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: Collaborative Minority Alcohol Research Center Development (U54)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-AA-10-001

Catalog of Federal Domestic Assistance Number(s)
93.891

Key Dates
Release Date: May 18, 2009
Letters of Intent Receipt Date: September 21, 2009
Application Receipt Date: October 21, 2009
Peer Review Date(s): February - March, 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: October 22, 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 NIAAA is committed to developing research on the health and well-being of ethnic minority and underrepresented populations, and to involve researchers in minority-serving institutions (MSIs) in both the training of investigators for careers in alcohol research and in the conduct of alcohol research.  Recognizing the importance of the involvement of minority institutions in research on minority health issues, the objective of the Collaborative Minority Alcohol Research Center Development (CMARCD) program is to enhance research potential and expertise on minority health issues.  Thus, a central aim of the CMARCD program is to enhance the research opportunities for scientists at MSIs by pairing them, through collaborative affiliations, with scientists, typically from research-intensive institutions, who have both the resources and demonstrated experience in establishing a long term, successful research program.  It is anticipated that accomplishment of this aim will enhance the research careers of minority scientists, attract qualified minority undergraduate and graduate students to careers in alcohol research and facilitate research on alcohol related health disparities in racial/ethnic minorities and underrepresented populations.

Background

Alcohol consumption is associated with a broad range of adverse health and social consequences, both acute (e.g., traffic deaths, other injuries) and chronic (e.g., alcohol dependence, liver damage, stroke, cancers of the mouth and esophagus). The scope and variety of these problems are attributable to differences in the amount, duration, and patterns of alcohol consumption; differences in genetic vulnerability to particular alcohol-related consequences; and differences in economic, social, and other environmental factors. Ethnic and cultural disparities in alcohol-related problems are of pressing public health concern. Alcohol-related death rates (for all categories of alcohol- related mortality combined) are higher among blacks than whites. Recent research indicates that cirrhosis death rates are higher among white men of Hispanic origin than among non-Hispanic black and white Americans. Alcohol-related traffic deaths are many times more frequent among American Indians or Alaska Natives than among other minority populations.

The incidence of fetal alcohol syndrome (FAS) appears to be several times higher in some African American and American Indian communities than in the general population. Research reveals that although African American teenagers typically drink less than their white or Hispanic counterparts, their mortality from cirrhosis is substantially higher as they approach

middle age. Other adverse health consequences associated with alcohol consumption such as cirrhosis, alcoholic liver disease, HIV/AIDS, cardiomyopathy, cancer, pancreatitis, psychiatric comorbidity, and alcohol-related sleep disorders also are more prevalent in some minority populations. Further, increases in risky drinking behavior (i.e., drinking and driving) have been reported among Hispanics. Since ethnic minority groups have different genetic backgrounds, it is possible that some of the disparities in disease incidence and prevalence are due to differences in genetic predisposition.  Genetic and biological factors may interact with behavioral, cultural, and environmental factors to manifest health disparities.

MSIs are effective in educating students from minority cultures to provide outreach to minority communities. They represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in alcohol research. However, few MSIs have developed the capacity for a sustained program in alcohol research on health disparities.  Thus, there is a need to increase the number of minority scientists that are pursuing successful biomedical and behavioral alcohol research careers. Specifically, there remains a serious shortage of minority scientists conducting independent alcohol research and of minority scientists who bring the cultural perspectives essential to successful research efforts on the disproportionate incidence, mortality and morbidity rates both within and between race and ethnic minority populations.  

Appropriate topics include but are not limited to those listed below. 

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 Cooperative Agreement (U54) award mechanism.
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".

MSI and non-MSI research intensive institutions are required to submit linked applications for one joint CMARCD partnership.

2. Funds Available

Applicants may request a project period of up to 5 years. The estimated total amount of funds available for support of 2 to 3 projects awarded as a result of this announcement is $2 M for fiscal year 2010.  Future year amounts will depend on annual appropriations. The direct costs budgeted for the MSI may not exceed $500,000 in Years 1-2, and $750,000 in Years 3-5.  The direct costs budgeted for the non-MSI research intensive institutions will include additional funds for the partnered research institution to cover mentorship, administrative costs (e.g., travel to the MSI) and related research expenses; these costs are limited to $100,000 per year for each partnering institution collaborating with the MSI.  An MSI can partner with more than one alcohol research institutions but total partnering costs may not exceed $200,000 direct costs per year. 

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.

The U54 award will provide support for:

1)     Administrative costs for managing the effort, such as salaries for key personnel, travel for key personnel, equipment, and supplies to support an administrative structure.

2)     Research costs for the conduct of collaborative research projects including equipment at the MSI and supplies.

3)     Training/Mentoring expenses for salaries of trainees and partial salaries of collaborating senior scientists.

4)     Recruitment costs and initial salary of highly qualified faculty at the MSI(s).

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:

Black Colleges and Universities [HBCUs], Hispanic-Serving Institutions [HSIs] and Tribal Institutions [e.g., colleges]) either in the U.S. or in territories under U.S. jurisdiction.

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 each application is scientifically distinct.

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.  

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

There are a number of Special Requirements and Provisions with which each MSI and its partnering non-MSI research intensive institution(s) must comply:

1) The non-MSI research intensive institution is defined as a well established, biomedical research institution with three or more principal investigators who have extensive alcohol research experience that has received extramural funding.

2) Partnership Structure: Each linked application must be submitted as a clear collaborative partnership between the MSI and (a) non-MSI research intensive institution(s). For the purposes of this RFA, hereafter these linked applications will be referred to as CMARCD. For each CMARCD, separate applications must be submitted: one from the MSI and one from each partnering non-MSI research intensive institution(s).  The overall objectives of the linked applications must be the same, but the activities and the individual budgets of the separate applications should indicate the tasks and obligations of each participant at each institution toward accomplishment of the proposal.

3) Leadership:  Each linked application may have multiple PIs but one PI from each institution is expected to be designated as a CMARCD Co-Director.  The CMARCD Co-Director on the application from the MSI should be listed as the Co-Director on the linked application(s) for the non-MSI research intensive institution(s) and the lead PI from the non-MSI research intensive institution(s) should be listed as the Co-Director on the linked application from the MSI.

4)  Letters of Commitment:  Each application must include written “Letters-of-Commitment” from the MSI leadership and the leadership of the non-MSI research intensive institution(s) that commit the resources necessary to ensure success.  Such letters should include the following items:

5)   Collaboration Plan:  Each of the linked applications must describe a collaborative plan that, at a minimum, includes the following components:

6)  Steering Committee:  The CMARCD Co-Directors from the partnering institutions will establish a Steering Committee that will be composed of the CMARCD Co-Directors and other key personnel from all participating institutions, the NIH Project Coordinator and, where appropriate, outside expertise.  The function of the Steering Committee is to facilitate the collaboration by monitoring progress and outcomes of individual collaborations, develop new collaborations, and review the strategies of the collaboration to see that it enhances the research environment of the MSI.

Applicants are encouraged to contact Program Officials for further guidance.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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.

There are a number of Special Requirements and Provisions with which each CMARCD grant application must comply:

Collaborative Structure.  Each CMARCD application must be submitted as a clear partnership between the MSI and non-MSI research intensive institution(s).  For each CMARCD partnership, two (or more, dependent on the nature of the collaborations) separate applications must be submitted: one from the MSI and one from each of the partnering non-MSI research intensive institutions.  The overall objectives of the two applications are the same.  Applicants should describe the types of activities that the MSI and the non-MSI research institution will conduct to ensure a highly interactive and integrated effort between their faculty and scientists, as well as demonstrate how they complement each other in achieving their common objectives.  How the CMARCD partnership facilitates intra-institutional collaborations and strengthens the research capacity of the MSI must be delineated.  In addition, applicants must describe the academic qualifications, research experience, and productivity of collaborators and explicate their contributions to the success of the CMARCD.

The linked applications from the minority-serving institution (MSI) and non-MSI research intensive institution(s) will be identical, with the exception of the Budget section (see Section II. 2. Funds Available and IV. 6. Other Submission Requirements for greater detail).  If there are variations in the Core(s) and Research Component sections, no matter how minor, these should be highlighted in a subsection within each Component with the heading “ELEMENTS UNIQUE TO THIS SITE”.  In this subsection PIs should describe the unique role of each site and core in the collaboration, such as data coordination, statistical analyses, genetic analyses, biological/biochemical assays, etc.    The following paragraphs describe other Special Requirements for a CMARCD application.

Number of Components and Organizational Structure.  The CMARCD must have a minimum of four (4) components (an administrative core and three collaborative research components).  The maximum combined number of components is 10 including core components and collaborative research components.  More than a total of 10 components is not acceptable even if some components are in operation for less than the 5-year period.  At least three collaborative research components must be active at all times.  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 Scientific Core; 25 page limit for each Research Component).  Pages not used for one component may not be used to extend the page limit of other components or cores.  In addition to special budget requirements (see Section II. 2. Funds Available and IV. 6. Other Submission Requirements for greater detail), each component requires a separate detailed budget. 

A CMARCD must be an identifiable organizational unit with an administrative structure and clear lines of authority for both the MSI and non-MSI research intensive institution(s) which will facilitate coordination among CMARCD personnel to assure maximum accountability and efficiency in CMARCD operations.

The CMARCD Co-Directors will have responsibility for planning and coordination of the CMARCD program, and other aspects of management and operation of the CMARCD.  In addition, CMARCD Co-Directors have responsibility for the preparation of the budget and oversight of expenditures, staff appointments, and space allocation at their respective institution(s).

The applicants also may designate a Scientific Director who will be responsible to the CMARCD Co-Directors and provide direct supervision of the scientific and operational aspects of the research program at each of the partnered institutions.  Such persons should be individuals who have established scientific credentials and who are capable of providing the leadership essential to the success of the CMARCD program.  The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the CMARCD.  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, as well as needs for additional resources or reallocation of resources.  If a CMARCD Director also serves as the Scientific Director, his or her functions as Scientific Director also should be described. The CMARCD Director may not be PD/PI on more than one Research Component.

CMARCD Components:

Administrative Core Component (12 pages)

The Administrative Core provides the organizational framework for the management, direction, collaborative planning process, and coordination of the CMARCD.  The Administrative Core must be managed by the CMARCD Director or Scientific Director at the MSI or the non-MSI research intensive institution.  A clear leadership plan that includes the organizational structure and reporting procedure should be included.  A thorough description of the partnership as well as the administrative and fiscal relationships that will be established within the CMARCD (i.e., between the MSI and non-MSI research intensive institutions) should be provided.  The applicants should clearly describe the kinds of planning activities that the MSI and the non-MSI research intensive institution(s) will conduct to ensure a highly interactive and integrated effort between their faculty and scientists.  These applicants also should relate each planning activity (e.g., training, workshop) to specific objectives of the CMARCD.  The Administrative Core should ensure that all proposed components and related activities will function in an optimal and synergistic manner.  An important function of this core is the administration of the budget.  It may include funds for scientific enrichment activities such as lectures, symposia, seminars, training, and workshops for research faculty and staff.  This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally.  In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core.

Scientific Core Component (12 pages)

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

Research Components (25 pages for each Research Core Component)

Research components are collaborative individual scientific research projects that contribute collectively to the goals of the CMARCD program.  Each Research Component Director should be a qualified alcohol research investigator who is responsible for the scientific direction and conduct of the individual research component.  A CMARCD Director or Scientific Director may not serve as a Component Director on more than one Research Component.  Each proposed research component should provide a clear description of its major goals, objectives, and how the research project relates to the overall goals of the CMARCD.  The hypotheses to be tested should be focused and fully detailed.  The research design and procedures should describe the strategies proposed to accomplish the specific aims and innovative aspects of the approach should be highlighted.  A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in proposed studies.  The interaction between paired investigators from the MSI and the non-MSI research intensive institution should be described in detail.  If core facilities are utilized, information on their use should be provided. In addition, a detailed budget for the entire proposed period of support should be included for each Research Component.    

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 linked application.  This option is not available for individual Administrative/Scientific Cores or the Research Components.  The linked applications from partnering institutions using the Multiple-PI option must provide a rationale for choosing this structure and explain how multiple-PIs will enhance the CMARCD’s strengths and promote its long-term viability.  Each of the PIs must be identified on a continuation of the Face Page of the PHS 398 form (http://grants.nih.gov/grants/funding/phs398/398_forms.doc) and descriptions of their roles should be integrated into all the appropriate components.  In addition, there should be a specific Multiple-PI Leadership Plan.

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: September 21, 2009
Application Receipt Date: October 21, 2009
Peer Review Date(s): February - March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 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: bautista@mail.nih.gov 

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: bautista@mail.nih.gov

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

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A “Award Administration Information.”

The standard PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398.html) and the standard PHS398 Forms should be followed unless specific exceptions and/or additional requirements are noted below.

Face Page (PHS398 Form Page 1).  The title of the CMARCD partnership should be the same for both the MSI and the non-MSI research intensive institution(s) linked applications.  The title should be unique to specific partnership (do not repeat the title of this U54) and should include the suffix “(1 of 2)” or “(2 of 2)” for applications from MSI and non-MSI research intensive institution(s), respectively. 

The linked applications from the minority-serving institution (MSI) and non-MSI research intensive institution(s) will be identical, with the exception of the Budget section (see also Section II.2 Funds Available). 

If there are variations in the Core(s) and Research Component sections, no matter how minor, these should be highlighted in a subsection within each Component with the heading “ELEMENTS UNIQUE TO THIS SITE”.  In this subsection PIs should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, genetic analyses, biological/biochemical assays, etc. 

MSI Budget.  The MSI will submit a separate standard budget and budget justification for the initial and entire proposed period of support using PHS398 Forms. MSI applications are limited to no more than $500,000 in direct costs during Years 1-2.  Direct costs can increase in Years 3-5 to a maximum of $750,000 per year. 

Non-MSI Research Intensive Institution Budget.  The non-MSI research intensive institution will submit a separate standard budget and budget justification for the initial and entire proposed period of support using PHS398 Forms.  Funds for the non-MSI are to cover mentorship and administrative costs and are limited to $100,000 direct costs per year for each partnering institution collaborating with the MSI.  A MSI can partner with more than one alcohol research institution but total partnering (i.e., across all non-MSI research institutions that form the CMARCD) costs may not exceed $200,000 direct costs per year.

Research Plan Page Limitations

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 Scientific Core; 25 page limit for each Research Component).

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. 

NIH considers the following in evaluating Center (CMARCD) grant applications:

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

For the CMARCD, the initial review for scientific and technical merit of applications will emphasize two major aspects:  (1) the review of each component: the administrative and resource scientific core(s), the scientific research, and pilot project components, as applicable; and (2) review of the CMARCD as an integrated whole working together, the collaborative structure between the MSI and non-MSI research intensive institution(s), as well as its potential to contribute to research training and serve as a regional and national resource to build MSI research capacity.  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 Collaborative Minority Alcohol Research Center Development (U54) are:

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

Significance: Do the CMARCD’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 project?  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 project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

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

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

Coordination and Cohesiveness:  Is the coordination among the administrative and scientific cores and the research components adequately explained?  Is the usefulness of the scientific core components magnified by their inclusion in the CMARCD?  Is there synergistic potential among the CMARCD’s research components? Is there synergistic potential across the linked applications to facilitate the CMARCD goals?

The ADMINISTRATIVE CORE will be evaluated with the following criteria:

Approach: Are the arrangements and organizational structure adequately developed, well integrated, well reasoned, and appropriate to the aims of the CMARCD?  Does the application describe how day-to-day management will be accomplished?  Does the application explicate the partnership and collaborative planning processes between the MSI and non-MSI research intensive institution(s)? Are the plans to facilitate and monitor attainment of CMARCD objectives appropriate?

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

Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the CMARCD?

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

Approach: Is the justification for the need of a core service or resource clearly stated?  Is the scientific and technical merit of the proposed core explained?  Are there appropriate plans for resource allocation?  Are quality control procedures in place?  Are the resources and environment adequate?  Are collaborative processes between the MSI and non-MSI research intensive institution(s) well considered and described?

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

The RESEARCH COMPONENTS will be evaluated with the following criteria (Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter NOT-OD-09-025):

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

Research Component 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.  Aresearch component 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 research component address an important problem or a critical barrier to progress in the field?  If the aims of the research component are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the research component?  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 research component 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 research component?

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 research component?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the research component is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the research component 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 research component proposed?  Will the research component benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  

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.

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 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).

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

The Principal Investigator will have the primary responsibility for:

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 NIH Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

An NIH Project Coordinator will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.  NIH Project Coordinator(s) will:

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 (optional)

The goal of the CMARCD program is to promote the development of alcohol research expertise and infrastructure to strengthen research capacity at Minority-Serving Institutions (MSIs).  To assist MSIs in achieving this goal, MSIs will submit linked applications that propose partnerships with a non-MSI research intensive institution(s) to form a CMARCD.  Awardees are strongly encouraged to participate in national scientific organizations convened to advance collaborative clinical, translations, and health disparities research.

A Steering Committee comprised of representatives from the MSI, non-MSI research intensive institution(s), the NIH Project Coordinator and, where appropriate, outside expert(s) will serve to facilitate collaboration by monitoring progress and outcomes of individual collaborations, develop new collaborations and promote strategies to enhance the research environment of the MSI.

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. Arbitration 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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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:

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: lgrandis@mail.nih.gov

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: shirleym@mail.nih.gov

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: bautista@mail.nih.gov

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: jfox@mail.nih.gov

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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NIH Funding Opportunities and Notices



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