Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

The Interplay of Substance Abuse and HIV-1 Infection on Glial Cell Function (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-13-011

Companion Funding Opportunity

RFA-DA-13-010, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA) solicits basic and pre-clinical research applications that study the combined and interactive effects of substance abuse and HIV-1 infection on glial cell biology. Glial cells contain a variety of neurotransmitter receptors, transporters, and other molecular entities that are targets of drugs of abuse. Additionally, viral and host responses to HIV-1 infection usurp and alter glial cell function. The goal of this FOA is to encourage research to determine the molecular and cellular consequences of substance abuse, HIV-1 infection, and their interactions on glial cells within the central nervous system (CNS).

Key Dates
Posted Date

August 24, 2012

Open Date (Earliest Submission Date)

October 19, 2012

Letter of Intent Due Date

October 19, 2012

Application Due Date(s)

November 19, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 2013

Expiration Date

November 20, 2012

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 purpose of this Funding Opportunity Announcement (FOA) is to solicit basic and pre-clinical research applications that study the combined and interactive effects of substance abuse and HIV-1 infection on glial cell biology. It is generally accepted that exposure to drugs of abuse alters neuronal function, yet emerging research suggests that drugs of abuse can disrupt glial cell function, as well. In addition, HIV-1 infection acting through viral and host factors affects glial cell function. This FOA encourages research to characterize the molecular and cellular actions of drugs of abuse and factors elicited by HIV-1 infection, giving emphasis to their additive or synergistic interactions, on glial cell function within the central nervous system (CNS).

Introduction

Injection drug use and high-risk sexual behavior associated with injection or non-injection drug use are leading causes of HIV-1 infection among substance users or their partners. Once HIV-1 enters the vascular system, the virus can infect not only CD4+ T lymphocytes, but also monocytes and peripheral macrophages that can enter the brain early in the course of infection by crossing the blood brain barrier (BBB). Within the CNS, HIV-1 infection causes neuroinflammation, neuronal dysfunction and neurodegeneration believed to underlie the neuropathogenesis, cognitive deficits and dementia observed in neuroAIDS. HIV encephalitis (HIVE) and HIV-associated dementia (HAD) were signature neuropathological hallmarks of HIV-1 infection prior to availability of highly active antiretroviral therapy (HAART). Even with current antiretroviral treatment regimens that reduce viral load and control many consequences of HIV-1 infection, HIV-associated neurocognitive disorders (HAND) remain prevalent, largely among individuals living longer with HIV infection and, perhaps, associated with the relative inability of many antiretrovirals to cross the BBB. Although there is increasing evidence that chronic substance use impacts neurocognitive outcomes of HIV infection, more research is needed to fully understand the neurobiological mechanisms of such interactions.

Upon infection of the CNS, resident microglia will become infected with HIV-1. While only microglia and monocyte-derived macrophages support productive HIV-1 infection, there is evidence that other glial cell types, particularly astrocytes, can harbor restricted infection and may contribute to a viral reservoir in the CNS. Although HIV-1 does not directly infect neurons, infection and activation of glia trigger the expression and release of both host and viral factors that can alter neuronal function or cause damage to cells within the CNS. For example, long-term production of cytokines, chemokines and other cellular factors, and of viral proteins such as gp120, Tat and vpr, by infected cells can damage neurons directly, as well as impact uninfected astrocytes and other glial cells by further releasing inflammatory and other cellular factors, impairing astrocyte function. Thus, axonal, neuronal, and glial damage can occur as a result of HIV-1 infection and disrupted glial cell function within the CNS.

The actions of drugs of abuse on glial cell function, particularly with regard to the consequent effects of these actions on neuronal function and the manifestation of substance abuse and addictive behaviors, are not well understood. We do know that glial cells of the CNS express a wide variety of neurotransmitter receptors, transporters and other molecular entities that are targets of drugs of abuse. In the drug abusing population, it is feasible that the interactions of drugs with these targets on glial cells, or other alterations that compromise glial cell function due to drug abuse and addiction, contribute to the behavioral changes associated with drug addiction. Of interest is that several drugs of abuse have been shown to promote the release of cytokines from glial cells. Intriguingly, and depending on the type of drug used, either pro-inflammatory (e.g. methamphetamine) and anti-inflammatory (e.g. opioids) cytokine release has been reported. Further, drugs of abuse are reported to have effects on metabolic processes of astrocytes and may regulate trophic factor release. There is emerging evidence that drugs of abuse affect gliotransmission from astrocytes, and disrupt myelination and oligodendrocyte function.

Furthermore, the actions of HIV-1 infection on glial cell function when co-occurring with substance use disorders may be especially problematic. HIV-1 infection alone destabilizes astrocyte function. Cellular and viral factors released in response to HIV-1 infection are reported to diminish the ability of astrocytes to provide metabolic and trophic support to neurons, and cause additional microglia and astrocyte activation. The host immune response to HIV-1 infection can exacerbate macrophage recruitment into the CNS, and induce microglial motility and activation. Each of these actions has the potential to damage or disrupt neuronal processes that contribute to the cognitive and behavioral deficits of neuroAIDS. Many of the actions of drugs of abuse on glial cells may further augment, otherwise modulate, or even protect against the actions of HIV-1 infection.

Taken together, there are many independent actions of HIV-1 infection and substance use on glial cells within the CNS, as well as inter-dependent actions. The overall goal of this initiative is to discern the nature of these interactions. In some cases, we expect that it will be necessary to first clearly delineate the main effects of either a drug of abuse or HIV-1 infection on a specific glial cell prior to the study of the combined effects and interactions. Furthermore, as there has been relatively little research in the area of the role of glia in substance use and HIV-1, we anticipate that some of the work may be descriptive (i.e. effects of chronic exposure of drugs of abuse on receptor density, neurotransmitter release, calcium signaling, etc.), before expanding into more elaborate in vitro systems (such as adding in HIV-1 infection into the model design), or utilizing in vivo approaches to address these questions. Well-justified, sound approaches and study designs will be critical to the success of this FOA.

Scientific Research Scope and Objectives

The objective of this FOA is to encourage the submission of research applications proposing to study the independent as well as the interactive effects of substances of abuse and HIV-1 infection on glial cell biology. Prior research in this area has largely studied the acute, pharmacological actions of drugs of abuse. A key consideration for applicants is that, in general, chronic exposure to substances of abuse precedes HIV-1 infection. As such, this FOA is particularly interested in applications that are likely to determine whether prior and concurrent substance abuse facilitates or exacerbates the consequences of HIV-1 infection on glial cell function. Therefore, investigators are strongly urged to utilize models of long-term or chronic drug exposure and to consider the consequences of drug-induced plasticity within the nervous system in employing appropriate research models for the study of the consequences between substance abuse and HIV-1 infection on glial cell biology. Given this model, study designs that determine additive or synergistic actions between substances of abuse and HIV-1 infection on glial cell function and biological processes, must consider the roles of host and viral factors generated in response to HIV-1 infection in the context of substance abuse and addictive behaviors.

R21 applicants are encouraged to consider the following in designing their studies:

Examples of Topics Appropriate for this FOA may include but are not limited to:

Effects of substance abuse on HIV-1 infection, latency and reservoirs in glial cells.

Glial cell biology, function and processes both with and without exposure to substances of abuse and/or HIV-1.

Nervous system processes both with and without exposure to substances of abuse and/or HIV-1.

NIDA Glia Function in Substance Abuse and HIV-1 Annual Meeting

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

NIDA intends to support 4 to 5 R21 applications solicited through this FOA. A companion FOA, RFA-DA-13-010, will support an additional 6 or 8 R01 Research Project Grant applications. NIDA intends to commit up to $5 million in total costs in FY 2013 to support meritorious projects solicited through these two FOAs.

Award Budget

The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed two 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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the 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.

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

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.

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: NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - DA-13-011
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

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 submission of applications for this FOA. 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

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 Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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(s)/PI(s) 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 NIDA, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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 pursue knowledge on the interactions between the effects of substance abuse and HIV-1 infection on glial cell function within the CNS?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

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?

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), 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:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. 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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

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, 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 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 Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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)

Diane M. Lawrence, Ph.D.
Associate Director, AIDS Research Program
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 3116, MSC 9581
Bethesda, MD 20892-9581
Telephone: (301) 594-3225
FAX:  (301) 594-5610
Email:  lawrencedi@nida.nih.gov

Roger G. Sorensen, Ph.D., MPA
Program Official, Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 4289, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 443-3205
FAX:  (301) 594-6043
Email:  rsorense@nida.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
Chief, Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone:  (301) 435-1389
Email: mswieter@nida.nih.gov

Financial/Grants Management Contact(s)

Diana Haikalis
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1373
Email: dhaikali@nida.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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