Part 1. Overview Information

Key Dates

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for certain pathogens. The purpose of this Funding Opportunity Announcement (FOA) is to solicit research applications for projects focused on preclinical development of lead candidate therapeutics or vaccines (or related countermeasures) that address select NIAID Emerging Infectious Diseases/Pathogens, as defined below.

For the purpose of this FOA, lead candidate is defined as a candidate product, or a collection of optimized products (e.g. lead candidate series), for which proof-of-concept data have been obtained and preclinical development is defined as all activities beyond lead candidate identification. Examples of supported research areas include: lead optimization; efficacy testing, safety evaluation; stability testing; manufacturing; development of broad spectrum platforms and/or production technologies; optimization of products or technologies; process development; scale-up; production of quantities sufficient for preclinical regulatory requirements; and IND-enabling activities required for initiation of Phase I clinical trials. Priority will be given to projects that address the greatest public health concerns.

Background

The National Institutes of Health (NIH) and other agencies in the Department of Health and Human Services (DHHS) support development of countermeasures to protect the public from infectious diseases. In 2002, the NIH initiated development of strategic plans to counter threats presented by emerging infectious diseases. As a component of these plans, NIAID was assigned responsibility for research leading to and development of candidate countermeasures against a growing list of emerging pathogens. NIAID established the Partnerships program to support discovery, preclinical research, product development and eventual commercialization of candidate products that address specific pathogens/agents. This FOA reflects current priorities outlined in the NIAID Strategic Plan for Biodefense Research, the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan, the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), the National Action Plan for Combating Multi-drug Resistant Tuberculosis, the HHS 2010 Medical Countermeasure Review, and Homeland Security Presidential Directive 18: Medical Countermeasures against Weapons of Mass Destruction.

Research Goals, Objectives, and Scope

The objective of this FOA is to support milestone-driven preclinical research that will advance the development and/or production of lead candidate therapeutics or vaccines (or related products) for select Emerging Infectious Diseases/Pathogens described below. Each application must propose a research and development project whose goal is to advance an already identified lead candidate. Proposed projects are not required to result in a "final" product, nor is it necessary to propose completion of the product development process up to the point of readiness for clinical trials or validation within the time frame of the project. Applications that would significantly advance a candidate product toward clinical or field usefulness are responsive and encouraged. Required industrial participation on applications from academic institutions (see below) will facilitate appropriate and validated product development activities. Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) are strongly encouraged to obtain expertise in the areas of product development planning and target product profile development in general, and regulatory matters in particular. Expertise needed to fulfill project objectives may be retained as defined effort or may be included as periodic consultation on specific issues.

Descriptions of supported countermeasure development activities and targeted pathogen categories are presented below:

Therapeutics

This FOA will support preclinical development of therapeutics against select NIAID Emerging Infectious Diseases/Pathogens (antimicrobial-resistant bacteria and emerging viral pathogens; see below), including immune-based and host-targeted forms, with emphasis on broad-spectrum therapeutics and those targeting pathogens for which no standard clinical treatment exists or for which drug resistance poses a significant public health concern. Therapeutics of interest include small molecules, biopharmaceuticals, nucleic acids, or peptides to be used as monotherapy or in combination, or as adjunctive therapy, with other drugs. Projects must initiate with a single candidate therapeutic or lead candidate series. For projects initiating with a lead series, down-selection to a single lead candidate must be accomplished within the first two years of the project period.

Immune-based therapeutic projects may focus on broad-spectrum or pathogen-specific immunotherapeutics. Of particular interest are immunotherapeutics that would enable prevention of infection or intoxication in the face of an immediate threat, protection of immunocompromised individuals, or post-exposure treatment to suppress infection and disease. NIAID encourages development of immunotherapeutics that directly affect pathogens and/or therapeutic approaches to stimulate non-specific immunity. Passive treatments may be especially valuable during the acute emergence of infectious diseases and may complement the use of antimicrobial drugs or vaccination programs to optimize protection.

Host-targeted therapeutic projects must focus on a host-encoded function required for infection, replication, spread and/or pathogenesis by one or more pathogens. Host-targeted therapeutic candidates that act primarily by stimulating the host immune response through direct regulation of interferon expression will be considered non-responsive. For host-targeted intervention projects, applicants must clearly define the specific required host-pathogen interaction(s) for development of the corresponding targeted therapeutic(s). NIAID encourages development of therapeutics that target specific host functions/pathways that are required for infection and pathogenesis by unrelated pathogens. Of particular importance for novel host-targeted therapeutics is consideration of proposed work that directly addresses the clinical and regulatory pathway to product registration and potential hurdles such as demonstration of pathogen susceptibility and therapeutic efficacy using non-standard in vitro assays and in vivo disease models, as well as potential toxicity issues.

Applications for development of a broad spectrum anti-infective against multiple targeted Emerging Infectious Diseases/Pathogens are encouraged. A broad-spectrum therapeutic is defined as a therapeutic agent that targets a common, invariable, or essential component of different strains or classes of microbes, or one that targets a host function required for infection and/or disease.

Each therapeutic development project supported by this FOA must focus on a previously-identified, well-characterized lead candidate (or lead candidate series) that targets one or more pathogen(s) from either of the following select pathogen categories:

Antimicrobial-Resistant Bacteria/Fungi

This initiative will support development of new or improved therapeutics for select pathogens for which drug resistance poses a significant public health concern. Responsive applications must target at least one pathogen listed in the Centers for Disease Control and Prevention’s Antibiotic Resistance Threats in the United States, 2019 report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf). Projects focused on drug-resistant Mycobacterium tuberculosis are limited to development and/or evaluation of therapeutic entities that are not currently licensed for another indication (i.e., projects focused on repurposed drugs are excluded). Antimicrobial categories supported by this FOA include, but are not limited to, narrow-spectrum drugs, broad-spectrum drugs, innovative therapeutic approaches/strategies, drugs targeting novel mechanisms, or adjunctive therapeutics.

Priority will be given to projects that focus on development of nontraditional therapeutics that limit antibacterial resistance. Such therapeutics have the potential to transform treatment of patients infected with antibiotic-resistant bacteria, reduce the spread of resistance and reinvigorate the dwindling pipeline of antibacterial agents. A non-traditional therapeutic is defined as an antibacterial agent/approach that is characterized by a mechanism that differs from traditional small-molecule antibiotics that directly kill or inhibit growth of bacteria. Included within this category are small molecules or biotherapeutics that do not directly target bacterial viability or growth but instead modulate virulence or pathogenicity. Also included are biological interventions such as bacteriophage, therapeutic bacteria (individual or combinations) or biologicals capable of modifying or restoring microbial communities for the purpose of treating or preventing infections.

Emerging Viral Pathogens

This initiative will support development of new or improved therapeutics for emerging viral pathogens of public health concern. Responsive applications must target at least one viral pathogen on the NIAID Emerging Infectious Diseases/Pathogens list (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). Note that this FOA will support development of a candidate therapeutic against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. Antiviral categories supported by this FOA include, but are not limited to, broad-spectrum antivirals, immunotherapeutics, or host-targeted therapeutics.

Priority will be given to projects that focus on development of broad-spectrum therapeutics against RNA viruses. Emphasis will be placed on therapeutics that show greater effectiveness than licensed antivirals and provide a longer treatment window for delayed therapy initiation. Responsive projects will focus on development of an antiviral that targets at least two distinct RNA viral pathogens, one of which must be an influenza virus or a listed enterovirus.

Therapeutics projects supported by this FOA may include, but are not limited to, one or more of the following preclinical activities:

• Lead optimization; medicinal chemistry; structure/activity relationships;
• Synthesizing, purifying, and testing lead candidates for efficacy and toxicity in in vitro assays and preclinical in vivo model systems;
• Performing preliminary pharmacokinetic (PK) and pharmacodynamics (PD) analyses on lead candidates;
• Preclinical testing for efficacy and safety in animals;
• Testing and validation of efficacy in in vitro or in vivo models (e.g., rodents, nonhuman primates);
• Optimization of dose, dosing interval, and route of delivery in preclinical evaluation or in animal models;
• Methods to modify existing drugs/therapeutics to improve economy of production, half-life in vivo, target affinity, neutralization potency, microbial clearance rates, or tissue accessibility; or to decrease adverse side effects of administration;
• Evaluation of the potential for the emergence of drug/therapeutic resistance in model systems;
• Assessing bioavailability and mechanism of action;
• Process development for the manufacturing of a therapeutic, including QA/QC, methods for product recovery, characterization, purification, identity, stability etc.;
• GLP or cGMP production to generate sufficient product to conduct pre-clinical and for future Phase I clinical studies; and
• Performing required benchmarks for successful submission and review of an IND application by the FDA.

Vaccines

Vaccines are the most effective method of protecting the public against infectious diseases. This FOA will support development of candidate vaccines (including immunoprophylactics) against emerging pathogens, focusing on multivalent/universal forms or vaccines targeting specific pathogens (see below). Development of candidate vaccines should initiate with previously-identified, well-characterized immunogens. Projects are expected to include proof-of-concept in animal models, preclinical evaluation, and if warranted, scale-up production under cGMP to provide sufficient quantities for pre-clinical FDA-required animal studies and early clinical evaluations.

Projects must focus on development of a lead candidate vaccine aligned with one of the following categories:

Multivalent/Universal Vaccines

Multivalent or universal vaccines are defined as broad-spectrum vaccines that provide protection against a group of taxonomically-related pathogens, or two or more unrelated pathogens. Vaccines characterized by broad-spectrum activity in this class include cross-protective forms, which induce an immune response against constant components of two or more microbes, and multiple component forms, which include elements that protect against microbes that are different and may or may not be related. Examples of this vaccine category include, but are not limited to, a universal influenza vaccine or a multivalent vaccine that protects against multiple flaviviruses.

Vaccines Against Antimicrobial-Resistant Bacteria/Fungi

This initiative will support development of candidate vaccines targeting select bacterial/fungal pathogens for which drug resistance poses a significant public health concern. Responsive applications must target at least one pathogen listed in the Centers for Disease Control and Prevention’s Antibiotic Resistance Threats in the United States, 2019 report. Note that NIAID currently supports development of candidate vaccines against Mycobacterium tuberculosis under several programs. Accordingly, projects focused on development of a vaccine against Mycobacterium tuberculosis will be considered non-responsive and will not be reviewed.

Vaccines Against Select Emerging Viruses

This initiative will support development of candidate vaccines targeting emerging viral pathogens of public health concern. Responsive applications must target at least one viral pathogen listed in the World Health Organization Research and Development Blueprint for action to prevent epidemics (http://www.who.int/csr/research-and-development/list_of_pathogens/en/). Note that this FOA will support development of a candidate vaccine against SARS-CoV-2, the virus that causes COVID-19.

For all vaccine projects, approaches should consider the ultimate potential of a candidate vaccine to quickly induce safe and protective responses in a diverse civilian population. Vaccine projects may include, but are not limited to, one or more of the following product development activities:

• Lead vaccine candidate optimization;
• Evaluation of safety, toxicity and immunogenicity in animals;
• Evaluation of efficacy in challenge models where appropriate animal models are available;
• Optimization of dose and route of delivery in preclinical evaluation;
• Optimization of production methodology including process development;
• Scale up and production of candidate vaccines including cGMP production;
• Process development for the production of vaccine components, including Quality Assurance (QA)/Quality Control (QC), methods for product recovery, characterization, purification, identity, stability, etc.;
• Manufacturing under GLP or cGMP to provide quantities sufficient for preclinical and early clinical evaluation;
• Performing preclinical testing for safety, toxicity, and efficacy in animal models and other benchmarks required for successful submission and review of an Investigational New Drug (IND) application by the Food and Drug Administration (FDA);
• Optimization of delivery platforms, antigen and adjuvant combinations/formulations;
• Advanced development of non-needle vaccine delivery systems, such as transdermal, oral, or nasal delivery; and
• Advanced development of formulation methodologies that obviate the need for cold-storage of the resulting product and/or extend shelf-life.

Industrial Participation

All projects submitted by academic institutions to this FOA must include substantive investment by at least one industry participant. For the purpose of this FOA, "industry" is defined as a large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, or chemical company, or a related non-profit entity with an established track record in product development, and substantive investment" is defined as a significant commitment of one or more resources to the project including, but not limited to: project and product development guidance/support (consultation), personnel, in kind contributions of materials and/or reagents (i.e., chemical libraries, innovative biotechnology platforms, scale up of cGMP chemical synthesis or production, etc.), provision of animal or other laboratory models for evaluation, subcontracts, data management resources, regulatory support, or alterations/renovations of facilities or provision of equipment to address biohazard concerns. For projects with consultation-only investment, the industrial partner must commit a specific level of effort (concomitant to stage of preclinical and/or product development activities) that is included in the requested budget. Support for industrial partner activities may be included in the project budget. There is no requirement for an academic participant on applications submitted by industrial organizations.

Applications including the following will be considered non-responsive and will not be reviewed:

• Projects lacking appropriate proof-of-concept data supporting the candidate therapeutic or vaccine.
• Projects from academic institutes that lack substantive investment by at least one industry participant.
• Projects focused on development of a therapeutic that acts primarily by stimulating the host immune response to infection through direct regulation of interferon expression.
• Projects focused on repurposing a licensed drug as a therapeutic for Mycobacterium spp.
• Projects focused on development of a vaccine against Mycobacterium tuberculosis.
• Projects on AIDS or HIV.
• Projects lacking an adequate Product Development Strategy.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

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

• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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) 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Letter of Intent

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:

Maryam Feili-Hariri, PhD
National Institutes of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5026
Email: [email protected]

with the following additional instructions:

Other Attachments: Responsive applications are required to include a Product Development Strategy attachment that includes both a "Milestones and Timeline" and a "Product Development Plan" section. The Product Development Strategy attachment must be in pdf format with a filename of "Product_Development_Strategy.pdf." Applications lacking a required section of the Product Development Strategy attachment will be deemed non-responsive and will not be reviewed.

The overall Product Development Strategy, made up of the "Milestones and Timeline" and the "Product Development Plan sections," is limited to 12 pages.

Milestones and Timeline: Applicants are required to provide detailed project performance and timeline objectives in a section entitled Milestones and Timeline. This section must be no more than 5 pages and must include:

• A clear description of all interim objectives (research and/or developmental milestones) to be achieved during the course of the project. Applicants also must identify any impediments that could require a revision in the work plan or milestones with a discussion of alternative approaches.
• Detailed quantitative criteria by which milestone achievement will be assessed.
• A detailed schedule or timeline for the anticipated attainment of each milestone and the overall goal(s).

Product Development Plan: Applicants are required to provide detailed development plans in a section entitled Product Development Plan . This section must be no more than 7 pages and must include:

• A statement of the intended use/indication of the proposed product and public health gap the product is intended to fill.
• A statement of the value of the project, including lay description of key technology objectives, innovation, and advantages compared to competing products, technologies, or services.
• A clear description of the goal(s) of the project, including one (or more) intermediate products (tools), final product(s) or stage(s) of product development to be completed during the award period. A specific final product profile that is intended for licensing indication is not requested.

Additionally, the Product Development Plan must include descriptions pertaining to preclinical product development activities pertaining to the product proposed. For the purpose of this FOA, preclinical is defined as all activities beyond lead candidate identification.

Product Development Plans for therapeutic or vaccine projects should summarize:

• The performance specifications and features the product should have in order to provide therapeutic or immunological benefit.
• A description of the candidate product or lead series as it is currently configured.
• A description and developmental status of the assays for product release and characterization, including activity and efficacy.
• Data that support the characterization and selection of the candidate product for further development. Specifically for vaccines, a summary of data that demonstrates efficacy in in vitro assays and/or in vivo models for one or more of the selected agent(s). This includes: a detailed description of the assays and animal models, the choice of pathogen challenge, strain and route, and a rationale for the choice of animal model, pathogen challenge, strain and route, as well as for the outcome/endpoints selected; documentation that the animal infection experiments were performed under well-controlled experimental conditions.
• Discussions with FDA, if any, which are relevant to development activities for the candidate product/technology.

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

Research Strategy: Therapeutics and vaccine applications must address the following:

• Describe how the project will significantly advance the development of a candidate countermeasure against one or more of the specified pathogens.
• Provide and describe pre-established proof-of-concept data in support of the single candidate therapeutic/vaccine or lead candidate series to be developed and plans to progress the candidate through preclinical development.
• For projects initiating with a lead series, clearly detail the process and timeline for down-selection to a single lead candidate within the first two years of the project period.
• For targeted pathogens that lack standard in vitro assays and/or in vivo disease models, describe the most appropriate experiments to demonstrate efficacy and address potential toxicity issues.

The following modifications also apply:

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA

Is this project likely to significantly advance the development of a candidate therapeutic or vaccine against one or more of the select pathogens identified in this initiative? If the aims of the application are achieved, is an important biomedical countermeasure or product likely to result?

Investigator(s)

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

Specific to this FOA

For applications from academic institutions, does the applicant describe the substantive investment and participation in the project of an industry participant? Will the industrial participation facilitate candidate product development and achievement of proposed objectives?

Innovation

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

Specific to this FOA

For applications from academic institutions, does the research plan leverage appropriate industry involvement to facilitate candidate product development, some aspects of which may not be inherently innovative? Does the project represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA

Is the research and development plan supported by strong proof-of-concept data that is appropriate for the candidate countermeasure and targeted pathogen?

Environment

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

Product Development Strategy

Is the Product Development Strategy well-conceived and appropriate for the proposed countermeasure category? Are the Milestones and Timelines proposed to achieve the goals of the project appropriate and feasible? Does the applicant propose quantitative criteria by which the milestones achievement will be assessed and are the criteria relevant for assessing the proposed product development? Is the proposed Product Development Plan feasible and appropriate for proposed and future product development?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

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.

• 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.

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

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

3. Reporting

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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:[email protected](preferred method of contact)
Telephone: 301-945-7573

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

Michael R. Schaefer, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3364
Email: [email protected]

Maryam Feili-Hariri, PhD
National Institutes of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5026
Email: [email protected]

Sufiyan Saeed
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3761
Email: [email protected]

Section VIII. Other Information