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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: NIAAA Collaborative Centers for HIV/AIDS and Alcohol Outcomes Research (U01, U24)

Announcement Type

New

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

Request For Applications (RFA) Number: RFA-AA-11-003

Catalog of Federal Domestic Assistance Number(s)
93.273

Key Dates
Release Date: September 13, 2010
Letters of Intent Receipt Date(s): December 11, 2010
Application Receipt Dates(s): January 11, 2011
Peer Review Date(s): March-April 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date: July 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 12, 2011

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
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

Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) solicits up to five-year cooperative agreement (U24, U01) grant applications from institutions/organizations to establish Consortiums for HIV/AIDS and Alcohol-Related Outcomes Research Trials (CHAART) to complement and collaborate with other existing centers/cohorts with alcohol and HIV/AIDS research focus. The current FOA will fund two or more consortiums to conduct alcohol-related outcomes and comparative effectiveness research. Research may include epidemiologic studies, natural experiments, quasi-experimental research, and practice-based strategic interventions that focus on patient and clinician-relevant outcomes of healthcare and the determinants of these outcomes for alcohol using HIV+ individuals. Overall the goal of this research activity is to advance operations or implementation research in the context of alcohol and HIV/AIDS and to develop a broader systems approach for intervening to reduce the impact of alcohol on HIV disease progression and transmission. The goals of this initiative are consistent with the National HIV/AIDS Strategic Plan (NHAS) for prevention and treatment of HIV.

Background

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 geog raphy. 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.

The overarching goal of this announcement is to create an implementation/operations research framework which allows for a dynamic interaction cohort studies which can monitor both short-term and long-term patient health and the development and strategic testing of interventions to reduce morbidity and mortality in alcohol consuming populations of HIV+ individuals. 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 treatment of HIV disease increases the need for attention to the impact of co-occuring disorders in the management of patients for optimal care and the prevention of transmission. Large-scale studies have shown that alcohol use, abuse, and dependence are highly prevalent 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 different domestic and international studies. Alcohol use disorders are increasingly recognized as a factor in morbidity and mortality among HIV-infected individuals may accelerate mortality particularly among those who are coinfected with HCV or have multiple other disorders impacted by alcohol use. While HIV treatment has improved and many patients successfully suppress viral infection 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, increase 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. Opportunities exist for further understanding the impact of alcohol use alone or in conjuction with other substances of abuse, psychological disorders, and other infectious diseases (E.g. HepC, TB) exist in ongoing cohort studies. Identifying individuals with alcohol problems can be effectively carried out using a range of validated behavioral and biological measures and these can be linked to existing information on HIV and other cofactors . Additional factors related to underlying biological processes such as inflammation and oxidative stress related to both alcohol use and HIV disease may impact tissue and organ injury and may exacerbate disease progression. Markers for these processes may need to be taken into account to appropriately inform clinical decisions.

The intention of this announcement is to build on pre-existing cohorts of patients with substantial alcohol use. 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. Interventions to change alcohol use patterns and moderate the effects of alcohol use on HIV disease progression put in place to test their efficacy and effectiveness. While the primary research cores (U01) and associated research activities must reflect these two aspects (cohort assessment and intervention) and their dynamic interaction, additional research core activities may take place. So for example, the intervention focus could reflect multiple approaches which include behavioral, pharmacological, and structural interventions to reduce alcohol use and mediators or moderators of HIV/AIDS-related outcomes. Additional goals could include prioritization of clinical decision making, specific biological outcomes related to organ or tissue injury, and health economics related to implementation of effective treatment programs. Administrative core(s) (U24) must coordinate and support the research activities and statistical approaches reflecting the dynamic changes in patient outcomes. A statistical core could stand separately from other cores if, for example, models for adaptive interventions need to be developed and tested using emerging technologies. The maximum total cost for each Consortium is anticipated to be $ 2.5 million.

Objective

These consortiums are intended to both 1) accurately characterize populations who are HIV infected and consume alcohol in hazardous or harmful quantities, and 2) to assess and strategically test interventions targeted to this population. These are considered separate components of the Consortium (see budget) and Consortiums must address both of these components. The overarching goal is to directly inform public policy and/or clinical practice related to alcohol use, abuse, and dependence in HIV+ populations. Each CHAART will conduct 1-3 research projects within both the epidemiological and intervention components in which multidisciplinary teams such as clinician researchers, behavioral scientists, health services researchers, biostatisticians, and/or health economists undertake novel research focusing on measuring, evaluating, and improving outcomes for HIV+ individuals who engage in hazardous or harmful drinking that increases risk of morbidity and mortality for HIV/AIDS. The goal of this research is to prevent the rapid progression of disease, prevent the transmission of HIV/AIDS, and change the early and/or later course of HIV/AIDS illness trajectories and prevent increased morbidity/mortality. Outcomes relevant for this FOA include reduction in alcohol-related HIV/AIDS mortality (e.g. hepatic, cardiovascular injury), clinical events related to non-compliance or inconsistency with medication use, and improving cost-effectiveness or quality of life for dually diagnosed alcohol/HIV individuals. Strategically targeting behavioral, biomedical, and structural interventions may change individual and/or organizational decision making. This FOA supports both methodological and applied research focused on patient outcomes. Aims could include assessing, monitoring, and enhancing the quality of care at patient, clinician, and system levels; translating research findings into practical care delivery strategies for health care practitioners, clinicians and decision-makers; improving the effectiveness and efficiency of delivering evidence-based care; enhancing the state of the science of outcomes measurement; and developing innovative study designs and statistical methods for quasi-experimental research for HIV/Alcohol care.

NIAAA recognizes the innovation, synergy, and conceptual advances that arise from interactions across scientific disciplines, methodologies, and levels of analysis. It is anticipated that with the incorporation of groups of scientists into a research consortium focused on both the course of HIV illness and alcohol use and the interventions that can be implemented in real-world settings with existing cohorts will generate new knowledge. This knowledge will be integrated from different perspectives and levels of analysis using state-of-the-art techniques at to understand multilevel level effects. This initiative would foster such integration and significantly speed up the translation of such critical information in target populations throughout the US that have increasing evidence of long-term consequences from HIV complications arising from continued alcohol consumption. .

Areas of research appropriate to this announcement include, but are not limited to

Organization

The following structure of CHAART is envisioned. This initiative is limited to human studies only. The CHAART Consortium will consist of a cluster of integrated cooperative agreement research applications (U01s) and core facilities (U24s), if necessary, and will be led by a Consortium Coordinator(s) (CC). A highly integrated multidisciplinary research consortium will thus be formed from groups of investigators (within and across institutions) whose scientific and technical expertise will enable them to interactively study 1) the effects of alcohol use on the course of HIV illness and 2) the development and testing of alcohol-related interventions to reduce morbidity and mortality in this population in a coordinated and adaptive manner. The goal of this research is to fully understand the role of implementation research in large generalizable cohorts of HIV infected individuals throughout their lifespan in the context of alcohol use, abuse, and dependence. The approaches should take advantage of existing cohorts with adequate alcohol use data to inform future activities for altering the early and later course of infection. The approaches used will reflect the blend of experience and creativity of the CHAART components and will be originated by these investigators. Through formation of CHAART, the integrated research project component groups will have access through the administrative core facility to resources, information, technologies, ideas, and expertise that are beyond the scope of any single research team.

The Consortium Coordinator or lead Principal Investigator is the scientist(s) who assembles the integrated and collaborative research consortium and is responsible for submission of the cluster of applications in response to this FOA and for performance of the project. The consortium coordinator must be recognized in the area of alcohol research, especially in one of the three interactive research areas or domains of CHAART described below. Because a substantial level of effort will be necessary to manage a project of this magnitude, the Consortium Coordinator is expected to make a major commitment to directing, managing and executing the goals and collaborative nature of this project.

The Consortium Coordinator’s application will be the lead application of the consortium and should include the Administrative Coordinating Core, together with the Administrative Management Plan, and the Plan for Data Sharing and Intellectual Property. This lead application should discuss the theme and goals of the consortium and should include a scientific rationale for the various research project components and resource core applications (if any) that make up the consortium. It should further describe the benefits of the proposed integration between projects and how the individual applications complement each other to enhance the scientific goals of the consortium. The lead application should also include a composite budget of the whole consortium in addition to its own individual budget. It is acceptable for the Consortium Coordinator to submit a research project component or a resource core application in addition to the lead application. While each application (U01 or U24) will originate from the principal investigator(s) research institution and awards will be made to individual institutions. I it is the responsibility of the consortium coordinator to submit the cluster of applications of the consortium together with the appropriate cover letter as one package (See Application Procedures and Application Submission Section).

OTHER ELEMENTS OF THE INTEGRATED AND COLLABORATIVE PROJECT CHAART

Administrative and Project Management Plans:

The Consortium Coordinator’s lead application must include an Administrative Management Plan that outlines the policies and procedures for access of participating investigators to the collaborative project resources. The application should address the flow of information within the project, the integration among individual projects, and plans for how the information will be integrated into the solution of the overall scientific theme or question being addressed. The application must include a Project Management Plan, including an ongoing evaluation plan, to ensure consistent forward progress of the project. The plan should also include proposed methods for information dissemination both within the collaborative project and to the scientific community. Furthermore, the application will include a mechanism to consider and respond to concerns of the scientific community directly affected by the operation and impact of the project. A discussion of scientific community views will be part of the agenda for annual meetings of the Steering Committee with the Scientific Advisory Panel.

In addition to the integration among the individual projects justified in the lead application, each individual U01 or U24 application should have a paragraph in the Approach Section stating its individual interactions with various other projects of the consortium.

Plan for Data Sharing and Intellectual Property:

NIH requires applicants who respond to this FOA to develop and propose specific plans for sharing the data and materials generated through the large-scale collaborative project. This requirement 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. Because dissemination is a critical and important aspect of this FOA, the proposed sharing and data release plans, after negotiation with the applicant when necessary, will be made a condition of the award. The members of the consortium should disclose to the Steering Committee their ties to profit-making organizations to aid the project in avoiding conflict of interest situations. Applicants are also reminded that the grantee institution is required to disclose each invention to NIAAA within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters.

The Role of NIAAA

The NIAAA staff role in these cooperative agreements will extend the level normally required for stewardships 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 primary purpose of participation by the Project Collaborator(s) is to facilitate the coordination necessary to perform this complex collaborative project. 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. To assist in fostering the collaborative nature of this project and to monitor its progress, NIAAA will sponsor an annual meeting at which each site will present the major findings of its activities and plan collaborative efforts to analyze, interpret, and disseminate findings based on the common items included across sites. Applicants should include the cost for this meeting in their budgets.

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 U01 and U24 award mechanisms. The U01 mechanism is to be used for scientific components related to either characterization of the cohort or intervention activities. The U24 mechanism is to be used for support cores, i.e., administrative, statistical, and/or specimen repositories.

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).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". There is intention to continue this consortium beyond 5 years subject to progress and availability of funds. A subsequent FOA will be re-issued for such a continuation (i.e., renewal applications).

2. Funds Available

The estimated amount of funds available for support of up to two (2) consortiums with multiple U01 and U24 awards as a result of this announcement is $ 4.5 million for fiscal year 2011. 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 NIAAA 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:

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. However, such institutions may participate as subcontractors on the application.

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 program support.

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

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

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
Letter of Intent Receipt Date(s): December 11, 2010
Application Receipt Date(s): January 11, 2011
Peer Review Date(s): March-April 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): June 1, 2011

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 emailed 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
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 CDs of the appendix material must 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
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 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 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

Application Research Strategy Length. For both U01 and U24 mechanisms, this FOA, follows guidance on new application structure and length established by NOT-OD-09-149. The application’s Research Strategy section of the PHS398 (Items 3-5; now known as the Research Strategy section) may not exceed 12 pages (see NOT-OD-09-149 for guidance), including tables, graphs, figures, diagrams, and charts. The new Research Strategy section will be subdivided into three parts: Significance; Innovation; and Approach.

For cooperative agreements, awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Administrative and Project Management Plans: The Consortium Coordinator must include an Administrative Management Plan that outlines the policies and procedures for access of participating investigators to the collaborative project resources. The application should address the flow of information within the project, the integration among individual projects and plans for how the information will be integrated into the solution of the overall scientific theme or question being addressed. The application must include a Project Management Plan, including an ongoing evaluation plan, to ensure consistent forward progress of the project. The plan should also include proposed methods for information dissemination both within the collaborative project and to the scientific community. Furthermore, the application will include a mechanism to consider and respond to concerns of the scientific community directly affected by the operation and impact of the project. A discussion of scientific community views will be part of the agenda for annual meetings of the Steering Committee with the Scientific Advisory Panel.

In addition to the integration among the individual projects justified in the lead application, each individual U01 or U24 application should have a paragraph in the Approach Section stating their individual interactions with various other projects of the consortium.

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

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

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. 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 should 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: Regardless of the amount requested, investigators 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

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

2. Review and Selection Process

Review 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 mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does this interactive multidisciplinary consortium project address a problem of overarching significance to biomedical science that would be difficult to address by separate grants?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the Consortium Coordinator well suited to the scientific and administrative leadership required to carry out this work? Is the level of effort proposed for the Consortium Coordinator appropriate?

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? Will the multidisciplinary consortium attack a problem in a significantly new way?

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? Is the project management plan in the consortium adequate? Is the administrative framework appropriate? Do milestones articulate key indicators set for appropriate times that will demonstrate significant forward progress for the consortium project? Are the plans to monitor and evaluate progress of the consortium project adequate? Are the plans to share the data and findings within the consortium adequate?

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? Are the requested core facilities critical to achieving the scientific goals of the multidisciplinary consortium, are they cost effective? Is access to the core facilities appropriate?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. Resubmissions are not applicable to this FOA.

Renewal Applications. Renewals are not applicable to this FOA.

Revision Applications. Revisions are not applicable to this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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. Foreign organizations are not permitted for this FOA.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

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.

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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement 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.

2. A.1. Principal Investigator Rights and Responsibilities

Consortium Coordinator s (PD/PI s) Responsibilities

The Consortium Coordinator (Project Director/Principal Investigator) will have the primary responsibility for coordinating project activities scientifically and administratively at the awardee institution. The Consortium Coordinator will have the overall responsibility for the scientific and technical direction and the administration and overall operation of the consortium. To assist the Consortium Coordinator with the governing of the project, a Steering Committee will be established from among the participating investigators and NIAAA staff. The Consortium Coordinator will chair the Steering Committee. As for all participating PD/PIs, they must abide by the operating rules and guidelines developed by the Steering Committee. The Consortium Coordinator will agree to accept participation of NIAAA staff in those aspects of management of the project described under "NIH Staff Responsibilities." The Consortium Coordinator will also ensure the timely dissemination of information generated by the consortium component projects to both the consortium project members and the scientific public.

Participating PD/PI Responsibilities:

In addition to the Consortium Coordinator, there are PD/PIs of individual research project components and core facilities of the consortium. Each research project component will include a team of investigators who will contribute to and benefit from participation in the consortium. The PD/PIs of these individual component (U01/U24) grants of the consortium will be referred to collectively as participating investigators. They will receive separate awards and have control over their own operating budgets. The PD/PI of the individual research project award will be responsible for the scientific and technical direction of the project, as well as for following consortium policies and rules. Participating PD/PIs must also agree to abide by the policies and rules set up for the collaborative research consortium.

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

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

2. A.2. NIH Responsibilities

An NIAAA Project Collaborator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIAAA Scientific Project Collaborator will not attend peer review meetings of applications. If such participation is essential, this individual will seek NIAAA waiver. An NIAAA Program Official will handle the normal stewardship of the award, as described below.

NIAAA Staff Responsibilities

The two NIAAA Project Collaborators will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the NIAAA Program Official, and the NIAAA Project Collaborators.

The two NIAAA Project Collaborators will have voting membership (one combined vote) on the Steering Committee and, as determined by that committee, its subcommittees.The NIAAA Project Collaborators will coordinate and facilitate the CHAART Consortium programs, will attend and participate as a voting member in all meetings of the CHAART Steering Committee, and will provide liaison between the Steering Committee, the CHAART Consortium, and the NIAAA.

The NIAAA Project Collaborators will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.

The NIAAA Program Official will review the scientific progress of individual components, and review them for compliance with the operating policies developed by the Steering Committee, and may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.

The NIAAA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Scientific Advisory Panel

The CHAART project will include an external Scientific Advisory Panel whose purpose is to meet annually with the Consortium Coordinator and the Steering Committee to assess progress and provide feedback to the CHAART investigators and NIAAA on proposed goals for the next year of support. The members will be designated by the NIAAA in consultation with the Steering Committee, after the award has been made, and will be drawn from research scientists not involved in the project. The NIAAA Project Collaborators will attend the meeting of the Scientific Advisory Panel as members of the Steering Committee, but will not be members of the Scientific Advisory Panel. The Scientific Advisory Panel will meet at least once a year immediately prior to the submission of the annual progress report.

Steering Committee

The NIAAA Project Collaborators and the awardees that comprise the CHAART will be responsible for forming a Steering Committee as defined below. The Steering Committee will be the main governing board of the CHAART. It will develop collaborative protocols, and function to set priorities, identify technological impediments to success and strategies to overcome them, and decide when resources should be made available to the research community for individual investigator-initiated projects.

The Steering Committee will be composed of the Consortium Coordinator, the PD/PIs of the research project components and core facilities, and the NIAAA Project Collaborators. The members of the Steering Committee will each have one vote, but the NIAAA Project Collaborators will have one combined vote. The Chairperson of the Steering Committee will be the Consortium Coordinator. NIAAA reserves the right to appoint additional members of NIAAA staff as nonvoting members of the CHAART Steering Committee and subcommittees.

The Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed. NIAAA reserves the right to augment the scientific or consumer expertise of the CHAART Steering Committee when necessary.

There will be two Steering Committee meetings initially (during the first two years of support), one in the Washington, D.C. area, and the other at a time and site agreed upon by the Steering Committee and the NIAAA. In years 3-5, the Steering Committee will meet once a year. The first meeting of CHAART will be a Planning Meeting, which will take place in the Washington, D.C. area very shortly after award of the grants. At the Planning Meeting, the Committee will: a) determine the size of the Steering Committee based on the representation of individual research project and resource core awardees on the Steering Committee, b) draft a charter, the purpose of which is to define the administrative policies and procedures for oversight of the project, the process for monitoring compliance with those policies and procedures, and the process for recommending that the NIAAA act on evidence of non-compliance of any consortium component with Steering Committee policies, c) agree upon the terms of the charter, d) discuss approaches that were proposed in the individual component and core applications, any relevant new information, and set initial priorities, including new technologies to be developed. At subsequent meetings, the Steering Committee will refine the scientific objectives and characterization and validation strategies of CHAART, as necessary, consistent with progress in the CHAART consortium components.

The Steering Committee will plan one or more workshops a year to which non-CHAART participants will also be invited to enable the CHAART Consortium to explore scientific or technologic innovation that occurs during the course of the project. For the second and subsequent years of operation of the CHAART Consortium, the Steering Committee will plan a symposium to inform the research community of the progress made in different research areas. The NIAAA Program Official and other NIAAA staff will provide the Steering Committee with advice on participants for the workshops and symposia, and manage the logistics for these meetings.

The Steering Committee may establish subcommittees as it deems appropriate. The NIAAA Program Official and the other NIAAA/NIH staff who are Steering Committee members may serve on subcommittees.

Each Steering Committee member will have one vote (with the NIAAA having one combined vote). Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution Process

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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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.

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:

Kendall J. Bryant, Ph.D.
Coordinator, HIV/AIDS and Alcohol Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2069 MSC 9304
Bethesda, MD 20892-9304 (for USPS mail)
Rockville, MD 20852 (for courier/overnight mail services
Telephone: (301) 402-9389
FAX: (301) 443-1650
Email: [email protected]

Deidra Roach, M.D.
Program Officer, Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2055 MSC 9304
Bethesda, MD 20892-9304 (for USPS mail)
Rockville, MD 20852 (for courier/overnight mail services
Telephone: (301) 443-6545
FAX: (301) 443-1650
Email: [email protected]

2. Peer Review Contacts:

Ranga V Srinivas, Ph.D.
Chief, Extramural Project Review Branch
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2085
Bethesda, MD 20892
Rockville, MD 20852 (for Express Mail)
Telephone: (301) 451 2067
FAX: (301) 443-6077
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Rockville, MD 20852 (for Express Mail)
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.


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-09-116.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.

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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