It is critical that applicants follow the Research (R) Instructions in the SF424 (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 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 application. 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 NIH Director's 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 is part of the High-Risk, High-Reward Research program, which also includes the NIH Director's Pioneer Award, the NIH Director's Transformative Research Award, and the NIH Director's Early Independence Award. The program is part of 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.

See Section VIII. Other Information for award authorities and regulations.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 the purpose of this FOA, multiple PD(s)/PI(s) are not allowed.

Applicants must meet the definition of an Early Stage Investigator (ESI) at the time of application. 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). See the Office of Extramural Research for a complete list of NIH grants that do not disqualify a PD/PI as a new investigator and for frequently asked questions about the NIH Early Stage Investigator (ESI) Policy.

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 . A request for extension must be approved at the time the NIH Director’s 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, 2018. 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 proposed 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, 2018, 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 NIH Director’s New Innovator Award application that does not overlap substantially with their New Innovator Award application. However, if that pending grant is awarded prior to the NIH Director’s New Innovator Award, 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.

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

Agency Routing Identifier: Enter Science Area Designations. Designate two scientific areas (a primary and secondary) from the list below. For each area, enter the one-digit code and abbreviation (e.g., 1 BBS).

1 BBS - Behavioral and Social Science

2 CB - Chemical Biology

3 CTR - Clinical and Translational Research

4 IDI - Infectious Diseases and Immunology

5 IE - Instrumentation and Engineering

6 MCB - Molecular and Cellular Biology

7 NS - Neuroscience

8 HIB - High-Throughput and Integrative Biology

9 BCB - Bioinformatics 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 two science areas that are most appropriate for your proposed project.

The selection of scientific areas by applicants is solely to aid in the assignment of reviewers on the panel does not in itself affect an application’s funding potential. The application requirements and instructions are identical for all the science areas. All applications are reviewed in the same time period and by the same panel, and compete for a single source of funds.

Important: For each of the two science area designations enter the one-digit code followed by one space and then the corresponding abbreviation. Enter the primary area first and secondary area second. Separate the two entries by a semicolon.

Correct Example: 1 BBS; 7 NS

Note: The science area designations (two-one digit codes and name of science areas) must also be included at the beginning of the Essay.

Type of Application: Must be New .

Proposed Project: The start date should be September 30, 2018 and the end date should be June 30, 2023.

Total Federal Funds Requested: Enter $1,500,000.

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $1,500,000.

Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total $1.5 million -- should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds". 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.

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

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

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

Equipment: DO NOT USE.

Other Attachments: DO NOT USE

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

Profile Project Director/Principal Investigator Field 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.

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.

Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.

Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Specific Aims: DO NOT USE

Research Strategy: Upload Essay here. Submit an essay 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 at a level 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. Do not provide a detailed experimental plan. Preliminary data are allowed but not required. The essay should include the following sections within the page limit, in the following order, with the headings shown:

Project science areas: Provide 1-digit code and abbreviation for primary and secondary science areas at beginning of essay. See "Agency Routing Identifier" information above for codes and format.

Project Description: Describe the scientific challenge or opportunity that you propose to address, its importance, and how addressing this would have a major impact on a broad area of biomedical/behavioral science. Describe the overall approach to be taken. State prominently that to comply with the FOA, a detailed experimental plan and extensive preliminary data are not being provided. However, the reviewers must still have a clear sense of what is being proposed to be done and why.

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?

Suitability for the New Innovator Award program: Why is the planned research uniquely suited to the New Innovator Award, rather than to a more traditional grant mechanism?

Statement of research effort commitment: 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.

Note: Bibliographic citations are not required but if included must fit within the ten-page limit. Inclusion of the most critical citations is encouraged. Figures and illustrations may be included but must also fit within the ten-page limit. Letters of collaboration will not be accepted. Information on collaborators may be included in the Essay and their names and affiliations should be listed in the PHS Assignment Request Form.

Consortium/Contractual Arrangements: DO NOT USE

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

For this FOA, the Resource Sharing Plans will be expected as Just in Time information if an award is being considered

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following modifications. Since all applications are received as "Office of the Director" applications and are reviewed by a single Special Emphasis Panel, applicants should not request assignment to a particular review panel or awarding component. Since letters of collaboration and biosketches of collaborators are not allowed, provide the names of collaborators here to identify them for exclusion during reviewer assignment.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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 SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Only documents to inform of unforeseen events, such as natural disasters, that substantially affect the ability to execute the proposed research will 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 essay focuses on the goals of the New Innovator Award program. Preliminary data are not required but may be included. Accordingly, reviewers will provide comments emphasizing 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.

Reviewers will provide an overall impact 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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

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

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?

Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

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 score.

Not Applicable.

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).

Since the resource sharing plans are expected just-in-time information, reviewers will not 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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May 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 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 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 , including
• Despite inherent scientific and technical risks, the potential for the investigator to lead research that may result in scientific breakthroughs of broad potential impact.
• Unusually cross-cutting or significantly underrepresented science.

PDs/PIs will be notified of their status in March 2017. Awardees will be notified by August 2018. Awards will begin in September 2018. PDs/PIs will be notified of their status in March 2017. Awardees will be notified by August 2018. Awards will begin in September 2018.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 eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year 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 using the RPPR 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Ravi Basavappa, Ph.D.
Office of the Director (OD)
Telephone: 301-435-7204
Email: [email protected]

Rajiv Kumar, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1212
Email: [email protected]

Srikanth Ranganathan, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1787
Email: [email protected]

Michael G. Morse
Office of the Director (OD)
Telephone: 301-435-5446
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 Part 75.