Part 1. Overview Information

Key Dates

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The Nonhuman Primate Reagent Resource (NHPRR) will identify, obtain, develop, characterize, produce, evaluate, and distribute to the scientific community key immunologic reagents for nonhuman primate (NHP) research that are not commercially available or, if available, are not optimized for use in NHP research. Supported reagent categories include those for: 1) in vitro assessment and characterization of the immune responses; 2) in vivo detection or imaging of immune molecules expressed extracellularly, intracellularly, or on the cell surface; and 3) in vivo immune-modulation and immune-based therapeutics. In addition to the development, production, and distribution of new reagents, the NHPRR will produce, maintain, and distribute existing NHPRR products. Examples include monoclonal antibodies (mAbs), soluble receptors/ligands, chimeric mAbs, and other novel, state-of-the-art immunologic reagents.

To facilitate the use of reagents produced by the resource, NHPRR will create and maintain a public website that includes a searchable reagent catalog with relevant information, technical specifications, and protocols for use of the reagents provided. The website will also provide a searchable database of information about available immunologic reagents, commercial and non-commercial, that cross-react with NHP cells or proteins.

Background

NIAID supports basic, translational, and clinical research to elucidate mechanisms driving immunological responses and apply research findings to the development of preventative and therapeutic strategies for diseases involving the immune system, including transplant rejection and infectious diseases. Although this NOFO does not itself require research in NHPs,  NHP species are a preferred model for late-stage preclinical research because they approximate human physiology, immunology, and genetics more closely than any other animal model, and, when required, provide compelling data facilitating Food and Drug Administration (FDA) Investigational New Drug (IND) approval prior to the initiation of clinical trials.

Use of NHP models has led to treatment advances for organ transplantation and many infectious and immune-mediated diseases and these models remain central to many aspects of translational and transformative biomedical research including: 1) development and evaluation of new strategies to prolong survival of and/or induce immune tolerance to organ, cellular, composite tissue transplants, and xenografts; 2) development of preventative and therapeutic strategies against human pathogens; and 3) studies of disease pathogenesis and host immunity. A specialized resource for NHP reagents is needed because many immune-monitoring, -depleting, and -modulating reagents developed for mouse or human research or clinical use are either nonfunctional, suboptimal, or not available for use in NHP research. The research tools generated and provided through this initiative will significantly enhance reproducibility, rigor, transparency, and optimal use of these critical research models.

Research Objectives and Scope

The objective of this NOFO is to support NHPRR with the goal of ensuring reagent accessibility to the NHP research community. The scope covers two broad categories: 1) development, acquisition, production, and distribution of immunologic reagents; and 2) website, management, and community engagement activities.

Reagent Development, Acquisition, Production, and Distribution

The responsibilities of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) include all aspects of the management, production, and distribution of the approximately 258 existing reagents developed under the current and previous NIAID NHPRR awards, including protocols, procedures, records for, and inventories of, those reagents.

This NOFO also supports the development of new reagents and outreach efforts to the scientific community to identify evolving immunologic reagent needs.

• Examples of reagent categories include: mAbs, soluble receptors/ligands, chimeric mAb, and other novel immunologic reagents.
• Examples of reagent applications include: 1) in vitro assessment or characterization of immune responses; 2) in vivo detection or imaging of immunologic cell surface, intracellular, or soluble molecules; and 3) in vivo immune-modulation and immune-based therapeutics.

Note that the development and provision of cell-depleting antibodies is not a focus of this NOFO. Cell-depleting reagents are currently supported by the NIH/OD Office of Research Infrastructure Programs (ORIP).

Applicants must propose development of at least two new (candidate) immunologic reagents potentially needed for NHP research, one for in vitro use and one for in vivo use. Each candidate reagent must be:

• Directed against a unique target or a unique specificity.
• Not commercially available, or if available, not optimally formulated for NHP use and not already provided by the NHPRR.

The candidate reagents may currently be in an early stage of development, or in consideration for development. One of the candidate reagents should be for in vitro detection or imaging of a cell surface, intracellular, or soluble molecule; and the other for in vivo immune-modulation (e.g. blocking, agonist, or antagonist), including potential immune-based therapeutics.

The development of new reagents includes all technologies required for state-of-the-art reagents. In addition, the PD(s)/PI(s) will be responsible for characterization, formulation, evaluation, and validation of the specificity, reproducibility, stability, activity, affinity, and unique characteristics of both in vivo and in vitro use reagents prior to larger production runs, as applicable.

Production and purification of reagents will require a range of small- to large-scale production runs (approximate range of 1 gram per 1 liter to 300 grams per 250 liters). Note that reagents produced are not required to be current good manufacturing practice (cGMP) compliant. However, reagents for in vivo use should meet Institutional Animal Care and Use Committee (IACUC) requirements and must be highly purified and produced and formulated as reagents that are safe and appropriate for use in NHPs.

The NHPRR will include quality control and assurance procedures for each product line and provide optimized protocols for the use, storage, and shipment of reagents, both domestically and internationally. The timely distribution of reagents to the NHP research community will require maintenance of sufficient inventories of frequently used reagents.

Website and Overall Management

The NHPRR will create and maintain a public website that includes a searchable reagent catalog with relevant information, technical specifications, protocols for use of the reagents provided, and means to submit user feedback and recommendations for new reagents. This website also will disseminate information about its activities and provide, or contribute and link to, a searchable database of existing commercial and non-commercial antibodies/immunologic reagents for NHPs or reagents developed for humans, mice, or other species that cross-react with NHP cells or proteins.

The NHPRR will inform the scientific community about its activities and promote use of the resource on an ongoing basis.

The PD(s)/PI(s) will be responsible for implementation and maintenance of state-of-the-art data management systems, including electronic production records, inventory and order tracking, and secure handling of sensitive information.

PD(s)/PI(s) will be responsible for management and oversight of the NHPRR activities described above as well as management and oversight of subcontracts, material transfer and licensing agreements, secure webhosting, and recovery of production costs of in vivo use reagents.

Note: Applications that do not include an Overall Management Plan will be considered incomplete and will not be reviewed.

Annual Meetings

The PD(s)/PI(s) will participate in an annual meeting with NIAID staff to update these personnel on the status of the NHPRR. The meeting may include external scientific advisors as determined by NIAID. Additional key personnel and other relevant staff may attend when appropriate. In addition, each year the PD/PI or up to 2 PDs/PIs, if multiple PD(s)/PI(s), will also attend one NIAID scientific or consortium meeting, determined by the NIAID Project Scientist and the Program Officer to update attendees about the NHPRR and to solicit recommendations for new reagent needs.

Applications that include research proposed in the areas below will be considered non-responsive and will not be reviewed:

• Development or provision of antibodies, therapeutics, or reagents to infectious disease agents or reagents for non-immunologic use (e.g., antibodies or other reagents to pathogen components, antibodies or recombinant proteins specifically designed to block entry of pathogens into NHP immune cells, or microbial recombinant proteins); however, development and/or provision of such reagents may be allowed after award under exceptional circumstances, e.g., public health emergencies, and if granted prior approval for a change in scope.
• Immunologic reagents not suitable for use in NHP research
• Viral stocks, unless used for generating immune reagents or for immune assays (e.g., NHP-specific transforming viruses for generating immortalized antibody producing plasma cells are within the scope of the NOFO)
• Reagents for animal models other than NHP species
• Reagents for clinical trials or clinical research
• Clinical trials or clinical research
• Applications not proposing the development of at least two new (candidate) immunologic reagents potentially needed for NHP research, each to a unique target or a unique specificity, one for in vitro use and one for in vivo use, that are not commercially available, or if available, are not optimally formulated for NHP use and are not already provided by the NHPRR.

For any questions concerning the scope of this NOFO, appropriateness of the intended resource plans for this program, and NIAID's program priorities, applicants are strongly encouraged to contact the Scientific/Research Contact.

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

Section II. Award Information

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

1. Eligible Applicants

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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

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 registrations; 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.

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 their organization to develop an application for 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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Equipment: Include a description of the equipment available for large-scale production (range of 100 – 250 liters/run) and purification (range of 75 – 300 grams/run) of monoclonal antibodies, and for storage of at least 12 months inventory of all reagents (see budget assumptions, below).

Other Attachments: Provide an Overall Management Plan for the NHPRR as a PDF attachment, with the filename of "Management_Plan.pdf". Applications lacking this Overall Management Plan will be deemed incomplete and will not be reviewed. The Overall Management Plan should include plans to develop and manage the proposed resource. The following tasks should be addressed:

• Inventory management for timely provision/distribution of over 200 existing reagents currently offered by the NHPRR to the NHP research community, including maintenance of reagent stocks and capacity to respond to unpredicted surges in demand.
• Risk management or contingency plans for proactively identifying and resolving potential logistic issues that could jeopardize or disrupt timely distribution of reagents to the NHP research community. For example, identification of alternate sub-contractors and partners if the NHPRR is unable to meet production goals.
• Management and oversight of subcontracts and any fee-for-service activities.
• Timely processing of materials transfer and licensing agreements, including plans for the management of Materials Transfer Agreements and Intellectual Property Rights for reagents provided by or developed under the NHPRR consistent with the goals of this NOFO.
• Website development and management, including:
  • processes for establishing and updating website information;
  • plans to provide or contribute and link to a regularly updated searchable database of commercial and non-commercial immunologic reagents that react with specific NHP species;
  • features that support secure user registration, feedback, new reagent requests, and order placement; and
  • secure payment processing for recovery of production and purification costs for in vivo use reagents.
• Process management and electronic records management systems that maintain detailed development and production records, technical data sheets, tracking systems for requests and orders, and plans for secure off-site or cloud-based data storage if not included in the Data Management and Sharing Plan.
• Leadership succession in the event it is necessary.
• Defining lines of authority and responsibilities of personnel.
• Outreach and needs assessments, including plans for interacting with the NHP research community, publicizing the NHPRR’s capabilities and services, and predicting and prioritizing the research community’s reagent needs.

Provide details of relevant experience for the activities described above.

Where appropriate, a timeline of tasks with defined criteria for acceptable outcomes for each task should be provided.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed with the following additional instructions:

In the biosketches discuss the PD(s)/PI(s) scientific, technical, and managerial expertise and experience in planning, managing, and directing projects of similar scope, complexity, and size as those required for this NHPRR. In addition, discuss the PD(s)/PI(s) experience in relevant community outreach and identification of research reagent needs.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Each PD/PI must commit a minimum of 4.8 person months (effort is cumulative for each PD/PI proposed).

Applicants should budget annually for the following:

a. Annual replenishment of existing reagents to maintain inventories. Include costs for the formulation, vialing, characterization, evaluation, quality control and quality assurance activities for each. Include production and purification costs for in vitro use reagents. Do not include actual production and purification costs for in vivo use reagents, which will be recovered from requesting investigators. Budgets should be commensurate with approximations of recent annual activities performed by the NHPRR.

b. Annual requests and shipments of existing reagents. Budgets should be commensurate with approximations of recent annual activities performed by the NHPRR.

c. Annual development, production, and evaluation of new reagents:

• Development, genetic engineering/modification, production for evaluation, and evaluation costs for both in vitro and in vivo new reagents based on annual anticipated demand/need. For development and engineering include all aspects as required. Specify the gram and liter production quantities required for evaluation.
• In vivo evaluation of at least two newly developed in vivo reagents per year, but do not include the purchase cost for nonhuman primates used in evaluation studies. NIAID will assist in identifying research collaborators or, if needed, provide animals at no cost.

d. Other annual costs:

• Costs associated with data management and website development and maintenance.
• Outreach costs to promote the NHPRR to new users and to identify reagents needed by the NHP research community.
• Travel for one PD/PI and one key personnel to attend an annual meeting with NIAID and an annual NIAID scientific consortium meeting, both held over 1.5 days in Rockville, MD.
• Travel for 1 staff member to 2 domestic scientific meetings a year, or for 2 staff members to travel to 1 domestic scientific meeting per year.

Do not budget for:

• Reagent shipment costs. Requesting investigators will be expected to pay for reagent shipping costs.
• Large-scale manufacturing costs for in vivo use reagents. The PI should plan to bill the requesting investigator to recover the costs associated with large scale manufacturing of in vivo reagents (e.g., production, purification, quality control, quality assurance, and vialing processes). Note that manufacturing costs do not include costs associated with reagent development and initial characterization and evaluation, which should be included in the application’s requested budget.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: List the specific aims of the proposed program and describe the resources that will be provided to the research community.

Research Strategy: Propose detailed plans and timelines for each of the following activities/areas. Include supporting data from similar work or relevant experience. The format may be adjusted to best reflect the aims and proposed work. Discuss how the proposed project will support the advancement of NHP immunology research and facilitate optimal use of the models for transplantation and/or infectious disease research.

Reagent Development, Acquisition, Production and Distribution

• Propose at least two new (candidate) immunologic reagents potentially needed for NHP research, each to a unique target or a unique specificity, one for in vitro use and one for in vivo use, that are not commercially available, or if available, are not optimally formulated for NHP use and are not already provided by the NHPRR. The candidate reagents may be currently in an early stage of development or in consideration for development. Note: the following are not considered a unique target or specificity: a reagent that is already available for a different NHP species than the species proposed, or a new label/tag or other immune-imaging or -detection modification to an already available reagent. Discuss how the candidate reagents will improve upon the development of immunological reagents by utilizing novel theoretical concepts, approaches, methodologies, or instrumentation. Discuss how the strategies proposed are limited to a single reagent application or specificity or applicable in a broader sense.
  • One of the two candidate reagents should be for: (a) in vitro detection or imaging of a cell surface, intracellular, or soluble molecule; and the other for (b) in vivo immune-modulation (e.g., blocking, agonist, or antagonist), including potential immune-therapeutics. Examples of reagent categories for the two proposed candidate reagents include, but are not limited to, mAbs, soluble receptors/ligands, and chimeric/recombinant mAbs or proteins.
• Justify each candidate reagent in the context of a compelling need and its potential impact on NHP immunologic research.
• Describe all aspects of development and production approaches and methods for the two candidate reagents. Plan final production runs in the range of 75 milligrams and 100 grams for in vitro and in vivo use reagents, respectively. Include supporting data from similar work or relevant experience as appropriate, including experience with development of novel or technically challenging reagents. Discuss feasibility, potential problems, and alternative strategies. Address anticipated timelines and benchmarks of success for the primary tasks and overall development and production stages below. Procedures/processes that are the same or highly similar for the two reagent categories may be presented as a single plan. For the development and production plans, as appropriate, describe approaches for and experience in each of the following:
  • All stages of development, including technologies used (e.g., machine learning and in silico screening for antibody design, cloning the gene of interest, generating a new mAb hybridoma, screening for specific characteristics, genetically modifying a newly generated or existing mAb, and/or using adduct technologies for tagging proteins/antibodies).
  • Reagent characterization, including functional evaluation and validation of its specificity, reproducibility, stability, activity, and unique characteristics, as applicable.
  • Production optimization and reagent purification, formulation, storage, vialing, and labeling.
  • Establishment and implementation of quality control and assurance procedures for each product line as well as overarching plans that will apply to all manufactured and distributed reagents (e.g., quality control and assurance, shelf-life determination, purity assessment and standards, bioburden determinations and limits, release criteria, and other key criteria identified by the applicant). Address approaches to ensure reagents intended for in vivo use will be safe and appropriate for NHPs and meet Institutional Animal Care and Use Committee (IACUC) requirements for use in animals.
  • Use of animals, when anticipated for optimal reagent development and/or production, should be clearly described and justified. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design. Applicants are encouraged to develop methodologies that minimize animal use and partner with requesting investigators to perform in vivo validation of target binding and pharmacokinetic assessments when possible.
  • Development of optimized protocols for the use, storage, and shipment of the two reagent categories. 

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.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

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

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, 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 may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients 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 prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Engaging the scientific community to assess or anticipate their reagent needs.
• Providing the NIAID Project Scientist with, at a minimum, a quarterly assessment of the aggregate value of each new reagent proposed for development by the PD(s)/PI(s), research community, or NIAID, that considers scientific justification of need; time, personnel, and resource requirements; feasibility; and necessary performance benchmarks.
• Cooperating with the NIAID Project Scientist as well as other NIAID staff members and NIAID appointed scientific advisors in periodic evaluation of the NHPRR.
• Providing data and budgetary information regarding NHPRR activities as requested by the NIAID Project Scientist.
• Identifying opportunities for collaboration with other investigators to optimize the development and evaluation of reagents for the NHPRR.
• Negotiating Material Transfer Agreements with donor institutions in a timely manner.
• Ensuring management of Materials Transfer Agreements and Intellectual Property Rights, with commercialization rights, for reagents provided by the NHPRR such that reagents remain readily accessible to the NHP research community consistent with the goals of this NOFO, including in the event of a change in the NHPRR award recipient.
• Maintaining a succession plan that addresses potential award leadership changes.
• The PD/PI(s) must attend one NIAID scientific or consortium meeting annually, determined by the NIAID Project Scientist and the NIAID Program Officer, to inform attendees of NHPRR activities and solicit new reagent recommendations.
• Recipients 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 HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Advising on management and technical issues including recommending changes in experimental approaches, which may or may not require prior approval.
• The NIAID Project Scientist and the NIAID Program Officer will identify the annual NIAID scientific or consortium meeting in which the PD/PI(s) must participate. The meeting is to inform attendees of NHPRR activities and solicit new reagent recommendations.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Conducting quarterly meetings to review new reagent requests and facilitate resolution of performance and/or management issues.
• Establishing agreed-upon performance measures (e.g., website traffic, user feedback; timelines for development, production, and request fulfillment; amounts of reagents produced; and numbers of reagents available, unique investigators utilizing the resource, requests received, and orders shipped).
• Reaching consensus decisions on the development of new, non-depleting immunologic reagents and, when applicable, for provision of reagents to investigators (e.g. for unusually large orders or shipments to institutions that are not strictly research-focused).
• Identifying collaborators, sources, or resources to facilitate program goals, including for accessing nonhuman primates for evaluation of newly developed in vivo reagents.
• Promoting and encouraging the use of the NHPRR and sharing of unique reagents developed by the research community with the NHPRR.
• Maintaining overall scientific balance commensurate with emerging research opportunities and NIAID priorities.
• When appropriate, developing a transition plan for the transfer of NHPRR activities and materials in the event of a change in the NHPRR award recipient.
• The PD/PI(s), NIAID Program Officer(s), and NIAID Project Scientist will participate in an annual meeting to provide updates on the status of the NHPRR. The meeting may include external scientific advisors as determined by NIAID. Additional key personnel and other relevant staff may attend when appropriate.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Shilpa Kulkarni, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-747-7365
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Nicole Gormley
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5449
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 2 CFR Part 200.