NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

This Funding Opportunity Announcement (FOA) invites applications to participate in a research program cooperative agreement to support the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The Network will have the capacity to develop and conduct innovative behavioral, community-based, translational, therapeutic, microbicide and vaccine trials in HIV-at-risk and HIV-infected youth ages 12 to 24 years, with a focus on the inclusion of minors. Investigators with innovative thinking and new approaches to address the public health issues facing adolescents are encouraged to apply.

The objective and overarching goal of this initiative is to increase the numbers of at-risk youth who are aware of their serostatus, and for those who are diagnosed with HIV, to increase the numbers in each segment of the care continuum to 95% and to bend the infection rate curve downward toward zero through the efforts of this Network.

This FOA builds on the ATN’s previous work (1994-2016) by encouraging a more focused, innovative, basic and clinical research agenda. For the next ATN cycle there will be a strongly renewed focus on an urgent public health issue in the United States the HIV epidemic in youth.

A multi-program project grant is proposed for the next ATN cycle that will be able to utilize a Network to answer questions not easily addressed in an R01 or U01. The applications should answer important fundamental questions related to HIV prevention and/or the care continuum that reflect not just larger or more complex projects but those where the scope is well matched to the resources and the over-arching research objectives. The research projects proposed must be scientifically meritorious, and also complement one another, be synergistic, and support the program's overall theme. The program's overall scientific merit should be greater than the sum of its parts.

Greater than of all new HIV infections in the US occur in youth. These infections are disproportionately distributed among ethnic/racial minorities and men who have sex with men (MSM), with more than of new infections occurring in young African American and Hispanic populations and 72% in young MSM populations. These groups are also unique compared to all others because longitudinal trends of infection over the last decade have increased. CDC guidelines for routine HIV testing across the US have increased the numbers of people identified with undiagnosed HIV infection, however up to 80% of youth are unaware of their infection. Additionally, establishing a durable linkage to care, an activity associated with improved outcomes, remains an elusive goal for many providers. This issue is especially important in vulnerable populations like youth, who may encounter more obstacles and challenges when attempting to access care. A significant portion of the youth targeted for the ATN studies will include traditionally difficult to reach populations of medically disenfranchised, low socio-economic status, sexual and gender minority and/or racial/ethnic minority young men and women.

This initiative calls for cooperative, multi-program project grants with well-defined themes that may include a broad array of interventional studies, conducted collaboratively and independently, aimed at the reduction of new HIV infections among at-risk youth and improvements in numbers across the HIV care continuum among HIV-infected adolescents and young adults who are medically disenfranchised, of low socio-economic status, sexual and gender minority, and/or of racial/ethnic minority constituency including African American, Hispanic, and/or substance abusing youth.

Primary prevention studies will focus on efforts to interrupt HIV transmission in uninfected populations. This will be accomplished by supporting clinical trials and formative work directly leading to such trials, evaluating HIV preventive vaccines, microbicides, PrEP and other combination biomedical and behavioral intervention modalities tailored for youth at greatest risk for HIV infection or transmission. These strategies include, but are not limited to, interventions in the following areas:

• Evaluation of the safety, acceptability, uptake and effectiveness of biomedical prevention modalities (e.g., vaccines, microbicides, PrEP), different long-acting formulations and delivery systems;
• Evaluation of novel approaches to identifying youth with undiagnosed HIV infection (e.g. technology based methods, point-of-care/home testing or testing at other settings outside of traditional healthcare venues, behavioral economics, social and sexual networks, and risk venue testing);
• Evaluation of theoretically-based behavioral and social interventions, including multilevel, combination prevention approaches, particularly relevant to minority youth facing co-occurring health risks (e.g. substance use, mental illness, homelessness).

Studies focused on the HIV continuum of care for adolescents and young adults that examine behavioral and therapeutic interventions, at earlier stages of infection, to preserve health and function in HIV-infected populations and to prevent secondary transmission events. These include, but are not limited to, studies in the following areas:

• Evaluation and optimization of interventions and programs grounded in a prevention infrastructure and implemented independently and collaboratively with federal, state and local authorities for youth with undiagnosed HIV infection, to improve early identification, linkage/retention in care and viral suppression;
• Evaluation of effectiveness of community-level interventions to improve HIV Care Continuum outcomes by mobilizing and partnering with communities to make appropriate structural changes and remove barriers to care;
• Development and evaluation of strategies to address emergent and evolving healthcare financing challenges youth face throughout the HIV continuum of care, including among youth with co-occurring health risks (e.g. substance use, mental illness, homelessness);
• Evaluation of the safety, acceptability, uptake and effectiveness of novel long-acting ART formulations and delivery systems that may improve youth uptake and adherence to ART;
• Interventions to promote safer sexual behavior among HIV-infected youth to prevent HIV transmission, with attention to mental health and substance use issues;
• Evaluation of programs designed to promote or optimize engagement in care and antiretroviral drug adherence in youth, including but not limited to, interventions that focus on novel uses of technology;
• Assessment and evaluation of integrated treatment approaches on HIV infection and its therapy, incorporating psychological, medical and ancillary services care.

This FOA will also support formative, test-of-concept/pilot clinical studies in HIV-infected and at-risk youth populations, if they are directly linked to a larger scale efficacy-level intervention for evaluation among these populations and proposed in the same application.

Applications proposing any of the following will be deemed non-responsive and will not be reviewed:

• Formative biomedical, behavioral, or community level interventions lacking a clear developmental trajectory and link to large-scale efficacy or effectiveness evaluations
• Studies evaluating or comparing antiretroviral treatment strategy trials
• Stand-alone pharmacokinetic/pharmacodynamics evaluations of ART
• Research focused only on neurocognitive dysfunction and HIV

U19s Multi-Program Project

The ATN is newly designed as a collaborative Network of up to 5 U19s, each of which will support a research program with a well-defined central theme, research focus, or objective(s), and which will draw on support, coordination and operational infrastructure from an ATN Coordinating Center (CC) funded through a separate FOA (see below).

Each ATN U19 will include 3-4 R01-like Research Projects and may include 1-2 R21- or R03-like pilot projects, along with Core(s) necessary to support the projects. All research projects should directly focus on one or more aspects of primary prevention and/or the continuum of care among adolescents in the US. The U19 research Network will be facilitated by the sharing of ideas, data, and specialized resources, such as equipment, services, and clinical facilities. The Research Projects proposed must be scientifically meritorious, and also complement one another, be synergistic, and support the program's overall theme. Thus, the program's overall scientific merit should be greater than the sum of its parts.

In addition to the research projects contained within each U19, each application should also include a proposal and process for the development of new protocols within the U19 as the science around primary prevention and the continuum of care among HIV-infected youth continues to evolve. Each application should also include brief proposals for one or more studies that require collaboration with other U19s and/or other domestic HIV clinical research networks. These will inform network discussions and planning that will involve the ATN Executive Committee and will be supported by the separate FOA (U24 below).

The Program Project must propose a sufficient number of scientifically meritorious Research Projects and enrollment capacities to permit an effective collaborative effort among the participating investigators. Research efforts should not be so diverse and diffuse in scope as to hinder productive collaboration. In addition to these focused Research Projects, the proposed structure should allow the continuation of an ATN able to perform high priority studies across U19s generated from the ATN Network or in collaboration with other networks, agencies and other outside sources.

ATN Executive Committee (EC)

The ATN Executive Committee (EC) will have representation from each U19 PD(s)/PI(s), the ATN Coordinating Center (CC) (U24) PD(s)/PI(s), NIH ICs, and other selected scientific experts. Additionally, a community representative will bring an added layer of community participation and engagement in the research agenda. The ATN EC will oversee the integration of efforts across the U19s though leadership, efficient communication, coordination and scientific collaboration across the multiple participating research institutions, as well as close interaction with NIH program staff members. Furthermore, the ATN EC will assist the network with identifying emergent scientific priorities and will help administer their implementation, with assistance from the ATN CC. It will also help develop cross-U19 collaborations and facilitate collaborations with other networks and investigators. In consultation with NIH scientists, the EC will also consult with an external Ethics Advisory Panel (EAP), as needed.

Single Institutional Review Board (sIRB)

In order to reduce the burden on local IRBs, to streamline the protocol approval process, and to standardize the oversight of human subjects protection in the ATN Studies, the use of a single IRB is strongly encouraged.

External Advisory Group (EAG)

An Independent External Advisory Group (EAG) will be convened by the ATN EC with assistance from the ATN CC to review the scientific progress and activities of each U19, as well as for cross-U19 and other collaborations across the Network, with the goal of maintaining the highest level of scientific progress and relevance of proposed and ongoing projects. The EAG may recommend new directions as appropriate. Members will have the scientific expertise but not be affiliated with components of the ATN U19s. The EAG will meet yearly at an ATN Meeting coordinated by the ATN CC. Following these meetings, the EAG will make recommendations in writing regarding scientific progress and activities of the Network to the NIH and the ATN Executive Committee (EC).

U24 ATN Coordinating Center (CC)

A separate award, which will facilitate collaborations through scientific leadership from the ATN EC and organizational support for the Network, including cross-U19 and external collaborations (including management and allocation of resources) for all ATN U19s and will coordinate logistical needs for the Network, is described in more detail under a separate solicitation for The ATN Coordinating Center (CC) (U24).

U19 Project Director(s)/Principal Investigator(s) and Component Parts

U19 PD(s)/PI(s)

The U19 PD(s)/PI(s) should be established investigator(s) with a record of scholarly achievements and publications, demonstrated leadership and administrative capabilities, and a proven track record designing and leading multidisciplinary research projects that may include formative basic and clinical research. They will be responsible for the projects and cores within the U19 and for communication, collaboration and coordination with other ATN U19s and the CC. The U19 PD/PI(s) will participate and collaborate with the Research Project leads, Core leads and others within the U19 to discuss, develop plans for and assist the ATN EC in guiding the Network in implementing scientific and administrative decisions. They should demonstrate a track record of proactive community engagement in development of research activities and ensure that the Research Projects proposed will be informed by ongoing community input.

U19 Research Project Lead(s)

The Research Project Lead(s) should be experienced investigators from backgrounds in a variety of disciplines/specialties, at varying career levels, with or without prior ATN experience, with a track record of PHS supported research, and will participate and collaborate with the U19 PD(s)/PI(s) to discuss and help guide the administration and science of the Program Project. They will also participate and collaborate with other ATN U19s in the execution of pertinent clinical protocols and will be expected to collaborate productively within and outside of the ATN so that new scientific information may be freely exchanged and can be effectively applied by others.

All Senior/Key Personnel (PD(s)/PI(s), Research Project Lead(s) and, Core Lead(s) should contribute to, and share in, fulfilling the program objectives, through regular meetings.

U19 Research Project Components

Each Research Project should contribute materially and intellectually to the specific goals and objectives of the Program Project, as well as the overall Network, contribute expertise and/or resources toward the aims of the Program Project, include plans for data sharing as appropriate, and emphasize collaboration across all components of the U19 and across the ATN via the ATN Coordinating Center (CC) in order to meet the objectives of the FOA.

Each Research Project should contain the scientific vision which anticipates the ongoing evolution of the field and an emerging scientific agenda by briefly addressing the current state of knowledge on adolescent HIV prevention and care, the significant scientific gaps and opportunities, and the research, tools and resources needed to progress toward the reduction of new infections and improvement of health outcomes in HIV-infected youth. The vision will lead to strategies to achieve the scientific goals, and the processes/approaches implemented to design, prioritize and conduct an emerging scientific agenda, including high priority studies across U19s generated from the ATN Network or in collaboration with other networks, agencies and other outside sources.

Management Core (MC) (required)

Each application must include a Management Core headed by Lead(s) with experience in project management. The Core Lead may also be the Principal Investigator of the application. A Management Core is a resource for the multi-project grant, providing for the overall management, coordination, scientific and analytic resource availability and supervision of the Program.

A Recruitment and Enrollment Center (REC; optional) may be a part of the Management Core.

This can be a resource for the multi-project grant as a whole and can be proposed when multiple subject recruitment venues (SRVs) are planned to provide enrollment capacity into specific projects.

Analytic Core (AC) (required)

Each application must include an Analytic Core headed by a Core Lead(s) with experience in modern analytic methods. The Core Lead may also be the Principal Investigator of the application. The Core Lead is responsible for ensuring that shared scientific and analytic resources/facilities are available and utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team in a timely manner.

The Lead(s) of the AC is responsible for working with the research teams to assemble all methodological and analytical expertise necessary, and to evaluate their scientific progress. An AC is a resource for the multicomponent cooperative agreement, providing for overall management, coordination, scientific and analytic resource availability and supervision of the Program.

Scientific Core(s) (SC) (optional)

A scientific core (SC) is a resource for the multicomponent cooperative agreement as a whole and, if proposed, must support at least two of the proposed research projects. The SC may contain unique resources, including facilities, equipment and expertise (e.g. a specialty laboratory for HIV diagnostics) that can be useful to the successes of and common to multiple research projects and which may not be otherwise available at or feasibly accessible by many institutions.

U19 Partnerships

A key component of this initiative is the formation of partnerships between academia and the community to facilitate the design and implementation of novel, innovative interventions that leverage new and existing relationships (e.g. academic-based clinical and research sites, and community based organizations, public health authorities and other private organizations providing services to youth at risk for and infected by HIV) to optimize impact on the epidemic.

Applications not including partnerships/collaborations with community entities on the research proposed will be considered non-responsive and will not be reviewed.

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.

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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall (use for Overall Research Plan)	12
Management Core	6
Analytic Core	6
Scientific Core	6 (per core)
Research Project	12 (per project)
Pilot Project	6 (per project)

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall Research Plan: required
• Management Core (MC): required
• Analytic Core (AC): required
• Scientific Core(s)(SC): optional - maximum of 4
• Research Projects: required - minimum of 3, maximum of 4
• Pilot Project(s): optional - maximum of 2

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

The U19 PD(s)/PI(s)

• should be established investigator(s) with a record of scholarly achievements and publications, demonstrated leadership and administrative capabilities, a proven track record designing and leading multidisciplinary research projects that may include formative basic and clinical research;
• will be responsible for the projects and cores within the U19 and for communication, collaboration and coordination with other ATN U19s and the CC;
• will participate and collaborate with the Research Project leads, Core leads and others within the U19 to discuss, develop plans for and assist the ATN EC in guiding the Network in implementing scientific and administrative decisions;
• should demonstrate a capacity to ensure subject recruitment based on demonstrated prior site experience and performance;
• should demonstrate a track record of proactive community engagement in development of research activities and provide plans to ensure that the Research Projects proposed will be informed by ongoing community input and to conduct ongoing monitoring for impact the research may have on the community.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Include Specific Aims of the U19 overall.

Research Strategy: Describe the major theme(s) of the overall U19 Cooperative Multi-Program Project, its goals and objectives, background information and the overall importance of the Research Projects to the theme of this program. Explain the strategy for achieving the goals defined for the overall program and how each Research Project and Core relate to that strategy. Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, and how the combined resources create an overall program that is more than the sum of its parts. Explain the strategy for facilitating efficient communication, coordination of organizational efforts and scientific collaboration across multiple research projects potentially spanning multiple research institutions. Include all necessary tables, graphs, figures, diagrams and charts in this section. In addition, provide the following information:

History, Purpose, and Objectives of the Program

Discuss the overall U19 program's objectives and general plans for the proposed project period, including relevant research experience that contribute to the objectives of the Program.

Administration, Organization, and Operation

Describe organizational framework and provide an organizational chart. In addition, the following elements should be included:

• Plans for separate administrative and analytic cores to support Research Projects to enhance the research objectives of the U19 and the Network
• A scientific core may also be proposed, but must support at least two research projects to be responsive (optional)
• A plan for adherence to a Network operations manual for staff training, quality assurance procedures, the operation and integrity of the ATN study databases including remote data capture capacity and study development

Research Program

Discuss the proposed research program, highlighting its central theme. Describe the relationship between the Research Projects and the Cores and their relationship to the central theme.

Demonstrate how partnerships between academia and the community have influenced and will continue to facilitate the design and implementation of novel, innovative interventions that leverage new and existing relationships (e.g. academic-based clinical and research sites, and community based organizations, public health authorities and other private organizations providing services to youth at risk for and infected by HIV) to optimize impact on the epidemic.. Also provide plans for the establishment of performance-based subcontracting where appropriate.

The following elements should be included in an application for the ATN U19:

An overview should explain the scientific vision which anticipates the ongoing evolution of the field and an emerging scientific agenda by briefly addressing the current state of knowledge on adolescent HIV prevention and care, the significant scientific gaps and opportunities, and the research, tools and resources needed to progress toward the reduction of new infections and improvement of health outcomes in HIV-infected youth.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support for the U19 Cooperative Multi-Program Project overall should be included with the Overall Component. Letters of support for individual Research Projects or Cores should be included with those components of the application. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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.

• A plan for providing and sharing data from the U19 research projects as well as those projects supported by multiple U19’s should be addressed

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.

When preparing your application in ASSIST, use Component Type Management Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities & Other Resources: If other funded networks, Centers, databases, NIH-funded cohorts, sites etc. are to be leveraged, this should be briefly described. It is expected that applicants will leverage existing government-funded resources, such as Clinical and Translational Science Awards, Roadmap programs, or Centers For AIDS Research whenever possible, and provide documentation in the application that such services and resources will be available to the program.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

• The U19 PD(s)/PI(s) will be expected to provide at least 25% FTE (4 person-months) to the program; increased effort is expected if the U19 PD(s)/PI(s) plan to also lead a research project within the U19;
• Funds for two yearly ATN meetings should be included in the budget.

Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, and travel expenses related to two annual meetings should be requested in the management core budget. Include in budget expenses for local CAB and appropriate staff.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Management Core.

Research Strategy:

The overview of the Management Core should articulate the strategy that the Program Project will adopt to achieve the scientific goals and describe the processes/approaches that will be used in decision-making and implementation of activities, including the establishment of scientific priorities, strategies used to expand the Program Project: defining scope, direction, and means, strategies used to redirect science or resources, efficient communication, frequency and means, and strategies to promote and facilitate collaboration in the Network via the ATN Executive Committee (EC), including a complete description of the roles of the ATN EC and of the External Advisory Group (EAG) or other groups/persons in decision-making activities.

For the Management Core, provide the following information:

Objectives of the Management Core

• Staffing: Structure of the core, roles of core staff, and lines of authority within the core
• Resources: Description of how Management Core resources will contribute to the objectives of the Research Projects.
• Services provided: Description of the services provided to other Cores and Research Projects.
  • A plan to address youth recruitment needed for the proposed studies and estimate/project a number of youth available for recruitment. Tables demonstrating previous success with recruitment and retention in studies should be included. Performance measures and monitoring plans of all sites under the proposed Program. Plans, processes, timelines, milestones, and site performance monitoring. Explain how resource allocation may be adjusted during protocol performance.
  • Coordination of Program components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Program
  • Plans for fiscal accountability
  • Plans for the regulatory infrastructure to support the proposed scientific agenda of the Program, including the investigator (and institutional) capacity to take on sponsorship of registrational research (IND) studies
• Include plans for monitoring potential impact of the research projects on the community. Also a plan to constitute a local youth community advisory board (CAB) to provide consultation to the ATN Executive Committee (EC) and budget support for selected members to attend ATN meetings.
• Administration:
  • Description of the strategies and processes that will be used to manage the U19 and achieve the overall goals.
  • Oversight plan for the Cores and Research Projects that should promote coordination and collaboration within the program and with investigators and organizations outside the program, as well as across the Network.
  • The Research Strategy should describe the planning and coordination of research activities, the integration of cross-disciplinary research, allocation of funds, management of resources and quality control, the maintenance of ongoing communication, and plans for evaluation of the Program Project by the ATN the Executive Committee.
  • Demonstration of successful community engagement and partnership in the development of the research plan and projects proposed, and plans for their ongoing engagement.
  • Indicate who will be responsible for each of these activities. Include information on the support and commitment of the parent institution for the program, the authority of the PD(s)/PI(s), the use of advisory committees, and method of determining Core access and space assignments. Do not list specific members for any external advisory committees or contact potential members. The list should only include the type of expertise of the proposed members and their role in advising Key Personnel of the Program Project. Describe structures for day-to-day management of the Program Project, including arrangements for internal quality control of ongoing research.

Include tables or organizational charts of the Management Core, if appropriate.

A Recruitment and Enrollment Center (REC) may be a part of the Management Core and described under research strategy. This will be a resource for the Program as a whole and should be proposed when multiple subject recruitment venues (SRVs) are planned to provide enrollment capacity into specific projects.

• The application should indicate the specific projects to be served by the REC.
• Staffing: Brief description of the roles of scientific, technical, and support staff.
• Resources: Description of how resources will contribute to the objectives of the Research Projects. This section of the application should present a clear picture of the facilities, techniques, and skills that will be provided and describe the roles of the key participants.
• Services provided: Description of current and projected services to other Core and Research Components, as well as the process for prioritizing requests for use of facilities by the various Research Projects. If a Recruitment and Enrollment Center or its equivalent already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.
• Management: Description of overall management of the REC, decision-making process for use of services, and plans for cost-effectiveness and quality control.
• Utilization: Provide a summary of past and/or projected usage of services (e.g., coordination of complex enrollments, enrollment into registrational trials, provision of IND capacity, etc.) from other projects.

Letters of Support: Include letters of support specific to the Management Core.

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,

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. The Management Core will provide all reporting for the entire U19; all other components of this application must reconcile any reports with the Management Core to avoid duplicative reporting to NIH.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. The Management Core will provide all reporting for the entire U19; all other components of this application must reconcile any reports with the Management Core to avoid duplicative reporting to NIH.

When preparing your application in ASSIST, use Component Type Analytic Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Analytic Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Analytic Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Analytic Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Analytic Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Analytic Core)

Each application must include an Analytic Core headed by a Core Lead(s) with experience in modern analytic methods. The Core Lead(s) may also be the PD(s)/PI(s) of the application. The Core Lead(s) is responsible for ensuring that shared scientific and analytic resources/facilities are available and utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team in a timely manner.

The Lead(s) of the Core is responsible for working with the research team to assemble all methodological and analytical expertise necessary, and to evaluate their scientific progress.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Analytic Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Analytic Core)

Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Analytic Core.

Research Strategy: An analytic core is a resource for the multi-project grant, providing for overall management, coordination, scientific and analytic resource availability and supervision of the Program. For the Analytic Core, provide the following information:

• Objectives of the Analytic Core
• Staffing: Structure of the core, roles of analytic core leader and core staff, and lines of authority within the core.
• Resources: Description of how Analytic Core resources will contribute to the objectives of the Research Projects. This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide.
• Services provided: Description of the services that will be provided to other Cores and Research Projects, including general plans for collaborations with other U19s within this FOA. Plans for the identification and assembly of the necessary analytic capacity, including experts who have demonstrated the development and application of innovative and cutting-edge methodologies and statistical analytics.
• Administration: Coordination of Program components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Program. The Analytic Core will provide analytic capacity for the Cores and Research Projects, and will promote coordination and collaboration within the program and with investigators and organizations within the Network as well as outside the program.
• The Research Strategy should describe the planning and coordination of research activities, the integration of cross-disciplinary research, allocation of funds, management of resources and quality control, the maintenance of ongoing communication, and plans for evaluation of the Program Project by the ATN Executive Committee. Indicate who will be responsible for each of these activities.

Include tables or organizational charts for the Core, if appropriate.

Letters of Support: Include letters of support specific to the Analytic Core

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:

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

Planned Enrollment Report (Analytic Core)

Please provide this information under the Management Core.

PHS 398 Cumulative Inclusion Enrollment Report (Analytic Core)

Please provide this information under the Management Core.

When preparing your application in ASSIST, use Component Type Scientific Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Scientific Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scientific Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Scientific Core)

Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Scientific Core.

Research Strategy: A Scientific Core (SC) is a resource for the Program as a whole and, if proposed, must support at least two of the proposed research projects. For the Scientific Core, provide the following information:

• Objective of the Scientific Core
• Staffing: Brief description of the roles of scientific, technical, and support staff.
• Resources: Description of how Scientific Core resources will contribute to the objectives of the Research Projects. The application must indicate the specific projects to be served by the Scientific Core(s).
• Services provided: Description of current and projected services to other Core and Research Components, as well as the process for prioritizing requests for use of Scientific Core facilities by the various Research Projects. If a Scientific Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.
• Management: Description of overall management of the Scientific Core, decision-making process for use of Scientific Core services, and plans for cost-effectiveness and quality control.
• Utilization of Scientific Core: Provide a summary of past and/or projected usage of Scientific Core services (e.g., assays performed, animals supplied, etc.). Include estimates of the percentage use of each Core unit by the affiliated Research Project components.

Letters of Support: Provide letters of support specific to the Scientific Core.

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:

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

Planned Enrollment Report (Scientific Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Scientific Core)

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

When preparing your application in ASSIST, use Component Type Research Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

The Research Project Lead(s)

• should be experienced investigators from backgrounds in a variety of disciplines/specialties, at varying career levels, with or without prior ATN experience, with a track record of PHS supported research
• will participate and collaborate with the U19 PD(s)/PI(s) to discuss and help guide the administration and science of the Program Project
• will participate and collaborate with other ATN U19s in the execution of pertinent clinical protocols
• should be willing to work with U19 PD(s)/PI(s) to proactively engage the community in development of proposed research projects and in their implementation
• will work with the U19 PD(s)/PI(s) to ensure subject recruitment
• will be expected to collaborate productively within and outside of the ATN so that new scientific information may be freely exchanged and can be effectively applied by others
• should demonstrate a capacity to ensure subject recruitment and retention based on demonstrated prior site experience and performance
• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Projects)

Budget forms appropriate for the specific component will be included in the application package.

Funds for two yearly ATN meetings should also be included in the budget

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Projects)

Specific Aims: Provide the Specific Aims for the Research Project

Research Strategy: Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details and provide the full reference in the Bibliography and References Cited section.

Clearly describe the Research Project, including the project's objectives, and explain its relevance and contribution to the overall program's theme. Discuss the significance of the work proposed and its scientific contribution to HIV primary prevention and/or the continuum of care among adolescents in the US. Such plans must include a clearly articulated and justified developmental timeline with milestones and contingency plans for anticipated challenges. As part of the Research Strategy, include information on preliminary studies and/or data pertinent to this application.

Describe the Research Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the Project. Describe how community engagement will help inform the work proposed and ongoing activities.

Include a plan and process for developing new protocols for use within the U19 as the science continues to evolve. In addition, include a brief (one to two paragraphs) proposal for one or more studies that would need the collaboration of other U19s and/or domestic HIV clinical research networks. This brief proposal should articulate the rationale and significance of the cross-U19 study collaboration. Also describe how the study would facilitate the integration of scientific efforts and infrastructure across the ATN U19 s. Include an explanation for how this proposal is separate from the main research project described above.

Letters of Support: Provide letters of support specific to the Research Project.

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.

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

Planned Enrollment Report (Research Projects)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Projects)

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

When preparing your application in ASSIST, use Component Type Pilot Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

This FOA will also support formative, test-of-concept/pilot clinical studies (Pilot Projects) in HIV-infected and at-risk youth populations, if they are directly linked to a larger scale efficacy-level intervention for evaluation among these populations and proposed in the same application. Prior to initiation of any pilot study-dependent large-scale clinical trials, results of these pilot studies will be reviewed and go/no go decisions will be rendered by the ATN EC with NIH Program staff and, as needed, the EAG.

SF424 (R&R) Cover (Pilot Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Pilot Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot Project)

Specific Aims: Describe the Specific Aims for Pilot Project.

Research Strategy: Following the instructions in the SF424 (R&R) Application Guide, describe each of the proposed Pilot Projects using the appropriate headings Significance, Innovation, Approach. Cite any published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section. The description should clearly relate the project's objectives to the Program Project's overall theme and must demonstrate direct linkage to a larger scale efficacy-level intervention for evaluation among the populations of focus of this FOA and planned to be implemented under this U19. Specify the biomedical significance of the work proposed. Although little or no preliminary data are required for a Pilot Project, any relevant studies or data that establish the feasibility and rationale for the project may be included. Describe the Pilot Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the project. Describe how the community has been engaged in helping inform the work proposed and ongoing activities.

Letters of Support: Provide letters of support specific to the proposed Pilot Project.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The Data Sharing Plan must address the explicit milestone of making data available for this purpose within one calendar year of study/research project completion.
• Applicants are expected to deposit biospecimens in the ATN Network Repository for storage and use, consistent with achieving the goals of the program. NICHD holds the exclusive authority to enter into agreements with outside parties for the purpose of sharing data and biospecimens in accordance with NIH policies. Therefore, awardees shall not enter into any third party agreements directed to aspects of an active study with any outside party, during the course of the study.

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

Planned Enrollment Report (Pilot Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Project)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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.

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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: peer review of NICHD Cooperative Program Project applications focuses on three areas: (1) review of the U19 Multi-Program Project as an integrated Network and collaboration of Projects and Cores oriented around a central theme, and the overall merit of the program; (2) review of the individual Research Projects and any optional Pilot Projects; and (3) review of the individual Cores.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the U19 Program 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 U19 Program 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 U19 Program Project that by its nature is not innovative may be essential to advance a field.

Does the U19 Program Project address an important problem or a critical barrier to progress in the field? If the aims of the U19 Program 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the U19 Program Project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the U19 Program Project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the U19 Program 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?

Do the research plans demonstrate material and intellectual contribution to the specific goals and objectives of the Program Project, as well as the overall Network, contribute expertise and/or resources toward the aims of the Program Project, demonstrate an explicit and detailed plan for data sharing as appropriate, and emphasize collaboration across all components of the U19 and across the ATN via the ATN Coordinating Center (CC) in order to meet the objectives of the FOA?

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? Was the community engaged appropriately to have input into the design of the U19 and its Research Projects? Are plans included for monitoring potential impact of the research projects on the community?

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.

Program Project as an Integrated Effort

The overall Program Project will be evaluated as an integrated research effort focused on one or more research areas listed under Research Objectives and Scope. The relationship and contributions of each Research Project and Core to the central theme will be discussed and evaluated. Reviewers will assign an impact score based on assessment of the scientific and technical merit of the Program Project overall. The assessment will take into consideration all proposed Research Projects and Cores, including any with poor ratings. The review of the Program Project as an integrated effort will include the following criteria:

• Will there be coordination, cohesiveness, and synergy among the Research Projects and Cores as they relate to the common theme of the Program Project?
• Are there clear advantages of conducting the proposed research as a Program Project rather than through separate Research Projects?
• Are mechanisms proposed for regular communication, coordination and collaboration among investigators in the Program Project, as well as with potential Investigators within the Network?
• Are there effective administrative structures for the day-to-day management of the Program Project, including arrangements for internal quality control of ongoing research?

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.

When the proposed U19 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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).

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.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Projects 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 proposed Program Project).

Reviewers will also consider each of the five review criteria below in the determination of scientific and technical 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 Research Project address an important problem or a critical barrier to progress in the field? If the aims of the Project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the Research Project Lead(s), collaborators, and other researchers well suited to the Research Project? If Early Stage Investigators, New Investigators, or investigators in early stages of independent careers will serve as Project Leads, 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-Lead, 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 Research Project? Are potential problems, alternative strategies, and benchmarks for success presented? If the Research Project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the Project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Research Project proposed? Will the Project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Do plans to access subject populations for this project demonstrate adequately the capacity to ensure subject recruitment, as shown by prior site experience and performance? Is the Project well-integrated into the Program Project as a whole? For any work proposing to employ staff and other clinical site or other community venue infrastructure to recruit and/or retain subjects on study, are plans for executing performance-based subcontracts adequate? Was the community engaged appropriately to have input into the design of the Research Project?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Research Project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the Research Project, 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.

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

Not Applicable

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.

For any optional Pilot Projects, note the following:

Pilot Projects are discrete, well-defined projects that can be completed in a relatively short time frame with limited funding but must be directly linked to a larger scale efficacy-level intervention for evaluation among the populations of focus of this FOA and planned to be implemented under this U19. Accordingly, reviewers should evaluate the conceptual framework, the general approach to the problem and the likelihood of successful implementation within the larger intervention. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, though they may be included if available.

Review of the Pilot Project Component must include consideration of any and all Pilot Projects proposed in the application.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Pilot Project(s) to make an important contribution to the overall Program Project, in consideration of the following scored review criteria and additional review criteria.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 Pilot Project Component have potential for addressing an important problem or a critical barrier to progress in the field? If the aims of the Pilot Project(s) 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 Pilot Project Lead(s), collaborators, and other researchers well suited to the Pilot Project(s)? If Early Stage Investigators, New Investigators, or investigators in early stages of independent careers will serve as Project Leads, 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-Lead, 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 Pilot Project(s)? Are potential problems, alternative strategies, and benchmarks for success presented? Will the strategy establish feasibility and will particularly risky aspects be managed? Is the Pilot work directly linked to a larger scale efficacy-level intervention for evaluation among the populations of focus of this FOA and planned to be implemented under this U19? If the Pilot Project(s) involve clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Pilot Project(s) proposed? Will the Project(s) benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Do plans to access subject populations for this pilot project demonstrate adequately the capacity to ensure subject recruitment, as shown by prior site experience and performance? Are the Pilot Projects well-integrated into the Program Project as a whole? Was the community engaged appropriately to have input into the design of the Pilot Project?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Pilot Project(s) involve clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the Pilot Project(s) 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.

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

Not Applicable

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.

Reviewers will assign an Impact Score for each core, including the Management Core, Analytic Core and any other Cores in terms of the following review criteria.

Reviewers will evaluate the following items while determining scientific and technical merit, and in providing an Impact Score, but will not give separate scores for these items.

Management, Analytic and Other Cores

For Management Core, Analytic Core and all other Cores, the review will evaluate the following:

• Are the qualifications, experience, and commitment of the Core Lead and other Core personnel appropriate?
• Will the services provided by the Core enable the investigators to achieve their research goals?
• Is the Core cost-effective, and are there appropriate quality control measures?
• Is the Core of utility to the Program Project overall?
• Does the Core facilitate collaboration within the Program, as well as across the Network?

Management Core

In addition to the above criteria for all Cores, reviewers will evaluate the following for the Management Core:

• Does the Core Lead have appropriate experience in research administration and management?
• Have they provided a brief description of the roles of key scientific, technical, and support staff?
• Have they provided a description of how resources will contribute to the objectives of the Research Projects?
• Has a clear description of the facilities, techniques, and skills to be used been provided?
• Is the decision-making process for evaluating research productivity, allocation of funds, and management of resources appropriate?
• Is the plan for evaluating the Program Project and its progress appropriate?
• Has a description of current and projected services to other Cores, as well as the process for prioritizing requests for use of facilities by the various Research Projects been addressed?
• Has a summary of past and/or projected usage of services such as coordination of complex enrollments, enrollment into registrational trials, provision of IND capacity, been addressed?
• If a (Optional) Recruitment and Enrollment Center (REC) is proposed:
• Is it a resource for the multi-program project grant as a whole?
• Does it propose multiple subject recruitment venues to provide enrollment capacity into specific projects?
• Are the specific projects to be served by the REC listed?
• If an REC or its equivalent already exists, has a description of past services been provided or other significant developments?
• Has an adequate description of overall management of the REC been provided?

Analytic Core

In addition to the above criteria for all Cores, reviewers will evaluate the following for the Analytic Core:

• Is the proposed Core Lead(s) experienced in modern analytic methods?
• Are plans for the identification and assembly of the necessary analytic capacity, including experts who have demonstrated the development and application of innovative and cutting-edge methodologies to the field of HIV research, as well as statistical analyses, appropriate?
• Is a plan included for ensuring that shared scientific and analytic resources/facilities are available and utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team both within the Program as well as throughout the Network, in a timely manner?
• Are the structure of the core, roles of analytic core leader and staff, and lines of authority well defined?
• Is there an adequate description of how Analytic Core resources will contribute to the objectives of the Research Projects?
• Are the facilities, techniques, and skills that the Core will provide adequate?
• Are plans for the services provided to other Cores and Research Projects, and other U19s appropriately addressed?
• Have coordination of Program components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Program and the Network been addressed adequately?
• Have tables or organizational charts been provided, if appropriate?
• Has information on past activities or accomplishments relevant to the Analytic Core been included, if appropriate?

Scientific Core (Optional)

In addition to the above criteria for all Cores, reviewers will evaluate the following for the Scientific Core:

• Are the proposed Core Lead(s) qualifications adequate for the management of a Scientific Core?
• Are plans for the identification and assembly of the necessary Scientific Core resources, including experts who have demonstrated the development and application of innovative and cutting-edge methodologies to the field of HIV research, appropriate?
• Is a plan included for ensuring that shared scientific facilities, equipment and expertise are available and utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team both within the Program as well as throughout the Network, in a timely manner?
• Are the structure of the Core, roles of scientific core leader and staff, and lines of authority well defined?
• Are the Scientific Core resources' contribution to the objectives of the Research Projects adequate?
• Are the facilities, techniques, and skills that the Core will provide adequate?
• Are plans for the services provided to other Cores and Research Projects (at least two), and other U19s clearly addressed?
• Have coordination of Program components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Program and the Network been addressed adequately?
• Have tables or organizational charts been provided, if appropriate?
• Has information on past activities or accomplishments relevant to the Scientific Core been included, if appropriate?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Cores involve clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the Cores 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.

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

Not Applicable

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 Core functions.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by Eunice Kennedy Shriver National Institute of Child Health and Human Development (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 range of topics are addressed (i.e., prevention approaches and specific parts of the continuum of care, diverse populations, and geographic distribution) to form a collaborative Network of multi-program projects.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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:

ATN U19 Cooperative Multi-Program Project

The ATN U19 consists of the Principal Investigator(s), Project Director(s), and supporting staff. The duties of the PD(s)/PI(s) of the U19 include, but are not limited to, the following:

• Provide administrative and scientific leadership expertise to all Cores under the U19 and to specific Research Projects, and collaboratively engage Research Project leads as well as any other independent investigators (e.g. at subject recruitment venues; at institutions external to ATN, etc.) to implement a scientific agenda that is feasible and appropriate for ATN youth;
• Implement all ATN-approved study protocols, where feasible, the recruitment and monitoring of study participants, associated data collection, and study-associated quality control measures at the clinical site including but not limited to identifying local CLIA-certified laboratory support in facilities participating in NIAID-supported quality assurance programs when indicated; these activities may be coordinated by the site(s) study coordinator(s) at the direction of the Principal Investigator;
• Obtain Institutional Review Board (IRB) approval of all ATN study protocols implemented locally and comply with both IRB and ATN policies and procedures;
• Collaborate and coordinate, as necessary, across other ATN U19s and with the ATN CC (U24) to implement Research Projects of relevance and significance to the ATN mission across the US;
• Participate and collaborate with the other U19 Research Project Lead(s) and others to discuss, develop plans for and assist in guiding the Network in implementing scientific and administrative decisions;
• Identify, with the assistance of the NICHD staff, resources within the U19 to support subject recruitment, enrollment, retention, data collection, specimen shipping, and negotiated protocol monitoring costs for ATN-approved protocols and recommend to NICHD the use of funds for such support;
• The PD/PI with the assistance of Research Project Leaders should ensure expedient and safe subject recruitment based on demonstrated prior site experience and performance, as appropriate;
• The PD/PI with the assistance of Research Project Leaders should ensure appropriate community engagement to inform development and implementation of research activities, and should implement any planned monitoring for potential impact of the research projects on the community;
• Establish and support Data and Safety Monitoring Board (DSMB) when instructed by NICHD;
• Participate in resource management decisions and scientific leadership of the network along with other ATN U19 PD(s)/PI(s), the ATN U24 PD(s)/PI(s), and NIH ICs on the ATN Executive Committee (EC);
• Provide counsel and advice to the ATN Executive Committee through its elected representatives on the feasibility of proposed research, implementation strategies, and subsequent data collection as well as further inform perceived gaps in the ATN agenda;
• Participate in regular conference calls and attend ATN EC meetings to be held at least semi-annually;
• Conduct a mid-project period review of the U19 portfolio and develop a strategic plan for addressing any imbalances that are noted in that review;
• Ensure optimal dissemination of research results by expedient data analysis and key publications within 1 year of study completion and implement explicit data sharing policy for public use thereafter;
• The PD(s)/PI(s) is responsible for the timely presentation/publication of work supported in part or in whole by this Cooperative Agreement. Prior notification of the NICHD regarding any presentations or publications and appropriate acknowledgement of NICHD support are required.

Management Core (MC)

The MC consists of the Core Lead, data managerial and regulatory staff, and other ancillary support staff. Duties of the MC Lead include, but are not limited to:

• Provide for effective communication within the U19 and within the ATN; disseminating information, coordinating conference calls, and collaboratively setting meeting and call agendas;
• Conduct U19 protocol and site registration and other regulatory duties as delegated from NICHD, including executing data use agreements to protect ATN data and subject rights;
• Provide training, including the development and updating of study manuals of operation, to all personnel related to acceptable quality control and quality assurance procedures at the sites as well as protocol-training where indicated;
• Participate in data collection procedures of the U19, arranging for combined efforts when indicated by scientific and regulatory demands of collaborative research;
• Support the most efficient transfer of study data generated by collaborative research either by maintenance of all necessary study-associated database(s) with their electronic transfer or arranging for on-site data entry;
• Work with the ATN Coordinating Center (CC) on-site monitoring for those studies being performed at particular sites
• Work with the PD(s)/PI(s) to evaluate progress of the Analytic Core's analytic capacity, as well as redirect resources, if needed to maximize success;
• Establish and execute performance measures and monitoring plans for all sites under the proposed U19, whether part of a Core or independent;
• Coordinate Program components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Program;
• Development of plans for fiscal accountability;
• Participate in the ATN EC to facilitate network-wide endeavors;
• Participate in regular conference calls and attend national ATN meetings to be held at least semi-annually.
• Recruit at least one youth per site to serve as a community representative, who shall be between the ages of 16 and 21 at the time of recruitment, to participate in the ATN Community Advisory Board;
• Recruit and support the local youth Community Advisory Board (CAB) staff person who will act as a liaison between the youth CAB members and the ATN, and provide logistical support to any CAB-associated meetings;
• Provide the regulatory infrastructure to support the proposed scientific agenda of the Program, including the investigator (and institutional) capacity to take on sponsorship of registrational research (IND) studies.

Analytic Core (AC)

The AC consists of the Core Lead, data managerial and biostatisticians and other ancillary support staff. Duties of the AC Lead include, but are not limited to:

• Provide for effective communication within the U19 and in the ATN;
• Participate in harmonization of data for use across the ATN U19s, when needed;
• Design the data collection forms and database(s) and maintain the database(s) necessary for all Research Projects proposed;
• Supervise all data collection procedures of the U19, arranging for combined efforts when indicated by regulatory demands of collaborative research;
• Provide for the most efficient transfer of study data generated by collaborative research either by maintenance of all necessary study-associated database(s) with their electronic transfer or arranging for on-site data entry;
• Identify and assemble the necessary analytic capacity, including experts who have demonstrated the development and application of innovative and cutting-edge methodologies and statistical analytics to the field of HIV research, to achieve Program objectives;
• Evaluate progress of the AC's analytic capacity, as well as redirect resources, if needed to maximize success.
• 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:

NIH Project Scientists will represent each of the institutes co-sponsoring the FOA.

The NIH Project Scientists will:

• Facilitate the exchange of information between the ATN and other existing research networks to support collaborative efforts;
• Participate in the ATN EC that oversees the establishment, maintenance and collaborative scientific efforts of the ATN and its progress in achieving program goals;
• Assist the ATN EC in monitoring the progress of ongoing studies, including field data collection, standardization of methods across study sites, and adherence to protocol and quality control measures;
• Assist the ATN EC in the selection of research topics, and the development or review of protocols for specific studies and interventions;
• Assist the ATN EC in identifying ATN resources required for the successful implementation of collaboratively developed research protocols;
• Arrange Program review of all new ATN protocols developed during the project cycle and, when necessary, the external peer review of the protocols, clearing these studies for implementation;
• Assist in data analyses, interpretation, and publication of study results;
• Assist in identifying the need to terminate or curtail the study (or an individual award) in the event of nonparticipation in the committee/group activities, substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of protocol, or substantive protocol changes without prior approval from NIH Program or the ATN Executive Committee.

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.

The duties of the agency Program Official include:

• Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
• Have the option to withhold support to a participating institution if technical performance requirements are not met.
• Perform other duties required for normal program stewardship of grants.

Areas of Joint Responsibility include:

ATN Executive Committee (EC)

The ATN EC will consist of the PD(s)/PI(s) from each U19, the PD(s)/PI(s) from the ATN Coordinating Center (CC) (U24), the NIH project scientists and other selected scientific experts as agreed to by the EC. Additionally, a community representative will bring an added layer of community participation and engagement in the research agenda. A Principal Investigator from one of the U19s will be elected by the EC to serve as chair of the group. A vice-chair will also be elected by the EC. The ATN EC will oversee the integration of efforts across the U19s through leadership, efficient communication, coordination and scientific collaboration across the multiple participating research institutions, as well as close interaction with NIH program staff members. The ATN EC will have the primary responsibility for identifying emerging scientific priorities, defining the cross-U19 and other collaboration research agenda, and implementing these in the network, and initiating and maintaining collaboration across U19s and with other NIH-funded HIV-related research networks within the guidelines of this FOA. The EC will retain custody of and have primary rights to the data and software developed under such cross-U19 and other collaborations, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Each full member will have one vote. Each NIH IC project scientist will also have one vote.

Awardee members of the ATN Executive Committee will be required to accept and implement policies approved by the ATN Executive Committee.

Specifically, the EC will:

• Draft, review and maintain all current ATN-wide policies and procedures in the ATN Manual of General Operations; any ATN Executive Committee-approved and NICHD-acceptable revisions of the Manual during the project period of these awards will supersede the provisions of these specified terms of award;
• Implement and enforce, either directly or through delegation to other ATN-supported personnel, a Conflict of Interest (COI) Policy acceptable to the Maternal and Pediatric Infectious Disease Branch, NICHD, that addresses any COI that may occur or may be perceived to occur through financial interest or other associations between members of the ATN and the private sector to ensure compliance with all Federal regulations and NIH policies applying to the conduct of research involving human subjects (these include, but are not limited to, Title 42 CFR 50 and Title 45 CFR 46). NICHD notes that the primary regulatory authority for enforcement of the COI Policy belongs to the grantee institution and NICHD does not intend by this term of award to abrogate that responsibility. Rather, NICHD is imposing on the ATN an additional responsibility to protect the integrity of the research produced by the ATN. Therefore, if either the ATN EC or the grantee institution identifies a real or perceived COI, both the ATN EC and the grantee institution must address the COI and inform NICHD of the resulting action;
• Execute all Memoranda of Understanding or Agreement with other entities to conduct ATN developed or co-endorsed research;
• Work with all ATN U19 PD(s)/PI(s)s to adopt and, if necessary, revise the current ATN policies and procedures for elected terms of office and voting procedures, protocol development and review, authorship and publication, collaboration, site and, where indicated, laboratory monitoring, repository requirements, and related issues and review these for approval;
• Work with the U19 PD(s)/PI(s), the ATN CC PD(s)/PI(s) and NIH Project Scientists to identify the most efficient and scientifically sound mechanisms for developing the research agenda as needs emerge during the project cycle, deciding if the specific agenda items are best pursued independently in the ATN, given resources, implement high priority protocols across several or all ATN U19s, and/or in collaboration with existing research networks;
• Coordinate ATN collaboration with investigators with funding from sources other than NIH-funded networks;
• Be responsible for the fiscal management and tracking of all network resources, either directly or through establishment of a specific subcommittee tasked with this function in an iterative and continuous manner, through a collaborative effort with the ATN CC;
• Approve use of discretionary funds as recommended by NIH;
• Develop a formal liaison with leaders of other appropriate HHS-supported HIV prevention and clinical trial networks to facilitate early interaction and communication in protocol design that address key questions in the adolescent population;
• Develop formal communication and liaison with existing HHS-supported prevention and clinical trials networks to inform the ATN leadership on protocols of interest; to define and resolve key logistical issues (e.g. data collection and transfer, drug repository and regulatory requirements; negotiate shared study costs;) which must be addressed to facilitate adolescent enrollment in collaboratively developed research protocols;
• Supervise progress, with the assistance of the NICHD staff, of the U19 PD(s)/PI(s) in identifying resources within the ATN to support subject recruitment, enrollment, retention, data collection, specimen shipping, and negotiated protocol monitoring costs for ATN-approved protocols and in recommending to NICHD the use of funds for such support;
• Participate in regular conference calls and attend ATN meetings to be held at least semi-annually.

For cross-U19 and other collaborations, and high priority protocols responding to emerging needs, the EC will:

• Retain the primary responsibility for defining and prioritizing the research agenda in collaboration with the NIH Project Scientists;
• Approve the direction of the research effort including any reconfiguration of research subgroups or working groups to better address the direction of the scientific agenda, and oversee the conduct and monitoring of the studies;
• Assist U19 PD(s)/PI(s) in oversight of site participation and performance, informing the appropriate program managers and taking necessary actions in accordance to ATN policies and procedures.
• Commit to the development of preventive and therapeutic adolescent-focused studies that take into account the needs and capacities of this special youth population through active consultation with local SRVs and their communities, as needed;
• Interact, coordinate, and, where indicated, contract with immunology and virology laboratories participating or willing to participate in NIH-supported quality assurance programs in order to provide the ATN with necessary laboratory support for independent ATN studies;
• Take responsibility for optimizing the Network’s collaboration through the overall scientific merit of components of the research agenda
• Negotiate any ATN rights to data and authorship with executive bodies of collaborating networks and external investigators;
• 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.

ATN Coordinating Center (CC) (U24)

The ATN Coordinating Center (CC) for all participating U19s will be described in a separate (U24) solicitation. A separate award will facilitate collaborations through scientific leadership from the ATN Executive Committee, which includes NIH representatives, and organizational support from the Network. This coordinating center grant will facilitate the development and implementation of cross-U19 and/or external collaborative protocols and sharing of data, data collection instruments and technologies and would manage and disburse protocol specific funds under a discretionary account for these collaborations and other high priority trials (e.g., adolescent trial of promising prevention product generated by another NIH network) through a protocol disbursement fund. Specific details, including personnel, duties and responsibilities that will provide support for the Network and all U19s under this FOA are described under that announcement.

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.

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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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Bill G. Kapogiannis, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0698
Email: [email protected]

Richard Jenkins, PhD
National Institute on Drug Abuse
Telephone: 301-443-1923
Email: [email protected]

Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: [email protected]

Francisco S. Sy, MD, DrPH
National Institute on Minority Health and Health Disparities
Telephone: 301-402-1366
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse
Telephone: 301-253-8729
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Priscilla Grant
National Institute on Minority Health and Health Disparities
Telephone: 301-594-8412
Email: [email protected]

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 45 CFR Part 75.