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.

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

The purpose of this FOA is to stimulate research to better understand and optimize the interaction of genital (female and male) and gastrointestinal (GI) tract mucosa with non-vaccine biomedical prevention (nBP) candidates and strategies with the long-term goal of enhancing the safety and efficacy of HIV prevention interventions. To achieve this goal, this FOA will support hypothesis driven biomedical research projects, addressing the following 3 underserved emerging areas of Programmatic interest:

• The role of different mucosal site physiological states in altering nBP safety and efficacy. Examples include, but are not limited to: normal, inflamed, and/or wounded tissue (from sexual activity or sexual violence, etc.),
• Pharmacokinetic (PK)/ pharmacodynamic (PD) relationships of nBP candidates in different mucosal compartments and novel models to measure these relationships, and
• Studies into the basic and molecular cellular and biological mechanisms by which female and/or male hormones, age, immune factors, genital secretions and the microbiome (bacterial, viral, archeal, fungal) affect HIV susceptibility and efficacy of nBP.

The male and female genital and GI mucosal tissues are modulated by a wide variety of endogenous and exogenous factors. Different commensal flora, unique innate and adaptive immune response mechanisms, immune cell compositions, and hormones continuously alter the physiology of these tissues. Numerous studies have shown that active pharmaceutical ingredients (APIs), delivery vehicles and formulations/excipients can induce changes in the mucosa, such as loosening of epithelial tight and adherent junctions, alter innate and/or adaptive immune mediators (i.e. inflammation), and modulate immune cell content (i.e. homing and trafficking). Sexually transmitted infections (STI) associated with HIV acquisition can also modulate genital and GI tract mucosal susceptibility to HIV transmission/acquisition in the absence of gross evidence of toxicity or damage to the tissues. Although not all mucosal changes induced by prevention candidates or strategies have been linked directly to altered HIV acquisition/transmission risk, these changes represent modifications of the physical and active barriers to HIV infection that, under the right circumstances, could positively or negatively modulate susceptibility to HIV infection.

Investigators are encouraged to develop applications that are hypothesis-driven with the goal of understanding the effects of nBP APIs, delivery vehicles, formulations/excipients and/or contraceptives on the genital and GI mucosa and HIV target cells. Applications with hypothesis-generating or descriptive studies are discouraged. For the purposes of this FOA, hypothesis-generating/descriptive applications are defined as those which propose descriptive and/or conditional analysis/surveys of mucosal environmental factors and responses to identify impacts on the mucosal environment, which might alter HIV susceptibility and/or nBP efficacy. Hypothesis-generating studies often involve broad surveys of hormonal and microbiome changes using systems biology approaches, i.e. omics or cytokine arrays, resulting in descriptive data sets that are used to tentatively identify factors or conditions that are proposed to negatively or positively impact the mucosal environment, nBP safety and/or susceptibility to HIV Infection.

It is not the purpose of this FOA to develop new prevention candidates, strategies, or delivery systems but to use existing candidates, strategies, and delivery systems as tools to probe the HIV target mucosa to develop a knowledge base that will lead to the creation of novel "mucosal friendly" prevention strategies.

The MEHP II concept has been previously released as RFA-13-012; investigators should note that this FOA contains significant changes in areas of interest and scope.

All examples of responsive areas of research assume that the identified activities are being conducted with the prerequisite of understanding the interaction of an API, delivery system and/or formulation/excipient within the male and/or female genital or GI mucosa. These studies may be carried out with human secretions, cells and /or tissues and/or animal models of HIV transmission and acquisition. Responsive studies include, but are not limited to:

• The influence of race, ethnicity, genital tissue maturation and mucosal injury (of particular interest is tissue disruption from normal sexual activity and/or sexual violence), as modifiers of the mucosal environment in the genital and GI tracts, and their relationship to HIV susceptibility and nBP candidate/strategy safety and efficacy.
• The role of the microbiome in HIV prevention. Investigators are strongly encouraged to focus on specific microbiome changes that may occur following exposure to APIs and delivery vehicles/systems rather than performing broad assessments of the organisms that comprise the microbiome or the dynamics of microbial communities. However, studies on how microbiome metabolism may affect HIV susceptibility and resistance are of interest.
• Genital and GI mucosal immune responses to prevention agents, devices, formulations and/or excipients, that may include, but are not limited to, alterations in HIV target cell homing, trafficking, turn-over and activation, and their effect(s) on the safety and efficacy of the intervention and/or susceptibility to HIV infection.
• The role of genital secretions and hormones, including the influence of the menstrual cycle, and prostate secretions on susceptibility to HIV infection/susceptibility and the safety and efficacy of prevention strategies.
• Understanding the interaction(s) of preventive agents and their vehicles (devices, formulations/excipients) with mucosal tissues and their effect(s) on API PK and PD. This work may include improved methods for determining tissue PK/PD, investigations of drug transporter expression and modulation in target mucosal tissues and/or API-induced mucosal tissue changes.
• The effect(s) of nBP candidates/strategies on the inflammatory state, i.e. inflammasome activation, pyroptosis, TLR engagement/signaling and the regulation of cytokine expression or release (rather than broad cytokine array studies), changes in inflammatory cell phenotypes, and the resolution of inflammation, etc. In addition, studies on how these inflammatory states may act to limit or enhance initial infection and the dissemination of infected cells from the site(s) of infection.
• Development of animal models or wound healing studies to measure genital and GI mucosal injury from normal sexual activity or trauma and how sexual activity or trauma affect susceptibility to HIV infection in the presence and absence of nBP candidates, strategies and their delivery systems.
• Effect of STIs associated with HIV acquisition on micro-/macro-environmental barriers to HIV infection, such as innate-, adaptive- and microbiome-derived defenses against HIV transmission/acquisition.

Applications focusing on the following areas will be considered non-responsive and will not be reviewed:

Applications proposing Phase I, II or III clinical trials or first in-human testing. Clinical research that uses clinical specimens may be supported under this FOA. Applicants are strongly encouraged to discuss any application that might be identified as a clinical trial or intervention in human subjects with Program staff prior to submission.

Basic research projects that focus on the mechanisms of, or earliest events in, HIV/SIV transmission, unless the activity is specifically linked to and required for meeting the FOA objective of enhancing HIV prevention strategy safety and/or efficacy by improving the interaction of the mucosa and the prevention strategy.

Development of new microbicides, PrEP agents or Multipurpose Prevention Technology (MPT) agents/strategies to prevent HIV or STI transmission (i.e. drug discovery and development). Development of new agents and strategies includes improving and/or altering dosing and delivery formats. As MPTs are still in early development and significant MPTs are in early development stages and their use is excluded from the FOA because significant development is still required prior to advancing MPTs for mucosal environment testing.

• Physical modification of prevention products and/or strategies that are currently in clinical trial testing or proposed for clinical testing, to enable small animal research, safety or efficacy testing.
• Development or modification of animal models to study or mimic Bacterial Vaginosis (BV) or study HIV/SIV/SHIV infection.
• Retrospective studies on samples from previous microbicide, PrEP, treatment as prevention trials.
• Proposed studies that utilize Tenofovir (TFV, PMPA, (R)-9-(2-Phosphonoylmethoxypropyl)adenine) or Tenofovir Disoproxil Fumarate (TDF or Viread ) as an nBP, unless they are used solely as controls in proposed studies.
• Studies that focus solely on the use of agents known to be cytotoxic to mucosal tissues, such as Nonoxynol-9 or microbicide products/candidates demonstrated to have caused harm in preclinical animal toxicology studies and/or clinical efficacy or safety trials. These agents may be used as positive controls with the appropriate negative controls, in efforts to delineate the upper and lower response boundaries of a proposed effect.
• Studies focused solely on spermicidal products or prevention strategies dependent on mechanical barriers to prevent HIV infection.
• Studies modulating mucosal susceptibility to HIV acquisition/transmission by thickening of mucosal epithelial barriers (i.e. increased numbers of cell layers, enhancement of keratinization, etc.).
• Strategies focusing on mucosal sites other than the genital or GI tracts. This includes, but is not limited to, the skin and upper respiratory tract (e.g. lung, tonsils, oral cavity, nasopharynx, etc.).
• Applications proposing to assess the effect(s) of bacterial, yeast, viral or fungal pathogens that are not sexually transmitted infections, or on STIs that have not been shown through clinical and epidemiological investigations to be associated with increased susceptibility or acquisition of HIV infection. All applications must have a focus on prevention of HIV, and those that focus solely on prevention of non-HIV STIs are not responsive.
• Use of natural products, representing extracts and/or complex mixtures of chemically undefined mixtures of plant and/or animal materials or derived-products to probe genital and GI mucosal responses.
• Use of beneficial bacteria, probiotics and/or bacterial drug delivery systems as a means to treat or modify microbiome imbalances to change HIV susceptibility and/or deliver an API.
• Studies proposing broad and unfocused proteomic, genomic, and metabolomic surveys of mucosal tissues, that are essentially hypothesis generating searches for interesting gene, protein and/or metabolic profiles. This includes studies to characterize "normal" or "abnormal" genital or GI microflora in individuals or defined populations of men and women in the absence of an API or formulation/excipient.
• Applications proposing any form of vaccine development (new mucosal vaccine, vector, insert, or delivery system) or research.
• Behavioral and/or social science research into the use or intent to use nBP candidate.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

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.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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, including Supplemental Grant Application Instructions 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.

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:

Peter R. Jackson, Ph.D.
Telephone: 240-669-5048
Email: pjackson@niaid.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

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

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

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

Research Strategy: Inclusion of animal studies/models is not required for this FOA. Applications may include research that proposes use of animal models such as humanized mice and/or nonhuman primates (NHP) that are designed to address basic and developmental science issues of virus transmission within the context of an nBP product or strategy. Examples are assessments of mucosal environmental and physiological factors resulting from nBP exposure that might alter susceptibility, acquisition and dissemination of virus at the mucosal tissues. These may include sexual trauma, age, hormonal and immune status. Please note, sufficient numbers of animals should be included in all groups to allow for endpoint statistical analysis.

Wherever possible formulated products, characterized for API stability and release should be used. Use of unformulated products and vehicle admixtures without establishing some level of drug stability and release are strongly discouraged.

Where appropriate, applicants are encouraged to include secondary endpoints to support the proposed prioritization such as pharmacokinetic (PK), pharmacodynamic (PD) and safety measurements (colposcopy, histology, vaginal pH, microbiome analysis and/or the immune response, etc.).

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.

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

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

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.

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.

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 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.

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

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.

For this particular announcement, note the following:

The MEHP II program is intended to support hypothesis-driven innovative research that can contribute significantly to our understanding of the genital and GI mucosal environments and their role(s) in the safety and efficacy of nBP strategies.

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

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

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?

Is the proposed research relevant to understanding the impact of nBP on prevention strategy efficacy and safety, and does the research have the potential to provide new knowledge that may be used to generate new targets/strategies for improving nBP safety and efficacy in future studies?

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?

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?

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 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?

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

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.

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

• 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.

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’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.

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 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.

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

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
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 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: 301-710-0267
Email: GrantsInfo@nih.gov

Kristen A. Porter, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4783
Email: porterka@niaid.nih.gov

Jim A. Turpin, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2732
Email: jturpin@niaid.nih.gov

Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5048
Email: pjackson@niaid.nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: adevine@niaid.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.