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 Early Independence Awards initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

The NIH Director’s Early Independence Awards provide an opportunity for exceptional junior scientists to accelerate their entry into an independent research career by forgoing the traditional post-doctoral training period. Though most newly graduated doctoral-level researchers would benefit by post-doctoral training, a small number of outstanding junior investigators would benefit instead by launching directly into an independent research career. For these select investigators, who have established a record of scientific innovation and research productivity and who have demonstrated unusual leadership, drive, and maturity, post-doctoral training would unnecessarily delay their entry into performing independent research. The NIH Director’s Early Independence Awards also provide an opportunity for institutions to invigorate their research programs by bringing in the fresh perspectives of the awardees that they host.

By the end of the award period, the Early Independence investigator is expected to be competitive for continued funding of his/her research program and for a permanent research position.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects all of its efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. Applicant institutions are always encouraged to consider talented researchers from diverse backgrounds underrepresented in biomedical research, including underrepresented racial and ethnic groups, persons with disabilities and women for participation in all NIH-funded research opportunities.

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

• Eligible Agencies of the Federal Government - including the NIH Intramural Program
• U.S. Territory or Possession

Other

• 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 will be accepted. Applications with multiple PDs/PIs will not be accepted.

Time window for eligibility: At the time of application, the individual either 1) within the preceding twelve months must have received a terminal doctoral degree or completed medical residency or 2) within the following twelve months must complete all the requirements for a doctoral degree or complete a medical residency. The fellowship training period is NOT included in the clinical residency or equivalent training period. The date of degree receipt is that which appears on the official transcript for the degree. The time of application is the date when the application is submitted electronically to NIH through Grants.gov. In addition, at the time of application, the PD/PI must not have served as a post-doctoral fellow following a previous doctoral degree for more than one year.

At the time of award to the grantee Institution, either 1) the Early Independence investigator must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution (it is the responsibility of the sponsoring institution to determine if a foreign doctoral degree is equivalent), OR 2) an authorized official of the degree-granting institution must certify that all degree requirements have been met and that the date of graduation as appearing on the transcript will be within one year of the date of application submission. In addition, the candidate must not already be a PD/PI on an NIH R01 or R01-equivalent award.

Level of effort: Individuals must commit at least 9.6 person-months (80% effort) during the first two years of the project period to research supported by the Early Independence Award. In the final three years of the project period, awardees may reduce effort toward the Early Independence Award, but the total effort towards independent research must still be at least 9.6 person-months (80% effort).

Research independence at time of application: Individuals are eligible only if they, at the time of application submission, do not have research independence. Lack of research independence is defined functionally rather than by position title. Eligible individuals must have all the following characteristics:

• The candidate's current research agenda is set through concurrence with mentors.
• The candidate's research is funded primarily through support to other investigators (mentored fellowships such as NIH F31/F32 Fellowships or NSF Graduate Research Fellowships do not preclude eligibility).
• The candidate does not have any space assigned directly by the institution for the conduct of his or her research.
• The candidate, according to institutional policy, cannot apply for an NIH R01 grant without special waiver or exemption from the institution.

Though candidates must not be functionally independent at the time of application submission, they may become functionally independent prior to time of award and still retain eligibility for the award.

Prospective candidates should contact appropriate Institutional leaders to seek an appointment in an independent research position. Alternatively, Institutions may actively recruit eligible junior scientists to apply for support through this program. In either event, the Institution will be expected to provide substantial support for the junior scientist as detailed below. To foster independence, it may behoove candidates to be hosted by institutions other than the ones at which they trained. To facilitate the matching of institutions and candidates, the NIH Common Fund is hosting a website (http://commonfund.nih.gov/earlyindependence/matchingportal/index.aspx) in which institutions interested in hosting candidates may choose to provide pertinent information such as particular areas of research being targeted, supporting documents to be submitted, and institution contact information.

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

Each institution normally defined by having a unique DUNS number or NIH IPF number may submit only up to two applications.

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 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, 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Ravi Basavappa, Ph.D.
Office of Strategic Coordination
Office of the Director, NIH
1 Center Drive, MSC 0115
Telephone: 301-435-7204
Fax: 301-435-7268
Email: [email protected]

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.

Cover Letter Attachment: The cover letter must include the list of referees (including name, department, and institution).

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

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

Facilities & Other Resources: Applicant institution officials must address each of the following items below. Use appropriate subheadings in the response.

Positions details:

• During the award period, the Early Independence Investigator must be scientifically independent and administratively independent. The appointment need not be permanent or tenure-track and may be contingent upon receipt of the Early Independence Award. Describe in detail the position into which the Early Independence Investigator will be appointed and how the candidate's independence will be ensured during the course of the award.
• Describe plans for maintaining protected time for the Early Independence Investigator so that he or she will be able to devote at least 9.6 person-months (80% effort) to conducting independent research during the project period, with at least the first two years being devoted entirely to the Early Independence Award project. Clinicians should be permitted to perform clinical duties to the extent necessary to maintain credentials.
• Describe the process and criteria used to select the candidate.
• Describe the Institutional organizational structure within which the Early Independence PD/PI's position will be administered (School, Department, etc.), and explain how this administrative structure will best meet the goal of supporting the success of the Early Independence PD/PI. Include details of responsibilities for integrating the Early Independence Investigator and their scientific project into the institutional culture and the faculty community. Describe the management of problematic situations as well as institutional expectations related to the retention or transfer of the candidate at the end of the funding period.

Institutional resources commitment:

• Describe details of the laboratory space to be provided to the Early Independence Investigator including physical structure and space layout along with the availability of support staff.
• Describe other administrative and support functions that will be available to the Early Independence Investigator (for example, human resources, supply and equipment ordering systems, administrative assistance, etc.)
• Describe the institutional financial commitment to the Early Independence Program. Matching funds are not required; however, an appropriate level of institutional support is expected. Institutional commitment to the development of the candidate as a successful and independent research scientist will be given considerable attention during the review and selection process.
• If the Early Independence Investigator already has commitment of funding for independent research, from the institutional perspective, describe how this award will affect the other funding and status.

Institutional career development commitment:

• Describe plans for assuring scientific independence. Particularly if the Early Independence Investigator is staying at the same institution at which he or she trained, indicate how independence from previous mentors will be established and maintained.
• Describe career enhancement plans for the Early Independence Investigator. Provide plans for assessing and monitoring the annual progress of the candidate supported by this award. Describe any additional plans for ensuring the success of Early Independence Investigators as productive, independent investigators.
• Describe plans for integrating each Early Independence Investigator into institutional scientific and administrative activities at the institution. Describe the scientific collaborative activities (attendance at faculty meetings, laboratory meetings, participation in Institutional scientific retreats, etc.) and career development resources (courses in laboratory management and grant writing, etc.) that will be available to ensure the Early Independence Investigator is successful. Describe the support from senior colleagues and leadership of the Program that will be available to the Early Independence Investigator.
• The primary goal of each Early Independence Investigator is to establish an independent scientific research program. If Early Independence Investigators have an interest in (limited) teaching, describe what opportunities will be available.
• Describe expectations and opportunities for the Early Independence Investigator to establish a record of independent funding by submitting and accepting grants from sources other than the Early Independence Award.

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

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

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

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:

Research Strategy: Organize the Research Strategy using the instructions provided below. Start each section of the document with the appropriate section heading.

1. Rationale for omitting post-doc: Why would skipping the typical post-doctoral fellowship benefit your long-term scientific career? What is driving your desire to pursue an independent research career at an earlier than usual stage?

2. Evidence of transition to an independent position: Provide evidence using all the characteristics described in Section III.1.(Eligible Individuals (Program Director/Principal Investigator)) that at the time of application submission, you do not have research independence. Also, describe any arrangements you may have made to assume an independent research position that would begin prior to award.

3. Personal/career development plan: What particular strengths and weaknesses do you have for launching a productive independent research career? How would you use this award period to build on your strengths and address your weaknesses? How would receipt of this award accelerate your establishment of an independent research career (especially if you already have made an agreement for a functionally independent position)? What will your planned career path be if an Early Independence Award is not provided?

4. Evidence of training ability and leadership: What activities have prepared you to lead a laboratory, train laboratory staff, and perhaps mentor students and post-doctoral fellows?

5. Host institution interactions: What arrangements have you made with your host institution to provide you with the support and feedback necessary to establish your research program while maintaining your intellectual independence? How will you try to integrate yourself as an active member in your institution's scientific community?

6. Research challenge: What is the scientific challenge that you wish to address in your research? Why is this challenge significant to the biomedical/behavioral research community? What is the expected impact of your research on this challenge? Why did you choose this particular challenge to begin your independent research career?

7. Approach: What is your experimental approach in addressing your research challenge? What is the logic that makes this scientifically compelling? No substantial preliminary data are expected, but will be considered if provided.

8. Innovation: What are the particularly innovative aspects of your proposed research?

9. Relationship to previous work: How is the proposed research related to your research as a student? How does it differ? How will this be accomplished independently from your previous mentors?

10. Timeline: What is the timeline for accomplishing intermediate steps in your award period? This should include steps in establishing a functioning laboratory, meeting career development objectives, as well as achieving your scientific objectives. Include a statement committing at least 9.6 person-months (80% effort) to independent research during the project period, with at least the first two years being devoted entirely to the Early Independence Award project.

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.

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 Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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.

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Letters of reference are an important element of the Early Independence Award application. Applicants must arrange to have at least three and no more than five 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. Applicants are responsible for monitoring the submission of letters to ensure that three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their Commons accounts.

Letters may be submitted beginning December 29, 2015, and must be submitted no later than 5:00 p.m. (EST) January 29, 2016.

To submit a letter of reference, the referee will need the following information:

• Funding Opportunity Number (FOA) for this announcement: RFA-RM-15-006;
• The applicant’s Commons User Name (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name only the Commons User Name of the applicant is required);
• The applicant’s first and 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);

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.

Instructions to Referees:

Letters must be submitted electronically paper copies will not be accepted.

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 possess the scientific, leadership and management skills necessary to conduct successful, completely independent research. When possible, give specific examples that illustrate these qualities.

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 provide the applicant’s Commons User Name (User ID) and the other information below:

Referee Information (the individual providing the letter of reference):

Referee’s First and Last Name (Required)

Referee’s Middle Initial (MI) (Not Required)

Referee’s Email Address (Required)

Referee’s Institution/Affiliation (Required)

Referee’s Department (Required)

Applicant Information (applicants must send this information to their referees):

Applicant’s Commons User Name (User ID), (Required) (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 (Required). (Note: must match exactly the applicant’s name in Commons)

Funding Opportunity Number (FOA) of this announcement: RFA-RM-15-006 (Required)

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 only when submitting a revised or changed/corrected letter. Please print the confirmation email for your records.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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 Early Independence Awards are designed to accelerate the entry of exceptional junior investigators into positions of independent research by providing support within one year before or after receipt of the terminal research degree or completion of residency, thereby omitting the traditional post-doctoral training period. Accordingly, though all review criteria described below will be used, the emphases will be on the qualities of the investigator and on the environment provided by the host institution. Substantial preliminary data are not expected; rather, the approach should be made compelling primarily by the logic of the arguments presented.

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, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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?

Is the investigator well suited to the project? Has the investigator demonstrated appropriate experience, training, and skills to conduct highly innovative research? Has the investigator demonstrated the leadership and management abilities necessary to successfully conduct completely independent research? Do the letters of reference indicate that the investigator is ready to embark upon an independent research career?

Is the Early Independence investigator at a juncture in his/her career at which the Early Independence Award would substantially accelerate establishment of his/her independent research career? Would the Early Independence investigator's long term career benefit from this acceleration?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is the logic of the approach compelling despite the lack of supporting preliminary data? Is the scope of the project appropriate for someone who, though highly qualified, is still establishing an independent research program?

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 contribute to the probability of success of the Early Independence investigator? Will the situation of the Early Independence investigator provide sufficient separation from previous mentors to promote true intellectual independence? Are the plans for institutional support, equipment, staffing, and other physical resources available to the Early Independence investigator adequate? Will the research activities within the Institution help foster the development for the Early Independence Investigator? Will the Early Independence investigator benefit from unique features of the scientific environment and collaborative arrangements? Is there evidence that the Early Independence Investigator will have the necessary Institutional commitment to conduct full-time, independent research for the duration of this award at the level of effort required? Will the Early Independence investigator be given appropriate access to facilities and resources? Are shared institutional resources being made available to the Early Independence investigator? Are the plans for appointing and integrating the Early Independence investigator into the Institutional scientific culture adequate and appropriate? Will the research activities and resources provided to the Early Independence investigator assist in the development and strengthening of their career? Are the strategies for addressing potential problems adequate? Are benchmarks for the success of the Early Independence Investigator presented? Are the proposed plans and criteria to monitor the long term success of the select Early Independence Investigator adequate?

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 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.

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).

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

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 (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

The review criteria described above will be used in all phases of the review process. Those candidates identified by the review panel as being the most outstanding will be invited to Bethesda, MD for interview in June 2016. Interviews will be conducted by the Center for Scientific Review Special Emphasis Panel (excluding Mail Reviewers) convened specifically for the review of the Early Independence Award applications. The application will be assigned an impact score after the interview process.

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.

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.

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.

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 Commons Help Desk (Questions regarding 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 CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

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

Weijia Ni, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-237-9918
Email: [email protected]

Dede Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
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.