Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional)
Activity Code

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Announcement Type
New
Related Notices

NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients

NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

Funding Opportunity Announcement (FOA) Number
RFA-HD-23-021
Companion Funding Opportunity
RFA-HD-23-020 , UM2 Program Project or Center with Complex Structure Cooperative Agreement
Assistance Listing Number(s)
93.865, 93.242, 93.279
Funding Opportunity Purpose

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 youth ages 13-24 years at-risk for HIV and living with HIV, with a focus on the inclusion of minors. Investigators with innovative thinking and novel approaches to address the public health issues facing adolescents are encouraged to apply.

Key Dates

Posted Date
December 01, 2021
Open Date (Earliest Submission Date)
February 28, 2022
Letter of Intent Due Date(s)

30 days before the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable Not Applicable March 31, 2022 July 2022 October 2022 December 2022

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

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

Expiration Date
April 01, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



  3. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The successes and productivity of the ATN since its inception, taken with the evolving research needs of HIV affected adolescents in the US, pave the way into a new era of ATN to develop and conduct interventions with increasing sophistication, complexity and scientific focus across epidemiologically targeted geographic breadth. In doing so, the ATN must also enhance capacity to rapidly respond to evolving scientific priorities during the project cycle with high-quality and rigorous science.

The ATN Operations and Collaborations Center (OCC) will provide support for the ATN Scientific Leadership Center (SLC) in developing and implementing the ATN scientific agenda and the infrastructure, organizational support and site consortium capacity for the ATN's Research Projects and with other external collaborations. The ATN OCC will also support the ATN Executive Committee (EC) as it executes its responsibilities which include, but are not limited to, the integration of efforts across the Network and with other networks and facilitation of transdisciplinary research.

The OCC will facilitate transdisciplinary research through organizational leadership and support of an adolescent-specific research agenda with emphasis on efficient communication, coordination of efforts and scientific collaboration across multiple research projects and institutions in the ATN and with other networks. This will include but is not limited to: participant accrual, staff and site consortium training, quality assurance procedures including necessary site monitoring, and the site consortium operation and integrity for the Research Projects and other collaboration study databases. The OCC will also support the ATN SLC to rapidly respond to evolving scientific priorities through open competitive solicitations of research projects.

Structure of the Network

The ATN is newly composed of a Scientific Leadership Center (SLC) (see companion RFA-HD-22-015) and an Operations and Collaborations Center (OCC) which will work collaboratively to achieve the mission of the ATN. Each will be funded through an independently-solicited FOA and each will contribute essential functions necessary to support a large-scale, complex clinical research program. While the emphasis of each network is on clinical trials, clinical research studies that are not NIH-defined clinical trials are also in scope when undertaken to support the program. For the purpose of this FOA, the term "clinical study" refers to both clinical trials and clinical research studies, and "clinical trial" is used to refer to clinical trials only.

In this new structure, the SLC consists of multiple interdependent functional components and research activities and will be responsible for governance of the network and its activities. The SLC consists of the ATN Scientific Leadership Group (ASLG) in developing and refining the research agenda, convening working groups as needed, prioritizing emerging research projects, efficiently managing the development of clinical protocols, implementing and completing clinical trials and ensuring timely publication and communication of results. The ASLG will provide the necessary multidisciplinary expertise to set, prioritize and manage the ATN scientific agenda. It will draw on the statistical and data management leadership and coordination expertise of the Statistical and Data Management Core (SDMC) to design and implement Research Projects proposed for this FOA and future research to address emerging scientific priorities during the project cycle. The ATN research agenda will ensure capacity for rapid response to evolving scientific priorities through recurring competitive open solicitations. These solicitations will be developed and published by the ASLG in collaboration with NIH project scientists and supported by the coordination and operational infrastructure of the Operations and Collaboration Center (OCC), which will 1) receive and convene reviews for applications, 2) coordinate and support application prioritization by the ASLG, and 3) implement funded meritorious research through OCC supported Site Consortiums after approval by the NICHD Director or her designee. Finally, the Research Projects will be conducted through the site consortia’s multidisciplinary, cross-sectoral collaborative relationships with various participant recruitment venues in their communities (e.g. academic, clinic, health department, community-based organizations, online, social media and other virtual health platforms, etc.).

  • ATN Executive Committee (EC)

The ATN Executive Committee (EC) will have representation from the SLC, the ATN OCC 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 Network through 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 oversee the network and SLC with identifying emergent scientific priorities and will govern the implementation of research studies and funding decisions, with assistance from the ATN OCC. It will also help develop and facilitate collaborations with other networks and investigators. In consultation with NIH scientists, the EC will also consult with an External Scientific Panel (ESP), 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 required.

  • External Scientific Panel (ESP)

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

Site Consortiums

Site Consortiums will participate in the development of trials and provide sites, local laboratory capacity, and pharmacy support. Innovation regarding successful recruitment and enrollment of participants requires Site Consortiums made up of established collaborations among clinics, academic universities, community-based organization, health departments, and other partners. Furthermore, the site consortiums would establish their own leadership model with meaningful and sustained community engagement efforts to ensure that research studies reflect where youth are accessing prevention and care services.

Essential Features of the ATN Operations and Collaborations Center

The ATN Operations and Collaborations Center (OCC) funded under this FOA will facilitate collaborations through scientific leadership from the ATN EC, provide operational and logistical support infrastructure, including Site Consortiums, and provide overall support for the ATN research program. The award funded under this FOA and the companion FOA will use cooperative agreement mechanisms (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close and substantial interactions between the NIH, and the ATN OCC and SLC awardees, are required to accomplish the objectives of the ATN and of this FOA.

OCC Project Director(s)/Principal Investigator(s)

OCC PD(s)/PI(s)

The OCC 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 communication, collaboration and coordination with the ATN SLC, as well as assist the EC in guiding the Network in implementing scientific and administrative decisions. They should demonstrate a track record of proactive community engagement in the implementation of research activities to ensure that research efforts proposed will be informed by ongoing input.

Operations and Collaborations Core

The ATN OCC is responsible for the monitoring and distribution of protocol funds. All funds for implementation of independent research trials (including completion of previous ATN research projects) and cross-network collaborative protocols and the development of emerging high-priority study protocols to be conducted by the Network and other external collaborations will be awarded to the ATN OCC in the Notice of Grant Award (NOA) as restricted protocol-related expenses. The use of these funds will require prior review and approval from NICHD. Upon approval the funds will be released for studies either in increments or full amounts for approved ATN protocols to the ATN OCC.

Site Consortiums

Site Consortiums will participate in the development of trials and provide sites, local laboratory capacity, and pharmacy support. Innovation regarding successful recruitment and enrollment of participants requires Site Consortiums made up of established collaborations among clinics, academic universities, community-based organization, health departments, and other partners. 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. Furthermore, the site consortiums would establish their own leadership model with meaningful and sustained community engagement efforts to ensure that research studies reflect where youth are accessing prevention and care services.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NICHD intends to commit an estimated total of $10M to fund 1 award.

Award Budget

Budgets up to $6.25M direct costs per year may be requested.

Award Project Period

Project period is 7 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
Foreign Institutions

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. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Sonia Lee, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: Sonia.Lee@nih.gov

Page Limitations

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

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Operations and Collaborations Core Op-Collab Core 12 Required 1 1
Site Consortiums Site Consortiums 6 Required 5 10

Instructions for the Submission of Multi-Component Applications

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

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Specific Aims: List and describe the scientific aims of the Operations and Collaborations Center for the ATN.

Research Strategy:

The Research Strategy must provide an overview of the infrastructure, leadership and organizational support plan for the ATN to develop, conduct, monitor and complete all clinical studies. Applicants should describe:

  • A performance-based, centralized, equitable, and efficient method for coordinating the distribution of protocol-restricted funds to site consortia based on actual subject accrual.
  • Full and transparent collaboration, including appropriate sharing of all necessary tools, materials, technologies, budget tracking tools and other essential methodologies necessary for clinical study protocol and program development, regulatory support, implementation and monitoring between the ATN OCC and ATN Research Projects is a critical requirement for the success of the Program.
  • Critical features and functions of the ATN OCC include, but are not limited to:
    • Administrative management and coordination of external collaborations with the network
    • Operational support for cross-network protocols, collaborations and other projects (e.g. conduct of trainings, development of manuals of operation, network public relations, maintenance of network website, communications and conference calls, convening committees and meetings, etc.)
    • Training on a breadth of research related topics (e.g. regulatory/IND, safety reporting, GCP/GCLP, HSP, etc.)
    • Management of resources and execution performance-based subcontracts (e.g. material distributors, specimen storage, pharmaceutical vendors, investigators, other collaborators, etc.)
    • Provision of a regulatory infrastructure for cross-network protocols, collaborations and emerging projects (e.g. site performance monitoring, quality assurance procedures and protocol registration)
    • Provision of mechanisms and metrics to monitor subject screening, recruitment, retention, and dropout, and procedures for adjustment if enrollment targets are not being met
    • Provision of a detailed system for reporting to the ATN Executive Committee (e.g. support of a progress and performance monitoring committee) regular tracking of study progress and performance of site consortia, including a description of performance metrics, milestones, timelines, and quality-control measures to keep the study on track and on budget and which includes strategies to identify and mitigate problems as they arise

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support for the program overall should be included with the Overall Component. Letters of support for individual Cores or Site Consotriums should be included with those components of 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.

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD requires that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, are expected to include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. This plan must include procedures, milestones, and timelines to make the data and bio specimens available for access and analysis by the research community as appropriate. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Operations and Collaborations Core

When preparing your application, use Component Type 'Op-Collab Core’

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

SF424 (R&R) Cover (Operations and Collaborations 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 (Operations and Collaborations Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Operations and Collaborations 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) (Operations and Collaborations 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 (Operations and Collaborations Core)

  • 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 (Operations and Collaborations 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 (Operations and Collaborations Core)

 

Specific Aims: List and describe the Specific Aims of the ATN Operations and Collaborations Core.

Research Strategy: The Research Strategy must provide the strategies and processes that will be used to manage the OCC and achieve the overall goals. Applicants should describe

  • Governance: Integral to the success of the network is establishing clear governance structures, including effective communication and decision-making plans lines of authority, plans for coordinating and collaborating effectively with external collaborators, as well as with NICHD and IC partners, and the Executive Committee.
  • Plans for a project manager possessing the scientific and operational content expertise in the conduct of HIV research among adolescents to support the PD(s)/PI(s) in successfully implementing and achieving the goals of the OCC,
  • The mechanisms proposed for staff and site training,
  • Site-specific subject accrual reimbursement through performance-based subcontracts
  • Plans for the provision and leadership of a full regulatory infrastructure to support all ATN investigational (IND/IDE) clinical trials
  • Quality assurance procedures, and establishment of progress and performance monitoring committee that reports to the ATN Executive Committee and NIH, including plans to establish and monitor milestones and timelines
  • The operation and integrity of the ATN study databases,
  • ATN study development and support, for cross-network and other collaborations, with plans, processes and timelines.
  • How the OCC will respond flexibly to the changing needs of the ATN research protocols as the projects unfold, adding and subtracting staff, as well as Site Consortiums, as the requirements of the protocols dictate. The strategies for the maintenance and oversight of the Site Consortiums should be described.
  • Plans for providing an electronic communication system to participants and components of the ATN, including the design of an ATN website where necessary resources for the Network and collaborating investigators and which allows separate access to the public
  • Community Engagement: Describe the experience, expertise, and track record of working collaboratively with communities and community-based organization, an evidence-based approach to community engagement and community building, a plan to actively engage communities in all aspects of the research, and application of principles from community-based participatory research paradigms. Establishment and regular meetings of a Community Advisory Board or equivalent that includes youth will be required. Must include plans for developing the Community Advisory Board, structure of the Community Advisory Board, and how they will be used, how often they will meet, and how they will meaningfully contribute to the research. Describe (i) plans for community engagement consistent with GCP, including organizational charts; (ii) the role of CAB(s) and how the CAB(s) will support the SC and their populations(s); (iii) existing relationships among the SC and community(ies) in which the research will be conducted, include information on nature and length of relationship as well as any outreach conducted to date; (iv) dedicated staff from the SC, if any, that will support community activities and a description of their roles and responsibilities; (v) CAB composition including process for elections, jurisdiction, representation, function, work products, resource requirements and frequency of meetings; (vi) the plans for training CAB members including mentoring and continuing education; and (vii) the process for determining the level of financial support that will be provided by the SC for CAB activities and how that level of support will be communicated to the CAB in a transparent manner and reassessed throughout the project period.

 

Letters of Support: Include letters of support specific to the Operations and Collaborations Administrative Core.

 

Resource Sharing Plan: Not applicable -- A Resource Sharing Plan is only required in the Overall Component of the application.

 

Appendix:

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

 

PHS Human Subjects and Clinical Trials Information (Operations and Collaborations Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

 

 

Site Consortiums

When preparing your application, use Component Type ‘Site Consortiums.’

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

 

SF424 (R&R) Cover (Site Consortiums)

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 (Site Consortiums)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Site Consortiums)

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) (Site Consortiums)

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 (Site Consortiums)

  • 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 (Site Consortiums)

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 (Site Consortiums)

 

Specific Aims: List and describe the Specific Aims of the Site Consortiums.

Research Strategy: The Research Strategy should describe the clinical, academic, government, community, and other partnerships needed to achieve the goals of the research and experience in developing and maintaining successful research collaborations. Include a Table listing the entities included in each Site Consortium (e.g., clinical sites, CBOs). The Research Strategy should also address the following:

Organizational Structure:(i) Provide an organizational chart describing the overall SC structure that demonstrates a cohesive, synergistic, integrated approach to supporting the ATN for which the SC is proposing to affiliate; include a detailed description of lines of authority; (ii) Describe plans for a staffing structure, with roles and responsibilities that capitalize on the specific strengths of the SC PD(s)/PI(s), SC Coordinator, Outreach Coordinator(s). (iii) Describe prior relationship(s) between SC elements and summarize outcomes, and/or planned collaborations and anticipated value; and (iv) address any innovations unique to their organizational structure or processes to facilitate optimal performance to manage, conduct and evaluate clinical research protocol activities.

Network Affiliations: Provide detailed justification for the proposed affiliation with the ATN and corresponding Network research priority areas.

Performance and Past Experience: Describe (i) performance over the previous 5 to 7 years with participation in IND-level or other complex HIV/AIDS multicenter clinical trials or equivalent experience; (ii) strengths in overseeing and managing a complex clinical trials enterprise; and (iii) challenges experienced in overseeing and managing a complex clinical trials enterprise, as well as activities undertaken to overcome those challenges.

Letters of Support: Applicant must include a letter of support(s) from each site Director indicating agreement for collaboration with the OCC PD/PI and other partners within the proposed Site Consortium.

Resource Sharing Plan: Not applicable -- A Resource Sharing Plan is only required in the Overall Component of the application.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

PHS Human Subjects and Clinical Trials Information (Site Consortiums)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

 

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

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential fieldof 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following: peer review of the NICHD cooperative Program Project applications focuses on three areas: (1) review of the UM2 program as an integrated collection of Cores and Site Consortiums, and the overall scientific and technical merit of the program; (2) review of the individal Core; (3) review of the individual Site Consortiums.

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

Does the PD(s)/PI)s have the relevant experience in leading and managing complex programs, including the roles and responsibilties served? Is there relevant experience in protocol design, regulatory compliance, site selection, study implementation and coordination? Is there experience in project management and resource management and/or clinical research programs of similar size and scope?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Does the application include an effective and comprehensive data and resource sharing plan?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Review Criteria for Operations and Collaboration Core

For this component, reviewers will provide an assessment of its strengths and weaknesses. In particular, the following items should be evaluated while determining scientific and technical merit, and in providing an Impact Score for the Core. However, separate criterion scores will not be given for these items.

      • Are the planning and coordination of research activities adequately described and appropriate to support the network?
      • Are the design of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control appropriate?
      • Are there effective and appropriate strategies and processes to be used for administration, management, operations and collaborations to achieve the overall goals, including monitoring progress with respect to Milestones, implementation of the overall strategy, and proposed Timelines?
      • Is information on the integration of cross-disciplinary research, allocation of funds, and management of resources adequately described and appropriate to support the network?
      • Are the qualifications, experience, and commitment of the Core Project Manager and other Core personnel appropriate?
      • Are the Core's governance and organizational structure appropriate?
      • Have strategies for the maintenance and oversight of the Site Consortiums been appropriately described to be effective?

Review Criteria for Site Consortiums

For this component, reviewers will provide an assessment of its strengths and weaknesses. In particular, the following items should be evaluated while determining scientific and technical merit, and in providing an Impact Score for the Core. However, separate criterion scores will not be given for these items.

      • Does the Site Consortium PD(s)/PI(s) have the relevant experience in leading and managing a complex HIV/AIDS clinical research operation including the roles and responsibilities served?
      • Is there appropriate experience providing oversight and management of IND-level protocols conducted at multiple clinical research sites, including scientific contribution, strategic planning, prioritization and resource allocation within a highly regulated and collaborative research environment?
      • Do the PI and staff have appropriate experience in multi-center clinical research networks?
      • Is there adequate demonstration of prior ability to manage and administer a clinical research site effectively and retain vital staff with expertise in adolescent medicine and research?
      • Is there evidence that the past contributions have provided innovative approaches for research activities for at-risk youth and/or youth living with HIV?
      • Is there demonstration of collaborative capacity through existing relationships with local health departments and their awardees in the community to facilitate improved and innovative approaches for the identification, linkage to health care, and engagement in research of at-risk youth?
      • Is there demonstration of past ability to successfully recruit and retain participants in ATN or equivalent studies?
      • Are the site's management and communication plans adequate?
      • Are there adequate plans for implementing multiple intervention trials, including the ability to expand?
      • Is there adequate evidence that past plans resulted in community outreach and collaboration, as well as community representation in ATN research?
      • Is there adequate evidence of the required expertise, experience, and capacity of all staff to carry out the aims of the ATN research agenda?
      • Is there evidence of a well-established and managed health care delivery system provided by a multidisciplinary care team with the full scope of adolescent-specific services available on-site?
      • Is there evidence of experience with community engagement and collaboration?
      • Do all of the partnerships/organizations within the Site Consortium contribute to the ATN effectively and appropriately?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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 will receive a written critique.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH 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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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.

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

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

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

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

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

 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

ATN Operations and Collaborations Center (OCC)

The ATN OCC will consist of the Principal Investigator(s), project manager, and staff deemed necessary to carry out the mission of the OCC. The OCC project manager will coordinate the activities of the OCC at the direction of the Principal Investigator.

The ATN OCC will:

  • Provide operational support for the development of independent research projects supply the required capacity through the Site Consortiums, either directly or through performance-based subcontracts;
  • 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 for the designated Research Projects;
  • Provide data management and integrity, harmonization and sharing for cross-network protocols, collaborations and related projects
  • Conduct protocol and site registration and other regulatory duties as delegated from NICHD, including executing data use agreements to protect ATN data and subject rights;
  • Establish and support Data and Safety Monitoring Boards (DSMB), protocol safety monitoring committees and other functional groups, when instructed by NICHD;
  • 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;
  • Provide on-site monitoring for those studies being performed at a particular site on a schedule dictated by the EC, its authorized subcommittee or NICHD, as regulatory needs arise (e.g. registrational/IND trials);
  • Support the National Community Advisory Board (CAB) Representative Liaison to be selected by the ATN EC and provide logistical support to any CAB-associated meetings at the in-person national ATN meeting;
  • Participate in regular conference calls and attend meetings to be held at least semi-annually.
  • Maintain the ATN protocol disbursement fund and execute all necessary agreements to support study and subject accrual costs for protocols and collaborations, reconciling reimbursement to site performance, in consultation with the NICHD Project Scientist.;
  • Collaboratively plan and conduct all recurring EC and ATN meetings and work with other ATN SLC and NIH to assemble and convene the ATN External Advisory Group (EAG) at least annually;
  • Coordinate and implement necessary protocol activities including protocol trainings, workshops, etc. for cross-network protocols, collaborations and other projects
  • Provide administrative management and coordination of external collaborations with the network (including previous ATN research studies)
  • Provide operational support for the network – public relations and media interviews in coordination with the participating NIH Institutes, dissemination and education priorities, communications within the network such as listserv e-mail, formation of subcommittees (on topics such as ascertainment and sampling, publications, clinical issues), and conference calls;
  • Provide for mechanisms to monitor subject recruitment, retention, and dropout, and develop procedures for adjustment if enrollment targets are not being met;
  • Provide for a detailed system for regular tracking and reporting of study progress, including a description of performance metrics, milestones, timelines, and quality-control measures to keep the study on track and on budget; this system must also include strategies to identify and mitigate problems as they arise;
  • For cross-network and other collaborations, and high-priority protocols responding to emerging needs, develop and ensure that the ascertainment and sampling strategies are appropriate for the stated goals of the research project, solicit appropriate epidemiological expertise as needed;
  • Develop and maintain policies for presentation (e.g., at scientific conferences) and publication of findings in peer-review journals from the consortium’s research activities;
  • Work with the ATN EC to produce and maintain documentation of Network manual of operations which includes standard operating procedures and training manuals;
  • Develop and maintain a web site to publicize Network activities and provide a venue for public access to available Network resources;
  • Provide for the consultation of dedicated expertise and plans to address the various bio-ethical issues and concerns (e.g., handling of sensitive data, participatory risk, involvement of vulnerable populations, incidental findings, early substance use or substance use problems in study participants) that are likely to arise during the conduct of the research;
  • Provide a data sharing policy with explicit plans, procedures, milestones, and timelines to make the data and bio specimens available for access and analysis by the research community, as appropriate and in accordance with NIH policies and guidance;
  • Fully and transparently collaborate, including appropriate sharing of all necessary tools, materials, technologies and other essential methodologies necessary for protocol and program development, implementation and monitoring between the ATN OCC and ATN SLC Research Projects.

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 and/or peer 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 the SLC, the PD(s)/PI(s) from the ATN OCC, 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. The ATN EC will oversee the integration of efforts 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 other collaboration research agenda, and implementing these in the network, and initiating and maintaining collaboration 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 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:

  • Assist the ASLG in the identification of adolescent HIV/AIDS research objectives;
  • Approve the direction of the research effort including any reconfiguration of working groups to better address the direction of the scientific agenda;
  • Approve the ATN policies and procedures adopted, revised, or developed by the ASLG;
  • Critically evaluate and approve the research agenda specific to its scientific merit, feasibility, clinical relevance, and implications as well as advise on the development of implementation strategies;
  • Establish timelines for the completion of tasks and monitor progress;
  • Execute all Memoranda of Understanding or Agreement with other entities to conduct ATN developed or co-endorsed research;
  • 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 OCC;
  • 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, 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 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;
  • 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.

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 Executive Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Sonia Lee, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: LeeSonia@mail.nih.gov

Richard A Jenkins
National Institute On Drug Abuse (NIDA)
Phone: 301-443-6504
E-mail: jenkinsri@mail.nih.gov

Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: allisonsu@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

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

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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