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

International Research Collaboration on Alcohol and Alcoholism (U01)

Activity Code

U01 Research Project – Cooperative Agreement

Announcement Type

Reissue of PAR-08-004

Related Notices

  • July 1, 2014 - This PAR has been reissued as PAR-14-268.
  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-11-282

Companion FOA

None

Number of Applications

See 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 applications for the purpose of fostering international collaborations between alcohol research investigators within the United States and investigators located at non-United States laboratories and performance sites for the mutual advancement of our understanding of alcohol problems and of clinical and public health approaches to their solutions. The program is intended to provide funds for research activities to be undertaken jointly between the U.S. and non-U.S. laboratory that expands the research direction of both the U.S. and non-U.S. laboratories in a collaborative manner.

Key Dates
Posted Date

July 27, 2011

Open Date (Earliest Submission Date)

September 5, 2011

Letter of Intent Due Date

30 days before the standard submission dates

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

Now July 2, 2014, reissued as PAR-14-268. (Originally September 8, 2014)

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

Research Objectives

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications for the purpose of fostering international collaborations between alcohol research investigators within the United States and investigators outside of the United States. The goal of the program is to facilitate, through international collaborations, advancements in the understanding of alcohol problems and the clinical and public health approaches to their solutions.

Applications are invited across the full spectrum of alcohol research from basic science to clinical, public health and health services research. Any of a large number of research questions may be addressed under this program, and may involve the use of human subjects, research animal models, statistical modeling, or in vitro approaches.

It is the expectation of NIAAA that both the U.S. and non-U.S. investigators will have pre-existing research programs at the time of application and the funds to be provided through this award will be used to enhance, through an active collaboration, the ongoing research efforts in both laboratories. Thereby, funds provided under this announcement will not substitute or replace the support for the on-going research efforts in the respective laboratories, but will be limited to support of new activities within the proposal for collaboration. Resources contributed to the collaborative research effort by each investigator may include contributions of personnel, access to study populations, laboratory, and other research facilities, etc.

Background

Alcohol is consumed worldwide and alcohol-problems are not unique to any particular country. Research on alcohol use disorders is conducted in many countries throughout the world, and supported by government and non-government organizations in the respective countries. With respect to the magnitude of alcohol problems, the World Health Organization (WHO) has estimated that there are about 2 billion people worldwide consuming alcoholic beverages and 76.3 million diagnosed with an alcohol use disorder. The global public health burden related in alcohol consumption in terms of both morbidity and mortality is substantial in most parts of the world. WHO estimates that alcohol consumption causes 3.2% of deaths (1.8 million) and 4.0% of the Disability- Adjusted Life Years lost (58.3 million). There are causal associations between alcohol consumption and more than 60 types of diseases and injury. Alcohol consumption is the leading risk factor for disease burden in developing countries, and the third largest risk factor in developed countries. Besides the numerous chronic, acute and developmental health effects, alcohol consumption is also associated with widespread social, mental health and emotional consequences. Clearly, alcohol problems are of an international scope and are a source of international public health concern. Collaborative research involving U.S. and non-U.S. laboratories provides a unique opportunity to expand our knowledge about alcohol effects, particularly when it affords the opportunity for the interaction of investigators and laboratories with unique skills, and the access of U.S. and non- U.S. investigators to resources, including scientific personnel, not otherwise available to them.

The objective of this program is to facilitate collaborations between laboratories located inside and outside of the U.S. for the mutual advancement of our understanding of alcohol problems and of clinical and public health approaches to their solutions. The program is intended to provide funds for research activities to be undertaken jointly between the U.S. and non-U.S. laboratory that expands the research direction of both the U.S. and non-U.S. laboratories in a collaborative manner. It is thereby expected that both the U.S. and non-U.S. laboratories will have current, on-going, research programs at the time of application for the proposed collaborative alcohol research efforts. There is no pre-requisite related to the funding source of the current on-going research efforts in either the U.S. or non-U.S. laboratory; however applicants must demonstrate support exists for both the US and non-US researchers.

This announcement is intended to cover the entire domain of research activities supported by NIAAA. Therefore, research priorities include but are not limited to:

Alcohol neuropharmacology- research that identifies mechanisms of alcohols biological effects, factors associated with the acquisition of tolerance and dependence, and biological factors underlying the transition into compulsive consumption. These studies may be comprised of either basic animal or human research or both.

Alcohol genetics and epigenetics research that identifies genotypic and epigenetic factors that contribute both to the liability for alcohol-associated problems and those factors that are protective against such problems.

Biomarkers- research that yields biomarkers of heavy alcohol consumption, the liability to alcoholism, biomarkers of physiological dependence on alcohol and compulsive drinking behavior.

Developmental effects of alcohol exposure- this includes mechanistic research elucidating alcohols impact on the developing fetus, research on the effects of alcohol exposure on the adolescent and pre-adolescent brain, studies that elucidate the relationship between drinking onset, and the development of alcohol use disorders, and the unique consequences of alcohol use on the aging population.

Comparative epidemiology-population-based research that identifies sociodemographic factors associated with patterns of alcohol consumption in settings that may help elucidate risk factors in the U.S. In addition, NIAAA is interested in trans-cultural diagnostic issues that advance our capacity to identify alcohol use disorders and comorbid conditions in a valid and reliable fashion.

Mechanisms of alcohol-related organ damage research that elucidates molecular pathways through which alcohol produces organ damage, as well as mechanisms of organ plasticity and organ recovery.

Mechanisms of Behavior Change research that identifies factors that underlie treatment-seeking behavior, adherence, and the process of recovery from alcohol use disorders.

Medications Development for the Treatment of Alcoholism research leading to the development of pharmacological agents that prevent or reduce alcohol intake.

HIV/AIDS Research research on alcohols pharmacologic interactions with AIDS therapeutics, alcohol and neuron-AIDS, and the integration of approaches from the basic behavioral sciences into the development of innovative alcohol-related HIV prevention interventions.

Alcohol and Safety research on causes of alcohol-associated accidents and injuries, and interventions to ameliorate the public health problems associated with drinking and activities such as driving.

Policies to reduce alcohol-related harms evaluations of policies enacted in other societies afford an otherwise unavailable opportunity to study the likely effects of policies that have not been enacted domestically, but might be under active consideration.

Research on prevention and intervention to reduce underage drinking and drinking in young adults.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Award Budget

 Application budgets need to reflect actual needs of the proposed project.  Applications may request up to $250,000 direct cost per year.  Exceptions to cost limitation will not normally be granted but if requested will require extensive justification and documentation.  

Award Project Period

  5 years

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign institutions may participate as applicants or subcontractors if they have unique patient or laboratory resources, unusual scientific merit, or documented evidence for support.

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 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.

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

On-Going Research Activity

 Both the U.S. and non-U.S. investigators should have a current on-going research activity, regardless of funding source that would benefit through the addition of an international collaborative partnership  

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 e-mailed to:

Dr. Abraham P. Bautista
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane Suite 2089
Rockville MD 20852
Telephone: 301-443-9737
Email: bautista@mail.nih.gov

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, with the following modifications:

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/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, NIH. Applications that are incomplete will not be reviewed.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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: Only the review criteria described below will be considered in the review process.

In addition to the standard review criteria listed in Section V.1, the applications will be reviewed to determine the extent to which the proposed international collaboration fosters the alcohol-related research activities within both the U.S. and non-U.S. laboratories, and as to whether the collaborative arrangement is an equal partnership that benefits both research laboratories.

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/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?   

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

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

Renewals

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

Revisions

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

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

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 (NIAAA) , 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the 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’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.

Principal Investigator Rights and Responsibilities:

The PD/PI(s) will have assigned primary responsibilities dedicated to specific research objectives, approaches and details of the project within the guidelines of the Funding Opportunity Announcement and performing the scientific activity as laid out in the leadership plan..

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH Responsibilities:

An NIAAA Project Coordinator will be assigned to the project based on the scientific area of expertise proposed by the project and will be an NIAAA extramural scientist from the appropriate scientific division relevant to the proposed area of study. The role of the NIAAA Project Coordinator is to provide technical assistance, advice, coordination, and other program actions supporting recipients of cooperative agreements during the conduct of the activity, above and beyond the levels required normally for program stewardship of grants, but without dominating the relationship. The NIAAA Project Coordinator may assist the awardee in performing project activities (e.g., coordinating research networks, providing access to NIH supported research resources, identifying other researchers/resources to participate), provide advice on compliance with NIH policies, and serve on committees as a voting member as needed. The NIAAA Project Coordinator may not attend peer review meetings of renewal or supplemental applications related to the project (unless IC waiver is obtained) and may not be involved in the normal programmatic stewardship of the project.

An NIAAA extramural Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official is distinctive from the NIAAA Project Coordinator because their responsibilities lie with the programmatic stewardship of the award. The program official interacts with grants management to approve actions required by NIAAA prior approvals, evaluates the progress reports and fiscal reports to determine if performance is consistent with the objectives and terms and conditions of the award, provides technical assistance requested by awardees, and works with the awardee to resolve unanticipated programmatic or financial deficiencies in awardees performance. The program official will be assigned to the project based on the scientific area of investigation and the area of expertise of the program individual.

Collaborative Responsibilities:

The leadership plan will outline the specific responsibilities of each PD/PI(s) and collaborators, including the planning, oversight, direction and reporting of results from the assigned tasks within the application. PD/PI(s) will be responsible for the coordination of the filing of progress reports, fiscal information relevant to the grant, and any inventions or patents resulting from the award, and the final program report and invention statement at the end of the award period.

Areas of Joint Responsibility include:

All responsibilities are divided between awardees and NIH staff as described above.

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 arbitration. An Arbitration 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 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)

Peggy Murray, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-2594
Email: pmurray@mail.nih.gov

Peer Review Contact(s)

Ranga Srinivas, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@mail.nih.gov

Financial/Grants Management Contact(s)

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



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



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