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 of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Pathophysiology of HIV-Associated Neurodegeneration in Aging Populations on Long-Term Anti-Retroviral Therapy (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-12-070

Companion FOA

RFA-MH-12-071, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242, 93.866, 93.853

FOA Purpose

The National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS) invite research grant applications focused on elucidating the mechanisms of HIV-associated neuropathogenesis in the context of aging, chronic infection with HIV, and long term exposure to Highly Active Antiretroviral Therapy (HAART). The neuropathogenic mechanisms of HIV-Associated Neurocognitive Disorders (HAND) may be distinct in the aging HIV-infected populations given the potential interactions between aging associated events, HIV-associated neurodegenerative processes, and exposure to HAART. Understanding the pathogenesis of HAND in HIV-infected individuals over 50 years of age, in light of potential interactions with HAART, neurodegenerative diseases, and aging-related co-morbid conditions are the focus of this announcement. Applications ranging from basic research to clinical diagnosis and treatment in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged, but not required.

Key Dates
Posted Date

April 6, 2011

Open Date (Earliest Submission Date)

August 9, 2011

Letter of Intent Due Date

August 9, 2011

Application Due Date(s)
Scientific Merit Review

October 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 2012

Expiration Date

September 10, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose

The National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS) invite research grant applications focused on elucidating the mechanisms of HIV-associated neuropathogenesis in the context of aging, chronic infection with HIV, and long term exposure to Highly Active Antiretroviral Therapy (HAART). The neuropathogenic mechanisms of HIV-Associated Neurocognitive Disorders (HAND) may be distinct in the aging HIV-infected populations given the potential interactions between aging associated events, HIV-associated neurodegenerative processes, and exposure to HAART. Understanding the pathogenesis of HAND in HIV-infected individuals over 50 years of age, in light of potential interactions with HAART, neurodegenerative diseases, and aging-related co-morbid conditions are the focus of this announcement. Applications ranging from basic research to clinical diagnosis and treatment in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged, but not required.

Background

A major age-related demographic shift in HIV-infected patients has been noted by clinicians and documented by the Center for Disease Control (CDC). The CDC projects that by 2015, more than half of all HIV-infected individuals in the United States will be over the age of 50. During the next decade, a rapid increase in HIV prevalence among the elderly is expected to derive from two subpopulations: (1) HIV-diagnosed cases of a “younger group” surviving into older age because of the efficacy of HAART in reducing mortality; and (2) newly HIV-infected cases of an “older group”. Coupled with the aging process, the extended exposure of these adults to both HIV and antiretroviral drugs appears to increase their risk of illness and death from cardiovascular, bone, kidney, liver, lung, neurologic and neuropsychiatric complications. While all of these complications impact HIV-infected aging populations the focus of this announcement is to stimulate research on the pathophysiology and treatment of HAND in HIV-infected people over 50 years of age who are on HAART.

The prevalence of HAND remains high despite wide spread use of anti-retroviral therapy. A recently completed large epidemiologic study by the CHARTER (CNS HIV Anti-retroviral Effects Research) group examined 1,574 participants cross-sectionally and 657 participants longitudinally and has reported a HAND prevalence rate of greater than 50% in HIV infected individuals in the United States.  Recent studies are showing that the phenotype of neurologic and neurocognitive complications are evolving in the era of HAART. In an effort to accurately classify the phenotypic changes seen in the HAART era, a revised American Academy of Neurology definitional criteria for HAND was adopted. The categories of HAND include Asymptomatic Neurocognitive Impairment (ANI), Mild Neurocognitive Disorder (MND), and HIV-Associated Dementia (HAD). In the current treatment environment, MND is the most prevalent form of HAND; yet even mild neurocognitive deficits can interfere with activities of daily living and reduce the quality of life in long-standing aviremic HIV-positive patients.

The pathophysiology of HAND may be distinct in older HIV-infected patients given the potential interactions between HIV-associated neurodegenerative processes, long term HAART, and aging-associated events. HIV-involvement of the brain has traditionally been classified as a subcortical dementia with productive infection of perivascular macrophages, microglia, and restrictive infection of astrocytes, but not neurons. Recent research suggests that both cortical and subcortical areas of the brain are affected by HIV in the HAART era. Additionally, functional MRI scans, which link neural activity levels to measured changes in cerebral blood flow and oxygenation in the brain, found HIV-positive subjects to be functionally equivalent to HIV-negative patients who were 15–20 years older. Long term HAART has been associated with increased neuronal toxicity and has been shown to exacerbate cerebrovascular disease resulting from hypercholesterolemia and diabetes. Coincident with the introduction of HAART, the rate of hospitalization due to ischemic stroke in HIV-infected patients rose by 67% between 1997 and 2006. As HIV-infected patients are growing older, adverse effects of HAART and drug-drug interactions with aging-related diseases and medications become relatively more important. Given the potential for synergy between HIV and aging, further research to determine whether HIV-related injury to the brain continues to accrue in some patients is needed.

There is a growing body of research indicating overlapping neuropathologic features between aging-associated neurodegenerative disease and HAND. Although the brain pathology differs between HAND and Alzheimer’s disease, HIV-positive brains derived from patients over 50 years of age have been shown to accumulate abnormal proteins including amyloid, alpha-synuclein, and hyper-phosphorylated tau. Measurements of ß-Amyloid (1-42) in the CSF of cognitively impaired patients with HIV were noted to be similar to those in patients with mild dementia of the Alzheimer type. The mechanism of HIV induced dysregulation of amyloid expression is an area of considerable research. For example, HIV Tat protein has been shown to inhibit neprilysin; a neuronal amyloid-beta degrading enzyme. Other studies have examined the impact of HIV on control of amyloid-beta production, solubility and clearance. Additional research to further define mechanisms of HIV-induced dysregulation of protein clearance and impact on neurodegenerative processes is needed.

The role of host genetic factors in determining susceptibility of the aging to HAND is also of interest for this initiative. Epidemiological data from the Hawaii Aging with HIV cohort demonstrated an association between the genetic apolipoprotein-epsilon4 allele, APOE-E4, and dementia among older, but not among younger HIV-1-infected patients. Other investigators have examined the relationship between cerebrospinal fluid apolipoprotein E (APOE) levels, the expression of various APOE alleles and cognitive impairment. Their research suggests that the relatively higher levels of CSF APOE in E4+ HIV+ (having APOE-E4 isoforms) may negatively impact the brain and lead to poorer cognitive outcomes, while those individuals without the E4 allele (with APOE-E2 and APOE-E3 isoforms) may show compensatory responses that lead to better cognitive performance. These initial studies have yielded valuable data and further research is needed to identify other host genetic factors that may predict the CNS metabolic, vascular, and neurobiological events that impact neurocognitive outcomes in aging HIV-infected individuals.

A variety of immunologic factors may also contribute to neurodegenerative processes in aging HIV-infected individuals. For example, the continued prevalence of cognitive impairment despite good virologic control in the era of HAART may be due to a “legacy effect” resulting from a history of advanced immunosuppression accompanied by high plasma viral load and low CD4 nadir. Age-associated declines in immune function, termed immunosenescence, may also impact HAND in the over 50 HIV-positive population. Senescence of T cells is normal given that production of naïve T lymphocytes by the thymus is reduced after the age of 50. Aging and chronic HIV-infection are both associated with activation of the immune system, increased levels of circulating inflammatory mediators, and inflammation which may have a significant impact on HIV-associated CNS disease.

In summary, the goal of this announcement is to define and elucidate novel mechanisms of pathogenesis that are driving neurocognitive decline at the intersection of HIV-associated neurodegenerative processes, aging associated CNS disease, chronic HAART treatment effects, and host susceptibility factors. The ultimate goal of this initiative is to help develop novel strategies for treatment of neurocognitive impairment in the HIV positive aging population.

Areas of Research Interest

The research areas that are pertinent to this FOA include, but are not limited to, the items listed below:

Leverage Existing Government Resources

The use of resources from large NIH-funded HIV related studies such as Multi-Center AIDS Cohort Study (MACS), Women’s Interagency HIV Study (WIHS), CNS HIV Antiretroviral Therapy Effects Research (CHARTER), the National NeuroAIDS Tissue Consortium (NNTC) and the HIV Brain Sequence Database is encouraged

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The participating ICs intend to commit the following amounts in FY 2012 for this FOA and the companion R21 FOA:

NIMH intends to commit up to $2,000,000 to fund up 4 awards

NIA intends to commit up to $550,000 to fund up to 2 awards

NINDS intends to commit up to $550,000 to fund up to 2 awards 

An award issued under this FOA is contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project. 

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

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 (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (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/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) 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/Principal Investigator (PD/PI) 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 SF 424 (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.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download 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.

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

The letter of intent should be sent to:

Jeymohan Joseph, Ph.D.
Division of AIDS Research
National Institute on Mental Health
6001 Executive Boulevard, Room 6219, MSC 9619
Bethesda, MD  20892-9619
Email:  jjeymoha@mail.nih.gov
Telephone: (301)443-6100

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

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.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive 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

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

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 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? Does the project have the potential to lead to further understanding of HIV neuropathogenesis, progression, or clinical manifestation of HAND in HIV-infected people over the age of 50 years?

Investigator(s)    

Are the PD/PIs, 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?   

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?  Does this project have the potential to discover novel neuropathogenic paradigms to account for potential interactions between the virus and aging-related disorders in the CNS?

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? Does the proposal for identification of aging related effects of HIV in the CNS include an idea of how one would validate their influence with respect to the pathophysiology of HAND?

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned 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:

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 business official.

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

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

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) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 Phone: 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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-6100
Email:  jjeymoha@mail.nih.gov

Miroslaw Mackiewicz, Ph.D.
National Institute on Aging (NIA)
Telephone:  (301) 496-9350
Email: mackiewiczm2@mail.nih.gov

May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:  (301) 496-1431
Email:  mw132k@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

Robin Laney
National Institute on Aging (NIA)
Telephone: (301) 496-1473
Email: Robin.Laney@nih.gov

Tijuanna E. DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9231
Email: decostert@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.


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