EXPANSION OF THE NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK

Release Date:  November 20, 2001

RFA:  RFA-DA-02-003

National Institute on Drug Abuse
 (http://www.nida.nih.gov)

Letter of Intent Receipt Date:  January 22, 2002
Application Receipt Date:       February 22, 2002

PURPOSE

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 Request for 
Applications (RFA) is the third solicitation for participation in the 
CTN.  As a nation-wide partnership among drug abuse treatment 
providers, researchers, and NIDA staff, the mission of the CTN is to 
conduct studies of behavioral, pharmacological, and integrated 
behavioral and pharmacological treatment interventions in rigorous, 
multi-site clinical trials to determine these interventions' 
effectiveness across a broad range of community-based treatment 
settings and diverse patient populations.  In addition, the CTN seeks 
to disseminate proven treatments to physicians, providers, and their 
patients to improve the quality of drug abuse treatment throughout the 
country, using science as the vehicle.  

CTN clinical trials are carried out in community-based treatment 
settings. 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). The CTN 
consists of multiple Nodes, and each Node works in concert with other 
Nodes and NIDA to conduct multi-site clinical trials research. Awardees 
deliver and test an array of both behavioral and pharmacological 
treatments and determine conditions under which novel and efficacious 
treatments are successfully adopted. Studies span multiple sites 
engaging diverse patient populations in dispersed geographical regions. 
As a cooperative agreement, there is substantial NIDA involvement in 
the management and administration of the CTN. 

Current CTN Nodes are located in California, Colorado, Connecticut, 
Florida, Michigan, New York, North Carolina, Ohio, Oregon, South 
Carolina, Maryland, Pennsylvania, and Washington. NIDA recognizes a 
need for greater geographic distribution of CTN sites as well as a need  
to encompass more subpopulations of minority groups and to broaden the 
range of treatment providers who work under varying systems of 
reimbursement and organization of care.  By expanding in these areas, 
greater variety in the types of studies conducted and greater 
confidence in the generalizability of those studies will be assured.  
Therefore, a particular purpose of this Request for Applications (RFA) 
is to expand the geographic distribution of CTN sites, and applications 
are encouraged from investigators in those geographic areas without CTN 
Nodes and where the CTN is not well represented. 

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 RFA, 
"National Drug Abuse Treatment Clinical Trials Network," 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/. 

ELIGIBILITY REQUIREMENTS 

Applications may be submitted by domestic for-profit and nonprofit 
organizations, private and public, such as universities, colleges, 
hospitals, laboratories, units of state or local governments, and 
eligible agencies of the federal government. Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to 
apply as Principal Investigators. The Principal Investigators must 
commit a minimum of 50 percent time to CTN and document a substantial 
history of leadership in clinical trials research and an extensive 
research publication record.  

MECHANISM OF SUPPORT 

The administrative and funding instrument to be used for this program 
will be a cooperative agreement (U10), an "assistance" mechanism 
(rather than an "acquisition" mechanism) in which substantial National 
Institutes of Health (NIH) scientific and/or programmatic involvement 
with the awardee is anticipated during performance of the activity. 
Under the cooperative agreement, the NIH purpose is to support and/or 
stimulate the recipient's activity by involvement in and otherwise 
working jointly with the awardee recipient in a partner role, but it is 
not to assume direction, prime responsibility, or a dominant role in 
the activity. Details of the responsibilities, relationships, and 
governance of the studies to be funded under cooperative agreement(s) 
are discussed in this document under the section "Terms and Conditions 
of Award." Potential applicants are encouraged to review definitions of 
key terms used throughout this announcement.  The anticipated award 
date is September 30, 2002. 

All policies and requirements that govern the grant program of the PHS 
and NIH apply. 

FUNDS AVAILABLE 

NIDA intends to commit approximately $5 million to support first year 
total costs of establishing additional CTN Nodes in FY 2002.  
Additional funds will be allocated to Nodes in subsequent years to 
support conduct of specific protocols.  This level of support is 
dependent on the receipt of a sufficient number and diversity of 
applications of high scientific merit.  NIDA expects to make up to 
three awards under this RFA for project periods of up to 5 years of 
support. More funding may be made available to fund additional sites if 
sufficient applications of high merit are submitted.  It is anticipated 
that there will be subsequent RFAs to expand the CTN.  It is projected 
that competing continuation applications will be invited upon 
expiration of the initial funding period of awards made under this and 
previous RFAs, subject to the availability of funds. 

Because the nature and scope of the research activities proposed in 
response to this RFA may vary, it is anticipated that the size of 
individual awards will vary also.  Budget requests should be carefully 
justified and commensurate with the complexity of the project.  
Although this program is provided for in the financial plans of the 
NIDA, awards pursuant to this RFA are contingent upon the availability 
of funds for this purpose.
 
RESEARCH OBJECTIVES 

Background 

The development of the CTN was based, in part, upon a recommendation 
from the National Advisory Council on Drug Abuse and conclusions of the 
Physicians Leadership on National Drug Policy.  The Institute of 
Medicine/National Academy of Sciences report "Bridging the Gap Between 
Practice and Research:  Forging Partnerships with Community-Based Drug 
and Alcohol Treatment" also recommended a national network for drug 
abuse treatment trials.  Following the first NIDA CTN solicitation in 
1999, six CTN awards were made to awardees in California, Connecticut, 
New York, Oregon, Maryland, and Pennsylvania. After a solicitation in 
2000, awards were subsequently made to eight additional sites in 
Colorado, Florida, Michigan, New York, North Carolina, Ohio, South 
Carolina, and Washington.  These sites represent a variety of treatment 
traditions that include pharmacological as well as behavioral and other 
psychosocial interventions.  Furthermore, NIDA ensured a wide variety 
of patient populations in the selection of CTN recipients, and women, 
minority groups, and adolescents are well represented.

The CTN is now established and is making progress toward its goals of 
(1) providing a clinical trials research infrastructure to test the 
effectiveness and usefulness of new and improved treatments in 
community-based treatment settings with diverse patient populations and 
(2) serving as a mechanism for the study of dissemination of new and 
improved interventions into community-based drug treatment settings. A 
number of functional committees to provide governance to the CTN are 
established, protocols for the study of both pharmacological and 
behavioral interventions are currently underway, data management and 
safety monitoring procedures are in place, and new studies are being 
planned and approved.  Details on the status of the CTN initiative may 
be found on the NIDA web site at: 
http://www.nida.nih.gov/CTN/Index.htm.

Strong partnerships and bi-directional collaboration between 
researchers and practitioners are an essential and defining 
characteristic of the CTN.  Although treatments for drug abuse exist 
and considerable research has been directed toward the improvement of 
treatment alternatives, most addiction treatment research prior to the 
CTN was conducted primarily in specialized research settings.  Through 
the researcher-practitioner partnership that characterizes the CTN, the 
CTN accelerates the pace of research and its application to real-life 
treatment settings by conducting large scale multi-site clinical 
treatment studies in community based treatment programs (CTPs).

Knowledge gained through the CTN is also expected to further the 
dissemination and adoption of research-based treatments. That is, CTN 
research will not only help determine which treatments should be 
implemented, it will also inform the process of implementation and 
dissemination to ensure the acceptability and sustainability of new 
approaches. 

CTN DEFINITIONS, ORGANIZATION, AND FUNCTIONS

Clinical Trials Network (CTN).  A collaborative group of geographically 
diverse regional research Nodes working collaboratively with NIDA to 
conduct multi-site and cross-regional (nationwide) clinical trials 
research on promising behavioral, pharmacological, or integrated drug 
abuse treatments.

Node.  A Node is the functional unit within the CTN. The Node consists 
of the Regional Research and Training Center (RRTC) and its affiliated 
Community Treatment Programs (CTPs).  The RRTC serves as the 
coordinating core and arranges a research partnership between the RRTC 
and CTPs. The CTN is comprised of multiple Nodes. Activities that occur 
primarily within a single Node (e.g., hiring of staff, RRTC-CTP 
activities) are called "Intra-Node" activities, as opposed to CTN-wide 
or "Inter-Node" activities such as implementation of protocols across 
one or more Nodes, development of CTN-wide policies, etc. 

Regional Research and Training Center (RRTC).  The RRTC is the 
recipient of the cooperative study award.  It is one of the two 
components of a Node.  It typically resides in the Principal 
Investigator's research institute or organization.  The RRTC provides a 
core of administrative and study operations services, as well as 
scientific leadership and management of clinical trials.  The RRTC, 
acting as the local operational center for a Node, has primary 
responsibility for 1) establishing the infrastructure, 2) generating a 
research agenda in collaboration with the CTPs, 3) providing 
administration and operations support, 4) building partnerships with 
the CTPs, and, 5) collaborating with NIDA and other Nodes to develop, 
implement, and disseminate findings from CTN research projects. 

--Infrastructure.  Infrastructure refers to the capacity of the RRTC 
and CTPs to 1) arrange and manage collaborative activities of at least 
five CTPs with the RRTC; 2) maintain scientific and technical personnel 
for protocol development and implementation, 3) coordinate intra-Node 
activities, and 4) provide resources for intra-Node activities.  It 
also refers to the physical resources (buildings, clinics, etc.) 
available. 

--Research Agenda.  In partnership with its affiliated CTPs, the RRTC 
develops and submits research concepts and protocols to the CTN 
Steering Committee for review and approval.  For each approved concept, 
a protocol specific project team is established to develop and 
implement the research project across the CTN. It is expected that 
there will be a Lead Investigator (LI) from the Node where the research 
concept and protocol originate. NIDA scientific and technical personnel 
are designated as collaborators on the project team. The LI assumes the 
leadership role for all aspects of that specific protocol and serves as 
the primary liaison to CTN-wide coordination/support centers as needed.  
The project team for each CTN research project includes personnel and 
experts across the network from all disciplines required for the 
development and implementation of the project.
 
--Administrative and Operations Support. The RRTC ensures appropriate 
administrative and operations support for Node activities. The support 
must ensure adherence to the Terms and Conditions of the Award and the 
policies and procedures of the CTN Steering Committee to: 1) design and 
develop CTN research projects; 2) develop and implement data 
acquisition and data management systems for CTN research projects 
conducted within the Node; 3) formulate and conduct general research 
and project specific training; 4) develop patient safety and other 
regulatory documents to obtain approvals needed to implement studies 
within the Node; and, 5) ensure the quality of research within the Node 
through on-site monitoring at participating clinical sites.

--Partnership with and Responsibility toward Affiliated CTPs.  The RRTC 
functions as a partner with its associated CTPs.  It provides CTPs with 
1) additional therapists, counselors, physicians, physicians' 
assistants, nurses, and other staff, as well as the additional training 
needed for the CTP, to implement a study protocol; 2) hardware, 
software, and training to support CTP-based data acquisition 
activities. Each RRTC will provide for a data acquisition system to 
collect intake, in-treatment, and outcome data for all study 
participants, according to protocol-specific requirements, and 3) 
additional support, such as quality control, to ensure the successful 
completion of the scientific goals of a research project. 

Community Treatment Programs (CTPs). Drug abuse treatment programs in 
the community (typically non-university-based) setting that have a 
history of providing quality treatment to large and diverse patient 
populations, including women, members of minority groups, and 
adolescents, and have the capability for and interest in participating 
in controlled clinical trials. Working as an equal partner with its 
RRTC, each CTP must: 
-- Agree to participate in controlled clinical trials, including 
randomization methods for assignment of patients to experimental or 
control groups or randomization of therapists to different conditions; 
-- Recruit adequate numbers (at least  100/year) of patients required 
for specific studies; 
-- Agree to provide routine clinical care to patients participating in 
protocols; 
-- Agree to provide experimental/standard care in accord with approved 
research protocols; 
-- Provide HIV risk reduction counseling and access to HIV testing; 
-- Maintain patient records and other source documents required for 
each protocol; 
-- Collect clinical and laboratory data, including biological specimens 
when indicated; 
-- Cooperate with quality control activities of the CTN and adhere to 
guidelines set by the RRTC, the Steering Committee, and NIDA; 
-- Participate in the development of research concepts and protocols 
for trials to be conducted in the CTN; 
-- Agree not to report data prior to collaborative reporting; 
-- Agree to periodic on-site audits by representatives of its RRTC, 
NIDA, or a NIDA designee to ensure appropriate use of investigational 
drugs; compliance with regulations for IRB approval or informed consent 
(compliance with 45 CFR 46); compliance with protocol specifications; 
quality control 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 Network. The committee membership consists of the 
Principal Investigators of each RRTC, representatives from CTPs, and 
two NIDA representatives one of which is the NIDA Director of the 
Center for Clinical Trials Network (CCTN). This group reviews and 
approves the research agenda, formulates and monitors policies and 
procedures guiding the research activities, and oversees communications 
within the CTN, as well as with the greater scientific community and 
the public. 

All major scientific decisions are determined by majority vote of the 
Steering Committee. All participating RRTCs and CTPs must agree to 
abide by the study designs and policies approved by the Steering 
Committee. It is important to note that research to be undertaken 
within the CTN is not limited to research concepts contained within 
awardees' applications, but are and will be determined by the Steering 
Committee based on input from the Nodes and subject to the approval of 
the external Ad Hoc Oversight Board and NIDA. Future research must be 
within and consistent with the scientific objectives of the RFA. 

The Steering Committee uses both established and ad hoc subcommittees 
and workgroups to assist it in carrying out its functions. The Steering 
Committee meets no more than six times per year, usually in the 
Washington, D.C., area. Applicants should include costs for travel to 
these Steering Committee meetings and subcommittee/workgroup meetings 
in their applications and should assure that adequate provisions are 
made to allow Principal Investigators, Node personnel and CTP 
representatives to participate fully in activities of the Steering 
Committee and its subcommittees/workgroups. 

NIDA Protocol Review Board.  An expert board authorized by the Director 
of NIDA that reviews the final draft of the protocol submitted by the 
CTN Steering Committee for scientific and regulatory approval.  

Data and Safety Monitoring Board (DSMB).  The DSMB is an independent 
expert board, appointed by and reporting to the Director of NIDA 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 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 non-voting 
members on the DSMB. 

CTN Ad Hoc Oversight Board.  An independent expert board, appointed and 
reporting to the Director of NIDA, that oversees all activities 
conducted under the CTN. The Board advises the NIDA Director regarding 
the programmatic advisability of proceeding with studies proposed by 
the Network Steering Committee and assists the Institute in 
prioritizing and approving protocols for implementation in the CTN. 
Protocols are implemented with the approval of the NIDA Director. 

Central Data Management Center (CDMC).  Clinical data information 
systems provided by each Node are required to implement standards 
established by NIDA and the CTN Steering Committee. Such standards 
guide development and implementation of the protocol-specific 
electronic case report form (eCRF) applications that each Node must 
implement at participating CTP sites. The CDMC reports directly to 
NIDA, although it functions as a resource to the CTN Steering Committee 
in all matters related to data management--from study design, data 
acquisition and analyses to report of study findings and conclusions.  

Administrative Support Center (ASC).  NIDA provides via contracts 
certain resources providing common services for CTN clinical trials, 
including support for administrative requirements and oversight 
functions mandated by NIH.  Specifically; 1) Regulatory affairs and 
Investigational New Drug (IND) filing; 2) Monitoring for clinical study 
sites; 3) Administrative support for protocol development; 4) Project 
management; 5) Training in Good Clinical Practice (GCP) etc.; In 
addition, central pharmacy services for medication packaging and 
shipping as well as clinical laboratory support are provided by NIDA as 
central resources for the CTN.  

Logistic Support Center  (LSC).  A contract awarded by NIDA to support 
many of the administrative and logistic functions of the CTN including:  
1) Coordinating logistic and operational support for a variety of CTN 
meetings with up to 250 attendees; 2) Handling all logistics and costs 
with coordinating over 400 conference calls on an as needed basis per 
year; 3) Support for consultants providing NIDA and the CTN grantees 
with expert advice on a variety of topics regarding the Network; 4) 
Preparing publicity, meeting, and protocol related materials as 
required; 5) Providing scientific writers/editors to prepare reports, 
take minutes of meetings and conference calls, edit documents; 6) 
Reproducing and distributing research materials, protocol related 
documents, and educational materials; 7) Creating and maintaining 
administrative records to support the CTN activities; 8) Providing 
translation services for CTN materials in languages other than English; 
9) Maintaining a CTN web site; and 10) Miscellaneous support services. 
[NOTE:  Funds to support Node personnel travel to meetings will not be 
disbursed by the LSC. Applicants should make adequate provision for 
these funds in the budgets submitted under the present RFA. See the 
Subsection "Budget" in the "APPLICATION PACKAGE" section below for more 
guidance on this issue.]

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

OBJECTIVES AND SCOPE

The overall goal of the National Drug Abuse Treatment Clinical Trials 
Network is to improve the quality of drug abuse and addiction treatment 
throughout the Nation using science as the vehicle.  

Specific objectives include: 

-- Supporting rigorous, multi-site clinical trials of efficacious 
behavioral, pharmacological, and combined behavioral and 
pharmacological treatment interventions in community-based treatment 
programs to determine effectiveness across a broad range of treatment 
settings and patient populations. 

-- Encouraging research on effective strategies for transporting 
science-based, treatment interventions into clinical practice. 

-- Furthering the development of effective treatments by integrating 
behavioral and pharmacological interventions. 

-- Ensuring that treatment research in drug abuse and addiction is 
extended to the wider community, such as minorities, women, children, 
adolescents, and underserved populations. 

-- Ensuring that treatment research in drug abuse and addiction 
addresses the needs of special populations within the wider community, 
including court-involved patients and patients with co-morbid 
psychiatric or medical conditions.

-- Fostering the collaboration between community practitioners and 
treatment researchers by providing opportunities for bi-directional 
education, exchange of ideas, information, and values. 

-- Investigating the impact of community-based treatment research on 
community treatment practices.

-- Determining whether transport of novel, effective treatments to the 
community impacts the incidence and prevalence of various other 
illnesses and conditions, such as blood-borne infections (e.g., HIV and 
hepatitis). 

Characteristics of the CTN

The CTN will provide the Nation with a stable and broadly 
representative platform for drug abuse treatment research through 
regional Nodes distributed throughout the country.  Each Node will 
encompass a substantial geographical area and a variety of treatment 
settings, patient populations, and drug abuse problems. The RRTC of 
each Node must have demonstrated expertise in conducting drug abuse 
clinical trials and in research and clinical training. Through its 
associated CTPs, each Node must demonstrate the capacity to recruit and 
treat a broad range of patients, including adolescent, women, patients 
with co-occurring mental disorders, those at high risk for HIV 
infection, members of 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 
behavioral therapies.  The term "behavioral 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 trials to be implemented and decisions concerning protocol 
design.

Current CTN Research

The CTN has implemented the following studies, which are provided as 
examples of the type of research appropriate for the CTN:

-- Buprenorphine/Naloxone versus Clonidine for Inpatient Opiate 
Detoxification

-- Buprenorphine/Naloxone versus Clonidine for Outpatient Opiate 
Detoxification

-- Buprenorphine/Naloxone:  Comparison of Three Taper Schedules for 
Opiate Detoxification

-- Motivational Enhancement Treatment to Improve Treatment Engagement 
and Outcome in Subjects Seeking Treatment for Substance Abuse

-- Motivational Interviewing to Improve Treatment Engagement and 
Outcome in Subjects Seeking Treatment for Substance Abuse

-- Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone 
Clinics

-- Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free 
Clinics

In addition to the above studies that are underway, the following 
protocols and concepts have been approved:

-- Characteristics of and practices among community-based providers

-- Smoking cessation treatment in substance abuse rehabilitation 
programs

-- Enhancing continuing care engagement to reduce relapse following 
residential treatment

-- Buprenorphine/Naloxone in the treatment of adolescent heroin addicts

-- Infections screening in substance abuse treatment programs 

-- Gender-specific intervention to reduce HIV risk behavior in drug 
abuse treatment

-- Treating trauma and substance abuse in women

-- Brief Strategic Family Therapy for adolescents

-- Performance monitoring and feedback to counselors to improve drug 
abuse treatment -outcome

-- Job seekers skills training

-- Motivational Interviewing for pregnant women

-- HIV intervention in drug treatment settings

As the CTN continues to develop, it is anticipated that other topics 
could be studied such as:

-- Techniques for transporting new behavioral therapies into community-
based treatment groups.  For example, the effectiveness of various 
approaches to therapist training could be compared within the clinical 
trial context.  In this fashion, information can be gained not only 
about whether a therapy performs better than standard care, but also 
about how a therapy may be transported.

-- Optimizing access to and effectiveness of currently marketed 
pharmacotherapies for treatment of drug abuse and addiction.  Examples 
are studies to determine the optimal approach for integrating 
medications with behavioral therapies at optimal levels and doses, such 
as naltrexone with cognitive behavioral therapy, or LAAM with drug 
addiction counseling. 

-- Behavioral interventions aimed at improving compliance with 
medication regimens in patients with co-morbid addictive and mental or 
physical disorders. For example, studies could be done to determine the 
best behavioral interventions to ensure antiviral medication compliance 
in drug addicted individuals with AIDS, or to investigate the 
effectiveness of a new behavioral intervention for patients with 
bipolar disorder. 

-- Models for integrating new behavioral interventions into existing 
clinical practices. 

-- Effective approaches to outreach and risk reduction counseling.  
Drug addiction and the spread of HIV/AIDS are intertwined epidemics, 
and the CTN will provide a vehicle to help facilitate reduction in risk 
behaviors given that CTPs participating in the CTN must provide HIV 
risk reduction counseling and offer HIV testing. 

-- Efficacy of drug abuse treatment on AIDS related outcomes, such as 
rate of progression to AIDS.  Studies could examine the effects of: 1) 
the early treatment of HIV, Hepatitis B and C and Sexually Transmitted 
Diseases, or 2) the prevention and early treatment of co-morbid medical 
and mental health conditions associated with HIV/AIDS infection. Such 
studies may incorporate the most current methodological advances for 
assessing a) biological and mental health risks and HIV status, and b) 
adherence and compliance to antiretroviral and other medical/mental 
health therapies.

CTN Platform for Other Funded Research

The CTN, with its core of CTPs engaging diverse populations, is also 
designed to provide a much needed vehicle to recruit study subjects for 
such related topics as the medical consequences of long-term drug use 
and the genetics of vulnerability to addiction, which would be funded 
under separate research grants. Although not all Nodes would be 
expected to have the capacity to conduct such studies, all Nodes will 
be expected to collaborate in research focusing on such issues and to 
aid in recruitment of appropriate subjects. 

The CTN, as a national network of community treatment programs, may 
provide a platform to study the factors impacting transmission of 
knowledge, change of treatment organizations, and adaptation of new 
treatments and their adoption into widespread clinical practice.  NIDA 
encourages researchers to study such treatment issues at the 
organizational/program levels under separate research project grants.

Research will be conducted collaboratively involving NIDA, RRTCs, and 
CTPs. The structure of the CTN permits rapid and concurrent multi-site 
testing of a wide range of promising science-based therapies in 
statistically sound designs. It is the intent of this national network 
that virtually all studies will involve multiple Nodes working in 
concert. 

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 under Application Procedures, below. 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 following terms and conditions will be incorporated into the award 
statement and are provided to the Principal Investigator(s) as well as 
the institutional official at the time of award.

Terms and Conditions of Award 

These 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, and other HHS, 
and NIH Grant Administration policy statements.  

The administrative and funding instrument used for this program is a 
cooperative agreement, an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which a substantial NIH scientific and/or 
programmatic involvement with the Awardee is anticipated during the 
performance of the activity. Under the cooperative agreement, the NIH 
purpose is to support and/or coordinate the recipient's activity by 
involvement and otherwise working jointly with the award recipient in a 
partner role, but it is not to assume direction, prime responsibility, 
or a dominant role in the activity.  

Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the Awardee(s) for the 
project as a whole, although specific tasks and activities in carrying 
out the studies will be shared among the Awardees and NIDA and its 
contractors. 

This cooperative agreement funding mechanism will require collaboration 
between the Director of NIDA's Center for Clinical Trials Network 
(CCTN) and the Principal Investigators of the CTN Nodes. The NIDA CCTN 
will assist in coordinating activities of the CTN as defined below and 
will facilitate the exchange of information. 

1. Awardee Rights and Responsibilities 

Awardees will have primary responsibility for defining the details for 
the project within the guidelines described in the Request for 
Applications and for performing the scientific activity, and agree 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. Specifically, awardees have 
primary responsibilities as described below. 

a. Steering Committee: 

Grantees must participate in The National Drug Abuse Treatment Clinical 
Trials Network (CTN) Steering Committee that serves as the governing 
body of the CTN.  The voting membership of the Steering Committee 
consists of the The Principal Investigator and a CTP representative of 
each RRTC, and two representatives from NIDA, one of which is the NIDA 
CCTN Director. The Steering Committee reviews and approves the research 
agenda, formulates and monitors policies and procedures guiding the 
research activities, and oversees communications within the CTN as well 
as with the greater scientific community and the public. 

All major scientific decisions are determined by majority vote of the 
Steering Committee. All participating RRTCs must agree to abide by the 
study designs and policies approved by the Steering Committee. Research 
undertaken within the CTN is determined by the Steering Committee based 
on input from the Nodes and subject to the approval of the external 
Network Advisory Board and NIDA. Future research must be within and 
consistent with the scientific objectives of the RFA. 

The Steering Committee policies and standard operating procedures 
govern all aspects of the CTN including, but not limited to, protocol 
design and development, protocol review and approval, study operations 
and standards, data acquisition and management, and data analysis and 
publication. The Steering Committee also has established CTN 
performance goals and standards, and it monitors progress throughout 
the life of the CTN and its research projects.  Standard operating 
procedures and policies governing the CTN are available at 
http://www.drugabuse.gov/CTN/policies.html.

Subcommittees and Workgroups have been and will continue to be 
established to assist the Steering Committee in carrying out its 
function.  

b. Policies/Operating Procedures 

The Steering Committee Chair will be responsible for ensuring that 
there are well documented policies and operating procedures guiding all 
aspects of CTN activities (e.g. protocol development, review, project 
initiation, conduct, and closure, data collection and management, 
publication, etc.) and bylaws delineating the requirements and 
expectations of collaborating institutions, membership criteria, and 
standards of performance, and procedures for removing institutions due 
to poor performance. 

2. 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 provides a core of administrative and study operations 
services, as well as scientific leadership and management of clinical 
trials.  The RRTC, acting as the local operating center for a Node, has 
primary responsibility for 1) establishing an infrastructure for core 
functions, 2) generating a research agenda, 3) providing the Node with 
administration and operations support, and 4) building partnerships 
with the CTPs. 

-- Infrastructure for core functions – This includes but is not limited 
to 1) arranging and managing the participation of at least five CTPs in 
the first year, with possibility for expansion in subsequent years, 2) 
maintaining scientific and technical personnel for protocol development 
and implementation, 3) coordinating intra-Node activities, and 4) 
providing resources for intra-Node activities. 

-- Research Agenda/implementation - In partnership with its affiliated 
CTPs, the RRTC develops and submits research concepts and protocols to 
the CTN Steering Committee for review and approval.  For each approved 
concept, a protocol specific project team will be established to 
develop and implement the research project. It is expected that a Lead 
Investigator will come from the Node where the research concept and 
protocol originate. NIDA Staff will be designated as scientific and 
programmatic collaborators on the project team. The Lead Investigator 
will assume the leadership role for all aspects of that specific 
protocol and serves as the primary liaison to CTN-wide 
coordination/support centers as needed. 

-- Partnership with CTPs- The RRTC provides CTPs with 1) additional 
therapists, counselors, physicians, physicians' assistants, nurses, and 
other staff as well as the additional training needed for the CTP to 
implement a study protocol, 2) the hardware, software, and training to 
support CTP-based data acquisition activities. Each RRTC must provide a 
data acquisition system to collect intake, in-treatment and outcome 
data for all study participants, according to protocol-specific 
requirements, and 3) additional support, such as quality control to 
ensure the successful completion of the scientific goals of a research 
project. 

a. Protocol Development: 

The Principal Investigator of a RRTC shall initiate the development of 
a trial concept/protocol and expeditiously draft a research protocol 
according to Steering Committee guidelines for protocol content and 
format. The Steering Committee will define and manage the review and 
approval of RRTC initiated protocols. Such review will include 
provisions for NIDA scientific review and comment, including review by 
an independent NIDA based CTN Protocol Review Board. The RRTC will be 
responsible for providing ancillary information about the protocol to 
permit review of the proposed project's scientific rationale, 
feasibility, costs, and compatibility with NIDA research priorities and 
existing clinical research programs. 

b. Data Management and Analysis: 

Each CTN RRTC is required to provide clinical data acquisition and 
management systems within their Node to gather, manage, and if serving 
as a Lead Investigator, analyze data collected as part of CTN multi-
site studies. The RRTC data systems will directly support data 
management activities within their Node at affiliated Community 
Treatment Programs. A Node may elect to operate its data management 
center directly or arrange these services through contract with an 
outside organization or by arranging with another CTN Node data 
management operation.

Data information systems operated by each Node are required to 
implement standards established by NIDA and the CTN Steering Committee. 
Such standards guide the development of protocol-specific electronic 
case report form (eCRF) applications each Node is responsible for 
implementing at participating CTP sites, and define a Node's 
responsibility and procedures for providing data to NIDA's Central Data 
Management Center.

NIDA maintains a Central Data Management Center (CDMC) to support its 
program oversight role and to provide a repository of clinical data 
from all the CTN Nodes.  The CDMC reports directly to NIDA and 
functions as a resource to the CTN Steering Committee in matters 
related to data management, from study design and data acquisition 
through study analysis and reporting of study findings and conclusions. 
The NIDA CDMC provides guidelines and technical support on matters 
related to clinical data management and informatics activities 
throughout a clinical trial project. 

The RRTC data centers are expected to provide incremental clinical and 
other trial performance data to the NIDA CDMC as determined by NIDA and 
the CTN Steering Committee. Each research project proposed under the 
CTN must include a data management plan that defines specific data 
acquisition requirements and identifies responsibility for data 
management throughout the research project life cycle. The NIDA CDMC 
will review, approve, and certify data acquisition and data management 
systems used in CTN research projects prior to the enrollment of any 
participants in CTN research projects.

The Principal Investigators of RRTCs agree to cooperate with the CDMC 
by implementing CTN-wide data standards for collection and analysis of 
data generated under the CTN, and to provide the CDMC timely, accurate, 
and complete data for purposes of monitoring the safety and progress of 
research projects conducted under the CTN. RRTCs agree to provide the 
CDMC final study data according to schedules developed and approved by 
the Steering Committee for individual research projects conducted 
through the CTN.

c. 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. 

d. Quality Control and Monitoring: 

All behavioral and medication trials are subject to quality control and 
monitoring as stated in the policies and procedures established by the 
Steering Committee.  The Lead Investigator of each trial is primarily 
responsible for study control and monitoring as defined by FDA rules 
and regulations.  In addition, NIDA or its representative will provide 
periodic oversight monitoring of all clinical trial sites.  The Awardee 
agrees to permit on site monitoring for all of its community treatment 
provider sites.  For Laboratory Quality Control and Data Management, 
the RRTCs agree to follow protocol-defined measures to ensure 
methodological and analytic guidelines established by NIDA through the 
Steering Committee. All RRTC participating laboratories performing 
analytic studies or services as part of CTN activities must participate 
in laboratory and data quality assurance programs established by NIDA 
to ensure standards across Nodes.  

For medication trials, the holder of the investigational new drug 
application (IND) is primarily responsible for study control and 
monitoring as defined by FDA rules and regulations. If NIDA should hold 
the IND, the RRTCs will be subject to additional review by NIDA to 
ensure adherence to FDA Good Clinical Practice (GCP). The Awardee 
agrees to provide material and documentation needed to assure GCP 
compliance.  Although behavioral therapy trials are not bound to FDA 
regulations, NIDA, through the Steering Committee, may implement 
quality control and monitoring procedures for behavioral trials with 
the same rigor defined by FDA rules and regulations. 

e. Training:

The RRTC will be responsible for providing regional training to node 
personnel involved in the conduct of clinical trials.  The training 
should support the implementation of protocols in which their 
affiliated CTPs will participate.  Training will include, but is not 
limited to, adhering to GCP guidelines, research ethics training, 
biological specimens handling, data management, quality control and 
regulatory procedures.  The RRTC may also be responsible for providing 
training for delivering the medications and behavioral therapies, and 
conducting assessments that are specific to each protocol, in 
accordance with protocol training plan specifications.  RRTCs are 
responsible for following the policies and procedures approved by the 
Steering Committee for conducting training in the CTN.

f. Subject Safety/Oversight 

The RRTC will develop protocol-specific measures to assure the safety 
and protection of the rights of volunteers involved in the clinical 
studies, and other research projects, to be conducted under this 
cooperative agreement. The Principal Investigator assumes and accepts 
the primary responsibility for ensuring CTN studies are conducted in 
compliance with all federal regulations and NIDA policies and 
procedures. These include, but are not limited to, Title 21 CFR Parts 
11, 50, 56, 312, and Title 45 CFR 46. The RRTC must be able to 
demonstrate that each institution and CTP has a current, approved, 
Institutional Assurance of Protection for Human Subjects on file with 
the Department of Health and Human Services Office for Human Research 
Protections; that each protocol and informed consent is approved by the 
recognized Institutional Review Board (IRB) prior to the enrollment of 
subjects in any study; that each Investigator has a current Food and 
Drug Administration Form 1572 curriculum vitae on file at the RRTC; and 
that each subject (or legal representative) has given necessary written 
informed consent prior to admission to any study conducted under this 
cooperative agreement.  The Principal Investigator agrees and assures 
that adequate records will be maintained, and that access to these 
records will be available, to enable outside monitors to assess 
compliance with applicable federal laws and regulations. 
 
g. Unexpected Adverse Experience Reporting: 

The Principal Investigator of the RRTC agrees to implement and adhere 
to an adverse event tracking system operated by NIDA and adopted by the 
Steering Committee.

h. 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: 

CTN Node Operations Reports:  Awardees are required and agree to 
provide quarterly reports of program activities to NIDA by the 10th day 
of the month following the end of programmatic quarters (90 days from 
the date of award).  These reports include a quarterly progress report 
of the activities of the Node within the reporting period and quarterly 
financial reports showing a breakdown of the costs incurred for both 
the RRTC and CTPs for the reporting period.  The quarterly financial 
report shall include a total of all costs spent in previous quarters 
for that year as well as the current reporting period.  This report is 
in addition to the yearly Federal Status Report (FSR) required by NIH.  
The CTN Steering Committee will define a recommended format and specify 
minimum content for these Program Operations Reports.  

CTN Research Project Reports:  Awardees are required and agree to 
provide periodic reports of the research projects undertaken in the 
CTN. At minimum the Lead Investigator must provide timely information 
on the tasks, schedule, and costs associated with the development and 
implementation of a CTN research project.  Enrollment information in a 
format and according to a schedule defined by NIDA and the Steering 
Committee are required for each CTN clinical research project. Other 
protocol-specific reports, such as those needed to monitor the safety 
and clinical effectiveness of drugs or other interventions under 
investigation will be required to allow the Steering Committee and Data 
and Safety Monitoring Board to monitor the research projects undertaken 
in the CTN. The Steering Committee will determine the nature, 
frequency, and content of reports as part of the protocol review and 
approval process. 
 
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). Data and other 
reports required of IND sponsors will be provided to the Steering 
Committee prior to dates established by the Steering Committee.  

i. Publication of Data: 

Prompt and timely presentation and publication in the scientific 
literature of findings resulting from research undertaken in the CTN is 
strongly encouraged. The Awardee agrees to acknowledge NIDA support in 
the publications and oral presentations resulting from research 
conducted under cooperative agreement. Prior to the submission of 
manuscripts for publication Awardees agree to provide preprint copies 
to the Steering Committee according to policies and procedures the 
Steering Committee may establish to monitor the presentation and 
publication of CTN results.  

j. Progress Review  

The CTN Steering Committee has established and will continue to 
elaborate procedures for monitoring the performance of the RRTCs and 
the CTPs participating in research under this cooperative agreement. 
Performance metrics, such as budget execution, subject enrollment, data 
acquisition and transmission, and study analysis and reports have been 
defined to permit NIDA and the Network Oversight Committee a means to 
assess progress of the CTN and provide information needed to support 
future funding decisions. 

The inability of an RRTC to meet performance requirements and 
responsibilities defined in these Terms and Conditions, and further 
elaborated by the Steering Committee may result in an adjustment of 
funding, withholding of support, restriction of funds already awarded, 
or suspension or termination of the award.

k. National Meetings: 

The Steering Committee may meet up to 6 times each year. The Principal 
Investigator agrees to provide adequate support for participation in 
CTN meetings as required by the Steering Committee. The Principal 
Investigator agrees to support participation by CTP personnel as 
required by CTN projects.

l. Conflict of Interest: 

The Steering Committee has developed policies on Conflict of Interest 
and monitors compliance to that policy. The Conflict of Interest Policy 
addresses issues that may arise through financial ties between RRTC and 
CTP participants and the private sectors. Awardees will abide by the 
Conflict of Interest Policy.

m. 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; and, 6) 
emergence of new information that diminishes the scientific importance 
of the study question. Financial support from NIDA through this 
cooperative agreement will cease upon project closure, except that 
funds may remain available for patients already enrolled in the study.

3. RRTC and CTPs: 

a. The RRTC agrees to negotiate and establish subcontracts with at 
least five community treatment programs (CTPs) to conduct research and 
training projects under this cooperative agreement.

Each CTP must: 
-- Agree to participate in controlled clinical trials, including 
randomization methods for assignment of patients to experimental or 
control groups or randomization of therapists to different conditions; 
-- Recruit adequate numbers (at least  100/year) of patients required 
for specific studies; 
-- Agree to provide routine clinical care to patients participating in 
protocols; 
-- Agree to provide experimental/standard care in accord with approved 
research protocols; 
-- Provide HIV risk reduction counseling and access to HIV testing; 
-- Maintain patient records and other source documents required for 
each protocol; 
-- Collect clinical and laboratory data, including biological specimens 
when indicated; 
-- Cooperate with quality control activities of the CTN and adhere to 
guidelines set by the RRTC, the Steering Committee, and NIDA; 
-- Participate in the development of research concepts and protocols 
for trials to be conducted in the CTN; 
-- Agree not to report data prior to collaborative reporting; 
-- Agree to periodic on-site audits by representatives of its RRTC, 
NIDA, or a NIDA designee to ensure appropriate use of investigational 
drugs; compliance with regulations for IRB approval or informed consent 
(compliance with 45 CFR 46); compliance with protocol specifications; 
quality control and accuracy of data recording; and completeness of 
reporting of adverse drug reactions.

CTPs are not expected to participate in every CTN research project, but 
must adhere to the above terms when they choose to participate in a CTN 
research project. 

b. The RRTC shall establish agreements with CTPs that 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 3) a 
financial and program reporting requirement, including access to data 
and materials, to facilitate CTN program operation and research project 
oversight and monitoring.  

4.  NIDA Staff Responsibilities

Staff of the NIDA do have and will have substantial scientific and 
programmatic involvement throughout the life of this cooperative 
agreement through technical assistance, and advice and coordination 
extending beyond normal program stewardship for grants, as described in 
these terms and conditions.

The role of the NIDA staff as described throughout these Terms and 
Conditions is to assist and facilitate, but not to direct the research 
activities.  Communication and interaction will occur primarily with 
the scientific leadership of the RRTC; however, NIDA may also interact 
directly with the Directors of any of the collaborating CTPs as needed.

The NIDA CCTN Director will be responsible for the normal stewardship 
and oversight of the awards as the responsible program official, and 
will have primary responsibility for periodic review and approval of 
RRTC progress.  In addition, the NIDA CCTN Director will be 
substantially involved as described in these terms and conditions. 

NIDA maintains a separate Administrative Services Center (ASC) and a 
Logistic Support Center (LSC) through contract. These central resources 
support certain administrative coordinating functions of the CTN. These 
include: 1) Logistical support for meetings of the Network, e.g., CTN 
Steering Committee, subcommittees, workgroups and other Boards (the 
Advisory Board, the DSMB, etc.), 2) Reproduction and distribution of 
research and educational materials, including treatment protocols, 
training manuals, and instrumentation, 3) Development, reproduction, 
and distribution of materials publicizing the activities of the CTN, 4) 
Provision of trial medications and clinical laboratory services and 5) 
Support for other operational needs, such as protocol development, 
regulatory affairs, monitoring/quality assurance, project management, 
etc.

a.  NIDA's Scientific Role 

NIDA Collaborating Scientists (CSs) with expertise in behavioral 
therapies, medications development, and practice research will 
participate in the development of study plans and protocols, quality 
assurance and control activities, and in coordinating projects across 
scientific disciplines and CTN Nodes. NIDA CSs may initiate or 
participate in publications in accordance with established professional 
and NIH guidelines for authorship. The NIDA CSs will not, however, have 
a direct role in assessment, testing, or treatment of human subjects 
participating in studies under this cooperative agreement.  

The NIDA CCTN Director, and/or designated staff, will work closely with 
the CTN Steering Committee to assure that the research 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.

The following Boards will have approval authorities as indicated:

NIDA Protocol Review Board: An expert board authorized by the NIDA 
Director that will review the final draft of the protocol submitted by 
the CTN Steering Committee for scientific and regulatory approval.  

Data and Safety Monitoring Board (DSMB). The DSMB is an independent 
expert board appointed by and reporting to the Director of NIDA that 
will review study plans and oversee and monitor the conduct of the 
clinical trials to ensure the safety of participants and the validity 
and integrity of the data. The DSMB will also make an independent 
assessment of the effectiveness of interventions under investigation 
and whether a trial will continue. One or more NIDA staff will serve as 
non-voting members on the DSMB. 

CTN Ad hoc Oversight Board.  An independent expert board, appointed by 
and reporting to the Director of NIDA, that oversees all activities 
conducted under the CTN. The Board will advise the NIDA director 
regarding the programmatic advisability of proceeding with studies 
proposed by the Network Steering Committee and will assist the 
Institute in prioritizing and approving final protocols. Protocols will 
be implemented with the approval of the NIDA Director. 

b.  NIDA's Role in Protocol Review and Approval

In order for a CTN research project to be initiated, the study proposal 
must be mutually approved by the CTN Steering Committee and a NIDA 
Protocol Review Board. Once notified that a clinical trial is under 
consideration, NIDA will evaluate the proposed trial according to 
NIDA's treatment research agenda, its likelihood of timely completion; 
patient safety; compliance with Federal regulatory requirements; plans 
for interim monitoring and final analysis of results; and resource 
requirements.  NIDA personnel will estimate required resources 
associated with the proposed clinical protocol and provide the CCTN 
Director with advice on proposed resource requirements.  

In the event a protocol is disapproved, the NIDA CCTN Director may work 
with the CTN Steering Committee to resolve specific deficiencies or 
concerns about the proposed project so that the protocol can be 
approved and implemented. Prior to protocol approval as defined above, 
NIDA will provide no trial materials or permit expenditure of CTN funds 
to implement the research project unless and until the proposed 
protocol is approved. 

Disagreements arising during the protocol approval process may be 
submitted to an arbitration panel for resolution.  A panel composed of 
one CTN designee, one NIDA designee, and a third member with drug abuse 
clinical trials expertise chosen by the other two members will be 
formed to review the NIDA decision and recommend an appropriate course 
of action to the Director, NIDA.  These special arbitration procedures 
in no way affect the Awardee's right to appeal an adverse determination 
in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and 
HHS regulations at 45 CFR Part 16.

c. NIDA Approval to Enroll Study Participants

CTN research projects may proceed upon the Lead Investigator receiving 
approval from the NIDA CCTN Director that enrollment may begin. The 
Lead Investigator is responsible for providing all necessary 
documentation of the readiness of each participating site to initiate 
participant enrollment. Such documentation will include evidence of IRB 
approval for each clinical site, evidence of participating Node data 
system readiness based on successful test and certification by NIDA's 
Central Data Management Center, evidence that all participating project 
personnel have received the training needed to conduct the research 
according to the protocol, and evidence that Node quality assurance 
plans are in place to monitor the research project at participating 
clinical sites.  

d.  NIDA's Role During Protocol Conduct

For ongoing research projects NIDA personnel and its contractors will 
monitor the safety of study participants through review of incremental 
case report form data collected by Node data acquisition systems, and 
data gathered through other means, including NIDA clinical monitoring 
activities.  For all clinical trials, NIDA will assign a Medical 
Officer who will be responsible for the review and disposition of 
adverse events that may arise in the course of a study.  NIDA 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).  

e.  NIDA's Role in Protocol Closure

The NIDA CCTN Director, and/or designated staff, will monitor the 
progress of CTN studies by reviewing data and other reports 
periodically submitted to NIDA. The independent NIDA Data and Safety 
Monitoring Board, consisting of experts from several disciplines, may 
determine a need to alter, suspend, or close an ongoing trial due to 
safety concerns or study performance issues.  Additionally, NIDA may 
deem it necessary to deny access to further investigational drug 
supplies and deny the expenditure of additional NIDA funds (except 
where volunteers are already enrolled) if any of the following reasons 
apply:  (1) scientific question no longer relevant, (2) slow accrual, 
(3) study will not answer questions intended in the proposed study 
plan, or (4) misuse of federal funds.  Appeal of such a decision by the 
RRTC would proceed in the same manner as an appeal regarding the 
disapproval of a protocol prior to opening.

f.  NIDA Access to Data

The NIDA CCTN Director, and/or designated staff, shall have access to 
all data generated under this cooperative agreement and may 
periodically review data recorded on clinical source documents, case 
report forms, or in electronic form in a RRTC local database system.  
Data must be available for external checking against original source 
documents as required by NIDA, and Federal regulations pertaining to 
the responsibility of NIDA as an IND sponsor.  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 and 
publication by the CTN.

g.  Clinical Trials Agreements

It is expected that for some clinical trials proposed by the CTN 
Steering Committee, a pharmaceutical company collaborator will provide 
investigational agents for the trials.  In order for the CTN, NIDA and 
the company to understand their respective responsibilities and rights, 
a Clinical Trials Agreement (CTA) will be negotiated and signed by NIDA 
and the company.  Important terms of the agreement include IND 
sponsorship, safety and data monitoring, and access to trial data.  
Concurrence with the RRTC Principal Investigator will normally be 
obtained prior to execution of any final agreement that deviates 
significantly from the standard NIDA CTA.  In general, terms in the CTA 
covering data access and sharing will conform to policies developed 
jointly by the CTN leadership and NIDA.

h.  NIDA Review of CTN Compliance with Federally Mandated Regulatory 
Requirements

The NIDA CTN staff will review applicable regulatory requirements and 
advise CTN members of mechanisms to meet; (1) FDA regulations for 
studies involving investigational agents, and (2) the DHHS Office for 
Human Research Protections regulations for the protection of human 
volunteers in clinical research studies.

i.  Review of Performance

The NIDA CCTN Director will review the performance of the CTN as a 
whole and of individual RRTCs at least annually.  Such reviews will 
include periodic reviews of the RRTC and its CTP sites for compliance 
with clinical and regulatory guidelines and success in achieving the 
performance standards established by NIDA and the Steering Committee. 
The annual review will be based on information provided in periodic 
progress reports defined elsewhere in these Terms and Conditions, and 
evaluations of site performance conducted by the Steering Committee, or 
its subcommittees.

Insufficient patient accrual, substandard data management or 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.

5.  Arbitration

When agreement between an awardee and NIDA staff cannot be reached on 
scientific/programmatic issues that may arise after the award, an 
arbitration panel will be formed.  A panel composed of one CTN 
designee, one NIDA designee, and a third member with drug abuse 
clinical trials expertise chosen by the other two members will be 
formed to review the NIDA decision and recommend an appropriate course 
of action to the Director, NIDA.  These special arbitration procedures 
in no way affect the Awardee's right to appeal an adverse determination 
in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and 
HHS regulations at 45 CFR Part 16. 

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 

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 AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN 
SUBJECTS 

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research conducted or 
supported by the NIH unless there are scientific and ethical reasons 
not to include them. This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998. 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" that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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 proposals for 
research involving human subjects.  This policy announcement is found 
in the NIH Guide for Grants and Contracts Announcement dated June 5, 
2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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.

LETTER OF INTENT  

Prospective applicants are asked to submit a letter of intent that 
includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the 
identities of other key personnel and participating institutions, and 
the number and title of the RFA in response to which the application 
may be submitted.  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 to: 

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852(for express/courier services)

APPLICATION PROCEDURES 

The PHS 398 research grant application instructions and forms (rev. 
5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must 
be used in applying for these grants. This version of the PHS 398 is 
available in an interactive, searchable format.  For further assistance 
contact Grants Info, Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.
  
Special 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 
will 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 (e.g., for font size and page limits) of the PHS 398 (rev. 
5/2001) with the exceptions noted below.   

Sections a-d need not be organized according to Specific Aims, 
Background and Significance, etc. as stated in the PHS 398 application 
kit.  It is suggested that sections a-d be replaced with the following 
six sections.
 
1. Understanding of and Ability to Contribute to the Mission of the 
CTN: 

This section should consist of a few pages to establish the applicant's 
understanding of the CTN.

2. Administrative and Management Plans: 
 
The qualifications and experience of the Principal Investigator must be 
described.  An individual should be designated as the coordinator for 
intra-Node research activities.  His or her qualifications and 
experience should also be described.  Each application must also 
demonstrate the ability to access professionals with the appropriate 
expertise to design and implement the proposed interventions and 
controlled clinical trials.  Evidence of participation in multi-site 
clinical trials is desirable.

It is important to demonstrate the Principal Investigator's ability to 
contribute to the scientific agenda and commit a minimum of 50 percent 
of time to provide protocol mandated leadership for the clinical trial.  
The accrual of geographically diverse CTPs should be evident.  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.

Plans for intra-Node communications and data management operations 
encompassing all of the Node's CTPs should be specified. Diagrams and 
descriptions of proposed intra-Node committee structures should be 
given. 

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.  This will include training in project 
management, data collection and data management, clinical trial design 
and analysis, clinical trial monitoring, and implementation of research 
protocols.

3. Research and Clinical Infrastructures:

The plans should document the availability of appropriate expertise 
within the RRTC to design, implement, and analyze the results of 
proposed trials. 

Description of the infrastructure for core functions, which include but 
are not limited to managing the participation of five CTPs in the first 
year, staffing technical personnel for protocol design, development and 
implementation, and providing resources for and coordination of intra-
Node activities. 

That plan should also elaborate on the infrastructure capabilities in 
research administration, project management, protocol design and 
development, clinical data information systems, and regulatory affairs. 
In order to reduce redundancy in functions among various CTN Nodes, 
NIDA advises that applicants utilize existent data center resources at 
currently funded CTN Nodes.  Therefore, the descriptions of local data 
information systems must clearly state the applicant's intention and 
arrangements to provide for intra-Node data acquisition, data 
management, and statistical analysis.  The appendix should contain 
letter(s) of agreement from CTN Principal Investigators, or existing 
CTN data management providers the applicant intends to contract with to 
provide data acquisition and data management services. Applicants may 
obtain a list of current CTN data management providers from the CTN 
CCTN Director.

The plans should describe the framework and procedures for training and 
supervision of treatment providers in the experimental and standard 
interventions that will be utilized in the CTN. 

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

4. Collaborations between the RRTC and CTPs:

The application should describe the relationships between the CTPs and 
RRTC.  It should provide detailed descriptions of five CTPs that will 
participate in the first year, with detailed descriptions of each CTP's 
characteristics, including patient population characteristics, patient 
throughput, types of treatment currently delivered, and staff number, 
characteristics, and structure.  Each CTP's description is limited to 
two pages of text. It will be critical for the Node to recruit and 
retain sufficient CTPs to participate in multiple simultaneous trials.  
The possibility of expanding the number of CTPs should be addressed.  
The appendix should contain letters of agreement from CTP directors and 
tables, as needed, to describe the CTPs.

An organizational chart to describe the functional structure of RRTC 
and CTP personnel in the design and implementation of a variety of 
clinical research projects should be provided in the body of the 
application (i.e., within the 45 pages). An organizational chart and a 
description of the RRTC operation should describe the relationship 
between the research and administrative functional units within the 
Node. Evidence of current or previous successful collaborations with 
the community treatment programs would be desirable. 

In each of these areas, it is crucial that the applicant describe how 
the treatment providers will function in true partnership with the RRTC 
in terms of research concept origination, protocol design, research 
project implementation, and administrative support services. 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. 

5. Research Concepts:

Applicants should not propose detailed research protocols, but should 
provide 2 or 3 specific examples of research concepts and abbreviated 
plans that could be undertaken and are consistent with the RFA to take 
advantage of the unique capabilities of the CTN, including 
collaboration across Nodes.  The concepts should present discussions of 
the types of research questions that could be addressed, research 
methods that might be used, and patient populations that might be 
employed.  Particular emphasis should be placed on how the applicant 
proposes to ensure that the RRTC and the CTPs of the Node will work 
collaboratively at all levels, and that the Node will be able to work 
collaboratively with other Nodes and NIDA in multi-site clinical 
trials.  It should be understood that the concepts given in the 
application will not necessarily be implemented in the CTN.

The research plans for the proposed controlled clinical trials should 
include descriptions of research study design, interventions, outcome 
measures, and statistical considerations; access to appropriate 
patients; procedures for data management, quality control and follow-
up; procedures for monitoring and reporting adverse events; and 
information on human subjects protections.  Each concept is limited to 
3 pages.

6. Other:

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

NOTE:  Human Subjects Research (research plan section e) instructions 
have been revised and must be addressed in the application; no specific 
page limits apply, but be complete and concise.  The application should 
describe plans on human subject protections, data safety monitoring and 
patient populations for the CTN Node as a whole.

Budget

The budget and accompanying justification are not part of the 45 page 
limit.  Applicants should include budget estimates and plans for 
participating in the CTN, organized around the areas of research 
planning, core functions, RRTC and CTP collaboration, and 
administrative and management plans.  

The applicant should prepare a separate detailed budget for 1) 
infrastructure to enable the RRTC to provide core functions for the 
Node (e.g., personnel, facilities, equipment, supplies, training costs, 
logistic support, travel, etc.) and; 2) research project specific costs 
such as training of therapists, research assistants, or data 
acquisition personnel, data management and analysis staff, clinical 
expenses related to the research (excluding costs of routine ongoing 
clinic treatment), laboratory costs, monitoring costs, publications 
costs; and 3) CTP support to conduct the clinical trials.  As noted 
elsewhere in this RFA, funds for Node travel should be included to 
provide for participation in CTN related meetings.

In general, no more than $1 million in direct costs should be allocated 
to support first year operations.  Most CTN participants have found 
that the initial year requires intensive developmental activities and 
that research is not actually undertaken until late in the first year 
or in the second year.  Therefore, the budgets for ensuing years (year 
two through year five) should be increased to reflect anticipated costs 
associated with maintaining the Node infrastructure and performing 
research projects.  

The "lead Node," or Node that has primary responsibility for leading a 
research project, will support costs related to that project either 
through their award, or with CTN central resources provided by NIDA 
contracts.  Such costs may include:  1) Reproducing and distributing 
research materials (including treatment protocols, training manuals, 
and instrumentation) and educational materials; 2) Monitoring and 
managing clinical supplies for medication trials; and 3) Supporting 
other operational needs, such as protocol development, regulatory 
assistance, monitoring/quality assurance, trial material distribution, 
central resources for analysis of biological fluids, etc.  The 
Applicant should prepare a budget request for each year (Year one 
through Year five) to include costs for Node infrastructure and three 
concepts proposed. 

Page Limits

To summarize the guidance above, the total length of the Research Plan, 
including the CTP descriptions and research concepts and administrative 
and management plan should not exceed 45 pages. Descriptions of CTPs 
should not exceed 2 pages per program. Descriptions of research 
concepts should not exceed 3 pages per concept.  Literature Cited and 
Consortium/Contractual Arrangements sections should be provided 
following the 45 pages and in total should not exceed 15 pages.  

The RFA label available in the PHS 398 (rev. 5/2001) application form 
must be affixed to the bottom of the face page of the application.  
Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA 
title and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked. The RFA label is also 
available at:  http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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, MSC-7710
6701 ROCKLEDGE DRIVE, ROOM 1040
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight services) 

At the time of submission, two additional copies of the application 
must be sent to: 

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier/overnight services)
Telephone:  (301) 443-2755 

Applications must be received by February 22, 2002. If an application 
is received after this date, it will be returned to the applicant 
without review. The Center for Scientific Review (CSR) will not accept 
any application in response to this RFA that is essentially the same as 
one currently pending initial review, unless the applicant withdraws 
the pending application. The CSR will not accept any application that 
is essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique. 

REVIEW CONSIDERATIONS  

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the (IC).  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIDA in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in 
which only those applications deemed to have the highest scientific 
merit, generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level review 
by the National Advisory Council on Drug Abuse.

Applications will be reviewed for scientific and technical merit using 
the following criteria. Applicants should note that the criteria 
incorporate consideration of the quality and feasibility of the 
proposed activities as well as consideration of past performance.  As 
part of the review process, the review panel will conduct an initial 
review to select the most meritorious applications for a site visit 
prior to final scoring.  It is expected that these site visits will 
occur early during the summer of 2002 and be followed by a final review 
meeting, at which time scoring will occur. 

REVIEW CRITERIA

1. UNDERSTANDING THE CTN

o  How well does the proposed Node (i.e., the applicant RRTC and its 
affiliated community treatment programs) demonstrate an understanding 
of the scientific agenda of the Clinical Trials Network (CTN)?  
o  To what extent would the proposed Node likely contribute to the 
goals and enhance the capability of a nationwide CTN? 

2. ADMINISTRATIVE AND MANAGEMENT PLANS	

o  How strong are the plans for overall Node management and operations, 
including the structure and mechanisms for effective intra-Node 
communication and collaboration?
o  How well documented are the applicant's previous experience and 
plans for training RRTC personnel, including therapists and research 
associates in implementing multi-site clinical trials?
o  How well developed are intra-node data management plans, including 
plans for incorporating CTN-wide standards, data collection, analysis, 
and site-specific training?
o  How strong are the plans for effective interaction and coordination 
with other Nodes and NIDA? 

3. RESEARCH AND CLINICAL INFRASTRUCTURE	 

o  To what degree is the proposed Principal Investigator (PI) able to 
devote adequate time to carry out the work of the CTN?  
o  How strong are the previous research experience and other 
qualifications of the PI and other named staff in design, 
administration, and management of multi-center clinical trials?  
o  How strong are the qualifications of key personnel and scientific 
staff in the areas of the proposed research concepts? 
o  How strong are the qualifications of staff in providing statistical 
and data management expertise for multi-site clinical trials?    
o  How adequate are the available resources and proposed personnel for 
administering Node activities?  
o  How strong is the evidence of infrastructure capabilities in project 
management, protocol development, clinical data information systems, 
and management of regulatory affairs?

4. COLLABORATION BETWEEN RRTC AND CTPs 

o  Is there a record of previous RRTC-CTP collaboration?  
o  What is the quality of plans for involving CTPs in the research and 
organizational activities of the CTN? 
o  How well developed are the RRTC's criteria for selecting CTPs with 
diverse geographic and population representation (as balanced by 
constraints of reasonable management)?
o  What are the quality of the proposed CTPs and the experience of 
their program directors?  
o  To what extent do the proposed CTPs vary programmatically?  To what 
extent are they able to accrue a demographically diverse patient 
population?
o  How feasible are CTP plans for patient enrollment and retention?  
How well do the CTPs demonstrate their ability to accrue patients at an 
adequate rate to support multi-site clinical trials?

5. RESEARCH PLANS	

o  How significant are the proposed research concepts?
o  How well do the proposed research concepts demonstrate knowledge of 
state-of-the-art research designs, methodologies, and operations?

6. OTHER
In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.
o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the 
project  proposed in the application.
o  The adequacy of the proposed plan to share data.
o  The plans for data safety monitoring will be assessed. 

7. BUDGET

o  The reasonableness of the proposed budget and duration in relation 
to the proposed research.
o  How appropriate are the budget estimates for infrastructure to 
enable the RRTC to provide core functions for the Node (e.g., 
personnel, facilities, equipment, supplies, training costs, logistic 
support, travel, etc.)?
o   How appropriate are budget estimates of protocol-specific costs, 
such as training, clinical expenses, laboratory costs, monitoring 
costs, and publication costs?
o   How appropriate are budget estimates for CTP support to conduct the 
clinical trials?
o   How adequate are plans for budgetary control and oversight?


SCHEDULE 

Letter of Intent Receipt Date:  January 22, 2002
Application Receipt Date:       February 22, 2002
Scientific Review Date:         May/June, 2002
Council Meeting Date:           September 2002
Earliest Award Date:            September 30, 2002

AWARD CRITERIA 

Award criteria that will be used to make award decisions include:  a) 
scientific and technical merit; b) program balance, including in this 
instance, sufficient compatibility of features to make a successful 
collaborative study a reasonable likelihood; and c) availability of 
funds. In addition, in order to heighten the generalizability and 
utility of findings, very high priority will be given to applications 
in geographic regions where the CTN is not currently well represented.  

INQUIRIES 

Inquiries concerning this RFA are encouraged. The opportunity to 
clarify any issues or questions from potential applicants is welcome. 

Direct inquiries regarding programmatic issues to: 

Betty Tai, Ph.D.
Center for the Clinical Trials Network  
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4234, MSC 9557
Bethesda, MD  20892-9557
Telephone:  (301) 443-2397
FAX:  (301) 443-2317
Email:  btai@nida.nih.gov
 
Jack D. Blaine, M.D.
Center for the Clinical Trials Network 
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4234, MSC 9557
Bethesda, MD  20892-9557
Telephone:  (301) 443-2246
FAX:  (301) 443-2317
Email:  jb167n@nih.gov

Direct inquiries regarding peer review issues to: 

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@nida.nih.gov

Direct inquiries regarding fiscal matters to: 

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 443-6847
Email:  gf6s@nih.gov

AUTHORITY AND REGULATIONS  

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.279.  Awards are made under authorization of Sections 301 and 
405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-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.


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