Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
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-08-028

Related Notices

  • December 6, 2013 - This PA has been reissued as PAR-13-071.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • June 17, 2013 - See Notice NOT-GM-13-119. Notice of Correction to Eligibility Information and Application Instructions.
  • April 19, 2013 - See Notice NOT-GM-13-009. Notice to Clarify Institutional Eligibility.
  • March 6, 2013 - See Notice NOT-GM-13-105. Notice of Correction to Eligible Applicant Organizations and Allowable Costs.

Funding Opportunity Announcement (FOA) Number

PAR-13-071

Companion Funding Opportunity

PAR-13-069, SCORE Advancement Award (SC1);
PAR-13-070 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, 93.121,93.855, 93.856

Funding Opportunity Purpose

The SCORE Program is a developmental program designed to increase the research competitiveness of faculty at minority-serving institutions and institutions with a historical mission of training students from backgrounds underrepresented in biomedical research. These institutions train a substantial number of professionals who pursue research careers or provide health care and health related services to populations who are underserved and not well represented in NIH funded research. SCORE offers three funding opportunities for individual investigator-initiated research awards according to their developmental level: Research Advancement Award (SC1), Pilot Project Award (SC2) and Research Continuance Award (SC3).

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 research productivity and peer-reviewed publications of SC3 principal investigators will increase so as to enable them to successfully compete in the future for non-SCORE support. In addition, the SCORE SC3 initiative seeks to broaden the exposure of students to the excitement of science and the conduct of biomedical research.

Key Dates
Posted Date

January 3, 2013

Open Date (Earliest Submission Date)

February 4, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 4, 2013; May 25, 2013 and September 25, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates  apply

Expiration Date

January 8, 2014

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 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 minority institutions 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 the near future. 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 minority-serving institutions, and 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 must 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. Collaborators, who may be from the applicant institution or another 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 in the application and fully justified.

SC3 projects are renewable but cannot be held in conjunction with any other SCORE investigator-initiated mechanism. SC3 new or renewal applications may request a maximum of four years of support. Although there is no limit to the number of SC3 renewals, 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. Since SC3 is a developmental award, multiple PD(s)/PI(s), co-PD(s)/PI(s) or co-Investigators are not allowed.

SC3 PD/PIs whose research productivity is significantly enhanced may apply for SC1 awards as well as other non-SCORE support. SCORE investigator-initiated research projects are limited to the NIH mission. SCORE PD/PI(s) 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.

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 for a maximum of four years 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

This funding opportunity announcement is open to all institutions of higher learning with a historical mission of educating students from diverse backgrounds 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. 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. In addition, these institutions must:

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

2. have received less than six million dollars from NIH R01 support in the last two fiscal years.

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 must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 are considered to be fully developed and may not apply for this award. 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 awards given as part of institutional centers or program projects. An applicant may not be the PI of any other SCORE or any other investigator initiated research grant at the time an SC1 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.

PD/PIs who have received one cycle of R01 or R21 support during their professorial career may apply for an SC1 award but would receive support for only SC1 grant cycle, i.e., no renewal is allowed. Current PD/PIs of R01, R21, or of other equivalent investigator initiated research awards are ineligible to apply for any of the SCORE mechanisms. Multiple PD/PI applications are not allowed. 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 of 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

Budget Component

List all costs for collaborators and consultants. Collaborators from the applicant institution may be paid for the limited time, not to exceed a total of 2 person months, devoted to a specific area of the project. Consultants may be paid a reasonable honorarium commensurate with their limited involvement in a project.

Other Project Information Component

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.

2) Total NIH R01 support in the last fiscal year (this information may be retrieved from NIH RePORTER at http://projectreporter.nih.gov/reporter.cfm).

3) Institutional data on:

a. Demographics of student body in the sciences, i.e., total and undergraduate (BS/BA) and graduate (MS/PhD) science student enrollment and graduation numbers and 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 in the past ten years (this information may be retrieved from NSF WebCaspar at https://webcaspar.nsf.gov/).

4) An institutional letter certifying that the time and effort requested by the PI will be provided. This letter must explain also the institution's commitment to the PD/PI's proposed research development.

Senior/Key Person Profile Expanded Component.

In the PD/PI's biographical sketch, his/her developmental objectives and plan should be included under a separate subheading of his/her Personal Statement. These objectives and plan must show how and when the PD/PI's SC3 and research and career goals will be achieved as a logical progression from the candidate's current support to SC3 support. The plan must justify the need for development, provide an explanation of how the proposed project and the time devoted to it will help the PD/PI further his/her research competitiveness, and describe how the proposed research will significantly improve his/her productivity and consequently his/her progress to the next step in terms of funding in his/her research career. A timeline for the transition to non-SCORE support must also be provided. Additionally, a PD/PI must provide information 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 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 personal statement of their biosketch.

PHS 398 Research Plan Component

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

Research Strategy

PD/PIs who have received previous S06 or SC support must include a progress report as part of the research strategy even if the proposed project is scientifically different or they have had a gap in funding.

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

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application before the deadline 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.

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 (SAM). 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-10-115.

Section V. Application Review Information

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?

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 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 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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 does the institution's historical mission and background information render confidence that there is a pool of students from diverse backgrounds underrepresented in biomedical and behavioral areas of research 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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), 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 on the basis of established PHS referral guidelines 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 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. 

4. Evaluation

In carrying out its stewardship of research development awards, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of their SC3 awards for information other than that available in databases that could be helpful in evaluating the impact of the program in their research career.

After ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in developing the PIs research competitiveness and in transitioning to non-SCORE support. Upon completion of this evaluation NIH will determine the program’s continuing need and whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

Listed below are key metrics to be used to help determine whether the program goals or outcomes have been met in a future evaluation:

1) Number of PIs who have successfully transitioned to non-SCORE support.

2) Types of NIH awards secured by the PIs who successfully transition to non-SCORE support.

3) Number of scientific publications resulting from SCORE support.

4) Number of students from underrepresented groups engaged in research conducted by SCORE PD/PIs.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Hinda Zlotnik, Ph.D.
National Institute of General Medical Sciences
Telephone: 301-594-5132
Email: zlotnikh@nigms.nih.gov

Diane Adger-Johnson
National Institute of Allergy and Infectious Diseases
Telephone: 301-402-8969
Email: dadger@niaid.nih.gov

Lynn Mertens King, Ph.D.
National Institute of Dental and Craniofacial Research
Phone: (301) 594-5006
Email: lking@dir.nidcr.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Lori Burge
National Institute of General Medical Sciences
Telephone: 301-451-3781
Email: burgel@nigms.nih.gov

Kim Cooper
National Institute of Allergy and Infectious Diseases
Telephone: 301-451-4576
Email: kim.cooper@nih.gov.

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research
Phone:  (301) 594-4798
Email:  dr258t@nih.gov

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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