Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

National Institute on Aging (NIA)

National Institute on Drug Abuse (NIDA)

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
Limited Competition to Convert the CNS HIV Antiretroviral Therapy Effects Research (CHARTER) Study Cohort to a Research Resource (R24 - Clinical Trial Not Allowed)
Activity Code

R24 Resource-Related Research Projects

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-MH-21-170
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.242, 93.279, 93.853, 93.866
Funding Opportunity Purpose

This Limited Competition Funding Opportunity Announcement (FOA) for a Resource-Related Research Project (R24) grant invites applications to continue the activities of CHARTER cohort (a cohort of individuals living with HIV on Antiretroviral therapy) to collect and provide research data as well as research specimens to interested investigators to address high priority research areas for studies of Central Nervous System (CNS) disease associated with HIV. This FOA only supports non-hypothesis driven activity to provide data, materials, tools, or services that are essential to making timely, high quality, and cost-efficient progress in the NeuroHIV field. Hypothesis-driven research applications should not be submitted in response to this FOA. The resource proposed should be available to any qualified investigator, should be highly quality controlled, and should not duplicate resources available commercially or through other sources. Resources should be designed to provide services to the broad NeuroHIV research community and should not be limited by any specific institutions.

Key Dates

Posted Date
March 08, 2021
Open Date (Earliest Submission Date)
April 09, 2021
Letter of Intent Due Date(s)

04/07/2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 10, 2021 Not Applicable May 10, 2021 July 2021 October 2021 December 2021

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

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

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date
May 11, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

This Limited Competition Funding Opportunity Announcement (FOA) for a Resource-Related Research Project (R24) grant invites applications to continue the activities of CHARTER cohort (a cohort of individuals living with HIV on Antiretroviral therapy) to collect and provide research data as well as research specimens to interested investigators to address high priority research areas for studies of Central Nervous System (CNS) disease associated with HIV. This FOA only supports non-hypothesis driven activity to provide data, materials, tools, or services that are essential to making timely, high quality, and cost-efficient progress in the NeuroHIV field. The resource proposed should be available to any qualified investigator, highly quality controlled, and not duplicate resources available commercially or through other sources. Resources should be designed to provide services to the broad NeuroHIV research community and should not be limited by any specific institutions.

Background:

Central Nervous System (CNS) disease associated with HIV continues to persist in people living with HIV despite effective antiretroviral therapy (ART). Although excellent virologic control in the periphery and brain has been achieved, CNS complications including neurologic, neuropsychiatric and mental health problems are observed. Despite efforts to alleviate CNS disease outcomes associated with HIV, there has been limited success with clinical trials due to heterogeneity of etiologies and presentation. People living with HIV can achieve nearly normal lifespans if treated with effective ART, in which case they are more likely to suffer chronic HIV-related comorbidities such as CNS complications due to impact of HIV, treatment regimens, legacy effects and immune dysfunction. In addition, there is increasing interest in achieving sustained viral remission (HIV Cure) in people living with HIV and the CNS is an important anatomical viral reservoir.

CHARTER is one of the very few long-term cohorts to-date that has followed HIV associated CNS co-morbidities and CNS viral dynamics (CSF Escape) in the ART era over the past two decades. CHARTER has six performance clinical sites that are geographically distributed across the U.S. The key focus areas of the studies have been neurocognitive/neurological disorders prior to ART and during ART; co-morbid risk factors; understanding distribution of ART in the CNS; impact of aging on CNS complications; impact of metabolic complications on the CNS; understanding peripheral neuropathy; role of viral and host genetics; acute/early infection of the CNS and neuroimaging biomarkers of CNS co-morbidities. These studies have resulted in a rich data repository containing neuro-medical data, neuropsychological assessments, psychiatric and drug abuse variables, treatment regimen data, neuroimaging data catalog, and viral and host genetics data. In addition, CHARTER also has data on lifetime and interval substance use data for 15 substances as well as lifetime and interval DSM-IV substance use diagnoses for all participants. This FOA is to support the continuation of the above-listed cohort activities and to provide the resources to the broad NeuroHIV community.

Supported Research Activities and Requirements

This FOA will support clinical sites to recruit new participants, re-consent of current participants, planning and operation of all study visits, and implementation of all study protocols. Furthermore, this FOA will support maintenance of a cohort of up to 500 current as well as new participants, gather relevant data across different matched age groups and demographies. The FOA supports maintenance of the cohort that can help in answering high-priority research questions on NeuroHIV that align with the science interests of NIMH, NINDS, NIDA and NIA.

This FOA will also support Data Coordination Center (DCC) activities related to the core infrastructure of the CHARTER including, but not limited to:

  • Coordination of a recruitment plan to recruit up to 500 current and new participants including both HIV-positive participants and HIV-negative participants with matched demographic profiles across different age groups;
  • Planning and coordination of efficient cohort consortium examination cycles;
  • Central support of study operations, internal and external collaborations, and data analysis;
  • Bio-specimen collection, storage, timely distribution and administrative management in collaboration with National NeuroAIDS Tissue Consortium (NNTC) DCC;
  • Maintenance, timely distribution and administration of neuromedical data, neuroimaging data and biospecimen data in collaboration with NNTC DCC;
  • Logistical communications including a public web portal for communicating resource details and management support necessary to coordinate the DCC tasks in collaboration with NNTC DCC.
  • Organization of virtual and in-person meetings to co-ordinate efforts between clinical sites, DCC and NNTC DCC

The Resource should align their Science Agenda for this FOA to include the below, but not limited to :

  • Understand the epidemiology and pathophysiologic mechanisms of Human Immunodeficiency Virus-1 (HIV-1) associated CNS disease outcomes;
  • Identify mechanisms of establishment and persistence of HIV-1 viral reservoir in the CNS and comprehend strategies for eradication of HIV-1 from the CNS reservoirs;
  • Identify and validate viral and host genetic factors that influence the pathophysiology of HIV-1 associated CNS dysfunction;
  • Development of novel pre-clinical therapeutic strategies to mitigate the CNS complications associated with HIV;
  • Understanding Aging related co-morbidities such as Alzheimer’s disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) in the context of people living with HIV;
  • Understanding how addictive substances or signaling pathways relevant to the function of addictive substances modify the CNS outcomes in people living with HIV.

In order to meet the NIMH, NINDS, NIDA and NIA NeuroHIV related research priorities all the clinical sites will support the collection of:

  • Tailored domain-based neuropsychological assessments data using the RDoC framework for all study participants;
  • Cognitive, behavioral, emotional, and neuropsychiatric data for all study participants;
  • Longitudinal neuroimaging data for study participants;
  • Longitudinal Data pertaining to pathway linked biological measures such as signaling pathways, neuroinflammation, and immune profiles;
  • Measures of mechanistic biological signatures/targets to aid in diagnosis and for developing pre-clinical therapeutic interventions for CNS co-morbidities;
  • Measures of viral dynamics in the CNS and periphery including state of the science assays to quantify viral reservoirs;
  • Viral and host genetic data that could aid in neuropathogenesis research;
  • Data related to Aging associated co‐morbidities such as Alzheimer’s disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) (Neuropathological indices, Neuroimaging data, Biomarkers);
  • All the above data resources in the context of substance use (Nicotine, cocaine, methamphetamine, stimulants, opioids, prescription drugs, and cannabinoids) and substance use data across the lifespan.

Program Expectations:

This research resource program is intended to support state-of-the-art resources of sufficient scope to serve a substantial user base.

Resource staff employed under this program are required to provide the community with efficient and productive service to users and normally should not be included as authors on users' publications that result from use of the resource. The users can acknowledge resource staff in their papers and must cite the facility's grant as providing support for their work. Authorship would only be appropriate if resource personnel contributed substantially to the intellectual development of the research and manuscript preparation, which should be thoroughly justified.  Resource personnel may have other independently supported research commitments that enable them to lead their own research projects and to collaborate on problems that require effort beyond normal resource services. 

Note: The Investigators are strongly encouraged to engage appropriate scientific/research contacts prior to submission of the application to ensure that the application addresses high priority interest areas of the participating institutes.

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

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

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIMH, NIA, NINDS and NIDA intend to commit $1,250,000 in direct costs in FY 2022 to fund 1 award in response to this FOA. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $1,250,000 in direct costs.

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Eligibility is limited to current awardee and clinical sites of the CHARTER Cohort study in collaboration with the awardee of the National NeuroAIDS Tissue Consortium Data Coordinating Center (U24), funded under RFA-MH-18-251. [Specifically, the institutions involved in the CHARTER Cohort Study include University of California, San Diego; Johns Hopkins University, Baltimore; Mount Sinai, New York; University of Texas, Galveston; University of Washington, Seattle; Washington University, St. Louis and National NeuroAIDS Tissue Consortium Data Coordinating Center site at University of Nebraska Medical Center, Omaha.]

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) 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.

Letter of Intent

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

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

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

The letter of intent should be sent to nimhpeerreview@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: 

For this FOA, the application should address the following:

  1. Management Capabilities and Organizational Structure
  2. DCC Scientific Expertise to fulfill the scientific goals
  3. Collaboration plan with NNTC DCC for processing data and bio-specimen requests; adjudication of data and bio-specimen requests; timely fulfillment of data and bio-specimen requests; data transmission and storage of resource related data; , and shipping of bio-specimens

The application should also address the items below for the clinical sites

  • Implementation of all study protocols to fulfill the scientific goals in collaboration with the DCC and other clinical sites
  • Plans to re-enroll current study participants as well as the enrollment of new participants according to defined inclusion criteria
  • Plans for retention of study participants throughout the period of the study
  • Plans for Contact and follow-up to ascertain and adjudicate participant clinical event
  • Plans to establish information technology infrastructure and data quality control procedures
  • Plans to assure Good Laboratory Practices (GLP) are practiced for specimen collection, handling, storage, and shipping
  • Delineate purpose, frequency, and methods of interaction with community advocacy groups, including plans to facilitate community engagement in recruitment
  • Integration of bioethical principles for bio-specimen collection, storage and distribution
  • Plans to assure institutional commitment to support its CHARTER cohort resource investigators

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

The following modifications also apply:

  • The application should include a unified Data Sharing Plan to ensure CHARTER Resource related Data is made widely and freely available as possible to the broader research community in a timely manner while safeguarding the privacy of participants in collaboration with NNTC DCC
  • Describe how the data from the clinical sites will be made available to the research community through publications or public website consistent with achieving the goals of the program.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Resource address the needs of the research resource that it will serve? Is the scope of activities proposed for the Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the NeuroHIV field related to pathogenesis, cure, genetics, aging and substance abuse research?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing NeuroHIV research? Do the investigators demonstrate significant experience with coordinating collaborative NeuroHIV research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their governance, plans for conflict resolution, and organizational structure appropriate for the Resource? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts in coordinating the research resource the center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed?

Does the application propose a novel resource not otherwise available to the broader NeuroHIV research community?

Approach

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

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies to continue resource related activities in a limited accessibility environment, and benchmarks for success presented? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of human subjects?

Have the investigators provided detailed information about how they will collaborate with NNTC DCC for processing data and bio-specimen requests; adjudication of data and bio-specimen requests; timely fulfillment of data and bio-specimen requests; data transmission and storage of resource related data and timely shipping of bio-specimens? Is the resource data shared in collaboration with NNTC DCC of sufficient quality to validate and replicate research findings? Is the resource data shared in collaboration of NNTC DCC in a format that is most appropriate for the given dataset?

Environment

Will the institutional environment in which the Resource will operate contribute to the probability of success in facilitating the research Resource it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource proposed? Will the Resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Vasudev R Rao, MBBS, MS.
National Institute of Mental Health (NIMH)
Telephone: 301-825-3259
Email: vasudev.rao@nih.gov

Mack Mackiewicz, Ph.D.
National Institute on Aging (NIA)
Phone: 301-496-9350
Email:miroslaw.mackiewicz@nih.gov

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

Peer Review Contact(s)

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Financial/Grants Management Contact(s)

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

Mitchell Whitfield
National Institute on Aging (NIA)
Phone: 301-827-6373
Email:mitchell.whitfield@nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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