Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The purpose of this Funding Opportunity Announcement (FOA) is to provide an immunologic reagent resource that will support and advance the optimal use of nonhuman primate (NHP) models of vaccine and adjuvant development and infectious and immune-mediated diseases, including transplantation. A specialized resource is needed because many immune-monitoring, -depleting, and -modulating reagents developed for mouse or human research or those approved for clinical use are either inactive or sub-optimally active with NHP cells or proteins, or are not available for use in NHP research. The NIAID NHP Reagent Resource will identify, obtain, develop, characterize, evaluate, produce, and distribute to the scientific community key immunologic reagents for NHP research that are either not commercially available or, if available, are not optimized for use in NHP research. Reagent categories include: 1) in vitro use diagnostic reagents to monitor, characterize, or determine the dynamics and parameters of immune responses; and 2) in vivo use reagents to modulate the immune response, deplete immune cell subsets, and characterize the immune response. Examples include monoclonal antibodies (mAbs), soluble receptors/ligands, chimeric/recombinant proteins or mAbs, virus stocks for transforming NHP cell lines, and other novel state-of-the-art immunologic reagents. Responsibility for production and maintenance of reagents, currently supported as part of the NIAID NHP Reagent Resource contract, is an additional activity supported under this FOA. The Resource will engage the scientific community and NIAID to identify and prioritize new reagents for development and to assess the continuing need for existing reagents. In addition, the Resource will develop, provide, curate, and maintain a public website and provide, or contribute and link to, a searchable database of information about commercially available immunologic reagents developed for human or mouse that cross-react with NHP cells or proteins. The website should also provide relevant information, technical specifications, and protocols for use of reagents provided by the Resource.

The Division of Allergy, Immunology, and Transplantation (DAIT) and the Division of AIDS (DAIDS) within the NIAID support basic, translational, and clinical research to understand both immunological responses and mechanisms, and to apply these research findings to the development of effective vaccine, prevention, and therapeutic strategies for infectious and immune-mediated diseases. The use of NHPs for translational research is a critical component of NIAID’s efforts to translate basic discovery research to clinical practice. NHP species are the preferred model for most late-stage preclinical research because they approximate human physiology, immunology, and genetics more closely than any other animal model. In addition, the U.S. Food and Drug Administration (FDA) often requires supporting data from NHP model research for licensure of new therapeutics. The most commonly used NHP species in immune and infectious disease research, and the primary focus of this FOA, are the:

• cynomolgus macaque (Macaca fascicularis),
• rhesus macaque (Macaca mulatta),
• baboon (multiple Papio species), and
• pigtail macaque (Macaca nemestrina)

These species are powerful models in which to: 1) develop and evaluate the safety and efficacy of candidate vaccines against human pathogens, including HIV and emerging infectious diseases; 2) develop and evaluate new strategies to prolong the survival of, and induce immune tolerance to, organ, cellular, and composite tissue transplants; and 3) study the pathogenesis of, and evaluate novel immune-based therapies for, infectious and immune-mediated diseases. Use of the NHP model has led to many notable immunologic and infectious disease research advances, most notably in AIDS pathogenesis, treatment, and vaccine development. A specialized resource is needed because many immune-monitoring, -depleting, and -modulating reagents developed for mouse or human research or clinical use either do not react, react sub-optimally, or are not available for use in NHP research. The research tools generated and provided through this initiative will greatly enhance the optimal use of these critical research models and will accelerate research targeted at developing cures, vaccines, and treatments for immune-mediated diseases, as well as emerging and reemerging infectious diseases.

To address the critical scarcity of in vitro and in vivo immunologic reagents for NHP model research, the NIAID initiated support of the NHP Reagent Resource in FY 2004 through a competitive contract solicitation and subsequent award that was competitively renewed in FY 2009. Currently, the NHP Reagent Resource contract offers approximately 90 unique reagents to researchers worldwide and fills over 500 requests annually, supplying approximately 250 to 350 grams of protein. This FOA is for the continued support of all activities of the NHP Reagent Resource. The central goal of this FOA is the development of products and technologies, with commercialization rights, that remain accessible to the NHP research community.

The objectives and scope of this FOA fall into two broad categories: 1) reagent development, reagent acquisition, reagent production, and reagent distribution for NHP model studies; and 2) website and management activities.

Reagent Development, Reagent Acquisition, Reagent Production, and Reagent Distribution

The responsibilities of the Program Director/Principal Investigator (PD/PI) include all aspects of the production and distribution of the approximately 90 reagents developed under the NHP Reagent Resource contract. Protocols, procedures and records for, and inventories of, reagents developed under the contract by the NHP Reagent Resource will be provided to the new awardee at the time of award. This FOA will support the development of new reagents as well as outreach efforts to the scientific community to identify evolving immunologic reagent needs.

• Examples of reagent categories include, but are not limited to monoclonal antibodies (mAbs), soluble receptors/ligands, chimeric/recombinant proteins or mAbs, virus stocks for transforming NHP immune cell lines, and other novel state-of-the-art immunologic reagents.
• Examples of applications for reagents developed, include, but are not limited to: 1) in vitro or in vivo detection or imaging of cell surface, intracellular or soluble molecules, 2) in vivo immune-modulation or immune-based therapeutics, and 3) in vivo depletion of select immune cells or subsets of cells.

The development of new reagents includes all technologies required for state-of-the-art reagents (e.g., cloning the gene of interest; generating a new mAb by various methods, screening for specific characteristics; genetically engineer a newly generated or existing mAb; and using adduct technologies for tagging proteins/antibodies). In addition, the PD/PI will be responsible for characterization, formulation, evaluation, and validation of the specificity, reproducibility, stability, activity, 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 (25 milligram to 200 gram/100 liters). Note that reagents produced are not required to be cGMP. However, products for in vivo use must be highly purified and formulated as products that are safe and appropriate for use in NHPs. In addition, in vivo use reagents should meet IACUC requirements for use in animals.

The Resource 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 maintaining sufficient inventories of frequently used reagents.

Website and Management Activities

The Resource will develop and provide a public website to disseminate information about the Resource activities and provide, or contribute and link to, a searchable database of commercial or non-commercial antibodies/immunologic reagents developed for human or mouse that cross-react with NHP cells or proteins. At a minimum the website will provide background information, registration information for ordering reagents, reagents available, technical specifications, protocols, and online user feedback and recommendations for new reagents capability.

The Resource will inform the scientific community about its activities and promote use of the Resource on an ongoing basis. The PD/PI 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.

Non-Responsive Applications

This FOA will not support the following activities or reagents:

• Antibodies, therapeutics, or reagents to infectious disease agents, including HIV, or reagents not for immunologic use (e.g., antibodies or other reagents to viruses or viral proteins or viral components, antibodies or recombinant proteins specifically to block entry of viruses into NHP immune cells, or microbial recombinant proteins).
• Immunologic reagents not suitable for use in NHP research.
• Viral stocks, unless used for generating immune reagents (e.g., NHP-specific transforming viruses for generating immortalized antibody producing plasma cells are within the scope of the FOA).
• Reagents for animal model research other than NHP species.
• Reagents for clinical trials or clinical research.
• Clinical trials or clinical research.

Applications that include proposed research in the excluded areas above or that do not include plans for the two broad categories: 1) immunologic reagent development, acquisition, production, and distribution; and 2) website and management activities, will be considered non-responsive and will not be reviewed.

For any questions concerning the scope of this FOA, applicants are encouraged to contact the Scientific/Research Contact.

Annual Meetings

The PD(s)/PI(s) will participate in an annual face-to-face meeting with the NIAID Program Scientist and other NIAID Program Officers to update these personnel on the status of the Resource. 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 the contact PD/PI, if multiple PD(s)/PI(s), will also attend one NIAID scientific or consortium meeting to update attendees about the Resource and to solicit recommendations of new reagents needs.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPH number) is allowed.

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).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Nancy V zquez-Maldonado, Ph.D.
Telephone: 240-669-5044
Email: nvazquez@niaid.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

Equipment: Include a description of the equipment available for large-scale production (up to 100 liter volume) and purification (up to 200 grams/run) of monoclonal antibodies, and for storage of at least 12 months inventory (see budget assumptions, below).

Other Attachments: Provide an overall Management Plan for the Resource as a PDF attachment, with the filename of "Management_Plan.pdf". Applications lacking this Management Plan will be deemed incomplete and will not be reviewed. This Management Plan must include plans for:

• Management and oversight of subcontracts and any fee-for-service activities.
• The timely processing of materials transfer and licensing agreements. Include plans for the management of Materials Transfer Agreements and Intellectual Property Rights for reagents developed under the NHP Reagent Resource consistent with the goals of this FOA to develop reagents, with commercialization rights, that will remain readily accessible to the NHP research community.
• Secure web hosting with credit card processing capabilities for recovery and tracking of production costs for in vivo use reagents.
• Succession of leadership in the event it is necessary.
• Lines of authority and responsibilities of personnel.
• The timely transition of these resources to a future awardee or other NIAID-designated resource at the end of this award.

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

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

The PD/PI must commit a minimum of 5 calendar months. If there are multiple PDs/PIs, each PD/PI must commit a minimum of 5 calendar months.

Applicants should budget annually for the following:

a. for annual replenishment of existing reagents to maintain inventories:

• 10 monoclonal antibody production runs for flurophore, enzyme or biotin conjugations at a 20 mg scale.
• 6 large-scale runs totaling approximately 400 grams of antibody for in vivo administration, with a single specificity, representing 200 grams:
• 4 large-scale monoclonal antibody production runs (50 grams and 50 liters each), for in vivo use. Include costs only for formulation, vialing, characterization, evaluation, quality control or quality assurance related activities.
• 2 large-scale monoclonal antibody production runs (100 grams and 100 liters each) for in vivo use. Include costs only for formulation, vialing, characterization, evaluation, quality control or quality assurance related activities.

b. for annual requests and shipments of existing reagents:

• 600 requests, representing ~600 shipments of the approximately 90 currently available reagents, with:
• 400 of the requests for in vitro reagents, including flurophore, enzyme or biotin conjugated antibodies.
• 200 requests for in vivo reagents and small amounts of other reagents (e.g., NHP cell lines).

c. for annual development and production of new reagents:

• Include all development, production and evaluation costs for both in vitro and in vivo reagents planned annually. Specify the gram and liter quantities required, as applicable. For development, include all aspects as required.
• In vivo evaluation of reagents developed for in vivo use in 6 animals for all costs, including per diems, except the purchase of the animals. Applicants should not include the cost for animals used in evaluation studies. NIAID will provide animals at no cost.

d. other annual costs:

• Outreach costs to promote new users.
• Travel for the PD/PI to attend an annual meeting with NIAID and an annual NIAID scientific consortium meeting, both to be held in Rockville, MD.
• Travel to 2 domestic scientific meetings a year or for 2 staff to attend 1 domestic scientific meeting a year.

Do not budget for:

• Shipments of reagents (investigators requesting reagents will pay for shipping costs).
• Production and purification costs for in vivo use reagents (typically gram quantities); production/purification does not include development, characterization, evaluation, quality control or quality assurance. Requesting investigators will pay for production/purification costs.

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

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

All instructions in the SF424 (R&R) 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.

Reagent Development, Acquisition, Production and Distribution

• Identify and prioritize four new (candidate) immunologic reagents, each to a unique target or a unique specificity, needed for NHP immunological research, which are not commercially available, or if available, are not optimally formulated for NHP use and are not already provided by the NHP Reagent Resource, which includes, but is not limited to the ~90 NIAID-supported reagents. Note: Proposing a reagent for a different species of NHP that is already available for another species is not considered a unique target or specificity, nor is providing a new label or other immune-imaging or -detection modification to a reagent specificity already available considered a unique specificity or target.
• Justify each of the four reagents identified above in the context of a compelling need and potential impact to NHP immunologic research. Discuss strategies to identify the reagent needs of the research community.
• Propose each of the following applications or uses: a) in vitro detection or imaging of cell surface, intracellular or soluble molecules for one of the four unique candidate reagents proposed above; b) in vivo immune-modulation, including potential immune-therapeutics, or in vivo depletion of select immune cells or subsets of cells for a second reagent from the remaining three candidate reagents above. Examples of reagent categories for the two applications above include, but are not limited to: mAbs, soluble receptors/ligands, and chimeric/recombinant proteins or mAbs.
• Propose development and production approaches and methods, as appropriate, for the two proposed reagents in the bullet above, representing one in vitro and one in vivo use reagent. Supporting data from similar work or relevant experience should be included, as appropriate. Discuss advantages, disadvantages and alternatives, where appropriate. Discuss feasibility, problems and alternative strategies. For the in vitro and in vivo use reagent productions runs, plan 25 mg and 100g runs, respectively. Address each of the following in the development and production plans, as appropriate:
• Propose plans for the development of reagents through all stages as required; including technologies incorporated (e.g., 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).
• Propose plans for the characterization, evaluation, and validation of the specificity, reproducibility, stability, activity, and unique characteristics, as applicable.
• Propose plans for optimized production, purification, formulation, vialing, and labeling.
• Propose plans for the establishment and implementation of quality control and assurance procedures for each product line. In addition, provide overarching plans that will apply to all products manufactured and distributed (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 how products intended for in vivo will be safe and appropriate for use in NHPs and meet IACUC requirements for use in animals.
• Propose optimized protocols for use, storage, and shipment of the two reagents included in the development and production proposal.
• Propose an overall plan for the continued provision of the ~90 reagents developed and offered by the current Resource and distribution of reagents to the NHP research community in a timely manner, including maintaining reagent stocks.
• Propose plans for outreach to the NHP research community, including publicizing Resource capabilities to inform the scientific community of available services and to identify and assess new reagent needs.
• Propose plans for an electronic data management system, including establishment and maintenance of detailed electronic development and production records, technical data sheets, and tracking systems for requests and orders.
• Website: Propose plans for the website development, procedures to update the website information and key features of the website, including those to improve usability, registration, user feedback, new reagent needs, reagent ordering and security. Discuss plans to provide or contribute and link to an updated searchable database of commercial or non-commercial antibodies/reagents that react with NHP species.

Letters of Support: Provide a letter of support stating that the institution will work with the current awardee and any future awardee, if applicable, to ensure that all required Material Transfer Agreements will be negotiated in a timely manner, and ensure an orderly transition of activities and resources to the grantee institution will be completed within three months of award or future award.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• All applications should include plans for sharing with the scientific research community all reagents, products, assays, methodologies, and protocols developed with NHP Reagent Resource funding.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Not Applicable

Not Applicable

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

Does the application support the advancement and facilitation of the immunologic NHP Reagent Resource for optimal use of NHP models in vaccine and adjuvant development and infectious and immune-mediated diseases, including transplantation. If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project and is their level of effort sufficient to ensure the success of the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does/do the PD(s)/PI(s) have documented scientific, technical and managerial expertise and experience for planning, managing, and directing projects of similar scope, complexity and size and performing the requirements of the project?

Does the application challenge and seek to shift current research and resource practices by utilizing novel theoretical concepts, approaches, methodologies, or instrumentation? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed?

Are the overall strategy, methodology, quality control procedures, and analyses well-reasoned and appropriate to accomplish the scope of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Are the candidates' reagents proposed for at least four unique specificities for in vitro and in vivo use appropriately prioritized? Is each reagent well justified? Are plans proposed for establishment and implementation of quality control and assurance procedures adequate?

Are the production plans for reagents intended for NHP in vivo use adequate? Are the plans for maintaining reagent stocks sufficient to minimize backorders or delays? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are the plans or systems for electronic data management and tracking of requests, shipments, and inventory appropriate? Is the overall management and operational plan well-reasoned and appropriate? Is the plan for development and maintenance of a public website and other proposed services appropriate? Are plans for community outreach appropriate?

Will the institutional and scientific environment in which the work will be done contribute to the probability of success in facilitating the Resource program? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, facilities, or collaborative arrangements?

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

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the 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 Collaborator with quarterly, or more frequent assessments, as necessary, for the need for development of new reagents proposed by the PD/PI, research community or NIAID, including scientific justification; time, personnel, and resource requirements; feasibility; and performance milestones.
• Cooperating with the NIAID Project Collaborator, other NIAID staff members and NIAID appointed scientific advisors in the periodic or annual evaluation of the Resource.
• Providing data and budgetary information regarding the Resource activities as requested by the NIAID Project Collaborator.
• Seeking opportunities for collaborations with other investigators in order to optimize the development and evaluation of reagents for the NHP Reagent Resource.
• Developing a final transition plan in collaboration with, and when requested by, the NIAID Project Collaborator for the transfer of the Resource activities and resources to the grantee institution.
• Negotiating Material Transfer Agreements with donor/recipient institutions in a timely manner.
• Ensuring management of Materials Transfer Agreements and Intellectual Property Rights, with commercialization rights, for reagents developed under the NHP Reagent Resource that will remain readily accessible to the NHP research community consistent with the goals of this FOA. This will include receiving materials under terms that permit continued access under this program, even if this grant is later assigned to a new grantee.
• Maintaining a succession plan that addresses potential changes in leadership of the award.
• Promoting the use of the Resource to the scientific community on an ongoing basis.
• 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:

A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIH Project Collaborator for this program, facilitating but not directing activities.

The NIAID Project Collaborator responsibilities will include, but not be limited to, the following activities:

• Monitoring the NHP Reagent Resource progress and when appropriate, coordinating reviews or advice from NIAID appointed external scientific advisors and other NIAID program staff.
• Providing NIAID approvals to the PD/PI for new reagent development and, when applicable, approval for provision of reagents to investigators.
• Assisting the PD/PI in identifying collaborators, sources or resources.
• Advising on management and technical issues.
• Assisting in promoting and encouraging the use of the resource and the sharing of unique reagents from the research committee with the NHP Reagent Resource.
• Assisting to maintain overall scientific balance commensurate with emerging research opportunities and NIAID priorities.
• 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:

None; all responsibilities are divided between awardees and NIH staff as described above.

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 or comparable body 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.

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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

The awardee is solely responsible for the timely acquisition of all appropriate propriety rights, including intellectual property rights, and all materials needed for the awardee to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any propriety rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Kristy Kraemer, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3520
Email: kkraemer@mail.nih.gov

Nancy V zquez-Maldonado, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5044
Email: nvazquez@niaid.nih.gov

Jenny Greer
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2949
Email: jenny.greer@nih.gov

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 45 CFR Part 75 .