Part I Overview Information

Department of Health and Human Services

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

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

Title: Strategic Program for Innovative Research on Drug Addiction Pharmacotherapy (SPIRDAP)

Announcement Type
New

Request For Applications (RFA) Number: RFA-DA-05-009

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: February 9, 2005
Letters of Intent Receipt Date(s): March 18, 2005
Application Receipt Date(s): April 18, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: April 19, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The National Institute on Drug Abuse (NIDA) invites applications to support innovative, integrated preclinical and clinical research to validate novel pharmacotherapeutic approaches and to identify potential compounds that are safe and effective, short-term (to reduce and stop drug use) and long-term (to prolong abstinence) pharmacotherapies for cocaine, methamphetamine and cannabinoid addiction. Significant progress in molecular biology, cell biology, genetics, immunology, neuroscience and behavioral sciences has provided the scientific basis for the development of innovative pharmacological interventions for drug addiction. The Strategic Program for Innovative Research on Drug Addiction Pharmacotherapy (SPIRDAP) encourages a collaborative enterprise between preclinical and clinical scientists in the conceptualization and proof-of-concept of a pharmacotherapeutic strategy. Novel approaches are of interest for the development of pharmacotherapies for cocaine, methamphetamine or cannabinoid addiction treatments which are based on molecular targets for specific receptor subtypes, transporters, intracellular organelles or metabolic pathways to modulate the neurotransmitter systems involved in the drug addiction processes. The applicant must possess the expertise necessary to (i) evaluate the proposed strategy in preclinical systems, and (ii) implement early phase clinical studies in volunteers or target populations to validate the therapeutic modality. The participation of commercial (pharmaceutical, chemical, or biotechnological) organizations is strongly encouraged.

Awards will be made as Cooperative Agreements (U19). The Cooperative Agreement is an assistance mechanism in which substantial NIDA programmatic involvement with the grantee is anticipated during the performance of the planned activity. An interim review of each SPIRDAP will occur at the end of the second year of funding by a panel that may include consultants to evaluate progress and status of the development project. This review will focus on the imminence of the initial clinical trial, which could be a factor for a decision by NIDA staff on continued funding.

NIDA intends to commit at least $2.0 million in FY2005. At least three awards are anticipated. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of individual awards will vary also. The applicants must seek agreement from the NIDA scientific contact person if the application exceeds $500,000 in direct costs for any of the years. Budget requests should be carefully justified and be commensurate with the complexity of the project.

You may submit (an) application(s) if your institution has any of the following characteristics:

Foreign institutions are not eligible to apply as the primary institution, but may enter into a consortium or subcontract with a domestic institution as the primary applicant.

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. There is no limit to the number of applications an applicant may submit under this announcement. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Applications must be prepared using the PHS 398 research grant application instructions, available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Telecommunications for the hearing impaired is available at TTY 301-451-5936.

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
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The National Institute on Drug Abuse (NIDA) invites applications to develop new medications for the treatment of cocaine, methamphetamine or cannabinoid addiction. This RFA will support innovative, integrated preclinical and clinical research to validate novel pharmacotherapeutic approaches and to identify potential compounds that are safe and effective, short-term (to reduce and stop drug use) and long-term (to prolong abstinence) pharmacotherapies for the targeted addiction. Studies submitted in response to this Request for Applications (RFA) should have a truly novel and innovative approach.

A Strategic Program for Innovative Research on Drug Addiction Pharmacotherapy (SPIRDAP) complements existing, more traditional preclinical and clinical programs managed by the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) of NIDA (e.g., medications development center grants, medicinal chemistry contracts, preclinical medications testing contracts and clinical trials contracts).

Of greatest significance, each SPIRDAP applicant is required to form a collaborative enterprise between preclinical and clinical scientists in the conceptualization and proof-of-concept of an identified therapeutic strategy. This will entail interactive research and information exchange between preclinical and clinical investigators in order to ensure effective development and refinement of the therapeutic concept. The applicant's Group must, therefore, possess the expertise necessary to (i) evaluate the proposed strategy in preclinical systems, and (ii) conduct early phase clinical studies in volunteers or target populations to validate the therapeutic modality. A SPIRDAP should be dedicated to the expedited transition from advanced preclinical research to clinical testing of promising therapeutics to treat drug addiction. The SPIRDAP applicants are encouraged to include investigators from commercial (pharmaceutical, chemical, or biotechnological) organizations.

DPMCDA at NIDA is currently supporting a comprehensive research program aimed at the development of safe and effective pharmacotherapies for drug addiction. Notwithstanding these efforts, no safe and effective pharmacotherapies have been approved by FDA for cocaine, methamphetamine or cannabinoid addiction.

In recent years, the scientific information base on the neurobiology of cocaine, methamphetamine and cannabinoid addiction has expanded, and the number of technological breakthroughs has increased significantly. Significant advances in molecular biology, medicinal chemistry, immunology, and neuroscience of cocaine, methamphetamine and cannabinoid addiction have been made: (1) genes for the cannabinoid, dopamine, glutamate, and serotonin receptors and transporters have been cloned, (2) novel receptor and transporter compounds with varying affinities have been synthesized and evaluated, (3) and animal models which permit the study of behavioral features of drug addiction in the laboratory are available.

Consequently there is a need to translate these advances in basic research into development of effective treatment strategies, an effort that requires interactive (interdependent) research activities involving both preclinical and clinical investigators in the planning and implementation of studies directed toward the development of an effective pharmacotherapy for drug addiction. A concerted effort to mobilize the nation's combined basic and clinical scientific expertise through SPIRDAP can accelerate advances in the development of effective treatments for brain disorders resulting from drugs of abuse.

This SPIRDAP will support research for the development of innovative hypotheses generating and proof-of-concept pharmacological interventions and strategies for the treatment of cocaine, methamphetamine or cannabinoid addiction.

Research Goals and Objectives of SPIRDAP

The principal goals of this RFA are to (i) bring together innovative, advanced preclinical research and clinical proof-of-concept of an identified pharmacotherapeutic strategy for cocaine, methamphetamine or cannabinoid addiction and (ii) implement early phase clinical studies to validate the therapeutic modality. In line with this objective, SPIRDAP will support projects with a common thematic goal for which advanced preclinical data exist. These efforts are to be implemented through a concerted, interactive (interdependent) group effort by components comprising the SPIRDAP Group.

Applicants are expected to have an identified strategic plan based on a creative, solid, scientific rationale and supported by advanced preclinical data, that leads to an early phase clinical evaluation in healthy volunteers or target population. Therapeutic strategies that require studies in humans, as well as preclinical studies to refine the clinical approach, are appropriate for funding under SPIRDAP. Each SPIRDAP application must propose a well-defined, central research focus consistent with the research objectives as stated in the RFA. The following approaches are provided as examples and are not intended to be inclusive or restrictive for the development of pharmacotherapies for cocaine, methamphetamine or cannabinoid addiction:

Novel approaches for the development of pharmacotherapy strategies based on molecular targets such as specific receptor subtypes, transporters, intracellular organelles or metabolic pathways that modulate the neurotransmitter systems involved in the drug addiction processes will be of interest. The class of compounds with potential as pharmacotherapies for cocaine, methamphetamine or cannabinoid addiction, include, but are not limited to, compounds interacting with corticotrophins, cannabinoid, biogenic amines, GABA, and glutamate systems. Other novel approaches or molecular targets with scientific rationale will also be of interest. Note that biogenic amine transporter compounds are not sought for this RFA as NIDA has previously supported development efforts in this area.

Applications should address advanced preclinical refinements of the proposed strategy; evaluation and demonstration of efficacy in laboratory animals; and implementation of early phase clinical studies. The cyclic flow of information between preclinical and clinical phases is critical for maximal refinement and optimization of the proposed clinical modality, clinical evaluation of the therapeutic concept, and ultimately, to accelerate transition to clinical treatment.

Studies required for the IND-targeted preclinical development (GMP synthesis, formulation, toxicology) of proposed treatments are generally beyond the scope of this RFA, but such development through private venture capital is encouraged. Alternatively, an applicant may request that NIDA assist in these developmental tasks using existing NIDA contract resources. In addition, NIDA/DPMCDA also has the contract capacity for clinical evaluation of pharmacotherapies. It is envisioned that extended clinical studies of treatments developed by a SPIRDAP Group can be accommodated under the clinical trial mechanisms available through DPMCDA. However, these resources are limited, and proposals including/requiring these services should contain documentation that such future collaborative efforts have been discussed with NIDA program staff. Queries about these programs/resources should be directed to NIDA scientific contact person (see Section VII.1) prior to the submission of grant application.

Project Organization and Definitions

Cooperative Agreement - An assistance mechanism in which substantial NIDA programmatic involvement with the recipient organization is anticipated during the performance of the planned activity.

Core , Administrative - An administrative facility that provides central operations, support, and leadership for the overall management, integration, communication, and coordination of the cooperative agreement and services shared by the Group as a whole. The Administrative Core should have a budget separate from that of the Principal Investigator's research project, but should be administered by an individual from the Principal Investigator's organization. The Administrative Core should include in its annual budget for travel expenses to support its SPIRDAP Steering Committee members to attend scheduled Steering Committee meetings. The Administrative Core will be responsible for allocating required travel expenses to appropriate members of the Group. Only SPIRDAP-related travel will be supported through the Administrative Core; travel funds to other domestic or foreign meetings are not provided. (For additional details of required travel see Section VI.2.A. Cooperative Agreement Terms and Conditions of Award)

Core, Scientific – A scientific service component which provides laboratory, or equipment support and services to two or more projects of the SPIRDAP. Examples of core components are: biochemical, cell-based, and immunological studies; animal model studies; pharmacology/toxicology studies; and scale-up synthesis of the test compound. The core can be defined as a facility laboratory with established techniques, which performs a service function resulting in an economy of effort and savings in the overall costs of the program operations. The core unit is to be described with the same detail as the research projects to enable evaluation of its scientific merit. A core component cannot be used toward fulfilling the minimum number requirement for research projects.

Core Leader - The leader of one of the Administrative or Scientific Cores of the SPIRDAP.

Group - see definition for SPIRDAP Group below.

Invention - An innovative therapeutic approach that is or may be patentable under Title 35 of the United States Code.

NIDA Program Director - A senior scientist of the NIDA extramural staff, who coordinates NIDA's participation in the SPIRDAP, oversees the operation of the entire SPIRDAP, maintains the program stewardship duties, and ensures that SPIRDAP Program is consistent with the mission of DPMCDA, NIDA.

NIDA Scientific Coordinator – A scientist of the extramural staff of the DPMCDA, NIDA, who functions as collaborator with the Principal Investigators and Project Leaders and who facilitates the partner relationship between NIDA and each Group. The Scientific Coordinator is the immediate NIDA contact person to the Group.

Principal Investigator - The person who assembles the SPIRDAP application, who is responsible for the performance of the Group as a whole and for that of each of the Project Leaders, and who is responsible for submitting the single application in response to this RFA. The Principal Investigator will coordinate Group activities scientifically and administratively and should be the project leader of one of the Research Projects of the Group and must commit at least 20 percent effort to the Program. The awardee (Principal Investigator's) institution establishes and manages the central operations office that funds Group members and is legally and fiscally accountable for the disposition of funds awarded.

Project Leader - The leader of one of the scientific research projects of the SPIRDAP who is responsible for the scientific conduct of that project. Project leaders are expected to devote 20% time and effort to their project.

Research Project - A discrete, specified, circumscribed research project that must relate to the overall theme (refinement and proof-of-concept of high-risk innovative pharmacological intervention and strategy for the treatment of cocaine, methamphetamine or cannabinoid addiction) of the SPIRDAP. A minimum of 2 research projects is required to constitute a viable program proposal. The maximum number of research projects allowed is five.

SPIRDAP (Strategic Program for Innovative Research on Drug Addiction Pharmacotherapy) Group - A SPIRDAP Group may be comprised of research staff as well as non-research professional staff. The research staff may consist of a number of scientific investigators, from academic and/or non-profit research institutions as well as scientists from commercial organizations, performing research on interactive projects whose central focus is the development of effective pharmacotherapies for addiction.

SPIRDAP Group Steering Committees - Each SPIRDAP Group will form a Steering Committee (SC), which will be the primary coordination center of the Group and will make all major scientific/programmatic decisions. Voting members of the Committee will be the Principal Investigator, the Project Leaders and the NIDA Scientific Coordinator. Non-voting members of the Committee will be the NIDA SPIRDAP Program Director and other non-voting consultants (e.g., scientists, relevant FDA officials) as needed. The SC will have the following responsibilities and authorities: 1) to develop a detailed plan and timetable to coordinate the various research activities among the Group's various research laboratories to ensure the preclinical concept/strategy will advance into clinical studies in a timely fashion; 2) to identify/allocate essential and additional studies or resources (toxicology, formulation) required for the IND targeted preclinical medication development activities; 3) to formulate strategies to successfully interact with the FDA, and/or local IRBs, etc., regarding the IND submission and quality control of the studies (GLP, GCP, GMP, etc); and 4) to develop policies on data sharing, access to data and materials, and publication authorship. The SC will meet one to three times a year and will tele-conference when requested. (For additional details on SC see Cooperative Agreement Terms and Conditions of Award at Section VI.2.A.)

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Cooperative Agreements (U19) award mechanism(s). The Cooperative Agreement is an assistance mechanism in which substantial NIDA programmatic involvement with the recipient is anticipated during the performance of the planned activity. As an applicant, you will be 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.

The NIH U19 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

All applications must consist of at least two interrelated research projects conducted by at least two independent research laboratories or commercial laboratories. The involvement of laboratories from commercial (pharmaceutical, chemical, or biotechnological) organizations as part of the project is encouraged.

This RFA is a one-time solicitation. All policies and requirements that govern the grant programs of the U.S. Public Health Service (PHS) and the National Institutes of Health (NIH) apply. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated (R01) applications and will be reviewed according to the customary peer review procedures.

2. Funds Available

NIDA intends to commit at least $2.0 million in FY2005. At least three awards are anticipated. An applicant may request a project period of up to 5 years. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of individual awards will vary also. The earliest anticipated start date is September 2005.

The applicants must seek agreement from the NIDA scientific contact person if the application exceeds $500,000 in direct costs for any of the years. Budget requests should be carefully justified and be commensurate with the complexity of the project.

Although the financial plans NIDA 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Native American tribal organizations are eligible. Foreign institutions are not eligible to apply as the primary institution, but may enter into a consortium or subcontract with a domestic institution as the primary applicant.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

2. Cost Sharing or Matching
Not applicable.

3. Other-Special Eligibility Criteria

All applications must consist of at least two interrelated research projects conducted by at least two independent academic research laboratories or commercial laboratories. The maximum number of research projects allowed is five. The involvement of laboratories from commercial (pharmaceutical, chemical, or biotechnological) organizations as part of the project is encouraged. The applications require an administrative core and have options for scientific cores that provide essential services to the proposed Research Projects.

The application's objectives and goals should be relevant to and compatible with the purposes and goals as stated in this RFA. Applicants should describe their plans to accommodate the stated SPIRDAP requirements, criteria, and NIDA involvement.

There is no limit to the number of applications an applicant may submit under this announcement. However, applications with significant overlap with other proposed or awarded projects from the PI(s) at NIDA will not be considered for funding.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

This RFA requires the submission of a single application for the proposed SPIRDAP. The SPIRDAP is headed by a Principal Investigator and includes research components called Research Projects headed by Project Leaders and Core components headed by Core Leaders. Each individual Research Project/Core comprising the SPIRDAP Group application is subject to the same format, page limitation, and separate budget as a research project grant (R01) application Form PHS 398 unless otherwise noted. Applications that are not received as a single package from the Principal Investigator and that do not conform to the instructions will be judged non-responsive and will be returned to the applicant.

SPIRDAP Applicants are encouraged to organize their application by initially presenting the Overall Program followed by Administrative Core, individual Research Project and Scientific Core.

Information for the Overall Program:

1. Face page (PHS 398 Form Page 1): This should be the first page of the entire application and contains information pertain to the entire SPIRDAP.

2. Description, Performance Sites, and Key Personnel (PHS 398 Form Page 2): This section should concisely state the overall goals of the SPIRDAP and clearly state the contribution of each component to the overall goals. Key personnel for the entire Group including consultants and consortium collaborators should be listed alphabetically. Use the terms "Project Leader" and "Core Leader" as appropriate to identify personnel performing these roles.

3. Table of Contents: The application is reviewed as a whole as well as Project by Project; therefore, prepare a detailed Table of Contents that enables reviewers to find specific information readily. Identify Research Projects by number, title, and responsible investigator. Identify Cores by letter, title and responsible investigator.

4. Budget: Prepare a composite budget for all proposed years of the entire SPIRDAP. In addition, prepare the budget for each individual Projects and Cores for all proposed years of support. Use PHS 398 Form Page 4 for individual Projects and Cores and include a justification for the budget elements. Travel costs for Group meetings should be included in the budget for the Administrative Core. All other scientific travel should be included in the budget for each individual Project and Cores. Indicate the page location of your budget in the table of contents.

5. Biographical Sketch of Key Personnel: Provide biographical sketches of professional personnel for all components with the principal investigator's first followed by the Project/Core leader and then other key personnel in alphabetical order.

6. Organization and Administrative Structure: Describe in detail and by diagram the chain of authority for decision making and administration, beginning at the level of the Principal Investigator. Include all investigators responsible for individual Research Projects and Cores and detail how the tasks are planned, coordinated, and evaluated. If internal or external advisory groups are to be used, list the membership (actual but not proposed members) and describe the role of each. List in a separate table all consultants, both paid and unpaid.

7. General Description of the Overall SPIRDAP Program: This section should not exceed 7 pages describing SPIRDAP as a whole with respect to the overall theme, goals, objectives, and research plan. It should contain germane information on i) the overall research theme, leadership role of the PI, and mechanisms and plans to ensure effective interactive research and information exchange between preclinical and clinical investigators in order to ensure effective development and refinement of the therapeutic concept; ii) the development timelines and milestones for each Projects in a graphic outline (Gantt and/or Pert charts) to clearly lay out the sequence of research events and their relationship to each other, and the critical go/no go criteria; iii ) any additional preclinical testing (performed by NIDA/DPMCDA resources) needed to file an IND to test the compound in human subjects; and iv) the proposed Principal Investigator or his/her institution to evidence the capability to carry out the scientific and administrative duties through a central operations office required in this RFA.

8. Appendix: The proposal, depending on the nature of the program, should also contain a special appendix with documents assuring the accessibility and availability of the proposed test compounds.

9. Checklist format page: Complete for the entire application and place at the end of the application package.

Information for Each Core:

1. Cover Page. Provide the name and title of the Core leader. For all Cores use a letter (e.g., A, B, C) to designate each Core unit and give each a unique title; type these on the upper left-hand margin of all pages in the Core section for easy cross-reference.

2. Description, Performance Sites, and Key Personnel (PHS 398 Form Page 2): Provide a description of the Core activities and services and how the Core services will contribute to attaining the program's objectives.

3. Table of contents (PHS 398 Form Page 3): Prepare the Table of Contents for the Core.

4. Budget : Omit, as these are included elsewhere in the application.

5. Biographical sketches: Omit, as these are included elsewhere in the application.

6. Research Plan (not to exceed 10 pages): This section describes the role of the Core component as a resource to the SPIRDAP as a whole. Clearly present the facilities, resources, services, and professional skills that the Core component provides.

Information for Each Research Project

1. Cover Page. For all Research Projects use a number (e.g., 1, 2, 3) to designate each Research Project and make sure each has a unique title. Give the name and title of the project leader. Type the number and title of a research project on the upper left-hand margin of all relevant pages for easy cross-reference.

2. Description, Performance Sites, and Key Personnel (PHS 398 Form Page 2): Information provided should pertain specifically to the research project and how the research project will contribute to attaining the objectives of the overall program.

3. Table of Contents (PHS 398 Form Page 3): Prepare a Table of contents for the research project.

4. Budget: Omit, as these are included elsewhere in the application.

5. Biographical Sketches: Omit, as these are included elsewhere in the application.

6. Resources and Environment: List only those specific to the Research Project. The Project Leader should be responsible for allocation of resources required for the research.

7. Research Plan (not to exceed 15 pages for items a-d): Describe the specific aims, background and significance, preliminary results, and research design and methods specific for the Project. In addition, describe in this section the relevance of the Research Project to the overall theme of the Group and the collaborations with other investigators within the Group. Describe how the proposed research will contribute to meeting the project's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims.

8. Human Subjects: If the project involves the use of human subjects, describe the plans for protection of human subjects from research risks, as well as plans for the inclusion of women, minorities and children, as described in the PHS 398 application instructions (Rev. 5/2001). This information must be noted on the face page for the overall application.

9. Vertebrate Animals: If the project involves the use of vertebrate animals, provide a detailed description and justification for the use of animals as described in the PHS 398 application instructions. This information must be noted on the face page for the overall application.

10. Consultants/Collaborators: (PHS 398 Continuation Pages). List only those consultants or collaborators who are specific to this Research Project.

11. Do NOT include a checklist for each Research Project. There should be only one checklist at the very end of the entire application, and that should come from the organization submitting the overall SPIRDAP.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): March 18, 2005
Application Receipt Date(s): April 18, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005

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 - DA-05-009
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Director - DA-05-009
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt 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 the CSR and responsiveness by the NIDA. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All 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 (see also Section VI.3. Reporting).

6. Other Submission Requirements

Special Requirements

A. The application's objectives and goals should be relevant to and compatible with the purposes and goals of this RFA. Applicants should describe their plans to accommodate the stated SPIRDAP requirements, criteria, and NIDA involvement.

B. A plan should be described for decision-making regarding selection and evaluation of promising pharmacotherapies for development. A plan should be provided for developmental activities not supported by this RFA but required for introduction of a pharmacotherapeutic agent into clinical trial.

C. The Principal Investigator and the project leaders are expected to contribute 20% time and effort to the program.

D. Failure to abide by any of the Terms of Award pertaining to awardee responsibilities stipulated in Section VI.2.A. may result in withholding of funds by NIDA until compliance with the Terms is restored.

E. Patent Coverage: Principal worldwide patent rights to an invention supported in whole or part with federal funds usually vest with the grantee/contractor organization. Under the existing regulation 37 CFR Part 401, grantee/contractor organization must promptly report all inventions disclosed to them by their investigators to the NIH Extramural Technology Transfer Office. A grantee can elect to retain title to any subject invention, although such title is subject to an nonexclusive, nontransferable, irrevocable, paid-up license to the Government to use, and license others to use, the invention for government purposes. If the grantee does not elect to retain title, the government may do so. Moreover, the Government retains march-in rights that require the patent holders to license others in certain circumstances, such as when the licensee has not taken effective steps within a reasonable time to achieve practical application of an invention or to alleviate a health and safety need.

F. An interim review of each SPIRDAP will occur at the end of the second year of funding by a panel that may include consultants to evaluate progress and status of the development project. This review will focus on the imminence of the initial clinical trial, which could be a factor for a decision by NIDA staff on continued funding.

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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 requires that grant awardee 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

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDA. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below.

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

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.

A scientific review panel will review the program as an integrated research effort focused on a central research strategy or theme, including the relationship of research components to the central strategy/theme and the effectiveness of the core units in supporting the program. The panel will evaluate individual components and the overall program as an integrated effort using the following criteria.

Program as an Integrated Effort

1. The significance and originality of the overall proposed research program and the development of a well defined central strategy relevant to the goals of the RFA.

2. The merit of the proposed overall research strategy, approach, methodology, and plans to address the goal of the RFA. The likelihood that an innovative preclinical therapeutic strategy for the development of medications to treat cocaine, methamphetamine or cocaine addiction will be refined and pilot clinical research implemented approximately two years after award date.

3. The design of clinical plan to confirm hypothesis established by the pre- clinical studies.

4. The integration of multi-disciplinary and multifaceted components within the thematic focus of the Program, and cohesion and coordination of individual projects and core(s).

5. The Principal Investigator's leadership, scientific ability, and administrative competence, and commitment to devote substantial time and effort for the development, implementation, and management of a comprehensive pre-clinical and clinical research program. It is anticipated that, due to the complexity and time required to maintain a well-coordinated and productive research effort, a minimum 20% time and effort by the Principal Investigator should be devoted to the study unless there are compelling arguments to the contrary.

6. The administrative arrangements and organizational structure, through an Administrative Core, to facilitate and monitor the attainment of objectives and internal quality control. For example, these factors will include plans to enhance communication and cooperation among the investigators involved in the program to establish mechanisms for the allocation of funds for day- to-day management. A well designed management plan that clearly defines the lines of authority, development timelines, and points of 'go' and 'no go' decisions, and clearly demonstrates that resources will be used efficiently in reaching SPIRDAP goals.

7. The availability of the resources necessary to perform the research; appropriateness of proposed methodology and demonstrated willingness to work as part of the cooperative program and with NIDA Scientific Coordinators.

8. The documented commitment of the institutions represented by Group members and the documented capability of the Principal Investigator's institution to serve as the Central Operations Office for the Group.

9. The appropriateness and duration of the proposed budget in relation to the proposed research.

Research Projects

Individual project components will be evaluated further using the following criteria:

1. Significance:
Does the project address the significance and originality of the proposed research and its relevance to the central strategy of the application? If the aims of the application are achieved, how will the development of medication be facilitated ? What will be the effect of these studies on the concepts or methods that drive the development of medications?

2. Approach:
Are the conceptual 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? Plans for the recruitment and retention of subjects will also be evaluated, when relevant. The assurance that hypothesis testing and experimental approach is supported by a strong rationale and/or preliminary data. The cohesiveness and coordination of individual projects and core(s) within the multi-disciplinary and multifaceted scope of the program. The reasonable assurance of accessibility of the test compounds proposed in the study. A prerequisite for consideration of any study within an application is the demonstrated access to the study compounds as well as necessary formulations as required. This includes necessary placebo forms of the test drug formulation.

3. Innovation:
Does the project employ novel concepts, approaches or methods? Are the aims of the study original and innovative? Does the project challenge existing paradigms or develop new concepts?

4. Investigators:
Are the investigators for the individual projects 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the Project Leader responsible for the individual research project devote adequate time and effort to the applicant Group? It is anticipated that due to the complexity and time required to maintain a well-coordinated and productive research effort, a minimum 20% time and effort by each Project Leader should be devoted to the study, unless there are compelling arguments to the contrary.

5. Resources and Environment:
Does the scientific environment 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, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Are there adequate resources and appropriate environment necessary to perform the research and the willingness to work as part of the cooperative program?

Cores

The evaluation of administrative and scientific cores will include the following criteria (1) The utility of the Core to the SPIRDAP, (2) each Core must provide essential facilities or services for two or more Projects judged to have substantial merit , (3) the quality of the facilities or services provided by the Core (including procedures, techniques, and criteria for prioritizing activities), and (4) for an Administrative Core: Resources and plans provided for Group communication and coordination of Group activities.

1. Significance:
Is the proposed core crucial to the proposed projects? What crucial support is provided to the research projects? Are the most efficient means identified? How do they enhance the effectiveness of individual projects? Are mechanisms identified to promote research collaborations, to develop new strategies, or to conduct pilot experiments? Are specialized substance abuse research clinics available? Has the possibility of an advisory steering committee been considered to evaluate progress of the program? What standardized tests, interventions, and evaluations are administered through the core? Are uniform operating systems proposed? Does the plan give careful consideration to overall timelines, choice and accessibility of medications, subjects recruitment issues, data management, and statistical resources? Is interface with FDA and other regulatory agencies considered?

2. Approach:
The effectiveness of administrative arrangements and organizational structure to facilitate and monitor the attainment of objectives and internal quality control, and plans to enhance communication and cooperation among the investigators involved in the program. Establishment of mechanisms for the allocation of funds for day-to-day management. A well-designed management plan that clearly defines the lines of authority, development timelines, points of 'go' and 'no go' decisions, and clearly demonstrates that resources will be used efficiently in reaching SPIRDAP goals.

3. Innovation:
Are innovative ways proposed in utilizing shared resources or benefiting from the Principal Investigator's leadership to support research projects, retain integrity, achieve efficiency, or minimize utilization of resources?

4. Investigators:
Does the personnel involved in the core have the appropriate qualifications, experience, and adequate commitment to the overall project?

5. Environment:
The quality and adequacy of available resources necessary to perform the research and the willingness to work as part of the cooperative program and with NIDA Scientific Coordinator. The documented commitment of the applicant institution and capability to serve as the Central Operations Office for the program.

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:

Data and Safety Monitoring Plan: The adequacy of the proposed plan for the oversight and monitoring of the conduct of proposed clinical studies to ensure the safety of participants and the validity and integrity of the data will be assessed.

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.

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 will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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://www.ott.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.

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.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

If the grantee organization is set up to receive e-mailed awards from NIH, the award will be e-mailed to the authorized business official of the grantee institution. If the organization is not e-mailed enabled, one copy of the Notice of Award will be mailed to the authorized business official. The business official's office is responsible for sending a copy of the award to the Principal Investigator.

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement (U19) , an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining the details for the project within the guidelines of the RFA; retaining primary authority and responsibility for the plan, conduct, analyses, and publication of results, interpretations and conclusions of their studies; and will agree to accept assistance in coordination, cooperation, and participation of NIDA staff in those areas of scientific and technical management identified below under 2.A.2, NIH Staff Responsibilities. The Principal Investigator and each Project Leader must provide a signed statement of acceptance of the participation of NIDA staff during performance of the award as outlined under "NIH Staff Responsibilities" below.

Awardees will participate on the SPIRDAP Steering Committee as described below under 2.A.3, Collaborative Responsibilities.

Awardees will retain custody of and have primary rights to the data and software developed under the award, subject to rules formulated by the Steering Committee and Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

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

NIDA shall work with each Group and shall be represented by the NIDA Scientific Coordinator. The NIDA SPIRDAP Scientific Coordinator will be a member of the SPIRDAP Steering Committee and will not serve as the Chair of the Committee. In light of the complex structure and research activities of the SPIRDAP and the medications development goal of the SPIRDAP, NIDA staff will provide technical assistance and advice in the area of pharmaceutical regulatory science and in the area of information management and project management to ensure effective and efficient progress of the study. Specifically, the responsibilities of NIDA staff are threefold: 1) to facilitate the effective communication among study laboratories to ensure expedited transition of research from advanced preclinical findings to applied clinical mode by means of their project management and information management expertise; 2) to provide pharmaceutical regulatory advice and support to the Group by serving as consultants for the Group in preparing IND submissions and in conducting studies that meet FDA standards (GLP, GMP, GCP) when needed; and 3) to provide appropriate assistance, advice, and guidance in general by participating in the design of Group activities; advising in the selection of sources or resources; coordinating or participating in collection and/or analysis of data and participating in the preparation of publications; but not participating in the actual implementation of the preclinical and clinical studies.

Additionally, NIDA's SPIRDAP Program Director oversees the operation of the entire SPIRDAP, maintains the Program stewardship duties, and ensures that the SPIRDAP Program is consistent with the program of DPMCDA and the missions and goals of NIDA. NIDA's SPIRDAP Program Director will be named in the award notice.

2.A.3. Collaborative Responsibilities

Under the Cooperative Agreement, a partner relationship exists between the awardee and NIDA. In order to facilitate the collaborative effort between the awardee and the NIDA extramural staff, a Steering Committee for each SPIRDAP will be established.

Each SPIRDAP Steering Committee will be composed of:

1. The Principal Investigator of the Group.

2. The Project Leaders of all preclinical and clinical projects.

3. The NIDA SPIRDAP Program Director as a non-voting member.

4. The NIDA Scientific Coordinator.

5. Additional non-voting consultants as needed.

NIDA will have one vote and will not be serving as the Chair of the Committee.

Each SPIRDAP Steering Committee will have the following authority and responsibilities: 1) to develop a detailed plan and timetable which will ensure active and frequent interactions among the various research laboratories and NIDA staff to expedite the transition of preclinical concept/strategy into clinical studies; 2) to identify and allocate all essential and additional studies or resources (toxicology, formulation) required for the IND targeted preclinical development; 3) to formulate strategies to interact with FDA, and/or local IRBs, regarding the IND submission and quality control of the study (GLP, GMP, GCP, etc.); and 4) to develop policies on data sharing, access to data and materials, and publication authorship. The Steering Committee will meet one to three times a year along with teleconferences where appropriate and when requested by the awardee or by NIDA staff.

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

2.A.4. Arbitration Process

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

3. Reporting

Awardees will be required to submit the 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:

Nora Chiang, Ph.D.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-8099
FAX: (301) 443-2599
Email: nchiang@nih.gov

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, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3. Financial or Grants Management Contacts:

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming@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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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.

Public 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 public 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 PA 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.

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.

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:
Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:
The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. 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 Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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