Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)

Title: NIDA Research "Center of Excellence" Grant Program (P50)  

Announcement Type
This is a reissue of PAR-08-046

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-189

Catalog of Federal Domestic Assistance Number(s)

93.279

Key Dates
Release Date: May 6, 2010
Letters of Intent Receipt Date(s): August 25, 2010, August 25, 2011, August 25, 2012
Application Submission Dates(s): September 25, 2010, September 25, 2011, September 25, 2012
AIDS Application Submission Dates(s): January 7, 2011, January 7, 2012, January 7, 2013
Peer Review Date(s): February 2011, February 2012, February 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date: July 2011, July 2012, July 2013
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 8, 2013

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 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 and Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

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

NIDA provides support for two types of investigator initiated research Centers: Core Center grants (P30) and Research “Center of Excellence” grants (P50). This FOA provides support for the P50 Research “Center of Excellence.”  Please see other FOA issuances for the P30 Core Center program.  Applicants interested in the P20 mechanism should consult current FOA listings.

Purpose:

NIDA provides support for research center grants to foster an innovative, synergistic and thematically coherent approach to drug abuse and addiction research and to enable studies that would not occur without the climate, facilities and research resources that a research center can uniquely provide. NIDA encourages the application of multiple scientific perspectives and approaches to the problem of addiction to support the highest quality, multidisciplinary programs of innovative research. Through the Centers program, NIDA seeks to encourage outstanding scientists to bring a full range of expertise, approaches, technologies, and creativity to the study of problems related to drug abuse and addiction. Investigative efforts are expected to be broadly based and to encompass a variety of areas, including biological, biomedical, social, behavioral, and/or clinical sciences as well as dissemination sciences to address critical research issues. 

NIDA Centers are expected to be scientifically innovative and provide the next generation of ideas and approaches. It is expected that a Center will transform knowledge in the sciences it is studying and be at the cutting edge of science, Incremental work, though valuable, should not be the focus of Center activities.

NIDA Centers support research projects that are synergistic, leading to creative thinking, novel approaches, innovations, and highly significant findings. The intellectual interdependency and linkage among the components and core(s) must result in levels of productivity, quality, and progress that will exceed those expected from combining the individual components in an additive fashion. A NIDA Center is expected to enable a level of achievement that exceeds that expected on the basis of "the sum of its parts." Center support should be essential to the achievement of the proposed work. 

NIDA Centers are expected to be thematically coherent and demonstrate the highest caliber of multidisciplinary scientific work; there must be an overarching theme that integrates and focuses the Center--each core and research component should relate to the overall Center theme and to other components of the Center. Interactions and integration of projects should be clearly evident, so that the Center does not appear to be a collection of independent research projects. Linkages may be conceptual, spatial, and/or temporal. Interdependency of the scientific projects may allow for a variety of arrangements, for example, multiple research components sharing a common subject pool managed through a core or a common imaging protocol managed in a core to allow for comparability of data across research projects. The type of integration proposed may be different for different genres of science, including:  conceptual integration or sharing of data, instruments, and other resources. Linkages should encourage cross-fertilization of ideas and interactions among investigators that are relevant to the theme.  Multidisciplinary research activity is expected across a variety of disciplines or sub-disciplines to bring multiple scientific perspectives and approaches to a research area or question.

In addition, NIDA Research Centers are expected to serve as national research resources in the drug abuse research field. They are expected to attract established and promising investigators into drug abuse research. The P50 Center application is expected to provide opportunities for research training, career development, and mentoring, as well as for effective dissemination of research findings.

Changes in Mechanisms

A project previously funded as a P20, P30, or P60 NIH grant may be submitted as a new P50 Center by application through this announcement. In order to help the review committee to assess the significance of this transition, the applicant is encouraged to provide information on previous specific aims and highlight scientific accomplishments and the importance and innovativeness of the findings. This section can be incorporated in the “Overall Center Characteristics” as preliminary studies.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see http://grants.nih.gov/grants/gide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Networking Website for Consultation and Collaboration

NIDA has established a web-based Networking Project (NNP) to encourage investigators to collaborate with other scientists to gain access to specialized expertise, unique research resources, diverse populations, or geographic locations not otherwise available.  For applicants interested in identifying potential collaborators, the NNP website is available at http://nnp.drugabuse.gov, as a source of information on the mission, focus, and leadership of NIDA’s research networks.  The website features an interactive map with more than 300 local network sites, a directory of close to 400 addiction researchers and practitioners, and the extensive resources of 14 NIDA-supported research networks located across the country.  If appropriate for the proposed research, NIDA encourages grant applicants to use the resources of the NNP and make reference in the grant application when they are utilized.

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 announcement will use the P50 award mechanism. The Project Director(s)/Principal Investigator(s) (PD/PI) is 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

Applicants may apply for up to five years of support, whether as new,  renewal, or resubmission applications.

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.

When an application proposes to support pilot projects, the annual direct costs for these activities may not exceed 25% of that year’s total direct costs for the Center (facilities and Administrative (F&A) costs requested by consortium participants are not included in the total direct cost) or $200,000, whichever is smaller.

Salaries and support may be provided for a limited number of administrative and clerical personnel directly supporting the Center, when not covered by institutional overhead charges.  However, salary and support for central administrative personnel, usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel, are not allowable.

Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment, when not covered by institutional overhead charges, are permitted.

Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowable.

Shared Resources and Services

Shared resources and services intended to provide access to technology that enhances the research productivity of the center and provides foci for scientific interaction and consultation, as well as access to services that facilitate the research and strengthen the administrative and organizational cohesion of the center may be requested.

Costs associated with sharing data and methodologies with the scientific community and training colleagues in the use of such methodologies may also be requested.

Costs for the use of ad hoc scientific and technical consultants when appropriate and for the conduct of seminar series designed to promote interdisciplinary interaction, education, and center cohesiveness may be requested.

Costs of center planning and evaluation, including the costs of an external advisory committee, may also be requested.

Travel of the center director and other investigators to scientific meetings justified as essential to the conduct of research under the center may be supported.

Travel of technical staff for training justified as essential to enhancing the quality of the research projects may be supported.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 programs. For this FOA, the PI may not concurrently be the PI on another NIDA supported Center grant. Because of the role of centers as national resources, investigators from foreign institutions are not eligible to serve as center directors but may serve as research project or core directors and otherwise participate in center programs.

More than one PD/PI, or multiple PDs/PIs may be designated on the application as center director. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on an application is available athttp://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 multiple PD/PI option applies only to the center as a whole; multiple PDs/PIs cannot be proposed for any center project or core.

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

The Center Director/PI must show a substantial commitment of time and effort (minimum 35%) to the program and exercise leadership in steering the Center direction and maintenance of its quality control.  When multiple PIs are involved, it will be expected that there will be a minimum percent effort of 20% for each Center Director/PI.  Center Directors may not direct more than one NIH Center.  This applies to applications with single or multiple PIs. If a PI is a Center Director on a Center with multiple PIs, he/she may not act as a Center Director on an application in response to this FOA.

Management support and shared functions should be accomplished through an Administrative Core.  The Administrative Core should provide for central operations, oversight activities, technical support and exercise of leadership for the overall project management, as well as integration, communication, and coordination of the Center. 

If there are clinical trials conducted using Center funds, each should be individually registered in ClinicalTrials.gov and obtain an NCT number.  This NCT number should be included in the Data and Safety Monitoring Plan as well as in the annual progress report for the grant.

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct. However, an individual who serves as a PI of a NIDA P50 Center may not concurrently serve as the PI of another NIDA supported Center.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. 

Renewals. Applicants may submit a renewal application by competing for additional project periods.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398.

For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

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 NIDA Research Center of Excellence application.

A NIDA Research Center of Excellence must have a minimum of four (4) components, where one is an administrative core and three are research components. The maximum combined number of components is 10, including the administrative core, research components and core components, and may include a pilot project core component. Individual pilot projects within a pilot project core do not count toward the total number of 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 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 pages for Overall Center, 6 pages for Administrative Core; 12 pages for each Research Core, 12 pages for Pilot Project Core, and 12 pages 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 the overall Center budget, each component requires a separate detailed budget.

Applications must be complete in order to be accepted. Applicants are encouraged to organize their application by initially presenting the face page, the abstract page with key personnel, a table of contents, and summary budget of the entire Center followed by core budget pages, biosketches for the entire Center, followed by resources and other documentation pertaining to the entire Center. This should be followed by an Overall  section of Center Characteristics that addresses the ways in which the application meets the criteria that define a NIDA Center, as described below. Then the Administrative Core, Research Cores and Research Projects should follow. Each component should present its Abstract, highlighting resources unique to this core, a Research Strategy (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods) as indicated in the PHS 398. If a Pilot Project core is included, it should present its Abstract, highlighting resources unique to this core, and describe management of the core.  Each full research project should be presented with its Abstract, a Research Strategy (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods) and other support information such as letters of support, as indicated in the PHS 398.

Training Activities

While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important secondary function is the training of research and clinical personnel. Training and mentoring to enhance junior researchers' or other researchers' skills should be conducted in the context of the research, but funds may not be used for training stipends or for training not required to conduct the research. However, Center staff may participate in the development of training programs, and Center resources may be made available for use by trainees. Training activities are also expected to recruit and nurture future generations of scientists to engage in drug abuse and addiction research.  The Center is strongly encouraged to provide programs to develop careers of researchers of ethnic minorities in drug addiction research and to develop programs to eliminate health disparities.

Education Activities

As part of serving as a national resource, a NIDA P50 Center is expected to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers.

CENTER APPLICATION COMPONENTS

Overall Center (12 pages)

Essential Organizational and Administrative Characteristics of a NIDA Center

Each Center application is expected to provide evidence of an environment that promotes the conduct of the highest quality, state-of-the-art research, innovation, and leadership in its areas of investigation. Applicants are expected to demonstrate that the Center is, or would serve as, a significant national scientific research resource soon after its establishment, to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers. For renewals, the application is expected to demonstrate its past success in doing so and how the Center will continue to serve as a national resource.

The application should document availability of appropriate and adequate facilities dedicated to the conduct of administrative, shared resource, and research activities. While all members of the Center need not be located physically in facilities controlled exclusively by the Center, there must be a clearly identifiable physical location for the Center which insure adequate administrative oversight for the Center and associated core units providing shared resources. Much of the shared research environment and many facilities will be located in or funded through the core components. The Overall section should discuss how each core component contributes toward cost-effectiveness and quality control in resource utilization; how data analytic capacities, database facilities and data resources would be utilized among Center components; and describe the types and quality of shared laboratory and clinical facilities.

All NIDA Centers are expected to clearly demonstrate that they support innovative, rigorous, thematically focused, and productive research that is the result of interacting components of the research program that would not emerge from the mere collection of those individual components. A cadre of experienced, independent and productive investigators should be present with active collaborations in place or planned. These investigators should evidence productivity, stature and leadership, or a potentially strong leadership role, in their respective fields. A broad range of expertise relevant to the Center's goals should be present. Investigative efforts may encompass researchers with primary appointments at the applicant institution as well as to other collaborating sites. Investigators are expected to commit to data sharing and ongoing communications with other investigators in the Center.

Applications should explicitly discuss the integration of work in the Center in the Overall section of the application. Further, applications should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities and research resources that a research Center can uniquely provide.  In addition to narrative, evidence of components' interdependency should be summarized in a table or chart showing how different elements of the Center interact. Organizational structure should be summarized in a diagram

Administrative Core Component (6 pages)

Each Center is expected to have a scientifically and administratively qualified Center director with responsibility for the scientific, administrative, budgetary, and operational aspects of the Center. The Center Director should be an outstanding, productive, senior researcher, as documented by publications, patents, honors, and similar indices of stature. The Center Director is responsible for overall coordination and development of the Center with the responsibility to provide leadership essential to the success of the Center program, to ensure interaction and collaboration among scientists conducting research, to monitor ongoing research and identify (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources.   

An individual cannot serve as director of a NIDA Center of Excellence P50 research Center grant while serving as the PI of another NIDA supported research Center. In addition, it is expected that the Center director will make a substantial commitment of time and effort to the Center. Although the average Center director will commit more time to the Center and associated activities than the minimum, it is expected that the Center director will commit at least 20 percent effort to Center administration including the administrative core and 15 percent effort to any other core and/or on research component directly supported by the Center grant, for a total of 35 percent effort.

Multiple Center directors are allowed; however, very strong justification for the need of such arrangement is expected to be provided. Also, a Leadership Plan is expected to be provided (see Section III/1B). When multiple PIs/Center Directors are proposed, each one is expected to commit a minimum of 20 percent effort.

The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, and to support planning and evaluation activities. There should be convincing evidence of the applicant institution's commitment to the Center. Administrative and organizational arrangements should promote joint planning and evaluation activities as well as collaborations and interactions within, between and among programmatic elements of the center. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research and publications, generation of future grant applications, and also takes maximum advantage of the Center’s's drug abuse research capability (the description of these attributes  is particularly important when there are multiple participating institutions in the Center); (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources; (c) the use of an external advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the Center director ; (d) an internal advisory, decision-making, and priority setting process  to support the activities of the Center; and (e) appropriate criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution.

To promote information sharing, to facilitate collaboration, and to address issues of common concern among NIDA research Centers, NIDA may ask Center Directors to participate in meetings on an as-needed basis.

In developing the budget for core Center activities, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

Research Cores (12 pages for each Research Core Component)

Each Research Core is expected to have a director who is scientifically and administratively well qualified, with responsibility for the scientific, administrative, budgetary, and operational aspects of the core and for coordination with the Center Director and other core/project directors. It is expected that the core director will make a substantial commitment of time and effort to the Center, at least 15 percent effort to administrative and research-related activities directly supported by the Center grant.

A Research Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities.  Research Cores are expected to support two or more Research Components and each Research Core should be clearly described in terms of the services and resources to be provided to other Center components.  Issues to be addressed include: quality control, procedures for selecting projects that use the Core, cost effectiveness, and increased efficiency.  Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives.  While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Pilot Project Core (up to 12 pages)

Applicants may choose to include pilot projects in the Center, as a separate Core component.  Descriptions of pilot project activities may not exceed 3 pages per pilot project.  Description of the  administration of the pilot projects  may not exceed 5 pages. Direct costs allocated to pilot projects in any year cannot exceed 25% of the Center grant’s total direct costs in that year or $200,000, whichever is smaller.  Pilot projects may be used for new, early stage or independent investigators and should represent new projects to develop and explore new activities or directions or take advantage of special opportunities. Pilot projects may be “research and development” pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research.  Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

The support of individual pilot project studies is typically of relatively short duration (e.g., 1-2 years), depending upon the nature of the research.  Applicants may propose and request funding in the first year for specific, already conceptualized pilot projects and also for pilot projects to be added in subsequent years of the project.  Applications requesting support for pilot projects must describe a process for within-Center scientific review of new pilot projects to be initiated in future years of the project and a process for evaluation of ongoing pilot projects for adequate progress. Pilot projects presented in the application will be reviewed as part of the assessment of scientific and technical merit of the application and as examples of the kinds of pilot projects the Center might initiate in the future as a result of its internal within-Center review process.

Before implementing any pilot projects not included in the application, Center grantees must obtain approval from the NIDA program officer by providing written notification of the initiation of a new pilot project.  The notification should contain a brief description of, and rationale for, the planned pilot project, the amount of pilot funds to be allocated to the project, the proposed length of the project, and a statement that the project will comply with applicable NIH policies and that the necessary assurances have been submitted and obtained.  The program officer must also be provided with assurance that the projects have received an appropriate within-Center review.  New pilot projects may not commence until they have been approved by the program officer.  For studies involving clinical trials, pilot projects may not start subject recruitment before a Data and Safety Monitoring Plan has been approved by the NIDA project officer.

Research Components (12 pages for each Research Component)

Each Research Component is expected to have a scientifically and administratively qualified investigator with responsibility for the scientific, administrative, budgetary, and operational aspects of the project and for coordination with the Center Director and other project/core directors. The project/component directors should be productive, outstanding researchers and leaders of the field. It is expected that the project director will make a substantial commitment of time and effort to the Center, at least 15 percent effort to research-related activities directly supported by the Center grant. Research may focus on any area of NIDA's mission, but must bear an essential relationship to the Center’s integrating theme and efficiently use and contribute to Center resources. Each Research Component that uses Center Research Core facilities should describe how the Core resources impact the proposed project.

Renewal Applications  

For renewal applications (formally competing continuations, type 2), a progress report of up to 6  pages must be provided in a section titled Progress Report, which includes a detailed summary of the previous application’s specific aims and highlights the importance of the findings. This section should precede the Overall section in the application.  In particular, the Progress Report should start with a subsection titled Key Findings of the Past Five Years, which summarizes in no more than 2 pages the most significant advances accomplished during the prior period of support.  The Progress Report should demonstrate the research environment's conduciveness to productivity by identifying the originally approved specific aims, the progress made on each specific aim, and relevant publications produced in the previous funding period. It is especially important that renewals (1) identify innovative work accomplished by the Center during the current funding period and (2) propose innovative work for the new funding period.  Changes in the Specific Aims, including termination of Research Components or Cores, should be described and justified and major findings presented with clear descriptions of the importance of these findings to advances in the field. For renewal applications,  the Bibliography and References Cited for the Overall Center should contain a separate section citing  complete references to appropriate publications and manuscripts accepted for publication that resulted from the work during the prior funding period.   The application should also address any significant organizational changes, and provide summaries of training activities for junior investigators as well as results of education and dissemination activities.  Centers that conduct clinical trials must also provide a summary of recruitment, retention, and safety issues, for each trial conducted.

For a project previously funded as a P20, P30, or P60 NIH grant that is now being submitted as a new P50 Center, applicants should provide information on previous specific aims, highlight scientific accomplishments, and describe the importance and innovativeness of the findings in order to document  the significance of this transition to the P50 mechanism. This section should be part of the Research Strategy section  and titled “Preliminary Studies.”

Resubmissions

When submitting a resubmission application, an Introduction section is required and should summarize any substantial changes made. A separate one page Introduction is allowed for the Center Overall section as well as one page for each core and research component.  Include responses to criticisms from the previous summary statement.

Revisions

Applications for Revisions (formally competitive supplements) to Center grants will be supported only under the most exceptional circumstances.  Revision applications are expected to meet all criteria for a NIDA Center listed above and are expected to contribute to the overall theme of the Center and be clearly linked to other ongoing Center projects in a synergistic fashion. NIDA staff should be consulted prior to submission of a revision application.

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 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.

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

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

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s):  August 25, 2010, August 25, 2011, August 25, 2012 
Application Receipt Date(s):  September 25, 2010, September 25, 2011, September 25, 2012
AIDS Application Submission Date(s): January 7, 2011, January 7, 2012, January 7, 2013
Peer Review Date(s): February 2011, February 2012, February 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date(s): July 2011, July 2012, July 2013

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.

Email:  NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Center Grant Applications
Director
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4245, MSC 9550
Bethesda, MD 20892-8401

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application 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 Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

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

Center Grant Applications
Director
Office of Extramural Affairs, NIDA
6001 Executive Blvd, Room 4245, MSC 9550
Bethesda, Maryland 20892-9550
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

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 P50 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 pages for Overall Center, 6 pages for Administrative Core; 12 pages for each Research Component, 12 pages for each Research Core and for  the Pilot Project Core. 

NIDA's P50 research Centers are expected to collect unique and important data, to develop innovative research assessments and methodologies, and to make critical research discoveries which lead their research fields to the next generation of ideas and approaches.  These NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community.  In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access.  In most instances, the data sharing will extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans must be provided (See Section VII Required Federal Citations and http://grants.nih.gov/grants/policy/data_sharing/ for more information.)   A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected.  The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important criterion in the evaluation and funding of a Center application.

PHS398 Research Plan Component Sections
All application instructions outlined in the PHS 398 Application Guide are to be followed, with the following additional requirements:

Budget Component

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

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs)  must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

Appendix Materials

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

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

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this 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 http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

Review criteria for NIDA’s Centers of Excellence (P50) are:

Criteria for the Center Overall

Overall Impact

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

Scored Review Criteria

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

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

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Does the Center Director have the ability to lead a scientific program as documented by scientific achievements, productivity, stature in a relevant field, and planned activities? Does the Center Director have the ability to lead administrative and operational aspects of the Center, as noted by administrative skills, achievements, and planned activities and is there evidence of ability to develop or maintain a role for the Center as a national resource? Is there adequate commitment of time and effort for the research and administrative functions of the Center? As a group, are research component and research core investigators well suited to the projects? Is there evidence of multidisciplinary backgrounds and interests?

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? Does the application clearly demonstrate, in a diagram, the feasibility of the organizational structure? Are the organizational and administrative structure and support conducive to research, synergy, and joint planning? Is a process in place for long range planning and evaluation of Center activities? Is there an operational programmatic structure that effectively promotes productive scientific interactions and takes maximum advantage of the applicant institution's drug abuse research capacity? Are there arrangements for internal quality control of research, publications, and grant applications? Does the  organizational structure have clear lines of authority that allow for efficient and cost-effective management and allocation of funds, as well as leverage of resources to enable additional or future work? Does the outside advisory structure have the capacity to provide appropriate and objective advice and evaluation? Is there an appropriate, fully described internal process that allows for priority setting and decision making to sustain the Center? Is there appropriate specification of criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution? Are there adequate plans for recruitment, training, and supervision of staff?

Is there a clear integration of Center components (including components not directly supported under a P50 but which utilize core functions) to an overarching theme that integrates and focuses the Center, as well as the presence of an essential relationship of each research and core component to the theme? Are there sufficient interactions and linkages of components to each other, to show that the impact of a coordinated Center goes beyond the impact of individual research projects? Does the approach taken for Center activities make use of a depth and breadth of expertise and experience not normally present in an individual research project grant?

Do the core components as a group, contribute resources that enhance cost-effectiveness and quality control in resource utilization?

Does the Center display the involvement of different scientific disciplines or subdisciplines in the Center's activities and the demonstration of substantial interaction among scientists from different disciplines or subdisciplines and different perspectives?

Will the proposed Education Activities provide high quality, appropriate research career development and are they likely to be effective in attracting and involving junior investigators and students who show potential for significant future contributions and independent research careers in the work of the Center?

Do the proposed educational and outreach activities to drug abuse research communities, organizations, general public, and/or policy makers support the ability of the Center to be a national resource?

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

Are there plans for development and maintenance of an environment that promotes the conduct of the highest quality of research, innovation, and leadership? Does past productivity indicate likely future productivity, especially in competing renewal applications, where innovation needs to be demonstrated? Are there appropriate and adequate facilities for administrative, research, and shared resources, including a clearly identifiable physical location for the Center, which assures necessary functions can occur? Do the facilities indicate the Center is, or would soon be, a national scientific research resource?

Is there adequate institutional support; for example, letters of support, space and resources to be allocated from the applicant’s institution, substantial commitment to the Center and appreciation of its goals and role in public health, especially in the drug abuse and addiction research field?

Does the environment provide adequate high quality data analytic capacity, data base facilities, coordination, and data resources? As needed, are there provisions for shared laboratory resources, high quality laboratory space, and clinical facilities?

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

Criteria for the CENTER ADMINISTRATIVE CORE and RESOURCE CORE COMPONENTS:

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Core to exert a sustained impact on the activities of the Center in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. A component does not need to be strong in all categories to be judged likely to have major impact. For example, a project that by its nature is not innovative may be essential to promote activities in the Center.

Significance. Does the core component address important scientific and administrative activities of the Center? If the aims of the core are achieved, how well will it contribute to the function of the Center? How will successful completion of the aims contribute to support of the concepts, methods, technologies, treatments, services, or preventative interventions carried out in other components of the Center? Is there adequate justification for this core activity being conducted within a Center structure?

Investigator(s). Are the PI/PD, the collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation. Does the core utilize novel theoretical concepts, approaches or methodologies, instrumentation, or interventions in support of the Center? 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 plans for day to day management well-reasoned and appropriate to accomplish support of Center activities? Are potential problems, alternative strategies, and benchmarks for success presented? Are the arrangements and organizational structure adequately developed, well integrated, well reasoned, and integrated with multiple other components of the Center?   Is the justification for the need for core services or resources clearly stated and are there appropriate plans for resource allocation?

If the core activity 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?

Criteria for a PILOT PROJECT CORE

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained impact on the activities of the Center, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. A core 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. Do the pilot research topics address an important problem or a critical barrier to progress in the field and are they consistent with the overall goals of the Center? If the aims of the project(s) 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? Do the projects have the potential to develop into full scale independent projects?

Investigator(s). Does the PD/PI have the qualifications to lead this component?  In the individual pilot projects, are the project leaders, their collaborators, and other researchers well suited to the projects? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation. Do the proposed pilot projects or the process for generating new pilot projects 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 for proposed pilot projects and the process for managing the pilot project core well-reasoned and appropriate to accomplish the specific aims of the projects? 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? Are the plans to evaluate progress of ongoing pilot projects and to generate and monitor new projects adequate? Are monitoring, oversight procedures and continuation decisions explained? Do the pilot projects chosen reflect that an appropriate process for selection of pilot projects is in place?

If the projects involve 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?

Criteria for a RESEARCH COMPONENT

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

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An research component does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the project well integrated into the overarching theme of the Center and interactive with other research components or cores?

Investigator(s). Are the PD/PI, the collaborators, and other researchers well suited to the project and do they commit sufficient time to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation. Does the project 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?

Additional Review Criteria 

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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.

Is there evidence of how the Center has attracted additional sources of funding or leveraged resources?

Is there evidence of high quality dissemination of findings and data to the drug abuse and addiction research community?

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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.

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.

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

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and 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:

Jamie Biswas, Ph.D.
Chief, Medications Research Grants Branch
Division of Pharmacotherapies and Medical
Consequences of Drug Abuse
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 402-3869
Tel.   301-443-8096
FAX 301-443-9649
Email: jb168r@nih.gov

Meyer D. Glantz, Ph.D.
Assoc. Director for Science
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse, NIH, DHHS
Suite 5185, MSC 9589
Bethesda, Maryland 20892-9589
Telephone: (301) 443-6504
Email: mglantz@nida.nih.gov

Paul Schnur, Ph.D.
Deputy Director
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Blvd., Rm 4273, MSC 9555
Bethesda, MD 20892-9555
Telephone:  301-435-1316
FAX:  301-594-6043
Email: pschnur@mail.nih.gov

Laurence R. Stanford, Ph.D.
Deputy Director
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
National Institutes of Health
6001 Executive Boulevard, Room 3165, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-3869
FAX: (301) 443-6814
Email: lstanfor@nida.nih.gov

Diane Lawrence, Ph.D.
Associate Director
AIDS Research Program
National Institute on Drug Abuse, NIH, DHHS
National Institutes of Health
6001 Executive Boulevard, Room 4224MSC 9581
Bethesda, MD 20892-9593
Telephone: (301) 594-3225
FAX: (301) 94.5610
Email: LawrenceDi@nida.nih.gov

2. Peer Review Contacts:

Mark Swieter, Ph.D.
Chief
Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4235, MSC 9550
Bethesda, Maryland  20892-9550
Telephone:  (301)  435-1389
FAX:  (301) 443-0538
Email:  mswieter@nida.nih.gov

3. Financial or Grants Management Contacts:

Pam Fleming
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4000
Bethesda, MD 20892-9560
Phone: 301-253-8729
FAX: 301-594-6849
Email: pfleming@nida.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.

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/.

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.

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.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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