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

Limited Competition: Specific Pathogen Free Macaque Colonies (U42 Clinical Trial Not Allowed)

Activity Code

U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements

Announcement Type

Reissue of PAR-18-669 - Limited Competition: Specific Pathogen Free Macaque Colonies (U42 Clinical Trial Not Allowed)

Related Notices
 
Funding Opportunity Announcement (FOA) Number

PAR-21-089

Companion Funding Opportunity

None

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

 93.351

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement is to provide continuing support for specific pathogen-free (SPF) macaque colonies previously funded under the auspices of PAR-18-669 and PAR-14-066. Breeding colonies are essential to sustain appropriate macaques for research related to Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS). Pedigree SPF macaques are free of certain viruses, which may confound the results of HIV/AIDS-related investigations or present a risk to the personnel who care for the animals. The SPF macaques are genetically characterized for major histocompatibility complex (MHC) class I types, because MHC class I genotypes have large effects on macaque immune responses to Simian Immunodeficiency Virus (SIV, which can induce AIDS in nonhuman primates (NHP)) and on human immune responses to HIV.

Key Dates

 

Posted Date

January 8, 2021

Open Date (Earliest Submission Date)

April 7, 2021

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Only accepting applications for the AIDS Application Due Date(s) listed below.  

AIDS Application Due Date(s)

Standard AIDS dates apply. The first AIDS application due date for this FOA is May 7, 2021. All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

January 8, 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) 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.


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. 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 NIH funds a vigorous research program to study the basic pathobiology of HIV/AIDS, development of this infectious disease, impact of co-infections and co-morbidities, and development and testing of new HIV/AIDS treatments/therapies and approaches to prevention, such as vaccines and microbicides. Macaque monkeys are closely related to humans in terms of genetics, anatomy, and physiology, and thus provide useful models to facilitate many aspects of HIV/AIDS-related research. For example, rhesus macaques (Macaca mulatta) infected with SIV are used to investigate many aspects of viral pathogenesis, including early events not readily studied in human patients, as well as development of HIV vaccines and other approaches to prevention. Macaques, particularly pigtails (Macaca nemestrina), are also used to investigate concepts for vaginal mucosal microbicides before testing them in human subjects. The influence of the vaginal microbiome, which is similar to that expressed in women, can be investigated in these animals to understand its role in HIV infection and prevention.

    The presence of certain viruses in the experimental primate subject can confound the results of HIV/AIDS-related studies. Therefore, the NIH/ORIP supports the continued maintenance of specific pathogen-free (SPF) macaque colonies under a single U42 FOA in alignment with ORIP's focus on the development and support of a biomedical research resource. Collectively, the colonies comprise a consortium of ORIP-funded resources that provide SPF macaques for NIH-funded HIV/AIDS research. As determined by current state-of-the-art assays, the SPF macaques are free of SIV, type D simian retrovirus (SRV), and simian T-cell lymphotropic virus 1 (STLV-1). The SPF animals are also required to be free of herpes B virus (also known as Macacine alphaherpesvirus 1), a potential health risk for personnel handling the animals.

    Understanding MHC genetics is essential for infectious disease research due to the pivotal role of MHC proteins in the immune response. SPF macaques are also characterized with respect to certain MHC class I types, which are responsible for antigen presentation to T cells. An important aspect of the evaluation of candidate HIV vaccines in NHPs (and humans) is the measurement of virus-specific T-cell immune responses. Most T-lymphocytes bind to immunogens presented by (or displayed on) MHC class I receptors. Certain MHC class I alleles, such as Mamu-A*01, Mamu-B*08, and Mamu-B*17, are associated with slow disease progression in rhesus macaques. When designing experiments with macaque models, it is therefore important to know if a research subject possesses MHC alleles that affect immune responses to SIV infection.

    The major emphasis of the breeding colonies has been the production of SPF, MHC-characterized Indian-origin rhesus macaques, which are a preferred model for studying the entire course of SIV infection leading to AIDS. The SPF cooperative agreements have also supported smaller numbers of SPF, MHC-characterized Chinese-origin rhesus macaques and pigtail macaques, which have specialized uses for various aspects of HIV/AIDS research such as the development of microbicides and exploration of sexually transmitted virus. Some investigators have derived sub-colonies of macaques that are SPF for additional viruses, such as cytomegalovirus, human papillomavirus, and herpes simplex virus. These expanded SPF (eSPF) animals are used for novel vector studies as well as co-infection research.

    Most of the SPF macaque resources are now effectively “closed” colonies that do not take in new animals for breeding purposes. The colonies derive animals for HIV/AIDS-related research strictly through the breeding stock that has been maintained through the U42 cooperative agreements.

    This FOA invites applications for the continued support of SPF macaque breeding colonies to ensure that investigators have access to these critical models for HIV/AIDS-related research.

    Applicants should include, but are not limited to, the following areas of service and support:

    • Breeding and maintaining the SPF colonies, minimally at current levels;
    • Allocating the SPF animals to HIV/AIDS researchers, giving priority to NIH-funded investigators;
    • Preserving the SPF status of the animals by assaying for the presence of specific viruses and mitigating against potential outbreaks;
    • Typing the animals for specific MHC loci; and
    • Plans for sustaining colony operations.

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

    Section II. Award Information

     

    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    Renewal

    Resubmission

    Revision

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

    Award Budget

    The Direct Costs requested per year cannot exceed a 5% increase over the highest Direct Cost amount awarded in any year of the previously funded grant period.

    Award Project Period

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

    Only grantees funded under an ORIP-supported SPF colony FOA (PAR-18-669 or PAR-14-066) are eligible to apply.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • 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.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number 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
    Number of Applications

    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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6

    Core (one each: Husbandry and Management, Viral Testing, and MHC Genetic Typing core)

    12

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

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

    The application should consist of the following components:

    • Overall: Required
    • Husbandry and Management Core: required, maximum of 1
    • Viral Testing Core: required, maximum of 1
    • MHC Genetic Typing Core: required, maximum of 1
    Overall Component

    When preparing your application, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

    Specific Aims: State concisely the goals of the proposed resource and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on HIV/AIDS research.

    Research Strategy: Applicants should include the following information:

    • Describe the management of the colony and how the output of SPF animals made available to HIV/AIDS researchers will be determined. Some colonies are at or near a steady state level of breeders, from which the output of animals for assignment to experiments will be relatively constant. Other colonies are still increasing the size of the breeding pool and will therefore be able to increase output over time until reaching a steady state. An increase of the size and output of the colony through the addition of animals is allowable, but this is not a requirement.
    • Describe the process by which the awardee plans to allocate animals in an attempt to meet the following goals. Allocation should be on a first come, first served basis, with NIH-funded HIV/AIDS researchers having highest priority. In order to serve HIV/AIDS-related researchers broadly, the goal is that 40% of the animals (or more) will be provided to researchers outside the awardee institution. Animals in excess of the demands of NIH-funded researchers can be provided to researchers funded by other sources, as described in ORIP's Guidelines for Prioritization of Requests for SPF Macaques Supported by U42 Awards, but this can only be done with prior approval of the ORIP Program Officer.
    • Provide information on lines of communication and processes to resolve potential conflicts.
    • Justify the inclusion of an expanded SPF component beyond the required 4 viruses, if applicable. Describe the additional pathogen(s) to be excluded, how this will be accomplished, and the proposed impact on HIV/AIDS research. An expanded SPF component is not required and should not result in enlargement of the colony.

    Letters of Support: Statements of Institutional Commitment, Letters of Support from the past and potential future users of the resources, Letters of Collaboration, and other similar documents, if appropriate, should be included in this section as an attachment (rather than in the Cores Section).

    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.

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

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Overall)

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

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    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 (Overall)

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

    Husbandry and Management Core

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (Husbandry and Management Core)

    Complete only the following fields:

    • ·    Applicant Information
    • ·    Type of Applicant (optional)
    • ·    Descriptive Title of Applicant’s Project
    • ·    Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Husbandry and Management Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Husbandry and Management Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Husbandry and Management Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Husbandry and Management Core
    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.    
    Budget (Husbandry and Management Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Husbandry and Management Core)

    Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

    Specific Aims: State concisely the goals for Husbandry and Management of the colony. List succinctly the specific objectives of the financial plan, e.g., to solve a specific problem, address a critical barrier to progress in the field that the resource supports, or develop new components (expanded SPF components), if applicable.    

    Research Strategy: Applicants should include:

    • A sustainability plan for the colony. Provide a table that shows how colony operations are currently funded, including support from: the current U42 cooperative agreement, Program Income, and other sources, if applicable. Program Income is defined as gross income earned by the recipient that is directly generated or earned as a result of the award. For the SPF colonies, Program Income is usually derived from animal sales, per diem charges, lease fees, and/or shipping costs. Support for the colony from sources other than the cooperative agreement and Program Income is strongly encouraged but not required.
    • A financial plan for the colony. Different colonies have grown at various rates and have accumulated different numbers of animals for breeding. Therefore, colonies may be at various stages regarding the amount of Program Income that can be generated, which depends on the size and breeding capacity of the colony. Regardless of the current baseline, the financial plan should provide a strategy for the renewal period such that Program Income and, if applicable, other sources of support generate approximately half or more of the amount of direct costs required to support the SPF colony. The sum of the direct costs requested plus contributions from the financial plan should equal the costs associated with all the functions of the SPF colony. Support for the colony from sources other than the Cooperative Agreement and Program Income is strongly encouraged but not required.
    • Provide a description of the colony management. This description should include husbandry and veterinary care that ensure maintenance of the SPF status; breeding protocols that preserve/document genetic diversity, parentage, ancestry, and MHC genotype; environmental and behavioral enrichment provided to the animals; and capability to support electronic information and handling of animal data. If additional pathogen(s) are proposed to be excluded, describe the plans for eliminating the pathogen(s) and subsequent maintenance of the colony.

    Letters of Support: Provide them in the Overall Section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: Address the Resource and Data Sharing Plan in the Overall Section.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    PHS Human Subjects and Clinical Trials Information (Husbandry and Management Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    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.

    Viral Testing Core

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (Viral Testing Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Viral Testing Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Viral Testing Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Viral Testing Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Viral Testing Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    Budget (Viral Testing Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Viral Testing Core)

    Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

    Specific Aims: List succinctly the specific objectives of the assays proposed, e.g., to solve a specific problem, challenge an existing paradigm, address a critical barrier to progress in the field, or use new technology to validate end results.

    Research Strategy: Applicants should include:

    • The current state-of-the-art assays utilized for the detection of: SIV, SRV, STLV-1, and herpes B virus (see https://www.ncbi.nlm.nih.gov/pubmed/26932456 for a review on viral testing of SPF Macaques).
    • Alternatives to validate the testing end-result.
    • Additional testing required to maintain the viral-free status of the animals with regard to other defined pathogens in expanded SPF colonies, if applicable.
    • Any proposed improvements to current viral testing assays including proposed benefits and measures to ensure rigor and reproducibility.

    Letters of Support: Provide them in the Overall Section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    Address the Resource and Data Sharing Plan in the Overall Section.

    Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    PHS Human Subjects and Clinical Trials Information (Viral Testing Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    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.

    MHC Genetic Typing Core

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (MHC Genetic Typing Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (MHC Genetic Typing Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (MHC Genetic Typing Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (MHC Genetic Typing Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (MHC Genetic Typing Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    Budget (MHC Genetic Typing Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (MHC Genetic Typing Core)

    Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

    Specific Aims: List succinctly the specific objectives of the MHC genetic typing proposed, e.g., to test novel markers, solve a specific problem, challenge an existing paradigm, address a critical barrier to progress in the field.

    Research Strategy: Applicants should include:

    • The current state-of-the-art assays utilized for genetic typing and any plans for additional testing or improvements of testing, including their proposed benefits as well as measures to insure rigor and reproducibility.
    • Current practice for the characterization/identification of MHC Class I and II alleles, as appropriate, associated with disease progression in macaques.
    • Any plan to expand the identification of specific MHC alleles that can affect the immune response to SIV infection.

    Letters of Support: Provide them in the Overall Section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    Address the Resource and Data Sharing Plan in the Overall Section.

    Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    PHS Human Subjects and Clinical Trials Information (MHC Genetic Typing Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    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.

    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) using ASSIST or other electronic submission systems. 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.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    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) and component Project Leads 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Requests of $500,000 or more for direct costs in any year

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific / Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

    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.

    The U42 application is a multicomponent application, with an "Overall" component that is the aggregate of the 3 Cores (Husbandry and Management, Viral Testing, and MHC Genetic Typing). During the review process, reviewers will first consider each of the review criteria listed for each of the Cores and provide a component score for each Core. Once the Cores are completed, an overall impact score will be assigned for the entire application.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the colony 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 colony proposed).

    Scored Review Criteria - Overall

    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 colony that by its nature is not innovative may be essential to advance a field.

    Significance

    How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the scope of the proposed colony management for the resource appropriate to meet the needs of the research community that it will serve? How will successful completion of the aims strengthen the resource and the value of the colony? Will the colony provide animals to investigators on a local, regional, and national basis? Are the plans for maintaining and funding the colony adequate to meet the stated goals for distribution of SPF macaques to the research community? If an expanded SPF component is proposed, will its use enhance an important aspect of HIV/AIDS research? Is the scientific justification sound for exclusion of the additional pathogen(s), if proposed?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the resource? 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 colony? Does the proposed team have appropriate experience and expertise to accomplish the overarching goals of the resource? Have they demonstrated a record of accomplishments in managing the resource? Do the investigators demonstrate significant expertise to allocate the animals requested by the research community? Are the PD(s)/PI(s) and the Core Leads collaborating effectively to provide unified leadership of the resources? Are lines of communications and plans for conflict resolution sufficient for an efficient resource? Does the applicant have experience overseeing selection and management of subawards, if needed?

    Innovation

    Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application propose novel management strategies, approaches, instrumentation, etc. in supporting the research that the resource will serve? Are refinements, improvements, or new applications of management strategies, approaches, or instrumentation proposed? Are plans for colony management and production in accord with current standards of practice and efficiency? How are the animal models created driving innovation in biomedical research?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the resource? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed colony? 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 colony 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?

    In addition, is the allocation plan for distribution of SPF animals appropriately aligned with NIH priorities and goals for HIV/AIDS-related research? Did the allocations during the past award adequately demonstrate prioritization toward HIV/AIDS investigators, particularly those funded by NIH? Does the application contain an adequate approach to try to meet the goal that 40% of the allocated animals (or more) will be provided to researchers outside the awardee institution, on average, over the proposed project period?

    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 proposed aims of the colony? Will the colony benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    Additional Review Criteria - (Overall)

    As applicable for the colony 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 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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    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.

    Vertebrate Animals

    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.

    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

    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 - Overall

    As applicable for the colony 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) Genomic Data Sharing Plan .


    Authentication of Key Biological and/or Chemical Resources

    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.

    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.

    Review Criteria for the Husbandry and Management Core

    As applicable for the proposed colony, reviewers will evaluate the following additional items while determining scientific and technical merit for the Core and in providing a component score for the Core. Reviewers will not give separate scores for the following additional items.

    • Are the different aspects of the Husbandry and Management Core adequately described?
    • Are procedures in place sufficient to maintain SPF status?
    • Are plans for environmental and psychological enrichment of the NHPs adequate?
    • Do the financial and sustainability plans provide adequate support to accomplish the goals of the project?
    • Does the facility have sufficient infrastructure for holding, breeding, and care of the colony animals?
    • Is there sufficient evidence of the ability of the colony to produce the target number of animals to be allocated annually?
    • Does the Husbandry and Management Core Leader have the proven experience and expertise to continue directing the Core?
    • Is there evidence of appropriate management experience to support and maintain the colony for another 4 years?
    • Are the responsibilities of key personnel clearly delineated and are they adequate to meet all requisite aspects of colony management, including: husbandry and veterinary care that ensure maintenance of SPF status; and breeding protocols that preserve/document genetic diversity, parentage, ancestry, MHC genotype, and environmental and behavioral enrichment provided to the animals?
    • If additional pathogen(s) are proposed to be excluded, are exclusion plans adequate to accomplish that goal and how this will impact HIV/AIDS-related research?
    • Are resources available within the scientific environment to support electronic information handling?
    Review Criteria for the Viral Testing Core

    As applicable for the proposed colony, reviewers will evaluate the following additional items while determining scientific and technical merit for the Core and in providing a component score for the Core. Reviewers will not give separate scores for the following additional items.

    • Are plans for viral testing sufficient to ensure SPF status of the colony? How will these plans enhance the colony?
    • Will the proposed technologies lead to improvement in the detection and validation of an outbreak in the colony and associated biosafety risks?
    • Does the Viral Testing Core Leader have the proven experience and expertise to continue directing the Core?
    • Are the proposed viral assays state-of-the-art?
    • Do plans for viral testing adequately address rigor and reproducibility?
    • If an expanded SPF component is proposed, are the plans for viral testing adequate to ensure that animals are free of the indicated additional viruses? How will the biomedical community benefit from the expanded viral testing?
    Review Criteria for the MHC Genetic Typing Core

    As applicable for the proposed colony, reviewers will evaluate the following additional items while determining scientific and technical merit for the Core and in providing a component score for the Core. Reviewers will not give separate scores for the following additional items.

    • To what extent is the proposed MHC genetic typing state-of-the-art?
    • Does the MHC Genetic Typing Core Leader have the proven experience and expertise to continue directing the Core?
    • How do the plans for MHC genetic typing adequately address rigor and reproducibility?
    • Is the plan to expand the MHC genetic typing feasible, if proposed?
    • How will the expanded MHC genetic typing, if proposed, impact HIV/AIDS-related Research?
    2. Review and Selection Process

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

    • Will receive a written critique.

    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 Council of Councils. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.  
    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.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    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.  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.

    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.    

    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.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardee is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and primary responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared among the awardee and the NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Planning the activities, defining the aims and objectives, and describing the methods, techniques, and other resources to be used for carrying out the work described.
    • Performing all aspects of colony management, characterizing animals in regard to viral status and MHC type, distributing animals to researchers, and deriving Program Income. It is understood that other personnel at the grantee institution (e.g., the business office) are involved in some of these activities.
    • Establishment and maintenance of an animal barrier facility (SPF) as well as procedural and managerial husbandry techniques and practices appropriate for maintaining a state-of-the-art facility for the SPF colony.
    • Providing colony data on a yearly basis or as requested by the ORIP in a format to be specified by the ORIP. These data will include colony demographics, the number of animals distributed, and the grants that were supported.
    • Allocating animals in an attempt to meet the goal that 40% (or more) of the animals allocated over the proposed project period are distributed to researchers outside the awardee institution.
    • Working with the ORIP Project Scientist to develop a remediation plan and appropriate allocation benchmarks if, based on animal allocations in the first half of the proposed project period, it is projected that fewer than 40% of the animals will have been distributed to outside investigators over the entire project period proposed.
    • Meeting with NIH staff and the other members of the SPF Macaque Grantee Consortium at least once per year to discuss consortium-based activities that will help coordinate activities common to the SPF macaque grants. These annual meetings will take place at the ORIP Offices in Bethesda Maryland, at one of the awardee institutions, or by video or teleconference. Additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled as needed.
    • Maintenance of a local electronic database for live animals (including animal health records).

    Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    NIH staff have substantial programmatic involvement that is above and beyond the normal

    stewardship role in awards, as described below:

    The ORIP Project Scientists will:

    • Assist with facilitating the coordination and management of the resource, ensuring that overall management of the resource is in compliance with NIH policies.
    • Coordinate and assist with establishing operating procedures regarding the sharing of SPF animals and related research data for use by other researchers.
    • Work with the PD(s)/PI(s) to develop a remediation plan and appropriate allocation benchmarks if, based on animal allocations in the first half of the proposed project period, it is projected that fewer than 40% of the animals will have been distributed to outside investigators over the entire project period proposed.
    • Have the option to recommend to the Program Officer withholding of support to the resource if aims are not met.
    • Have substantial scientific involvement during the conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants.

    Additionally, an ORIP Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

    The ORIP Program Officer will:

    • Be responsible for the normal scientific and programmatic stewardship of the award.
    • Carry out continuous review of all activities to ensure the project aims are being met.
    • Pursue enforcement actions including withholding of support for failure to meet the terms and conditions of the award or failure to show satisfactory progress in achieving the aims.

    Areas of Joint Responsibility include:

    • Coordination of the activities of the SPF Macaque Grantee Consortium. This will be accomplished through a Steering Committee composed of each U42 grant PD/PI (or their designees) and the NIH Project Scientist and Program Officer (or their designees). The function of the Steering Committee is to coordinate consortium activities through consultation and discussion, and to identify common problems and solutions as they arise.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    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)

    Matthew Arnegard, Ph.D.
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-451-2074
    Email: matthew.arnegard@nih.gov

    Sheri Hild, Ph.D.
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-594-8937
    Email: sheri.hild@nih.gov 

    Peer Review Contact(s)

    Ross Shonat, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-435-2786
    Email: ross.shonat@nih.gov

    Financial/Grants Management Contact(s)

    Nicole Franklin – Grants Management Specialist
    National Heart, Lung, and Blood Institute (NHLBI)

    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-402-8682
    Email: nicole.franklin@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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