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

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Limited Competition:  National NeuroAIDS Tissue Consortium (NNTC) Data Coordinating Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-MH-13-071

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-18-251

Companion Funding Opportunity

RFA-MH-18-250, U24 Resource-Related Research Projects – Cooperative Agreements

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

  93.242, 93.855

Funding Opportunity Purpose

 This Limited Competition Funding Opportunity Announcement (FOA) invites one application to continue the activities of the Data Coordinating Center (DCC) of the National NeuroAIDS Tissue Consortium as previously funded under RFA-MH-13-071. The DCC will function as part of the NNTC, a national resource that provides clinical data and biological specimens to NeuroAIDS investigators interested in conducting research toward a cure of Human Immunodeficiency Virus (HIV-1) infection from the central nervous system (CNS), and research on the neuropathogenesis of HIV-1 induced CNS and peripheral nervous system (PNS) dysfunction in the context of anti-retroviral therapy (ART). The DCC works cooperatively with the NNTC-affiliated clinical sites to provide the following: 1) management and database capabilities to ensure effective clinical and brain banking operations, and to serve as the data repository for the NNTC; 2) scientific expertise in biostatistics and HIV-1 epidemiology to enable broad analyses of the NNTC clinical database, and to aid in statistical analysis of recruitment and retention goals for the clinical sites affiliated with the NNTC; and 3) expanding the capability to include coordinating the distribution of data and specimens stored at other national and international clinical sites to ensure that NeuroAIDS investigators have access to CNS and PNS resources that are difficult to obtain from HIV-1 infected individuals across the lifespan. The clinical sites affiliated with the NNTC will have all patient contact which will include all clinical assessments ante mortem. The clinical sites will also be responsible for the collection and housing of post mortem clinical specimens. The DCC will serve as a NeuroAIDS data repository which will include the clinical assessment data and data obtained post mortem including brain pathology reports, laboratory tests conducted on the collected specimens/fluids, a comprehensive inventory of those specimens housed at each clinical site, and research data, such as bioinformatics datasets. A limited competition application for the NNTC DCC is being sought under a separate but related companion FOA (RFA-MH-18-250)   

Key Dates
Posted Date

April 19, 2017

Open Date (Earliest Submission Date)

June 26, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

July 26,2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

July 26, 2017, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

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

Scientific Merit Review

November 2017

Advisory Council Review

January 2018

Earliest Start Date

March 2018

Expiration Date

July 27, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners.

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

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

Table of Contents

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

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

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

This funding opportunity announcement (FOA) is being re-issued with the aim of supporting continuation of the NNTC as a resource for studies on the neuropathogenesis of HIV-1 induced CNS and PNS dysfunction in the context of ART, and research towards a cure of HIV-1 infection from the CNS including studies of viral persistence, latency, reactivation and eradication.

The NNTC is currently comprised of one Data Coordinating Center (DCC) and four NNTC Clinical Sites. The consortium works cooperatively to provide NeuroAIDS investigators with clinically annotated data sets and with specimens that have been obtained during life (plasma, CSF, blood); and at post- mortem (HIV-1 positive brains, HIV-1 negative brains, PNS tissue, heart, lung, liver, kidney, lymph nodes, blood and cerebral spinal fluid (CSF)). The NNTC Clinical Sites recruit and manage the NNTC Cohort which is comprised of late stage HIV-1 positive subjects who are willing to participate in organ donation and most of whom use ART. The NNTC Clinical Sites perform comprehensive clinical assessments (neuromedical, neuropsychological, psychiatric and virological data are collected ante mortem), and then at post-mortem, they collect brain and neurological tissues and fluids, perform neuropathological diagnosis and laboratory assessments and transfer all data generated from these activities to the data repository which is maintained by the DCC.  Research investigators may query the available NNTC clinical specimens and data at the NNTC website. 

HIV-1 induced neurological dysfunction and HIV-1 persistence in the CNS continue in people with chronic HIV-1 infection despite suppressive ART. To provide NeuroAIDS investigators with access to resources from such individuals, the resources of the CNS HIV-1 Antiretroviral Therapy Effects Research (CHARTER) studies are now fully integrated with the NNTC. The CHARTER specimens (plasma, CSF, buccal swabs, nucleic acids and neuroimaging) are maintained by one of the four NNTC Clinical Sites, the California NeuroAIDS Tissue Network. CHARTER data sets (clinical, laboratory, genetic, neuroimaging and research) are maintained by the DCC, and external requests for data or tissues are managed by the DCC in collaboration with the NNTC Clinical Sites. The DCC has also recently established the Global HIV-1 CSF Escape Consortium. CSF escape is a rare phenomenon that occurs when rebound viremia is detectable in the CSF of patients despite ART suppression of the virus in the peripheral blood. Researchers may contribute their relevant data for potential collaborative studies and participate in on-line forums by contacting the DCC. The specimens from CSF escape cases are stored at the clinical sites of origin. This funding opportunity announcement encourages expansion of the existing multi-site brain bank structure of the NNTC to affiliate the DCC with other national and international Clinical Sites that have collected CNS and PNS specimens and clinical/experimental data. The DCC-affiliated Clinical Sites will contribute NeuroAIDS data sets. The DCC will manage external requests for the data and the specimens stored at the affiliated clinical sites or other appropriate location. This will ensure that NeuroAIDS investigators have access to CNS and PNS resources that are difficult to obtain from HIV-1 infected individuals across the lifespan.

The NNTC has defined criteria for a unique subset of HIV-1 positive participants of the NNTC Cohort who were on suppressive ART in life and who participated in organ donation. Brain and other tissue specimens from this unique subset of the NNTC repository are entitled, "Virally Suppressed Cases" (NOT-MH-16-008). ART suppresses HIV-1 RNA levels in peripheral blood and CSF, yet it does not completely eliminate the virus. Viral rebound becomes detectable in the peripheral blood and CSF within weeks when patients cease taking their anti-retroviral medication. The NNTC successfully documents the neurocognitive status and last known HIV-1 viral load prior to death for the late-stage NNTC Cohort. However, ethical and palliative care of individuals often involves cessation of ART. Brain and fluid resources obtained in combination with de-identified medical records from donors who die suddenly from other causes may support studies on the mechanisms by which comorbidities develop in association with the neurological complications of chronic HIV disease. Additional brain specimens and clinical data from HIV-1 positive donors who die suddenly from other causes are also needed to support researchers involved in determining the cellular and tissue sources of latent HIV-1 under suppressive therapy. This is critical since latent virus may be a source of rebound viremia if ART resistance develops in the CNS or upon cessation of therapy. This FOA encourages identification of additional CNS and PNS research resources from individuals who are surviving HIV-1 infection with ART suppression, yet die suddenly from other causes.

The key consortium wide objectives for this and the companion FOA, RFA-MH-18-250, are to ensure that NNTC CNS and PNS tissues/fluids and data are available and useful to investigators for examining emerging topics in the NeuroAIDS field such as research: a) towards a cure of HIV-1 infection from the CNS including studies of viral persistence, latency, reactivation and eradication in the context of ART; b) on neuropathogenic mechanisms of HIV-1 induced neurological dysfunction in the setting of ART; and c) on understanding comorbidities associated with HIV-1 induced neurological dysfunction including aging with chronic HIV-1 disease. Through these two FOAs, the NIH expects to continue to fund one DCC (RFA-MH-18-251) and up to four NNTC Clinical Sites (RFA-MH-18-250).

Data Coordinating Center Objectives

The key objective for this FOA is to pursue the continued operations of the DCC. The DCC works with the NNTC Clinical Sites which manage the late stage NNTC cohort and NNTC-affiliated Clinical Sites with the NNTC to provide the following: 1) management and database capabilities to ensure effective clinical and brain banking operations and to serve as the data repository for the NNTC; 2) scientific expertise in biostatistics and HIV-1 epidemiology to enable broad analysis of the NNTC database; and 3) expansion capability to include coordinating the distribution of specimens and data stored at other national and international clinical sites to ensure that NeuroAIDS investigators have access to CNS and PNS specimens that are difficult to obtain from HIV-1 infected individuals across the lifespan.

In this consortium, the clinical sites affiliated with the NNTC will have all patient contact which will include all clinical assessments ante mortem. The clinical sites will also be responsible for the collection and housing of post mortem clinical specimens. The DCC will serve as a data repository for all NNTC-affiliated clinical site activities including the clinical assessment data and data obtained post mortem including brain pathology reports, laboratory tests conducted on the collected specimens/fluids, a comprehensive inventory of those specimens housed at each clinical site, and research data including bioinformatics data sets and research data provided by NeuroAIDS investigators who have used NNTC resources. 

The DCC works collaboratively with the clinical sites to define recruitment strategies used to selectively enhance the recruitment of HIV-1 infected subjects into the clinical site cohort.  Recruitment strategies should be responsive to the evolving research needs of NeuroAIDS investigators for CNS and PNS tissue, fluids and data sets. The needs of NeuroAIDS investigators for resources may be identified and informed by the scope of prior requests, statistics and epidemiological analysis of the NNTC database and the state of the science. This FOA encourages development of recruitment strategies to enhance the clinical sites to help address the following research areas of high priority to the NIH: a) curing HIV-1 infection in the CNS, including studies of viral persistence, latency, reactivation and eradication in the context of ART; b) research on the neuropathogenesis of HIV-1 induced CNS and PNS dysfunction in the context of ART; and c) understanding comorbidities associated with HIV-1 induced neurological dysfunction including aging with chronic HIV-1 disease.

Protections for Human Subjects:  Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly.  Clinical research policies, guidance, and resources can be found on the NIMH Clinical Research website: http://www.nimh.nih.gov/funding/clinical-research/index.shtml

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

Renewal

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

Funds Available and Anticipated Number of Awards

NIMH and NINDS intend to commit approximately $600,000 in FY 2018 to fund 1 award. Although the financial plans of NIMH and NINDS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. Funding beyond the first year will be contingent upon satisfactory progress during the preceding years and availability of funds.

Award Budget

Budgets for direct costs may not exceed $600,000 per year.

Award Project Period

 The total project period for an application submitted in response to this FOA may not exceed five years.     

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

 The competition for this FOA is being limited to the current awardee of the National NeuroAIDS Tissue Consortium Data Coordinating Center (U24), funded under RFA-MH-13-071.  

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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:
Email: NIMHReferral@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

PD(s)/PI(s) of the DCC

Due to the complexity and time required to maintain a well-coordinated, communicative and productive research effort, a minimum effort of 3.6 person months effort to DCC activities including the combined effort of potential multiple PI(s)/PD(s) is required by this FOA.

NNTC Clinical Site Visits

The PD(s)/PI(s) of the DCC will schedule clinical site visits to perform training, data audits and data management at the four NNTC Clinical Sites which oversee the late-stage NNTC Cohort on a yearly basis.  Applicants to this FOA should include travel to the NNTC Clinical Sites in their proposed budget. (See Section VI.2 Cooperative Agreement Terms and Conditions of Award).

Annual Meetings

The PD(s)/PI(s) of the NNTC Data Coordinating Center is expected to attend an annual meeting of the NNTC Steering Committee (SC) in the Washington D.C. area, or another agreed upon locality.  The meeting will also be planned and attended by the PD(s)/PI(s) of the DCC and any delegates of the DCC PD(s)/PI(s). Applicants to this FOA should include travel to the annual meeting in their proposed budget, which should include travel for themselves and a Scientific Advisor (SA). (See Section VI.2. Cooperative Agreement Terms and Conditions of Award).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims

The specific aims should include management strategies and processes for efficient database operations to ensure effective clinical and brain banking functions. The PD(s)/PI(s) should articulate plans to conduct ongoing biostatistical and epidemiological analysis of the NNTC database to feedback information to the NNTC Clinical Sites to guide recruitment of new subjects into the cohort and to the research community at large to inform new hypothesis driven research. 

Research Strategy

Complete applications will address each of the following components:

1.  DCC Overview

2.  DCC Management Capabilities

3.  DCC Database Capabilities

4. DCC Scientific Expertise in Biostatistics and HIV-1 Epidemiology

5. DCC Collaboration with the Steering Committee and affiliated clinical sites

1. NNTC Overview

Background and Experience.  Describe the DCC in relation to the NNTC. Describe the experience of the DCC in providing management of effective tissue and data repository operations including providing NeuroAIDS pathology expertise, database expertise and security, biostatistics and HIV-1 epidemiology expertise to aid recruitment and retention goals for the NNTC Cohort and to inform new hypothesis driven research.

Organizational Structure. Describe the governance of the DCC in relation to the NNTC including the role of the team in responding to cohort changes and the changing needs of NeuroAIDS investigators for CNS and PNS resources.

Database. Describe the unique characteristics of the NNTC database including the clinical, bioinformatics and incorporation of research data from NeuroAIDS investigator requests. Describe the ability of the DCC to incorporate management of resources and de-identified clinical data from other national and international clinical sites and include information pertaining to database security and available back-up systems.

Progress. Describe the activities of the DCC in managing the NNTC. Describe any perceived gaps in NNTC research resources based on NeuroAIDS investigator requests, DCC biostatistics and epidemiological analysis of the database and the state of the science. Provide an analysis of the NNTC database and bioinformatics repositories including efforts to incorporate research data from requestors who have used the NNTC resources. Provide a table summarizing the active NNTC cohort, the number and types of specimens collected at the NNTC Clinical Sites including integration of CHARTER study resources and provide the number of requests for resources and the number of specimens shipped to investigators.

2.  DCC Management Capabilities

Describe plans and activities to meet and fulfill the DCC-specific activities and goals of the DCC, which include:

  • Support and collaborate with the NIH, clinical sites, Steering Committee (SC), and NeuroAIDS investigators to yield a research resource capable of providing access to clinical specimens, research data and tools to accelerate discovery research on the neuropathogenesis of HIV-1 induced CNS and PNS dysfunction in the context of ART, and CNS-based HIV-1 cure research.
  • Ensuring logistical communications and management support necessary to coordinate the DCC tasks including, but not limited to: conducting monthly teleconferences of the SC and work groups, writing, organizing and distributing NNTC-related reports including regular conference calls of the SC, annual meetings of the SC, other work groups and reports that may be requested by the NIMH PS and NIH Program Staff; coordinating and archiving information regarding NNTC activities; and producing any NNTC-related resource reports.
  • Providing a description of the overall strategy and operational plan to serve as an information conduit between the consortium members, scientific community being served, and layman public audiences by producing appropriate distribution materials on behalf of the NNTC. This includes updating, and advertising a public NNTC website, actively promoting broad utilization of NNTC resources by outside investigators, and providing toll-free telephone access by which researchers may contact the DCC.
  • Including a description of the communications and organizational structure of the DCC and describe any cooperative administrative arrangements involved if multiple institutions will be involved with the DCC. Providing a DCC work flow plan which fosters reasonable and synergistic approaches to interact with the clinical sites and the Steering Committee to ensure the following: internet query tools are available to researchers for conducting searches of the NNTC specimen and data resources, ensuring technological collection and tracking of requests from researchers for specimens and data, distributing requests to individual clinical sites, coordinating the approval of requests in a timely manner with the SC, coordinating shipments of specimens to domestic and foreign countries (i.e., meeting local and international shipping regulations and laws; assuring sample integrity for extended shipment), and following up on receipt of sample delivery along with investigator feedback.
  • Maintaining and distributing a list of all publications, manuscripts in progress, abstracts, and presentations for which NNTC data and/or clinical specimens are involved. Maintaining a searchable web-based archive of NNTC publications. Providing a forum for posting, circulating and consolidating input on drafts of manuscripts by consortium participants. 
  • Coordinating and providing access to NNTC datasets for presentations and publication of study-wide data.
  • Monitoring adherence to clinical and laboratory protocols across the clinical sites, and coordinating implementation of any new or modified protocols that the SC approves during the course of the project.
  • Preparing and updating operations manuals and data collection forms, as well as coordinating the revision of existing NNTC questionnaires, and the development and testing of new questionnaires for utilization by the Clinical sites, including the standardization of procedures for data collection.
  • Preparing a quarterly NNTC public-use data (PUD) electronic file covering the data collection period. All collected variables must be provided in a widely useable format with appropriate, complete data dictionaries to accompany the data.
  • Providing the research community with a better understanding of the strengths, limitations, and flexibility associated with research projects based on NNTC collections.

3.  DCC Database Capabilities

Provide a description for the DCC-specific capabilities that will allow the DCC to fulfill the primary objectives, which include:

  • Maintaining the centralized NNTC database on a secure network server that contains unidentifiable patient-related information (such as cognitive status, drug use history, neuropsychological history, and CD4 count etc.), general demographics, and pathological data. The NNTC data management system should be capable of processing and retrieving of NNTC-related data, and facilitating the rapid transfer, editing, cleaning, quality, reporting, and storing for query of data. The NNTC database should have a data dictionary appropriate to the research on the neuropathogenesis of HIV-1 induced CNS and PNS dysfunction in the context of ART, and CNS-based HIV-1 cure research terminology that is able to be updated with new terminology as the field progresses. Inclusion of the following datasets into the NNTC database is expected: the central NNTC clinical database, past NNTC-related clinical and specimen data files obtained from the NNTC Clinical Sites since 1998, the bioinformatics repository, the CHARTER study data sets and future NNTC-associated biomedical research data sets into a NNTC database.
  • Maintaining and monitoring a password-protected website accessible to authorized users.
  • Providing a detailed plan to ensure a rapid, streamlined, yet quality controlled process for data acquisition from the Clinical sites and biomedical investigators engaged in studies which utilize the NNTC resources.
  • Training consortium staff and NeuroAIDS investigators in any data collection, submission to the database, query of the database and any new database entry method that results from SC approved changes in database operations. Providing technical assistance related to data transfer.
  • Describing the role, responsibilities, requirements, and timelines of the DCC for rapid placement of all clinical site-related data obtained from clinical assessments, telephone interviews, and specimen annotations from the longitudinal databases into the public domain via the DCC, according to the "Cooperative Agreement Terms and Conditions of Award" outlined in Section VI.2, and in collaboration with the four NNTC Clinical Sites which oversee the late-stage NNTC Cohort, including responsibilities, effort, requirements for collaboration with the clinical sites, and timelines.

4.  DCC Scientific Expertise in Biostatistics and HIV-1 Epidemiology

Describe how the DCC will:

  • Provide the scientific expertise in HIV-1 epidemiology and biostatistics to support analysis of the NNTC database on behalf of NeuroAIDS investigators.
  • Conduct post award statistical analysis of recruitment and retention goals for the NNTC Cohort.
  • Perform on-going database-derived scientific analyses for the clinical sites to guide ongoing recruitment of new subjects into the end-stage cohort and identify gaps in the available NNTC resources as determined by investigator requests, inform reports for the SC and NIH Program Staff, generate descriptive statistics for the public website and provide reports to the research community at large that may inform new hypothesis driven research.
  • Facilitate query and statistical analysis of the NNTC database by research investigators.

5.  DCC Collaboration with the Steering Committee and Clinical sites

Address plans to:

  • Work collaboratively with the Steering Committee, the clinical sites, a NIMH Project Scientist, and Program Staff from both NIMH and NINDS.
  • Collaborate with the clinical sites to provide, update, and maintain a detailed NNTC Specimen Inventory according to the guidelines specified by the SC. Coalesce data from each NNTC Clinical Site and provide an annual summary of the NNTC Specimen Inventory in annual Project Reports to NIH.
  • Present clinical specimen requests from NeuroAIDS investigators to the SC according to the procedure and timelines specified by the SC.

Remain responsive to the Steering Committee which governs the NNTC. Note that all activities of the NNTC must be reviewed, discussed, and shaped by the SC.

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

It is expected that NNTC applications will include plans for interactions with the clinical sites and the DCC as well as other relevant ongoing studies of NeuroAIDS within the NNTC to maximize investments and further standardization and sharing across projects.

  • All applications, regardless of the amount of direct costs requested for any one year, should address an individual Resource Sharing Plan which will then be incorporated into a consortium wide NNTC Data-Sharing Plan prior to award. For this FOA and the companion FOA (RFA-MH-18-250), the PD(s)/PI(s) of the NNTC DCC and Clinical Sites will collaborate with NIMH during the pre-award period to develop a consortium-wide NNTC Resource Sharing Plan consistent with achieving the goals of the program. The consortium-wide NNTC Resource Sharing Plan that will specify the criteria for access to specimens, de-identified data, conditions for research use and procedures and timelines for vetting requests for access to data maintained by the NNTC-affiliated clinical sites and the DCC. The consortium-wide NNTC Resource Sharing Plan and other Just-In-Time information are required prior to award. The applicant should propose a resource sharing plan in the application that takes into account this expectation. Applications should include information on the data dictionary, type and descriptors of data to be shared (i.e., national and international clinical site protocols and data, laboratory, bioinformatics and research data sets), as well as a plan for data quality control and assurance, coordination, standardization, access privileges, and the schedule and timeline for release of data (time from acquisition to release to the public), consistent with achieving the goals of the program.
  • Describe how the data from the site should be made available to the research community through publications, or public website consistent with achieving the goals of the program.
  • Describe the procedure to be followed in the event that participants withdraw consent to share their individual-level data (i.e., the timeframe and documentation for alerting the NNTC DCC to request that the specific research participant’s data be removed from future data distributions and any data that may have already been distributed to researchers will not be retracted).
  • Include plans for maintenance, or transfer of ownership of the NNTC database and bioinformatics repository if they are to be stored beyond the funding period, as appropriate and consistent with achieving the goals of the program.

Appendix:

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

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

 Does the proposed project address the needs of the research resource that it will serve? Is the scope of activities proposed for the project appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource? Does the DCC fulfill other roles and duties that are critical to the success of the NNTC and to the work of external collaborators? 

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the project? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing the research resource? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the project is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Project? Does the applicant have experience overseeing selection and management of sub awards, if needed? Are the expertise and commitment of the PD(s)/PI(s) and other key personnel adequate for the required scope and objectives of the Data Coordinating Center?  Have the PD(s)/PI(s) demonstrated sufficient leadership in coordinating tissue banking activities across multiple institutions?  Are there key personnel in place to conduct NNTC operations ranging from epidemiology, statistics and bioinformatics to managing resource requests, managing websites and communication portals, and ensuring high quality NNTC data is received from the clinical sites and made available to NeuroAIDS investigators? Do the PD(s)/PI(s) have experience with database platforms and data security? Have the PD(s)/PI(s) budgeted sufficient time to ensure appropriate oversight of the Data Coordinating Center? 

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research resource the Project will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, or management strategies proposed? Do the PD(s)/PI(s) propose innovative approaches and practices in data and inventory management systems, database capacity, and communications in support of the clinical and banking operations?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the project will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? Have the PD(s)/PI(s) appropriately addressed the responsibility of developing the logistics and communications that are necessary to coordinate the NNTC activities?  Has the application demonstrated how appropriate training will be conducted to ensure rapid, high quality data collection, submission to the database, and query of the database?  Is the approach for working with the clinical site PD(s)/PI(s) and Steering Committee members reasonable and synergistic? If multiple institutional sites are involved does the application include a detailed description of the cooperative administrative arrangements? Does the application incorporate novel technologies to enhance the tracking of NeuroAIDS investigator requests and query tools?

Environment

Will the institutional environment in which the project will operate contribute to the probability of success in facilitating the research projects it serves? 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 institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Does the environment in which the work will be done contribute to the probability of the success of the NNTC DCC and PD(s)/PI(s) in addressing the multifaceted responsibilities?  

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, 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.

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 National Advisory Mental Health Council. The following will be considered in making funding decisions:

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

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

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

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75and other HHS, PHS, and NIH grant administration policies. 

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

The Data Coordinating Center PD(s)/PI(s) will have the following primary responsibilities:

  • Committing at least 3.6 person months effort to DCC activities including the combined effort of potential multiple PI(s)/PD(s).
  • Developing a plan for ongoing analysis of data generated by clinical and pathological assessments provided by the NNTC Clinical Sites which oversee the late stage NNTC cohort and to ensure that the recruitment and retention of the NNTC Cohort remains statistically powered to achieve the priorities and to identify gaps in the available resources as determined by investigator requests. Providing scientific expertise in biostatistics and HIV-1 for all aspects of the DCC operations where the expertise is needed, including analysis of the NNTC database as needed.
  • Integrating the other national and international NNTC-affiliated Clinical Sites into the DCC including the Global CSF Escape Consortium.
  • Implementing policies related to the NNTC activities including publication, resource allocation, tissue request management, and anti-retroviral medication reporting which have been approved by the Steering Committee (SC).
  • Implementing and maintaining a detailed system for tracking Clinical Site data and specimen inventory. The DCC will obtain data and specimen inventories within two months of collection at the clinical sites. Any lapses in data transfer from the four NNTC Clinical Sites which oversee the late-stage NNTC Cohort should be communicated and dealt with according to the guidelines set up by the SC and communicated to the NNTC Clinical Sites which oversee the late stage cohort and NIH Program Staff within two months. NIH reserves the right to restrict funds to the NNTC Clinical Sites which oversee the late stage cohort on a semi-annual basis for failure to comply with data sharing goals of the consortium.
  • Enabling rapid receipt, quality control and assurance, and investigator access to all NNTC-related clinical datasets and specimen annotated data held in the NNTC database.
  • Providing logistical support for the consortium including distributing documentation and writing meeting summaries for the regular conference calls of the SC, annual meetings of the SC, and other committees.
  • Organizing, attending and leading the annual SC meetings.
  • Scheduling site visits to the NNTC Clinical Sites which oversee the late stage NNTC cohort to perform training, data audits and data management at the four NNTC Clinical Sites which oversee the late-stage NNTC Cohort on a yearly basis.
  • Management of NeuroAIDS investigators' requests for specimens and data with the SC, prioritizing requests for specimens, and facilitating delivery of specimens to investigators in a timely manner.
  • Providing an annual progress report on the following: a) a summary of the biostatistics and epidemiology activities; b) progress on the methods used to affiliate other national and international Clinical Sites with the DCC including the Global CSF Escape Consortium; c) progress on efforts to re-capture research data from requestors who have used the NNTC resources; d) management of the DCC and Consortium; e) an updated NNTC Specimen Inventory; f) a table summarizing the active NNTC cohort enrolled at the four NNTC Clinical Sites which oversee the late-stage NNTC cohort, the number and types of specimens collected at the four NNTC Clinical Sites, the number of requests for resources and the amount of time lapsed from receipt of requests for resources and approval/denial by the Allocations Committee, the number and quantity of specimens actually shipped to investigators and the time lapsed from approval to actual shipment, identification of gaps in NNTC research resources, reports of problems in data collection, record abstraction and information flow, and an annual analysis of the NNTC database and bioinformatics repository. The DCC will provide a Clinical Site-specific and consortium wide Specimen Inventory for inclusion in an annual progress report to the SC, NIMH, and NINDS Program Staff.
  • Providing centralized storage, security, processing and retrieval of NNTC data within a data management system and ensure its adequacy for the expanding needs of the NNTC including facilitating the rapid transfer, editing, cleaning, quality, reporting, and storing for query of data collected from clinical sites.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Project Scientist:

The NIMH will appoint a Project Scientist (PS). Only the NIMH PS will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants or cooperative agreements. The NIMH PS will be responsible for:

  • Participating as a voting member of the NNTC SC. 
  • Contributing to the post award design. 
  • Monitoring study results and quality assurance across all sites. 
  • Reviewing all study protocols and data. 
  • Overseeing the collection, storage, and inventory along with cataloging of clinical specimens. 
  • Creating reports from the NNTC data for use in internal reports. 

Program Officer:

One program official from NIMH will be the assigned program officer on the cooperative agreement applications and will work closely with a program director from NINDS.  Jointly, the two will be responsible for the normal scientific and programmatic stewardship of the award and will both be named in the award notice.

Areas of Joint Responsibility include:

Members of the NNTC Steering Committee (SC) include the following:  NIH Program Officers and NIMH Project Scientist; the PD(s)/PI(s) of each grant award, or a designated representative in the case of a multiple PI award; and one Scientific Advisor (SA) from each clinical site.  The Data Coordinating Center PD(s)/PI(s) (DCC PI), or a delegate of the DCC PI, will serve as Chair of the SC (SC Chair).  Voting members will consist of each Clinical Site PD(s)/PI(s), the DCC PI or the delegate, the SC Chair (if different from the DCC PI), and the NIMH Project Scientist (NIMH PS).  In the case of multiple-PD(s)/PI(s) or in the case of a delegate of the DCC PI serving as SC Chair, consensus should be reached among those PD(s)/PI(s) in casting a single vote.  Decisions of the steering committee will be accepted by all members.  The SC has the following responsibilities:

  • Implementing the Consortium objectives at the Clinical Sites and updating these as needed especially in regards to updated factors for selecting subjects into the late stage NNTC Cohort. 
  • Ensuring the continued allocation of the CHARTER study resources.
  • Ensuring overall operations and directions of the NNTC are in keeping with very high standards, ensuring systematic assessment of priorities and timelines, suggesting improvements to the selection of the existing cohort, providing guidance on how best to accomplish quality control of clinical specimens and data, and promoting the utilization of NNTC specimens and data resources. 
  • Establishing and maintaining collaborative relationships that facilitate the Consortium’s objectives. These relationships include those between the Clinical Site investigators, the Steering Committee members, patient communities, the staff at the NIH institutes that are funding the NNTC, and other research communities relevant to goals of the Consortium. 
  • Establishing clear data sharing guidelines for the Consortium to ensure rapid transfer of all quality controlled data and specimen inventories to the DCC. Lapses in data transfer from the Clinical Site to the DCC that are longer than two months after data collection should be communicated to the SC in a timely manner. NIH reserves the right to restrict funds on a semi-annual basis for failure to comply with the data sharing timelines of the Consortium. 
  • Conducting an annual, full-day meeting of the SC. The meeting will be convened in the greater Washington, DC area, or other convenient location. These meetings are intended to: identify new areas of collaboration among the Consortium; decide scientific policy; address organizational issues concerning implementation and oversight of selective recruitment of the NNTC Cohort; identify gaps in the available research resources; determine the need for and memberships on working groups; and discuss issues regarding publications, access to data, interim data monitoring, and investigator access to clinical specimens and data sets.  The focus of the meetings will also include: determining how the scientific and technical expertise, facilities, and other resources of the NNTC can contribute to ongoing or new projects; and sharing of data.  PD(s)/PI(s) will also be expected to present their progress and discuss future strategic plans for the Consortium. 
  • Specifying the guidelines and procedures for the Consortium including: (1) the timely approval of requests for biological specimens, clinical data, mining of NNTC datasets, analytical assistance provided by the NNTC, and access to NNTC-related research data; (2) the timely shipment of clinical specimens to approved requestors including careful consideration to releasing specimens at risk of depletion from the NNTC tissue banks and coordinating shipments of specimens to domestic and foreign countries (i.e., meeting local and international shipping regulations and laws; assuring sample integrity for extended shipment), and following up on receipt of sample delivery along with investigator feedback; (3) contributing to the establishment and maintenance of a NNTC specimen inventory to be administered by the DCC; (4) monitoring adherence to informed consent procedures including the signatures of the NNTC participants; (5) reviewing all NNTC-related policies and documents in the first 6 months of the funding cycle, and making amendments if necessary; (5) notifying NNTC-affiliated investigators to include a Human Subjects Section if they incorporate use of NNTC resources into an NIH grant application, or if they meet the definition of an investigator in a recipient's research.
  • The timely dissemination of study results to the communities involved is strongly emphasized.

Access to Data and Specimens

In view of the importance of biological specimens and data, a detailed specimen inventory including the number and types of biological specimens and clinical data should be reported to the DCC by the Clinical Sites.  All requests for access to and/or release of NNTC-related specimens and/or data, whether from investigators internal or external to the NNTC, should include a detailed description of the study for which specimens are sought and the number and volume of specimens requested.  Such requests should be made in accordance with a standardized NNTC Data and Specimen request form which is provided to the SC for consideration.  Prior to approval and release of specimens and/or data, research plans submitted to the SC will be evaluated to determine appropriate procedures are in place for any additional human or vertebrate animal work.

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

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Scientific/Research Contact(s)

Deborah Colosi, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-605-2275
Email: Deborah.Colosi@nih.gov

May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:  301-496-1431
Email:  wongm@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

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

Tijuanna Decoster, Ph.D
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231 
Email: tijuanna.decoster@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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