It is critical that applicants follow the instructions in the Research Instructions for 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

NIGMS Interest in Diversity

The mission of the National Institute of General Medical Sciences (NIGMS) is to support research that increases understanding of life processes and lays the foundation for advances in disease, diagnosis, treatment, and prevention. NIGMS funded researchers seek to answer important scientific questions in fields such as cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, biomedical technology, bioinformatics, computational biology, selected aspects of the behavioral sciences and specific cross-cutting clinical areas that affect multiple organs systems. To assure the vitality and continued productivity of the research enterprise, NIGMS is particularly interested in enhancing faculty development and institutional research infrastructure and in training the next generation of scientists and developing and enhancing the diversity of the scientific workforce. To accomplish some of these objectives, NIGMS supports a variety of capacity building programs with the ultimate goal of enhancing the pool of investigators available to compete independently for external research support.

Background

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

In spite of tremendous advancements in scientific research, information, educational, and research opportunities are not equally available to all. This program encourages institutions to diversify their faculty and student populations and thus to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences research enterprise, as described in NOT-OD-15-053.

Need of the Program

To achieve its mission of improving health, the National Institutes of Health must recruit and train

outstanding individuals for the biomedical workforce. Underrepresentation of certain groups, e.g., from certain racial and ethnic groups, women, and individuals with disabilities in science, technology and engineering fields increases throughout the training stages and it is more pronounced in the biomedical research workforce (NSF, 2015). In addition, it is particularly difficult for some of the underrepresented groups to achieve success in receiving NIH funding (Ginther et al, 2012). A more recent analysis of NIH data showed that award probabilities are correlated with NIH-funding rank of the applicant's institution and are a reflection of the infrastructure advantages enjoyed by the most research intensive institutions (ACD WGD). Therefore, there is a continued need to broaden opportunities for faculty research career enhancement at under-resourced institutions, particularly those that train and serve the underrepresented groups as defined in NOT-OD-15-053, in order to enhance their research competitiveness and productivity, capitalize on their innovative ideas and distinct perspectives, augment the diversity of the biomedical research workforce, and foster their long-term involvement in NIH-funded research and the research enterprise of the nation.

Programmatic Approach

The Support of Competitive Research (SCORE) program provides research capacity building support to under-resourced institutions with limited NIH R01 funding that have explicitly stated historical missions or historical track records focused on training and graduating students from backgrounds nationally underrepresented in biomedical research with B.S./B.A., M.S. or Ph.D. degrees in biomedically-related sciences, who represent an invaluable source of untapped talent. These institutions include those that have: 1) an explicitly stated historical mission or a demonstrated historical track record in educating students from underrepresented groups in biomedical research including underrepresented racial and ethnic groups (i.e., African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians and other natives of U.S. Pacific Islands), 2) an explicitly stated historical mission or a demonstrated historical track record of training and graduating substantial numbers of undergraduate students from financially disadvantaged backgrounds, as defined in NOT-OD-15-053, and 3) an explicit mission or a demonstrated historical track record in educating students with disabilities.

The SCORE program offers opportunities for faculty research career enhancement, which are expected to increase their research competitiveness and productivity and enable their transition to non-SCORE support.

The SCORE program offers three distinct support mechanisms for individual investigator-initiated biomedical or behavioral research projects of different scope and for different program director/principal investigators (PD/PIs) developmental levels:

• Research Advancement Award (SC1) is for investigators with a track record of research activity who are seeking to enhance their research productivity in order to transition to non-SCORE support in a limited period of time.
• Pilot Project Award (SC2) is for those who are at the beginning stages of a research career, applying for their first independent award, and who are interested in testing a new idea, or generating preliminary data.
• Research Continuance Award (SC3) is for those investigators who have been engaged in scholarly research and published, and who seek to continue to conduct competitive research of limited scope to increase their publications and eventually transition to non-SCORE support.

The SC3 mechanism allows investigators who already have conducted research and published to continue to engage in meritorious research projects of limited scope in a given biomedical area within the scope of the NIH mission. It is expected that the SC3 award will increase gradually the PD/PI's research productivity and peer-reviewed publications, thus allowing SC3 investigators to eventually transition to non-SCORE support. Moreover, the SCORE SC3 initiative seeks to expand the national research base, particularly at institutions that have an explicitly stated historical mission focused on serving students from underrepresented backgrounds. Since this award seeks to increase the research competitiveness of PD/PIs, it is not for PD/PIs who have been successful already in securing non-SCORE research support. Since the SC3 award is a career enhancement award for a single PD/PI, having more than one, i.e., multiple PD/PIs is not allowed. Student training is not permitted in SCORE. PD/PIs may hire part-time or full-time technicians who will help them move the research forward and increase the pace and productivity of their projects.

There is no limit to the number of SC3 renewals; however, a progressive development of the PD/PI's research trajectory as indicated by an increase in the number and quality of publications must follow each renewal application. Detailed research career goals and objectives, i.e., career enhancement objectives, as well as plans to achieve them, are required in an SC3 application (see Section IV below).

SC3 investigators are encouraged to establish meaningful collaborations with R01-funded investigators in the U.S., particularly outside of the applicant's institution, that will increase the progress and productivity of the project. These collaborators or consultants should be recognized experts in a field and must have their own research support, i.e., SC3 funds may not be used to support a consultant's or collaborator's research project. Additionally, a SCORE project cannot depend fully on the collaborators' research resources (e.g., space, personnel, equipment, animal or other specialized facilities) and it is expected that a SCORE SC3 PD/PI will conduct his/her research at his/her institution. Collaborators, who may be from the applicant institution or another domestic institution, generally provide expertise in a very specific aspect of the execution of the proposed project in which the PD/PI has little or no experience. Consultants from domestic institutions other than the applicant institution are individuals who have committed to contributing intellectually to the scientific project development or execution but are not committing any specified measurable effort (in person months) to the project or conducting any part of the project. The role of a consultant/collaborator in a project and in the PD/PIs research enhancement must be fully justified (see instructions in Section IV below). Foreign collaborators or consultants are not permitted.

SCORE investigator-initiated research projects are limited to the scope of the NIH mission. Clinical trials or clinical interventions are not supported by SCORE developmental awards. Applicants are strongly advised to review the SCORE Answers to Frequently Asked Questions section in the NIGMS website before they consider applying for any SCORE individual award. Submitted applications that are found not to fall within the NIH mission will be withdrawn prior to review.

Goals or Outcomes

The overarching goal of the SCORE program is to foster research career enhancement opportunities for faculty at institutions that have an explicitly stated historical mission focused on training students from nationally underrepresented backgrounds and/or a documented historical track record of recruiting, retaining, training, and graduating underrepresented students as defined and described in NOT-OD-15-053, in order to increase their research competitiveness and promote their transition to non-SCORE external sources of funding. This is anticipated to augment the number of PD/PIs from underrepresented groups who receive SCORE and non-SCORE NIH funding and the number of laboratories in which nationally underrepresented students, especially those supported by other NIGMS-supported programs, engage in biomedical research.

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

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

Higher Education Institutions

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

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

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

This funding opportunity announcement is open to all institutions of higher learning that:

1) award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S./Ph.D.);

2) have an historical mission statement that explicitly states that it was founded to educate students from nationally underrepresented backgrounds in biomedical research (i.e., underrepresented racial and ethnic groups [African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities] and/or undergraduate students from financially disadvantaged backgrounds, as described in NOT-OD-15-053) and/or a documented historical track record of recruiting, retaining, training, and graduating these groups of underrepresented students and contributing substantially to the national pool of individuals who pursue biomedical research careers.

3) have received less than $6 million dollars per year from R01 support (total costs) in each of the last two fiscal years.

Applicant institutions must be located in the United States of America or its territories including Puerto Rico, Virgin Islands, the Canal Zone, Guam, America Samoa, or the successor States of the Trust Territory of the Pacific Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

Institutions that have active NIGMS Initiative for Maximizing Student Development (IMSD) awards are not eligible to apply to SCORE.

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 not 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.

Since SC3 is a research enhancement award for an individual PD/PI, multiple PD(s)/PI(s) are not allowed.

An SC3 PD/PI must have a full-time regular faculty appointment at the applicant institution and be eligible to apply for a NIH R01 research grant. Postdoctoral fellows, research or teaching instructors, research assistant professors, research scientists, other research appointments or appointments contingent on an individual securing his/her salary from grants, and part-time or adjunct faculty and faculty who have joint appointments in which one is at a research intensive institution are not eligible to apply for SCORE individual awards. Emeritus or distinguished/retired investigators/professors as well as individuals with a track record of research support, e.g. R01, R15, or other research grant awards from federal or non-federal sources are considered to be fully developed and may not apply for this award. Current PD/PIs of R01 or of other federal or non-federal investigator initiated research awards or of program projects, center grants, cooperative agreements or other institutional research awards are ineligible to apply for/receive any of the SCORE awards. PD/PIs who transition to non-SCORE support while holding an active SC3 award are expected to complete this award, except when there is overlap with the other funded project. In this case, the SC3 award will be terminated. Once this SC3 award is completed, the PD/PI will no longer be eligible to apply to SCORE.

Investigators who have other developmental/enhancement grant support are ineligible to apply for SCORE individual awards until the completion of these awards, i.e., SCORE awards are not intended to duplicate other individual or institutional developmental awards; these include K awards and research support provided as part of institutional centers, program projects, cooperative agreements such as from COBRE, INBRE, RCMI, BUILD, etc. An applicant may not be the PD/PI of any other SCORE or any other investigator-initiated research grant in excess of $75,000 total costs at the time an SC3 award is made. Concurrent or duplicate application to any of the SCORE mechanisms (SC1, SC2, or SC3) by a single PD/PI is not allowed. A PD/PI may only apply for/receive one SC award at a time.

SC3 awards may not be transferred from one PD/PI to another or from one institution to another.

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. Institutions may submit individual SC1, SC2 or SC3 applications to a combined maximum of 20 total applications and awards at any time. The maximum number of individual SCORE awards (combination of SC1, SC2, SC3) that a single institution may hold is 20.

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

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

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

It is critical that applicants follow the instructions in the Research Instructions for 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.

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

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

Other Attachments: The application must include a single attachment titled "Institutional Information and Research Enhancement Plan".

A) Institutional information must include:

1) Description and evidence of the institution's explicit historical mission to educate students from backgrounds nationally underrepresented in biomedical research, and efforts to provide services to the underserved community.

• For institutions whose historical mission explicitly states that it was founded to educate students from nationally underrepresented backgrounds in biomedical research (i.e., underrepresented racial and ethnic groups [African Americans, Hispanic Americans, American Indians or Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and individuals with disabilities] and/or students from financially disadvantaged backgrounds, as defined in NOT-OD-15-053) provide the institution's original mission statement and any other information that justified the institution's creation and describes its main functions and services provided.
• For institutions whose mission statement does not explicitly state that they were founded to educate any of the underrepresented groups mentioned above but have a demonstrable historical track record of recruiting, retaining, training, and graduating underrepresented students, the institution must provide information and current figures compared to baseline data from ten years ago that show how the institution's historical track record of training and graduating underrepresented students in biomedical and behavioral-related sciences has improved significantly and how much it has contributed to a substantial increase in the national pool of graduates from underrepresented backgrounds who have pursued or are pursuing biomedical research careers.

2) Institutional data. Provide the following numerical information in tabular form:

• Demographics of student body in the sciences in the last two academic years, i.e., total, undergraduate (BS/BA) and graduate (MS/PhD) science student enrollment and graduation numbers as well as percentages of the different groups nationally underrepresented in biomedical and behavioral research.
• Number of underrepresented students graduating from the applicant institution who have completed the Ph.D. in biomedical or behavioral sciences in the past ten years (this information may be retrieved from NSF WebCaspar at https://webcaspar.nsf.gov/).
• Total faculty in the biomedical and behavioral-related sciences and number and percentages from each of the underrepresented groups.

3) NIH R01 support (total costs) calculated from data retrieved from NIH RePORTER at http://projectreporter.nih.gov/reporter.cfm) for each of the two last fiscal years.

4) Institutional letter certifying from a department chair or dean certifying that the time and effort requested by the PD/PI for the proposed project will be provided. This letter must explain also the institution's commitment to the PD/PI's proposed research development during the duration of the award.

2) PD/PI's Research Enhancement Objectives and Plan:

These objectives and plan must explain in detail how the PD/PI's SC3 and research career enhancement objectives will be achieved as a logical progression from the applicant's past training and track record as a researcher and how SC3 support will allow the PD/PI to increase his/her research productivity. The plan must justify the PD/PI's need for development via the SC3 mechanism and provide an explanation of how the proposed project, the time devoted to it and the participation of domestic collaborators/consultants (if applicable) will help the PD/PI further his/her research competitiveness and significantly improve his/her productivity to allow him/her to compete eventually for other external support. The career enhancement plan must provide also the steps to be followed to achieve the PD/PI's objectives, include specific milestones and a detailed timeline for publications. Applications lacking this information will be considered incomplete and will not be reviewed.

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

Biographical Sketch: Include a biosketch for each collaborator and consultant. Collaborators, who may be from the applicant institution or another domestic institution, generally provide expertise in a very specific aspect of the execution of the proposed project in which the PD/PI has little or no experience. Consultants from institutions other than the applicant institution in the US are individuals who have committed to contributing intellectually to the scientific project development or execution but are not committing any specified measurable effort (in person months) to the project or conducting any part of the project. Foreign collaborators or consultants are not allowed. The role of a domestic consultant/collaborator in a project must be described and clearly justified in the personal statement section of each biosketch.

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:

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:

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

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.

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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.

SCORE SC3 awards include some restrictions as to how the funds may be used. The following account summarizes some of the allowable and non-allowable costs under the SCORE SC3 mechanism.

Allowable Costs

• Costs essential to the conduct of the research project, such as salaries of technicians, equipment,
• PD/PI's travel, supplies, fees-for-service.
• Faculty salaries, typically based on full-time, nine-month contractual appointment with the applicant organization, and reimbursed according to person months dedicated to the proposed research. PD/PI summer salary support based on person months spent on the SCORE research project is allowable if permitted by institutional policy. The maximum summer-salary support provided by the program may not exceed the equivalent of two months or another length of time specified by the institution as its policy, whichever is shorter.
• Travel costs for external consultants/domestic collaborators or PD/PI's travel to collaborator's domestic institution are permitted.
• Consultants may be paid a reasonable honorarium commensurate with their role on the project.
• Consortium agreements and subcontracts are only allowed with SCORE-funded institutions.

Unallowable Costs

• Salary for postdoctoral fellows or equivalent positions is not allowed.
• Student stipends, salaries, or tuition are not allowed.
• Textbooks, journals, memberships, and Internet or cell phone subscription costs are not allowed.
• Employees of the applicant institution may not serve as paid consultants.
• Support for foreign institutions, foreign research services, foreign collaborators/collaborations/consultants, or foreign components/consortia or is not allowed.
• Travel for technical personnel is not allowed.
• Funds for faculty salaries cannot be used to supplement the PD/PI's actual academic year salary or to increase the base by which academic year PD/PI salaries are calculated.
• Domestic collaborators' salary or other compensation is not allowed. SCORE funds cannot be used to support the research of domestic collaborators/consultants.
• Secretarial or clerical support is not allowed.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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.

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? 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? How will successful completion of the proposed research objectives allow the PD/PI to enhance his/her research competitiveness?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the PD/PI's research enhancement objectives and plan reasonable and what is the likelihood that they will be accomplished? Do the proposed project, PD/PI's research enhancement objectives plans, timeline and past track record as a researcher render confidence that the PD/PI will increase his/her research productivity, particularly the number of peer-reviewed publications?

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? 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? How committed is the institution to the PD/PI's research development during and beyond SCORE support? To what extent do the institution's explicit historical mission and/or historical track record of training and graduating underrepresented students in biomedical and behavioral research and other background information render confidence that there is a significant pool of underrepresented students who may benefit from the increased research competitiveness of the PD/PI and an enhancement of the institutional research capacity?

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period, including progress achieved towards the PD/PI's developmental objectives.

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 (GDS).

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, 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.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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.

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

Evaluation

NIH or its Institutes and Centers will periodically evaluate the SCORE Program by retrieving information from databases and PDs/PIs. The evaluation measures to be used will include:

-Number of SCORE SC1 PDs/PIs who secure subsequent SCORE, NIH or other external research funding.

-Number of Publications.

-Demographic data of faculty engaged in SCORE funded research.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to a) continue the program as currently configured, b) continue the program with modifications, or c) discontinue the program.

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 Center Telephone: 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: 301-945-7573

Irina N. Krasnova, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Brian Pike, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: [email protected]

Christy Leake
National Institute of General Medical (NIGMS)
Telephone: 301-594-7706
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.