Release Date:  December 20, 1999

RFA:  DA-00-004

National Institute on Drug Abuse

Letter of Intent Receipt Date:  February 28, 2000
Application Receipt Date:       March 28, 2000



This Request for Applications (RFA) encourages a new generation of drug abuse 
prevention research.  Applications are solicited to examine components of 
empirically validated drug abuse prevention interventions that may account 
for program effectiveness.  The purpose is to gain a better understanding of 
what accounts for program effectiveness through:  (1) empirical tests of 
theoretically derived processes that may account for program effectiveness, 
(2) identification of patterns related to differential effectiveness, (3) 
generating and testing alternate hypotheses accounting for effectiveness 
based on differential outcomes from previous research, and
(4) specification and testing of components singularly and in combination 
that contribute to effectiveness.


The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of “Healthy People 2000,” a PHS-
led national activity for setting priority areas.  This RFA, “The Next 
Generation of Drug Abuse Prevention Research,” is related to the priority 
area of alcohol and other drugs.  Potential applicants may obtain a copy of  
“Healthy People 2000” 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.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 
Investigators.  This RFA invites applications from both investigators with 
experience in drug abuse research and investigators who have not typically 
conducted drug abuse research. 


The mechanisms of support will include the investigator-initiated research 
project grant (R01) and the exploratory/developmental grant (R21).  
Applicants are advised to contact NIDA program staff listed under INQUIRIES 
for additional information and specific application procedures. 

Because the nature and scope of the research proposed in response to this RFA 
may vary, it is anticipated that the size of an award will vary also.  
Modular budgeting procedures apply for grants up to $250,000.  See for further 
information about modular budgets. 

When applying under the R21 mechanism, the applicant should obtain a copy of 
the R21 announcement, as it contains instructions for the preparation of the 
application and other useful information.  R21 grants are limited to $100,000 
in direct costs per year and to a 3 year effort.  The announcement may be 
obtained from NIDA staff or at


NIDA intends to commit approximately $2,000,000 in FY 2000 to fund six to 
seven new awards in response to this RFA.  Because the nature and scope of 
the research proposed may vary, it is anticipated that the size of each award 
will also vary.  Although the financial plans of the Institute 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 applications 
of outstanding scientific and technical merit.  


Over the past 20 years NIDA has supported research on a number of drug abuse 
prevention programs that have been shown to be efficacious and effective. 
Primary evidence for efficacy and effectiveness has taken the form of long-
term positive results in reducing the onset or progression of drug abuse 
among intervention compared to control group subjects. To date, demonstrating 
global results of effectiveness has been the goal of much prevention 
research.  Given the substantial number of empirically supported, theory-
based interventions available, the primary evolving questions address which 
components, strategies, or “active ingredients” account for program success 
alone or in interaction with other program components. Specifically, when 
drug abuse prevention programs work, what accounts for their success?  For 
whom do they work?  Under what conditions are they successful?  Answers to 
these questions should be expected to vary depending on the underlying 
theory, the program’s aims derived from that theory, the program’s content, 
the implementer, the target population, the delivery, and the interactions 
among these program aspects.  Addressing these questions is a necessary next 
step for prevention science.

Although few studies have focused exclusively on examining success-related 
drug abuse prevention program components and strategies in any depth, several 
have studied such factors.  These studies suggest that crucial components and 
strategies include the match between program aims and content delivered, 
number of sessions provided, the number of sessions attended, the match 
between the program delivered and the program designed, the use of 
interactive techniques, and the grouping of clients.  Research in other 
domains suggests that other components may also influence successful 
outcomes.  These include implementer training, “goodness of fit” between 
implementer and target population, characteristics of the target population, 
interpersonal communication styles, and sequence in which content is 
delivered.  Since these findings have emerged from program evaluation 
studies, few careful descriptions of how program components or strategies 
contribute to outcomes have emerged.  Further, these findings rarely rely on 
theory-driven analyses.  In addition, these studies have not yet tied results 
back to the theoretical aims that inform the development of program 
components.  Finally, these studies are only beginning to advance new 
hypotheses aimed at the refinement of underlying theories and program 
components.  In general, the active components and strategies of prevention 
interventions that account for successful outcomes have been inadequately 

At least four general areas should be considered in determining what accounts 
for program success; i.e.,  content, delivery, implementer, and client.  Each 
area may include active ingredients in the change process intended by the 
intervention, and both process and outcome research can provide important 
information.  Examples of unanswered research questions related to each of 
these four areas follow.


Theories on which prevention programs are based inform the development of 
program aims.  These aims, in turn, are used to develop program content.  
Because theories are multi-dimensional, most drug abuse prevention programs 
have multiple content components.  In general, multi-component programs have 
been found to be more effective than single-component programs.  However, 
little research has examined, either prospectively or retrospectively, the 
effectiveness of content components singularly or in combination.  It is 
possible, for example, that one component of a program may be ineffective in 
bringing about change when implemented alone, but in combination with another 
component(s), it may be very effective.  It is also possible that several 
components in combination account for the effectiveness of large multi-
component, multi-session interventions.

Effectiveness or ineffectiveness could also be related to the sequencing of 
content components.  Some prevention interventions use self-contained 
sessions or units whereas others use a curriculum approach with each session 
building on previous sessions. With each of these two approaches it will be 
important to discover if there are within or across session sequencing 

Finally, for some drug abuse prevention programs, the question may be whether 
the content, or something else, accounts for effectiveness.  For example, 
interactions between the target group and the group leader, or among members 
of the target group, may lead to changes in norms that then influence 
outcomes independent of content components.  Alternately, normative change 
could result from an interaction between content and environment.  Thus, what 
is effective in one setting may not be effective in another due to 
differences in either the environment or the target population. 


Delivery refers to the methods through which program content is imparted to 
program clients.  Delivery is perhaps the most well studied area with regard 
to components of drug abuse prevention effectiveness.  There is well-
documented evidence of effectiveness on components; such as, number of 
sessions provided, number of sessions attended, booster sessions, and match 
between program design and program delivered.  However, these components have 
not been well tied to the other component areas of content, client, and 
implementer.  For example, most drug abuse prevention interventions 
incorporate multi-component delivery systems.  Research exploring the 
differential effectiveness of these modes has found that interactive delivery 
strategies are more effective than didactic strategies.  However, there is 
little research to suggest why this is the case, which interactive methods 
are the most effective, and whether there are subgroup differences in 
delivery mode acceptance and effectiveness.  In addition, drug abuse 
prevention researchers have not yet examined which delivery modes account for 
the largest effects, whether widely used modes are indeed the most effective 
for imparting program content, whether the level of exposure interacts with 
subgroup differences, or whether there is situational specificity in 


For drug abuse prevention programming to be maximally useful it must be 
capable of being delivered by a wide variety of implementers.  However, there 
is wide variation in implementer characteristics that may influence 
effectiveness.  Some intervention studies have examined training, personal 
and interpersonal characteristics, and fit between target populations and 
implementers.  This research is only beginning to extend to drug abuse 
prevention.  Thus, characteristics related to implementers need to be 
examined to explore the possibility that the success of some program results 
are in large part contingent on the qualities of the group leader.  

Untapped areas of research include identifying overarching qualities of 
excellent implementers, examining whether excellent implementers are 
universally acceptable and successful with all targeted groups, and 
determining what qualities can be taught with lasting effect.  Further, 
characteristics of the implementer may influence the selection of content for 

In addition, research in other areas suggests that characteristics such as 
open interpersonal communication style, receptive body language, ability to 
empathetically listen, and social reinforcement of pro-social qualities are 
important characteristics of successful implementers.  However, qualities 
such as these may not affect all members of a target group in the same way.  
Moreover, there may be bi-directional effects in the implementer–individual 
client process such that those individuals who are experiencing positive 
changes may be more receptive and motivated.  In turn, when particular group 
members are more receptive and motivated this may make implementers more 
responsive in general.


Many prevention models are effective for some populations in some contexts.  
But what kinds of clients make what kinds of gains in specific program types, 
and why?  Characteristics of individuals and groups can include fixed 
characteristics, such as gender; receptivity characteristics, such as 
cognitive and communication styles; and grouping characteristics, such as 
high-risk behaviors. Theory-based drug abuse prevention programs typically 
specify target populations based on levels of client characteristics.  In 
general, the universal, selective, or indicated audiences classification is 
used, with some studies taking a tiered approach in which individuals are 
moved from universal to selective to indicated based on level of risk or 
need.  Beyond these rather global classifications, little work has focused on 
targeting prevention content to specific subgroups, and it remains unclear 
how well client characteristics fit with content, delivery, and implementer 
components of programs.

In some cases, it may be easier to uncover answers to these questions through 
data on universal interventions in which there is a full range of client 
types who can be carefully monitored to determine which program components 
appear to lead to the greatest gains for which subgroups.  Recent findings 
regarding gender differences in program effectiveness underscore both the 
usefulness of universal level data for examining these issues and the need to 
develop a better understanding of what subgroup characteristics influence 
effectiveness.  When specific subgroups are selected for inclusion, they tend 
to be high-risk populations.  These groups may offer special opportunities 
for uncovering client-related programming components because they maximize 
the potential for detecting interpersonal processes that might account for 
outcomes.  That is, when there is a high density of shared characteristics 
among member of the intervention group, it may be easier to detect underlying 
processes that contribute to or detract from program effectiveness.

Subgroup analyses can be used to provide feedback for program design and for 
the development of alternative hypotheses concerning the processes through 
which program content components may be more or less effective for subgroups.  
Further, some subgroups may self-select out of particular portions of the 
intervention.  Finally, program content should be examined in terms of 
whether the client actually learned or mastered the content in the way 

Barriers and Approaches

Moving into the next generation of drug abuse prevention research will be 
challenging.  Tying program aims, content, delivery, client, and implementer 
components to theory in a way that allows for decomposing theory into 
testable hypotheses is a difficult task.  In this applied area of research, 
this strategy will result in the ability to test the generated hypotheses and 
reformulate theory on the basis of the findings from experiments in real-
world settings.  

Challenges exist for accomplishing the drug abuse prevention research that 
will be necessary to answer questions about components.  A number of 
approaches could be taken in conducting the next generation of prevention 
research.  Data might come from existing longitudinal studies on a single 
implementation of a given program, from the collapsing of data across 
multiple replications of the same intervention, or through the conduct of 
small-scale microanalyses that address a limited number of hypotheses on 
specific components developed out of prior prevention research.  Specific 
approaches could include dismantling designs, tests of mediational models, or 
tests of process models.   Dismantling designs can be used to systematically 
add in or take away program components or to determine combinations of 
components that produce maximum effectiveness for specific subpopulations.  
Mediational models can use new or existing data to test specific hypotheses 
generated from the underlying theoretical base. Confirmation and 
disconfirmation of specific aspects of these models can lead to theory and 
program refinement.  Finally, process evaluations can be used to document and 
describe important sequences and patterns related to component effectiveness.

Despite the challenges inherent in conducting this research, there are 
important heuristic and practical reasons for moving in this direction at 
this time.  The field of prevention science is ready to enter into a phase of 
validating existing findings through de-composing the program components that 
contribute to those findings and, in so doing, build new hypotheses on active 
program elements.  This may set the stage for combining effective components 
from different interventions to create interventions that target unique 
community needs.


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 or justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This new 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 
“NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research,” published in the Federal Register on March 28, 1994 (FR 59 14508-
14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, 
March 18, 1994, available on the Web at:


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 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 Council before 
submitting an application that will administer compounds to human subjects.  
The guidelines are available on NIDA’s home page at or may be obtained by calling (301) 443-2755.


Prospective applicants are asked to submit by February 28, 2000, a letter of 
intent that includes a descriptive title of the overall proposed research; 
the name, address and telephone number of the Principal Investigator; and the 
number and title of this RFA.  In addition, the letter of intent should 
identify other “key personnel” who will be involved in the research and the 
names of their institutions. Although the letter of intent is not required, 
is not binding, does not commit the sender to submit an application, and does 
not enter into the review of subsequent applications, the information that it 
contains allows NIDA staff to estimate the potential review workload and to 
plan for the review of the applications.  

The letter of intent is to be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, 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.  Application kits are available at most 
institutional offices of sponsored research and may be obtained 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 


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 the 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 key project personnel, including their names, percent 
of effort, and role in 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 in 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.  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 
title and number of this RFA must be typed in Item 2 on the face page of the 
application form, and the YES box must be marked.  The RFA number must be 
typed on the label as well.

The sample RFA label is 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 Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)

Applications must be received by March 28, 2000.  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 the 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.  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.


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.

(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?  
For the R21 mechanism, a strong rationale and conceptual framework are 
normally sufficient for establishing the feasibility of the project in lieu 
of extensive preliminary data.  This may be true of some R01 applications as 

(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 

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, as appropriate for the scientific goals of the research.  Plans 
for the recruitment and retention of subjects will also be evaluated.
-  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.
The adequacy of plans for including children as appropriate for the 
scientific goals of the research.

Letter of Intent:          February 28, 2000
Application Receipt Date:  March 28, 2000
Council Review:            September 2000
Earliest Start Date:       September 29, 2000


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 inquiries regarding programmatic issues to:

Elizabeth Robertson, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room. 5160, MSC 9589
Bethesda, MD 20892-9589
Telephone:  (301) 443-1514
FAX:  (301) 443-2636

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) 594-6847

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Director, Office of Extramural Program Review
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 the Public Health Service 
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 
USC 241 and 285) and are administered under PHS grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Part 74.  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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