RFA-DA-10-009: The National Drug Abuse Treatment Clinical Trials Network (U10)

Department of Health
and Human Services (HHS)

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Part I Overview Information

Department of Health and Human Services

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

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

Title: The National Drug Abuse Treatment Clinical Trials Network (U10)

Announcement Type
This is a reissue of RFA-DA-07-001.

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

July 3, 2014 - This RFA has been reissued as RFA-DA-15-008.
July 29, 2009 - See Notice NOT-DA-09-009 The purpose of this notice is to publish the link to a website containing answers to Frequently Asked Questions (FAQs).

Request For Applications (RFA) Number: RFA-DA-10-009

Catalog of Federal Domestic Assistance Number(s)
93.279

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

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This Funding Opportunity Announcement (FOA) from the National Institute on Drug Abuse (NIDA) announces a competition for new cooperative agreement applications and cooperative agreement renewal applications from established clinical investigators to participate in the National Drug Abuse Treatment Clinical Trials Network (CTN). As a nation-wide partnership for translational research among addiction treatment providers, researchers, and NIDA staff, the CTN’s mission is to test and validate effective and efficient treatments that can be adopted by addiction treatment providers throughout the Nation, using science as the vehicle. The CTN provides an enterprise in which community-based addiction service providers, other health practitioners working with patients that have addiction problems, addiction treatment researchers, and NIDA cooperatively develop, validate, refine, and deliver new treatment options for patients in community-level clinical practice.
Mechanism of Support. This FOA will utilize the National Institutes of Health (NIH) cooperative agreement (U10) award mechanism.
Funds Available and Anticipated Number of Awards. In response to this FOA, the National Institute on Drug Abuse (NIDA) anticipates that approximately $13.5 million in total costs in FY2010 will be awarded to fund up to 12 applications for this announcement.
Budget and Project Period. It is expected that each Node will have an operating budget of up to $750,000 direct costs per year for the 5 year project period. NIDA may consider budget requests of up to $875,000 direct costs per year for applications that propose multiple PIs from one or more institutions.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization 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.
Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
Number of Applications. Applicants may not submit more than one application in response to this FOA.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Renewals. Renewal applications are permitted in response to this FOA
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
Application Materials. See Section IV.1 for application materials.
Hearing Impaired. Telecommunications for the hearing impaired are 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, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose of this FOA

The National Institute on Drug Abuse (NIDA) invites cooperative agreement applications from established clinical investigators to participate in the National Drug Abuse Treatment Clinical Trials Network (CTN). Applications from geographic areas not currently well represented in the CTN are particularly encouraged. This Funding Opportunity Announcement (FOA) is the sixth solicitation for participation in the CTN. It is intended for both new applications and competing continuation (renewal) applications.

The CTN is a nation-wide partnership for translational research among addiction treatment providers, researchers, and NIDA staff. The CTN mission is to test and validate effective and efficient treatments that can be adopted by addiction treatment providers throughout the Nation, using science as the vehicle. The CTN provides an enterprise in which community-based addiction service providers, other health practitioners working with patients that have addiction problems, addiction treatment researchers, and NIDA cooperatively develop, validate, refine, and deliver new treatment options for patients in community-level clinical practice. This unique partnership aims to achieve these primary objectives: to conduct multi-site clinical trials of addiction treatment interventions to address a broad spectrum of translational research questions, ranging from efficacy studies to practical clinical trials, across a wide variety of community-based treatment settings and diverse patient populations; and to facilitate the dissemination, implementation, and adoption of evidence-supported treatments by physicians and other clinicians, providers, and patients.

CTN clinical trials may be carried out in various settings, including community-based treatment programs, specialty substance abuse or mental health clinics, primary and specialty care medical offices and clinics, emergency medical care facilities, or other venues that typically are not considered research intensive. Each awardee functions as a CTN Research Node, consisting of a Regional Research and Training Center (RRTC) that is linked in partnership with community-based treatment programs (CTPs) and other clinical settings. Each of the multiple CTN Nodes works in concert with other Nodes and NIDA to develop and conduct multi-site clinical trials. Awardees test and deliver an array of both psychosocial and pharmacological treatments and determine conditions under which treatments can be effective. Studies typically span multiple sites engaging diverse patient populations in various settings across dispersed geographical regions. As a cooperative agreement, there is substantial NIDA involvement in the scientific management and administration of the CTN. NIDA recognizes a benefit in broadening the types of treatment providers who participate in the network, including primary care and other medical clinicians and encompassing more subpopulations of minority and other under-studied groups, thereby attaining greater variety in the types of studies conducted and greater confidence in their generalizability.

Background

The development of the CTN was based in part upon guidance from the National Advisory Council on Drug Abuse, recommendations from the Institute of Medicine, and suggestions from the Physicians Leadership on National Drug Policy. Between the first NIDA CTN solicitation in 1999 to the fifth in 2006, awards have been made to a total of nineteen different Nodes in California (two sites), Colorado, Connecticut, Florida, Maryland, Massachusetts, Michigan, New York (two sites), Ohio, Oregon, New Mexico, North Carolina, Pennsylvania (two sites), South Carolina, Texas, and Washington. Sixteen Nodes are funded currently in the CTN and all will complete their project periods on August 31, 2010.

Under the current FOA, NIDA seeks to enhance the network to include additional types of treatment settings and patient populations as well as to balance geographic and regional representation. In particular, applicants are encouraged to seek collaborations that combine activities with or between existing Nodes or to bring other under-represented regions into associations with proposed Nodes, thereby condensing infrastructure costs while extending the breadth and depth of the CTN. Strong partnerships and bi-directional collaborations between researchers and practitioners are two essential and defining characteristics of the CTN. These partnerships and collaborations are the vehicle by which the CTN seeks to accelerate the pace of research that is most relevant to addiction treatment practice. NIDA also encourages the development of collaborative relationships with institutions supported under the Clinical and Translational Science Awards (CTSAs) and other established clinical research networks. More information regarding the CTSA consortium may be found at: http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/.

Knowledge gained through the CTN is expected to support the dissemination, implementation, and adoption of research-supported treatments. Over the past nine years, the CTN has: (1) established a clinical trials research infrastructure to test the effectiveness and usefulness of drug abuse treatments in community-based settings with diverse patient populations, (2) expanded the dissemination and implementation of effective and useful interventions into its community-based drug treatment settings and (3) provided unique opportunities to train clinical researchers. Details on current and past CTN activities and organization, including findings from completed studies and status of ongoing protocols, may be found on the NIDA web site at: http://www.nida.nih.gov/CTN/Index.htm.

CTN Definitions, Organization, and Functions

Clinical Trials Network (CTN). A collaborative group of regional research Nodes working under a cooperative agreement award with NIDA. This group conducts multi-site, cross-regional (nationwide) as well as other clinical trials research projects on promising psychosocial, pharmacological, and combined psychosocial and pharmacological addiction treatments.

Node. The Node is the functional unit within the CTN, consisting of a Regional Research and Training Center (RRTC) and its affiliated Community Treatment Programs (CTPs) - see definitions below. The RRTC arranges and coordinates the research, training, and dissemination partnerships among the RRTC and the CTPs. The CTN comprises multiple, geographically diverse Nodes.

Regional Research and Training Center (RRTC). The RRTC provides scientific leadership for the clinical trials conducted within the CTN and is an entity that resides within the grantee institution of the cooperative agreement award. The RRTC 1) establishes Node infrastructure, 2) builds partnerships with the CTPs, 3) provides administrative and operations support for trials, 4) collaborates with the CTPs to generate research, training, and dissemination agendas, 5) collaborates with NIDA and other Nodes to develop, disseminate, and implement findings from CTN research projects, and 6) works cooperatively with the CTN Clinical Coordinating Center and Data and Statistics Center.

Specifically the RRTC will be responsible for:

Infrastructure: Infrastructure refers to the physical and operational capacity to 1) arrange and manage collaborative activities of at least five CTPs within the Node, 2) maintain scientific and technical personnel for protocol development and operations, and 3) coordinate and provide resources for CTN activities that occur within the Node, including training and dissemination operations.

Research Agenda: In close partnership with the CTPs within its Node and with colleagues across the CTN, RRTCs develop research concepts for potential CTN trials and submit them to the CTN Steering Committee (or its designated subcommittee) for discussion and review.

Training Agenda: The CTN structure provides many opportunities for pre-doctoral, post-doctoral and junior faculty researchers to gain valuable experience in designing, participating in, and managing complex clinical trials.

Dissemination Agenda: RRTCs develop and support activities to facilitate the implementation and adoption of CTN research-based treatments by Node-affiliated practitioners, clinicians, and service program directors and, when directed, to collaborate with other segments of NIDA to disseminate proven addiction treatments more broadly to the field.

Administrative and Operations Support: The RRTC ensures appropriate administrative and operational support for Node activities, including but not limited to the conduct of trials. The support must ensure adherence to the Terms and Conditions of the Award and the policies and procedures of NIDA and the CTN as specified in the CTN Bylaws (http://www.nida.nih.gov/CTN/Structure.html).

Partnership with and Responsibility toward Affiliated CTPs: The RRTC functions as a partner with its associated CTPs. It provides CTPs with 1) support for the CTP Director representing the Node on the Steering Committee, 2) scientific mentoring during the process of developing research concepts and conducting trials, and 3) support for CTP participation in relevant CTN activities and operations, including publication of findings, dissemination and implementation of research results and strengthening the capacity of the CTP to serve as a research site.

Principal Investigator(s): The senior scientist(s) named in the grant by the applicant institution to lead and manage the activities within the Node. This FOA supports and encourages the use of the multiple-PI model. (See NOT-OD-07-017; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html) This model offers an important opportunity for investigators seeking support for activities that require a team science approach and which do not fit the single-PI model. This approach by applicants could enhance a strong research network with its broadened expertise and allow for an increase in diversity at all levels within the research plan. The multiple-PI option may be utilized with PIs from a single or multiple institutions; however, only one applicant institution is allowed. The first PI listed must be affiliated with the institution submitting the application and will serve as the contact PI. If this model is used, the application must provide a Leadership Plan describing the roles and areas of responsibility of the named PIs, the process for making decisions on scientific direction including a communication plan to ensure timely information sharing, allocating resources, and resolving disputes that may arise. The quality of the Leadership Plan will be considered by peer reviewers as part of the assessment of scientific and technical merit. Details on the multiple-PI model can be found at the website noted above and at http://grants.nih.gov/grants/multi_pi/index.htm. The decision to apply for a single PI or a multiple PI grant is the responsibility of the investigators and the applicant organization.

Community Treatment Programs (CTPs): CTPs affiliated with the CTN over the first nine years typically have been drug abuse treatment programs in community settings that provide treatment to large and diverse patient populations. NIDA now broadens this definition to include additional service entities such as physicians offices and other medical care settings (e.g., emergency departments, general medicine, infectious, chronic disease and public health clinics), psychiatric and other mental health treatment settings, and other entities outside the traditional substance abuse treatment practice system that provide addiction services. Under this FOA, the term CTP is used to encompass this broader spectrum of settings and services. Potential CTPs must have, or be willing to develop, the capability for and interest in participating in controlled clinical trials.

Working as an equal partner with its RRTC, each CTP agrees to:

Designate the Director (or other senior official) of the CTP to represent the CTP for CTN activities and to ensure fulfillment of CTP obligations;
Participate fully in the development of research concepts and protocols for trials to be conducted in the CTN;
Participate in clinical trials and adhere fully to Good Clinical Practice and to the specific protocol and operations manual applicable to each trial;
Cooperate with periodic on-site audits by NIDA or its designees to ensure appropriate use of investigational drugs; compliance with regulations for IRB approval and informed consent (e.g., 45 CFR 46); compliance with protocol specifications; quality assurance and accuracy of data recording; and completeness of reporting of adverse drug reactions.

CTN Steering Committee. The Steering Committee constitutes the primary governing body of the CTN. Voting members are one Principal Investigator and one CTP representative from each Node, the CCTN Director or Deputy Director, and one representative each from the CTN Clinical Coordinating Center and CTN Data and Statistics Center. The Steering Committee uses both established and ad hoc committees and workgroups (e.g., Executive Committee, Research Development Committee, Research Utilization Committee, Publications Committee) to assist in carrying out its functions.

Protocol Review Board. An independent expert board, appointed by the NIDA CCTN Director, which reviews proposed protocols and informed consent documents. The DSMB makes recommendations to the NIDA CCTN Director based on its review activities. To minimize delay and provide continuity, this board may be combined with a DSMB (see below) for a given study.

Data and Safety Monitoring Board (DSMB). An independent expert board appointed by the NIDA CCTN Director, that oversees and monitors the conduct of the clinical trials to ensure the safety of participants and the validity and integrity of data for each study. The DSMB makes recommendations to the NIDA CCTN Director based on its oversight activities. The DSMB may also conduct a scientific review of the protocol if necessary (see above). The DSMB makes independent assessments of the interventions under study and whether or not any trial undertaken in the CTN will continue. One or more NIDA staff serves as a non-voting administrator of the DSMB.

Data and Statistics Center (DSC). The entity established under a contract awarded by NIDA to provide data management and analysis systems as required to implement standards established by NIDA CCTN. The major tasks of DSC are to:

Establish systems for the collection, management and storage of study data
Design and perform all statistical analyses
Review and monitor the quality of study data
Monitor trial progress
Prepare reports for the DSMB
Provide data management and statistical support for protocol development
Provide other expert consultation and support services as directed by NIDA

Clinical Coordinating Center (CCC): The entity established under a contract awarded by NIDA to provide certain resources and services for CTN clinical trials, including support for regulatory requirements and oversight functions mandated by NIH and DHHS. Specific functions of the CCC include:

Regulatory affairs and human subjects research support;
On-site monitoring of clinical study sites, quality assurance support, and serving as NIDA's safety officer for CTN trials;
Central pharmacy services for medication packaging, shipping, and inventory control;
Clinical laboratory support and drug testing;
Coordinating the distribution of trial supplies, medications, forms, and manuals;
Providing regulatory, Quality Assurance and training plans for protocols;
Providing training in a variety of venues;
Providing other expert consultation and support services as needed.

Logistic Support Center (LSC). The entity established under a contract awarded by NIDA to support administrative and logistic functions of the CTN including:

Coordinating logistic and operational support for CTN meetings and conference calls;
Supporting consultants to provide NIDA and CTN grantees with expert advice;
Preparing, meeting, protocol-related, and publicity materials as required;
Creating and maintaining administrative databases to support CTN activities;
Maintaining a CTN web site.

Center for the Clinical Trials Network (CCTN). The organization within NIDA responsible for the scientific, administrative, and operational management of the CTN research program.

Objective and Scope

The overall goal of the National Drug Abuse Treatment Clinical Trials Network is to test and validate effective and efficient treatments that can be adopted by addiction treatment providers through the Nation, using science as the vehicle.

Specific objectives include:

Supporting multi-site clinical trials of psychosocial, pharmacological, and integrated psychosocial and pharmacological treatment interventions to answer a broad spectrum of translational research questions, ranging from efficacy studies to practical clinical trials, across a wide variety of community-based treatment settings and diverse patient populations
Facilitating research and development of comprehensive addiction treatment programs that integrate co-occurring medical and mental health conditions
Facilitating research on integrating addiction treatment into the mainstream medical care system
Facilitating research on the effectiveness of eHealth technologies and other innovative electronic technologies in improving addiction treatment
Ensuring that treatment research in drug abuse and addiction is extended to a wider community, such as minorities, women, children, adolescents, underserved populations, and other special populations, patients with co-occurring psychiatric or medical conditions or including court-involved patients
Fostering the collaboration between practitioners and treatment researchers by encouraging practitioner involvement in developing research questions and by providing opportunities for bi-directional education, exchange of ideas, information, and values
Exploring the effectiveness of psychosocial, pharmacological, and integrated psychosocial and pharmacological treatment interventions to reduce the transmission of HIV and other diseases (such as Hepatitis B and C or sexually transmitted infections) and to enhance adherence to treatment for HIV and other diseases among drug users
Supporting efficacy trials of promising theoretically-grounded psychosocial, pharmacological, and integrated psychosocial and pharmacological treatment interventions in hard-to-recruit patient populations that must use multi-site designs to obtain sufficient participants for a valid study
Supporting efficacy trials of promising theoretically-grounded psychosocial, pharmacological, and integrated psychosocial and pharmacological treatment interventions when there is a reasonable basis for believing that the trial could lead to a CTN sponsored multi-site trial
Facilitating the dissemination, implementation, and adoption of evidence-supported addiction treatments by physicians and other clinicians, providers, and patients and increasing scientific knowledge of these processes

CTN to Date

The CTN has provided a stable and broadly representative platform for drug abuse treatment research through regional Nodes distributed throughout the country. Each Node encompasses a substantial geographical area and a variety of treatment settings, patient populations, and drug abuse problems. The RRTCs have demonstrated expertise in conducting drug abuse treatment research, clinical trials and clinical training. Through its associated CTPs, each Node demonstrates the capacity to recruit and treat a broad range of patients, including adolescents, women, patients with co-occurring mental and/or physical disorders, those at high risk for HIV infection, members of minority racial/ethnic groups, and those abusing or addicted to various drugs of abuse. All Nodes must demonstrate the capacity to deliver and test a variety of both pharmacological and psychosocial therapies. The term "psychosocial therapy" is used here in the broadest sense and is meant to include, for example, counseling, various aspects of therapeutic community approaches, cognitive behavioral therapy, operant behavioral therapy, and family therapy.

For the CTN to be maximally effective, the CTPs must be partners in the research enterprise by participating in research decisions, including selection of research concepts to be tested and decisions concerning protocol design.

Specific details on completed and ongoing CTN trials are available on the CTN website (http://www.drugabuse.gov/CTN/research.html).

Research concepts and questions for potential future CTN trials will be developed through a close partnership among the scientific and clinical leaders within both the RRTCs and the CTPs. Selection of specific concepts to be conducted as CTN trials will occur through a collaborative effort between CTN grantees and NIDA. Furthermore, as the CTN continues to evolve, NIDA encourages investigators both within and outside the existing network to propose additional research questions that can be answered through studies funded under separate research grants that are either proximally or distally related to the broader CTN trials and to use the CTN infrastructure or ongoing studies as a platform. Furthermore, the CTN, with its core of CTPs engaging diverse populations, can provide a vehicle to recruit study subjects for such related topics as the genetic vulnerability to addiction, health service research, and studies of patients with co-occurring mental and/or physical disorders. Although not all Nodes would be expected to have the capacity to lead studies in every potential area of interest such as HIV/AIDS, genetics, health services research or other examples noted above, all Nodes will be expected to collaborate in research focusing on such issues and to aid in recruitment of subjects to participate in such studies. Please reference the CTN policy on using the CTN as a research platform (http://www.nida.nih.gov/CTN/home.html).

Special Considerations

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

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

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

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the U10 award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

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

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". This FOA is a one-time solicitation. NIDA expects to award these cooperative agreement projects for a 5 year project, subject to availability of funds. NIDA also expects to issue a revision of this FOA at the close of the 5 year project period.

2. Funds Available

NIDA expects to make up to 12 awards under this FOA for project periods of 5 years of support. It is expected that each Node will have an operating budget of up to $750,000 direct costs per year. NIDA may consider budget requests of up to $875,000 direct costs for applications that propose multiple PIs from one or more institutions. Costs for specific protocols are managed centrally at NIDA and dispersed as supplements to the U10 grants. Requested budgeting for future years of the U10 award should reflect core support only, as described below. The anticipated award date for this FOA is August 31, 2010. Because the role and function of a CTN Research Node is well established, it is expected that the size of individual awards for core support will be similar. Budget requests should be carefully justified and commensurate with the complexity of the proposed Node. Although this program is provided for in the financial plans of NIDA, awards pursuant to this FOA are contingent upon the availability of funds for this purpose. It is anticipated that there will be subsequent FOAs to sustain or expand the CTN, subject to availability of funds.

The estimated amount of funds available for support of up to 12 projects awarded as a result of this announcement is $13.5 million total costs for fiscal year 2010. Future year amounts will depend on annual appropriations.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribally Designated Organizations
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
U.S. Territory or Possession
Indian/Native American Tribal Governments (Other than Federally Recognized)
Regional Organizations
Other(s):
- Eligible Agencies of the Federal Government
- Faith-based or Community-based Organizations.

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. 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 PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may not submit more than one application in response to this FOA.

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

Renewals. Renewal applications are permitted in response to this FOA.

Special Requirements

To promote the development of a collaborative program among award recipients, a number of issues need to be addressed in applications as discussed below under Application Procedures. Applicants should document their ability to recruit a sufficient number of participants, and should demonstrate their ability and willingness to work cooperatively with NIDA, other awardees, and CTPs, and to follow common protocols. The Principal Investigator(s) must commit a significant level of effort to this project

The Principal Investigator(s) must commit to and be actively involved in the research and governance of the CTN at a significant level of effort, typically between minimum of 35 percent effort and a maximum of 50 percent effort. Prospective PIs must document a substantial history of leadership in clinical trials research in addiction treatment and an extensive research publication record.

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: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

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

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

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

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: October 2, 2009
Application Receipt Date: November 2, 2009
Peer Review Date: February 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010

3.A.1. Letter of Intent

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

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.

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

Director - DA-10-009
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

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

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

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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

This does not preclude the submission of an application already reviewed with substantial changes, 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 NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

Supplementary Instructions

Specific content must be present in the application to document the technical and scientific merit of the applicant's plan for a Node that addresses the fundamental goals and collaborative nature of the CTN. The use of tables, diagrams, and organizational and flow charts is strongly encouraged.

Application Package

The application should conform to the general instructions and requirements of the currently approved version of the PHS 398 with the exceptions noted below.

PHS 398 Sections 2-5 need not be organized according to Specific Aims , Background and Significance , etc., as stated in the PHS 398 application kit. Rather, sections 2-5 should be replaced with the following sections, described as sections 1 6 below, and conform to the 25 page limit described in a subsequent section of this announcement. The section on Human Subjects Research (referred to as research plan section e in the PHS 398 application kit) and other sections described below, including the budget section, should follow section 6 and are not counted within the 25 page limit.

Specific Requirements for Applications

Two different types of applications are expected in response to this solicitation: competing continuation (renewal) applications for a currently-funded or previously-funded CTN Node and new applications for a new CTN Node. These applications will differ from each other in certain respects, as addressed below.

Competing Continuation (Renewal) Applications

1. Progress Report Section

In this section each competing continuation application should describe features unique to that specific Node as well as activities carried out in common with other CTN Nodes. Applications are expected to provide evidence of their contributions to shared CTN activities as well as to provide evidence of their unique strengths, accomplishments and capabilities.

A competing continuation application must include a progress report that at minimum consists of:

Evidence of efficient administrative structure/personnel in managing multi-site trials and of the ability to participate in multi-site trials;
A summary of research activities and accomplishments during the prior funding period, including a clear presentation of annual recruitment to all participating protocols, the gender/ethnic minority composition of recruited study populations from affiliated CTPs, and how well recruitment met CTN targets;
Documentation of scientific productivity as reflected in scientific publications and presentations pertaining to CTN activities;
Description of efforts to facilitate dissemination, implementation, and adoption of CTN results for affiliated CTPs;
Progress in developing and conducting research protocols, including details of the process and organizational structure for protocol development and implementation, training activities with CTP and other Node staff, and effective site management;
Evidence of engagement with community treatment programs in bi-directional communications to bridge the research to practice gap;
Evidence of participation and leadership in CTN research and administrative activities;
Examples of how the RRTC has conserved and prudently managed previously-obligated infrastructure costs; and
Summary of unique contributions of the Node to CTN-wide activities in the prior funding period.

2. Ability to Contribute to and Advance the Mission of the CTN: This section should establish the applicant’s understanding of the CTN and describe how the proposed Node expects to contribute to, and advance the CTN goals. The proposed Node’s unique and specialized expertise, capabilities, and resources should be described here.

3. Administrative and Management Plans: The qualifications and experience of the Principal Investigator(s) must be described. If multiple PIs are designated then a Leadership Plan must be provided. (See the Multiple PI website http://grants.nih.gov/grants/multi_pi/index.htm for more details.)

It is important to demonstrate the ability of the Principal Investigator(s) to contribute to the CTN’s scientific agenda and commit the level of effort required to provide appropriate leadership. Evidence of current or previous successful collaborations with community treatment programs and of participation in successful multi-site trials in collaboration with other research centers would be desirable. The selection for CTN participation of CTPs serving diverse populations and from varied treatment settings should be evident and well-described.

Plans for organizational and communications structures encompassing the Node's CTPs should be specified. Diagrams and descriptions of proposed structures should be included.

Each applicant must demonstrate the ability to train and maintain the proficiency of RRTC and CTP personnel to successfully manage treatment and clinical trials research, as well as to disseminate evidence-supported treatments to community-based practitioners.

4. Research, Clinical and Dissemination Infrastructures

Descriptions should document the availability of appropriate expertise within the RRTC to perform critical CTN activities. These include, but are not limited to, infrastructure and staffing for: protocol design; research administration; project and site management; publication of study results; and other critical Node functions, such as managing CTP participation, planning and executing dissemination and implementation procedures for treatment supported by CTN research findings, and other within-Node activities.

Applicants must demonstrate access to diverse racial and ethnic populations through the aggregate of their proposed community treatment providers.

5. Collaborations between the RRTC and CTPs

The application should name and describe, as detailed below, five representative CTPs proposed as collaborators. The application should describe the current relationship between the RRTC and each of the CTPs as well as the nature of prior relationships between the applicant and the CTP, if any. No more than a total of six pages are to be used in this section. It will be critical for the Node to engage sufficient CTPs to participate in multiple simultaneous trials; the possibility of expanding the number and clinical focus of CTPs for Node affiliation should be addressed. Signed letters of agreement from CTP directors and the additional tables described below must appear in the application appendix.

It is crucial that the applicant describe how the treatment providers will function in true partnership with the RRTC in terms of research concept development, protocol design, research project conduct, administrative support services, and eventual research dissemination, implementation, and adoption. Applicants should anticipate potential problems and challenges that may arise in this process and propose mechanisms for collaborative resolution among the Node participants. The NIH policy regarding consortium agreements must be considered in describing the relationship between the RRTC and the CTPs. http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm

For each proposed Community Treatment Program (CTP) provide the following descriptive table in Section 5:

Name of Organization
Organization/Program Type (i.e., drug/alcohol treatment program, primary care medical clinic, HIV/AIDS clinic, hospital clinic/department, mental health agency, etc.)
Unique characteristics of CTP and potential contributions to CTN mission
Number of clinical sites in organization
Primary source of program funding: Patient Fees, Public Insurance, Public grant or contracts, Private Insurance.

For each proposed Community Treatment Program (CTP) provide the following additional table in the application appendix:

Address
Telephone
Fax Number
Director
Contact Person who will work with the CTN, serve on committees, etc, if different than above
E-Mail Address of Director/Contact
Static capacity -- at any one time, what is the CTP’s total patient census?
Accreditation(s)/certification(s) and name of accrediting/certifying entity
If addiction treatment program, what is predominant treatment modality?
Annual patient admissions by treatment modality
Clinic patient characteristics:
Rural, suburban or urban setting

6. Proposed Research Agenda:

Applicants should provide a detailed description of a research agenda consistent with the goals and objectives of this FOA, which could be carried out to take advantage of the unique capabilities of the CTN. The proposed research agenda is not meant to be the description of a single study; rather it must encompass a broader set of research ideas that address current public health needs in addiction treatment and describe how knowledge gaps would be filled if the agenda were to be pursued. It should discuss the types of critical research questions that the applicant asserts must be addressed by the addiction treatment research field in order to advance scientific knowledge and improve practice. This discussion should include the relevance and feasibility of the proposed research agenda to community treatment providers, research methods that might be used, patient populations that might be studied, the potential for implementation and adoption by service providers, and how potential findings would lead to changes in clinical practice in addiction treatment settings and/or the mainstream medical system and other systems. The discussion should also address how the applicant proposes to ensure that the RRTC and the CTPs will work collaboratively at all levels to advance the research agenda, as well as how the Node will be able to work collaboratively with other Nodes and NIDA. It should be understood that this agenda is not expected to be a detailed concept for a research protocol and that the proposed research agenda will not necessarily be conducted in the CTN; however, the proposed visions for a CTN research agenda could constitute one source of research ideas to be considered during the project period. Each of the specific research areas within the proposed agenda should include: scientific rationale and significance, main research questions; feasibility for execution in the CTN; public health impact; and plans for dissemination, implementation, and adoption of findings. The proposed research agendas do not need to undergo IRB review for the purposes of this application. No more than four pages of text shall be used to describe the proposed research agenda.

7. Human Subjects Research (PHS 398 research plan, section 8): The application should describe plans for human subject protections. These descriptions are to be based upon prior clinical research conducted by the applicant, either as part of the CTN or elsewhere, as well as upon one or more of the elements of the proposed research agenda described above.

8. Other: There should be information on literature cited, contractual arrangements, etc. as specified in the PHS 398.

New Applications for a New CTN Node

Applicants must follow all of the requirements specified above in Section 1 8, with the following exception:

Section 1 will be titled Preliminary Studies and will be expected to provide evidence of the applicant’s future abilities to contribute to shared CTN activities as well as to provide evidence of the unique strengths, accomplishments and capabilities of the proposed Node.

Budget

The budget and accompanying justification are not part of the 25 page limit. Detailed individual and overall 5-year summary composite budgets are required for each individual project, component and or sub-recipient (i.e., infrastructures, CTPs, consortiums, etc.). These detailed budgets should identify the sub-recipient's name, if different from the grantee, and include applicable narrative budget justification for items requested in order to preclude disallowance of costs. In addition, an overall 5-year composite summary budget incorporating all costs requested in the project period by category is required.

Page Limits

To summarize the guidance above, the total length of sections 1 - 6, including the CTP descriptive tables, proposed research agenda, and administrative and management plan, should not exceed 25 pages. Descriptions of CTPs should not exceed 6 pages in total. Descriptions of the proposed research agenda should not exceed 4 pages. Literature Cited and Consortium/Contractual Arrangements sections should be provided following the 25 pages and in total should not exceed 10 pages.

Plan for Sharing Research Data

The NIH expects investigators supported by NIH funding to make their research data available to the scientific community for subsequent analysis based on a data sharing plan approved as part of the award; see the NIH data sharing policy website at http://grants.nih.gov/grants/policy/data_sharing. The CTN is intended as a national resource for the advancement of treatment for addicted individuals and other affected persons. The Awardee of this agreement acknowledges that NIH has access to any and all data generated under this cooperative agreement and the Awardee agrees to provide royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement. Data collected or derived under this cooperative agreement must be shared upon request with the Steering Committee, or its designee, for external monitoring pursuant to NIDA responsibilities under agreements with other government agencies (e.g. Food and Drug Administration) or commercial pharmaceutical companies where NIDA may co-develop investigational agents. At the conclusion of each protocol, the Lead Investigator will be required to direct the data coordinating center to produce a public use file of all related study data, as specified in the CTN-wide data sharing policies. The format and documentation of the data should be complete enough to replicate the studies outcomes and ensure its broader utilization by the drug abuse treatment community while maintaining subject confidentiality.

The applicant also agrees to cooperate with NIDA’s contracted Data and Statistics Center (DSC) with regard to CTN-wide standards for collection and analysis of data generated under the CTN. This will enable the DSC to provide timely, accurate, and complete data for purposes of monitoring the safety and progress of research projects conducted within the CTN, as well as final study data according to schedules developed and approved by the Steering Committee for individual research projects conducted through the CTN.

Appendix Materials

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

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

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

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

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

Be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Advisory Council on Drug Abuse.

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

Scientific and technical merit of the proposed project as determined by peer review
Availability of funds
Relevance of the proposed project to program priorities

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

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

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

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

If a competing continuation (renewal) application, does the progress report indicate active and engaged participation in CTN trials and in other CTN activities? If a new application, does the application provide evidence that the proposed Node would be capable of active and engaged participation in CTN trials and in other CTN activities?
What are the proposed Node’s unique strengths, accomplishments and capabilities and how would these contribute to the mission of the CTN?
Will the proposed Node foster collaboration between practitioners and treatment researchers?
If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? Is this proposed Node likely to advance the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

How strong are the previous research experiences and other qualifications of the PI(s) and other key staff in design, administration, and management of multi-site clinical trials?
How strong are the qualifications of the PI(s) and other key staff in developing and maintaining collaborative relationships with community-based treatment providers in order to develop relevant and feasible research questions and to foster dissemination, implementation, and adoption of research findings?

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

Does the proposed Node address new, scientifically valid approaches to establishing evidence of therapeutic effectiveness?
Does the proposed Node infrastructure include plans for providing technological support for innovative approaches to the collection of clinically relevant data?
Does the proposed Node describe innovative methods to facilitate the implementation and adoption of evidence-supported treatment models in community and other clinical settings?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

If a competing continuation (renewal), how has the Node contributed to protocols, trials, research dissemination or other measures of Node performance in the last period of funding? If a new application, does the application present evidence for the capability of achieving such contributions?
How strong are the plans for overall Node management and operations, including the structure and mechanisms for effective intra-Node communication and collaboration and involving appropriate personnel in the design and conduct of protocols?
How strong are the applicant's previous experience and plans for training RRTC and community treatment personnel, including therapists and research associates, in conducting multi-site clinical trials?
How strong are the plans for effective interaction and coordination with other Nodes and NIDA?
Does the proposed Node describe effective collaborations with existing CTSA infrastructure and institutions, or other clinical research networks?
Does the application demonstrate a capacity to manage CTPs across state boundaries and geographic regions?
Does the application encourage and provide opportunities, for bi-directional input from practitioner and treatment researchers?
What is the quality of plans for involving CTPs in the research and organizational activities of the CTN? Does the approach expand and broaden the types of treatment providers who participate in the network?
Has the proposed Node established partnerships with treatment providers meeting the broadened definitions as stated in this FOA?
Will the proposed Node be capable of incorporating addiction treatment into mainstream medical settings?
Does the proposed Node bring unique strengths or capabilities to the CTN as a whole?
Does the plan enhance the geographic dispersal and reach of the CTN?

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

How appropriate are the available resources and proposed personnel for administering Node participation in clinical trials, and assure the safety of patients/participants?
How strong is the Node’s capacity to include appropriate representation of gender, minorities and their subgroups, subjects with a range of ages, and those with co occurring conditions in order to advance the mission of the CTN?

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

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

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

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

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

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

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

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

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

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

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator (PI) will have the primary responsibility for defining the details for the project within the guidelines described in the Request for Applications DA-10-009 and for performing the scientific activity. The PI agrees to accept close coordination, cooperation, and participation of NIDA staff in those aspects of scientific and technical management of the project described in these terms and conditions. The PI agrees to accept close coordination and to cooperate fully with NIDA designated coordinating centers and contractors. The PI further agrees to participate fully in the activities of the Clinical Trials Network (CTN) Steering Committee and in other committees and workgroups as formed.

Each awardee functions as a CTN Research Node, consisting of a Regional Research and Training Center (RRTC) that is linked in partnership with community-based treatment programs (CTPs).

a. Responsibilities of the CTN Regional Research and Training Center (RRTC):

Generally, Awardees under this agreement have the following rights and responsibilities as a National Drug Abuse Treatment Clinical Trials Network (CTN) RRTC:

The RRTC builds partnerships with the CTPs and provides scientific leadership and management of clinical trials as well as administrative and study operations services for the Node. The RRTC agrees to negotiate and establish formal relationships with a minimum of five community treatment programs (CTPs) to participate in CTN activities and conduct research and training projects. These agreements will include, at minimum: 1) a statement of work defining the goals and objectives of the research projects to be undertaken under this cooperative agreement; 2) a budget for support of the research projects that clearly identifies the personnel, equipment, materials, and other costs required to successfully conduct high quality research in the community treatment program according to the requirements of specific protocols approved for implementation by the CTN Steering Committee and NIDA; and 3) a financial and program reporting requirement, including access to data and materials, to facilitate CTN program operation and research project oversight and monitoring. Initial agreements between the RRTC and the CTPs may need to be more general as specific details will depend on the particular research projects that are conducted in each CTP.
Infrastructure for core functions This includes but is not limited to 1) arranging and managing the participation of affiliated CTPs; 2) maintaining scientific and technical personnel for protocol development and operations; 3) coordinating and providing resources for activities within the Node; 4) collaborating with NIDA and other Nodes to develop, disseminate, and implement findings from CTN research projects; and 5) working with the CTN Clinical Coordinating Center and Data and Statistics Center. The Principal Investigator agrees to provide adequate support for RRTC and CTP participation in Steering Committee and other CTN meetings as required.
Research Concept Development and Implementation - In close partnership with the CTPs, and in collaboration with other CTN members, the RRTC develops research concepts for potential CTN trials and submits them to the CTN Steering Committee (or its designee) for discussion and review, and to NIDA for approval.

b. Data Rights:

The CTN is intended as a national resource for the advancement of treatment for addicted individuals and other affected persons. The Awardee of this agreement acknowledges that NIH has access to any and all data generated under this cooperative agreement and the Awardee agrees to provide royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement. Data collected or derived under this cooperative agreement must be shared upon request with the Steering Committee, or its designee, for external monitoring pursuant to NIDA responsibilities under agreements with other government agencies (e.g. Food and Drug Administration) or commercial pharmaceutical companies where NIDA may co-develop investigational agents. At the conclusion of each protocol, the Lead Investigator (LI) will be required to direct the data coordinating center to produce a public use file of all related study data. The format and documentation of the data should be complete enough to replicate the study’s outcomes and ensure its broader utilization by the drug abuse treatment community while maintaining subject confidentiality. The Awardee also agrees to cooperate with NIDA’s contracted Data and Statistics Center with regard to CTN-wide standards for collection and analysis of data generated under the CTN, and enabling the Data and Statistics Center to provide timely, accurate, and complete data for purposes of monitoring the safety and progress of research projects conducted within the CTN, as well as final study data according to schedules developed and approved by the Steering Committee for individual research projects conducted through the CTN. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

c. Quality Assurance and Site Management:

The RRTC and participating CTPs are responsible for the proper conduct of CTN studies at their site and must appoint qualified staff to perform site management activities. All clinical trials are subject to quality control as stated by the ICH Good Clinical Practice (GCP) guidelines. Each RRTC and participating CTP must agree to periodic on-site visits by staff from the Node and the NIDA appointed Coordinating Centers to perform the following: use of investigational drugs; compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse events. Reports of such on-site audits will be reviewed by the CCTN. In addition, NIDA program and grants management staff will review protocol accrual, and fiscal and administrative procedures.

d. Reporting Requirements:

In addition to periodic financial and administrative reports required by NIH for administration of this cooperative agreement, the Awardee agrees to furnish the following reports according to the schedule indicated:

Investigational New Drug (IND) Reports: Awardees are required and agree to provide reports according to regulations and guidelines established by the Food and Drug Administration (FDA).

Final Study Report: Lead Investigators are required to provide CCTN with a Final Study Report within 120 days of data lock upon completion of the protocol. In addition, The Lead Investigator will present primary outcome results to the trial DSMB and the Steering Committee prior to publication.

e. Publication of Data:

Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken in the CTN is required. It is expected that the Lead Investigator will have an initial outcome paper completed and submitted to an appropriate peer-reviewed scientific journal within 180 days of data lock for the protocol. The Awardee agrees to acknowledge NIDA support in the publications and oral presentations resulting from research conducted under cooperative agreement. The Awardee agrees to present all CTN manuscripts to the Publications Committee for review and approval prior to journal submissions.

f. Protocol Closure:

Throughout the term of the cooperative agreement NIDA may request that a research project be terminated for reasons including: 1) insufficient subject accrual; 2) accrual goal for the protocol is met; 3) poor performance in conducting the protocol; 4) safety of the subjects in the study; 5) achievement of conclusive study results; 6) emergence of new information that diminishes the scientific importance of the study question; 7) misuse of federal funds; and 8) serious shortfalls in appropriated funds available to pursue the study. Financial support from NIDA and access to further investigational drug supplies through this cooperative agreement will cease upon project closure, except that funds and other resources may remain available for patients already enrolled in the study.

2. A.2. NIH Responsibilities

The Center for the Clinical Trials Network (CCTN) is the organization within NIDA responsible for the scientific, administrative, and operational management of the CTN research program funded by NIDA.

NIDA staff has substantial scientific and programmatic involvement throughout this cooperative agreement through technical assistance, and advice and coordination extending beyond normal program stewardship for grants as described below.

a. NIDA’s Scientific Role

The Director of the NIDA CCTN will appoint CCTN Protocol Coordinators (CPC) with expertise in clinical research to participate in the development of study plans and protocols, and to coordinate projects across scientific disciplines and CTN Nodes. NIDA CPCs may initiate or participate in publications in accordance with established professional and NIH guidelines for authorship.

The NIDA CCTN Director or Deputy Director will be a voting member of the CTN Steering Committee.

The NIDA CCTN Director, and/or designated staff, will work closely with the CTN Steering Committee to assure that CTN efforts are consistent with NIDA’s research objectives and complement other clinical trial activities supported by NIDA under other means.

NIDA will serve as a resource, and will disseminate information regarding promising new therapies. NIDA staff will advise the clinical investigators, as requested or needed, of results from other trials (e.g., adverse experiences and study termination) that could influence the design, development, or conduct of clinical trials under this cooperative agreement.

NIDA will appoint advisory boards as deemed necessary during the development and progress of protocols and trials

For ongoing research projects NIDA personnel and its contractors will monitor the safety of study participants through review of incremental case report form. NIDA and its contractors will prepare periodic reports profiling the conduct of the study including the safety of study participants for review by the CTN Data and Safety Monitoring Board (DSMB). The DSMB may recommend to NIDA a need to alter, suspend, or close an ongoing trial due to safety concerns or study performance issues.

b. NIDA’s Role in Protocol Review and Approval

In order for a CTN research project to be initiated, a research concept must be mutually approved by the CTN Steering Committee and NIDA. Once a concept is presented for consideration, NIDA will evaluate the proposed trial according to: NIDA s research agenda; potential impact on scientific or treatment parameters; relevance to current national priorities, likelihood for timely completion; patient safety; compliance with Federal regulatory requirements; plans for interim monitoring and final analysis of results; and resource requirements. The Lead Investigator for the protocol is required to provide the CCTN with a cost projection and rationale for the resource requirements for protocol implementation.

NIDA will provide no trial materials or permit expenditure of CTN funds to conduct the research project unless and until the proposed protocol is approved.

c. NIDA Access to Data

The NIDA CCTN Director, and/or designated staff or agents, shall have access to all data generated under this cooperative agreement. Monthly reports on trial progress will be prepared by the DSC and reviewed by CCTN, the CTN Executive Committee, and the study Lead Investigator. Data must be available for external verification against original source documents as required by NIDA, and Federal regulations pertaining to the responsibility of NIDA as an IND sponsor.

Monitors from one or both of the Coordinating Centers will perform periodic onsite review of data recorded on clinical source documents, case report forms, or in electronic form. These Coordinating Centers, (the Clinical Coordinating Center [CCC] and the Data and Statistics Center [DSC]) are established under a contract awarded by NIDA to provide certain resources and common services for CTN clinical trials, including support for regulatory requirements and oversight functions mandated by NIH and DHHS.

The awardees will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies, including a policy to provide public access to selected, significant data sets generated with the use of public funds, within a reasonable period of time after primary analysis or publication by the CTN.

d. NIDA Monitoring of Trials

Monitoring of clinical trials is the regulatory responsibility of the study sponsor. All clinical trials are subject to monitoring; the RRTC and participating CTP must agree to periodic on-site monitoring visits by the Clinical Coordinating Center representatives. During the course of a clinical trial, monitoring is conducted to assure that: the rights and well-being of participants are protected; the reported trial data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.

e. NIDA Review of Performance

The NIDA CCTN Director will periodically review the performance of the CTN as a whole and of individual RRTCs. Such reviews will include periodic reviews of the RRTC and its CTP sites for compliance with clinical and regulatory guidelines and success in achieving established performance standards. The review will be based on information provided in periodic progress reports compiled from data on recruitment, retention, follow-up, treatment exposure, quality assurance, and other factors, as well as from evaluations of site performance conducted by the CCTN staff. Insufficient patient accrual, substandard data quality, inadequate progress in executing the research agenda, or noncompliance with the Terms and Conditions of Award may result in a reduction in budget, withholding support, suspension, or termination of award.

f. Normal Program Stewardship

A separate NIDA Program Official other than the CCTN director will be responsible for the normal programmatic stewardship of the award and be identified in the Notice of Award.

2.A.3. Collaborative Responsibilities (optional)

CTN Steering Committee. The Steering Committee constitutes the primary governing body of the CTN. Voting members are one Principal Investigator and one CTP representative from each Node, the CCTN Director or Deputy Director, and one representative each from the CTN Clinical Coordinating Center and CTN Data and Statistics Center. The Steering Committee uses both established and ad hoc committees and workgroups (e.g., Executive Committee, Research Development Committee, Research Utilization Committee, Publications Committee) to assist it in carrying out its functions. By accepting a Cooperative Agreement award, all participating RRTCs and CTPs must agree to abide by the policies and By-laws approved by the Steering Committee.

Protocol Review Board. An independent expert board, appointed by and reporting to the NIDA CCTN Director, that reviews proposed protocols and informed consent documents. To minimize delay and provide continuity, this board may be combined with a DSMB (see below) for a given study.

Data and Safety Monitoring Board (DSMB). An independent expert board, appointed by and reporting to the NIDA CCTN Director, that oversees and monitors the conduct of the clinical trials to ensure the safety of participants and the validity and integrity of data for each study. The DSMB may also conduct a scientific review of the protocol if necessary (see above). The DSMB also makes an independent assessment of the interventions under study and whether or not any trial undertaken in the CTN will continue. One or more NIDA staff serves as a non-voting administrator of the DSMB.

2.A.4. Arbitration Process

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

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Betty Tai, Ph.D.
Center for the Clinical Trials Network
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 3103, MSC 9557
Bethesda, MD 20892-9557
Telephone: (301) 443-6697
FAX: (301) 443-2317
Email: btai@nida.nih.gov

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3. Financial or Grants Management Contacts:

Deborah S. Wertz
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: dwertz@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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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