Department of Health and Human Services


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

Innovation for HIV Vaccine Discovery (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-14-006

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855, 93.856

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from institutions/organizations proposing innovative, high risk, high impact research to identify novel vaccine concepts and targets that will aid in the design and development of an effective immunogen that may provide long-term protection from either acquisition of or ongoing infection by HIV.  The emphasis of this FOA is early discovery research that incorporates new ideas leading to the development of newly engineered conventional or entirely novel approaches for vaccines that may have significant impact on the design of immunogens or immunization strategies for an effective HIV vaccine.  The program is open to established and new investigators and does not require research expertise in HIV prevention as a prerequisite for submitting an application.

Key Dates
Posted Date

February 18, 2014

Open Date (Earliest Submission Date)

June 15, 2014

Letter of Intent Due Date(s)

June 15, 2014

Application Due Date(s)

July 15, 2014, 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.

AIDS Application Due Date(s)

July 15, 2014, 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.

Scientific Merit Review

November 2014

Advisory Council Review

January 2015

Earliest Start Date

March 2015

Expiration Date

July 16, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to foster novel, high risk, and unconventional research that, if successful, may have a substantial impact on approaches to HIV/AIDS vaccine discovery and development. 

Recent advances in biomedical technologies, such as molecular and structural imaging, deep sequencing, and new ways of probing the antibody repertoire, have generated insight into the virology and immunology of HIV.  Clearly, a more intense effort focused on the application of these evolving research tools poses an exciting potential for vaccine discovery.  Projects proposed will be expected to explore and test novel hypotheses that, if successful, would significantly impact the design of immunogens or immunization strategies leading to an effective HIV vaccine.

Background

Identifying safe and effective preventive vaccines against HIV transmission and infection is a major research priority of NIAID.  The limited immunogenicity and breadth of multiple vaccine candidates tested in phase I and phase II studies and the modest success in efficacy trials, highlight the fact that identifying highly effective vaccination approaches may prove more elusive than anticipated.  Previous research has led to a better understanding of the transmission process and of the complexities of the virus’ structure, diversity and biology, all of which demonstrate the need for clever new approaches in designing a successful prophylactic vaccine.  Major gaps still exist in our basic understanding of how to convert antigenicity of a promising candidate into effective immunogenicity, and the type(s) of immune responses that correlate with protection.  Since the NIAID-sponsored Vaccine Summit in 2008, when investigators/attendees were solicited for ideas about the status of the field and the research approaches that should be pursued to reinvigorate the effort, one of the strongest recommendations was to invest substantially in fostering new discoveries that improve understanding of the immune responses most relevant for preventing or clearing early HIV infection, and novel approaches for generating those responses.  This need continues, and through this FOA, NIAID intends to continue the support of innovative ideas, new investigators and new interdisciplinary collaborations.

The current AIDS vaccine candidate pipeline is limited and the eventual effectiveness of many candidate vaccines remains uncertain unless strong in vitro or in vivo correlates of protective responses in animal models and/or in humans are defined.  Multiple recent attempts have led to clinical testing of candidates expected to produce both T cell- and antibody-mediated protective effects.  However, there has only been modest success in the effort to identify an effective vaccine.  Because of the urgent need for highly effective AIDS vaccine candidates, more effort must be devoted to exploring and exploiting relevant findings from basic mechanistic research that can be translated into, and tested as, effective strategies.

The broad scientific objective of this FOA is to fill knowledge gaps in the basic understanding of the immunity required to block acquisition of virus or to eliminate virally infected cells. The expectation is to stimulate novel areas of research with the goal of discovering new AIDS vaccine strategies and/or measures that require a single or limited number of steps to prevent HIV acquisition and/or dissemination from the portal of entry, or to durably eliminate virally infected cells. Cross-disciplinary collaborations among virologists, immunologists, biochemists, molecular biologists, cell biologists, microbiologists, clinical scientists and other relevant specialists are strongly encouraged.  Research conducted under this FOA is expected to clarify the critical cellular and molecular events involved in HIV acquisition and early infection events, thus contributing significantly to the knowledge base needed to identify, evaluate and develop novel vaccines.

Innovation for HIV Vaccine Discovery Research Initiative

The effort to stem the AIDS epidemic is confronted with unique challenges.  New discoveries in HIV pathogenesis and virus adaptation in the host continue to provide useful information and fresh opportunities that guide development of effective strategies to prevent initial acquisition of infection, curb the spread of virus from initial entry to distant sites, or to eliminate infected host cells.  For example, findings on how host genetics influence HIV infection, while adding another layer of complexity to the problem, may provide new leads for identifying effective prevention targets.  Such hypothesis-generating leads are needed to invigorate the field and stimulate novel vaccine design and testing.  There is continuing substantial need to probe fundamental aspects of HIV immunity, both at mucosal “portal-of-entry” surfaces and in critical tissue compartments (e.g., local and systemic lymph nodes) to gain insights for the future development of vaccines.  In the HIV vaccine field, multiple gaps exist in understanding basic mechanisms that induce broad mucosal and systemic immunity, priming, protection, and tolerance.  This lack of information hampers the design of effective vaccines that provide adequate protection.  The types of early immune responses that will be effective are unclear; for instance, the need to elicit local IgA responses (largely undetected during infection) through mucosal immunization is still debated.  Functional genomics studies with licensed vaccines have suggested some leads to designing effective vaccination strategies by modulating dendritic cells with appropriate Toll-Like or other Pattern Recognition Receptors.  While other similar leads are being explored, the HIV vaccine field must improve its fundamental understanding of viral immunity and expedite discovery of ways to achieve robust adaptive and innate immunity to prevent either initial virus acquisition or the establishment of chronic and or latent HIV infection.

Several key features of this FOA are designed to emphasize that applications should be very different from conventional investigator-initiated R01s.  The information to be included in the research plan should focus primarily on the importance of the scientific problem being addressed, the novelty of the hypothesis and proposed methodology, and the magnitude of the potential impact on vaccine design.  At the Program level, unavoidable risk is considered acceptable if the probability for a successful outcome is reasonable.  The PD’s/PI’s record of overcoming difficult scientific hurdles, appropriately gauged to their career stage, also will be evaluated for likelihood of success.  These features are intended to emphasize the goal of the initiative, which is to support bold and potentially transformative research.  Further, unlike standard R01 applications, this FOA does not require preliminary data because the principal aim is to support new ideas that may have insufficient preliminary data to be competitive for standard R01 grants.

Scope of the Solicited Research

Preventing HIV acquisition infection encompasses events associated with infecting initially susceptible cells, local propagation, and initial dissemination of virus from the first infected cells.  For the purpose of this FOA, HIV acquisition is defined to encompass the initial infection of susceptible target cells at sites of entry, as well as the early dissemination of HIV from a local infection to nearby or distant tissues before latency of infection is established.  Under this definition, initial infection involves the process of a host target cell acquiring the virus from a source such as secretions (fluid or blood) carrying free virus and/or infected cells.  Then the host target cell replicates virus that is transmitted to other host target cells.  This process can be halted by preventing the initial infection of host target cells, or by preventing the active or passive spread of virus from the initial infection foci to other target cells.  Therefore, blocking the initial entry of the virus into a host, and/or preventing/inhibiting/clearing or reducing its subsequent replication, may result in protection of the host from HIV acquisition, an ongoing chronic infection, or even latent infection.  These processes could include innate and adaptive immunological processes that may promote, inhibit and/or delay infection of host target cells and spread of HIV.

Animal model evaluation of a proposed hypothesis using HIV, SIV or pathogenic SHIV challenge is strongly encouraged during the award period (see Section II. Award Information: Award Budget for available funds).

The following list is not intended to emphasize or limit applications to any specific areas of research, but only to serve as a set of examples of high risk, high impact and novel research projects.  Research projects and studies may include, but are not limited to, the following topics listed below:

Applications proposing any of the following research topics will be considered

non-responsive and will not be reviewed:

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIAID intends to commit $2.0M in total costs in FY2015 to fund 4-5 awards.

Award Budget

Application budgets are limited to $350,000 per year in direct costs.  Applicants may request up to an additional $150,000 in direct costs per year in any year when nonhuman primate research is proposed and justified.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 4 years.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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.

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


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

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

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:

The letter of intent should be sent to:

Sujata Vijh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive, Room 3118
Bethesda, MD 20817
Telephone: (301) 594-0985
Fax: (301) 480-2408
Email: vijhs@niaid.nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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.

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.

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:

Research Strategy: Within the page limits of the Research Strategy, and under the appropriate headings of Significance, Approach, and Innovation, applicants should clearly address the following issues. Applicants should offer a potential prophylactic vaccine solution for preventing virus acquisition or clearing virus infection, and explicitly describe the novelty of a single hypothesis or the importance of a single scientific problem being addressed, and highlight why the hypothesis or proposed solution to the problem is considered unconventional, unique or exceptionally novel.  Applicants should clearly state how their proposed new idea/approach can be stringently tested (for example, in a well-justified vaccine animal challenge model or using a unique research cohort), provide a clear rationale for the choice of methods for the proposed work, state how their proposed new idea/approach can be potentially implemented, indicate how the hypothesis or proposed solution to the problem challenges standard paradigms (e.g., how it differs from current or previously failed approaches) and how it will contribute, inform, or provide more than incremental knowledge to the field regardless of the outcome of the proposed work.  Applicants should also describe the likelihood of obtaining a significant outcome (this could be addressed by briefly describing past achievements that best illustrate exceptional innovativeness, ability to make paradigm-shifting discoveries or solve very difficult problems, and the impact of past discoveries or solutions.), and why the proposed research is uniquely suited to the stated goals of the FOA.  If applicable, applicants must illustrate how the proposed research differs from currently funded research in the applicant’s lab (or applicants’ if multi-PD/PI). 

Further, applicants should describe any potential cross-disciplinary collaboration(s) for the proposed research.  To foster the inclusion of new investigators within multidisciplinary teams, established investigators working in fields not traditionally directed toward HIV, and established HIV investigators whose research ideas are novel and untested (but not iterative to development of previous or current work), this FOA will not require the inclusion of preliminary data.  However, applicants are encouraged to include relevant information or data that supports the development of a sound rationale/hypothesis, and to provide evidence of success in overcoming scientific hurdles and making discoveries appropriate to their career stage.

While the evaluation of animal models for a proposed hypothesis using HIV, SIV or SHIV challenge is strongly encouraged, the applicant should provide sufficient justification of the use of nonhuman primates as opposed to other animal species.

Timeline: Applicants must provide a detailed project performance timeline in a section entitled “Timeline” under the Approach. This section should be no more than one half-page in length. The timeline section should indicate points on the timeline when essential aspects of the project will be completed (e.g., protocol optimization, reagent generation, critical experimentation, and novel tool or technique verification).  In addition, applicants should discuss alternate plans and timelines for conducting the study in the face of adverse outcomes or problems. Note: Applications lacking the Timeline section will be deemed non-responsive and will not be reviewed.  

Letters of Support: Collaborations are strongly recommended/encouraged, and the applicant should include letters of collaboration and agreements addressing the proposed research.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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 Applying Electronically.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Prior Consultation with Scientific/Research Staff

Because of the complexity in the research areas being solicited, potential applicants are strongly encouraged to communicate with the Scientific/Research Contact, listed in Section VII. Agency Contacts of this FOA, to discuss the responsiveness of their proposed work scope.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? Does the rationale for the proposed project clearly explain how the outcome(s) will directly contribute to the design and potential development of an effective vaccine to prevent acquisition of HIV infection or to clear established HIV infection?

Investigator(s)    

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? Is the proposed timeline realistic and likely to contribute to the success of the proposed research? Is there evidence of strong, appropriate, cross-disciplinary collaboration?   If proposed, is a justification presented for specific and unique cohorts? If proposed, is there sufficient justification for the use of nonhuman primates as an animal model?

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 children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAID, 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:

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:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Jon Warren, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-0633
Email: JWarren@niaid.nih.gov

Peer Review Contact(s)

Sujata Vijh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-0985
Email: vijhs@niaid.nih.gov

Financial/Grants Management Contact(s)

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: adevine@mail.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 Parts 74 and 92.


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