Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title
Resource-Related Research Projects for Development of Animal Models and Related Materials (R24 Clinical Trials Not-Allowed)
Activity Code
R24 Resource-Related Research Projects
Announcement Type

Reissue of PAR-16-369

Related Notices

NOT-OD-19-128 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

NOT-OD-19-137 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Funding Opportunity Announcement (FOA) Number
RFA-OD-19-027
Companion Funding Opportunity

None

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

93.351

Funding Opportunity Purpose

The Office of Research Infrastructure Programs (ORIP) encourages grant applications aimed at developing, characterizing or improving animal models of human diseases; improving access to information about or generated from the use of animal models of human disease; or improving diagnosis and control of diseases of laboratory animals. The animal models and related materials developed must have broad application to multiple NIH Institutes or Centers (ICs) to align with the ORIP’s trans-NIH mission. Applications must describe the need and potential impact of the proposed resources on broad research areas supported by multiple NIH ICs. Applications to develop models that relate strictly to a specific disease or a select area of research will not be considered acceptable. Projects that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other Institutes and Centers will also not be acceptable for this FOA.

Key Dates

Posted Date

September 11, 2019

Open Date (Earliest Submission Date)
September 28, 2019
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)
October 28, 2019, January 27, 2020, May 27, 2020, September 28, 2020, January 26, 2021, May 26, 2021,   September 28, 2021 and January 26, 2022, May 26, 2022

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

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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)

January 8, 2020, May 8,2020, September 9, 2020, January 8, 2021, May 10, 2021, September 8, 2021 and January 10, 2022, May 10, 2022 , September 8, 2022

apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. 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
Advisory Council Review
Earliest Start Date
Expiration Date
September 09, 2022
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Background

    Animal models are indispensable for studying the genetic basis and mechanisms underlying human diseases, identifying drug targets, and developing effective preventive and therapeutic approaches. Efficient use of animal models is facilitated by readily available animal-related resources. Animal-related resources include mutant and transgenic animals; related biological materials, such as nucleic acids, proteins, cell cultures, and tissues; and knowledge of an animal’s genome, life cycle, molecular, cellular and physiological phenotypes, and behaviors. Animal-related resources can also include information needed for optimal use of animal models, such as physical and genetic maps or computer models, without archiving animals or animal-based materials. ORIP supports development, maintenance and distribution of these various types of resources related to animal models of human disease.

    Purpose and Scope

    ORIP’s intent with this FOA is to support resource-related research projects that are aimed at developing and characterizing new animal-based resources, improving existing resources, or acquiring deep understanding of a model system in order to improve the utilization, accessibility and translational values of animal models to the research community. The trans-NIH mission of ORIP is assisting NIH ICs to strengthen existing programs, develop resources, advance areas of emerging science, and develop new initiatives to move biomedical research forwards. Therefore, proposed studies, models, technologies, and biological materials must be applicable to multiple NIH ICs and must explore multiple body systems or evaluate diseases and processes that impact multiple body systems. An application can be predominantly research based (if that research potentially leads to the development of resources). An application can also be aimed at final development or enhancement of resources (if most of the necessary research has already been carried out).

    Applications responding to this FOA should:

    • Demonstrate the need for the proposed resources within broad biomedical research communities.
    • Address the impact, benefit, utilization, distribution, and accessibility of the proposed resources to broad biomedical research areas supported by multiple NIH ICs.
    • Describe plans to track potential impact of proposed resources.
    • Describe potential sources of support for the resources and their availability to the research community after the ORIP grant is terminated.

    Cost recovery is not required for applications responding to this FOA.

    Proposed studies, models, technologies, and biological materials that relate strictly to a specific disease or research discipline or are relevant to the mission and programs of a single NIH IC will not be considered suitable for this FOA. Such applications should be directed to the IC with specific interest in that mission. For example, investigators interested in developing resources with a primary focus on aging, cancer, heart disease, or neurological disorders should contact respective NIH ICs relevant to these topics. Furthermore, applications proposing studies that are related predominantly to the interest of one NIH IC and only peripherally to the interests of other ICs are not acceptable.

    Examples of resource-related projects suitable for this FOA, include, but are not limited to:

    • Mutant or transgenic animal models for studying fundamental biological processes and investigating mechanisms underlying a broad range of human diseases that impact multiple body systems;
    • Antibodies or other reagents for quantifying or characterizing macromolecules or cells in animal models of human diseases;
    • Development of information resources for generating novel hypotheses and improving the utilization of animals in biomedical research, including deep phenotyping of organelles, single cells, cellular network, microbiome, or behaviors;
    • Informatics tools or systems biology approaches, especially artificial intelligence or machine learning tools, that integrate various types of data, including genomic, proteomic, metabolomic, imaging, or phenotypic data, to generate novel hypothesis and improve the value of animal models for biomedical research;
    • Animal-based genetic, genomic, proteomic, metabolomic or phenomic tools for deep characterization and understanding of disease-related biological processes;
    • Genetic resources, including DNA or viral vector libraries of the genome scale, for gene editing of cell lines, germ plasm, or somatic cells;
    • Methods or tools for improving cryopreservation, or other long-term preservation approaches, of animal cells, germ plasm, embryos, or genetic stocks;
    • Methods or tools for characterizing stem cells and advancing the techniques of regenerative medicine in animal models;
    • Diagnostic, preventive, or treatment methods for emerging or potential pathogens in animal resource facilities;
    • Models or resources that may contribute to the understanding of newly emerging human pathogens and in response to recently active NIH public health initiatives;
    • Animal resources, including genetically engineered animal models and related biological materials, for supporting trans-NIH initiatives, including AIDS, Women’s Health, Alzheimer’s Disease and Related Dementias, and BRAIN.

    Examples of projects that will NOT be supported under this FOA include those that:

    • Focus on genomic sequencing of model organisms (e.g., only for deposition into a database).
    • Primarily focus on creating, expanding, or maintaining genomic or other types of databases
    • Create or maintain individual model organism databases.
    • Develop or distribute wild-type animals and related biospecimens treated with diet, drug, toxin, infectious agents, or other environmental factors.
    • Develop or distribute wild-type animals and related biospecimens subjected to physical or surgical manipulations.
    • Involve threatened and endangered species.
    • Develop, expand, or maintain repositories of specific tissues and related bio-specimens (i.e. RNA extracts, processed tissues) from model organisms.

    This FOA intends to support the development of animal models and related resources that would serve broad research areas. Applications for developing a limited number of resources are not suitable for this FOA and may be appropriate for research project grant activities through R21 or R01 awards supported by ORIP. Those applications proposing to develop resources should register catalogs of their resources with current resource tagging and identification initiatives, such as FORCE 11. These projects should also encourage investigators who use the resources to apply the Research Resource Identifiers (RRIDs) in their publications and reports.

    Program Directors/Principal Investigators (PD/PIs) planning to submit applications to this FOA are strongly encouraged to contact the scientific contacts prior to submission (see Scientific/Research Contacts in Section VII. Agency Contacts) to be advised on appropriateness of the intended resource and research plans for this program, competitiveness of a potential application, and alignment with ORIP's program priorities.

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

    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
    Revision

    New or resubmission grants funded under the auspices of this FOA will be eligible for only one funded renewal (i.e., a new grant has the potential for two four-year cycles of funding). Renewal grants, whether originally funded under the current FOA or the previous FOAs PAR-16-369 and PAR-13-253, are eligible to compete for only one four-year cycle of funding.

    A new application must be submitted for any unfunded application submitted under any previous funding opportunity announcement.

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?
    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The National Institutes of Health (NIH) intends to commit $5,000,000 per fiscal year in FY2020-2022 to fund at least six awards per fiscal year.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project for new applications.

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact for approval at least 6 weeks before submitting the application.

    For Renewal (a.k.a. Type 2) applications including Renewal Resubmission applications , no more than a 5 percent increase of direct cost based on a previous non-competing year with the highest direct cost in the prior four-year funding cycle will be accepted.

    Award Project Period

    The duration of the proposed project may not exceed four years.

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

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession
    Other
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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 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.

    • 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) – 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.
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. 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.

    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.

    2. Cost Sharing

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

    3. Additional Information on Eligibility

     

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

    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)

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the Research (R) 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.

    Not applicable.

    Page Limitations
    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
    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.
    SF424(R&R) Senior/Key Person Profile
    All instructions in the SF424 (R&R) Application Guide must be followed.  

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

    R&R Subaward 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:

    The application to this FOA should:

    • Describe how the proposed resources or resource-related research align with the interests of multiple NIH ICs that focus on various diseases or body systems.
    • Describe how the proposed resources or resource-related research meet the need of broad research areas supported by multiple NIH ICs.
    • Describe how the proposed resources or resource-related research impact broad research communities supported by multiple NIH ICs and describe how impact will be tracked.
    • Describe how the proposed resources will improve diagnosis and control of specific diseases that interfere with animal use in biomedical research (if this is the intent of the project).
    • Describe how the proposed information about the resources or resource-related research will be disseminated to the scientific community as well as plans for sharing the resources with the scientific community.

    Letters of Support: Letters of support can be provided but are not required. If letters of support are included, they should directly address how the proposed project will help develop or enhance animal-based resources as described in the "Research Objectives" sections of this FOA.

    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.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    Appendix:
    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
    PHS Human Subjects and Clinical Trials Information
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form
    All instructions in the SF424 (R&R) Application Guide must be followed.

    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

    7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials
    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information

    1. Criteria

    Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission 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.

     

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

    Does the proposed resources or resource-related research meet the need of broad research areas supported by multiple NIH ICs?

     

    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?

     

    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 included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?

    Is the approach to developing animal models or related resources feasible? Does the application describe a plan to track the impact of the proposed resources or resource-related research on broad research areas? Is the proposed plan reasonable and feasible? Does the application describe a clear plan to disseminate information and possible future distribution of the proposed resources or resource-related research to the scientific community after the project is completed?

    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 individuals of all ages (including children and older adults), 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?

    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.

     

    For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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.

     

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    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.

     

    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.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review   in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:
    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.
    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the 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.

    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. 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.

    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 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.

    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.

    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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://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 https://www.hhs.gov/civil-rights/for-individuals/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

    3. Reporting

    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 RPPR, 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.

    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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Stephanie Murphy, VMD, PhD
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-451-7818
    Email: stephanie.murphy@nih.gov

    Sige Zou, PhD
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-435-0749
    Email: zous@mail.nih.gov

    Peer Review Contact(s)

    Elena Smirnova, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-357-9112
    Email: smirnove@mail.nih.gov

    Financial/Grants Management Contact(s)

    Stephanie Blackford
    National Heart, Lung, and Blood Institute (NHLBI)
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-827-7536
    Email: Stephanie.Blackford@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 Part 75.


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