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 Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Announcement of a Limited Competition for the Continuation of the Cooperative Agreement on the Interaction of HIV Infection and Alcohol Abuse on Central Nervous System Morbidity (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of RFA-AA-07-019

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AA-12-011

Companion FOA

None

Number of Applications

The applicant institution may submit only one application under this announcement.  Section III. 3. Additional Information on Eligibility.

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

93.273

FOA Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites a limited competing renewal of a cooperative agreement application to evaluate the cumulative and progressive effects on the brain of combined HIV infection and alcohol abuse using advanced in vivo magnetic resonance imaging methods.  The investigator will work collaboratively under the cooperative agreement with NIAAA over a five-year period to conduct investigations of the separate and interactive effects of chronic alcohol use and HIV infection on neurocognitive function and brain structural and functional integrity.  The long-term goal is to elucidate in vivo markers of neuropathology underlying the cognitive and motor decline observed in heavy drinking HIV-infected individuals or improvement with sustained abstinence from alcohol and their interaction with HIV disease status.  Improvement in brain structure and function accompanied by ART/HAART/CART may be curtailed by comorbid conditions, notably alcohol use disorders, Hepatitis C, and potential neurotoxic effects of antiviral medication regimes.  Now that individuals infected with HIV are living well longer than earlier cohorts, liabilities lurk that have the potential of reducing pharmacological benefits, and include a return to risky behavior with the possibility of increased or additional infections, alcohol abuse, and cognitive, sensory, and motor compromise associated with normal aging.  Clinical research knowledge obtained from this study could position "translational" efforts in the development of better and more focused treatments for observed neurological, cognitive, and motor deficits in this patient population.  

Key Dates
Posted Date

January 18, 2012

Open Date (Earliest Submission Date)

March 16, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

April 16, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June-July 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 1, 2012

Expiration Date

April 17, 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

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites a limited competing renewal of a cooperative agreement application to evaluate the cumulative and progressive effects on the brain of combined HIV infection and alcohol abuse using advanced in vivo magnetic resonance imaging methods. The investigator will work collaboratively under the cooperative agreement with NIAAA over a five-year period to conduct investigations of the separate and interactive effects of chronic alcohol use and HIV infection on neurocognitive function and brain structural and functional integrity. The long-term goal is to elucidate in vivo markers of neuropathology underlying the cognitive and motor decline observed in heavy drinking HIV-infected individuals or improvement with sustained abstinence from alcohol and their interaction with HIV disease status. Improvement in brain structure and function accompanied by ART/HAART/CART may be curtailed by comorbid conditions, notably alcohol use disorders, Hepatitis C, and potential neurotoxic effects of antiviral medication regimes. 

Now that individuals infected with HIV are living well longer than earlier cohorts, liabilities lurk that have the potential of reducing pharmacological benefits and include a return to risky behavior with the possibility of increased or additional infections, alcohol abuse, and cognitive, sensory, and motor compromise associated with normal aging.  Associated with normal aging is an inexorable decline in many cognitive and motor functions co-occurring with in vivo macrostructural and microstructural signs of involution.  As now established, the aging brain is increasingly vulnerable to endogenous and exogenous insult, such as occurs in the age-alcoholism interaction on brain tissue integrity.  Investigation of a similar interaction between normal aging and HIV infection is now especially germane given the extended longevity of individuals with HIV infection. Alcoholism-HIV infection comorbidity has been shown to be additive or even synergistic in its deleterious effects on the brain and performance measures cross-sectionally and in certain cognitive domains longitudinally.

The purpose of this Announcement is to support an ongoing program of research that has accumulated longitudinal brain structural, functional, and neuropsychological data concurrent with extensive clinical data in an actively followed cohort comprising four groups: HIV infection, alcoholism, HIV with alcoholism, and unaffected controls.  Clinical research knowledge gained from such a study could position "translational" efforts in development of better and more focused treatments for observed neurological, cognitive, and motor deficits as well as precautions relevant to disease-affected geriatric populations.

Background

Despite the advent of highly active antiretroviral therapy (HAART) in the mid 1990's, and a reduction in AIDS-related opportunistic infections, there has been a recent resurgence in the frequency of HIV encephalitis and cognitive impairment in patients on stable antiretroviral therapy. Research suggests that the re-emergence and progression of brain damage and cognitive impairments in HIV patients on long-term antiretroviral therapy may be due to the additive or interactive effects of multiple factors including development of drug resistance, Hepatitis C, nutritional factors, alcoholism and/or drug abuse, chronic antiretroviral treatment, and aging. Since hazardous drinking and chronic alcohol abuse are common problems in HIV infected individuals, it is important to study the additive and/or interactive effects of both conditions on brain structure and function.

In vivo neuroimaging data indicate that HIV infection and chronic alcohol abuse each affects many brain regions, particularly the frontal lobes, corpus callosum, basal ganglia, brainstem, and the cerebellum. Despite these overlapping areas of damage, only a few studies have used imaging technologies to examine the additive or interactive effects of these two diseases on brain structure and function. Neuropsychological studies on the combined effects of HIV infection and chronic alcohol abuse, although limited, are also beginning to more consistently show additive if not interactive effects of HIV and alcohol abuse on cognitive and motor performance that differs with the component functions assessed. However, the relation between alcohol-related adherence problems and progression of brain structural and functional (namely, cognitive and motor) decline remains elusive and would be best addressed with longitudinal study using multi-modal neuroimaging, neurocognitive, and clinical assessment in an established cohort.

The research problem is complicated by the fact that both alcoholism and HIV/AIDS diseases are characterized by a dynamic course of exacerbation and remission.  This complication makes a longitudinal study both challenging and necessary to elucidate factors responsible for observed improvement or decline, such as nutrition, medication adherence and neurotoxicity, hepatitis C infection, alcohol consumption patterns, and normal senescence. Further many of the untoward consequences may take years to manifest and should be considered given the demographic bolus of the U.S. population soon to enter their sixth and seventh decades.  The existence of an ongoing program of research on a well-characterized cohort spanning early adulthood to pre-retirement age at study entry with multiple longitudinal observations provides the basis upon which an extended longitudinal study can pursue the potential throes of an aging-alcoholism-HIV interaction.

Given the large investment and longitudinal nature of the investigation, it is necessary that the Institute have close oversight and provide continual advice while not assuming the role of directing the research project.

Objectives of Research Program

This program is a five-year continuation project using advanced in vivo magnetic resonance (MR) imaging modalities:  MRI for quantification of regional brain macrostructures and tissue types, MR diffusion tensor imaging (DTI) for examination of brain white matter fiber tract microstructure connecting macrostructures; and functional connectivity MRI (fcMRI) for identification of disruption in functional connections between brain sites that otherwise enable normal performance.  Assessment of different levels of brain integrity will inform the basis of the pathophysiology of HIV and alcohol abuse in dually afflicted individuals with prolonged life spans, the result of successful pharmacological treatment.  As non-invasive methods, these imaging approaches allow the observation of changes over time and the degree to which these disease-induced changes relate to clinical state, cognitive and motor performance, and advancing age.

Since its inception, this project has evaluated the cumulative and progressive deleterious effects on the brain of combined alcohol abuse and HIV infection in an ethnically diverse community sample comprising four groups: high and low alcohol consuming HIV-infected subjects and high and low alcohol consuming HIV sero-negative subjects. Cross-sectional analysis at study entry demonstrated substantial macrostructural, microstructural, and functional brain abnormalities in alcohol abusing patients with HIV infection, especially those whose disease had progressed to AIDS, compared with selective sparing in asymptomatic HIV-infected patients. These findings are echoed in cognitive and motor performance and self-assessed quality of life. In addition to the synergistic burden of alcohol abuse, the data also indicate significant effects of sex and CNS penetration of antiretroviral medication as important factors in detecting brain pathology. Longitudinal analyses of structural MR indicate a prominent role for continued alcohol abuse in progressive brain damage that has the potential of exacerbating such declines in HIV-infected subjects.  The additional health problems arising from alcoholism comorbidity in HIV-infected individuals highlight the need for detection and treatment of alcohol abuse in these patients.

The objectives of the next five years of this research program are to 1) establish the longitudinal pattern of brain and behavioral changes in terms of disease and age trajectories with disease projection or effective control, using quantitative MR imaging and neuropsychological measures the current sample 2) identify factors that modify disease trajectories, such as nutrition, medication adherence and neurotoxicity, hepatitis C infection, alcohol consumption patterns, and normal senescence ; 3) recruit an expanded sample of older individuals with HIV infection with or without the combined morbidity of alcohol abuse; and 4) establish cross-sectional and longitudinal within-subject relationships among neuroimaging measures, cognitive and motor performance, and clinical status.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

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

Funds Available and Anticipated Number of Awards

NIAAA intends to commit up to $1,210,000 in FY 2012 to fund one award, dependent on the availability of funds.

Award Budget

Award budget should be no more than $810,000 in Direct Costs.

Award Project Period

The total project period for the application submitted in response to this funding opportunity announcement 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

Only those institutions currently funded by NIAAA to support a U01 on human HIV, alcohol, and neuroimaging research at the date of issuance of this FOA are eligible to apply.

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 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.

This announcement is limited to the particular applicant organization because it uniquely has the capability to follow the preexisting cohorts entered into the research project in the first ten years of the study. The applicant will carry out longitudinal analysis of the interactive effects of alcohol abuse and HIV infection on brain structure and function, an area that is high priority to the NIAAA AIDS portfolio. Approximately 100 participants, 20-30 in each diagnostic group, are in active follow-up. The next wave of the study will re-contact the existing cohorts and recruit Cohort 3 to expand the age range upwards to age 70+ years to enable hypothesis testing regarding age-disease interactions.  All three cohorts will undergo extensive quantitative assessment including 1) MR protocols developed explicitly for this project, including a) volumetric structural MRI, b) and fcMRI, all at 3T field strength; 2) clinical and neurocognitive tests; 3) clinical evaluation with quantitative assessment of neuropathy and formal evaluation of medication compliance in HIV-infected patients. Analyses will test a dual model of the comorbidity of alcoholism and HIV infection: interactive effects on structures disrupted by both diseases (e.g., frontal lobes) and additive effects on structures disrupted by only one disease (e.g., basal ganglia in HIV infection and cerebellum in alcoholism). Thus, the substantial investments in patient recruitment and enrollment, assessments and follow-up evaluations, the strength of the findings to date, the emerging data from the follow-up evaluations, and the neuroimaging technical strength of this research team indicate that it is important to continue the longitudinal assessments and data analysis from this project.   

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

 The applicant institution may submit only one application under this announcement.

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. NIH will not accept any application that is essentially the same as one already reviewed.    

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.

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, 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.

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 National Institute on Alcohol Abuse and Alcoholism (NIAAA), 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. 

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?  

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

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

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

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute on Alcohol Abuse and Alcoholism 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 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 NIAAA National Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for the following:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Areas of Joint Responsibility include:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.  

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 301-435-0714
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)

John Matochik, Ph.D.
Program Officer, Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-7319
Email: jmatochi@mail.nih.gov

Peer Review Contact(s)

Ranga Srinivas, Ph.D.
Chief, Extramural Projects Review Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@mail.nih.gov

Financial/Grants Management Contact(s)

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@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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