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Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Support of Competitive Research (SCORE) Research Continuance Award (SC3)

Activity Code

SC3 Research Continuance Award

Announcement Type

Reissue of PAR-13-071

Related Notices

  • September 21, 2016 - This PAR has been reissued as PAR-16-437.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • March 14, 2014 - See Notice NOT-OD-14-070. Adjustments to May 25-28, 2014 Grant Application Due Dates.

Funding Opportunity Announcement (FOA) Number

PAR-14-018

Companion Funding Opportunity

PAR-14-019, SCORE Research Advancement Award (SC1)
PAR-14-017, SCORE Pilot Project Award (SC2)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

The SCORE Program is a developmental program designed to increase the research competitiveness of faculty and research base of institutions with a historical mission and/or demonstrated track record of training and graduating students from backgrounds underrepresented in biomedical research. In addition, eligible institutions must award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S. or Ph.D.) and have received on average less than 6 million dollars per year of NIH R01 support (total cost) in the last 2 fiscal years.

Key Dates
Posted Date

December 6, 2013

Open Date (Earliest Submission Date)

December 25, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 25, 2014, (Extended to May 29, 2014 per NOT-OD-14-070), Originally May 25, 2014, January 25, 2015, May 25, 2015, January 25, 2016, May 25, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

May 7, 2014, September 7, 2014, May 7, 2015, September 7, 2015, May 7, 2016, September 7, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

July 2014, November 2014, July 2015, November 2015, July 2016, November 2016

Advisory Council Review

October 2014, January 2015, October 2015, January 2016, October 2016, January 2017

Earliest Start Date

January 2015, April 2015, January 2016, April 2016, January 2017, April 2017

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable

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.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

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 also provides leadership in training the next generation of scientists and is particularly interested in developing and increasing the diversity of the scientific workforce by focusing on individuals from backgrounds underrepresented in biomedical and behavioral research. A recent report from an Advisory Committee to the National Institutes of Health (NIH) Director on Diversity of the Biomedical Research indicates that achieving diversity in the biomedical research workforce remains an important problem that must be actively addressed (see http://acd.od.nih.gov/dbr.htm).

The unique historical mission of some institutions of higher learning has been to educate students from underrepresented backgrounds, and to provide assistance to the underserved communities that the students come from. For example, the focus of minority-serving institutions (MSIs) has been the education and graduation of students from backgrounds underrepresented in biomedical and behavioral research, including underrepresented racial and ethnic groups (i.e., African Americans, Hispanic Americans, Native Americans, and natives of U.S. Pacific Islands). Some other institutions have a mission to educate students with disabilities, and provide services to the disability community (J.V. Van Cleve and B. A. Crouch, A Place of their Own: Creating the Deaf Community in America, GU Press, 1989). As a group, these institutions have trained science graduates from underrepresented groups who have gone on to pursue research careers (NSF Women, Minorities and Person with Disabilities Report 2011) and have gained scientific prominence in their research. Some of these graduates provide health care to underserved populations and are, therefore, uniquely positioned to engage underserved populations in research and in the translation of research advances into culturally competent, measurable, and sustained improvements in health outcomes (Estape et al., Clin. Transl. Sci. 5(10): 112, 2011). NIH support of faculty-initiated research endeavors in these institutions has promoted increased student exposure to research in biomedical and behavioral sciences and an enhancement in the number of students from underrepresented groups who seek advanced degrees and provide much needed services to these communities.

The Minority Biomedical Research Support (MBRS) Program was created in 1972 under authority of sec. 301(c) of the PHS Act. It is comprised of Support of Competitive Research (SCORE) and two other initiatives [Research Initiative for Scientific Enhancement (RISE) and Initiative for Maximizing Student Development (IMSD)]. One of the goals of the MBRS Program is to increase the pool of students from underrepresented backgrounds engaged in biomedical and behavioral research, and to broaden the opportunities for underrepresented faculty and students to participate in biomedical and behavioral research.

The goal of the MBRS-SCORE program has evolved over the years, and the program now seeks to foster the development of faculty at institutions that have a historical mission focused on serving students from underrepresented backgrounds (i.e., minority-serving institutions, and/or institutions with historical missions to serve students with disabilities) in order to increase their research competitiveness and promote their transition to non-SCORE external sources of funding. This goal is expected to translate into an increase in the pool of individuals from diverse backgrounds nationally underrepresented in biomedical and behavioral research available to compete for NIH funding and professionally engaged in these areas of research. 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. It is expected that SCORE support will enable faculty at institutions that have a historical mission focused on serving students from underrepresented backgrounds to conduct high-quality research and to increase their research competitiveness by progressively enhancing the pace and productivity of their projects. This in turn will provide opportunities for underrepresented students, especially those that participate in MBRS-RISE programs, to experience research and will reinforce their motivation to pursue advance degrees.

The SCORE mechanisms available to investigators according to their experience/track records are:

Research Advancement Award (SC1), which 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 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 increase their publications and eventually transition to non-SCORE support.

The SC3 mechanism allows investigators who are at intermediate stages of development to continue to engage in meritorious research projects of limited scope in a given biomedical/behavioral area within the NIH mission. It is expected that the SC3 award will increase 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 a historical mission focused on serving students from underrepresented backgrounds, and to broaden the exposure of students to the excitement of science and the conduct of biomedical research.

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). 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 development (see instructions below) must be described clearly in the application and fully justified.

SCORE investigator-initiated research projects are limited to the NIH mission. SCORE PD/PIs are strongly encouraged to use the Research Portfolio Online Reporting Tools (RePORT) at http://report.nih.gov/index.aspx, to search for all past and currently funded NIH grants and their descriptions. 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.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets may not exceed $75,000 direct costs/year and must reflect actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period of support is 4 years.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

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 any of the populations that have been identified as underrepresented in biomedical and behavioral research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or a documented track record of recruiting, retaining, training, and graduating underrepresented students as defined by NSF (see above) which has resulted in the demonstrable outcome of increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical and behavioral research careers; and

3) have received on average less than $6 million dollars per year from R01 support (total cost) in 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.

Foreign Institutions

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.

Required Registrations

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

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 developmental award for an individual PD/PI, multiple PD(s)/PI(s) are not allowed.

An SC3 PD/PI must also 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 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 are not eligible to apply for SCORE individual awards. Emeritus/retired investigators/professors as well as individuals with a track record of R01 or equivalent 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, R21, or of other equivalent investigator initiated research awards or of program projects, center grants or cooperative agreements are ineligible to apply for/receive any of the SCORE awards.

Investigators who have developmental award support are ineligible to apply for SCORE individual 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 or program projects such as from COBRE, INBRE, RCMI, cooperative agreements, 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.

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 should follow each renewal application.

SC3 awards may not be transferred from one PD/PI to another. If an SC3 PD/PI moves to another SCORE eligible institution, his/her award may be transferred to the new institution provided that all transfer requirements as per NIH and SCORE policy are fulfilled.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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.

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: Prepare a single attachment titled "institutional information" and upload it via the Other Attachments section. The attachment should include:

1) Background information and evidence of the institution's historical mission to educate students from backgrounds nationally underrepresented in biomedical and behavioral 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 populations underrepresented in biomedical or behavioral research as defined by the National Science Foundation (i.e., African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities), 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 populations that have been identified as underrepresented in biomedical and behavioral research as defined by the National Science Foundation but that have a demonstrable record of recruiting, retaining, training, and graduating students from these diverse backgrounds, 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 and how much it has contributed to an increase in the national pool of graduates from underrepresented backgrounds who have pursued or are pursuing biomedical and behavioral research careers.

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

a. 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.

b. Number of underrepresented students graduating from the applicant institution who have gone on and completed the Ph.D. in biomedical and behavioral sciences in the past ten years (this information may be retrieved from NSF WebCaspar at https://webcaspar.nsf.gov/).

c. Total faculty in the biomedical and behavioral-related sciences and number and percentages from each of the underrepresented groups.

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

4) An institutional letter 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.

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketch: In addition, in the Personal Statement part of the PD/PI's biographical sketch include a separate subheading for the PD/PI's developmental objectives and detailed plan to accomplish them. These objectives and plan must present how the PD/PI's SC3 and research career goals will be achieved as a logical progression from the candidate's past training and experience and how SC3 support will allow the PD/PI to increase progressively his/her research productivity. The developmental plan must also provide a detailed timeline for publications and submission of other grant applications, when applicable. Additionally, a PD/PI must provide information in his/her Personal Statement on past/current student involvement from underrepresented groups (especially RISE students, if applicable) in their research projects.

Include an entry 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 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 must be described clearly and fully justified in the personal statement section of their biosketch.

Modular Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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
Unallowable Costs
6. Other Submission Requirements and Information

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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

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.



1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will successful completion of the proposed research objectives allow the PD/PI to enhance his research competitiveness?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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 developmental objectives and plan reasonable and what is the likelihood that they will be accomplished? Do the proposed project, PD/PI's developmental plans, 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?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the 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?

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?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? How committed is the institution to the PD/PI's research development during and beyond SCORE support? To what extent do the institution's 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 participation in SCORE-supported research?

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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:

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 NIGMS Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Scientific/Research Contact(s)

Hinda Zlotnik, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-5132
Email: [email protected]

Peer Review Contact(s)

Helen R. Sunshine, Ph.D
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Financial/Grants Management Contact(s)

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: [email protected]

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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