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-11-018
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855, 93.856
FOA 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 acquisition of HIV. The emphasis of this FOA is early discovery research that incorporates new ideas leading to the development of new conventional or outside-the-box approaches for vaccines that may have significant impact on the design of novel 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.

Posted Date	June 16, 2011
Open Date (Earliest Submission Date)	November 7, 2011
Letter of Intent Due Date	December 6, 2011
Application Due Date(s)	January 6, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	April, 2012
Advisory Council Review	May, 2012
Earliest Start Date(s)	July, 2012
Expiration Date	January 7, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to foster original, high risk, and unconventional research that, if successful, may have a substantial impact on approaches to HIV/AIDS vaccine discovery and development. Applicants must clearly state how their proposed new idea, approach and rationale: (1) offer a potential solution for preventing acquisition of infection, (2) could be stringently tested (e.g., in a vaccine animal challenge model) and potentially implemented, (3) differ from current or previously failed approaches, and (4) will contribute, inform, or provide more than incremental knowledge to the field regardless of the outcome of the proposed work.

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 remains one of the highest research priorities 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. NIAID held a Vaccine Summit in early 2008 to solicit ideas from investigators/attendees about the status of the field and the research approaches that should be pursued to reinvigorate the effort. One of the strong recommendations was to invest substantially in fostering new discoveries that improve understanding of the immune responses most relevant for preventing HIV infection, and novel approaches for generating those responses. This need continues, and through this FOA NIAID intends to support 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 there is an 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 viral infection. 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. Cross-disciplinary collaboration among virologists, immunologists, biochemists, molecular biologists, cell biologists, microbiologists, clinical scientists and other relevant specialists is strongly encouraged. Research conducted under this FOA is expected to clarify the critical cellular and molecular events involved in HIV acquisition and significantly contribute to the knowledge base needed to identify, evaluate and develop novel vaccines to prevent acquisition of infection.

Innovation for HIV Vaccine Discovery Research Initiative

The effort to stem the AIDS epidemic is confronted with unique challenges, and new discoveries in HIV pathogenesis and virus adaptation in the host continue to provide useful information and fresh opportunities to guide the development of effective strategies for prevention of acquisition of infection or to curb the spread from initial site of entry to infection at distant sites. For example, recent findings on how HIV infection is influenced by host genetics, 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 to stimulate the design and testing of novel vaccines to prevent HIV acquisition or the initial spread and establishment of infection. There is continuing need to probe fundamental aspects of immunity to HIV at mucosal surfaces, with the goal of gaining new insights that could lead to future development of vaccines. Recent data demonstrating the very early development of escape mutations in the virus to both CTL and antibody pose challenges to the design of protective vaccine immunogens. In the HIV vaccine field, multiple gaps exist in the understanding of the basic mechanisms required for induction of broad mucosal immunity, priming, protection, and tolerance. This lack of information hampers design of effective vaccines to provide adequate mucosal 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 tantalizing 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 gradually explored, the HIV vaccine field needs to improve its fundamental understanding of viral immunity at mucosal surfaces and to expedite the discovery of ways to achieve robust innate immunity, especially to prevent acquisition and establishment of 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 describe explicitly and 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 as long as 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 in judging the likelihood of success. These features are intended to emphasize the goal of the initiative, which is to support bold and potentially transformative research. Further, since a principal aim of this FOA is to attract and support new ideas, a key feature of this FOA is that preliminary data, unlike as in standard R01 applications, are not required for this R01 submission.

Scope of the Solicited Research

Preventing acquisition of HIV 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 site 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 target cell acquiring the virus from an infected source. Then the target cell replicates virus and subsequently transmits infectious virus to new target cells. An infectious source could be secretions (fluid or blood) carrying free virus or infected cells. This process can be halted by preventing the initial infection of target cells, or by preventing the active or passive spread of virus from the initial infection foci to new target cells. Therefore, blocking the initial entry of the virus into a host and/or preventing/inhibiting/reducing its subsequent replication such that initial spread of infection is aborted may result in protection of the host from HIV acquisition and infection. These processes could include innate and adaptive immunological processes that may promote, inhibit and/or delay infection of target cells and spread of HIV.

Although research involving human subjects (clinical research) is permitted, this FOA will not support clinical trials. Applications proposing clinical trials will be considered unresponsive and will not be reviewed. For the NIH definition of clinical research versus clinical trials, please see: http://funding.niaid.nih.gov/researchfunding/sci/human/pages/default.aspx.

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 for available funds).

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.

Research projects and studies may include, but are not limited to, the following topics listed below. The 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.

Studies may propose to investigate:

• the potential of host proteins to act as immunogens alone or together with HIV immunogens
• previously unexplored HIV- (or SIV-) encoded targets as immunogens
• agents generated in vivo by vaccination that may directly or indirectly lead to inhibition of processes required for, or that contribute to, susceptibility to HIV infection
• novel vaccination approaches to produce or release infection-blocking processes or agents in vivo, including at relevant mucosal sites
• in vivo-generated immune mediators that modulate adaptive and innate immune responses at mucosal sites alone or together with HIV immunogens
• HIV/SIV immunogens that stimulate potentially helpful CD4+T cell or other immune cell activation without resulting in enhancement of HIV infection
• novel approaches that modulate B cell responses to HIV immunogens to facilitate induction of broadly neutralizing antibodies
• clinical research that answers key questions on systemic and/or mucosal immune response to HIV infection in humans that could lead to testing a plausible intervention
• homing to and retention of memory cells in mucosal sites
• relationships between the susceptible target cell pool and recruitment of activated immune cells
• roles for and induction of mucosal IgA and/or IgG in protection at mucosal sites
• need for local antibody vs. transudation of serum antibodies in the mucosa
• need for mucosal delivery of vaccines to induce protective responses at mucosal sites
• role for mucosal adjuvants, including use of innate immune factors as adjuvants and induction of innate defense factors
• cross talk between innate and adaptive immunity at mucosal sites in response to HIV/SIV vaccine
• vaccine induced/imprinted innate immune responses that can be recalled in response to subsequent infection
• systems biology approaches to dissect effective innate and/or adaptive mucosal immune responses to vaccines

Applications proposing any of the following research topics will be identified as non-responsive and will not be reviewed.

• human clinical trials
• use of an oral antiretroviral therapeutic agent as part of a vaccination strategy
• incorporation of a behavioral research component within a vaccination strategy
• vaccines targeted to individuals with established HIV infection, e.g., for reduction of viral load; as therapeutic vaccines
• incremental improvements of approaches already under development such as combination strategies incorporating multiple candidate vaccines or vaccines with microbicides or ART agents
• research concepts currently being conducted in the applicant s laboratory that are supported by NIH or other funding entities
• purely descriptive basic research or structural studies not addressing a clear hypothesis for prevention of HIV infection through vaccination approaches
• product development
• iterative studies that propose the next step(s) in the development of a vaccination approach currently under development or in clinical studies
• studies that are not linked to a novel intervention strategy for prevention of acquisition of HIV infection, including:
  • development of new animal models
  • assay development and validation
  • vector development

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIAID intends to commit an estimated total of $3.0M in total costs in FY 2012 to fund 5-10 applications submitted in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are limited to $350,000 per year in direct costs over a four year period. 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	Scope of the proposed project should determine the project period. The maximum 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.

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-8426
Fax: (301) 480-2408
Email: pjackson@niaid.nih.gov

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

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

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 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 also describe how the hypothesis or proposed solution to the problem challenges the standard paradigm, 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 should illustrate how the proposed research differs from currently funded research in the applicant’s lab (or applicants if multi-PD/PI). Finally, applicants should propose a clear rationale for the choice of methods for the proposed work.
• Applicants should describe any potential cross-disciplinary collaboration (collaborations are strongly recommended/encouraged), and include letters of collaboration and agreements addressing 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.
  
  
• Note that preliminary data are not required to be included within the Research Strategy; however relevant information or data that supports the development of a sound rationale/hypothesis may be included.

• Applicants must provide a detailed project performance timeline in a section entitled Timeline under the Approach heading within the Research Strategy section. This section should be no more than one half page in length. The timeline section should indicate points on the timeline when essential components 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. Applications lacking the Timeline section will be deemed non-responsive and will not be reviewed.

Applicants should provide a description of the specific public value to be obtained if the proposed Research Plan is successful in achieving its stated goals. Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience. This statement of relevance is the second portion of the Project Summary/Abstract (i.e., Description) and should be uploaded as the Project Narrative using the SF424 Other Project Information Component (see SF424 R&R Application Guide for NIH and Other PHS Agencies , Section 4.4).

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:

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

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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 the National Institute of Allergy and Infectious Diseases (NIAID), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

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

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

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? Does the application contain a concise statement of the specific public health value of the proposed research to HIV vaccine discovery and development (see Section IV. 2. Content and Form of Application Submission Relevance to HIV Vaccine Design and Development)?

Investigator(s)

Are the PD/PIs, 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 PDs/PIs 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?What is the level of innovation with respect to the 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?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is there an adequate description of the timeline to meet specific objectives for the project? Is there evidence of strong, appropriate, cross-disciplinary collaboration? If proposed, is there a justification presented for any proposed specific and unique cohorts?

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?

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

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/priority score.

If proposed, is there sufficient justification for the use of nonhuman primates as an animal model?

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.

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. Review assignments 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/priority score.
• Will receive a written critique.

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 l. 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 , including the contribution of the project to achieve programmatic balance.

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

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Peter Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 496-8426
Email: pjackson@niaid.nih.gov.

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.