but not required. Bibliographic citations (references), figures, and illustrations may be included, but must fit within the 10-page limit. The essay should include the following sections within the 10-page limit, in the following order, with the headings shown:

Project Description: Describe the scientific problem that you propose to address, its importance, and how solving this problem would have a major impact on a broad area of biomedical/behavioral science. Why is the planned research uniquely suited to the New Innovator Award program, rather than a traditional grant mechanism? How is this project distinct from other research that may be supported in your laboratory?

Innovativeness: State clearly and concisely what makes your project unusually innovative. If the approaches entail a high degree of risk, what will you do if these approaches are not successful?

Investigator Qualifications: Provide evidence to support your claim of innovativeness and creativity in your research. For example, which personal qualities and experiences demonstrate your inclination to challenge paradigms and take intellectual risks, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?

Note: Bibliographic citations are not required but if included must fit within the ten-page limit. Figures and illustrations may be included but must also fit within the 10-page limit.

Field 2.4 Inclusion Enrollment Report: DO NOT USE

Field 2.5 Progress Report Publication List: DO NOT USE

Field 2.12 Multiple PD/PI Leadership Plan: DO NOT USE. Multiple PD(s)/PI(s) are not allowed.

Field 2.13 Consortium/Contractual Arrangements: DO NOT USE

Field 2.14 Letters of Support: DO NOT USE. Letters of Support are not allowed.

DOCUMENTS TO BE UPLOADED: The following table is a summary of the documents that must be uploaded to the application. Detailed instructions for completing each application component are below.

Document Name	Form/Field	Special Instructions
Cover Letter	Cover Letter Component	Provide names and affiliations of significant collaborators for the New Innovator Award project. Letters of collaboration and biosketches of collaborators are not allowed.
Abstract	SF 424 (R&R) Other Project Information Component, Field 7 (Project Summary/Abstract)	30 lines of text maximum
Public Health Relevance Statement	SF 424 (R&R) Other Project Information Component, Field 8 (Project Narrative)	2 3 sentences maximum
Facilities & Other Resources	SF 424 (R&R) Other Project Information Component, Field 10 (Facilities and Other Resources)	One page maximum
Biographical Sketch	SF 424 (R&R) Senior/Key Person Profile, field titled Attach Biographical Sketch	Two pages maximum; omit section A (Personal Statement) and section D (Research Support) Submit only for PD/PI
List of Current and Pending Research Support	SF424 (R&R) Senior/Key Person Profile Component	Provide current year direct costs to applicant and percent effort for each project. Include statement that at least 25% of research effort will be for New Innovator Award research.
Essay	PHS 398 Research Plan, Field 2.3 (Research Strategy)	Ten pages maximum; must include science area (1-digit code and name of science area at beginning of essay). No Specific Aims pages should be provided.
Human and Vertebrate Animal Subjects Plans (If applicable)	PHS 398 Research Plan Component, Fields 6-10	Complete instructions for the PHS398 Research Plan component are in the SF424 Application Guide, Section I, part 5 (Completing PHS 398 Components) see page I-109. There are also supplemental instructions for preparing the human subjects plan in Part II of the Application Guide.

Note: All documents must be in PDF format and must comply with prescribed page limits. No additional documents should be uploaded to the application and applications that contain additional materials may not be reviewed.

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:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but for this FOA, the resource sharing plans will be requested as just-in-time information if an award is being considered.

Appendix

Appendix materials are not allowed.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

For the purposes of this FOA, post submission materials are not allowed and will not be accepted.

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 New Innovator Award (DP2) grant supports innovative research that has the potential to produce a major impact on a broad area of biomedical or behavioral research. A DP2 grant application does not have extensive background material, and the 10-page essay focuses on the goals of the New Innovator Award program. Preliminary data are not required but may be included. Accordingly, reviewers will emphasize the following: 1) the importance of the scientific problem and the potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early stage investigator.

Applications that are complete and responsive to this FOA will be reviewed in two phases by a multidisciplinary scientific review group of outside experts convened by the Center for Scientific Review on behalf of the Office of the Director and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. Applications will initially be evaluated for scientific and technical merit by outside reviewers. Overall impact/priority scores and standard criterion scores will not be given. Subsequently, an editorial-style panel will consider the applications and the comments of the initial reviewers to select the most meritorious applications. These will be discussed, and the panel will determine overall impact/priority scores for them. Applications that the panel considers less meritorious will not be discussed. The Director of the Division of Program Coordination, Planning, and Strategic Initiatives in the Office of the Director, NIH, will select awardees based on the outcomes of the scientific peer review, the recommendations of the Council level of review, programmatic considerations, and availability of funds. Notification of awardees will be in September 2013.

Applications that are not selected for discussion in the second phase of review will receive summary statements with brief reviewer comments. These applications will be designated as Not Discussed and will not receive a numerical impact/priority score. Applications selected for discussion in the second phase of review will receive summary statements with brief reviewer comments and a numerical impact/priority score. Criterion scores will not be provided for any application.

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,. 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?

Investigator(s)

Are the PD/PI, 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)? Does the PD/PI devote 25% or more of his/her research effort on the New Innovator Award project each year?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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

Environment

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

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

Not Applicable.

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) 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 written critique.

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

Applications will be assigned 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 appropriate Council-level body. 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.

Applicants will be notified of their status in March 2012. Awardees will be notified in August 2013. Awards will begin in September 2013.

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.

Progress reports for multiyear funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multiyear funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm.

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Ravi Basavappa, Ph.D.
Office of Strategic Coordination
Office of the Director, NIH
1 Center Drive, MSC 0189
Building 1, Room 203
Bethesda, MD 20892-0189
Telephone: 301-594-8190
Email: newinnovator@nih.gov

Rajiv Kumar, Ph.D.
Musculoskeletal, Oral and Skin Sciences (MOSS)
Division of Translational and Clinical Sciences
Center for Scientific Review
6701 Rockledge Dr., Room 4216
Bethesda, MD 20892
Telephone: 301-435-1212
Email: kumarra@csr.nih.gov

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
Email: morsem@mail.nih.gov

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.