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)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Detection of HIV for Self-Testing (R61/R33 Clinical Trial Not Allowed)
Activity Code

R61/R33 Exploratory/Developmental  Phased Award

Announcement Type

Reissue of PAR-17-471 - Detection of HIV for Self-Testing (R61/R33)

Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-21-070
Companion Funding Opportunity

None

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

93.855, 93.865, 93.279, 93.242

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support collaborative, interdisciplinary early-stage research to inform the development of innovative rapid, sensitive, simple, and cost-effective diagnostic technologies that will enable HIV self-testing during the earliest phases of acute infection or during viral rebound.

Key Dates

Posted Date
November 13, 2020
Open Date (Earliest Submission Date)
February 17, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

Only accepting applications for the AIDS Application Due Date(s) listed below.

AIDS Application Due Date(s)

March 17, 2021; March 17, 2022; March 17, 2023

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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

July 2021; July 2022; July 2023

Advisory Council Review

October 2021; October 2022; October 2023

Earliest Start Date

February 2022; February 2023; February 2024

Expiration Date
March 18, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

More than 38 million individuals worldwide are currently living with HIV; new infections occur at a rate of 1.7 million per year worldwide, and 39,000 per year in the U.S. Although currently there is no cure for HIV, current antiretroviral treatment (ART) regimens are very potent and reduce plasma virus to undetectable levels in most patients, leading to reduced morbidity, mortality, and transmission. Multiple clinical studies have provided strong evidence that Undetectable = Untransmittable (U=U) — people who maintain an undetectable viral load cannot sexually transmit the virus to others. However, at least 20% of HIV-positive individuals are unaware of their HIV status, and nearly 40% are not on suppressive treatment. For individuals who do achieve undetectable HIV levels in blood, viral rebound can occur following inconsistent adherence to the treatment regimen, intentional treatment interruption, or emergence of drug resistance mutations. The timing of rebound can be unpredictable, usually with a rapid increase in viral load. Regular self-monitoring for HIV would help individuals identify viral rebound quickly and seek intervention to prevent clinical progression and transmission.

Since 2016, the World Health Organization has recommended HIV self-testing as an additional approach to increase HIV testing services. Currently available rapid HIV self-tests depend on detection of host antibody responses, which are most reliably detectable several weeks after infection. These tests could not be used to detect the initial peak viremia in early infection, before antibody production, nor viral rebound following treatment interruption or emergence of drug resistance, where antibodies would already be present prior to rebound. Direct detection of HIV, rather than antibody, would be necessary in these cases. Sensitive and accurate tests to directly measure HIV involve either expensive, sophisticated equipment in a lab or hospital setting, or point of care devices that require a trained individual to administer the test and read the result. Development of simple, inexpensive, rapid self-testing assays to directly detect HIV would enable individuals to more easily monitor their HIV or viral suppression status. Rapidly evolving molecular diagnostics and manufacturing technologies could be useful in developing innovative approaches to fulfilling this need.

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to stimulate innovative, collaborative, interdisciplinary research and early-stage diagnostic technology development focused on rapid, simple, sensitive, and cost-effective assays appropriate for HIV self-testing during the earliest phases of acute infection and/or during viral rebound. The proposed research should establish feasibility for direct detection of HIV (RNA, DNA, protein, or biomarkers that reliably correlate with HIV positivity or rebound) in a qualitative or semi-quantitative diagnostic self-test assay. The assays should be designed with a user-centered approach and should be as easy to perform as a home pregnancy test or an in-home glucose monitoring device.

Research Objectives and Scope

This FOA will support high-risk, bi-phasic, milestone-driven research and early-stage development of innovative technologies designed to enable rapid self-testing assays to meet one or both of the following research objectives:

  • detecting HIV (RNA, DNA, protein or biomarker) at the earliest stage of initial infection, ideally less than 2 weeks post-infection; and/or
  • detecting HIV rebound in treated individuals as early as possible following treatment interruption or loss of viral suppression by ART.

Strategies may include either the initial development of a novel technology or adaptation of an existing technology to detect HIV from finger stick blood or other biospecimen. Proposed studies are expected to be at the discovery and feasibility stage, designed to show potential efficacy in the detection of HIV and feasibility as a self-test platform.

Proposed studies should emphasize innovation and exploratory research with a focus on qualitative or semi-quantitative HIV detection and assay development. Innovative technologies such as microfluidics for electricity-free RNA/DNA amplification, synthetic biology approaches, paper- or plastic-based analytical platforms, and smartphone-enabled diagnostics are highly encouraged. Additional studies to address assay feasibility may include but are not limited to:

  • comparison of multiple related detection strategies
  • development and integration of sample preparation technologies
  • development and integration of readout technologies
  • evaluation of different biospecimens for virus detection
  • evaluation of biomarkers for reliable correlation with HIV infection and/or rebound

Development of such technology is expected to require collaboration among experts in the fields of virology and biotechnology (e.g., microfluidics, bioengineering, synthetic biology, nanotechnology, and/or manufacturing), as well as clinical, social and behavioral science. Applicants must demonstrate that they are capable of developing the proposed technologies and assay, have access to appropriate virus and biospecimen resources, and have the means to obtain meaningful end-user input on assay performance and usability during early-stage assay development.

Upon completion, successful projects will have demonstrated proof-of-concept for prototype assay technology capable of detecting HIV in human biospecimen samples without the use of expensive equipment or trained individuals. Assays ready for more advanced product development and commercialization would be potentially appropriate for the NIAID SBIR/STTR program (https://www.niaid.nih.gov/research/grants-small-business).

Specific performance criteria are not required, but assay design, proposed studies, and milestones for feasibility should consider how to achieve desirable features for an ideal diagnostic:

  • Rapid: The test should have a short target diagnostic time to final result.
  • Culture-independent: The test should allow direct detection of HIV or other biomarkers from human samples without relying on cell culture.
  • Accurate and sensitive: The test should accurately identify HIV when the plasma viral load is at levels appropriate for early detection (e.g. equivalent to 1000 to 5000 copies/ml).
  • Specific: The assay should be able to detect any major circulating HIV clades in the target population with high specificity. For monitoring viral suppression, the assay should appropriately consider the need to prevent detection of cell-associated HIV DNA and RNA.
  • Easy to use: for example, an integrated, closed sample-to-answer system with simple, automatic analysis and/or result presentation that does not rely on laboratory facilities or trained individuals to administer or interpret results.
  • Acceptability: for example, themes such as fit with lifestyle or routine activities, no or limited side effects, attitudes toward test, and confidentiality and privacy concerns.
  • Refrigeration-independent: The diagnostic should be designed to operate in a normal range of ambient temperature without need for cold storage.
  • Minimally dependent on electricity: The diagnostic should be designed to operate either without electricity or with a simple battery. Readout devices requiring a cell phone would be acceptable.
  • Cost-effective: Anticipated production and operating costs should be as inexpensive as possible so as to be affordable and practical for repeated testing by the end user.

NIDA is interested in the following research areas relevant to people who inject and/or use drugs (PWID/PWUD) who are likely to experience gaps in HIV testing and care:

  • Studies that address feasibility as it applies to substance using populations living with HIV (i.e., easy to self-administer, cost effective, and potential for mail-in testing and follow up through mobile technologies)
  • Studies focused on developing technologies with sensitive and rapid read out
  • Studies that include plans for post-administering surveys to assess rates of access, acceptability (stigma and ethical concerns), accuracy, and treatment outcomes
  • Studies proposing technologies that are easily adaptable for implementation in homeless shelters, community clinics, criminal justice and emergency department settings

NICHD is interested in the following research areas:

  • Research on the discovery of novel and innovative self-test assays optimized for use in infants, children, adolescents and pregnant as well as non-pregnant women to detect the earliest stage of initial HIV infection (ideally less than 2 weeks post-infection) and/or detect HIV rebound in treated individuals as early as possible following treatment interruption or loss of viral control
  • Formative studies of self-test assays that also explore the feasibility, acceptability and use patterns of self-testing in infants, children, adolescents and pregnant as well as non-pregnant women and the consequences of regular self-test use (e.g. appropriate end users, fit with life routines, testing attitudes and unintended uses like serosorting, confidentiality and privacy issues)

Applications Not Responsive to this FOA

Applications including any of the following will be considered non-responsive and withdrawn prior to review:

  • Focus on detection of SIV or pathogens other than HIV-1
  • Studies focused on detection of host antibody responses or CD4 T cell levels as biomarkers for infection
  • Applications that are focused exclusively on sample preparation, target enrichment, and/or readout without substantial emphasis on virus or biomarker detection
  • Proposal of an assay that is not designed to be a self-testing assay or that requires a trained technician, laboratory setting, or sending of self-collected samples to a separate facility
  • Advanced product development, scale-up manufacturing, and commercialization of assays beyond the discovery, feasibility, and proof-of-concept stages for HIV detection
  • Applications that do not include milestones
  • Applications that do not include aims for both R61 and R33 phases
  • Applications proposing only the R61 phase or only the R33 phase
  • Studies including vertebrate animal models
  • Clinical trials

Phased Innovation Awards

Due to the high-risk, high-impact nature of the research, this funding opportunity will use the R61/R33 phased innovation grant award mechanism. Support will be provided for up to three years (R61 phase) for hypothesis- and milestone-driven basic technology research, assay development, and end-user input. Up to two years of support may follow (R33 phase) for additional activities as appropriate, such as expanded assay development, optimization, proof of concept validation with human samples, and usability testing. Proposed milestones will be reviewed and negotiated prior to award.

Before the end of the R61 phase, awardees will submit the R33 transition package, which includes a detailed progress report describing advancement toward the initial milestones and a description of how the completed work justifies continuation with the originally proposed R33 studies. These materials will be evaluated by NIH Program staff; grants selected for continued funding will be transitioned to an R33 award without the need to submit a new application. Transition to the R33 phase is neither automatic nor guaranteed; R33 funding decisions will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, Program priorities, and availability of funds. It is expected that approximately one-half of the projects supported during the R61 Phase will continue into the R33 Phase.

See Section VIII. Other Information for award authorities and regulations.

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
Resubmission
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID and partner components intend to commit an estimated total of $2,800,000 to fund 3-6 awards. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $300,000 in direct costs per year in the R61 phase and $500,000 in direct costs per year in the R33 phase. All F&A costs are excluded from this limit. Requested budgets should reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period for an application submitted in response to this FOA cannot exceed five years. Applicants may request up to three years of support for the R61 phase, and up to two years of support for the R33 phase.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

Local 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)

Federal Governments

  • 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)
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.

  • 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) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

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.

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).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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.

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:

  • 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:

Kumud K. Singh, Ph.D.
Telephone: 301-761-7830
Email: kumud.singh@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

with the following additional instructions:

Applications must include budgets for both the R61 and R33 phases for up to a total of 5 years.

R&R Subaward 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:

Specific Aims: Briefly describe the long-range objectives and goals of the proposed research. Concisely and realistically describe the hypothesis or hypotheses to be tested. State in clearly marked sections the overall objective(s) and specific aims for both the R61 and R33 phases of the proposed research.

Research Strategy: In preparing the R61/R33 application, investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the Transition Milestones are critical. Within the Research Strategy section, applicants should include:

  • A clear description of how the proposed research addresses one or both research objectives of this FOA and establishes feasibility for direct detection of HIV in a qualitative or semi-quantitative diagnostic self-test assay.
  • A description of how the assay design and proposed studies address the desirable general characteristics and appropriate features of an ideal HIV diagnostic as described in the research objectives of this FOA.
  • Evidence for appropriate expertise and capability for developing the proposed technologies and assay and for accessing appropriate virus and biospecimen resources.
  • A plan to obtain meaningful end-user input on assay performance and usability during early-stage assay development.
  • Separate sections that describe the R61 and R33 phases, as appropriate. It is not necessary to repeat information or details in the R33 section that were already described in the R61 section.
  • Milestones for the R61 Phase (required): In a clearly labeled section at the end of the R61 section within the Research Strategy, provide milestones including Go/No-Go statements that address critical aspects and performance metrics for the R61 phase, a discussion of the suitability of the proposed milestones for assessing progress in the R61 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 phase. Transition Milestones should be specific, quantifiable, rigorous, and scientifically justified; they should not be simply a restatement of the R61 specific aims.
  • Milestones for the R33 phase are not required but may be provided at the discretion of the applicant. If included, R33 Milestones should be clearly labeled within the Research Strategy section.

Letters of Support: When appropriate, include letters of support or collaboration to demonstrate the commitment and specific involvement of collaborators, partners, or available resources. For research involving materials that are protected by intellectual property, a letter from a patent or license holder in support of the proposed research must be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

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

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R61/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R61/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 phases.

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? Is the prior research that serves as the key support for the proposed project rigorous? 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?

Specific to this FOA:

How well does this project address the need for rapid self-testing approaches during the earliest stage of initial HIV infection and/or HIV rebound in treated individuals?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Specific to this FOA:

Is there evidence for appropriate expertise and capability for developing the proposed technologies and assay and for accessing appropriate virus and biospecimen resources?

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? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Are the specific goals and relevance to one or both research objectives clearly described? How well will the proposed approach establish feasibility for direct detection of HIV in a qualitative or semi-quantitative diagnostic self-test assay? Do the assay design and proposed studies address the desirable features for an ideal HIV diagnostic? Is there an adequate plan to obtain meaningful user input and/or usability testing during early-stage assay development? Are the Transition Milestones well-defined and adequately described, with scientifically rigorous and quantifiable criteria that will enable clear decisions about the success of the R61 phase? Is it clear how the R33 phase of the study will develop and expand once the R61 Transition Milestones are achieved?

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 National Institute of Allergy and Infectious Diseases, 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 will receive a written critique.

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.

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Diane Lawrence, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3202
Email: lawrencedi@niaid.nih.gov

Joseph Fitzgibbon, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3088
Email: jfitzgibbon@mail.nih.gov

Bill G. Kapogiannis, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 402-0698
Email: kapogiannisb@mail.nih.gov

Raul Mandler, M.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-2541
Email: mandlerr@nida.nih.gov

Gregory Greenwood, Ph.D., M.P.H.
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: gregory.greenwood@nih.gov

Peer Review Contact(s)

Kumud K. Singh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7830
Email: kumud.singh@nih.gov

Financial/Grants Management Contact(s)

Jenna Briggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5137
Email: jenna.briggs@nih.gov

Bryan Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: rita.sisco@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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