RELEASE DATE:  October 17, 2002 

July 26, 2006 - This PA has been replaced by 
PA-06-495 (R01), PA-06-496 (R21) and PA-06-497 (R03)

PA NUMBER:  PA-03-011

EXPIRATION DATE:  October 31, 2005, unless reissued.
National Institute on Drug Abuse (NIDA)


o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


The National Institute on Drug Abuse (NIDA) invites applications to conduct 
health services research on the practice and delivery of drug treatment in 
the National Drug Abuse Treatment Clinical Trials Network (CTN).  By 
encouraging the use of the existing CTN network of treatment providers and 
research centers as a platform for new research, this PA enhances research 
efforts to improve the delivery of drug abuse treatment, and translate 
science-based treatments into practice in community treatment settings.


This PA is meant to support health services research in connection with the 
CTN, a research partnership of community treatment providers (CTPs) and drug 
abuse researchers in multiple sites across the country.  With its extensive 
network of providers serving diverse populations of drug users, the CTN 
provides a ready platform for investigating the accessibility, delivery, 
quality, and portability of drug treatment services as well as research on 
the organization and financing of treatment programs and the adaptation of 
innovative strategies for the treatment of drug abuse and addiction.

The researcher-practitioner partnership that characterizes the CTN is 
designed to accelerate the pace of research and determine the effectiveness 
of drug abuse treatment approaches in real-life treatment settings. In 
addition, services research conducted through the CTN is meant to enhance the 
translation of science-based treatments into practice in community-based 
treatment settings. 

NIDA inaugurated the CTN in 1999 as a cooperative agreement research program 
consisting of drug abuse researchers, community treatment providers, and NIDA 
staff.  Since its beginning, the primary mission of the CTN was to conduct 
studies of behavioral, pharmacological, and integrated behavioral-
pharmacological treatment interventions in rigorous, multi-site clinical 
trials.  Primary objectives were to: (1) determine the effectiveness of 
therapies across a broad range of community-based treatment settings and 
diverse patient populations, and (2) find ways to integrate proven 
medications and behavioral interventions into mainstream clinical practice.

Under this PA, CTN and non-CTN investigators will be in a position to conduct 
health services research in collaboration with existing regional research and 
training centers (RRTCs) and CTPs.  Although not all RRTCs have the capacity 
to initiate health services research themselves, all Nodes are expected to 
collaborate in such research and to aid in the recruitment of appropriate 
The CTN currently consists of 14 investigator-led research Nodes representing 
California, the Delaware Valley, Florida, the Great Lakes region, New York 
City, Long Island, the Mid-Atlantic area, New England, North Carolina, the 
Ohio Valley, Oregon, the Rocky Mountain region, South Carolina, and 
Washington State. Each Node consists of an RRTC and five or more 
participating CTPs.  Plans call for the addition of new Nodes in 2002 as well 
as increased numbers of treatment providers allied with each Node. (Further 
description of the CTN and currently participating RRTCs and CTPs can be 
found at

New Studies 

This PA encourages investigators to focus on research that will enhance the 
adoption of effective treatment strategies, especially:  (1) systems research 
to identify organizational features, policies, and financing systems that 
affect treatment delivery and the adoption of treatments found to be 
effective in the CTN; and (2) practice research to identify and improve 
program parameters that influence quality and accessibility of care, clinical 
epidemiology, and innovation.  In as much as recent research has shown that 
drug abuse and addiction present different challenges to women's health and 
may require different services approaches and strategies, researchers are 
encouraged to take a gender-based approach to generating hypotheses that will 
ultimately enhance the delivery of effective drug abuse treatments for women.  
Possible research topics include – but are not limited to – the following 

o  Application of the chronic disease model to drug abuse treatment.  
Research is needed to test drug abuse treatment and recovery models that 
account for drug use as a chronic, relapsing disease, e.g., treatments that 
target the underlying biological disorder as well as the behavioral and 
social aspects of drug seeking and addiction, and that take into account the 
patient's sex and ethnic background. 

o  Cost of various treatment services/interventions delivered in the CTN.  
Cost analyses of several kinds are encouraged, including studies of the cost 
effectiveness of CTN-tested drug abuse treatment and ancillary services; cost 
offsets of treatment (medical or social costs); and cost/benefits of care.  
Studies are also needed to improve and standardize measurements of costs, 
cost effectiveness, cost offsets, and cost benefits.

o  Financing of drug treatment.  Studies are needed to examine the impact of 
health plan parity benefits, managed care practices, and other cost control 
measures on the coverage of, access to, and utilization of treatment for drug 
abuse and addiction.  Comparisons between more and less integrated treatment 
services and between more or less tightly managed systems of care are 
welcome. Research is also needed to develop outcome measures related to the 
quality and management of resources. 

o  Linkage of drug treatment with other medical services.  Research is needed 
to understand how drug treatment can be effectively linked to medical service 
where drug users, including those who are HIV-positive, are likely to seek 
access to care, e.g., such settings as primary care, emergency care, 
obstetric and gynocologic care, and mental health care.  Research is needed 
to develop effective methods for screening, identifying, and referring 
medical patients to drug treatment services.

o  Adaptation and change within CTPs.  Little is known about the processes by 
which innovations in treatment and service delivery are identified, 
evaluated, initiated, and adopted by CTPs.  Understanding the process of 
adaptation and change includes research in the areas of organizational 
culture, learning, and innovativeness; capacity and readiness for change; 
change management and follow-through; and performance management approaches.  

o  Adoption of research findings in applied practices. Research is welcome on 
the adoption of behavioral and pharmacological therapies found to be 
effective in CTN studies, including studies of organizational motivation, 
leadership, and social influence; management strategies to transfer new 
methods and technologies; and mechanisms to facilitate adoption of CTN-tested 
treatment approaches, such as manualized behavioral treatments, professional 
society workshops, and technology transfer centers.

o  Adoption of injection-related HIV risk reduction interventions by drug 
treatment providers.  Investigators are invited to examine factors related to 
the organizational culture, policies, and treatment philosophies which 
encourage or discourage providers to offer clients instruction in the 
avoidance of risky injection practices, such as showing how to clean 
injection equipment or providing referrals to syringe exchange programs.  

o  Status of the counseling workforce.  Investigators are welcome to study 
trends in the training, accreditation, remuneration, and stability of 
employment of drug treatment counselors, especially as these trends are 
affected by economic or other social factors (such as cost containment 
measures, employment rates, infectious disease transmission, and so on).

o  Quality of care studies.  Studies are needed to identify specific 
components or characteristics of care that affect treatment outcomes.  
Examples include clinical practice guidelines; patient subpopulation (e.g., 
women, ethnic minorities, adolescents) outcomes linked with quality of care; 
and the impact of system changes on quality of care.  Additionally, studies 
are needed to develop and evaluate measures of quality of care and patient 
placement criteria.

o  Clinical epidemiology.  Studies are welcome to identify processes and 
interactions of population groups with treatment providers, e.g., variations 
in prevalence of substance use; clinical practices with respect to 
subpopulations (such as women, ethnic minorities, adolescents, individuals 
with comorbid mental health problems, and individuals who are HIV-positive), 
barriers to treatment faced by specific population groups, and programmatic 
features designed to reduce such barriers.  

The topics bulleted above are meant only as illustrations of the types of 
health services research that an applicant can propose.  All applications are 
welcome that are appropriate to the research objectives of this PA.   


This PA will use the NIH project grant (R01), NIDA small grant (R03), and the 
NIDA exploratory/developmental grant (R21)  award mechanisms.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  

The total project years for an application submitted in response to this PA 
may not exceed five years for the R01; two years for the NIDA R03 (see, and three years 
for the NIDA R21 

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see   
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.


You may submit (an) application(s) if your institution has any of the 
following characteristics:
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations 


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


Most research projects proposed under this PA will require participation, 
collaboration, cooperation, or other support by CTN investigators or 
community treatment provider staff or patients.  Although the CTN is creating 
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.  Thus, it is incumbent 
on the principal investigator of proposed research to get general preapproval 
of a 1-2 page research concept from the CTN Concept Review and Development 
Subcommittee, to submit evidence of support from affected CTN participant 
organizations, and to obtain written approval to access any required data 
that is controlled by the RRTCs or the CTN Steering Committee. Information 
about the CTN, including contact information, is available at


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

o Direct your questions about scientific/research issues to:

Jerry Flanzer, D.S.W.
Services Research Branch
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

o Direct your questions about financial or grants management matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
Fax:  (301) 594-6847


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at  Application 
deadlines are also indicated in the PHS 398 application kit.

up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
1) Contact NIDA program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that NIDA will accept your application 
for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member 
and NIDA who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at The CSR will not 
accept any application in response to this PA 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.  

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

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on Drug 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.


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

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


involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 

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 
(; a complete 
copy of the updated Guidelines are available at  
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 

The NIH maintains a policy 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 is available at 

policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing services.  Persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see

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

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

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
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