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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)

Title: Comprehensive Alcohol Research Center on HIV/AIDS (P60)

Annoucement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AA-09-002

Catalog of Federal Domestic Assistance Number(s)
93.891

Key Dates
Release Date: August 11, 2008
Letters of Intent Receipt Date(s): April 1, 2009
Application Receipt Dates(s): May 1, 2009
Peer Review Date(s): July-August, 2009
Council Review Date(s):October, 2009
Earliest Anticipated Start Date: November 1, 2009
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: May 2, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad based Comprehensive Alcohol Research Center program on HIV/AIDS to conduct interdisciplinary, collaborative research on the effects of alcohol use on HIV infection and HIV related medical complications. This research may include study of HIV/AIDS in humans, SIV/SHIV in animal models, and HIV protein in transgenic animal models. The NIAAA Centers Program provides leadership in research, research methodology development and information dissemination relevant to the Institute’s mission to reduce vulnerability, morbidity, and mortality in at-risk and HIV infected alcohol using populations.

The Centers must be planned around the important research theme of alcohol and HIV/AIDS and must develop an effective translation and dissemination of research findings for the benefit of public health. Comprehensive Alcohol Research Centers on HIV/AIDS also are expected to function as regional and national resources in their particular area of expertise. Further, these Centers must provide opportunities for research training and a context for collaborations with outside investigators. It is particularly important that new investigators be mentored in the combined areas of alcohol and HIV/AIDS research issues.

Background:

Despite increasing knowledge about the cellular targets and the modes of HIV transmission, and available prophylaxis therapy, the overall rate of newly acquired HIV infections in the United States has remained constant for more than a decade, though the rate among young women and MSM (Men Who Have Sex with Men) of racial and ethnic communities continues to increase. In resource-constrained countries, HIV infections continue to increase at an unacceptably high rate. Problem alcohol use and identification of alcohol use disorders is one of the most common co-occurring diagnoses among patients in treatment for HIV/AIDS. It also is one of the best predictors of risk for infection among high-risk men and women in prospective studies. Importantly, there is an increasing recognition that biology and behavior interact in complex ways to affect HIV transmission, acquisition, and disease progression. For example, it is now clear that the probability of transmitting HIV very early in infection is higher than later when viral load is more controlled, even given the same risk behaviors at both time points. Recent research in animal models has demonstrated that chronic alcohol use alters the viral set point early in infection and subsequent course of disease resulting in more rapid mortality. Less clear are the complex interactions of behavioral and cellular events and the potential differential of susceptibility between individuals of different racial and ethnic backgrounds. So for example continued use of alcohol after initial infection may alter immunity as well as reduce adherence to life-saving medical regimens resulting in increased viral replication and mutation, viral shedding, and more rapid failure of medication effectiveness with clinical consequences. Thus the use of alcohol may have combined biological, behavioral, and health consequences that relate to susceptibility to infection, increased transmissibility, and differential response to treatment which results in complex population-level disease dynamics which requires further research.

The NIH/NIAAA expects that a significant amount of useful information for prevention efforts will continue to be generated through studies on the mechanisms by which alcohol use, abuse, and dependence affects HIV infection and changes the natural history of HIV infection among current and past drinkers. Chronic alcohol consumption is associated with immunesuppression. In most infected individuals, HIV infection is marked by immune dysfunction, depletion of CD4+ T cells, impaired cytokine production, and relatively unencumbered viral reproduction. Studies of virology and immunoregulation have identified some mechanisms by which these effects are produced, but more is yet to be learned about the interdependencies and interactions of immunological control mechanisms under the influence of acute and chronic alcohol ingestion. For example, the roles of CD25+ regulatory T cells in immunoregulation and follicular dendritic cells as reservoirs of HIV are only beginning to be understood.

The development of combination therapies for the treatment of HIV disease has resulted in extended survival and improved quality of life for those individuals who have access to antiretroviral drugs, can tolerate their toxicities and side effects, and can adhere to complicated treatment regimens. However, recent epidemiologic studies and clinical reports have shown increasing mortality due to liver dysfunction, malignancies, as well as cardiovascular and metabolic complications, associated with long-term HIV disease and antiretroviral therapy (ART). Alcohol is a common risk factor in these complications. Increased understanding of the pharmacological kinetics and dynamics in the context of alcohol use related to establishing safer ART treatment regimens is needed.

Strategic Priorities:

Through this FOA, NIAAA seeks to stimulate research to target strategic priorities of the changing AIDS epidemic in accordance with the Trans-NIH Plan For HIV-Related Research ((http://www.oar.nih.gov/strategicplan/fy2009/pdf/Overview.pdf)). These priorities include (but are not limited to):

1. Prevention of acquisition and transmission of HIV: The NIAAA biological prevention research agenda includes: basic, translational, and clinical research on the role of alcohol use in the immune function impairment that promote HIV infection and transmission which may inform potential preventive interventions; and research on the impact of alcohol use on efficacy of microbicides, vaccines, and preventive therapeutics, and other agents targeted at immune reconstitution of tissue and organs impacted by both alcohol and HIV/AIDS. Of particular interest is research on strategies that can be used in resource-limited settings. These interventions could mitigate the joint influence of alcohol and HIV infection through improving specific nutritional deficiencies and/or enhancing immune reconstitution.

2. Alcohol’s role in HIV-associated co-morbidities, co-mortalities, and co-infections: Alcohol abuse and dependence remain some of the primary comorbidities of HIV infected individuals. These HIV related comorbidities include hepatic, pulmonary, neurological, cardiovascular, metabolic diseases, malignancies, and other clinical manifestations, associated with long-term HIV disease and prolonged antiretroviral therapy. All of these conditions are exacerbated by alcohol abuse and dependence which result in reduced life expectancy through increased toxicities, rapid viral mutation, and regimen failure. Research that will lead to a better understanding of the combined health effects of alcohol on these HIV-associated comorbidities is a high priority. These combined effects may be of particular interest in the emerging field of system biology. In addition, translational and clinical studies are needed to transform fundamental research results into improved strategies for preventing and treating these HIV associated co-morbidities, co-mortalities, and co-infections.

Specific Research Objectives:

A wide range of center-based research projects are sought under this FOA. Appropriate projects may include, but are not limited to, research in the following directions:

Develop knowledge of the biological mechanisms by which alcohol use might affect the entry of HIV into different target cells, particularly with relation to the interactions of HIV envelope and cell receptors, and apply that knowledge to develop immunoprotective agents, microbicides, and vaccines to prevent acquisition and to block transmission of HIV. Design, develop, and test candidates and strategies that will increase the likelihood of preventing HIV infection in the context of alcohol use.

Develop and test biomedical prevention technologies that apply basic knowledge of how HIV enters cells in the context of alcohol use to prevent the establishment and spread of HIV between individuals. Examples of areas where increased emphasis is likely to produce insights for prevention include mucosal immunology studies to determine methods to prevent entry of HIV into target cells at the mucosal interface in the context of alcohol use.

Develop further understanding of biological interactions in the context of alcohol use related to changes in transmission risks over the course of HIV infection and disease, such as those differentially associated with acute and chronic infection accompanied by antiretroviral treatment, and later-stage disease in relationship to different short-term and long-term patterns of drinking.

Develop knowledge on behavioral and immune mechanisms in the context of alcohol use that explain a reduced/elevated rate of infection after exposure to HIV in certain individuals/animal model and apply such knowledge in vaccines and other prevention efforts, as well as treatment. Develop novel biomedical strategies (immunreconstitution, microbicides), as well as practical biopsychosocial interventions for adopting these biomedical strategies, that can be applied to appropriate alcohol use risk groups.

Develop research on combining neuroimaging and neuropsychological assessment to determine the relationship between medication adherence, biomarkers of HIV infection, and the decline in brain and cognitive function in HIV-infected heavy drinkers. Identify markers for neuropsychological functioning that will be predictive of treatment efficacy.

Evaluate the role of alcohol use in the efficacy and/or effectiveness of existing and emerging biomedical strategies (microbicides and vaccines) in clinical trial settings, which will explore various high-risk transmission/acquisition scenarios (e.g., acquisition from male and female sexual partners, blood-borne transmission/acquisition associated with alcohol/drug use) to inform and optimize future product design and application. Identify markers or bioassays that will be predictive of efficacy and safety of biomedical interventions.

Develop and evaluate new agents and drug regimens to prevent and treat comorbidities and comortalities associated with alcohol use and long-term HIV disease and antiretroviral treatment (metabolic disorders, malignancies, liver and cardiovascular diseases, neurological disorders, and other complications). In particular identify effective agents and drug regimens for assisting in immune reconstitution and alcohol-related tissue/organ damage.

Develop knowledge of mechanisms by which alcohol affects HIV coinfections. Develop and evaluate new strategies to prevent and treat HIV coinfections that might be promoted by alcohol use, including TB and HCV.

Develop knowledge on the development/pathogenesis of the complications in the context of alcohol use, as well as the mechanisms of toxicity of antiretroviral drugs that are resulting in these manifestations and complications.

Develop longitudinal approaches to evaluate neuropathological changes and cognitive deficits in individuals on long-term ART regimens in the context of alcohol use and abuse. Develop knowledge of the neural and behavioral consequences of an increased life-span with HIV infection as a result of long-term medications.

Develop research on metabolic, endocrine, cardiovascular, neurologic, renal, and bone complications of ART in the context of alcohol use. Develop clinical protocols that integrate studies on the complications of ART in the context of alcohol use and develop regimens to prevent and treat these comorbidities.

Develop basic and clinical research on the effects of coinfections (HCV or TB) on HIV transmission, pathogenesis, and disease progression in the context of alcohol use. Develop strategies for the prevention and treatment of HIV coinfections in the context of alcohol use.

Center specific objectives:

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad based Alcohol Research Center program to foster and conduct interdisciplinary, collaborative research on alcoholism, alcohol abuse and the impact of alcohol on health and disease. This FOA uses the NIH Comprehensive Research Center (P60) mechanism to support an integrated, broad-based multidisciplinary, multi-investigator, long-term program of research and research support activities planned around a specific major research theme on alcohol and HIV/AIDS. In addition, a Comprehensive Alcohol Research Center on HIV/AIDS (P60) is required to develop an effective research translation or information dissemination component to help accelerate the translation of research findings for the benefit of public health. Outreach activities could be pursued in collaboration with other Centers, thereby optimizing the impact. Comprehensive Research Centers also are expected to function as a National resource in their particular area of expertise, to facilitate research training, to develop research collaborations with outside investigators, and to provide a means to develop and explore new research activities or directions via pilot projects. The Research Centers program is interrelated with, and complementary to, all other research support mechanisms and scientific activities that comprise NIAAA programs. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated, integrated and synergistic effort.

The Comprehensive Research Center grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting high-quality alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. Unique scientific opportunities including sharing of resources or expertise warrant collaboration with investigators from other centers or from other institutions domestic or foreign. The director of component(s) in which collaborative activity with a foreign organization is proposed should be affiliated with a domestic institution.

Research Translation / Information Dissemination Component (for P60 applications)

Comprehensive centers (P60) must include a component which supports activities designed to translate research findings into health care practice, public information dissemination, or education curricula or programs for students, health professionals and community agencies. For Centers new to the P60 mechanism, such activities may require a substantial portion of the first year for planning and development with actual implementation beginning near the second year and continuing in subsequent years. These projects shall in a meaningful way reflect the Center's research theme. The following examples are types of projects that may be undertaken but are not intended to be limiting.

Research Translation:

Dissemination of Scientific Information and Research Progress:

All translational and educational projects should have specific objectives and include a method for monitoring the effectiveness of the effort.

Multiple Principal Investigator Leadership Structure:

In light of the increasing contributions of multidisciplinary team science NIH has instituted the opportunity for applicant institutions to use multiple-PIs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).

The prospect of incorporating Multiple-PI leadership structures into Comprehensive Research Centers complements NIAAA s long-standing commitment to a Centers program specifically directed toward multidisciplinary, collaborative research. Examples include support for: clinical and basic research collaborations, translational research, cross-institutional transdisciplinary collaborations, the development of experimental models targeted to significant issues in alcohol research, the rapid adoption and application of new technology, and the addition of an educational or information dissemination component for Comprehensive Research Centers (P60). In further support of these goals, the NIAAA invites applicants to consider using the multiple-PI leadership format.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH P60 Comprehensive Research Center grant award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The following information must be included (paragraph or bulleted form):

The estimated amount of funds available for support of one Center awarded as a result of this announcement is $2.0 million for fiscal year 2010. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Resubmissions are not permitted for this FOA.

Renewals are not permitted for this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct. Applicants are encouraged to contact Program Officials for further guidance.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

The following paragraphs describe the Special Requirements for a Comprehensive Center application.

Only applications that focus on alcohol and HIV/AIDS related research will be considered responsive to this FOA.

The Comprehensive Center must have a minimum of six (6) components (an administrative core, three research components, a pilot project component, and a research translation or information dissemination component). The maximum combined number of components is 10. More than a total of 10 components is not acceptable even if some components are in operation for less than the 5-year period. At least three research components must be active at all times. The research plan for each component is limited to twenty five (25) pages. Pages not used for one component may not be used to extend the page limit of other components or cores. In addition to the overall Center budget, each component requires a separate detailed budget.

A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations.

The Center Director will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center.

The applicant also may designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the center program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and identifying (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director also should be described.

A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, should be composed of at least five members. These members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the management of pilot projects. If committees other than the Program Advisory Committee are included, specific plans regarding committee selection and function should be provided in the application.

Training

While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important secondary function is the training of research and clinical personnel with a focus on new investigators. The applicant institution must therefore demonstrate or give reasonable assurances that it has: a) the capacity to train pre-doctoral and/or postdoctoral students for careers in alcohol research; and b) the capacity to conduct programs of continuing education in the Center's designated research theme in the basic, behavioral, epidemiological, or health service fields.

While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs; however, Center staff may participate in the development of training programs, and Center resources may be made available for use by trainees.

Multiple Principal Investigators (optional)

Applications using the Multiple-PI option must provide a rationale for choosing this structure and explain how multiple-PIs will enhance the Center’s strengths and promote its long-term viability. Each of the PIs must be identified on a continuation of the Face Page of the PHS 398 form (http://grants.nih.gov/grants/funding/phs398/398_forms.doc) and descriptions of their roles should be integrated into all the appropriate components. In addition, there will be a specific Multiple-PI Leadership Plan (see below).

Center Components:

Administrative Core Component

The Administrative Core provides the organizational framework for the management, direction, and coordination of the Center. It must be managed by the Center Director or Scientific Director. A clear leadership plan that includes the organizational structure and reporting procedure should be included. This core should ensure that all proposed components and related activities will function in an optimal and synergistic manner. An important function of this core is the administration of the budget. It may include funds for scientific enrichment activities such as lectures, symposia, seminars, and workshops for research faculty and staff. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core.

Scientific Core Component (s)

Core components are shared research resources that provide Center investigators with techniques, instrumentation, services, or resources that will enhance alcohol-related research to accomplish the common goals of the Center. A core component is a laboratory, facility, service, or other resource that provides support for scientific research projects of the Center. Cores should be used primarily to support projects which are part of the Center Grant award. Each core component is directed by an investigator with established expertise relevant to the support or service to be provided. Each shared scientific resource component should be clearly described in terms of the services and resources to be provided to investigators. The description should include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the cores also should be addressed. A core component should support two or more of the Center’s scientific research components and also may support independently funded research project grants related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact those objectives. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible to access the core facility. Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Research Components

Research components are individual scientific research projects, integrated with the overall Center program that contribute collectively to the goals of the Center program. The Research Component Director should be a qualified investigator and is responsible for the scientific direction and conduct of the individual research component. A Center Director or Scientific Director also may serve as a Component Director. Each proposed research component should provide a clear description of its major goals, objectives, and how it integrates with the other research components in relation to the overall Center program. The hypotheses to be tested should be focused and fully detailed. The design and procedures should describe the strategies proposed to accomplish the specific aims and innovative aspects of the approach should be highlighted. A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, subjects, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in proposed studies. If core facilities are utilized, information on their use should be provided.

Research Translation or Information Dissemination Component (required for P60 applications)

For each project in the research translation/dissemination component, a clear description of its major goals, objectives, and integration with the research components in relation to the overall center program should be provided. While the specific number of education projects is at the discretion of the applicant, requested funding for education component activities may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year. A staffing plan and rationale for organization of this component should be presented. Methods, techniques, and technologies to be used for proposed activities should be defined as well as the targeted audience or participants. Issues of cultural sensitivity with regard to the intended audience should be addressed. When appropriate, activities should be designed to effectively reach underserved populations and/or subgroups based on age or gender.

The scientific knowledge base and research topics or areas upon which proposed translational activities will be developed should be identified and explained.

A discussion of the design, plans and procedures for development including time lines should describe strategies proposed to accomplish specific aims of the project(s). Innovative aspects of the approach to be used should be highlighted.

A description of the resources, facilities, agencies, and/or institutions with working arrangements to plan, implement and conduct the proposed activities should be fully elaborated. Particular attention must be devoted to a description of necessary resources, including specialized expertise, and the target audience or participants who will derive benefit from the activity. If core facilities or services are utilized, information on their use should be provided.

A description of plans to evaluate the success and/or effectiveness of educational translational activities with emphasis on their impact on knowledge, attitudes, and behaviors should be described.

Pilot Project Component

The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects. The pilot project component is required and should include the planned pilot studies as well as procedures for selecting new projects. There is no limit to the number of proposed pilot projects; however, these pilot project funds are not intended to supplement ongoing research projects. The application must provide thorough and concise descriptions of the projects to be supported in the first two years. For years 03-05, the applicant should specify the number of pilots planned in each year and a brief description of the anticipated directions of these pilots. All proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide sufficient information to enable adequate scientific evaluation by a peer review committee. The application should include a full description of the management of the pilot project component, including a description of the process used to solicit and select pilot projects. This includes the selection of new projects to replace those proposed in the application should it become necessary. Each pilot study proposed in the first 2 years should be fully described, including its rationale, objectives, approach, investigators, and significance for the Center. Also a brief description (2 to 3 pages) and anticipated direction of pilot projects planned for the 03-05 years, and their potential significance to the Center should be included. The research description of any individual pilot project may not exceed five pages; the entire narrative for this Pilot Project Component may not exceed 25 pages irrespective of the number of pilot projects proposed. A budget should be submitted for the pilot project component as a whole for each year in which pilots are proposed and for each individual project. For years 01 and 02 the budget will reflect costs of pilots proposed in the application. Budget information provided for each project anticipated for the 03-05 years should reflect best estimate costs based on number and kind of pilot projects to be pursued. While the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $120,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: April 1, 2009
Application Receipt Date: May 1, 2009
Peer Review Date(s): July-August, 2009
Council Review Date:October, 2009
Earliest Anticipated Start Date:November 1, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX: 301-443-6077
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX: 301-443-6077
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

For a detailed description of required NIAAA Center grant application format and page limitations see http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/RFAs/Supplemental_Instructions.htm

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only.Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAAA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:

Significance: Do the Center’s research goals address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

* Does the application provide a well developed and well-defined central theme?

* Is there potential for the Center to serve as a regional or national resource in its area of expertise?

* Will the Center provide opportunities for research training and independent career development?

* Will the Center be able to develop scientific collaborations with outside investigators including those at other NIAAA Alcohol Research Centers?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

* Does the Center demonstrate a multidisciplinary and interdisciplinary approach appropriate for its theme and research goals?

* For COMPETING RENEWAL APPLICATIONS: Has the Center achieved its stated and has the scientific achievement of completed research been satisfactory? Have new scientists been recruited into alcohol research? Has the development of an interactive multidisciplinary team working together on a central theme been accomplished? Has progress been made in developing opportunities for collaborative research outside the Center? Has there been success in contributing to research training?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers?

* Is the Center Director capable of providing the scientific leadership and administrative oversight required to lead a Center?

* Do the investigators bring complementary and integrated expertise to the project?

* Will the investigators be able to form and integrated team appropriate to the Center’s theme and the long-term goals of the project?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

* What is the capacity to provide quality research training, and opportunities for independent research career development?

* Is the potential for interaction or collaboration with scientists from other departments and institutions described?

* Is the academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials well defined?

Coordination and Cohesiveness: Is the coordination among the administrative and scientific cores and the research components adequately explained? Is the usefulness of the scientific core components magnified by their inclusion in a Center? Is there synergistic potential among Center’s research components?

* Is there justification for each research component in terms of the central theme and the overall research goals of the Center?

* Does the Center have the potential to achieve a whole greater that the sum of its parts?

NIH considers the following in evaluating Center grant applications:

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the rating

For the NIAAA Alcohol Research Centers the initial review for scientific and technical merit of applications will emphasize two major aspects: (1) the review of each component: the administrative and resource scientific core(s), and the scientific research, and pilot project components, as applicable; and (2) review of the Center as an integrated whole working together to focus on a central theme, as well as its potential to contribute to research training and serve as a regional and national resource. Review also will include an assessment of the academic and physical environment and special considerations, e.g. compliance with human subjects and animal welfare requirements, and compliance with policies concerning inclusion of women, minorities and children in clinical research study populations. Review criteria for Comprehensive Alcohol Research Center on HIV/AIDS (P60) are:

The ADMINISTRATIVE CORE will be evaluated with the following criteria:

Approach: Are the arrangements and organizational structure, adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the application describe how day-to-day management will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate?

* Are there adequate plans for communication and cooperation among investigators?

* What are the quality control and oversight mechanisms in place for ongoing projects?

* What is proposed for long-term management and periodic evaluation of goal attainment?

* Are contractual and consortium arrangements described (as applicable)?

* What procedures will be used for replacement of key personnel should that become necessary?

Investigators: Are the investigators appropriately trained and well suited to carry out the proposed organizational interactions?

* Are the qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate?

* Is there a substantial time and effort commitment made by the Administrative Core Director?

* Does the Scientific Director have sufficient professional experience and leadership?

The SCIENTIFIC CORE COMPONENT(S) will be evaluated with the following criteria:

Approach: Is the justification for the need of a core service or resource clearly stated? Is the scientific and technical merit of the proposed core explained? Are there appropriate plans for resource allocation? Are quality control procedures in place? Are the resources and environment adequate?

Investigators: Are the investigators appropriately trained and well suited for the core activities? What are the qualifications, experience, and commitment of the component director? Is there a sufficient time and effort commitment made by the core component director?

The RESEARCH COMPONENTS and the RESEARCH TRANSLATION/INFORMATION DISSEMINATION COMPONENT will be evaluated with the following criteria:

Significance: Does this study address an important problem? If the proposed aims are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the investigator acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methodology? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigators: Is the Research Component Director appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the component director and other researchers involved?

Environment: Is the scientific environment sufficient for the needs of the project? Does the proposed research take advantage of unique features of the environment such as: access to at risk populations, community resources or mutually-beneficial collaborative arrangements? Is there evidence of institutional support?

The PILOT PROJECT COMPONENT will be evaluated with the following criteria:

Significance: Are the pilot research topics important? Does the pilot have the potential to develop into a full-scale independent project?

Approach: Is there an adequate selection process for new and replacement pilot projects? Are monitoring, oversight procedures and continuation decisions explained? Are the resources and environment for the projects adequate?

Investigators: Are the qualifications of the pilot project Component Director and the individual pilot project leaders appropriate for the proposed research?

The MULTIPLE-PI LEADERSHIP PLAN (optional Section I) will be evaluated with the following criteria:

Significance: Does the Multiple-PI Leadership Plan offer a clear and compelling advantage to a traditional single PI model? Will the Leadership Plan contribute to the overall scientific integration and productivity of the Center?

Approach: Is the leadership approach appropriate for the scientific goals and personnel of the Center? Do the identified roles and responsibilities for the PIs match their experience and areas of expertise? Is the proposed governance and organizational structure consistent with and justified by the aims of the project and the roles of the PIs?

Innovation: Does the Multiple-PI Leadership plan contribute to the Center s originality or innovativeness? Does the Multiple-PI Leadership plan facilitate the development of novel concepts, approaches, or methodologies appropriate for the Center’s intended theme?

Investigators: Are the designated PIs appropriately trained and well suited to carry out their roles as described in the application? Is the work proposed appropriate to the experience level of the PIs and other researchers? Do the PIs and the investigative team bring complementary and integrated expertise to the project?

Environment: Does the proposed administrative environment enhance the productivity of the PIs and thereby serve the ultimate goals of the project? Specifically:

* Are the budgetary and administrative roles and areas of responsibility for each of the PIs sufficiently described to assure effective and collegial leadership?

* Are there appropriate plans for the coordination of the fiscal and managerial aspects of the Center?

* Is there an appropriate process for making decisions on scientific direction and allocation of resources?

* Are there adequate plans for data sharing and communication among the investigators?

* Is there a need for publication and intellectual property policies and if so, is it adequate for the circumstances?

* Are there procedures in place for resolving conflicts?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated. Also required are other reports in accordance with NIH policy.

In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

H. Joe Wang, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2029
Bethesda, MD 20892
Telephone: (301) 451-0747
FAX: (301) 594-0673
Email: [email protected]

2. Peer Review Contacts:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX: 301-443-6077
Email [email protected]

3. Financial or Grants Management Contacts:

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304 Room 3023
Bethesda, MD 20892-9304
[For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-4704
FAX: 301-443-3891
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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