Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title
Limited Competition: Nonhuman Primate (NHP) Radiation Survivor Cohort (RSC) (U01 Clinical Trial Not Allowed)
Activity Code
U01 Research Project ? Cooperative Agreements
Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-AI-19-010
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855

Funding Opportunity Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support continued care for and conduct of specialized research using a unique nonhuman primate (NHP) population.  Specifically, the preservation, medical monitoring, study, treatment, and intervention in the development of late effects in NHP survivors of radiation exposure. NHPs most closely resemble human responses to radiation exposure and, as such, long-term studies on a radiation survivor cohort will permit continuous observations and treatment of this valuable population, while providing a critical understanding of the natural history of radiation exposures, including early and late injuries and disease development.  The successful applicant must have facilities and staff to care for a combined minimum of 120 irradiated and unirradiated control NHPs, exposed at various ages and available for study, and must be able to accommodate receipt of additional radiation-exposed animals from other government-supported studies.

Key Dates

Posted Date
February 25, 2019
Open Date (Earliest Submission Date)
April 30, 2019
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

May 31, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
November 2019
Advisory Council Review
January 2020
Earliest Start Date
March 2020
Expiration Date
June 01, 2019
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support continued care for and conduct of specialized research using a unique nonhuman primate (NHP) population.  Specifically, the preservation, medical monitoring, study, treatment, and intervention in the development of late effects in NHP survivors of radiation exposure. NHPs most closely resemble human responses to radiation exposure and, as such, long-term studies on a radiation survivor cohort will permit continuous observations and treatment of this valuable population, while providing a critical understanding of the natural history of radiation exposures, including early and late injuries and disease development.  The successful applicant must have facilities and staff to care for a combined minimum of 120 irradiated and unirradiated control NHPs, exposed at various ages and available for study, and must be able to accommodate receipt of additional radiation-exposed animals from other government-supported studies.

Background

The Department of Health and Human Services (HHS) has charged the NIH with the responsibility to identify, characterize, and develop new medical countermeasures against radiological or nuclear attacks.  On October 14, 2004, the NIH convened an expert panel to review the “NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats” (https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf). This strategic plan and research agenda outline a flexible, collaborative, and comprehensive NIH research and product development program focused on animal model development and medical therapies and diagnostics to address injuries sustained during a radiation public health emergency.  On behalf of the NIH, NIAID is charged with implementing this research agenda. An updated Radiological and Nuclear Threats Program Progress Report and Future Research Directions was published in 2012 and can be found at https://www.niaid.nih.gov/sites/default/files/radnucprogressreport.pdf.

Concern about the threat of nuclear or radiological attacks has grown in recent years due to the increased activity of global terrorist organizations and documented illicit trafficking of radioactive materials. In addition, recent natural disasters, which have threatened the security of nuclear power facilities, highlight the need to stockpile countermeasures to treat radiation injuries in the civilian population.  The overall goals of NIAID's program are the establishment of animal models for radiation-induced injuries, and the rapid development of safe and effective radiological/nuclear medical countermeasures for clinical use under emergency situations. To achieve these goals, it is critical to understand the natural history of radiation effects in the animal models that will be used to show efficacy of approaches to mitigate radiation-induced injuries.

Many radiation injuries that have been noted among human survivors of exposure lie in long-term effects, including organ failure, fibrosis, cardiovascular abnormalities, and cancer. A major gap exists in our understanding of how radiation exposures lead to the development of late effects in the months to years after irradiation.  In particular, knowledge about the natural history of radiation injuries in nonhuman primates (NHPs) is especially important, since the NHP model is increasingly used to establish both the efficacy of candidate medical countermeasures and applicability of biodosimetry biomarkers and devices to support Food and Drug Administration licensure for use during and following a radiation incident.

For this reason, the NIAID’s Radiation and Nuclear Countermeasures Program (RNCP) has placed a strong emphasis on studying the late effects of radiation injury in a population of NHPs that have survived a prior radiation exposure.

An existing cohort of over 130 NHP (all rhesus macaques (Macaca mulatta), including unirradiated control animals and radiation survivors) is currently maintained as a Center-wide core within the RNCP’s Centers for Medical Countermeasures Against Radiation Consortium (CMCRC).  Animals acquired and placed in the cohort have been exposed to single, whole-body doses of ionizing radiation in the range of 2 to 8.4 Gray (Gy). Animals receiving partial-body radiation exposures, as well as animals exposed to radiation and then treated with drugs have also been accepted into the cohort.  Age-matched, non-irradiated animals have been acquired to serve as controls for normal growth, behavior and aging.  Both male and female animals are being monitored.  Maintenance of and studies on radiation NHP survivors has led to many important observations to date, including immune dysfunctions, development of cardiovascular, kidney, liver and lung complications, and cognitive impairments. In the current cohort, several unexpected patterns of radiation-associated disease have emerged.  These findings have led to research publications documenting the development of these disease states in the monkeys.  In addition, collected samples and data have been made available to more than 50 investigators in the research field.

Research Objectives and Scope

NHP cohort characteristics and research areas of interest for this FOA include, but are not limited to, the following:

NHP Cohort

  • Access to an existing cohort of at least 100 NHP survivors of radiation exposures between 1 and 10 Gy (male and female, rhesus macaque - Chinese origin preferred – ranging from 3 months to 12 years or more post-irradiation), plus at least 20 age-matched unirradiated control animals to be used for comparison purposes;
  • Animals exposed to radiation at ages ranging from as young as two years, and as old as >12 years (age at time of irradiation);
  • Animals that have survived partial-body exposures are desired but not required;
  • Animals that have received therapeutic interventions (e.g. medical countermeasures) following radiation exposure are desired but not required;
  • And ability to biobank, archive, and assure long-term maintenance of biological and data resources, and maintain a catalogue/database of available samples (e.g. whole blood, serum, plasma, tissue and organs), as well as data, to be made available to the research community.

Areas of Research

This FOA will support both observational (e.g. behavioral monitoring, and assessment of biomarkers of injury and animal disease status) and interventional (e.g. possible testing of treatment regimens) studies on animals in the NHP cohort.  Types of studies that are of interest include, but are not limited to the following:

  • Assessment of any cognitive deficits resulting from prior radiation exposure in the NHPs;
  • Determination of biomarkers of radiation exposure that might correlate with the evolution of late effects in the irradiated animals;
  • Tracking of animals for the development of immune dysfunction and other disease states, including but not limited to:
  • Diabetes
  • Cancer
  • Cardiovascular complications
  • Lung injuries
  • Renal insufficiencies
  • Neurological concerns
  • Cataracts
  • Testing of interventional treatments in animals diagnosed with late effects (e.g. lung or cutaneous fibrosis, immune insufficiencies, cardiovascular complications, etc.).

Milestones

The proposed research plan should encompass a milestone-based approach with explicit, detailed, and quantitative yearly milestones. These milestones will be used by NIAID program staff to assess progress and recommend continued funding on an annual basis.

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

  • Studies in animal models other than NHPs, unless the model is used solely as an in vivo assay for assessment of the NHP immune response.
  • Studies focused on HIV/AIDS-related research.
  • Studies proposing NHP research in animals other than previously-irradiated rhesus macaques.
  • Applicants without access to the existing NHP radiation survivor cohort.  
  • Human clinical trials (all phases).

Applicants are advised to contact the Scientific/Research Contact with any questions they may have regarding the responsiveness of their application.

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

Section II. Award Information

Funding Instrument
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $3 million in FY 2020 to fund 1 award.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 7 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Eligible applicant organizations are limited to those receiving grant and/or cooperative agreement funding from NIAID‘s Radiation and Nuclear Countermeasures Program (RFA-AI-14-055) at the time of application submission, and provide documented ability to access the existing NHP RSC cohort. NHP comprising the cohort must be housed at the applicant organization.

Foreign Institutions

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. 
Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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

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

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

 

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:
 

Louis Rosenthal, Ph.D.
Telephone: 240-669-5070
Fax: 301-480-2408
Email: rosenthalla@niaid.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
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. Completion of this section should describe all performance sites for all animal activities involving Nonhuman Primates (NHPs) or other live vertebrate animals.

SF424(R&R) Other Project Information

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

Facilities & Other Resources: In addition to the information requested, the Facilities & Other Resources attachment should also address the following:

Availability of laboratory space and the ability to perform the following NHP studies and testing:

  • Pathology and necropsy (to include histology and immunohistochemistry) and sample imaging
  • Physiological testing (e.g. cardiac and respiratory, endocrine and metabolic; microbiome, immune surveillance and other aspects of immune function/vaccine response, neurologic and behavioral assessments, etc.);
  • Standard analyses such as serum chemistries, blood counts, as well as molecular and cellular analyses and radiographic exams (e.g. x-rays, CTs, MRIs) and other imaging studies to evaluate animal health status.

Provision of safe and reliable NHP transport to and from the site for accrual and evaluations in compliance with USDA AWA transportation regulations.

Applicant must demonstrate the availability of Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited NHP facilities with adequate housing and caging, including indoor and outdoor access.

Performance sites must maintain an exemplary program of animal care and use consistent with current Public Health Service (PHS) Policy. Basic evidence for this is accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC) International.

For all performance sites where animal activities involving live vertebrate animals/NHPS, please provide the Animal Welfare Assurance number and indicate if the facility is a Category 1, AAALAC accredited, or Category 2, not AAALAC accredited, institution as described in the Assurance. The organization must negotiate an Assurance with the Office of Laboratory Animal Welfare, NIH, if not previously approved. The Assurance is a commitment that the organization will adhere to the PHS Policy on the Humane Care and Use of Laboratory Animals and comply with the Guide for the Care and Use of Laboratory Animals (Guide) (National Research Council 2011) and the applicable regulations (9CFR, Subchapter A) issued by the United States Department of Agriculture (USDA) under the Animal Welfare Act (AWA).

Since the proposed work involves the use of NHPs, which are USDA-regulated species, each organization will have to register with the USDA and agree to comply with the AWA and annual inspections. If currently licensed or registered, please provide the license or registration number for each facility.

Provide verification of IACUC approval for activities at all performance sites, which may be filed before award with JIT procedures or earlier if required by the IC.
SF424(R&R) Senior/Key Person Profile

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

A biostatistician, an individual with radiation biology experience (e.g., conducting radiation diagnostic and treatment protocols), and at least one veterinarian with experience in handling irradiated NHPs should be included as key personnel. 

Applicant must demonstrate the availability of Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited veterinary services with NHP research expertise.
 

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

Animal care costs: Applicants should assume that up to 25 animals will be added to the cohort each year from other government-funded studies.  These animals will be designated by NIAID staff, in conjunction with the PD(s)/PI(s).

Travel: Proposed budgets should include travel costs for the PD(s)/PI(s), or their representative, and one additional investigator to attend one meeting/event at the NIAID each year.  Travel for up to two scientists to attend a scientific meeting each year (in order to present results from study of the cohort) may also be budgeted.

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 hypothesis or hypotheses to be tested.  This could include observational studies to correlate observed late effects with radiation dose received, or the testing of different treatment protocols to address radiation-induced complications in animals in the cohort.

Research Strategy: Use this section to summarize the research strategy, including significance, innovation and approach and explain the rationale for selecting the methods to accomplish the specific aims.  Applicant should assume that any diagnostics that are proposed to be carried out and/or standard, medical management and treatment(s) provided to the animals in the cohort would be consistent with treatment(s) provided to humans with similar symptoms (e.g. blood products, steroids, antibiotics, analgesics, anti-pyretics, etc.), with some exceptions, including use of cellular therapies (other than their use as part of a proposed, defined study) or other invasive/heroic measures (e.g. growth factor or other drug treatments (e.g. insulin for diabetes), cancer therapies, transplants, etc.).  Detailed information should be included concerning standard clinically-relevant assessments that will be performed on animals in the cohort, and on what triggers to treat morbidities will be applied.  Applicants should also discuss what samples will be archived from the animals, and what data will be preserved

Milestones:  Include a synopsis and an assessment diagram/timeline detailing proposed diagnostic and/or treatment protocol(s), with clearly defined triggers to treat animals.  Provide detailed, explicit and, where applicable, quantitative milestones that should be achieved each year of the project. 

Letters of Support: Provide letter of support documenting access to the existing NHP radiation survivor cohort.

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.

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.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or 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 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.

  • Awards issued under this FOA will be incrementally funded awards for project periods of up to seven years.  Multi-year funded grants will not be awarded.
  • Grants awarded under this FOA will be excluded from automatic carryover – all carryover requests must be approved.
  • Grants awarded under this FOA will not be provided the authority to automatically extend the final budget period one time for up to 12 months beyond the original expiration date shown in the Notice of Award – all extensions, including the first extension, will require approval.
  • Progress and financial reporting will be required and reviewed annually.
  • All funds must be expended within the approved project period. 

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.

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions 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.

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

 

Does the 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?

 

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

Do the investigators have appropriate veterinary expertise in handling irradiated NHPs? Do the investigators have appropriate expertise in biostatistics, radiation biology, pathology, and radiation dosimetry?  Are AAALAC-accredited veterinary services with NHP research expertise available?  

 

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?

 

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

Are the proposed approaches appropriate for NHP research? Are approaches to study underlying mechanisms and/or biomarkers appropriate? Are the milestones and timelines adequate, appropriate, and reasonably attainable?

Is the justification for the numbers of NHP to be selected for any particular observational study reasonable? Are the statistical considerations of the proposed experiments appropriate? Are the preparation of tissues or cells to be archived and the proposed methods, source, and number of NHP samplings/biopsies appropriate?

 

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?

 Specific to this FOA

Are appropriate and sufficient AAALAC accredited veterinary services and NHP housing and care facilities available to carry out the proposed work? Are appropriate and sufficient NHP evaluation and treatment facilities available to carry out the work?

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

 

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

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

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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.

 

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.

 

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

 

Not Applicable

 

Not Applicable

 

Not Applicable

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

 

Not Applicable

 

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

 

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

 

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.

 

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.

As part of the scientific peer review, all applications:
  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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 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 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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.html or 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

  • Planning, directing, and executing the proposed research study and setting project milestones and timelines to achieve the proposed goals;
  • Overseeing/performing scientific activities and ensuring successful completion of yearly milestones within the timeframe and budget proposed;
  • Sharing data collected under this award as well as any collected biological samples with the scientific community, consistent with achieving the goals of the program;
  • Compliance with requests for dosimetry information and radiation equipment testing as part of a NIAID radiation program-wide dosimetry harmonization effort.
  • Possible modification of yearly milestones prior to award or post-award, based on review and/or NIH Project Scientist and/or PD/PI assessment of the proposed yearly milestones.
  • Agreeing to participation in collaborative studies, including those that involve interactions with biotechnology and pharmaceutical companies that may be requested by NIAID.
  • Ensuring that all NHPs obtained for inclusion in the cohort are used for purposes approved by the NIAID (following discussions with the PD/PI) and will maintain all necessary licensures and accreditations required to work with NHPs.
  • Timely submission for publication of manuscripts (co)authored by members of the research team and supported in part or in total under this Agreement.
  • Making new information and materials, including research samples, tools, methods, reagents, and data developed, available to the broader research community through publications, presentations, web announcements, submission to public resources or databases, and reports to the NIAID.
  • In addition to normally required progress reporting, other reports concerning the status of the cohort that may also be requested for use internally and to be shared with other partner government agencies.  The reports will be submitted to the NIAID Project Scientist within a timeframe jointly agreed upon by the NIAID Project Scientist and the PD(s)/PI(s).

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

A NIAID program official will serve as the Project Scientist and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

  • The NIAID Project Scientist will provide advice, technical assistance, and guidance on technical and management issues, such as reviewing progress and award requirements.
  • The Project Scientist will serve as a liaison/facilitator in identifying potential sources of reagents or other resources and identifying potential collaborations to further the goals of the NHP radiation survivor cohort.
  • The Project Scientist will also serve as a resource of scientific and policy information related to the goals of the awardee’s research. However, the role of the Project Scientist will be to facilitate and not to direct activities.
  • Awards are milestone-based and include flexibility for the NIAID Project Scientist to approve redirection of research aims within the scope of the original award during the funding period. NIAID reserves the right to terminate or curtail a study within a project in the event of a substantial shortfall in study milestones or other major breach of the approved project.
  • 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:

  • The PD(s)/PI(s) and NIH Project Scientist will review the entirety of program milestones annually and update.
  • In order to efficiently utilize research resources and rapidly exchange scientific information to promote NIAID objectives, it is anticipated that cooperation or opportunities to collaborate with other NIH funded programs, including contracts, will be initiated in future years and will be coordinated and facilitated by the NIH Project Scientist in consultation with the PD(s)/PI(s).

Dispute Resolution:

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

3. Reporting

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

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

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

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
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: 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: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Andrea L. DiCarlo-Cohen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3492
Email: cohena@niaid.nih.gov

Peer Review Contact(s)

 Louis Rosenthal, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov

Financial/Grants Management Contact(s)

Trevor Alford
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-747-7398
Email: Trevor.alford@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.
Authority and Regulations
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.


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