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Part I Overview Information

Department of Health and Human Services

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

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

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

Announcement Type
New

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 general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf. 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-08-046

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.399

Key Dates
Release Date: December 13, 2007
Letters of Intent Receipt Date(s): January 28, 2008; January 26, 2009; January 26, 2010
Application Receipt or Submission Date(s): February 26, 2008; February 26, 2009, December 1, 2009 (per NOT-DA-09-007 ), February 26, 2010
AIDS Application Receipt Date(s): May 7, 2008; May 7, 2009; May 7, 2010
Peer Review Date(s): July, 2008; July, 2009; July 2010
Council Review Date(s): October, 2008, October, 2009; October, 2010
Earliest Anticipated Start Date(s): December, 2008, December 2009; December 2010
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: New Date January 8, 2010 (per issuance of NOT-DA-09-007) Original Expiration Date: May 8, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

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 three types of investigator initiated research centers: core center grants (P30), research center of excellence grants (P50), and comprehensive research center of excellence grants (P60). This FOA provides support for the P50 Research center of excellence. Please see other FOA issuances for the P30 and P60. Applicants interested in the P20 mechanism should consult current RFA listings.

Overall Characteristics of all NIDA Centers

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. NIDA's research centers program is intended to support the highest quality, multidisciplinary programs of innovative research.

NIDA centers are expected to have three essential and defining qualities. First, they are expected to be scientifically innovative. Centers are expected to provide the next generation of ideas and approaches. Incremental work, though valuable, should not be the focus of Center activities. Rather, new and creative directions are required, and it is expected that a Center will transform knowledge in the sciences it is studying. Second, each NIDA center is expected to be thematically coherent and is expected to demonstrate the highest caliber of multidisciplinary scientific work. The uniqueness of each center emerges from the confluence of thematic integration, and multidisciplinary involvement. The third quality of a NIDA center is synergy. Taken as a whole, a NIDA center is expected to enable a level of achievement that exceeds that expected on the basis of "the sum of its parts." Research supported at a NIDA research center is expected to reflect an inter-dependence of the individual research projects that would not occur simply from the collection of the individual components. Center support should be essential to the achievement of the proposed work.

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 and P60 center applications are expected to provide opportunities for research training, career development, and mentoring, as well as for effective dissemination of research findings.

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.

Program Objectives of a P50 Center

A P50 provides support for a broadly based, multidisciplinary, innovative research program consisting of related research endeavors and associated core infrastructure to ensure their effective and synergistic functioning. The activities included in the supported research is expected to be innovative, thematically integrated, multidisciplinary, and synergistic. It is important that the research supported not be simply a collection of independent research projects that are only loosely related. Each individual research component is expected to be systematically related both to some other components and to the core infrastructure. 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 training not required to conduct the research.

Elements of NIDA Centers

Essential Organizational and Administrative Characteristics of a NIDA Center

The application needs to justify the configuration and numbers of components proposed and to demonstrate that the proposed center infrastructure would facilitate effectively the achievement of the desired level of integration and synergy. The center mechanism is not appropriate to support a set of complex unitary investigations that would be best supported as individual R01s.

All NIDA centers are expected to clearly demonstrate the occurrence of innovative, rigorous, thematically focused, and productive research that emerges from interdependent components of the research program and that would not emerge from the mere collection of those individual components. Applicants should explicitly discuss the integration of work in the center in the introductory section of the application. Further, it is expected to be demonstrated that the use of the research center mechanism is essential to accomplishing the scientific aims set forth in the application. In addition to narrative, evidence of components' interdependency should be summarized in a table. Organizational structure should be summarized in a diagram.

Three characteristics are necessary for meeting this set of requirements:

1) Innovation -- There must be evidence of scientific innovation. Centers must be at the cutting edge of the science. Centers are expected to provide the next generation of ideas and approaches. Incremental work, though valuable, should not be the focus of Center activities. Rather, new and creative directions are required, and it is expected that a Center will transform knowledge in the sciences it is studying.

2) Thematic integration and multidisciplinary involvement -- There must be an overarching theme that integrates and focuses the center. Further, there must be an essential relationship of each component part to the overall theme of the center and to the other components. Interdependency and integration of the projects should be clearly evident, so that the center does not appear to be a collection of independent research projects. These linkages may be conceptual, spatial, and/or temporal. The type of integration proposed may be different for different genres of science. Some types may emphasize conceptual integration and focus, while others may emphasize sharing of data, instruments, and other resources. Linkages should encourage cross-fertilization of ideas and interactions among investigators that are relevant to the theme. There must be multidisciplinary involvement. That is, there must be research activity across a variety of disciplines or sub-disciplines such that multiple scientific perspectives and approaches are brought to bear on an area or question. There must be evidence that significant multidisciplinary collaborations will occur and contribute to thematic integration as described above.

Interdependency of the scientific projects may allow for a variety of arrangements including, for example, sharing a common subject pool managed through the core which the center’s other components draw from or, for example, the core may provide a common imaging protocol to allow for comparability of data across research projects.

3) Synergy -- Synergy is evidenced by creative thinking, a novel approach, innovations, and highly significant findings. The degree of coordination, interaction, and collaboration should foster original and creative contributions to scientific understanding over and above that which would be obtained if each component existed independently. Synergy refers to the intense interaction among participating components that results in greater depth, breadth, quality of research and productivity. 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. The center must demonstrate that the whole is greater than the sum of its parts.

In addition, NIDA P50 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 center applications are expected to provide opportunities for research training, career development, and mentoring, as well as for effective dissemination of research findings.

Research Activities

NIDA's centers should support research activities of the highest and most innovative caliber. Research may occur in any area of NIDA's mission. Each separate project should bear an essential relationship to the integrating theme and efficiently use and contribute to center resources. Centers should enable highly innovative and important studies, whether they are developmental activities and pilot projects or more mature, complex investigations. The center should also support the education, training, and mentoring of new investigators, who should be given meaningful roles to play in the center projects. Further, there should be evidence that the presence of a center structure is essential for the accomplishment of the research activities. Although center support is not intended to support direct research activities in P50s, there should be evidence that the support of the core activities enable the more efficient implementation of associated research and that this research is innovative and of the highest caliber, as well as consistent with the overall purposes of the NIDA Centers program.

The NIH policies regarding human subjects protection, data safety and monitoring, and inclusion of women, minorities and children must be followed for research proposed involving human subjects. Data Safety and Monitoring plans must be included for all clinical trials, and Data and Safety Monitoring Board plans must be included for phase I, II and III pharmaceutical trials, and stage 1, 2 and 3 behavioral studies, multi-site clinical trials, and to prevention health services and other interventions, when appropriate or required. (See Section VIII Required Federal Citations for more information; and NIDA Guidelines for Data and Safety Monitoring plans and Data and Safety Monitoring Board plans at http://www.nida.nih.gov/Funding/DSMBSOP.html and http://www.nida.nih.gov/Funding/GuideDSMB.html, respectively).

The NIH policies regarding use of animals in research must be followed for research proposed involving live vertebrate animals. See section of 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.

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. 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.

Data, Findings, & Resource Sharing

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 in 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.

Research Environment and Facilities

Each center is expected to provide 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. For resubmissions, the application is expected to demonstrate how the Center continues to serve as a national resource and its success in doing so.

There must be 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 insures adequate administrative oversight for the center and the 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. Each core component should contribute toward cost-effectiveness and quality control in resource utilization. Data analytic capacities, database facilities, and data resources should be specified as needed. Provisions for shared laboratory resources and the quality of laboratory space should be indicated. Similar information should be provided for clinical facilities.

Center Director (Program Director/Principal Investigator (PD/PI))

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 a productive, senior (as documented by publications, patents, honors, and similar indices of stature) and outstanding researcher. The center director is responsible for overall coordination and for the development of the center. An individual cannot serve as director of more than one NIDA research center grant. 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 administrative core and 15 percent effort to any other core and/or on research component directly supported by the center grant.

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).

Scientific Project Director

Each project 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 directors should be productive, outstanding researchers and leaders of the field. The project director is responsible for overall coordination and for the development of the core. It is expected that the project director will make a substantial commitment of time and effort to the center, at least 25 percent effort to research-related activities directly supported by the center grant.

Core Director

This section does not apply to administrative core since the center director must be the director of the administrative core.

Each core is expected to have a scientifically and administratively qualified investigator 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. The core directors should be productive, outstanding researchers and leaders of the field. The core director is responsible for overall coordination and for the development of the core. It is expected that the core director will make a substantial commitment of time and effort to the center, at least 25 percent effort to administrative and research-related activities directly supported by the center grant.

Center Investigators

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 is expected to commit to data sharing and ongoing communications with other investigators in the center.

Administrative and Organizational Structure

The center is expected to have appropriate and effective administrative and organizational capabilities to conduct multidisciplinary research, to foster synergy, and to plan and evaluate center activities. There should be clear and 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, publications, and generation of future grant applications, and also takes maximum advantage of the center'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 a standing outside advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the center director; (d) internal advisory, decision-making, and priority setting processes appropriately charged to conduct 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. Administrative support might also include plans for recruitment, training, and supervision of staff.

The center is expected to have both research projects and supporting core units that provide support to the research projects of the center. The center should have an administrative core that provides general administration, coordination, and oversight of the center activities. Specialized core units should not provide service to only one project. Core activities is expected to be clearly described.

Allowable Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the Public Health Service Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated on the Notice of Grant Award. Under these rules, the center director may exercise flexibility to meet unexpected center requirements by re-budgeting or requesting approval to re-budget among budget categories within the total direct cost budget of the center (as shown on the Notice of Grant Award). 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, as noted below:

Center Administration

Salaries and support may be provided for a limited number of administrative and clerical personnel. 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.

Planning and Assessment of Progress

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

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.

Other Information

Changes in Mechanisms

A project previously funded as P20 or P30 NIH grant may be submitted as a 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 highlighting scientific accomplishment, and the importance and innovativeness of the findings. This section can be incorporated in the Overall Center Charateristics.

Revisions

Applications for Revisions (formally competitive supplements) to center grants will be supported only under the most exceptional circumstances. Applications for such revision to center grants are expected to meet all criteria for a NIDA center listed above and is expected to contribute to the overall theme of the center and be clearly linked to other ongoing center projects in a synergistic fashion.

Meetings of Center Grant Directors

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.

Resubmissions

The resubmission (formally revision) application should include the usual NIH required three pages Introduction to the resubmission describing the changes in the entire application. In each of the cores/projects, three pages are allowed to describe, changes/responses in the respective core/project.

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, and to provide 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/guide/notice-files/NOT-DA-07-013.html

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.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity announcement will use the P50 award mechanism.

The applicant is solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The P50 mechanism supports an administrative core and one or more other research support cores and scientific projects. Applicants may apply for up to five years of support, whether as new or competing renewal 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.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Applications may be submitted by :

A single individual may not concurrently be the center director on more than one NIDA center grant. Because of the role of the centers as national resources, foreign applicants are not eligible as center directors but can serve as project or core directors and otherwise participate in center programs.

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 support. Investigators from foreign institutions are eligible as component directors of a project or core.

More than one principal investigator 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 at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on an application share the authority and responsibility for leading and directing the center, 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 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

Not applicable.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. Application kits are downloadable at NIH website, http://grants1.nih.gov/grants/funding/phs398/phs398.html#forms.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

Multiple PDs/PIs can not be proposed for any core or project. The multiple PD/PI option applies only to center as a whole.

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All applications proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (section 14 of the Research Plan Component in the SF424 (R&R) or Section I of the Research Plan in the PHS 398), 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, including 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.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
 Letters of Intent Receipt Date(s): January 28, 2008; January 26, 2009; January 26, 2010
Application Receipt or Submission Date(s): February 26, 2008; February 26, 2009, December 1, 2009 (per NOT-DA-09-007 ), February 26, 2010
AIDS Application Receipt Date(s): May 7, 2008; May 7, 2009; May 7, 2010
Peer Review Date(s): July, 2008; July, 2009; July 2010
Council Review Date(s): October, 2008, October, 2009; October, 2010
Earliest Anticipated Start Date(s) : December, 2008, December 2009; December 2010

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Director
Office of Extramural Affairs, NIDA
6101 Executive Blvd, Room 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

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

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review .

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. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component

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 you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your 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 (type 1) applications, renewal ( formerly competing continuation type 2) applications, revision( formerly called competing supplement)applications, or resubmission (formerly amended or revised) applications version of these grant application types. See NOT-OD-02-004, October 16, 2001.

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, summary budget of the entire center followed by core budget pages, Biosketches for the entire center, Resources and other documentation pertaining to the entire center. This should be followed by an overall section of Center Characteristics of no more than 15 pages that addresses the ways in which the application meets the criteria that define a NIDA center. Then the cores/projects follow. Each core should present its Abstract, (Resources unique to this core, if any), 15-page Research Plan (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods) as indicated in the PHS 398. Each research project should be presented with its Abstract, (Resources unique to this project, if any), other support information such as letter of support, and 20 pages for the Research Plan (i.e., specific aims, background and significance, preliminary studies/progress report, and research design and methods) as indicated in the PHS 398.

Renewals

For renewals (formally competing continuations, type 2), a progress report of the previously funded research must be provided. There should be evidence that the previously funded center enables the more efficient implementation of research projects and that this research is innovative and of the highest caliber, as well as consistent with the overall purposes of the NIDA Centers program. In addition, applicants 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 competing continuations (1) identify innovative work accomplished by the center during the current funding period and (2) propose innovative work for the new funding period.

In the text of the application, there must be a section titled Progress report which includes a detailed summary of the previous application’s specific aims and highlights the importance of the findings. The innovation of the work/results must be highlighted. The application should provide the initial Specific Aims, describe and justify the changes in the Specific Aims and present major findings, describing clearly the importance of these findings to the advances in the field, and include the complete references to appropriate publications and manuscripts accepted for publication. 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, this progress section should not exceed 10 pages.

A project previously funded as a P20 or P30 NIH grant that is now being submitted as a P50 center, in order to help the review committee to assess the significance of this transition, the applicant is strongly encouraged to provide information on previous specific aims and highlighting scientific accomplishment, and the importance and innovativeness of the findings. This section should not exceed 10 pages and should be part of the Overall Center Charateristics.

Appendix material

Appendix material limits apply to each component separately; each component's appendix must follow PHS 398 guidelines (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html). Applications exceeding page limits, font limits, or appendix limits will be returned to the applicant without review. Appendices should not be placed within the body of the application but should be bundled separately, component by component.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

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

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

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the National Institute on Drug Abuse in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?

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

Center Specific Criteria

Applicants should ensure that their applications are responsive to the research goals of NIDA and to the "Essential Organizational and Administrative Characteristics of a NIDA Center" as described in these guidelines.

To be competitive, NIDA center applications must clearly display exceptional quality for both sets of criteria: the highest caliber of innovative scientific research and the unique characteristics of a research center. The application will receive one score; that score will reflect the overall evaluation of the center, its scientific projects and cores. Thus, the application will be evaluated using specific criteria for the overall center, the scientific projects and the cores. In addition, applications will be reviewed for appropriateness of budget and protections for human subjects, animal subjects, and the environment, as needed. Gender and minority representation will be assessed as needed, as will the inclusion of children. The adequacy of the data and safety monitoring procedures, where relevant, will be considered, as will research data and resource sharing plans.

Applicable to all competing renewals and to applications that change mechanisms: In addition to the criteria stated below, progress will be assessed regarding the innovation and impact of work completed during the previous/current funding period. Evidence is expected to be provided of substantial progress in reaching stated goals: These include, but are not limited to, records of publications, quality and quantity of publications, dissemination, patents, awards, training activities, placement record of trainees.

1. Criteria for determination of overall scientific and technical merit of the center

Scientific Review Group members will be asked to exercise their considerable professional judgment in determining an overall score for the center application. This will be based on an assessment of the extent to which innovation, thematic integration, synergy, and multidisciplinary involvement -- the key characteristics of a NIDA center-- are present, and how well the center will serve as a national resource. The score will be based on the scientific and technical merit of the center as a whole, the scientific and technical merit of each project, the appropriateness of each core, the likelihood of scientific productivity, and an overall assessment of the work's potential scientific and public health impact. Innovation is an especially important component of the scientific and technical merit assessment of each component and of the center as a whole. As noted elsewhere, a NIDA Center is expected to propose and to accomplish innovative, not incremental, work. It is expected to lead to the transformation of knowledge in the areas of science under study. Innovation may be evident in theoretical, analytic or other aspects of the components.

The criteria used in assessing the overall scientific and technical merit of the center are as follows:

Criteria to be used for determination of scientific merit of individual scientific project components

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the scientific project component in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: Each of these criteria will be considered in assessing merit. Of particular importance will be the innovation of the project and the likelihood that the results would have a major impact. Furthermore, successful centers are expected to show outstanding merit on all criteria.

Significance: Does this study address an important problem in drug abuse and addiction field? Is the project well integrated into the overarching theme of the center? If the aims of the component are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

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

In addition, if pilot studies are proposed in the scientific projects, what is the likelihood that the research will contribute to the development of multidisciplinary programs or more mature research endeavors?

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

Investigators: Is each investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the principal investigator considered a leader in the field or has the principal investigator demonstrated potential leadership quality? How does the principal investigator contribute to the research team for this project and for the center as a whole? Does the investigative team bring complementary and integrated expertise to the project or core?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

Criteria to be used for determination of scientific and technical merit of individual core components

2. A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score for the center as a whole:

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B.Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

Glen D. Morgan, Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Rm. 4034
6130 Executive Blvd., MSC 7337
Bethesda, MD 20892-7337
[Rockville, MD 20852 (express mail)]
Telephone: 301-496-8585
Fax: 301-496-8675

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Director Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

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
6101 Executive Boulevard, Room 270
Bethesda , MD 20892
Phone: 301-443-6710
FAX: 301-594-6849
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 PAR 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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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NIH Funding Opportunities and Notices


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