Release Date:  September 6, 2000

RFA:  DA-01-003

National Institute on Drug Abuse

Letter of Intent Receipt Date:  November  20, 2000
Application Receipt Date:       December  19, 2000



This Request for Applications (RFA) encourages (a) research on changes in 
clinical management and organizational practices of community treatment 
providers participating in the National Institute on Drug Abuse’s National 
Drug Abuse Treatment Clinical Trials Network (CTN); (b) research to improve 
the ability of non-network providers to adopt new research-based treatments; 
and (c) research on the cost-effectiveness of treatments tested in the CTN 
compared with typical treatment.  Research on other health services issues 
related to the CTN and its overarching goal to improve drug abuse treatment 
nationwide is also encouraged.


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 is related to one 
or more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at


Applications may be submitted by domestic for-profit and nonprofit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of state and 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.


This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this RFA may 
not exceed five years.  This RFA is a one-time solicitation.  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated applications and be reviewed according to the 
customary peer review procedures.  The anticipated award date is July 2001.


NIDA intends to commit approximately $2.0 million in FY 2001 to fund up to 
five new and/or competitive continuation grants in response to this RFA.  The 
level of support is dependent upon the receipt of a sufficient number and 
diversity of applications of high scientific merit.  Because of the nature 
and scope of the research proposed, it is anticipated that the size of an 
award will also vary.  Although the financial plans of NIDA provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  At this time, it is not known if this RFA will be reissued.


This RFA encourages research on health services issues related to the 
National Drug Abuse Treatment Clinical Trials Network (CTN).  Specific areas 
of research focus include studies on the process of change in clinical 
practices and organizational processes and structures of community treatment 
providers participating in the CTN; research on the effectiveness of 
strategies to help non-network providers adopt new research-based treatments; 
and research on economic issues related to treatments being tested in the 


The potential public health benefit of new behavioral and pharmacological 
treatments for drug abuse has not been fully realized because many providers 
have not adopted these new treatments.  In 1999, the National Institute on 
Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical 
Trials Network, a cooperative research program to conduct coordinated multi-
site clinical trials of behavioral and pharmacological therapies for drug 
abuse and addiction.  Funded under RFA 99-004, the CTN presently consists of 
six nodes representing the Delaware Valley, Mid-Atlantic, New England, New 
York, Pacific Northwest, and West Coast regions.  Each node consists of a 
regional research and training center, all currently based in academic 
institutions, and five or more participating community treatment providers.  
Plans call for the addition of new community treatment providers in each 
node.  Additionally, the CTN is expected to be expanded in fiscal year 2000 
by the addition of up to six more nodes, and further nodes may be added in 
the future.

The CTN’s overarching goal is to improve the quality of drug abuse treatment 
in the nation by conducting clinical trials to test behavioral and 
pharmacological therapies for a broad range of patients in a variety of 
clinical settings, and by finding ways to integrate these tested medications 
and behavioral interventions into mainstream clinical practice.  In addition, 
the CTN is expected to provide an infrastructure and a platform to research 
other questions relevant to the improvement of community-based treatment 

References made in this RFA to "CTN-tested treatments" include treatment 
interventions being tested in the CTN as well as those under consideration in 
the CTN.  In addition, studies may be proposed using science-based, effective 
interventions similar to those being tested in the CTN if the research 
focuses on processes or models that are not dependent upon a specific 
treatment intervention.

I.  Organizational and Practitioner Adaptation and Change in CTN Community 
Treatment Providers and in Other Community Treatment Providers

Adopting new treatment methods into clinical practice, be they 
pharmacological or behavioral in nature, involves change at both the 
organizational and practitioner levels.  The introduction of new treatment 
approaches into an existing provider organization may require adaptation of 
clinical and business practices to sustain treatment advances over the longer 
term.  There has been little research to understand organizational adaptation 
and change by organizations or practitioners in the drug abuse treatment 
system, with the consequence that little is known about the processes by 
which change occurs or how to facilitate change to improve the overall 
quality of drug abuse treatment.

Understanding the process of adaptation and change includes research in the 
areas of organizational culture, readiness and motivation for organizational 
change, and change management and follow-through.  Research is needed to 
understand the process of change with regard to how treatments being tested 
in the CTN can be successfully assimilated by the treatment organizations, 

-  adoption of behavioral and pharmacological therapies tested in clinical 
trials by community treatment providers, and effective models and practices 
to plan and manage such adoption;

-  readiness and capacity to successfully adopt new treatment methods;

-  business practices that increase motivation for change and improvement; 

-  effects of change in clinical and business practices on organizational 
climate and culture, particularly with regard to innovation in clinical 

Organizational culture.  Sustained change in clinical practice may require 
reframing of the organizational culture to accommodate new values, beliefs, 
and therapeutic and business practices.  The reframing process can include 
altering organizational structures, modifying fiscal and resource management 
procedures, acquiring new job skills, revising treatment philosophies, 
renegotiating the nature of linkage relationships, or revising staff and 
client interactions.  Research is needed to determine how participation in 
the CTN may improve the quality of drug abuse treatment services and outcomes 
through changes in organizational culture or changes in therapeutic and 
business practices.

Capacity and motivation for change.  Adoption of research-based treatments 
require that organizations have the capacity to change.  Barriers to adoption 
include lack of needed resources, philosophical resistance toward the 
research-based treatment, resistance from clientele or payers, or lack of 
time to plan and implement change.  Research is sought to improve the 
organization’s capacity for change.

Although workforce consensus for change may result from crisis, current 
organizational theory suggests that effective change results from a routine, 
normative practice of continuous improvement of services and products.  
Continuous improvement efforts might include outreach to other community 
providers, client focus groups, or partnerships between staff and management.  
Research is sought on how organizations effectively learn and adopt 
techniques or methods needed to effect change, such as benchmarking, formal 
training, attending workshops or conferences, and other approaches to 
identify promising clinical and business practices.

Change management and follow-through.  Research is sought on the processes 
needed for successful adoption of a new treatment after the decision to adopt 
has been made.  These processes may include planning, implementing, and 
managing change, as well as monitoring to ensure that anticipated benefits 
are realized and that quality of services is maintained.  Research is needed 
on the application of systematic knowledge of how to plan and manage change 
and how to monitor processes to insure that changes in business practices are 
sustained.  Research on change management may include studies of the effects 
of improved management information systems or improved decision-making 
procedures on treatment performance.

II.  Effective Strategies to Help Non-Network Providers Adopt New Research-
Based Treatments

Although non-network treatment providers do not receive training or financial 
research incentives to implement new treatment technologies, they are under 
the same competitive pressures as CTN providers to improve their clinical and 
business practices in order to provide effective and efficient drug abuse 
treatment.  While the research infrastructure of the CTN promotes short-term 
adoption of new treatment approaches, research is needed in the area of 
organizational change to support long-term adoption of treatment technologies 
found effective in the CTN.

Research is encouraged to develop and test models for integrating new CTN-
tested interventions into existing clinical practices, including studies on 
levels of theoretical and practical knowledge needed by practitioners; how to 
assess patient need for the new intervention; how the new treatment is staged 
or incorporated into an ongoing treatment regimen; how to measure program 
performance, outcomes, and cost-benefits for the new intervention; and how to 
integrate the new treatment with linked services.  Areas of research interest 

-  strategies to effectively transport CTN-tested treatment interventions 
into clinical practice;

-  organizational or management strategies or processes to improve 
transmission of knowledge, adaptation of new treatments, and their adoption 
into widespread clinical practice;
-  enhancements to technology transfer methods and mechanisms;

-  improvements of existing mechanisms to facilitate adoption of treatment 
approaches, such as research to improve the capability of Addiction 
Technology Transfer Centers, funded by the Substance Abuse and Mental Health 
Services Administration’s Center for Substance Abuse Treatment, to 
disseminate CTN-tested treatments beyond the network.

III.  Economic Research on Treatments Being Tested in the CTN

Economic research on drug abuse treatment services informs decisions related 
to the allocation of resources and the desire to enhance efficiency and 
equity.  Whether CTN-tested treatment interventions will be adopted by 
community treatment providers depends in part on whether these interventions 
are covered by public or private payers.  Research is needed on:

-  Costs, including direct and indirect costs, of drug abuse services and 
ancillary services, as well as studies on the component unit service costs of 
drug abuse services to improve knowledge about full cost pricing of service 
delivery for CTN-tested drug abuse treatments.

-  Cost-benefit and cost-effectiveness analyses on innovative treatment 
therapies and interventions in the CTN and in non-network treatment 

-  Cost savings (or "cost-offsets") resulting from CTN-tested treatments that 
reduce or avert medical or social costs.

-  Outcome measurement and monitoring to improve the quality and management 
of resources.

-  Impact of health plan parity benefits and managed care practices on 
coverage of and access to CTN-tested treatments.


Some research projects proposed under this RFA may require the participation, 
collaboration, cooperation, or other support by CTN investigators or 
community treatment provider staff or patients.  Although the CTN is expected 
to create a research infrastructure that will support studies such as those 
encouraged here, some studies involving the CTN may not be feasible given the 
mission, goals, and timetables of the CTN cooperative studies.  It is 
incumbent on the applicant to demonstrate that the support required of CTN 
participants has been obtained so that the proposed project is feasible.  The 
use of data collected by the CTN is governed by rules established by the CTN 
Steering Committee, so it is especially important to demonstrate the 
feasibility of research proposing to use CTN-owned data.  Information about 
the CTN, including contact information, is available at


It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
a complete copy of the updated Guidelines is available at  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) 
all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subject 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 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning these policies.


The National Advisory Council on Drug Abuse recognizes the importance of 
research involving the administration of drugs to human subjects and has 
developed guidelines relevant to such research.  Potential applicants are 
encouraged to obtain and review these recommendations of the Council before 
submitting an application that will administer compounds to human subjects.  
The guidelines are available on NIDA's Home Page at 
under Funding or may be obtained by calling (301) 443-2755.


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.


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 NIDA staff 
to estimate the potential review workload and plan the review. 

The letter of intent is to be sent to the following staff by the letter of 
intent receipt date listed.

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538


The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach 
and Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail:


The modular grant concept establishes specific modules in which direct costs 
may be requested, as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below:


Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested in accordance with the program guidelines and modifications made 
to the standard PHS 398 application instructions described below:

PHS 398

FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative  (F&A) costs] for the initial 
budget period. Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See for 
sample pages.)  At the top of the page, enter the total Direct Costs 
requested for each year.  This is not a Form page.

Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (Direct 
plus F&A) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of key personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested Modular Direct Cost amount.  Include the 
letter of intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years; and
- List selected peer-reviewed publications, with full citations.

CHECKLIST - This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of 
agreement and the date.  All appropriate exclusions must be applied in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

The RFA label available in the PHS 398 (rev. 4/98) 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 on the face page of the application form, and the YES box must be 

The sample RFA label available at: has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

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

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 Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Research (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.


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA.  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 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 NIDA's National Advisory Council.

Review Criteria

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

(1)  Significance:   Are the goals and objectives of this application 
relevant to this RFA?  Does this study address an important problem?  If the 
aims of the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of these studies on the concepts or 
methods that drive this field?  

(2)  Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  

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

(4)  Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5)  Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?  Has the support required of CTN participants been obtained so that 
the proposed project is feasible?

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

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 

The adequacy of plans to make data available to other investigators in a 
timely fashion.

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

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.

Letter of Intent:          November 20, 2000	
Application Receipt Date:  December 19, 2000
Council Review:            May 2001			
Earliest Start Date:       July 2001		


Award criteria that will be used to make award decisions include:  scientific 
merit as determined by peer review, availability of funds, and programmatic 


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

Direct inquires regarding programmatic issues to:  

Bennett W. Fletcher, Ph.D.
Division of Epidemiology, Services,
  and Prevention Research
National Institute on Drug Abuse 
6001 Executive Boulevard, Room 4222, MSC 9565,
Bethesda, MD  20892-9565
Telephone:  (301) 443-4060
FAX:  (301) 443-6815

Direct inquiries regarding fiscal matters to:  

Jack Manischewitz, Ph.D.
Grants Management Branch, OPRM
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849

Direct inquiries regarding 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


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 Part 52 and CFR Part 
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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