Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to support early to mid-stage research focused on development of candidate medical countermeasures (MCMs) with post-radiation exposure administration data demonstrating efficacy to mitigate and/or treat radiation injuries. Product development should focus on mitigating acute radiation syndromes and/or the delayed effects of acute radiation exposure. Additionally, elucidation of mechanisms of action of MCMs necessary to meet product licensure requirements.

Background

The mission of the Radiation and Nuclear Countermeasures Program (RNCP), guided by the NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiation and Nuclear Threats is to accelerate the development of approaches to diagnose, mitigate, and treat radiation injuries resulting from a mass casualty, radiological or nuclear incident. The RNCP, established in 2004 under NIAID/DAIT to help the U.S. Government ensure medical preparedness to address radiation injuries quickly and effectively during a public health emergency, is committed to engaging in research that is rigorous, reproducible, and inclusive.

Under normal conditions, the hematopoietic, gastrointestinal, cardiovascular, and central nervous systems, as well as skin and mucosal tissues interact with each other to maintain physiological homeostasis. Data obtained from prior radiological and nuclear incidents demonstrate that these homeostatic mechanisms are severely disrupted due to the compromise and progressive failure of these interdependent organ systems, potentially leading to multiple organ failure and mortality. The management of radiation casualties leading to multi-organ dysfunction syndrome is extremely complex, and effective MCMs are still lacking to address many aspects of radiation-induced injuries. Therefore, an urgent need exists to develop clinical tools and new strategies to treat multiple organ failure (both acute and delayed injuries) to restore physiological functions of critical organs after exposure.

With all its complexities, the field of radiation research has made great progress in the development of MCMs. Since 2015, the U.S. Food and Drug Administration (FDA) has licensed Neupogen®, Neulasta®, and Nplate® (Amgen), and Leukine® (Partner Therapeutics) to treat the hematopoietic (H) sub-syndrome of acute radiation syndrome (H-ARS). Clearly, progress has been made to counteract the immediate effects of H-ARS; however, due to the multiple organ injuries and inflammation that ensue radiation exposure, other damaging biological impacts must also be addressed. High dose radiation exposures can cause acute gastrointestinal (GI) complications, cutaneous injuries, and vascular dysfunction, including mucosal, vascular, and skin barrier breakdown, bacterial translocation, and loss of GI structural integrity, which can lead to rapid death. Furthermore, victims who survive ARS may suffer from the delayed effects of acute radiation exposure (DEARE), which could manifest years to months later and include pulmonary, renal, cardiac, and cutaneous complications. No products are currently approved for the treatment of these other radiation sub-syndromes.

Research Objectives and Scope

The focus of this NOFO is to advance medical treatments for use in radiation mass casualty situations, with a focus on mitigators/treatments of short- and long-term consequences of radiation exposure for civilian populations in the event of a nuclear incident (accident or attack).  Thus, research activities ranging from mechanism of action studies for a candidate MCM to advanced product development are requested.  Selection of radiation exposure type, dose level, and dose rates proposed for studies should be relevant to a radiological or nuclear incident and verified by appropriate dosimetry assessments.

Studies in animal models will be required to demonstrate efficacy of the MCM to be tested. Applicants are strongly encouraged to justify the selection of their animal model and its relevance to expected human responses (i.e., the model is expected to behave similarly to the human for both the radiation exposure and response to the MCM). Progress toward licensure or approval of the proposed MCM should be in accordance with the FDA Animal Rule (see 21 CFR 314.600 Subpart I for drug products and 21 CFR 601.90 Subpart H for biologic products).

Research to advance medical products already licensed for other indications (i.e., repurposed) or approaches in early developmental stages for different indications (including all radiation applications) are encouraged.  Applicants must have identified at least one MCM candidate with positive, preliminary efficacy data when the MCM is administered at least 24 hours or more following radiation exposure. Administration of the MCM at time points beyond 24 hours post-radiation exposure (to determine how long administration can be delayed while still retaining efficacy) is encouraged. Studies focusing on MCMs targeting amelioration of neutropenia or thrombocytopenia resulting from H-ARS must provide evidence of efficacy of the product at time points no earlier than 48 hours post-irradiation.

NIAID is interested in supporting studies that propose, but are not limited to, the following (all areas do not have to be addressed in the application to be considered responsive):

• Research and development of a lead MCM to enhance survival (primary endpoint) or mitigate major morbidities in irradiated animal models predictive of human responses, when administered as a single or multiple-dose regimen after radiation exposure (with administration of the first dose beginning at a minimum of 24 hours or later post-irradiation (48 hours or later for neutropenia or thrombocytopenia-targeted H-ARS products)), with emphasis on broad activity (i.e., multi-syndrome, multi-organ). 
• Research and development of MCMs for mitigation or treatment of potentially lethal, ARS or DEARE, including radiation injuries to the GI, cutaneous, pulmonary, renal, cardiovascular, and/or central nervous system compartments of the body. In addition, MCMs intended to address hematopoietic injuries not associated with neutrophil or platelet loss are of interest; however, if amelioration of radiation-induced neutropenia or thrombocytopenia is the target of the MCM, they must be effective at time points no earlier than 48 hours post-irradiation.
• Testing combinations of new and/or existing therapeutic products to enhance efficacy (e.g., lead MCM concomitantly tested with expected standard of care such as antibiotics and/or growth factors).
• MCMs to treat radiation combined injuries (e.g., radiation exposure concomitant with burn, wound, infection or other physiological trauma).
• Formulations of products and/or improvements to existing products for civilian populations that can be easily administered in a mass casualty scenario either by first responders or self-administered are preferred; (e.g., via oral, subcutaneous, trans-cutaneous, intramuscular or inhalation routes, as opposed to intravenous routes which are challenging in a mass casualty setting).
• Testing of candidate MCMs in animal models that are representative of adult, pediatric and/or geriatric human populations, and consideration of any possible sex differences of the radiation or drug response in these models.
• Testing of small molecules, biologics, and cell products for ARS or DEARE.
• Identification of early surrogate markers of candidate MCM efficacy post-radiation exposure (e.g., in hematologic parameters, cytokine or enzyme profiles, histological markers, inflammatory responses) that could potentially be used as secondary endpoints/observations to support mechanisms of action and linkage of pharmacodynamic (PD) effects across species (note that this is not a request for biomarkers for the purpose of biodosimetry).
• Product development efforts to support submission of an Investigational New Drug Application (IND) to the FDA to facilitate licensure and potential inclusion in the Strategic National Stockpile.  Examples include:
  • Efficacy studies to optimize formulation, dose, and dose scheduling;
  • Pilot efficacy studies to inform the design of subsequent Good Laboratory Practice (GLP);
  • Pivotal efficacy study protocols;
  • Drug product stability studies;
  • Drug product current Good Manufacturing Practice (cGMP) manufacturing scale-up;
  • GLP toxicology and pharmacology safety studies;
  • Pharmacokinetic (PK), pharmacodynamic (PD) studies;
  • Development of GLP analytical methods for efficacy studies, PK, product characterization.

These product development efforts will advance the development of MCMs for radiation injury toward Phase I clinical trial safety studies and/or GLP animal model pivotal efficacy studies for FDA licensure (not supported by this NOFO). Applicants are encouraged to begin the process early to partner with industry and consult with the FDA on the proposed approach.

It is acknowledged that basic testing of compound efficacy and/or formulation work may not be considered inherently innovative; however, application and optimization in target tissues are highly valued.

Milestones

The research plan must include specific, detailed, explicit, and quantitative annual milestones. For example, it is not appropriate to state only that "countermeasure A will be tested for its ability to mitigate radiation damage," or that “specific aim A studies will be initiated.” An appropriate milestone might include, but not be limited to the following: "These studies will demonstrate a statistical difference in survival (p<0.05) when MCM A is subcutaneously administered at 24 hours post-exposure in an appropriate animal model". These milestones will be used by NIAID program staff to assess annual progress and support funding decisions.

Applications proposing any of the following will be considered non-responsive and will not be reviewed:

• Studies proposing testing for a radio-protectant (compound(s) that must be administered prior to radiation exposure to be efficacious).
• Studies proposing administration of a candidate MCM at times earlier than 24 hours after radiation exposure (or earlier than 48 hours after radiation exposure for MCMs targeting neutropenia or thrombocytopenia resulting from H-ARS).
• Clinical trials (all phases).
• Work proposing dose ranges or exposure parameters that are not relevant to a radiation accident or attack (e.g., studies using fractionated radiation exposures, unless justified by opportunity to collect samples from radiotherapy patients).
• Biodosimetry devices and biomarkers to be used to determine radiation dose received (radiation triage).
• Studies to investigate MCMs for thermal-only burns; radiation-induced cancers; cataracts; or other ocular, reproductive, or muscular damage.
• Lack of preliminary data and/or milestones.
• Studies with a primary focus on HIV/AIDS-related research. 

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• 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)

Local Governments

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

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Hiten Chand, Ph.D.
Telephone: 240-627-3245
Email: hiten.chand@nih.gov  

Page Limitations

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 NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Within the budget section, include funds to support travel for the PD(s)/PI(s), and if necessary, the minimum number of additional relevant staff, to participate in a once yearly, 1-day program progress meeting with NIAID and other US Government Program staff, to be held in the Rockville, MD area.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed project. Concisely describe the work to be completed. 

Research Strategy: Use this section to summarize the research strategy, including significance, innovation and approach of the application and explain the rationale for selecting the methods to accomplish the specific aims. Describe how the application focuses on basic or translational research aimed at the development of an MCM at timepoints 24 hours (or 48 hours for H-ARS targeted products) or later post-irradiation. Applicants are required to provide preliminary data and, if applicable, provide a description of how the proposed study will lead to a future approval under the FDA Animal Rule. Also describe specifics of the irradiator(s), dosimetry methodology, and plans for dosimetry calibration to be used at the institution(s) where radiation will be employed.

Milestones (required): Briefly describe for all years of the award; specific, detailed, explicit, and quantitative milestones that will be achieved in each year of the Research Project. Describe the milestones explicitly for each step of the studies (i.e., it is not appropriate to state only that "countermeasure A will be tested for its ability to mitigate radiation damage," or that “specific aim A studies will be initiated”). 

Letters of Support: Provide any letters of support from collaborators that are specific to the Research Projects.

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• Recipients will be expected to share data collected under this award through ImmPort (https://www.immport.org/home).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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 the National Institute of Allergy and Infectious Diseases (NIAID), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

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

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

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

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

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at  2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

• Submitting manuscripts to the Project Scientist right after acceptance for publication so that an up-to-date summary of program accomplishments can be maintained, and press conferences and press releases prepared.
• Research design and protocol development, data collection, final data analysis and interpretation, preparation of publications, as well as collaboration with other PD(s)/PI(s) under this NOFO.
• Developing milestones annually for the project. In the case where the milestones are not met, PD(s)/PI(s) will be responsible for setting and implementing corrective plans that will be negotiated with and approved by NIAID.
• Recipients will be required to participate in a NIAID-sponsored, program-wide dosimetry harmonization effort to ensure accurate radiation exposures.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• If milestones are not met during the course of the project period, the NIAID Project Scientist will provide guidance to remediate the milestones to ensure successful completion of the project.
• The Project Scientist will advise in the selection of sources or resources (e.g., determining where a particular reagent may be found); provide advice and guidance on technical issues; coordinate or participate in the collection and/or analysis of data; and advise on the management and technical performance.
• The Project Scientist will provide scientific input toward the preparation of publications and direction of collaborations with, and access to, other NIAID-supported research resources and services, as needed.
• 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:

• Participate in monthly and annual meetings to facilitate the achievement of program goals.

Dispute Resolution:

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

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Carmen I. Rios, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3553
Email: carmen.rios@nih.gov 

Hiten Chand, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3245
Email: hiten.chand@nih.gov 

Nicole Gormley
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5449
Email: nicole.gormley2@nih.gov 

Section VIII. Other Information

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

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 and 2 CFR Part 200.