Part 1. Overview Information

Key Dates

All applications are due 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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

OBJECTIVE

The main objective of this notice of funding opportunity (NOFO) is to support large, electronically generated cohorts in Latin America of HIV-negative men who have sex with men (MSM), transgender women (TGW), and other groups at increased risk of HIV acquisition and follow them to study the epidemiology of HIV incidence. Continued follow-up of those persons who acquire HIV should be conducted to study the epidemiology of viral suppression. Comparisons of participants by seroconversion status will provide information on geographic and socially defined areas of high HIV incidence as well as on both personal and structural vulnerabilities to HIV infection. Among participants who seroconvert, comparisons of those becoming rapidly engaged in care and who reach non-detectable HIV levels to those whose virus remains detectable will inform on the treatment of HIV in Latin American countries. This NOFO will allow digital clinical, non-IND trials to determine optimal study approaches or pilot evidence-based digital (mHealth and online) HIV prevention and treatment interventions to reduce HIV transmission.

BACKGROUND

Increasing knowledge about HIV epidemics in Latin America is crucial to addressing these epidemics. Smart phones, the internet, and other technologies have changed the ways that MSM and TGW meet and interact and offer new approaches to track and gather information from these populations. Gay dating apps were successfully used in U.S.-based Limited Interaction Targeted Epidemiology (LITE) studies to enroll large cohorts of HIV-negative participants at increased risk of HIV acquisition. Epidemiology studies that use these and other remote technologies have been able to identify “hot spots” of HIV infection and identify subgroups of MSM and TGW most at risk who can be prioritized for HIV prevention programs. These same remote methods, including gay dating apps, are also feasible in Latin America and would be likely to generate important HIV research findings relevant to improving prevention and treatment programs there. Growing evidence indicates that digital interventions, delivered online or through smartphones, can advance primary HIV prevention outcomes such as reduced sexual risk behavior, decreased sexually transmitted infections (STI), and improved use of oral or long-acting pre-exposure prophylaxis (PrEP).

Digital studies use remote methods (e.g., online surveys and postal delivery) to collect participant data and samples, and they involve limited or no in-person visits. These studies offer at least five advantages relative to studies conducted through “brick-and-mortar” locations or clinical trials units (CTUs): 1) the preponderance of persons living in Latin America, including those at risk for HIV, have ready access to both the internet and postal services; (2) the remarkably large study sizes attainable through digital enrollment allow studies to be powered on an HIV incidence outcome, as well as on outcomes related to HIV incidence, such as PrEP use, self-reported behavior change, and STI incidence; 3) electronic cohorts facilitate engagement of participants in rural, underserved areas and can overcome geographic limitations to assemble large subgroups of MSM, such as adolescents, or groups such as transgender persons, female sex workers, or people who inject drugs (PWID) who are dispersed sparsely throughout South and Central America; 4) the ability to rapidly enroll participants using smartphone apps and other electronic methods facilitates digital clinical trials that can be conducted more rapidly than clinic- or community-based clinical trials, and, thus, results can be more quickly available to inform resource allocation; and 5) digital interventions are inherently scalable and can be implemented inexpensively if found useful.

Information from proposed studies on risk factors for HIV among Latin Americans may also be relevant to HIV prevention and treatment among persons of Latin American origin living in the U.S., a major risk group for HIV. This initiative will require involvement of an investigator currently residing in each country where research is conducted. Investigators from the United States may be included, but this is not required.

IMPORTANCE: According to the most recent UNAIDS Global AIDS Update, Latin America has made little progress in reducing new HIV infections in the region since 2000, with the total number increasing by 8% from 2010 to 2022, representing a 14% decline in HIV incidence among women and a 17% increase among men. According to the most recent data, about 110,000 Latin Americans acquire HIV annually, which is almost twice the 2022 total of 58,000 for Europe and North America combined. In comparison, over the 2010 to 2022 timeframe, yearly global HIV infections declined 38% from 2.1 million to 1.3 million infections. As of 2022, approximately 2.2 million people in Latin America (1.5 million–2.8 million) were living with HIV, of whom approximately 82% knew their HIV status, 69% were accessing treatment and 63% were virally suppressed. Thus, about a third of people living with HIV (PLWH) in Latin America are not suppressed, many of whom are capable of transmitting HIV to others. UNAIDS data show that HIV epidemics in Latin America are primarily due to unprotected sex among MSM and TGW. Among 15 to 49-year-olds, males account for 76% of annual cases, with females accounting for the other 24%. The major behavioral risk groups for yearly infections are MSM (48%), TGW (6%), sex workers (6%) and partners of these major risk groups (29%). However, although the epidemics are concentrated in these risk groups, there exist subgroups within these broader risk groups, for whom HIV risks are especially high. Gay dating apps were successfully used in U.S.-based LITE studies to screen and enroll the highest risk participants within these subgroups, and after follow-up these subgroups were found to have exceptionally high HIV seroconversion rates. These same methods can be used in Latin America to describe the subgroups within these broader risk groups who should be prioritized for PrEP and other prevention programs. With about a third of PLWH in Latin America not being viral suppressed, it is also important to describe the PLWH who are least likely to be retained in care and virally suppressed, a group which should be prioritized for programs improving HIV therapy to reduce HIV transmission.

Research Objectives and Scope

The primary goal of this NOFO is to generate information needed to develop public health interventions to reduce HIV transmission in Latin America. Study teams must develop technology-focused approaches and demonstrate the capacity to enroll large numbers of people without HIV in high-incidence groups including: MSM, female sex workers, PWID, or transgender persons who have sex with men. Enrollment success will be measured by the ability of the study to enroll and retain enough people without HIV (N ? 5,000) who are at a high enough risk of HIV to allow meaningful and statistically significant prevention research with an HIV incidence outcome to be pursued as well as studies of HIV therapy among participants who acquire HIV. Cohorts will also need to be large enough to allow for sufficiently detailed research that brings new understanding of the likelihood of transmission in the setting of complex interactions between individual and contextual factors. Applications must demonstrate sufficient statistical power to advance knowledge of HIV transmission and to identify points of intervention to advance HIV prevention and treatment. Applicants will be expected to establish and meet enrollment milestones for their studies, including overall enrollment goals, any benchmarks for stratified over-enrollment of youth, racial/ethnic minorities, PWID, and rural residents, and numbers of acute HIV diagnoses at baseline or during follow-up as an indication of expected HIV incidence. Investigators are encouraged to recruit participants across categories of socio-economic status (SES) and ethnicity/race.

This funding opportunity uses a two-phase grant mechanism (UG3/UH3) that allows for up to two years of funding for the UG3 phase and up to three years of funding for the UH3 phase, The UG3 plan must specify Go/No-Go criteria with the number of participants to be enrolled, the anticipated retention level, and the number of HIV seroconversions expected in the initial period. These criteria will be subject to negotiation. Evaluation of criteria for enrollment and seroconversion will determine eligibility for transition to UH3 awards. If criteria are met, recipients may receive up to an additional three years of support to conduct epidemiological research. Non-IND behavioral interventions and trials may be included during the UH3 phase but are not required.

A secondary goal of this NOFO is to facilitate interactions among grant recipients to share approaches, data, and methods, and to develop harmonization standards. Investigators applying to this NOFO need to plan for and attend conference calls and annual meetings focused on cohort enrollment, testing, follow-up, data analysis, and, if appropriate, intervention development. Investigators will be expected to participate in an annual meeting with other funded investigators and with NIH staff.

Studies of particular interest include:

• Identification of micro-epidemics in high HIV transmission areas (hot spots) and of key sub-populations where HIV prevention and treatment efforts in Latin America are most needed.
• Characterization of subgroups of PWID, female sex workers, transgender persons, and MSM who could be prioritized for HIV prevention and improved treatment strategies.
• Descriptions of risk behaviors and risk determinants in these key populations that can inform onward interventions to reduce HIV incidence.
• Studies using the assembled cohorts to investigate patterns of HIV testing and mechanisms to optimize testing frequency and rapid linkage to treatment.
• Monitoring HIV PrEP or U=U awareness, uptake, and adherence and identifying associated determinants.
• Mental health as a determinant of HIV exposure risk and engagement in prevention and treatment if living with HIV.
• Multi-level analyses of individual and social-contextual determinants of HIV risk behavior, seroconversion, or reaching viral suppression if living with HIV.
• Development and testing of scalable, digitally delivered primary HIV prevention interventions that promote HIV risk reduction and may include support for PrEP use or viral suppression of HIV-positive sex partners among high-risk groups through digital clinical trials.

Applications including the following types of studies will be considered non-responsive and will not be reviewed:

• Studies limited to studying PLWH.
• Studies of subjects residing outside South or Central America.
• Studies not including a co-investigator from each country in Latin America providing participants.
• Studies not proposing the use of technology-focused approaches to establish and follow cohorts of HIV-negatives for epidemiologic research.
• Studies not focused on at least one of the high-incidence groups prioritized by this RFA: MSM, female sex workers, transgender persons, or PWID.
• Studies not including an analysis that demonstrates that the expected statistical power of their planned investigations will be adequate.
• Studies planning to enroll fewer than 5,000 individuals without HIV during the UG3 phase.
• Studies proposing a clinical trial that requires an Investigational New Drug Application (IND).
• Studies lacking clearly described timelines for the UG3 and UH3 phases and studies lacking clearly defined and quantifiable Go/No-Go transition milestones.

UG3/UH3 Phased Innovation Awards

Applications must be structured around two phases. The UG3 phase will focus on a maximum two-year award to demonstrate enrollment of sufficient numbers of participants from high-incidence populations. The UH3 phase will focus on an additional up to three years to conduct research to advance our knowledge of when, where, why, and how HIV transmissions currently occur in Latin America as well as to provide information on retention in care and viral suppression of participants who acquire HIV. Transition to the UH3 award will be determined by a scientific evaluation by NIH staff of Go/No-Go transition milestones accomplishment, preparedness of the cohort to implement the proposed epidemiology and optional intervention studies, as well as programmatic priorities, and available funds.

Applications must include Go/No-Go transition milestones to be assessed at the end of the UG3. Funding of the UG3 phase does not guarantee support of the UH3 phase award for research implementation, and it is anticipated that not all funded UG3 projects will transition to the UH3 phase. Transition to the UH3 phase will be determined by a programmatic evaluation at NIH that is based on accomplishment of Go/No-Go transition milestones, for example, demonstration that investigators enrolled significant numbers either of participants who recently acquired HIV before enrollment or originally HIV-negative participants who acquire HIV while under study. Continued programmatic priorities and availability of funds also will impact the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted. Recipients will be required to follow all participants testing HIV-positive to appropriate treatment centers and follow them to viral suppression outcomes.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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 Organizations)

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 How to Apply - Application Guide.

 Applications must include a co-investigator from each country where the research is being conducted. 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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:

Robert Unfer, Ph.D.
Telephone: 301-641-1981
Email: robert.unfer@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: Provide the overall goals or hypotheses for the entire project and indicate separate Specific Aims to be accomplished in both the UG3 phase and the UH3 phase. Clearly state the importance of the research question in terms of advancing HIV prevention and treatment of people with and without HIV, particularly among those most likely to acquire HIV and transmit it. Explain the need for and timeliness of the planned studies, including a digital intervention trial, if that is planned.

Research Strategy: Without duplicating information in the biosketches, please describe any previous experience in performing the following activities: enrollment of high-risk populations, including documenting their socio-economic status (SES) or ethnicity status, age, rural or urban status, and sexual risk status, as well as measuring retention rates, and annual HIV seroconversion rates.

Provide detailed descriptions of any supporting data and your experimental approach for the following:

• Significance of identifying subgroups in Latin America of people with or without HIV who are most at risk of transmitting or acquiring HIV for whom public health interventions to reduce HIV transmission would be beneficial.
• Enrollment and follow-up of high-risk populations with minimal or no face-to-face interaction and use of primarily digital enrollment and follow-up procedures, including qualitatively evaluating and improving the recruitment and retention process.
• Strategies in digital settings to verify the ethnicity/race, SES, sex, and age of participants and to measure stigmatized topics such as substance use and same sex activity.
• Plans to determine the HIV status of the cohort, both at enrollment and during follow-up. Include a description of the methods to determine the HIV status of participants in a non-clinic setting, for example, use of screening programs, home-based tests, HIV self-tests, electronic medical records, and self-report. Applicants are encouraged to explore the pros and cons of different approaches with respect to feasibility, cost, and veracity among other parameters.
• Strategies to ensure that the cohort includes discrete, non-duplicated subjects living in Latin America (i.e., no duplicate enrollments).
• Unique statistical analysis challenges posed by an HIV incidence endpoint and approaches to manage other expected study outcomes, including a description and statistical evaluation of the sample size needed to test the study hypothesis and study the individual and contextual factors associated with HIV seroconversion among people without HIV and viral suppression among PLWH.
• Plans to determine the viral suppression status of participants who test HIV-positive during the study.
• Prediction of expected numbers of HIV seroconversions among study participants during follow-up.
• In the context of digital enrollment and intervention, discuss the unique needs for assessment of HIV risks for participants, including measuring HIV risks, health seeking behaviors, and PrEP uptake and use as well as other characteristics potentially associated with HIV seroconversion or its surrogate measures.
• A strategy to assess contextual factors potentially associated with HIV seroconversion and viral suppression.
• A strategy to develop models to explain patterns in social networks, behavior risk, and health-seeking behaviors, in space and time or to develop models to anticipate responses to HIV prevention or treatment messages for different subgroups of those at risk.
• For the UH3 (years 3-5), include a description of research to understand individual and contextual predictors of HIV seroconversion and viral suppression and to identify actionable approaches to expand epidemiologic knowledge and optimize HIV prevention and treatment.
• A description of the hypotheses to be tested in the UH3 phase of the study.
• A description of the analytic plan for the UH3 phase of the research, including statistical and other methods to be employed.
• A description of the feasibility of the research approaches to result in scalable and efficient study designs that are sufficiently robust to address generalizability of the study results to populations not enrolled.

Timelines

Applicants are required to propose well-defined timelines for the entire project, i.e., both the UG3 and the UH3 phases. Applications must describe timelines that could include, but are not limited to, meeting specified enrollment targets and retention rates of members of specified cohorts, with specified numbers of participants acutely acquiring HIV at baseline, annual HIV-seroconversion rates, and the detection of a specified number of HIV seroconverters within the two-year period of the UG3 phase.

Go/No-Go Transition Milestone for transition from the UG3 Phase to the UH3 Phase

Include clearly identified Go/No-Go transition milestones for completion of the UG3 phase at the end of Year 2 and transition to the UH3 phase for 3 years of additional funding. The Go/No-Go transition milestones chosen by the applicant must be quantifiable, feasible, and appropriate to achieve UH3 research goals. Include in the milestones critical parameters that demonstrate the recruitment of an appropriate cohort that meets the proposed seroconversion rate. A restatement of an application’s specific aims will not be considered adequate Go/No-Go transition milestones. Applicants may use Gantt charts or other graphics to support the timelines and the Go/No-Go transition milestones.

The following is an example of possible Go/No-Go transition milestones. Applications must propose specific Go/No-Go transition milestones in the context of their proposed research and are not limited to this example:

The proposed study will enroll by the end of Year 2 a total of (fill in number) MSM, transgender persons, female sex workers, and/or PWID. The study retention rate will be (fill in percentage) or higher, and the annual HIV-seroconversion rate of the assembled cohort will be (fill in percentage) or higher. Thus, we expect to detect a minimum of (fill in number) of persons either having recently acquired HIV at baseline or persons who are initially HIV-negative but who seroconvert by the end of Year 2.

Note: Applicants are required to enroll at least 5,000 people without HIV by the end of Year 2. Applications lacking clearly described timelines for the UG3 and the UH3 phases, as well as the Go/No-Go transition milestones will be considered non-responsive and will not be reviewed.

Applicants are encouraged to review specific NIH policies regarding “Research Involving Human Subjects”. Information about enrolling adolescents in clinical research is available at the following web site: https://www.niaid.nih.gov/research/daids-clinical-research-protocol-informed-consent.

Describe any data sources that will be required for the project (such as electronic medical records (EMR), census or HIV surveillance data, clinical trial data, etc.) and include any differences in requirements between the UG3 and UH3 phases.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of laboratories, other collaborators, and access to any data sources required. If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g., type, amount, and source of support), signed by a business official on organization letterhead, must be included in the Letters of Support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• With respect to sharing data with other investigators, the DMSP must describe plans and approaches for securing and anonymizing highly sensitive data, preventing data breaches, reidentification, loss of privacy and confidentiality. Address ethical considerations for protecting participant anonymity, prevent loss of privacy and confidentiality of personally identifiable information.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply - 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 How to Apply - Application Guide must be followed with the following additional instructions:

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Describe unique challenges and approaches to a digital non-clinic-based recruitment plan. Describe engagement and retention strategies in the context of digital strategies.

2.7 Study Timeline

All applicants proposing trials or interventions must provide a Study Timeline for the entire duration of the award, including specific milestones for the following activities:

• Submission of the Clinical Protocol and Subject Informed Consent Form for NIAID review.
• Completion of regulatory approvals for the Clinical Protocol as applicable.
• Enrollment of first participant
• Last participant off study (must be within the period of the UH3 award).
• Within this section, discuss the feasibility of achieving and completing the milestones on-time, including alternate approaches and contingencies for dealing with potential problems and impediments.

2.9 Inclusion Enrollment Report(s)

Applicants should create one Inclusion Enrollment Report (IER) or more than one IER to enable reporting depending on the scientific goals for the study and whether monitoring of inclusion enrollment would benefit from being combined or separated. NIAID recognizes that traditional definitions of a geographical site may not be relevant in this setting.

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

3.1.2. Adequacy of Protection Against Risks

3.1.2.b. Protections Against Risk

• Describe plans to protect the security of participants’ personally identifiable information with respect to the virtual, electronic recruitment and maintenance of study cohorts. A discussion of any impediments that could require an addendum to the research plan or timeline with a discussion of alternative approaches.
• Describe approaches for referring people who acquire HIV for treatment as defined by their IRB.

3.3 Data and Safety Monitoring Plan

For this NOFO, it is anticipated that a Safety Monitoring Committee should provide the appropriate level of monitoring for studies proposing optional behavioral trials. Additional guidance can be found at:

https://www.niaid.nih.gov/research/daids-clinical-research-event-reporting-safety-monitoring and https://www.niaid.nih.gov/sites/default/files/StudyProgressSafetyMonitoringPolicy.pdf.

3.5 Overall Structure of the Study Team

If clinical trials are proposed, describe the management of the study team with respect to the various roles and responsibilities that are unique to implementation and conduct of digital clinical trials. In addition, describe the role of any non-traditional study team members (e.g., social media consultants, privacy in digital platforms, Scientific Advisory Board, etc.) in the study team functions.

Section 4 - Protocol Synopsis

4.2 Outcome Measures

If a clinical trial is proposed, in addition to standard instructions, include innovative use of digital and remote assessment of trial measures and outcomes.

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments

For each required attachment, applicants proposing clinical trials must include the available information and describe the plan including the timeline for developing final versions in time to implement the clinical trial within the first 12 months.

1. Laboratory Measurement Assays

The filename “Laboratory Assays Plan.pdf” should be used and will be reflected in the final image with bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

Describe the assays proposed to measure HIV status and HIV viral load. Provide data or references supporting the reliability of the assays and the validity for their use. Describe plans to adhere to NIAID’s policies when proposing endpoint assays that are for investigational use only, and not approved by the FDA nor validated by the International Council for Harmonization (ICH) or U.S. Pharmacopeia. If assay results will be used to determine participant eligibility for trials or treatment decisions during trials, address plans to ensure the relevant assays are CLIA compliant and performed in CLIA-certified laboratories. Address compliance with Good Clinical Laboratory Practices (GCLP) and for performing proficiency assessments. For guidance, see: https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures.

Describe plans for managing the quality of the assays by leveraging resources, collaborations, and/or sources of external support.

2. Clinical Site Monitoring

The filename “Clinical Site Monitoring Plan.pdf” should be used and will be reflected in the final image bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

Describe plans to conduct independent clinical site monitoring as appropriate. Refer to https://www.niaid.nih.gov/research/daids-clinical-site-implementation-operations and https://www.niaid.nih.gov/sites/default/files/crs-site-visits.pdf.

3. Good Clinical Practices, Good Laboratory Practices, and Good Manufacturing Practices

The file name “GCP, GLP, GMP Plan.pdf” should be used and will be reflected in the final image bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

Describe plans to implement and monitor Good Clinical Practices (GCP) (see NOT-OD-16-148), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), as appropriate.

4. Regulatory Plan

The filename "Regulatory Plan.pdf" should be used and will be reflected in the final image with bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

Describe plans and capability to provide appropriate regulatory support for the development and implementation of the clinical trial.

Describe plans to comply with current FDA guidance, regulations for Electronic Signatures described in 21 CFR Part 11, and predicate rules set forth in the PHS Act. Applicants are encouraged to also consider the FDA requirements for providing regulatory submissions in electronic format.

5. Clinical Data Collection and Validation Plan

The filename “Clinical Data Collection and Validation Plan.pdf” should be used and will be reflected in the final image with bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

Include a description of the approach to clinical data collection and validation, including data collection systems, methods of data entry and cleaning, event tracking and logistics, case report forms, and methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; data confidentiality and subject privacy; adjudication of events (as needed); and data reports. Indicate plans for storage of data in a suitable data repository for internal use.

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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 the National Institute of Allergy and Infectious Diseases, 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

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 UG3/UH3 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. A UG3/UH3 grant application is not required to have extensive preliminary data, background material or preliminary information, but these may be included if available. Appropriate justification for the proposed work can also be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will focus their evaluation on 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 the UG3 and UH3 phases.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

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

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.

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.

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 policies and practices, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Ensuring that all participants receive standard-of-care HIV prevention and treatment modalities as defined by the relevant IRB.
• The planning, direction, and execution of the proposed research, including the following: definition of objectives and approaches, implementation, data management and analysis, interpretations, and publication of results.
• Participating in the planning for meetings of award recipients, to focus on cohort enrollment, study initiation and study results.
• Referring all participants testing HIV-positive to treatment. Information about referral efforts and the treatment status of all participants who seroconvert on study is also required in annual progress reports.
• Making drafts of manuscripts available for review (electronically) to the NIH Project Scientists and other NIH staff at the time they are circulated to co-authors and when the final manuscripts are submitted for publication. This ensures the program can maintain an up-to-date summary of program accomplishments and can prepare for press-releases of findings if warranted.
• Two months prior to the end of the UG3, recipients will submit the transition package, which includes the UG3 progress report, progress toward UG3 milestones including successful enrollment of the appropriate cohort (PWID, female sex workers, transgender persons or MSM), and detecting a sufficient number of HIV seroconversion events and a description of readiness to implement the UH3 research.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

During performance of the award, the NIH Project Scientists, with assistance from other NIH scientific staff will provide appropriate assistance, advice, and guidance in the design of the activities; the analysis of data; management and technical performance; and preparation of publications. The Project Scientists will serve as liaison between the recipient, the pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, USDA, and CDC) and will serve as a resource for scientific and policy information related to the goals of the recipient's research. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and that NIH staff will be given the opportunity to offer input into this process.

The NIH Project Scientists will also:

• Monitor study results and quality assurance across all research sites to ensure the production of high-quality, unbiased results.
• Coordinate a committee of LITE-Latin America (LITE-LA) award recipients and NIH staff to facilitate shared goals, enhance resource sharing and foster collaborations.
• Facilitate access to technical resources to increase harmonization and interoperability of study datasets.
• Periodically request research data for use in preparing internal reports on LITE-LA activities.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Participate in a committee of NIAID program staff and LITE-LA award recipients to facilitate shared goals, enhance resource sharing, and foster collaborations.
• Develop a data structure that results in a findable, accessible, interoperable, and reliable dataset to be made available for controlled access public use at the end of the program.
• Coordinate and facilitate access to LITE-LA datasets for all approved internal and external research collaborators.
• Provide input and generate research presentations and publications of LITE-LA data.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

With respect to sharing data with other investigators, the DMSP must describe plans and approaches for securing and anonymizing highly sensitive data, preventing data breaches, reidentification, loss of privacy and confidentiality. Address ethical considerations for protecting participant anonymity, prevent loss of privacy and confidentiality of personally identifiable information.

4. Reporting

When multiple years are involved, recipients 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition 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.

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: https://www.era.nih.gov/need-help (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: 301-480-7075

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

Gerald B. Sharp, Dr.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3217
Email: GSharp@niaid.nih.gov 

Robert Unfer, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-641-1981
Email: robert.unfer@nih.gov 

Mark Hodor
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5712
Email: Mark.hodor@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.

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 2 CFR Part 200.