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)

Funding Opportunity Title

Novel NeuroAIDS Therapeutics: Integrated Preclinical/Clinical Program (P01)

Activity Code

P01 Research Program Projects

Announcement Type

Reissue of PAR-10-216

Related Notices

  • January 10, 2014 - See Notice NOT-MH-14-003. The purpose of this Notice is to clarify the instructions posted under Section IV. Application and Submission Information.

Funding Opportunity Announcement (FOA) Number

PAR-13-267

Companion Funding Opportunity

None  

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242 

Funding Opportunity Purpose

The National Institute of Mental Health invites research grant applications to develop innovative programs to advance therapeutics for NeuroAIDS. This Funding Opportunity Announcement (FOA) will support research programs that will advance central nervous system (CNS)-focused therapeutic approaches to: a) address HIV-associated neurocognitive disorders in HIV-infected individuals on highly active anti-retroviral therapy (HAART), b) eradicate persistent HIV-1 from the CNS during chronic infection, c) prevent establishment of HIV-1 in the brain during early infection, and d) assess the potential for CNS toxicity using HAART or candidate drugs that are currently in clinical studies to eradicate HIV-1. Studies to create or adapt existing animal models of HIV-1 infection in the CNS may be proposed to enable assessment of novel HIV CNS-focused therapeutic candidates. Multi-disciplinary, multi-project programs that are focused on improving neurocognition in HIV-infected persons are encouraged. A well defined, synergistic and milestone-driven plan for discovery, preclinical, and/or early clinical hypothesis-driven research should be presented. Public-private partnerships are encouraged but not required.

Key Dates
Posted Date

July 8, 2013

Open Date (Earliest Submission Date)

December 7, 2013

Letter of Intent Due Date(s)

December 7, 2013; December 7, 2014; December 7, 2015, by 5:00 PM local time of applicant organization.   

Application Due Date(s)

Not Applicable

AIDS Application Due Date(s)

January 7, 2014, January 7, 2015, January 7, 2016, by 5:00 PM local time of applicant organization.

Scientific Merit Review

March 2014; March 2015; March 2016 

Advisory Council Review

May 2014, May 2015, May 2016

Earliest Start Date

June 2014, June 2015, June 2016

Expiration Date

January 8, 2016

Due Dates for E.O. 12372

Not Applicable 

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
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


Background

The first goal of this funding opportunity is to foster translation of research discoveries that will help to advance a safe and effective preventative strategy and/or therapeutic drug to treat HIV-Associated Neurocognitive Disorders (HAND). Despite the widespread use of anti-retroviral therapy, the prevalence of HAND remains significantly high. HAND uses defined criteria for classifying various stages of CNS disease in the post-HAART era. The categories of HAND include Asymptomatic Neurocognitive Impairment (ANI), Mild Neurocognitive Disorder (MND), and HIV-Associated Dementia (HAD). According to the NIMH-supported CNS HIV Anti-Retroviral Therapy Effects Research, or CHARTER Study, begun in 2002, the prevalence of MND and ANI are high, and these mild neurocognitive deficits can interfere with activities of daily living and reduce quality of life in long-standing aviremic HIV-positive patients. Thus, there is a vital need to develop novel therapeutic strategies to treat the consequences of HIV infection in the CNS.

HIV-associated injury to the CNS is thought to result from viral neurotoxicity that leads to direct neuronal loss and indirect chronic low level immune activation in the CNS. HIV-1 infection of the brain involves productive infection of perivascular macrophages, T cells, microglia, and restrictive infection of astrocytes, but not neurons. Identification and validation of viral and host factors that are associated with HIV-related CNS injury will likely aid in the drug discovery process. 

The second goal of this funding opportunity is to foster research that is focused solely on CNS HIV-1 latency that will provide the foundation for rapid development of innovative therapeutic interventions to eradicate HIV-1 from the brain. One of the challenges includes ensuring the discovery and development of drug candidates that are able to penetrate the blood-brain barrier. Another challenge is that the current HIV-1 eradication strategy to reactivate the virus may have detrimental effects in the CNS due to neuronal toxicity and inflammatory sequelae. Therefore, there is a need for discovery research to identify and advance therapeutic approaches that are focused on eradication of latent HIV-1 specifically from the brain compartment. 

Given the difficulty of pursuing HIV-1 in the CNS of humans, this funding announcement also encourages applications that focus on adapting or refining existing animal models that will then be used to test CNS-focused therapeutic strategies. Thus, animal models of viral infection of the CNS will be used for the two therapeutic goals of this initiative: treatment and prevention of HAND and HIV-1 eradication from the CNS.       

Research Objectives

The objective of the Novel NeuroAIDS Therapies: Integrated IPCP is to develop new therapeutic approaches to HAND and CNS HIV-1 eradication.

Applications focused on a plan to advance the program from discovery to clinical research are encouraged.

Discovery research.  Examples of discovery research include, yet are not limited to, the following:

Preclinical research:  Examples of preclinical research include, yet are not limited to, the following:

Clinical Research: For the purposes of this FOA, clinical research refers to Phase 1 studies in humans (10-30 subjects).  Note: This FOA will support one clinical study that is authorized by the FDA for IND status,IND-ready, as appropriate.

Research Scope

Examples of the CNS-specific research focus areas that are pertinent to this FOA include, but are not limited to, the following areas:

Neurological and neurocognitive deficits in HIV-infected individuals on HAART

Eradicate HIV-1 from the brain

Applications that propose research on non-targeted random screening of potential inhibitors or research on AIDS-associated pathogens or malignancies are not considered relevant to this FOA.

Partnerships

This FOA provides the option to form partnerships between academia and the private sector to facilitate the translation of innovative therapeutic discoveries to clinical evaluation in humans. For the purpose of this FOA, the term “private sector” comprises large and small, domestic and foreign, for-profit and non-profit pharmaceutical, biotechnology, bioengineering, and chemical companies.

Intellectual Property

Applications are encouraged to reach early consensus with any proposed partners regarding intellectual property, data sharing, and other legal matters that may arise during the project in order to ensure that the goals of this program will be met. In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that is consistent with meeting the goals of the award and the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to NIH, consistent with laws, regulations, and NIH policies.

Administrative Core

Each application will include an administrative core headed by an Administrative Core Lead with experience in program project management. The Administrative Core Lead is the PD(s)/PI(s) of the application. The administrative core is a resource to the program, providing for the overall management, coordination and supervision. The administrative core is required as it provides the program with leadership and guidance in fulfilling the stated objective of the program. To accomplish this, the applicant must create, within the administrative core, an infrastructure that promotes interactions among all of the research projects and scientific cores.

The structure of the administrative core will provide:

Scientific Core

A scientific core is a resource to the multi-project program as a whole by performance of a service-type activity rather than hypothesis-driven research. Examples of services that may be provided by a scientific core include, yet are not limited to the following: routine in vitro assays, cell processing and preparation, DNA analysis, standard pharmacology and toxicology tests.

Research Projects

Each research project should reflect a distinct, separate, scientifically meritorious research effort. In addition, the individual research projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual research projects separately. The research projects included in the application should share a common HIV-1 CNS-focused central theme.

Leverage Existing Government Resources

It is expected that applicants leverage existing government-funded resources, such as Clinical and Translational Science Awards, programs for AIDS research and NIH Roadmap programs, whenever possible. For more information see, the Common Fund research resources.

The National NeuroAIDS Tissue Consortium (NNTC) is a resource of high quality post tissue (CNS, PNS, etc.) and fluid specimens (CSF, blood, etc.) from patients who have died with HIV. The NNTC is also a potential source of primary cells which may prove useful in the design of assays. The NIMH Stem Cell Program is a resource for postnatal-to-adult human control patient-derived neuronal stem cells (iPSCs) which supports stem cell research in mental disorders including HAND. The use of resources from large NIH-funded HIV-related studies such as Multi-Program AIDS Cohort Study (MACS), Women’s Interagency HIV Study (WIHS), CNS HIV Antiretroviral Therapy Effects Research (CHARTER), and the HIV Brain Sequence Database (HIVBrainSeqDB) is encouraged.

Scientific Advisory Panel

The PD(s)/PI(s) will constitute a Scientific Advisory Panel (SAP) of 3 investigators not affiliated with any of the institutions comprising the program team within six months of the award. The SAP will attend the awardees' annual meeting to review program activities and evaluate progress, adherence to the benchmarks and timelines, and the continued relevance of each research project and scientific core to the overall goals. The SAP will recommend new directions as appropriate and will provide the PD(s)/PI(s) and NIH with a comprehensive written evaluation of the group’s activities following each annual meeting.

Annual Meeting

An annual meeting is required and should be held at the NIH in Bethesda, MD with the following in attendance: the SAP, NIH Program Staff, Research Project Leads, Scientific Core Leads and Co-Investigators. During this meeting, presentations will be expected to include summaries of all goals, timelines proposed and milestones achieved along with Go/No Go decisions, and a description of all problems that may be encountered and that may have an impact on the future direction of the scientific hypotheses and scope of the research. The objective of the meeting is to ensure that NIH understands the advances in the program, to provide an opportunity for collective problem solving among investigators, and to reinforce the programmatic goal of maintaining an integrated scientific approach to moving candidate therapies to the clinic.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision
Renewal

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

For applications proposing basic research exclusively throughout the 5 year term, up to $675,000 direct costs may be requested yearly.  Applications proposing the use of large animals (e.g., non-human primates) may request up to $800,000 direct costs in any year(s) that such large animals will be needed and, for applications proposing pilot clinical studies, the budget may include up to $950,000 direct costs in any year(s) in which clinical studies are being conducted.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 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

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) 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.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

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

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

The letter of intent should be sent to:

Deborah Colosi, Ph.D.
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6115D, MSC 9619
Rockville, MD  20892-9610
Rockville, MD  20852 (for express/courier service)
Email:  colosida@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core

6

Core (use for Scientific Cores)

6

Project (use for Research Projects)

12

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments:  The following "Other Attachments" should be included with the overall component in order to aid in the review of applications.  The filename provided for each attachment will be the name used for the bookmark in the application image.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

Private sector partners should include key personnel who have authority within the company to allocate resources and ensure successful completion of the proposed translational research.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. The Overall PD(s)/PI(s) are required to be the Lead of the Administrative Core and Lead of one at least one Research Project.

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

Budget (Overall)

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

This program strongly encourages resource contributions (financial and in-kind) of the private sector partners within the program for IND-directed toxicology and safety studies and for Phase I studies.  Private sources of funding should be identified in the application to support Good Manufacturing Practice (GMP) synthesis, formulation, and/or IND filing costs.

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

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:  List in priority order, the broad, long-range overall objectives and goals of the proposed Program. Concisely and realistically describe the hypothesis or hypotheses to be tested.

Research Strategy:  Applicants are advised to address the three parts of the Overall Research Strategy:  Significance, Innovation and Approach.

Significance: Clearly describe the CNS-focused translational problem that is being addressed by the Overall program and detail how the problem relates to the NIH priorities in Section 1 - Funding Opportunity Description. Describe the central theme, objectives and goals of the Overall program in relation to their potential to enable discovery and development of innovative CNS-focused therapeutic strategies for HAND or HIV-1 eradication.

Provide justification for the ability of the Overall program team to move therapeutic strategies for HAND or HIV-1 eradication along a translational trajectory during the award as follows: (a) transition to preclinical and/or clinical research during the award from discovery research, if appropriate; (b) from preclinical research seek FDA authorization for IND status and enter into clinical research, if appropriate; (c) to conduct a clinical study, provide documentation of FDA approval, if appropriate, and provide a Milestone Plan and Complete Clinical Protocol for one pilot clinical study (10-30 subjects). See the SF424 (R&R) Other Project Information form in the Research Project component..

Innovation: Describe what makes the Overall program innovative. Describe how new discovery/preclinical/clinical research directions or therapeutic strategies for HAND or CNS-focused HIV-1 eradication will arise from accomplishing the goals and objectives of the Overall program. Describe the unique advantages of the Overall program such as tailoring experimental design to the availability of valuable resources, translational expertise, or the multi-disciplinary advantages of the program. Describe how such unique advantages create synergy within the Overall program beyond what could be achieved through a traditional research project.

Approach: Describe the role of each research project and each scientific core in contributing to the objectives of the Overall program including background information. This section should provide the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for addressing the problem. As the strategy develops, each research project and scientific core should be cited briefly as to its place in the overall scheme. Summarize the special features of the resources and in the environment that make this application strong or unique. The Overall program should reflect the integration of research projects, scientific cores and expertise in support of the discovery and advancement of therapeutic strategies for HAND or HIV-1 eradication.

Outline the short and long term goals into an Implementation Plan with a timeline for achieving the goals and milestones for assessing progress. The milestones will be the criteria for evaluating the progress and direction of the program by the PD(s)/PI(s). Milestones should be well described, quantifiable, and scientifically justified. Drug discovery decision criteria, or other relevant criteria, should be indicated when appropriate and used to measure progress of the research over the life of the program.

Applicants are advised to ensure that mechanism of action studies for all therapeutic interventions regardless of whether the emphasis of the program is on discovery, preclinical, or clinical research are included in the program or have already been accomplished. This is especially important given the potential for off-target side effects and HAART-candidate drug interactions which must be taken into consideration, along with CNS penetration of the blood-brain barrier, the potential for brain efflux and toxicities of candidate drug interventions in the brain.

Renewal Applications. In the Research Strategy, renewal applications are advised to include a general progress report that describes achievements in the Overall program since the last competitive review. This is the section where the benefits of the Overall program may be expressed and demonstrated. Items to be included are: a summary of the major accomplishments that can be attributed to the Overall program; provide an explanation of the accomplishments of the program with regard to how they contribute to the advancement of novel therapeutic approaches for HAND or HIV-1 eradication; report the scientific and/or translational progress on research projects and scientific cores that are not being continued, and the reason for deleting them from the program. Please reference relevant tables (e.g. "Table of Changes to Research Projects and Scientific Cores").     

Letters of Support:  Include letters of commitment to the Overall collaboration, the implementation plan and the communication plan (described in the Research Strategy) that is signed by all Research Project and Scientific Core Leads. Provide documentation if existing government-funded services and resources will be available to the Overall program.

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 SF424 (R&R) Application Guide, with the following modifications: 

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.

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core’.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the ProjectExempt from Federal regulations?’ questions.

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

Project Narrative:  Do not complete.

Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

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

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

Budget (Administrative Core)

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

Administrative Core Time Commitment:  Due to the complexity and time required to maintain a well-coordinated, communicative and productive research effort, a minimum effort of 1.8 calendar months by the Administrative Core Lead is required by this FOA.

Annual Meetings:  Administrative Core Lead applicants will include the cost of travel to the annual meeting in their proposed budget, which should include travel for themselves, Co-Investigators, and any proposed costs for the to-be-named members of the SAP.

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

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  List in priority order, the broad, long-range objectives, and goals of the proposed administrative core. Concisely and realistically, describe the hypothesis or hypotheses to be tested.  In addition, state the administrative core’s relationship to the program goals and how it relates to the research projects and scientific cores in the application.

Research Strategy:  The research strategy for the administrative core must address the three parts of the Research Strategy:  Significance, Innovation and Approach.

Significance:  Describe the following subsections: Overall Goals and Objectives; Program and Resource Management including how the research projects and scientific cores will be coordinated and how oversight for the program will be managed. Detail the experience of the Administrative Core Lead in program project management.

Innovation: Provide insight into how the administrative core will be used to establish a strong collaborative environment and manage an integrated, synergistic scientific endeavor.

Approach: Provide an Organizational Plan that includes a description of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; describe resources available to the administrative core; how fiscal and other resources will be prioritized, allocated and managed; and how research-related travel and training will be budgeted; Roles of the administrative core staff; Lines of Authority; Organizational Structure; Intellectual Property Consensus; Publication Guidelines and timelines; and Fiscal Accountability.

Provide a Communications Plan that assures collaboration and effective communication among PD(s)/PI(s), Research Project Leads, Administrative Core Lead, and Scientific Core Lead(s). Include a description of the decision-making and problem solving processes. Summarize the interrelationships between the professional and technical experts, partnerships, environment and resources to provide synergy to the Overall program and make it unique. Detail the means that will be used to establish, communicate and coordinate program activities into a collaborative program; integrate cross-discipline research; and identify and solve problems to ensure management of an integrated scientific program.

Describe plans for a SAP, which should consist of three independent subject matter experts. (Note: The names of proposed SAP members should NOT be included in the application.) It is expected that the SAP members will attend an annual meeting sponsored by the grantee to assist with interpretation of results and planning of future studies, and to assist NIH Program Staff with assessing progress during the course of the program. These presentations will be expected to include summaries of all goals and milestones achieved during the review periods and a description of all problems encountered that may have an impact on the future direction of the scientific hypothesis.

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 SF424 (R&R) Application Guide, with the following modifications;

Scientific Core

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

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

SF424 (R&R) Cover (Scientific Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Core Information (Scientific Core)

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

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

Project Narrative:  Do not complete.

Performance Site Location(s) (Scientific Core)

List all performance sites that apply to the specific component.

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

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

Budget (Scientific Core)

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

Scientific Core Lead Time Commitment:  Due to the complexity and time required to maintain a well-coordinated and productive research effort, a minimum effort of 1.8 calendar months by each Scientific Core Lead is required by this FOA.

Annual Meetings:  The Scientific Core must include the cost of travel to the annual meeting in their proposed budget, which should include travel for themselves and Co-Investigators.

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

PHS 398 Research Plan          (Scientific Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  List in priority order, the broad, long-range objectives, and goals of the proposed scientific core.  Concisely and realistically, describe the hypothesis or hypotheses to be tested.  In addition, state the scientific core’s relationship to the multi-project program goals and how it relates to the research projects and the other scientific cores in the application.

Research Strategy: The scientific cores must address the three parts of the Research Strategy: Significance, Innovation and Approach.

Significance: Describe how each scientific core will contribute to meeting the program goals and objectives. Explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the scientific core to the primary theme of the application. Each scientific core service must support at least two research projects in the program.

Innovation: Describe how the scientific core resources contribute to the synergy of the program and address the probability of successful program integration (e.g., institutional support, physical resources, and intellectual rapport).

Approach: Indicate the facilities, techniques, services and professional skills that the scientific core will provide. Detail the resources available to the core and describe any special facilities used for working with biohazards or other potentially dangerous substances.

Identify measureable milestones and a timeline of the scientific core activities over the life of each scientific project it supports. Milestones should be well described, quantifiable, and scientifically justified. The milestones should be regarded as criteria for evaluating the progress and direction of the scientific core.

Renewal Applications. In the Research Strategy, renewal applications are advised to include a general progress report that describes achievements in the scientific core since the last competitive review. Items to be included are: a summary of the major accomplishments that can be attributed to the scientific core; report the scientific and/or translational services provided by the scientific core that are not being continued, and the reason for deleting them from the program. Please reference relevant tables (e.g. "Table of Changes to Research Projects and Scientific Cores").

Letters of Support:  Provide documentation if existing government-funded services and resources will be available to the Scientific Core.

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 SF424 (R&R) Application Guide, with the following modifications:

Note: This FOA is not intended to fund cell repositories.

Research Project

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

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

Project Narrative:  Do not complete.

Facilities and Other Resources: Provide information on resources available for the research project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early State Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe how the resources contribute to the synergy of the program and address the probability of successful integration with the program (e.g., institutional support, physical resources, and intellectual rapport). Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Other Attachments:  Applications that include a clinical research project should include the following "Other Attachments" with the research project component in order to aid in the peer review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. The Milestone Plan and Complete Clinical Protocol must be included as a single PDF attachment, not to exceed three pages, and loaded as a file titled, "Clinical Research Project".

Applications that propose a clinical research project yet lack a Milestone Plan and Complete Clinical Protocol document, will not be reviewed.

Applications that do not include the following details for clinical research projects will be considered incomplete:

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

List all performance sites that apply to the specific component.

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

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

Budget (Research Project)

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

Research Project Time Commitment:  Due to the complexity and time required to maintain a well coordinated and productive research effort, a minimum effort of 2.4 calendar months by each Research Project Lead is required by this FOA.

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

PHS 398 Research Plan          (Research Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  List in priority order, the broad, long-range objectives and goals of the proposed research project. Concisely and realistically, describe the hypothesis or hypotheses to be tested.  In addition, state the research project's relationship to the multi-project program goals and how it relates to the other research projects and scientific cores.

Research Strategy:  Each individual research project must address the three parts of the Research Strategy:  Significance, Innovation and Approach.

Significance: Provide the major goals and objectives of the research project. Detail the effect that the research project will have on the overall effort of the program. Describe how the research questions posed relate to the objectives of the particular research project and the program as a whole. Indicate how the research project integrates into the primary theme of the multi-project program application, maintains program synergy and adds value to the program.

Innovation: Describe what makes the proposed research project innovative. How will new preclinical research directions for HAND or CNS-focused HIV-1 eradication efforts arise from accomplishing the specific aims of the research project? Highlight the rationale for identification and validation of new viral and host molecular factor(s) for drug discovery research, if applicable. Describe the unique advantages of the research project such as tailoring experimental design to the availability of uncommon/valuable resources or translational expertise, and how this synergizes with the program beyond what could be achieved through a traditional research project.

Approach:  Detail the value and feasibility of the proposed research project, the potential pitfalls, and the advantages of new methodologies, if applicable, with respect to completion of the specific aims and attainment of program objectives.

Describe the major tasks each research project will accomplish and justify the need for alternative approaches to ensure the objectives of the research project and the program as a whole are met.

Identify measureable milestones and a timeline of the research activities for the research project over the life of the program. Milestones should be well described, quantifiable, and scientifically justified. The milestones should be regarded as criteria for evaluating the progress and direction of the research project.

Applicants are advised to include detailed information regarding the resources the research project contributes to the program and also the resources the research project will draw upon.

Clinical Research Projects: When a clinical study is proposed as a research project, applicants should address the following three sections in the Research Strategy: Significance, Innovation, and Approach.

Significance: Discuss the significance of the problem being studied, need for the clinical study, and potential impact of the results, as well as how the clinical study will test the hypotheses proposed. Discuss the studies that led to the proposed clinical study and information or data from preliminary studies that address the need for and the feasibility of the clinical study.

Innovation: Describe what makes the proposed clinical research project innovative. Describe the unique advantages of the clinical study, and how this synergizes with the program beyond what could be achieved through a traditional investigator-initiated clinical study.

Approach: Provide a concise description of and rationale for the proposed study design. Describe the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the clinical research project. Describe the intervention to be tested and the protocol to be followed in each arm of the clinical study, if appropriate, including potential biases or challenges in the protocol and how they will be addressed. Describe the study organization and administration, including the following: committee structures needed to manage the complexity of the clinical study; the role of any internal or external advisory committees; oversight, responsibilities, and coordination of any sites or cores proposed; role of any subcontractors or service providers for personnel or facilities. Detail the statistical methods that are appropriate for the study design, including sample size and power calculations and the underlying assumptions (and data) used to link these calculations to the endpoints and to the hypothesis being tested.

To be considered within the scope of this FOA, a clinical research project must be directly linked to other research projects within the program, such as determination of molecular mechanism of action, discovery research or preclinical research. Justification regarding the duration of the proposed clinical research project in relation to realistic HIV-associated neurocognitive outcome improvements and measures in humans is advised.

Note: Applications that do not include a Milestone Plan and Complete Clinical Protocol, yet propose a clinical research project, will not be reviewed. It is recognized that while the details of the clinical study will change as a result of scientific progress and as a function of review by various institutional and governmental bodies, a Milestone Plan and Complete Clinical Protocol are required and should be loaded as a file as instructed in "Other Attachments" above.

Private Sector Research Projects: Research projects from a private sector partner proposing to provide only resources or services, even if unique, will be deemed non-responsive, and the application will not be reviewed. Applicants are advised that if a private sector partner is included in the application, they should:

Renewal Applications. In the Research Strategy, renewal applications are advised to include a general progress report that describes achievements in the research project since the last competitive review. Items to be included are: a summary of the major accomplishments that can be attributed to the research project; report the scientific and/or translational progress on the research projects that are not being continued, and the reason for deleting them from the program. Please reference relevant tables (e.g. "Table of Changes to Research Projects and Scientific Cores").     

Letters of Support: Letters of collaboration should indicate the contribution he or she intends to make and his/her commitment to the work. For consultants, letters should include rate, frequency, outcomes for consulting services and timelines for delivery of expected reports. Provide documentation if existing government-funded services and resources will be available to the Research Project.

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 SF424 (R&R) Application Guide, with the following modifications:

Note: This FOA is not intended to fund cell repositories.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post-Submission Materials

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

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 - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? Do the overall program goals provide a solution to the problem of HAND or HIV-1 eradication of HIV-1 from the CNS? Is the overall program focused solely on the CNS, or related physiologically to the CNS in terms of the proposed clinical impact on neurocognitive outcomes in HIV-infected persons? Do the overall program goals demonstrate a capacity for translation of basic research to discovery research, discovery into preclinical research, or does it merit translation to a clinical trial?

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the collaborating investigators and private partners have adequate experience to lead their individual research project in a collaborative way to meet the overall goals? Have the PD(s)/PI(s) and the key personnel committed adequate time and effort to the program? Is the program composed of independent investigators from diverse research settings, e.g. from different academic departments within the same institution, from different institutions, and/or from the private sector? 

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? If this application is successful, will it provide the foundation for development of innovative preventative or therapeutic interventions to address the clinical problem(s) of HAND or HIV-1 eradication?   

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? 

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?

Is the approach of the research projects and scientific cores justified and integrated into a multidisciplinary program? Are the projects synergistic to the overall program objective? Has the applicant described plans to leverage existing government funded resources and provided documentation that these resources will be available? Do the program management plans include short and long term management components such as communication, problem resolution, and decision making?

Environment

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

Additional Review Criteria  Overall  

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

Administrative Core

Does the proposed plan address the qualifications of the Administrative Core Lead in program project management, past performance (if applicable), and time commitments? Does the proposed plan provide insight into how the administrative core will be used to establish a strong collaborative environment and manage an integrated, synergistic program? Is the quality of the proposed Organizational, Communications, SAP and Resource Sharing Plans strong?

Scientific Core(s)

Does the scientific core adequately indicate support for the program in a manner that cannot be supported through other resources? Do the activities of the scientific core integrate with those of the research projects to meet program objectives? Is the quality of the relevant facilities or services strong (including criteria for prioritization and usage, procedures, techniques, and quality control)? Does the proposed plan address the qualifications, past performance (if applicable), and time commitments of the Scientific Core Lead(s)?

Research Projects

Is each research project innovative in addressing a therapeutic strategy for HAND or HIV-1 eradication? Does each research project make effective use of the integrated, synergistic program environment?  If there is a private sector partner, is the research plan able to contribute materially and intellectually to the overall goals and objectives of the program? Is the private sector partner committed to the discovery/preclinical/clinical development of the proposed therapeutic entity? Does the private sector partner have a track record of past successes in moving therapeutic strategy to practical applications?

Benchmarks and Timeline

Are the proposed benchmarks and timelines appropriate for each research project/scientific core and for the program as a whole? Are the proposed benchmarks measurable? Are appropriate intermediate goals addressed and monitored?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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) Genome Wide Association Studies (GWAS).

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 the 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:

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 . 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:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Certain Program Projects may propose a clinical study as a research project component. Since the clinical study to be carried out under this program may pose more than minimal risk to study subjects, the P01 will be converted to a cooperative agreement (U19) when the research project transitions to the clinical study. Terms of agreement will be negotiated with the PD(s)/PI(s) and the applicant institution at the time of the transition.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Deborah Colosi, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6100
Email: colosida@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

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 Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



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



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