Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed)

Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed) is sponsored by NIH. Supports the maintenance of specific pathogen-free macaque colonies for HIV/AIDS research, crucial for advancing understanding and treatment of HIV.

PAR-24-129: Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 ) Office of AIDS Research ( OAR ) Funding Opportunity Title Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed) U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 January 25, 2024 - Notice of Early Termination of PAR-24-078: Limited Competition: Specific Pathogen Free Macaque Colonies (U42 Clinical Trial Not Allowed).

See Notice NOT-OD-24-056 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to provide continuing support for specific pathogen-free (SPF) macaque colonies previously funded under the auspices of PAR-21-089 and PAR-18-669 that support Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) research.

Breeding colonies are essential to sustain appropriate SPF macaques for research related to HIV/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) that can induce AIDS in nonhuman primates (NHPs) and on human immune responses to HIV.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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. New Date September 26, 2026 per issuance of NOT-OD-26-029 .

(Original Expiration Date: January 08, 2027) Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of 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. Notice of 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, thus providing 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 SPF macaque colonies under a single U42 NOFO in alignment with ORIP's focus on the development and support of biomedical research resources. 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 (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 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 NOFO 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; Genotyping 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 Cooperative Agreement: A financial assistance 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 NOFO. Application Types Allowed 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 NOFO.

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.

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

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 NOFO.

Section III. Eligibility Information Only recipients funded under an ORIP-supported SPF colony NOFOs (PAR-21-089 and PAR-18-669) are eligible to apply. Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

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.

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. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; 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 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) Only the PI/PDs associated with the award issued under PAR-21-089 and PAR-18-669 is eligible to apply for this funding opportunity.

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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2- Definitions of Terms.

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 per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

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 NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). 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 NOFO. See the administrative office for instructions if planning 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 How to Apply - Application Guide , except where instructed in this notice of funding opportunity 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- 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: Husbandry and Management Core: required, maximum of 1 Viral Testing Core: required, maximum of 1 MHC Genetic Typing Core: required, maximum of 1 When preparing the 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) 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 Locations (Overall) 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 and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) 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.

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. An increase of the size and output of the colony through the addition of animals is allowable. Describe the process by which the recipient plans to allocate animals 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 50% of the animals (or more) will be provided to researchers outside the awardee institution, on average, over the proposed project period.

Animals in excess of the demands of NIH-funded HIV/AIDS researchers can be provided to HIV/AIDS 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.

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 Core Sections). Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

A Data Management and Sharing Plan is not applicable for this NOFO. Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide ; any instructions provided here are in addition to the 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.

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 How to Apply- Application Guide must be followed. PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Husbandry and Management Core When preparing your application, use Component Type ‘Core. ’ All instructions in the How to Apply- 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: 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 ‘Project 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.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO–specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support.

Delete “Letters of Support” if there are no NOFO-specific instructions. 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. It is expected that the SPF Macaque Colony cooperative agreements will generate Program Income and will recover a certain percentage of their operating cost.

Program Income is defined as gross income earned by the awardee 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 is strongly encouraged.

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.

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 Sharing Plan in the Overall Section. Only limited items are allowed in the Appendix.

Follow all instructions for the How to Apply- Application Guide ; any instructions provided here are in addition to those in the 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 How to Apply- 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. When preparing your application, use Component Type ‘Core.

’ All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Viral Testing Core) Complete only the following fields: 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 ‘Project 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.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO–specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support.

Delete “Letters of Support” if there are no NOFO-specific instructions. 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: P rovide 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 How to Apply- Application Guide. Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide ; any instructions provided here are in addition to those in the 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 How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects