Required Application Instructions

It is critical that applicants follow the 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 Pioneer Award initiative 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 significant problems with no clear solution 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.

To be considered pioneering, the proposed research must reflect ideas substantially different from those being pursued in the investigator’s research program or being pursued elsewhere. The program is not intended to expand a current research program's funding in the area of the proposed project. While the research direction may have as its foundation the applicant’s prior work and expertise, it cannot be an obvious extension or scale up of a current research enterprise which could be anticipated to be competitive as a new or renewal R01 application. Rather, the proposed project must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of radically unconventional hypotheses. Applications for projects that are extensions of ongoing research should not be submitted.

Pioneer awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Pioneer Award research project in the first three years of the project period. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. Awardees will be allowed to reduce effort to 33% and 25% in the fourth and fifth years, respectively, to help them transition to other sources of support. Applicants with current research commitments exceeding 49% must provide a detailed explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project. Applicants who will not be able to meet this requirement should not submit applications.

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.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

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. PD(s)/PI(s) may submit only one application 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).

Applicants must obtain 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, 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 Field: 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 IMM - 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 Science Area Designations are to assist in assigning applications to reviewers. The science areas are very broad and frequently overlapping. Pioneer Award reviewers are chosen for their breadth of knowledge and expertise and their ability to review a broad range of applications. Choose the primary and secondary science areas that are most appropriate for your proposed project.

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 two scientific area designations (one digit code and abbreviation for each) must also be included at the beginning of the Essay.

Type of Application: Must be New .

Proposed Project: Enter start date: 09/30/2017; Enter end date: 07/31/2022

Total Federal Funds Requested: Enter $3,500,000. (See note below.)

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $3,500,000.

Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in Fields "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 $3,500,000 -- should be entered in Fields "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.

Cover Letter: List significant collaborators for the proposed Pioneer Award project. Letters of collaboration and biosketches of collaborators are not allowed. Provision of names here is only to help exclude conflicts during reviewer assignment. Information regarding any collaborators may be included in the Essay.

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 modifications:

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

Facilities & Other Resources Statement: 1 page maximum.

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: 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.

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:

Introduction to Application: Do not use.

Specific Aims: Do not use.

2.3: Research Strategy: Upload the Essay here.

Describe your innovative vision for addressing a major biomedical or behavioral problem or challenge, the importance of this problem or challenge, and your qualifications to engage in groundbreaking research. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below:

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

Project Title: The project title must be descriptive of the proposed project.

Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What is the premise of the project, including strengths and weaknesses of prevailing relevant theories? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results? How will you ensure that the results will be robust and unbiased? The writing should be at a level that conveys the significance and impact of the application to broadly knowledgeable scientists with different expertise domains.

Evidence of PD(s)/PI(s) innovativeness: What concrete evidence can you provide for your claim of innovativeness? For example, qualities common to many highly innovative people include an interest in, and the ability to integrate, diverse sources of information; an inclination to challenge paradigms and take intellectual risks; persistence in the face of failure; an ability to attract the right collaborators; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.

How the planned research differs from the PD(s)/PI(s) past or current work: How does the proposed project represent a new and distinct direction for your research? While a new research direction may have as its foundation the applicant's prior work and expertise, it cannot be an obvious extension or scale-up of a current research enterprise, which could be anticipated to be appropriate for a new or renewal R01 application. Rather, a new research direction must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of radically unconventional hypotheses. Applications for projects that are extensions of ongoing research should not be submitted.

Suitability for Pioneer Award program: Why is the planned research uniquely suited to the stated goal of the Pioneer Award program, rather than a more traditional grant mechanism?

Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the PD/PI will commit a minimum of 51% of his/her research effort to the project supported by the Pioneer Award. Applicants with current research commitments exceeding 49% must provide a compelling explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project.

Note: References are not required but if included must fit within the five-page limit. Figures and illustrations may be included but must also fit within the five-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 Cover Letter.

Progress Report Publication List: Do not use.

Multiple PD/PI Leadership Plan: Do not use.

Consortium/Contractual Arrangements: Do not use.

Letters of Support: Do not use.

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: Appendix materials are not allowed.

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

Since all applications received in response to this FOA are assigned to a single Special Emphasis Panel and initially to the Office of the Director, do not suggest assignment to a specific study section.

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.

Letters of reference are an important part of the Pioneer Award application. Applicants must arrange to have three (and no more than three) letters of reference submitted on their behalf. Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. Letters must be submitted electronically paper copies will not be accepted.

Applicants are responsible for monitoring the submission of their letters in the grant folder in the eRA Commons to ensure that three letters have been submitted prior to the submission deadline.

Letters must be submitted no later than 5:00 p.m. (local time of the referee) on the Application Due Date of the competition, September 2, 2016.

To submit a letter of reference, the referee (the individual submitting the letter) will need the following information:

Funding Opportunity Number (FOA) for this announcement: RM-16-005;

The PD/PI's (Applicant's) Commons User ID - (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name only the PD/PI's (Applicant's) Commons User ID is required);

The applicant’s last name (note the name must match exactly the applicant’s name in the Commons);

The URL to the letter submission page: (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new ).

The letter of reference submission deadline: The deadline for receipt of letters is 5:00 p.m. (local time of the referee) on the Application Due Date of the competition, September 2, 2016.

Letters of reference are confidential. Applicants will not have access to the letters. Email confirmations will be sent to both the applicant and the referee. The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and applicant’s names, a confirmation number, and the date and time the letter was submitted.

Note: Since email can be unreliable, it is the applicant s responsibility to check the status of his/her letters of reference periodically in the Commons.

Applicants are strongly encouraged to send the following to their referees or to send their referees the following link to this information: (https://commonfund.nih.gov/pioneer/LettersofReferenceFormat.aspx).

Instructions for Referees:

Letters must be submitted to the Commons at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) by 5:00 p.m. (local time of the referee), on the Application Due Date of the competition, September 2, 2016. Late letters will not be accepted and applications with fewer than three letters will not be reviewed. Letters must be submitted electronically paper copies will not be accepted.

IMPORTANT: The applicant’s name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.

In two pages or less, describe the applicant’s qualities that support the applicant’s claim to scientific innovativeness and creativity. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct groundbreaking research in the proposed research area.

Note: The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons. Referees must enter the following information when submitting letters:

REFEREE INFORMATION (the individual providing the letter of reference):

• Referee s First and Last Name
• Referee s Email Address
• Referee s Institution/Affiliation
• Referee s Department

APPLICANT INFORMATION (applicants must send this information to their referees):

• Applicant s Commons User Name (User ID), (Important this must be the applicant s, not the referee s, Commons User Name (User ID). The letter will not be linked to the appropriate application if the Applicant’s User Name is not entered here.)
• Applicant s Last Name. (Note: must match exactly the applicant’s name in the Commons).
• Funding Opportunity Number (FOA) of this announcement: RM-16-005
• Confirmation Number (Required only when resubmitting a letter, that is, when submitting a revised or changed/corrected letter for the current FOA).

Email confirmations will be sent to both the applicant and the referee following submission of the letter. The email confirmation will include a Confirmation Number that will be required when submitting revised or changed/corrected letters. Print the confirmation email for your records.

Note: Referees who submitted letters for Pioneer Award applicants in prior years must submit new letters of reference this year. Previously submitted letters will not be retrieved.

Please see the detailed instructions on submitting letters of reference at (https://commonfund.nih.gov/pioneer/LettersofReferenceFormat.aspx), and the Frequently Asked Questions at (https://commonfund.nih.gov/pioneer/faq.aspx). Send question to [email protected].

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 Pioneer Award (DP1) applications are meant to support individual scientists of exceptional creativity who propose pioneering -- and possibly transforming -- approaches that, if successful, will have a major impact on a broad area of biomedical or behavioral research. Pioneer Award applications do not require preliminary data, scientific aims, or a detailed research plan. Accordingly, reviewers will emphasize the following:

1) the significance and innovation of the proposed project;

2) the investigator (evidence for past innovation; and the PD(s)/P('s) demonstrated ability to devote 51% or more research effort on DP1 project); and

3) the suitability of the proposed project for the Pioneer Award mechanism, which includes evidence that the proposed research is of sufficient risk/potential impact that it is more suitable for the Pioneer Award program than for a traditional grant mechanism, and that the proposed research represents a new research direction for the PD(s)/PI(s). A new research direction is defined as a significant departure from the direction of ongoing or previously funded research in the PD(s)/PI(s) laboratory.

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 more than 51% research effort to the Pioneer Award project?

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).

Not Applicable

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.

The locus of review must be shown below. Please enter convened by the {IC name} or convened by the Center for Scientific Review after appropriate Scientific Review Group(s) for the locus of review as appropriate.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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. Using the review criteria stated above, those candidates identified as the most outstanding will be invited to Bethesda, MD for interviews in May 2017. Interviews will be conducted by a panel of distinguished outside experts.

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 review results for applications submitted to this FOA are not allowed.

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.

Applicants will be notified in April 2017 of the outcome of the first review phase - whether or not they have been selected for an interview; awardees will be notified in August. Awards will begin in September 2017.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

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: https://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 CenterTelephone: 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]

James Mack, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2037
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.