Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H) (UG3/UH3)

Activity Code

UG3/UH3 Exploratory/Developmental  Phased Award Cooperative Agreement

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HD-18-032

Companion Funding Opportunity

None

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

93.865, 93.307, 93.273 

Funding Opportunity Purpose

The purpose of this FOA is to stimulate much needed research in an important area of public health significance: prevention of new HIV infections among adolescents at risk, and the identification of, linkage to and retention in care of, and long term viral suppression among youth living with HIV in low-to-middle income countries.  These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV prevalence of 3% or more.

The UG3/UH3 Phased Innovation Awards Cooperative Agreement involves 2 phases. Funding for a UG3 phase will be used to demonstrate sufficient preparation, feasibility and capacity to meet foundational milestone targets specific to the work proposed. A UG3 project that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award. Applicants responding to this FOA must address objectives for both the UG3 and UH3 phases.

Key Dates
Posted Date

October 18, 2017

Open Date (Earliest Submission Date)

November 22, 2017

Letter of Intent Due Date(s)

November 22, 2017

Application Due Date(s)

December 22, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

December 22, 2017, 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 this date.

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

March 2018

Advisory Council Review

May 2018

Earliest Start Date

July 2018)

Expiration Date

December 23, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The purpose of this initiative is to develop a robust research agenda to address an important area of public health significance: adolescents substantially impacted by HIV in low and middle income countries. This initiative will build on the current state of integrated biomedical and behavioral/social science strategies to support innovative research activities, including clinical trials and other studies, that involve oral pre-exposure prophylaxis (PrEP), microbicides, vaccines, behavioral and social sciences, and therapeutics and will address two overarching priorities:1) reduction of the incidence of HIV/AIDS infections and 2) reduction of health disparities among HIV-infected and at-risk adolescents and young adults. These settings must be in low or middle income countries (LMICs) and must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV prevalence of 3% or more. Applications focused on the HIV prevention and/or HIV care continuum (PHCC) will be invited which will address prevention innovations for HIV uninfected at-risk youth, and also treatment and care interventions for those who are HIV-infected. This initiative will leverage scientific advances and existing infrastructure to increase the scientific capacity for research among adolescents and HIV in LMICs, improve the knowledge base in this area and inform national and global guidelines on the clinical management of at-risk, uninfected and HIV-infected young people in these regions. It is expected that the critical collaborative relationships with policy makers and key stakeholders needed for these applications will also lay the foundation for large scale implementation and sustainability after the grant cycle is over.

Applications should be structured around two phases. The UG3 (Phase 1) will be a two-year award to demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for larger scale subsequent studies planned as part of a response to this FOA. Transition to the UH3 award (Phase 2) will be determined by an administrative scientific evaluation of pre-specified Go/No-Go Transition Milestone accomplishment, preparedness of awardee to implement the proposed interventional, larger scale studies, programmatic priorities, and available funds. The UH3 phase of the project will provide support for an additional three years to conduct more advanced, large scale research which will advance our knowledge of and inform global policy and guidelines about interventions to reduce new HIV infections among at-risk adolescents and improve the achievement of all milestones along the HIV care continuum for adolescents living with HIV.

Background

Adolescents and young adults 10-24 years of age represent over 25% of the world population. Throughout international settings where resources are scarce, adolescents' lives are substantially impacted by HIV infection, whether they live amid generalized or concentrated epidemics, or both. The contextual risks such youth are experiencing not only threaten their ability to remain HIV-uninfected, but also their ability to stay healthy and thrive if they are already living with HIV. HIV is a major cause of death in adolescents in resource constrained settings, and the numbers continue to increase each year.

Over the past few years, the HIV/AIDS research arena has experienced numerous triumphs, including several groundbreaking milestones in biomedical prevention of HIV infection as well as the adaptation and implementation of a systematic approach to address and improve health outcomes among those living with HIV infection using the HIV care continuum as a model. Noteworthy among these successful interventions is their dependence on excellent adherence and engagement in care, areas which are particularly challenging for adolescents. Despite the advances made, many of which were undertaken in internationally-based resource constrained settings, adolescent representation in these research activities has been scant to non-existent. This has resulted in tremendous gaps for youth populations affected by HIV in these settings in biomedical prevention interventions and among critical milestones within the youth-specific HIV care continuum which are critical to ensure improved health outcomes.

The context of HIV care varies incredibly due to resources, healthcare provision and policies and geographical settings. Striving for healthy outcomes during adolescence must encompass consideration of the complex developmental, psychosocial and cultural issues facing children and adolescents at risk of HIV and with HIV as they transition to adulthood. There is an urgent need for developing and testing interventions that can achieve long-term viral suppression among youth living with HIV and reduce onward transmission to and acquisition of HIV in at-risk youth, and for evaluating scalable and sustainable efficacious interventions that can be successfully implemented by programs serving these vulnerable populations.

Research Objectives and Scope

The primary goal of this initiative is to generate the needed scientific innovation that will yield effective public health interventions for 10-24 year-old adolescents and young adults (with emphasis on age 20 or younger) affected by HIV in LMICs. Applications are encouraged to take a developmental approach acknowledging the many changes/transitions that adolescents and young adults are experiencing. Specifically, the goals are to characterize and improve upon the critical milestones of the HIV prevention continuum to reduce HIV infections among uninfected youth at high risk for HIV infection and to improve the proportion of youth living with HIV who successfully achieve each milestone on the HIV care continuum. To accomplish this, investigators will need to employ a variety of innovative combination interventions aimed at the individual, family, clinic, community, structural and education and health systems levels. Recruitment and retention strategies should enroll sufficient numbers of adolescents to undergo HIV education and testing and proceed through each successive, and in some cases, bidirectional step, of the PHCC. Such strategies must reflect an understanding of how, why, where, when and the patterns with which youth demonstrate health-seeking behaviors, if at all, and a knowledge grounded in local epidemiology of which youth may be at higher risk of HIV infection due to specific practices or behaviors (e.g., adolescent girls and young women in settings with generalized epidemics; YMSM in settings with concentrated epidemics affecting that population).

Projects must include collaborations with local agencies and regulatory bodies, including policy and program leaders, to advance achievement of the research objectives and maximize implementation and sustainability of efficacious interventions and best practices after the grant cycle has ended. The necessary agreements should be forged to indicate how information and resources have been or will be committed, invested, distributed and/or shared (e.g. local health ministry financial and human resources, data sharing, other efforts to link newly identified infected youth to clinical care; efforts to track HIV-negative youth for re-testing and linkage to prevention services). These collaborations must have been established and agreements executed for inclusion as Transition Milestones. Projects should align with national HIV/AIDS plans and the efforts of bilateral (e.g., PEPFAR) and multi-lateral (e.g., Global Fund, UNAIDS) planning and program efforts that are related to these plans. Projects should seek innovation while minimizing duplication with efforts being supported by international donors. Project success will be determined by the level, breadth and quality of the collaborations forged, and enrollment success will be measured by the ability of the study to accrue and retain sufficient numbers of at-risk, uninfected youth and youth living with HIV, or sufficient settings or systems associated with services to youth, so that meaningful prevention and care research can be pursued with the greatest prospect of implementation and sustainability.

A secondary objective of this FOA is to facilitate interactions among awardees to share approaches, data, and methods, and to develop harmonization standards. Awardees must plan to attend meetings focused on cohort enrollment, study initiation and study results approximately at the start of year one, and at the end of years two, three, and four, respectively.

Each application must include at least two priority areas below that address gaps along the HIV PHCC to be responsive:

  • Early phase "bridging" studies (e.g. for licensure) and demonstration projects to improve our understanding of the feasibility, uptake, adherence and safety of promising biomedical HIV prevention interventions and the impact of these on sexual behaviors of at-risk youth and to facilitate expeditious regulatory approval in this age group.
  • Evaluation and/or implementation of wrap-around services and youth-friendly strategies for dissemination and implementation of evidence-based practices (inexpensive and youth-accessible services, culturally competent programs, innovative technology, mass media, etc) to improve uptake of HIV biomedical interventions for infected and/or at-risk youth.
  • Foundational evaluation of and preparation for ethical, legal and regulatory issues in HIV research with adolescent minors and young adults.
  • Individual behavioral and/or community level combination interventions to reduce HIV incidence among at risk youth and/or improve disease course among youth living with HIV.
  • Individual, clinic and/or community/system level combination interventions to improve outcomes on the HIV care continuum for youth living with HIV, including rates of 1) HIV testing, 2) linkage to care, 3) retention in care, 4) initiation of ART, 5) adherence to ART, and 6) achievement of long-term viral suppression.
  • Individual, clinic and/or community/system level combination interventions for at-risk, HIV-negative youth to improve linkages to HIV prevention services and uptake of efficacious interventions.
  • Health system level interventions to develop or strengthen linkages for health information sharing and utilization as youth transition from pediatric to adolescent to adult health care providers and clinic settings, and through other co-occurring transitions such as migration for school, work and/or military service.
  • Projects that target "key populations" among youth such as YMSM, TGY, youth engaging in transactional sex, and substance users.

Studies of particular interest to NIAAA include:

Individual behavioral and/or community level combination interventions which screen for alcohol problems, and address the pattern and severity of use and early initiation of alcohol, to reduce HIV incidence among at risk youth and/or improve disease course among youth living with HIV

Non-responsive areas:

  • Any application that does not include demonstration of likely successful collaboration with established infrastructures such as in-country programs, policy and/or regulatory agencies addressing the HIV epidemic in youth.
  • Among studies of the HIV prevention continuum, those with any aims not directly and entirely addressing HIV acquisition risk.
  • Among studies of the HIV care continuum, any that focus on less than three milestones among the following: HIV testing; linkage to care; retention in care; initiation of ART; adherence to ART; achievement of long-term viral suppression.
  • Studies focused primarily in geographic areas representing high-income or more developed countries (based on World Bank definition).
  • Studies that do not propose the engagement of community and youth input prior to development and implementation.
  • Studies proposing to directly test interventions already found to be efficacious in adults without proposing to evaluate developmentally and contextually appropriate adaptations of these interventions.

UG3/UH3 Phased Innovation Awards

This UG3/UH3 Phased Innovation Award has two phases. The UG3 (Phase 1) will be a two-year award for milestone-driven studies to demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for larger scale subsequent studies planned as part of a response to this FOA. Applications must include Go/No-Go Transition Milestones to be assessed at the end of the UG3. These Transition Milestones will be specific to the project being proposed, discrete and measurable, and must be clearly defined for a possible transition to the UH3 award (Phase 2) for research activities implementing the successful larger-scale interventions, projects and/or cohorts established. The UH3 phase of the project will provide support for an additional three years to conduct more advanced, large scale research which will advance our knowledge of and inform global policy and guidelines about interventions to reduce new HIV infections among at-risk adolescents and improve the achievement of all milestones along the HIV care continuum for adolescents living with HIV.

Funding of the UG3 (Phase 1) does not guarantee support of the UH3 (Phase 2) 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 1) appropriate sustainability plans with successful engagement of local collaborating agencies and partners and 2) Go/No-Go Transition Milestone accomplishment specific to the project being proposed [e.g., demonstration that investigators have enrolled and retained significant numbers of HIV negative youth who have been linked and engaged in a feasibility and safety study of oral PrEP; establishment of relevant collaborations with local agencies (health ministries, schools, work programs, etc) and regulatory bodies to advance achievement of the research objectives as demonstrated by the execution of necessary agreements with these agencies for committed financial and/or human resources, data sharing and other efforts to link newly identified HIV-infected youth to clinical care and/or efforts to track HIV-negative youth for re-testing and linkage to prevention services]. Continued programmatic priorities and availability of funds also impact the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD and partner components intend to commit an estimated total of $9,000,000 to fund approximately 8-9 awards for fiscal year 2018. Future year amounts will depend on annual appropriations

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The project period may be up to 5 years: up to 2 years for the first phase (UG3) and up to 3 years for the second phase (UH3).

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

Buttons to access the online ASSIST system or to download application forms 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 Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Bill G. Kapogiannis, MD
Telephone: 301-402-0698
Fax: 301-496-8678
Email: kapogiannisb@mail.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 Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Awardees must budget to attend meetings focused on cohort enrollment, study initiation and study results approximately at the start of years one, three and four, respectively.

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: Provide the overall goals or hypotheses for the entire project and indicate separate Specific Aims to be accomplished in the UG3 phase and in the UH3 phase.

Research Strategy: In preparing the 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 Go/No-Go transition milestone are critical. The Research Strategy should include:

  • Separate sections that describe both the UG3 and the UH3 phases. Do not repeat information or details that are described in the UG3 section.
  • A discussion of the significance of the proposed research to define HIV-negative adolescents at highest risk of HIV seroconversion, including any special populations whose behaviors may pose a particularly high risk, and the critical steps along the HIV prevention continuum that will advance effective interventions to reduce HIV infections in these youths. Additionally, among adolescents living with HIV, a discussion of the importance of youth-specific research interventions that will inform best practices to improve health outcomes along the HIV care continuum.
  • A description and justification for the target study population(s) for the research question(s) posed and any interventions being tested. Include a discussion of generalizability of the study results, as well as a discussion of efforts that will be made to recruit adequate numbers of high-risk groups, such as adolescent girls and young women and/or special populations of at-risk youth who are often marginalized [e.g. young men who have sex with men (YMSM), transgender youth (TGY) and youth who engage in transactional sex (YCSW) or use substances].
  • A description of the age range to be recruited and enrolled, with a rationale provided that addresses the ethical, legal and regulatory considerations needed to enroll persons under the local age of majority. This includes attention to local laws and policies regulating the participation of minors in research and the provision of clinical services to such youth, with appropriate consideration of issues such as cognitive capacity, truly informed consent, and autonomy, and the appropriate roles of parents and/or guardians. Age ranges should reflect local epidemiology; the existence of legal or policy protections for younger youth should not deter sampling of epidemiologically justified populations.
  • Plans for how interventions and assessments will be grounded in an understanding of an adolescent's developmental trajectory and stages, and how they will address an adolescent's evolving cognitive and decisional capacity, judgement, emotional development, social competence, risk and health seeking behaviors, and contextual factors such as sex role, community norms and familial expectations. The plans should also detail how these impact health outcomes along the youth-specific PHCC.
  • For any work proposing enrollment of a cohort, a description of and compelling justification for the enrollment and follow-up approaches and access to appropriate populations, including a discussion of their cost effectiveness, scalability, and how this approach will minimize barriers associated with bias and loss to follow-up. Include a description of the operational definition of retention in the study and methods to qualitatively evaluate and improve the recruitment and retention process during the UG3 phase to optimize the cohort composition. Also include a description of how such a cohort may be leveraged to rapidly implement key interventions and/or research that cannot be done independently.
  • For work proposing to develop, test, evaluate and/or refine strategies of dissemination and implementation of evidence-based practices to improve outcomes along the youth-specific PHCC, a clear description of the conceptual models appropriate for dissemination and implementation (D & I) research that will be used and how potential mediators and moderators that may explain the impact of D & I strategies on improving these outcomes will be identified and measured. Include a description of how strategies will be adapted for youth developmental trajectory and local context, and a description of how program costs and other economic outcomes will be incorporated in to evaluations that will help address scalability and sustainability.
  • A description and statistical evaluation of the sample size needed to test the study hypothesis and study the individual and contextual factors associated with health outcomes or milestones across the entire spectrum of the PHCC.
  • Plans to verify the sex and age of participants, including the strategy to be used to ensure that participants are discrete, not duplicated, individuals living in the geographic area of interest.
  • Plans to determine the status across the PHCC of an individual study participant, and if appropriate, of the cohort, both at enrollment and during follow-up (e.g. HIV education, testing, re-testing, access/linkage and adherence to pre-exposure prophylaxis (PrEP) and/or other prevention services, linkage to care among youth with positive HIV test, care engagement, drop-out and re-engagement, adherence to ART, viral suppression, etc). Include a description of the methods to be used and appropriate validation plans, as needed. Applicants are encouraged to explore the pros and cons of different innovative approaches with respect to feasibility, cost, and accuracy among other parameters.
  • Explicit plans for management of study participants at any stage across the PHCC (e.g. referrals for adolescents who seroconvert during the project for HIV treatment, including the care provider or providers to which they will be referred and a description of how they will be followed to obtain information on their subsequent treatment for HIV and tracking of their PHCC outcomes; referrals for high-risk exposures among HIV-uninfected youth to HIV prevention services like post-exposure ART prophylaxis (PEP) and/or PrEP and descriptions of how their PHCC outcomes will be tracked). These plans should include necessary and relevant collaborations and agreements with local agencies and regulatory bodies to facilitate the successful achievement of the research objectives.
  • Plans to protect the security of participants’ personally identifiable information. A discussion of any impediments that could require an addendum to the research plan, milestone, or timeline with a discussion of alternative approaches.
  • For the UH3 (years 3-5), include a description of research to understand individual and contextual predictors of successful achievement of milestones across the youth-specific PHCC and identify actionable approaches to expand knowledge and optimize HIV prevention and care.
  • A description of the hypothesis 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.

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 study participants, with specified annual rates of youth achieving successive health outcomes across the PHCC (e.g. proportion of adolescents with HIV viral suppression at <200 copies/ml at year 2). These timelines should also include the additional achievement of relevant agreements forged for collaborations with necessary local agency partners and regulatory bodies to ensure achievement of long-term objectives (e.g. local health ministry sharing of data, financial and/or human resources and other capital needed to link at-risk, uninfected and/or HIV-infected adolescents to care and track their health outcomes). Where appropriate, they could also include 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 a clearly identified Go/No-Go transition milestone 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 milestone chosen by the applicant must be quantifiable and identify critical parameters that demonstrate the recruitment and retention of an adolescent study population that meets the proposed rate of achievement of the PHCC health outcome of primary interest. A restatement of an application specific aim is not considered an adequate Go/No-Go transition milestone. Applicants may use Gantt charts or other graphics to support the timelines and the Go/No-Go Transition Milestone.

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

The proposed study will enroll (fill in blank) number of HIV-negative adolescent girls and young women (AGWY) who self-identify as engaging in intergenerational sex work and of whom at least 75% will be expected to begin oral PrEP combined with a behavioral intervention tailored to reduce HIV risk among young sex workers. The study retention rate will be (fill in percentage) or higher, and the annual HIV seroconversion rate of the AGWY with adherence to daily PrEP of less than 4 doses per week will be (fill in percentage) or higher than those who adhered to taking 4 or more doses per week.

Note: Applications lacking clearly described timelines for the UG3 and the UH3 phase, as well as the Go/No-Go Transition Milestone will be considered incomplete and will not be reviewed.

Note: A requirement for successful transition will be an explicit sustainability plan that includes the successful engagement and establishment of relevant collaborations with local agencies and regulatory bodies to advance achievement of the research objectives as demonstrated by the execution of necessary agreements with local health ministry(ies) for committed financial and/or human resources, data sharing and other efforts to link newly identified HIV-infected youth to clinical care and/or efforts to track HIV-negative youth for re-testing and linkage to prevention services. The agreement must also indicate a commitment by the program or agency partner to evaluating and incorporating strategies which are proven to be both successful and cost-effective. 

Protection of Human Subjects: Applicants are encouraged to review specific NIH policies regarding “Research Involving Human Subjects (https://grants.nih.gov/grants/policy/hs/index.htm)”. Information about enrolling adolescents in clinical research is available at the following web site:

http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Pages/Protocol.aspx

(http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Pages/Protocol.aspx).

Describe the following, including any differences between the UG3 and the UH3 phases:

  • Describe any data sources to be employed.
  • Provide documentation of access to data sources.
  • Provide a draft privacy policy, as applicable.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of laboratories and other collaborators, including in-country program, policy and/or regulatory partners (e.g. letter of support from local health ministries, international organizations, etc). 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, and 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 SF424 (R&R) Application Guide, with the following modification:

Investigators will be expected to develop data structures that are findable, accessible, interoperable, and reliable. This will produce PATC3H data sets that are harmonized and facilitate progressive data sharing models (e.g. de-identified data files that can be read by common statistical package software). Resources generated by awardees are expected to be shared with the broader scientific community for research. Applications are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the PATC3H project. An example plan may include the NICHD Data and Specimen Hub (DASH). After all awards have been made, the PATC3H Consortium will develop a unified policy for data and resource release, and the application is expected to include a statement that the investigators will abide by the Consortium’s data and resource policy, consistent with the relevant NIH policies, laws and regulations.

Use of Common Data Elements (CDEs) such as those defined on the on the National Library of Medicine website (https://www.nlm.nih.gov/cde/) is encouraged.

It is anticipated that applicants may propose new approaches for informed consent that improve participant understanding and allow for use of data across a range of health and other electronic platforms.

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

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.     

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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The 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. The UG3 and UH3 should be united through a conceptual framework that links the two phases of the project and the activities and hypotheses that are proposed. Reviewers will assign a single impact score for the entire application, which includes the UG3 and UH3 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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)

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

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 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 children, justified in terms of the scientific goals and research strategy proposed?

Is there sufficient access to the appropriate population(s)? Are there appropriate methods of assessing the HIV health outcomes along the PHCC of the adolescent participants? Will the proposed research strategy lead to enrollment and retention of adequate numbers of high-risk groups targeted by this FOA (AGWY, YMSM, TGY, YCSW, and adolescents who use substances)? Does the application include an appropriate plan to insure that the study includes discrete, non-duplicated subjects living in the geographic area of interest? Will the proposed approach support a statistically significant study of the individual and contextual factors associated with various health outcomes along the PHCC for at-risk, uninfected adolescents and youth living with HIV?

Are the proposed Timelines for both the UG3 and UH3 phases of the project and the Transition Milestone well-defined, feasible, quantifiable, and appropriate to demonstrate the recruitment and retention of an adolescent study population that meets the proposed rate of achievement of the PHCC health outcome of primary interest and which will feasibly achieve the phase 2 research goals with the study developed in phase 1?

Are the approaches likely to result in scalable and efficient study designs? What is the prospect for implementation and sustainability after the grant cycle has ended?

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 Minor Participants

For this FOA the committee will specifically evaluate: 1) if appropriate, a description of the ethical approaches to be used to enroll persons under the jurisdictional age of majority, 2) plans for referring participants who demonstrate high risk of HIV acquisition to HIV prevention services, 3) plans for referring participants who seroconvert during the project for HIV treatment, and 4) plans to protect the security of participants’ personally identifiable information.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. 

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  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 NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

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

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD). 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.
  • Compliance with data and resource sharing policies.
  • NIH discretion with application selection to ensure a synergistic and equitable range of topics are addressed (i.e., prevention approaches and specific parts of the continuum of care, diverse populations, and geographic distribution) and which have maximal likelihood of scalability and sustainability of impact.
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.

NIH reserves the right to negotiate the transition milestone with the applicants before making an award. The Go/No-Go criteria milestone for transition to the UH3 award will be referenced in the notice of award, and applicants must achieve their target milestone by the end of Year 2 for the subsequent UH3 grant to be awarded. Achievement of the transition milestone (Go) will enable consideration for transition from the UG3 phase to the UH3 phase at the end of Year 2. Support for UG3 awards that do not meet their transition milestone (No-Go) will not continue. Appeals of the transition decision will not be accepted. 

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • The planning, direction, and execution of the proposed research, including: definition of objectives and approaches; implementation; data management and analysis, interpretations and publication of results;
  • Participating in the planning for meetings of the PATC3H award recipients, to focus on cohort enrollment, study initiation and study results;
  • Participating in educational and training opportunities relevant to the conduct of implementation research (e.g. George Washington University Translational Health Sciences courses, etc) and in regional meetings and conferences attended by grantees conducting similar research (e.g. NIH FIC-sponsored Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) meetings, etc);
  • The management of plans for study participants at any stage across the PHCC (e.g. referrals for adolescents who seroconvert during the project for HIV treatment, including the care provider or providers to which they will be referred and a description of how they will be followed to obtain information on their subsequent treatment for HIV and tracking of their PHCC outcomes; referrals for high-risk exposures among HIV-uninfected youth to HIV prevention services like post-exposure ART prophylaxis (PEP) and/or PrEP and descriptions of how their PHCC outcomes will be tracked). These plans should include necessary and relevant collaborations and agreements with local agencies and regulatory bodies to facilitate the successful achievement of the research objectives. Information about management status of all subjects 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 coauthors 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;
  • Prior to the end of the UG3, awardees will submit the transition package, which includes the UG3 progress report, progress toward UG3 milestone including successful enrollment and retention of the appropriate study population (AGWY, YMSM, TGY, YCSW, and adolescents who use substances), demonstration of the recruitment and retention of such a population that meets the proposed rate of achievement of the PHCC health outcome of primary interest, and a description of readiness to implement the UH3 research;
  • Awardees 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 DHHS, 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/facilitators between the awardee, 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 awardee's research. 

The NIH Project Scientist will additionally:

  • Monitor study results and quality assurance across all research sites to ensure the production of high-quality, unbiased results;
  • Monitor progress towards study goals and achievement of study timelines and Go/No-Go Transition Milestone;
  • Coordinate a committee of the PATC3H 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 PATC3H activities.

The NIH Program Official will additionally:

  • Take responsibility for the normal scientific and programmatic stewardship of the award and will be named in the award notice; these responsibilities include:
  • ·    Enforcement of general statutory, regulatory, or policy requirements;
  • ·    Approval of awardee plans prior to award and review of performance after completion;
  • ·    Evaluation of progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award;
  • ·    Technical assistance requested by awardees, or unanticipated procedures to correct programmatic or financial deficiencies in awardees' performance;
  • ·    Scientific/technical discussions with awardees, or actions to facilitate or expedite interactions between awardees, e.g., organizing and holding meetings of investigators;
  • ·    The option to halt a project if technical performance and/or objectives are not met;
  • ·    Transition to the UH3 phase will be determined by a programmatic evaluation at NIH that will include the IC program official or program director.

Areas of Joint PD/PI and NIH staff Responsibility include:

  • Participate in a committee of NICHD program staff and PATC3H 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 PATC3H datasets for all approved internal and external research collaborators;
  • Provide input and generate research presentations and publications of PATC3H data (PD/PI and NIH Project Scientist).

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

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

Kendall J. Bryant, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: kbryant@mail.nih.gov

Richard Berzon, DrPH
National Institute on Minority Health and Health Disparities (NIMHD
Telephone: 301-594-8949
Email: Rick.berzon@nih.gov

Dara Blackman-Demner, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-435-6002
Email: dara.blachman-demner@nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 
Telephone: 301-451-3415 
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

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

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412 
Email: Pg38h@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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.