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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: Resource Core Alcohol Research Centers (P30)

Announcement Type
This is a reissue of RFA-AA-08-004.

Request For Applications (RFA) Number: RFA-AA-10-002

Catalog of Federal Domestic Assistance Number(s)
93.891

Key Dates
Release Date: June 26, 2009
Letters of Intent Receipt Date: November 2, 2009
Application Receipt Date: December 2, 2009
Peer Review Date(s): June-July 2010
Council Review Date: October 2010
Earliest Anticipated Start Date: December 1, 2010 
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: December 3, 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

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
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration 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) supports a broad based Alcohol Research Center program to foster and conduct interdisciplinary, collaborative research on alcoholism, alcohol abuse and the impact of alcohol and health and disease.  The NIAAA Centers Program provides leadership in research, research methodology development and information dissemination on a wide variety of topics relevant to the Institute’s mission.  These topics include, but are not limited to, investigations into the nature, etiology, genetics, diagnosis, treatment, and prevention of alcohol use disorders and their biomedical, psychosocial, and economic consequences across the lifespan.  Centers are also major contributors to the development of new research methods, integration of new technologies and theoretical approaches, and methodologies that sustain innovative goal-directed research.

This FOA uses the NIH Resource Core Center mechanism (P30) to support shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common research problem.  The core grant is integrated with the Center’s component projects or program projects, though funded independently from them.  This support, by providing more accessible resources, is expected to assure a greater productivity than from the separate projects and program projects.  These shared resources are expected to promote greater efficiency, productivity and creativity than would be possible from separate projects. Resource Core Alcohol Research Centers (hereafter called Resource Core Centers) are expected to become regional and national resources in their particular area of expertise.  NIAAA's Resource Core Center program will support centralized resources and facilities shared by investigators conducting alcohol research.  Each Resource Core Center will be composed of administrative, resource and developmental components, which together will enrich the effectiveness of ongoing research and stimulate new research directions to advance the field.  Resource Core Centers will enhance individual research projects by providing necessary resources or performing required services that would be difficult, costly, or impractical to be provided by individual labs or projects.  The Resource Core Centers will foster a cooperative and interactive research environment through which multi-disciplinary approaches and collaborative research projects will be stimulated.  The Resource Core Centers should provide a means to develop cutting edge research ideas and encourage new investigators in alcohol research via pilot projects. 

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 P30 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 estimated amount of funds available for support of 1-2 projects awarded as a result of this announcement is $2-3 million for fiscal year 2011. The total cost for a P30 Center may not exceed $1.25 million in direct costs per year. 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.

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. 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

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 permitted in response to this FOA.

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 Resource Core Alcohol Research Center application.  For a complete description of required NIAAA Center grant application format and page limitations see:

http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/RFAs/Supplemental_Instructions.htm

Only P30 applications that focus on alcohol related research will be considered responsive to this FOA.

To be responsive to this FOA the P30 application must identify three or more currently funded research projects (i.e., at the time of submission) that will become users of the Shared Resources. 

A Resource Core 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 Resource Core 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 may also 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 the coordination of activities within the Center and the scientists collaborating with 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 Resource Core 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 in the application, specific plans regarding committee selection and function should be provided. 

The Center Director(s) will establish a Steering Committee that will be composed of the Center Director(s) and Core Component Directors, and three representatives (preferably the contact PD/PI) from the participating independently funded alcohol-related projects.  The function of the Steering Committee is to facilitate the collaboration by monitoring progress and outcomes of the use of shared resources, develop new collaborations, and review the Center’s strategies for achieving its goals.

Resource Core Alcohol Research Center Components

Resource Core Centers must have a minimum of three components including an Administrative Core (1), a Shared Resources Core (2), and a Pilot Project Component (3).  They may also contain an optional Research Translation Component as described below.  All applications and proposals for NIH funding must be self-contained within specified page limitations per component (12 page limit for Administrative Core; 12 page limit for Shared Resources Core; 25 page limit for Pilot Project Component; 12 page limit for Research Translation Component).  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.

1. ADMINISTRATIVE CORE (required; 12 pages)

There are two major responsibilities within the Administrative Core.  The first is the management and administration of the resources, facilities, staff, and activities conducted by the Resource Core Center and funded by its budget.  The second is the management of relationships, joint projects, and collaborations with other research studies which participate in the use of the Shared Resources.  The former is described in the "Internal Administration" subsection below; the latter in the "External Collaborations" section.

Administrative Core: Internal Administration

The Administrative Core provides the organizational framework for the management, direction, and coordination of the Resource Core Center. It must be managed by the Center Director.  This Core should ensure that all of the related activities will function in an optimal and synergistic manner. An important function of this Administrative Core also 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 Administrative Core should be described in sufficient detail to assure that all proposed 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 Administrative Core.

Administrative Core: External Collaboration

An important purpose of Resource Core Centers is to serve as a nexus of scientific contact between multiple projects investigating related research areas or sharing similar resources.   Thus a portion of the application should describe both the initial collaboration among the qualifying projects and describe the plans for the evolution of future collaborations in the use of the Shared Resources.

Proposed Resource Core Centers should contain a minimum of three independently funded alcohol-related projects (i.e., qualifying projects) that share resources provided by the Center.  These qualifying projects may be funded by NIH, other government agencies, or private organizations but must have been awarded through a peer-review process; moreover, they may be located at the same institution or at other institutions.  Typically, the three qualifying projects will be comparable to R01 projects in scope and complexity.  Each of the identified qualifying projects must be a significant user of the Center resources, with no more than 50% of the total Center usage allocated to a single qualifying project.  While qualifying projects are required, other projects may also use the Shared Resources of the Center. 

During its lifetime, a Center should seize opportunities to attract, promote, and initiate additional collaborations among investigators whose work could benefit by access to the Shared Resources provided by the Center.  At least three collaborating projects must be active at all times.  Collaborating projects should be encouraged among independent investigators either residing in the same institution as the Resource Core Center or at other institutions.  Applications should contain a description of steps that will be taken to seek and establish collaborative projects with investigators not currently collaborating with the Center and identify potential areas of research where the Shared Resources available to the Center could be brought to bear to stimulate new and promising research directions.  Principal Investigators of all collaborating projects, existing and future, should be provided with an appropriate voice and role in the governance of the Center, and this should be described as a part of the Administrative Component of the application.

In addition, the application should specifically address the need for this particular Resource Core Center.  Need could be in terms of efficiency of scale, but would also be expected to provide greater flexibility, innovation or responsiveness to the changing requirements of the collaborating research projects.

Readers should note that throughout this document "collaboration" is used in a wide sense to describe a range of participating activities that can take place between a Resource Core Center and the projects that use its Shared Resources.  In some cases, there may be extensive cooperation and partnership in all phases of study design, data collection, analysis, and publication of results.  In other cases, joint participation might be more limited, such as the use of Shared Resources to analyze data only, secondary analysis of data previously collected, access to data, equipment, services, or facilities through subcontracts or other commercial arrangements, or the use of Shared Resources by junior investigators to conduct small pilot projects.  All such forms of joint activity are considered collaborations for the purposes of this funding opportunity.

2. Shared Resources Core (required; 12 pages)

Shared Resources Core include datasets, tissue repositories, genetic information repositories, equipment, and laboratory facilities that are shared among several projects in order to enhance or make more effective the data, services, techniques, or instrumentation used by investigators of the Resource Core Center.  The main function of the Resource Core Center program is to support the existence of Shared Resources which are designed to furnish groups of Resource Core Center investigators with data, tissue samples, services, or instrumentation that will enhance the research in progress, consolidate effort, and contribute to cost effectiveness.  These resources should be sufficiently large, expensive, or complex so as to be more efficiently supported by a Resource Core Center than by individual research project grants alone.  The utilization of Shared Resources by pilot projects is also required.  Shared Resources provided by Resource Core Centers should be unique and not duplicate services or facilities that already exist at the parent or at a collaborating institution.  Proposed Shared Resources that appear to replicate data, tissue samples, services, or instrumentation already available to the applicant institution will not be allowed without extensive justification.

The applicant organization should prepare a plan that explains how Resource Core Center capacity will be allocated to Principal Investigators of collaborating projects.  The plan should permit appropriate access to Shared Resources for investigators who do not direct collaborating projects, so that the Center will serve as a shared resource for all participants.  Plans should establish guidelines to determine the most appropriate methods for providing access to the shared resources, facilities, and services, and for prioritizing work within the Center.

3. Pilot Project Component (required; 25 pages)

Applications should include a Pilot Projects component, which would provide modest support for new initiatives or feasibility projects.  Pilot Projects should be based on the opportunities uncovered by ongoing projects or made possible by the existence of Shared Resources Component.  Such projects would be appropriate for either new or experienced investigators.  Pilots should be short-term projects to explore the feasibility of new areas of study which lead to the collection of sufficient data to pursue support through other funding mechanisms.  A plan to support pilot studies should be included in the application.  The description of a plan to solicit, review, and administer pilot projects should be included.  Criteria and procedures for the review of proposed Pilot Projects, making awards, and evaluation of progress should be described in the application.

4. Research Translation Component (optional; 12 pages)

An important goal of all NIH Institutes is that scientific advances achieved through NIH-sponsored research should supply a basis for improving health.  This research translation goal has two meanings.  For basic research, the goal is to encourage the incorporation of new scientific discoveries into clinical trials of promising treatment or prevention protocols.  For clinical trials and prevention studies, the goal is to facilitate the adoption of recent research discoveries into routine clinical and public health practice.  Resource Core Centers may optionally elect to include a component that encourages and stimulates the use of scientific findings generated by ongoing research into the next step along a continuum that moves research advances from bench to bedside.  Example studies proposed under this component might include, but would not be limited to:  incorporation of new basic science discoveries into animal models for further laboratory experimentation; incorporation of results from animal studies into protocols for clinical trials; and improving current understanding of the processes whereby recent findings from human trials are incorporated into in routine clinical or public health practice.

Other Requirements:

Facilities and Environment

Applicants must demonstrate the availability of adequate laboratory, clinical, office and other facilities needed to carry out the objectives of the proposed Alcohol Research Center program.  To the extent possible it is desirable for Resource Core Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility.  Internet access to scientific literature and other information must be readily available.  Relevant support services, including for example adequate data processing facilities, must also be readily accessible and documented in the proposal.

Renewal Applications

A comprehensive progress report is required for renewal applications. A statement describing the progress made by the Resource Core Center to provide and support centralized shared resources for alcohol research and promote greater efficiency, productivity and creativity that are otherwise not available to individual projects should be included.  How the Resource Core Center serves as a local, regional, or national alcohol research resource should be addressed. Collaborative activities if any, with other NIAAA Alcohol Research Centers should be described along with a list of joint accomplishments.  In addition, for each qualifying project of the existing Research Core Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal.  For each component, a bibliography of relevant publications should be included in the progress report. Ongoing or completed core activity that has enhanced or facilitated alcohol research should be described.  Past performance and accomplishments based on Resource Core Center related collaborations should be described, as should the effect of services provided by Shared Resources on investigators' scientific progress and productivity. For renewal applications, information should be provided on past experience in utilizing pilot funds to further Resource Core Center goals.  This should include an assessment of overall benefits derived from the availability of pilot resources. 

Progress Report for Components being extended into the next funding period are to be included in the Administrative, Shared Resources and Research Translation Core Components (12-page limits for each of these components); and within the 25-page limit for the Pilot Project Component.  Progress Reports for Components that have been terminated are limited to 5 pages. 

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.

More than one PD/PI (i.e., Multiple PD/PI) may be designated on each P30 application with a rationale for how this will enhance the Resource Core Center’s strengths and long-term viability.  .  This option is not available for individual Administrative/Shared Resource Cores or the Pilot Project or Research Translation Components. 

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: November 2, 2009
Application Receipt Date: December 2, 2009
Peer Review Date(s): June-July 2010
Council Review Date: October 2010
Earliest Anticipated Start Date: December 1, 2010

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.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
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 (for guidance regarding the submission of appendix materials see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html) must be sent to:

Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
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

Research Plan Page Limitations

For special requirements for submission of P30 applications, please refer to Section IV-2.  All applications and proposals for NIH funding must be self-contained within specified page limitations per component(12 page limit for Administrative Core; 12 page limit for Shared Resource Core; 25 page limit for Pilot Project Component; 12 page limit for Research Translation Component).

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

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 the National Institute on Alcohol Abuse and Alcoholism 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:

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. 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

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 shared resource core(s), and the pilot project component, and research translation component as applicable; and (2) review of the Resource Core Alcohol Research Center as an integrated whole working together to: (1) promote interdisciplinary, collaborative alcohol research; (2) support centralized resources and facilities shared by investigators conducting alcohol research; and (3) 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 the Resource Core Alcohol Research Center (P30) are:

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

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 core review criteria, and additional review criteria (as applicable for the project proposed). 

Significance: Do the Resource Core Center’s research goals address an important problem or a critical barrier to progress in the field?  If the aims of the application 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?

Investigators: Are the PD/PIs, collaborators, and other researchers well suited to the proposed work?  If Early Stage Investigators or New Investigators, 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 Resource Core Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed project(s)?  Will the proposed projects benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of institutional support?

Coordination and Cohesiveness: Is the coordination among the administrative and shared resource cores, the pilot project component, and research translation component (if applicable) adequately explained? Is the usefulness of the Shared Resources Core maximized?  Is there synergistic potential among the Resource Core Center’s components?

The ADMINISTRATIVE CORE will be evaluated with the following criteria:

Administrative Core: Internal Administration

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

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?

Environment:  Does the environment contribute to the successful management of scientific projects?  Do the proposed arrangements take advantage of unique features of the environment such as subject populations, mutually-beneficial collaborative arrangements, or access to community resources?  Is there evidence of institutional support?         

Administrative Core: External Collaboration

As each collaborating project is expected to be independently funded, the scientific merits of each project will have already been reviewed.  For the review of the Resource Core Alcohol Research Center application, the quality of these projects as a package, the extent to which they make use of and further develop the Shared Resources, and the promise of plans to attract new collaborating projects should be the basis of the P30 review.

Significance:  Do the proposed collaborations have the potential to advance research on important problems?  Do they make full use of the Shared Resources?  Does the plan for attracting new collaborating projects improve the effective use of the Shared Resources and create additional opportunities to advance knowledge?

Investigators:  Are the collaborating investigators scientific leaders in the field?  Does the collaboration plan also attract promising new/early stage investigators and make the Shared Resources available to them?

Innovation:  Does the plan to use the Shared Resources create new and promising uses of these scientific tools, methods, or facilities? 

Approach:  Do the scientific approaches employed by the collaborating projects make appropriate and optimal use of the Shared Resources?  Does this collaboration lead to further improvement of the Shared Resources?  Will the enhanced interactions among the participating projects contribute to the Center’s overall success and research advancement? 

Environment:  Does the proposed environment have the features and resources necessary to promote effective collaboration among multiple projects?  Is there a plan for sharing the resources effectively among the participating investigators?

The SHARED RESOURCES CORE will be evaluated with the following criteria:

Significance:  Do the Shared Resources have the potential to contribute to research on important problems and will scientific knowledge be advanced?  Are the Shared Resources appropriately ones that are too large, expensive, or complex to be feasibly and efficiently supported by individual project grants?

Investigators:  Are the investigators appropriately trained and experienced to carry out the proposed work?  Does the investigative team bring complementary and integrated expertise to the use and development of the proposed Shared Resources?

Innovation:  Is the use of Shared Resources original and innovative?  Does the use of the Shared Resources make it possible to challenge existing paradigms, address an innovative hypothesis, or overcome a critical barrier to progress in the field?

Approach:  Are the procedures used to obtain and create the Shared Resources of the highest scientific quality in design, methods, instrumentation, and analysis techniques?  Does the application acknowledge potential problems, consider alternative approaches, describe strategies for conflict resolution, and propose improvements in existing methods?

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

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

Significance:  Will the pilot projects prepare the way for important scientific advances and promising new methods?  Do they have the potential to develop into full-scale independent projects of fundamental importance?

Investigators:  Do the proposed investigators have the necessary training, expertise, and experience to use the Shared Resources to their best potential?  Are new investigators with creative pilot projects encouraged and attracted?

Innovation:  Do the pilot projects explore and develop new and complementary uses of the Shared Resources?  Do they use the Shared Resources in ways that reflect the cutting edge of scientific inquiry?  Do they propose ways that the existing Shared Resources can be improved?

Approach:  Do the pilot projects contribute to the full and appropriate use of the Shared Resources?  Is there an adequate selection process for new and replacement pilot projects?

Environment:  Does the research environment contain a variety of facilities, equipment, data sources, etc. that can be used to support pilot projects in new areas?  Are the Shared Resources managed in such a way that they are appropriately available to use by the pilot projects?

The RESEARCH TRANSLATION COMPONENT (optional) will be evaluated with the following criteria:

Significance:  Do the proposed translational activities overcome significant barriers in moving research findings from bench-to-bedside?  Do they effectively bridge the gap between basic research findings and their application in proposed clinical trials or between clinical findings and their adoption in routine care and public health practice?

Investigators:  Does the investigative team have the multidisciplinary mix of skills and expertise that will facilitate the translation of new findings into the next phase of research or practice adoption?

Approach:  Are appropriate and effective methods of using existing knowledge to stimulate the next phase of research translation proposed?

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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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.

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.

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.

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (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).

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.

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:

Lindsey Grandison, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2057
Bethesda, MD 20892
Telephone:  (301) 443-0606
FAX:  (301) 594-0673
Email: [email protected]

Mariela C. Shirley, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2086
Bethesda, MD 20892
Telephone:  (301) 443-9787
FAX:  (301) 443-8614
Email: [email protected]

2. Peer Review Contacts:

Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
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, Room 3023, MSC 9304
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.

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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