and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|
Funding Opportunity Title |
Interventions to Improve HIV/AIDS and Alcohol-Related Outcomes (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AA-12-009 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.273 |
FOA Purpose |
This FOA issued by the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, solicits cooperative agreement grant applications (U01) to develop and strategically test coordinated interventions to reduce alcohol use and alcohol-related consequences in HIV-impacted populations. In addition, this research seeks to develop a new framework for sustainable implementation research among HIV+ alcohol users, with the ultimate goal of significantly improving health care systems. This initiative intends to build on existing cohorts of HIV+ patients, including those who have been diagnosed recently and are just entering treatment, and those who are well-established in HIV treatment. |
Posted Date |
January 26, 2012 |
Open Date (Earliest Submission Date) |
February 27, 2012 |
Letter of Intent Due Date |
February 25, 2012 |
Application Due Date(s) |
March 26, 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 |
March 27, 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.
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
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) solicits up to five-year cooperative agreement (U01) grant applications to develop and test coordinated interventions for individuals living with HIV/AIDS who drink alcohol at harmful or hazardous levels. Applications may come from institutions/organizations with established HIV/AIDS cohorts or from organizations that are seeking to collaborate with such organizations. The current FOA will fund three or more applications to conduct research on interventions for alcohol misuse among HIV+ populations. Studies may include both experimental and quasi-experimental research, natural experiments, and research on practice-based adaptive interventions, with emphasis on both patient and clinician-relevant outcomes. The overarching goal of this research activity is to advance implementation research on coordinated interventions for people with co-occurring alcohol misuse and HIV/AIDS, with the ultimate goal of developing more effective systems to reduce the impact of alcohol on HIV transmission and disease progression. The goals of this initiative are consistent with the National HIV/AIDS Strategic Plan (NHAS) for the prevention and treatment of HIV/AIDS.
The proposed research initiative supports and strengthens the research base for the National HIV/AIDS Strategic Plan (NHAS) and is consistent with the goals and directives of the NHAS Federal Implementation Plan:
People with HIV also have other significant challenges. Many people living with HIV have other co-occurring conditions, such as heart disease, depression or other mental health problems, or drug or alcohol addiction. In addition, poverty, unemployment, domestic violence, homelessness, hunger, lack of access to transportation, and other issues can prevent people from accessing health care. There are also differences in health care access and treatment outcomes by race/ethnicity, gender, and geography. HIV-positive African Americans and Latinos are more likely to die sooner after an AIDS diagnosis compared to HIV-positive Whites; HIV-positive women are less likely to access therapy compared to HIV-positive men; and access to care and supportive services is particularly difficult for HIV-positive persons in rural areas, as well as other underserved communities. While research has already brought us a long way, continued research is needed to develop safer, less expensive, and more effective treatments and drug regimens, as well as to evaluate new approaches to meeting HIV treatment needs while also responding to co-occurring conditions or other barriers to care. National HIV/AIDS Strategy (NHAS) and NHAS Federal Implementation Plan.
Within the next decade, more than half of the patients in the U.S. living with HIV will be over fifty years old and with appropriate treatment may expect to live for multiple decades after detection of infection. However, the extended course of HIV disease increases the need for attention to the impact of co-occuring disorders on HIV transmission and disease progression. Large-scale studies have revealed a high prevalence of alcohol use, abuse, and dependence among HIV-infected patients both in and out of care. From 30-75% of HIV+ individuals have been identified with current alcohol use disorders in various domestic and international studies. Alcohol use disorders are increasingly recognized as factors in morbidity and mortality among HIV-infected individuals, particularly among those who are coinfected with HCV or have multiple other disorders that may be exacerbated by alcohol use and/or environmental circumstances where alcohol plays a significant role in vulnerability and recovery (e.g., homelessness).
While HIV treatment has improved and many patients successfully suppress viral replication and maintain adequate immune function throughout many years of treatment, a significant portion of alcohol users do not. Alcohol use has been associated with late entry into HIV treatment, higher viral set points, reduced adherence, increased cART toxicities, more rapid progression of disease, and liver failure. Recent studies have demonstrated that there is no safe level of drinking for some patients infected with HIV and that even low levels of drinking may be associated with increased morbidity and mortality over the lifespan. In addition, research indicates that over half of alcohol users who are HIV- infected may be receiving little or no treatment as a result of having exhausted their treatment options or of having inadequate access to appropriate care settings.
The overarching goal of this announcement is to support research that will inform the development of optimized systems of care for people with co-occurring HIV/AIDS, harmful drinking, and other comorbid health and mental health conditions. The primary aim of the research is to conduct efficacy studies of interventions which reduce alcohol use and the short and long-term consequences of harmful drinking among individuals living with HIV disease. Potentially effective interventions will be identified as part of a broader plan to create an implementation/operations research framework which allows for evaluation of both individual interventions and the impact of important structural factors, such as training, coordination of care and service integration, quality assurance processes, and community poverty and violence. Investigators will work with existing cohorts of people living with HIV/AIDS to assess the effects of interventions on both short-term and long-term health outcomes, including outcomes related to co-occurring mental health and substance use disorders (e.g., depression; nicotine addiction, etc.) and on social outcomes such as housing stability and employment. In conceptualizing the approach to this research, it may be particularly important to consider how selected interventions may interact with emerging HIV preventive interventions, given that the overarching goal is to create systems that generate the maximum benefit in all health-related domains for both current and future patient populations.
Working with existing cohorts of people living with HIV/AIDS, individuals with alcohol-related problems may be effectively identified using a range of validated behavioral and biological measures. Information from these cohorts related to alcohol use and alcohol-related consequences should be accurately assessed and changes in alcohol use patterns related to HIV treatment and outcomes. The choice of optimally effective interventions for such patients will necessarily involve consideration of underlying biological processes such as inflammation and oxidative stress which may be related to both alcohol use and HIV disease, and may accelerate disease progression by causing tissue and organ injury. Markers for these processes, as well as environmental factors that drive the risk for re-infection and acceleration of the course of disease should be taken into account in making clinical decisions, and are an important area of emphasis within this initiative. Additional areas of emphasis are the use of adaptive strategies involving changes in intervention dosage or type based on clinical response, and of innovative statistical methods for the evaluation of these strategies and related clinical outcomes. For example, the intervention could encompass multiple components, including behavioral, pharmacological, and structural interventions to reduce alcohol use, which are modified according to a pre-determined algorithm based on an individual patient's clinical response. Other priorities for this research are methods to improve standardization of care, evaluation of specific biological outcomes related to organ or tissue injury, and economic impact of selected interventions. The maximum total cost for each study is anticipated to be $500,000 dollars in direct costs.
The overarching goal of this initiative is to prevent alcohol-related HIV transmission and disease progression by informing public policy and/or clinical practice related to alcohol use, abuse, and dependence in HIV+ populations. The approach may involve multidisciplinary teams such as clinician researchers, behavioral scientists, health services researchers, biostatisticians, and health economists who work together to develop and evaluate novel approaches to improving outcomes for HIV+ individuals who engage in hazardous or harmful drinking. Optimally the involvement of multidisciplinary teams will enable the integration of knowledge from different perspectives and the use of state-of-the-art techniques to understand the effects of selected interventions at multiple levels. Specific goals of this research may include but are not limited to reducing alcohol-related HIV/AIDS mortality (e.g. hepatic, cardiovascular injury) and the number of clinical events related to poor compliance with medications; improving patient quality of life; improving the cost-effectiveness of care; and development and evaluation of enhanced models of service delivery. Specifically, health services-related research may include assessing, monitoring, and enhancing the quality of care at patient, clinician, and system levels, and evaluation of innovative approaches to improving standardization and coordination of care. Other areas of interest include enhancing the state of the science of outcomes measurement and developing innovative study designs and statistical methods for quasi-experimental research on integrated HIV and alcohol treatment. By supporting both methodological and applied research focused on patient outcomes, it is anticipated that this initiative will significantly accelerate the translation of critical research findings in multiple domains of interest to effective strategies for significantly improving patients' quality of life.
Areas of emphasis include but are not limited to:
Plan for Data Sharing and Intellectual Property:
NIH expects applicants who respond to this FOA to develop and propose specific plans for sharing the data and materials generated, consistent with achieving the goals of the program. This addresses the interests of the Government in the availability of and access to the results of publicly funded research. The initial review group will comment on the proposed plans. In addition, as one of the criteria for award, NIAAA staff will also consider the adequacy of the plans.
Rapid dissemination and implementation of findings are critical to achieving the goals of this FOA, consistent with the overarching goal of the National HIV/AIDS Strategy (NHAS) and accompanying Federal Implementation Plan to develop a more coordinated and effective national response to the HIV epidemic within the next 5 years. The NHAS calls for an unprecedented commitment to collaboration, efficiency, and innovation that may only be achieved by the free and rapid flow of information among members of the research community, and between members of the research community and the health and social services community. Accordingly, responsive applications will address in detail how findings will be shared with the research community and with members of the communities targeted by the research to achieve these program goals. Where relevant, applicants should discuss plans for developing health information tools and dissemination techniques tailored to the needs of specific high risk populations, such as minority women and girls, immigrant or migrant populations, and a subpopulation of men affected by HIV/AIDS. Negotiations with the applicant to fully address dissemination and implementation goals outlined in the application will be made a condition of the award.
Applicants are also reminded that the grantee institution is required to disclose each invention to NIH within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. Grantees are expected to timely report all subject inventions developed under this funding agreement to the NIH through http://iEdison.gov, under the NIH Division of Extramural Inventions & Technology Resources (DEITR), OPERA, OER.
The Role of NIAAA
The NIAAA staff role in these cooperative agreements will extend the level normally required for stewardship of a grant because of the need for coordination across sites. An NIAAA Program Official will be assigned to effect management decisions required during the course of the project. In addition, an NIAAA Project Collaborator(s) will have substantial scientific input, in collaboration with award recipients, in both the planning and conduct of the study. The NIAAA Project Collaborator(s) will participate in monitoring the progress of the ongoing study, perform quality control, data analysis, and interpretation, and possibly assist in the preparation of publications.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
New |
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. NIAAA intends to commit $2.5 million in FY 2012 for up to 4 awards. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 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.
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
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 allowed.
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.
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 FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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.
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.
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.
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:
Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service,
non-USPS)
Telephone: 301-443-9737
Email: [email protected]
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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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 modification:
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.
Not Applicable.
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.
This initiative is not subject to intergovernmental review.
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.
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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
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).
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/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?
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
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.
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 . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:
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.
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.
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 U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
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, 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:
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Kendall J. Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9389
Email: [email protected]
Ranga V Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451 2067
Email: [email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]
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.
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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||