Release Date:  December 6, 2001

RFA:  RFA-DA-02-006

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 11, 2002
Application Receipt Date:       April 11, 2002



The National Institute on Drug Abuse (NIDA) is committed to the development 
of behavioral therapies that will be utilized in community treatment 
settings. The purpose of this initiative is to support studies that will 
adapt existing, efficacious behavioral therapies for community treatment 
settings, or prepare for such adaptation by identifying key components of 
efficacious therapies to be retained in adapted therapies.


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, Modifying and 
Testing Efficacious Behavioral Therapies to Make Them More Community 
Friendly, 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 and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government. Faith-based organizations are eligible to 
apply for these grants.  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 
(R01), small grant (R03), and exploratory/developmental grant (R21) award 
mechanisms.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant. 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 September 30, 2002.

The exploratory/developmental (R21) grants are limited to 3 years and small 
grants (R03) are limited to 2 years.  Both are non-renewable and limited in 
direct cost amount per year (R03, $50,000; R21, $100,000).  The R03 mechanism 
( is intended for 
newer, less experienced investigators, for investigators at institutions 
without well-developed research traditions and resources, or for experienced 
investigators wishing to change research directions or test new methods or 
techniques.  The R21 mechanism 
is intended to encourage exploratory research projects 
with sound methodology and strong rationales in underdeveloped research areas 
of drug abuse, such as the areas covered in this RFA.  Investigators may also 
choose to include methods development as one component within any of the 
other mechanisms.  Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at


NIDA intends to commit approximately $2 million in FY 2002. Because the 
nature and scope of the research proposed may vary, it is anticipated that 
the size of each award will also vary. It is anticipated that approximately 
8-10 awards will be made under this announcement. 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.


Background and Rationale 

A heterogeneous group of public and private treatment programs, including 
small local clinics and large complex programs sponsored by medical centers 
and managed care organizations, comprise the community-based drug and alcohol 
treatment system in the United States. A 1998 study by the Institute of 
Medicine devoted to bridging the gap between drug abuse treatment providers 
and researchers determined that despite the availability of a number of 
efficacious behavioral treatments, established research-based treatments have 
not been adopted widely in clinical practice. A major barrier to the adoption 
of research-based, efficacious behavioral treatments by community treatment 
providers is that these treatments may not be "community friendly."  For 
instance, treatments may be too lengthy, costly, complex, or difficult to 
integrate with usual care to be considered feasible in a community setting, 
where resources are limited.

A variety of research activities are needed to make efficacious behavioral 
therapies more community friendly. One activity involves identifying 
essential components and/or key mechanisms of efficacious therapies so that 
these can be preserved when therapies are adapted for a community setting. 
Examples of this activity include, but are not limited to: 1) studies that 
test the components of multicomponent therapies alone and in combination with 
one another (i.e., dismantling studies); 2) studies that test the required 
dose and timing of efficacious components; and 3) studies testing theory-
driven hypotheses regarding the mechanisms of action of a behavioral 
treatment. Although theories exist about why behavioral therapies work, more 
systematic studies are needed to identify the key components and mechanisms 
of behavioral therapies so that these can be retained in the process of 
adapting them for community settings. Such activities may allow a therapy to 
be streamlined making it more community friendly by paring the treatment down 
to reduce the staff, time, or cost required. Streamlining may be appropriate 
when behavioral treatments have multiple components, some of which may not be 
necessary, or when the length or intensity of treatment can be reduced 
without diminishing efficacy. 

Another way that an efficacious therapy can be modified is by altering the 
modality of the therapy from individual to group treatment. Group treatment 
is a particularly attractive modality of treatment in community settings 
because of its apparent efficiency and lower cost. More studies are needed to 
develop manualized group therapies, to identify key components of group 
treatment, and to test for whom different group treatments are appropriate.

Developing therapy modules that can be delivered independently or as adjuncts 
to usual care also can modify an efficacious therapy. Behavioral treatment 
that can be delivered as stand-alone or not necessarily sequential modules 
may be especially useful to community providers given the need to respond to 
revolving admissions. Additionally, therapy modules allow community providers 
to target specific patient needs as adjuncts to usual care. More studies are 
needed of the appropriateness of creating modules from traditionally 
sequential therapies or therapies with multiple components or foci. 

Modifying the method of therapy from in-person to telephone, computer, mail, 
etc. is another alternative for making efficacious therapies more community 
friendly. Behavioral therapies that can be conducted across remote sites, or 
that utilize web-based services, may be especially useful for community 
treatment settings, and studies of the development and manualization of such 
approaches to patient care are needed.

These are only some of the ways in which efficacious behavioral treatments 
might be adapted to be more community friendly. Innovative and creative 
studies on therapy adaptation are encouraged. For more information on 
efficacious behavioral treatments, please see Principles of Drug Addiction 
Treatment: A Research-Based Guide at

Conceptual Framework for Modifying Efficacious Behavior Therapies 

NIDA is committed to a comprehensive program of treatment research to ensure 
that science-based treatments are developed and ultimately used in the 
community. This RFA should be understood in the context of NIDA's Behavioral 
Therapies Development Program Announcement (PA NUMBER: PA-99-107). NIDA's 
Behavioral Therapies Development Program delineates three stages of 
behavioral therapy research. Stage I, the earliest stage of behavioral 
therapy development research, is viewed as an iterative process involving 
identifying promising clinical, behavioral, and cognitive science relevant to 
treatment, generating new behavioral therapies, operationally defining the 
therapies in manuals, and pilot testing and refining the therapies. Stage II 
research consists of efficacy testing of promising therapies and 
investigation of the mechanisms and key components of behavioral therapies. 
Stage III research is aimed at understanding if and how an efficacious 
therapy may be transported to the community, including testing the utility of 
training procedures and techniques. 

This RFA is intended for two kinds of proposals. Stage I proposals will adapt 
existing efficacious interventions into new community-friendly behavioral 
treatments, operationally defining the therapies in manuals and pilot testing 
and refining the therapies. Stage II proposals will identify mechanisms 
and/or key components of efficacious behavioral treatments in preparation for 
adaptation to be community friendly.

Areas of Interest:  

This RFA is intended to support behavioral therapy development. This 
initiative targets for funding, in a systematic way, essential research 
needed for adapting existing efficacious treatments for use in community drug 
clinics and by other community-based providers who treat drug abusers 
including private practitioners and primary care physicians. This includes, 
in particular, critical areas of research that have been overlooked in the 
past. Illustrative examples of research described below serve as a guide and 
are not meant to subsume all research topics that would be appropriate under 
this RFA.

Examples of STAGE I activities:

o Research streamlining an existing treatment to include only hypothesized 
key components.

o Studies that adapt a traditionally individual intervention to a group 

o Research modifying a traditionally sequential treatment for administration 
as free-standing modules. 

o Studies that adapt an existing treatment for a mixed gender group to single 
sex groups for conduct in clinics which traditionally serve a single gender, 
i.e., adapting a treatment for use in a women's clinic. 

o Research translating efficacious treatment to administration via computer, 
videotape, telephone, mail, etc.

o Studies aimed at modifying efficacious therapies to make them appropriate 
for use in the community with particular racial or ethnic groups.

o Research to modify efficacious therapies to make them less complex to 
administer and/or less complex to train.  

o Research modifying efficacious treatment for rural settings, or patients 
with transportation limitations, utilizing real-time technologies such as 
private Internet chat sessions or streamlining video.

o Studies that modify behavioral treatments to improve adherence to 
medications in programs combining behavioral and medication treatment. 

o Research that adapts existing treatments by reducing time required for 
administration. For example, converting a standard-length treatment to an 
extremely brief treatment for use in settings that do not traditionally 
provide extensive behavioral treatment (e.g., some methadone clinics, primary 
care settings, recovery houses, etc.).

o Studies that test the required dose and timing of efficacious behavioral 

o Research that modifies efficacious behavioral treatments for drug abuse to 
incorporate HIV/AIDS risk reduction modules.

Examples of STAGE II activities:

o Studies which identify key components and underlying mechanisms of a 
treatment (i.e., dismantling studies). 

o Studies identifying differential mechanisms of action for various 


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 
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 


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 

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


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:


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.


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:

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.


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.


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 by the letter of intent receipt date 
listed to:  

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 or express delivery)
Telephone:  (301) 443-2755


The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at 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 GrantsInfo, 
Telephone 301/710-0267, Email:


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 NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.

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:

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

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:

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 service)
Telephone: (301) 443-2755
FAX: (301) 443-0538

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 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.


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 the National Advisory Council on Drug Abuse.

Review Criteria

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 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:  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?  Are the goals and objectives of the application relevant 
to the RFA?

(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 
methods that will meet the goals of the RFA? 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 

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 

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

o The adequacy of the proposed protection for humans (including data safety 
monitoring plans), animals or the environment, to the extent they may be 
adversely affected by the project proposed in the application.


Letter of Intent Receipt Date:    March 11, 2002
Application Receipt Date:         April 11, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002


Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.


Potential applicants are strongly encouraged to contact the appropriate staff 
for additional information and specific application procedures or to clarify 
any issues.

Direct inquiries regarding programmatic issues to:

Cecelia L. McNamara, Ph.D.
Division of Treatment Research and Development
Behavioral Treatment Development Branch
National Institute on Drug Abuse 
6001 Executive Boulevard, Room, MSC 9551
Bethesda, MD  20892-9551
Telephone:  (301) 402-1488
FAX:  (301) 443-6814

Direct inquiries regarding review matters 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

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9541
Bethesda, MD  20892-9541
Telephone:	(301) 443-6710
FAX:  (301) 443-6847


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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