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

Prevention Innovation Program (PIP) (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-AI-13-008

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-13-059

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

This Funding Opportunity Announcement (FOA), the Prevention Innovation Program (PIP), encourages Research Project Grant (R01) applications in non-vaccine biomedical prevention (nBP) research. The PIP is intended to support high-risk/innovative research and development efforts to establish and maintain a sustainable pipeline for the prevention of HIV acquisition/transmission. The PIP will support discovery and development of novel and under-explored nBP candidates/strategies, nBP delivery strategies, studies of the impact of nBP prevention strategies on genital and gastrointestinal (GI) mucosa function and emerging technologies that support microbicides, pre-exposure prophylaxis (PrEP), and Multipurpose Prevention Technologies (MPT) for prevention of HIV acquisition/transmission. 

Key Dates
Posted Date

February 20, 2014

Open Date (Earliest Submission Date)

June 10, 2014  

Letter of Intent Due Date(s)

June 10, 2014  

Application Due Date(s)

July 10, 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 10, 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

April 2015 

Expiration Date

July 11, 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 the Preclinical Innovation Program (PIP) is to support novel, high-risk and under-explored strategies in the field of non-vaccine Biomedical Prevention (nBP). Non-vaccine Biomedical Prevention strategies are composed of, but not limited to, topical microbicides and topical and/or systemic pre-exposure prophylaxis (PrEP), and Multipurpose Prevention Technologies (MPT). All of these strategies when applied topically to genital and gastrointestinal (GI) tract mucosa or delivered systemically (oral, implanted, transdermal, injection or by other means) to men and/or women can result in inhibition of the transmission/acquisition of HIV.

The dosing regimen(s) used to deliver the prevention product play a critical factor in the success of the prevention strategy. Evidence is accumulating that daily or coital-associated dosing may not be the optimal way to deliver prevention strategies to some at-risk populations. Analysis of self-reported adherence and plasma drug concentration from the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial where daily dosing in women of 1% Tenofovir vaginal gel or oral Tenofovir or Truvada strongly suggests that adherence was the primary driver for lack of efficacy in this trial. Thus, in an attempt to create new dosing schedules and regimens that may help individuals maintain adherence, this FOA will focus on supporting the development of pericoital and sustained release drug delivery systems (DDS). 

For the purposes of this FOA the following pericoital and sustained release definitions will be used:

Therefore, as a part of the forward looking aspect of research supported under this FOA and its focus on building and maintaining a sustainable pipeline of prevention strategies and delivery systems, the development of products and DDS that provide for longer intervals of protection is encouraged.  Development of vaginal products with windows of protection less than one (1) week will be considered non-responsive and will not be reviewed.

Specific Areas of Research Interest

Discovery, development and testing of new and innovative nBP candidates, mucosal and HIV inhibition targets and supporting technologies are complex processes that require multi-disciplinary resources and expertise. The PIP program is designed to assist in this effort by supporting the advancement of high-risk and innovative approaches that can substantially advance nBP in six general areas.

Year 2 Go/No-Go Decision Criterion

Given the high-innovation and high-risk research targeted by the PIP program, applicants are required to identify within the application a SINGLE Go/No-Go criterion to be achieved as a deliverable for the Year 2 progress report in order to enable advancement to years 3 -4 funding. The Go/No-Go criterion will be referenced in the notice of award. Achievement of the stated goal (Go) will enable a total of 4 years of support, while failure to achieve the stated goal (No-Go) will result in negotiation of a reduced budget for year 3 and award close out.

Use of Animal Models

Applicants may include research that uses animal models such as humanized mice and/or nonhuman primates (NHP) for safety and/or efficacy determinations of the nBP strategies or candidates. For the purposes of this FOA, animal studies are divided into two categories. The first category includes studies that address the basic and developmental science issues of virus transmission within the context of the nBP candidate or strategy. Examples are assessments of 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. The second category is the use of animal models for screening/testing of candidates to support their plausibility as clinical candidates. For this latter case the NIAID/DAIDS prevention program strongly encourages and makes the following recommendations when animal model efficacy results are proposed as a mechanism to prioritize nBP development.

Clinical Research

The PIP FOA will not support Phase 1, 2 or 3 clinical trials; however it can support limited clinical research that meets the following criteria. Proposed clinical research must be low risk to participants with limited human exposure to test products. For the purposes of this FOA, Low Risk is defined to be the use of clinical sample collection procedures, i.e. biopsy, Cytobrush, swabbing, or the use of test products with established and documented safety risks. To meet the latter part of this definition, the only allowable test products are: (1) A licensed product, i.e. licensed contraceptive, used only for its approved use or (2) A low-risk placebo. An antiretroviral licensed only for treatment and proposed for use for HIV prevention does not meet this definition. A low-risk placebo is defined as a clinical trial quality product with phase 2B or 3 safety data demonstrating minimal or no impact on the integrity or inflammatory state of the genital and/or GI mucosa, or a Good Manufacturing Practices (GMP) manufactured product that was evaluated in a Good Laboratory Practices (GLP) Rabbit Vaginal Irritation (RVI) studies and showed Draize scale irritation scores lower than Gynol II or other relevant N-9-based control and passed relevant United States Pharmacopeia (USP) microbial limits testing.

Limited clinical research testing designed to address a nBP attribute should incorporate exploratory endpoints such as expression of innate and adaptive immune responses, acceptability or PK studies, and be limited to no more than 20 total participants per proposed study. Studies involving behavioral/social research are limited to no more than 50 participants per proposed study. Studies that exceed these criteria may be categorized as phase 1 clinical trials and will not be reviewed. Applicants may propose multiple studies per application, but are cautioned that poorly justified or duplicative studies could reduce reviewer enthusiasm for the application. Study cohorts may include HIV-positive, specific at-risk populations, such as adolescents, post-menopausal women, specific ethnicities, intravenous drug users (IDUs) and alcohol users and abusers when scientifically appropriate.

Responsive Areas of Research

Examples of the types of studies that are considered responsive to this FOA include, but are not limited to:

Non-Responsive Areas of Research

Applications proposing research in the following areas will not be considered responsive to this FOA 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 $2.4 million in FY 2015 to fund 4 - 6 awards.

Award Budget

Application budgets are limited to a direct cost of $400,000 per year.

Award Project Period

Applicants will submit a 4 year R01 application, and are required to identify a single Go/ No-Go decision criterion to be achieved as a deliverable for the Year 2 progress report. Achievement of the stated goal (Go) will enable continuation of the R01 for a total of 4 years, while failure to achieve the stated goal (No-Go) will result in negotiation of a reduced budget for Year 3 and award close out.   

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:

Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
6700 B Rockledge Drive, Room 3133
Bethesda, MD 20817 (use zip 20892 for courier)
Telephone: 301-496-8426
Fax: 301-480-2310
Email: pjackson@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. 

Modular or R&R 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: Applicants must provide a section with a single, clearly identified Go/No-Go decision criterion for year 2 of the application. Applicants are required to identify in the application a single Go/No-Go decision criterion to be achieved as a deliverable for the Year 2 progress report and for advancement to years 3 -4 funding. The Go/No-Go criterion will be referenced in the notice of award. Achievement of the stated goal (Go) will enable a total of 4 years of support, while failure to achieve the stated goal (No-Go) will result in negotiation of a reduced budget for year 3 and award close out. The Go/No-Go section may be placed at the end of the Research Strategy Section, and applicants should consider the use of timelines and Gantt charts to support the choice and timing of the Go/No-Go decision.

The Go/No-Go criterion chosen by the applicant must identify a critical parameter that is essential for the success of the proposed research in subsequent years. The Go/No-Go criterion should be specific to the proposed research and represent a quantifiable outcome. A restatement of an application specific aim is not considered an adequate Go/No-Go criterion, and lack of a sufficiently robust Go/No-Go criterion may reduce enthusiasm of the peer review panel for the proposed research. 

Selected examples of possible Go/No-Go criterion are:

In these examples "Fill in blank" denotes an applicant chosen, single specific criterion that is essential for the success of the proposed research in subsequent years.

If the application includes a Targeted Product Profile (TPP) to be used to support the development and validation of candidates, the TPP may be placed as a table in the Research Strategy Section. Applicants are encouraged to capture properties in table format that lists the product attributes and both the optimal and minimally acceptable chemical and physical properties of the candidate or DDS. Examples of potential product attributes that can be captured are: product release profile of the DDS, delivery/injection/implant volume, pharmacokinetic (PK) maximums and minimums, stability and storage requirements, desirable physical attributes, acceptability, cold chain requirements and feasibility of GMP production. Applicants are advised that the proposed TPP should be used as a tool for identifying the optimal candidate/DDS proposed in this application, and therefore is less complicated and comprehensive than the FDA required TPP used to map and guide regulatory responses for the complete product development pathway from nonclinical studies to licensure.

If the research strategy includes clinical research, applicants should include a discussion as to how this research meets the FOA-defined criteria for low risk.

The proposed research may require reliance upon relational and/or inferential data to establish the potential for research impact/success rather than substantial experimental data directly supporting application objectives.

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.  

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.

For this particular announcement, note the following:

The R01-based PIP program is intended to identify high-risk and high-innovative research that can contribute significantly to the preclinical nBP prevention pipeline. Accordingly, evaluation of the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge and understanding of nBP-mediated prevention will be critical to achieving the goals of this program and submitted applications. Although preliminary data can play a significant role in providing a justification or rationale for the approach taken and the projected impact of proposed research, the high level of innovation and risk requested for PIP applications may not be supported by extensive preliminary data. Thus, judgments regarding potential success for the proposed research may require reliance upon relational and/or inferential data to establish the potential for research impact/success rather than substantial experimental data directly supporting application objectives.

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?  

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? Does the approach meet the FOA-defined criteria for low risk clinical research? For the purposes of this FOA, Low Risk is defined to be the use of clinical sample collection procedures, i.e. biopsy, Cytobrush, swabbing, or the use of test products with established and documented safety risks. See Section 1, Clinical Research for more information on low risk clinical research.  

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? 

Go/No-Go Decision Criteria

Given the critical nature of the Go/No-Go decision criterion for continuation of funding past year 2 of the award, is the proposed Go/No-Go decision criterion well-defined with a quantifiable and measurable outcome appropriate for assessing the success of the first 2 years of the application? Is the Go/No-Go decision criterion sufficiently described to enable a clear decision about its attainment? Given the potential benefits and innovation of the proposed research, is the applicant provided Go/No-Go decision criterion commensurate with the overall projects proposed advancement of the candidate, target, technology or strategy?   

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.

Year 2 Go/ No-Go Decision Point

Given the high-innovation and -risk research targeted by the PIP program, applicants are required to identify in the application a single Go/ No-Go decision point to be achieved as a deliverable for the Year 2 progress report and for advancement to years 3 -4 funding. The Go/No-Go criterion will be referenced in the notice of award. Achievement of the stated goal (Go) will enable a total of 4 years of support, while failure to achieve the stated goal (No-Go) will result in negotiation of a reduced budget for year 3 and award close out.

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.

Year 2 Go/No-Go Criterion

In the Year 2 progress report, awardees must address the status of the project in regards to the single Go/No-Go decision criterion identified in the application. Achievement of the stated goal is required for future year funding.

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)

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

Kristen Porter, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-3044
Email: porterka@niaid.nih.gov 

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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