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

Preclinical Innovation Program (PIP) (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • March 29, 2016 - This RFA has been reissued as RFA-AI-16-025.
  • February 20, 2014 - This RFA has been reissued as RFA-AI-13-059.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

RFA-AI-13-008

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 Preclinical Innovation Program (PIP), issued by NIAID, 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 designed to establish and maintain a sustainable pipeline of nBP candidates, drug delivery systems (DDS) and supporting technologies for the prevention of HIV acquisition/transmission. The PIP will support novel and under-explored approaches to strengthen and maintain an innovative pipeline of nBP strategies including microbicides, pre-exposure prophylaxis (PrEP), and Multipurpose Prevention Technologies (MPT). To accomplish this, the PIP will also support a range of nBP DDS including, but not limited to, pericoital and sustained delivery of single and combination candidates and strategies using gels, films, intravaginal rings (IVR), oral, implant and/or injection delivery methods. The PIP is a replacement program for the Microbicide Innovation Program (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-10-011.html) and investigators are urged to read the current FOA closely to identify critical differences between this and previous programs.

Key Dates
Posted Date

March 7, 2013

Open Date (Earliest Submission Date)

July 1, 2013

Letter of Intent Due Date(s)

July 1, 2013

Application Due Date(s)

August 1, 2013, 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)

August 1, 2013, by 5 PM local time of the applicant organization.

Scientific Merit Review

December, 2013

Advisory Council Review

January, 2014

Earliest Start Date

April, 2014

Expiration Date

August 2, 2013

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.

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/Research Objectives

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). A safe, effective, acceptable nBP strategy that prevents the sexual transmission of HIV could play a major role in world-wide reduction of the over 7,000 new HIV infections per day, potentially saving millions of lives. nBP strategies are composed of, but not limited to, topical microbicides and topical and/or systemic 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 and injected) to men and/or women can result in inhibition of the transmission of HIV and/or other sexually transmitted infections (STI) that may act as susceptibility co-factors for HIV transmission and acquisition. MPTs strategies may be composed of combinations of HIV and STI inhibitory strategies, including the prevention of conception using licensed contraceptive methods. The term nBP will be used to collectively identify microbicide, PrEP, and MPT prevention strategies for the purpose of this FOA.

Specific Areas of Research Interest

The discovery, development and testing of nBP candidates, targets and supporting technologies are complex processes that require multi-disciplinary resources and expertise to support the discovery/identification and development of candidates that are safe, effective, and acceptable. The PIP program is designed to assist in this effort by supporting the advancement of novel scientific ideas, models, tools, agents, targets, technologies and strategies that can be implemented iteratively to substantially advance nBP in six general areas.

(1) Discovery and exploration of new and novel microbicides and PrEP strategies (singly or in combination) directed against HIV and sexually transmitted infections (STIs) linked by clinical evidence to enhanced HIV acquisition/transmission.

(2) Development of sustained-release formulations using DDS such as intravaginal rings (IVRs), injection and implants to disassociate coitus from prevention candidate application. Oral delivery methods may also be used to achieve coital-disassociation.

(3) Support emerging technologies or models that contribute to the development of new and/or more efficient methods of assessing nBP strategy safety, efficacy, acceptability, and adherence.

(4) Support the development of quantitative biomedical methods to measure adherence to nBP strategies.

(5) Support pharmacokinetic (PK) and pharmacodynamic (PD) modeling of nBP candidates and strategies in animal models to create linkages between tissue and cell concentrations and in vivo observed safety and efficacy.

(6) Support the development of new technologies, approaches and processes, including engineering and soft/hardware solutions, to support the nBP pipeline.

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. The Go/ No-Go criterion chosen by the applicant should identify a critical parameter that is essential for the success of the proposed research in subsequent years. The provided Go/No-Go criterion should be specific to the proposed research and represent a quantifiable outcome of the research. Restatement of a specific aim is not considered to be an adequate Go/ No-Go criterion, and lack of a sufficiently robust Go/ No-Go criterion may reflect poorly on the overall enthusiasm of the peer review panel for the proposed research. Selected examples of possible Go/No-Go criteria are:

In these examples "Fill in Blank" denotes the applicant specified critical parameter that is essential for the success of the proposed research in subsequent years

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 types. The first are 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 include the endogenous hormonal state, use of exogenous hormones, pregnancy, age and immune status. The second category is the use of animal models for screening/testing candidates to support their plausibility as clinical candidates. For this latter case, the recent trends of (1) investigator use of animal studies as gateways for clinical selection and establishment of biological plausibility in the absence of a requirement for demonstration of animal model efficacy by the FDA, (2) the cost of using these resources as screening tools , (3) limited availability of some species of animals and (4) the cost of producing and maintaining some animal species/subspecies/models for relevant experimental periods has led the NIAID/DAIDS prevention program to make specific recommendations regarding these types of studies. The NIAID/DAIDS prevention program strongly encourages investigators proposing the use of animal models as gateways to design robust experiments for assessing efficacy and safety of nBP. Robust experiments are defined as studies that: (1) include superiority assessments (selecting best candidate or more potent candidate) with positive control and/or placebo arms, (2) use of a sufficient number of animals in all groups to allow for endpoint statistical analysis, and (3) studies that use a formulated product. Studies should be designed to allow a statistical assessment of the outcomes. Applicants are cautioned that inclusion of too few animals in groups can reduce enthusiasm of the study section for the application. Selection of animal numbers should be supported by power calculations, and for NHP studies applicants should consider group sizes of 6 or more animals. The formulated product used for testing should have undergone sufficient development to establish product stability, retention of antiviral activity and release from the dosing vehicle. Studies in which unformulated prevention candidates are mixed in vehicles without establishing some level of stability or release from the vehicle are strongly discouraged in this FOA. The proposed animal studies, wherever possible, are encouraged to include additional study endpoints such as PK and PD determinations and safety measurements (colposcopy, histology, monitoring of vaginal pH, microflora analysis and/or measurement of adaptive/innate immune markers, etc.). Applicants performing PK and PD studies in these models are encouraged to incorporate adequate pharmacological and analytical expertise to select optimal sampling regimes and perform analysis of outcomes.

Responsive Areas of Research

Examples of the types of studies that are considered responsive to this FOA and could be supported under this program include, but are not limited to:

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/DAIDS intends to commit $3,500,000 in FY 2014 for funding 4 to 8 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 Go/ No-Go decision point 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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3133, MSC 7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (for Express Mail 20817)
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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applications must contain a detailed, non-modular budget. Applicants should ignore the following warning that will be generated for applications requesting budgets of $250,000 or less per year: The direct cost requests of $250K or less each year (on the 424 R&R Budget page section F-K) must be in modules of $25K, using the PHS 398 Modular Budget Form and not the R&R Budget Form. Incorrect applications may be delayed in the peer review process or rejected."

PHS 398 Cover Letter

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 clearly identified Go/ No-Go decision point for year 2 of the application. 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. The 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.

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.

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-10-115.

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 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 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? Is the application innovation embodied by the advancement to the field of nBP prevention by provision of new candidates, strategies and/or technologies required to sustain and/or maintain a pipeline of nBP prevention strategies and technological infrastructure?

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?

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? Does the Go/ No-Go decision reflect the impact of the proposed research on the nBP pipeline and field?

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 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

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 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:

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.

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.

Year 2 Go/ No-Go Decision Point

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

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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
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 Center Phone: 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
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

Peer Review Contact(s)

Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone 301-496-8426
Fax: 301-480-2310
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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NIH Funding Opportunities and Notices



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