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) Clinical Sites (U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	New
Related Notices	April 19, 2017 - This RFA has been reissued as RFA-MH-18-250. August 17, 2012 - Frequently Asked Questions available for RFA-MH-13-070. See Notice NOT-MH-12-031.
Funding Opportunity Announcement (FOA) Number	RFA-MH-13-070
Companion Funding Opportunity	RFA-MH-13-071, U24 Resource-Related Research Project - Cooperative Agreement
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.853
Funding Opportunity Purpose	This limited competition Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH) and the National Institute of Neurological Disease and Stroke (NINDS) solicits applications to continue the activities of the National NeuroAIDS Tissue Consortium (NNTC) Clinical Sites as previously funded under RFA-MH-08-021. The NNTC Clinical Sites collect neuromedical and neuropsychiatric data from late stage, HIV-infected subjects who have indicated a willingness to participate in organ donation. The NNTC Clinical Sites perform clinical assessments, collect brain and neurological tissues and fluids, perform neuropathological diagnosis and laboratory assessments and transfer select data generated from these activities to the NNTC central database which is maintained by the Data Coordinating Center (DCC). The mission of the NNTC is to maintain a research resource that supports studies on the pathophysiology of nervous system complications of HIV infection in the current era of anti-retroviral therapy. The Clinical Sites work cooperatively with the DCC to provide the clinical data and specimen resources to research investigators. Competitive applications for the NNTC DCC are being sought under a separate but related companion FOA (RFA-MH-13-071).

Posted Date	July 5, 2012
Letter of Intent Due Date	August 4, 2012
Application Due Date(s)	Not Applicable.
AIDS Application Due Date(s)	September 4, 2012
Scientific Merit Review	November 2012
Advisory Council Review	January 2013
Earliest Start Date(s)	April 2013
Expiration Date	September 5, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This funding opportunity follows RFA-MH-08-021 and RFA-MH-08-020 issued jointly by NIMH and NINDS, and aims to continue the NNTC as a resource for investigators interested in conducting NeuroAIDS research to identify the neuropathogenic mechanisms involved in HIV disease of the central and peripheral nervous systems (CNS and PNS, respectively).

The NNTC has served as a unique resource to NeuroAIDS investigators interested in conducting research in HIV disease of the CNS and PNS since 1998. The four current NNTC Clinical Sites and the Data Coordinating Center, (DCC), work cooperatively to provide research investigators with clinically annotated data sets that have been obtained during life, and associated post mortem brain tissue and fluids. This research resource is critical given the investigators need for high quality CNS tissue that is inaccessible to biopsy during life. The Clinical Sites, in collaboration with the DCC, comprise the NNTC. This Consortium has been credited as being instrumental in the research findings of more than 170 publications, and for having compiled an inventory of clinical datasets and specimens, all of which are made available as a research resource including; brain tissue, thousands of plasma and CSF specimens, and additional organs and tissues of interest.

HIV-infected subjects who have advanced disease are enrolled in the NNTC cohort, yet with improvements in disease management and anti-retroviral therapy, survival frequently exceeds expectations, thus the accrual of brain/tissue specimens has been slower than originally expected. The consortium also collects tissue and data from HIV negative individuals who wish to donate. The cohort currently consists of 604 HIV-infected subjects who are evaluated clinically at 6 month intervals. Evaluations are tiered and range from a full clinical assessment to a telephone assessment depending on the clinical status of the subject. Data and biological specimens are obtained using protocols that have been standardized and quality controlled across the consortium. Continuation of the data and specimen collection at the existing NNTC Clinical Sites is critical given that depletion of clinical specimens in high demand has occurred at a time when expanded studies of the mechanisms involved in the manifestation of HIV-associated CNS and PNS diseases is needed.

The key objective for this FOA is to pursue the continued operations of the NNTC Clinical Sites. The NNTC Clinical Sites will continue to collect CNS and PNS tissue and associated clinical data that will be made available to scientific investigators. Included in this goal is the need to incorporate recruitment strategies, based on current data and state of the science, and to selectively enhance the composition of the NNTC cohort. The Clinical Site recruitment strategies should take into consideration the resource needs of investigators engaged in NeuroAIDS research.

The secondary goal of this FOA is to ensure that all data from clinical assessments, pathology, and laboratory tests of clinical specimens performed at the NNTC Clinical Sites are rapidly deposited into the NNTC database to make them available to the research community. The DCC is responsible for the central management of data and will serve as the data repository for the NNTC Clinical Sites. The NNTC Clinical Sites should also ensure that the DCC has an up-to-date inventory of all tissue and fluid specimens collected and housed at the sites. In keeping with this goal, the Clinical Sites are also encouraged to collaborate with the DCC post award to enable deposition of all past clinical data, which has been collected at each site since 1998, into the NNTC central database. These data shall be made available to all qualified investigators via the DCC. Include a description of how the site will ensure quality control and confirmation for delivery of clinical data sets to the DCC.

The tertiary goals of this FOA include the use of the following common, standardized approaches: clinical assessment measures and methods among the NNTC Clinical Sites, a database system to exchange clinical data across NNTC Clinical Sites and with research investigators, and ensuring comparable quality assurance of data across sites. Such a standardized, high quality repository of NeuroAIDS data will enable multidisciplinary query capabilities and tools to accelerate discovery research for HIV-associated CNS and PNS diseases.

Recruitment strategies, which will be used to selectively enhance the continued recruitment of HIV-infected subjects into the NNTC cohort, should be responsive to the research needs of investigators. Investigator needs for research resources may be identified and informed by the scope of prior requests from investigators for NNTC resources and the state of the science. This FOA encourages developing recruitment strategies to enhance the NNTC cohort to help address the following emerging research areas in the NeuroAIDS field: a) eradication of HIV from persistent CNS reservoirs; b) pathogenic mechanism of HIV-associated neurocognitive disorders (HAND) in the setting of long term HAART; and c) HIV and aging.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIMH and NINDS intend to commit approximately $3.1 million in FY 2013 to fund 4 awards, including the four current NNTC clinical sites.
Award Budget	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. The application budget for each NNTC Clinical Site is capped at $775,000 per year direct cost.
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.

As this FOA is a limited competition opportunity, only the institutions that are the principal employers of the PD(s)/PI(s) of the National NeuroAIDS Tissue Consortium are eligible to apply in response to this FOA.

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

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, 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.

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 research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Dianne Rausch, Ph.D.
Division of AIDS Research
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6105, MSC 9616
Rockville, MD 20892-9616
Telephone: 301-443-6100
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: 301-443-3367
FAX: 301-443-4720
Email: [email protected]

All page limitations described in the PHS398 Application Guide must be followed, with the following requirements:

• Specific Aims section is limited one page maximum.
• Research Strategy section is limited to 12 pages including tables, graphs, figures, diagrams, and charts

The following section supplements the instructions found in the PHS Form 398 for preparing the grant application (U24). Additional instructions are required because the PH398 application Form 398 is designed primarily for the traditional individual, free-standing research project grant (R01) application and several sections have to be modified and expanded so that the form can be used to provide the information needed for a multi-component resource grant application.

Annual Meetings

The PD(s)/PI(s) of the Clinical Sites are expected to attend an annual meeting of the NNTC Steering Committee 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 will 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).

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Specific Aims (No more than 1 page.)

Each Clinical Site should articulate a plan for continuing resource operations including patient assessments, tissue collections, integration with the DCC, and novel recruitment strategies for enhancement of the NNTC cohort to meet the emerging needs of investigators engaged in NeuroAIDS research.

Research Strategy (No more than 12 pages.)

Responsive applications will address each of the following components (Page numbers indicated below are provided only as guidelines.):

1. NNTC Overview - 1-4 pages

2. Clinical Site Functions and Operating Procedures - 1-6 pages

3. Clinical Site Collaboration with the DCC 1-3 pages

1. NNTC Overview

Each Clinical Site application will provide background information regarding the overall NNTC approach to providing clinically annotated specimens and data to research investigators.

In addition, each site should include their progress in meeting their targeted enrollment and recruitment goals for the prior year, provide the number of annual autopsies collected by the site and identify whether they were conducted as part of the NNTC clinical protocol or outside of the NNTC clinical protocol. Each site should also include accomplishments from the previous award period.

2. Clinical Site Functions and Operating Procedures

Applicants should provide the following details:

• escribe the standard operating procedures to be used by the Clinical Site for performing clinical assessments and collecting clinical data and associated CNS and PNS specimens.
• Describe the recruitment and retention strategies and unique strengths of the Clinical Site to enhance recruitment into the NNTC cohort in order to meet the needs of the research community. In particular, provide details of unique site-specific strengths for collecting specimens and performing clinical assessments.
• Describe the Clinical Site-specific activities including monitoring adherence to informed consent and following-up cohort subjects to monitor disease outcomes. Describe how full participation in Steering Committee activities will be ensured, such as contributing to the agenda and work group activities, and including plans to participate on the Steering Committee calls, and teleconferences.
• Provide a description of the Consortium wide structure and operational agenda, and how the specific Clinical Sites will contribute and enhance the overall Consortium goals.
• Describe plans to include a Scientific Advisor (SA) on the team, preferably one who is not directly associated with the NNTC institutions and who can bring a broad and independent perspective to the NNTC, particularly in light of the rapidly changing manifestations of HIV-associated complications of the nervous system in the era of HAART.
• Define the process that the site will use to contribute to the current NNTC standardized assessments of neurocognitive, neurobehavioral, and other clinical status, laboratory assessments and specimen collections; include potential cost containment procedures for the structure, timing and tiered subject visits; describe quality control and quality assurance measures for the laboratory and the clinic; and describe how the site will facilitate access to care for HIV-infected patients.
• Describe how the Clinical Site will address between-site differences in the subjects recruited and retained within the NNTC cohort (demographics, language, recruitment number, length of patient enrollment and follow up), and how the site differences integrate into the Consortium-defined requirements.
• Discuss how collaboration and synergy with other NNTC Clinical Sites will be fostered and maintained; discuss how the specific-site will interact with the Steering Committee (SC) and the DCC (See Section VI. 2 - Cooperative Agreement Terms and Conditions of Award.); describe intra-site communication and decision-making practices. Each Clinical Site PD(s)/PI(s) should address how they will actively assume the responsibility and remain engaged with all SC activities and issues.

3. Clinical Site Collaboration with the DCC

To fully integrate the DCC into the Consortium and encourage capabilities for a federated repository of NeuroAIDS data and specimens, applications are expected to address the following:

• Detail Clinical Site plans for seamless and timely collaboration with the DCC.
• Describe the role and responsibilities of the Clinical Site to ensure transfer of the clinical, specimen and site-specific specimen inventory data to the DCC including: data configuration requirements, checks for quality control, and timelines.
• Describe the Clinical Site’s plan for ensuring transfer of all past NNTC clinical data, since the beginning of the NNTC in 1998, to the DCC for storage in the NNTC database and query by NeuroAIDS investigators within one year of award notice. The plan should include data collected from NNTC clinical assessments and in-clinic interviews, results from telephone interviews, and specimen annotations.
• Describe plans to provide the DCC a site-specific Specimen Inventory.
• Detail plans for maintaining the NNTC clinical database with a data dictionary which reflects the state of the science and nomenclature for the field of NeuroAIDS.
• Detail the process to be implemented by the site for responses to requests from investigators for research resources and provide a timeline for responsiveness.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

It is expected that applications will include information on the following aspects of data coordination, standardization, and sharing:

• Plans for interactions with other relevant ongoing studies of NeuroAIDS to maximize investments and further standardization and sharing across projects.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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

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

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

NIMH will hold a pre-application teleconference on Tuesday July 17, 2012 from 11:00am - 12:00pm (EST) to which all prospective applicants are invited. This is a technical assistance teleconference conducted by NIMH staff involved in managing this program to explain the goals and objectives of this initiative and answer questions from the attendees. Participating in the teleconference is neither required nor necessary for a successful application. It is intended to be an opportunity to clarify the objectives of the initiative. Potential applicants are encouraged to submit their questions or comments to [email protected] in advance of the call. Applicants interested in participating in the technical assistance call should send a message to the mailbox above to obtain a dial-in number. A set of Questions and Answers from the teleconference will be posted after the session on a site-to-be-determined and announced.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Has the site successfully recruited and retained sufficient numbers of participants and served as a research resource for NNTC data and specimens?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are there key personnel in place to conduct NNTC Clinical Site operations ranging from clinical exams and tissue banking to computer management and general study design and analyses?

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? Do the investigators present innovative recruitment strategies for enhancement of the NNTC cohort to fulfill the resource needs of investigators engaged in NeuroAIDS research? Are the site clinical, laboratory, and banking plans innovative?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Has the site budgeted sufficient time to ensure appropriate oversight of the NNTC site?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the recruitment strategies for the NNTC cohort feasible given the size and make-up of the cohort? Are the clinical plans for selecting and maintaining the cohort and obtaining data and specimens financially feasible and well coordinated with other Clinical Sites? Does the site propose an organizational structure that facilitates collaboration with the Data Coordinating Center, NNTC Clinical Sites, and research investigators?

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? Does the environment foster collaboration with other HIV/AIDS research groups through proximity to patient populations, established interactions with community advocacy groups, or access to other sources of funding in areas of science related to the aims of the NNTC? Are the infrastructure, available resources, study populations, and institutional collaborations in place and adequate to support the overall objectives of the NNTC?

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the 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/priority 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; 3) Genome Wide Association Studies (GWAS); and 4) Plans for interactions with other relevant ongoing studies of NeuroAIDS to maximize investments and further standardization and sharing across projects.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the participating ICs, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 and the National Advisory Neurological Disorders and Stroke 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.

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

The NNTC Clinical Site PD(s)/PI(s) have the following primary responsibilities:

• Committing at least 10% effort to: overseeing site-specific clinical assessment, specimen banking and brain pathology/specimen laboratory testing activities including follow-up of subjects to determine disease outcomes; ensuring that informed consent has been conducted appropriately; fully participating in Consortium wide activities including the SC meetings, work group meetings, and teleconferences and contributing to the determination of the agenda for the annual SC meeting.
• Implementing the NNTC recruitment strategy at the Clinical Site to inform the selective enhancement of the NNTC cohort and ensure the strategy for recruitment is responsive to the research resource needs of investigators; ensure rapid sharing of clinical data and associated clinical CNS and PNS specimens; and ensuring analysis of the resources according to NNTC standard operating procedures.
• Providing yearly progress reports which should include: a site specific report on the yearly change in cohort recruitment and retention including a table of participants under follow-up, the number of autopsies conducted on subjects and whether they were conducted on subjects in the cohort, the current specimen inventory, the requests for resources that have been received, a list of the number and types of resources provided to the investigators, a list of publications, articles in press, manuscripts in preparation, and abstracts.)
• Rapidly sharing quality controlled NNTC-related clinical data and specimen inventories with the DCC, updating the clinical data and specimen inventory within two months of data collection. Providing prompt responses to requests from investigators for NNTC-related research resources. Address any lapses in data transfer from the Clinical Site to the DCC according to the guidelines set up by the SC and communicate these lapses to NIH Program and scientific Staff within two months. NIH reserves the right to restrict funds to any NNTC clinical site on a semi-annual basis for failure to comply with the data sharing goals of the Consortium.
• Implementing policies related to the NNTC activities including publication, resource allocation, tissue request management, anti-retroviral medication reporting, quality control and quality assurance in the collection of resources, information flow, relevant staff changes, and training.
• Using methodologies determined by the DCC (in collaboration with the SC) and in accordance with the NNTC data sharing plan, provide all clinical data, specimen annotation data, and NNTC-related research data, dating back since 1998, to the DCC within one year of the notice of grant award.
• Retaining custody of and having 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:

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 Steering Committee.
• 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, inventory and cataloging of clinical specimens.
• Creating reports from the NNTC data for use in internal reports.
• Additionally, one agency program official from NIMH and one program director from NINDS will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

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), 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 NNTC cohort.
• 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) guidelines for the 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) providing rapid release of clinical specimens including careful consideration to releasing specimens at risk of depletion from the NNTC tissue banks; (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; and (5) reviewing the publication policy in the first 6 months of the funding cycle, and making amendments if necessary. 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 clinical data, a detailed inventory of 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 approval or not. 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 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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3012
Email: [email protected]

May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

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

Tijuanna DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9531
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.