Release Date:  December 31, 2001

RFA:  RFA-DA-02-004

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 26, 2002
Application Receipt Date:       April 26, 2002


The National Institute on Drug Abuse (NIDA) invites applications to 
participate in NIDA's National Prevention Research Initiative (NNPRI), which 
is comprised of three components: 1) Community Multi-Site Prevention Trials 
(CMPT), 2) Transdisciplinary Prevention Research Centers (TPRCs), and 3) 
Basic Prevention Science grants.  This Request for Applications (RFA) calls 
for investigator-initiated research project grant applications (R01) for the 
Community Multi-Site Prevention Trials component. The overall goal of the 
CMPT is to accelerate research on the processes and mechanisms that 1) 
contribute to the adoption, adaptation, and implementation of science-based 
prevention models, and 2) examine prevention delivery factors such as 
structural features, management practices, and financial strategies that 
foster the sustainability of such models in community settings.  

This goal will be accomplished through the support of several field trials, 
each of which will study one science-based drug abuse prevention intervention 
in several experimental and control sites. Strong collaboration among 
researchers, prevention practitioners, and state and local agency partners is 
an essential component of CMPT field trials.

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, "NIDA National 
Prevention Research Initiative (NNPRI):  Community Multi-Site Prevention 
Trials (CMPT)," 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 
nonprofit organizations, private and public, such as universities, colleges, 
hospitals, laboratories, units of State or local governments, and eligible 
agencies of the Federal Government.  Faith-based organiztions are eligible to 
apply for these grants.  Racial/ethnic minority individuals, women and persons 
with disabilities are encouraged to apply as principal investigators.  Because 
of 1) the objective to conduct rigorous research on aspects of prevention 
practice and 2) the complexity of the required research designs, it is 
important for the principal investigator to commit a minimum of 30% time to 
the CMPT.


This RFA will use the National Institutes of Health (NIH) 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 (5) 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 September 2002.


NIDA has set aside $4 million to support the total costs of establishing 
Community Multi-Site Prevention Trials (CMPT) in FY 2002. This level of 
support is dependent on the receipt of a sufficient number and diversity of 
applications of high scientific merit. NIDA expects to make up to 4 to 8 
awards under this RFA for project periods of up to five years of support. 
Because the nature and scope of the research activities proposed in response 
to this RFA may vary, it is anticipated that the size of individual awards 
will also vary.  Budget requests should be carefully justified and 
commensurate with the complexity of the project.  Although this program is 
provided for in the financial plans of the NIDA, awards pursuant to this RFA 
are contingent upon the availability of funds for this purpose. 



Over the past 25 years, the field of drug abuse prevention science has 
demonstrated the efficacy and effectiveness of a number of prevention 
programs and strategies.  The most successful have focused on skill and 
competency building in the personal, social, and academic arenas among a 
variety of populations and in a variety of settings.  Interventions generally 
include content that addresses key mediators of subsequent drug use such as:  
school bonding and commitment, drug refusal skills, alternative behaviors, 
decision-making and management skills, and parental monitoring skills.

Of the large number of interventions that have undergone testing, a limited 
number have been subjected to Field Trials (FTs)(see Definitions).  These FTs 
have provided important data on the ability to maintain significant program-
related reductions in initiation and progression of drug abuse across 
contexts and over time. However, they have not examined the processes and 
mechanisms associated with the successful implementation of science-based 
interventions in communities.  NIDA has identified this gap area in 
prevention research as a priority. The CMPT FTs will conduct research on 
processes and mechanism that influence the successful adoption, adaptation, 
and sustainability of programs at the community level.  

Specific Objectives

o Conduct research on barriers and facilitators to the adoption, adaptation, 
implementation and successful outcomes of science-based drug abuse prevention 

o Conduct research to identify strategies that maximize human, financial, and 
temporal resources that contribute to the affordability and practicality of 
implementing science-based drug abuse interventions in communities;

o Conduct research on structural, management and financial delivery features 
that contribute to sustainability of prevention approaches when taken to 

Inclusion Criteria for Interventions

Each CMPT FT can include only one intervention with demonstrated high 
standards of evidence of effectiveness.  At a minimum, the intervention must 
have successfully undergone a randomized control group design efficacy study 
and a small-scale controlled effectiveness trial [see Definitions].


The types of studies appropriate to the CMPT FTs include, but are not limited 
to, those that take to scale research-based drug abuse prevention 
interventions to determine adoption, adaptation, and implementation 
strategies that influence successful outcomes and sustainability in "real 
world" settings. Intervention types could include family-, school-, 
community-, workplace-, media-based, or multi-component programs that have 
shown reductions in initiation or progression of drug use through efficacy 
and small-scale effectiveness trials. Research on diverse populations and 
communities is encouraged. Specific examples might include:

o Studies that examine the mechanism and processes that account for 
differential effectiveness of interventions with specific populations defined 
by for example level of risk, gender, or location;

o Multidisciplinary research to improve the likelihood that a successfully 
implemented prevention intervention continues to remain effective over time;

o Studies to determine how a prevention intervention shown to be efficacious 
in a controlled experimental study can sustain its effectiveness when 
implemented on a large scale; and

o Studies to examine critical organizational, managerial, or economic 
components of an effective intervention for at-risk youth.


Efficacy Studies test theory-based models of interventions to demonstrate 
hypothesized prevention outcomes in small, randomized, control-group design 

Small-scale Effectiveness Trials test the effectiveness of efficacious 
interventions in larger populations (i.e., several hundred subjects per 
condition) with control-experimental group designs. These trials are less 
stringent in their control of contextual influences, but are comprehensive in 
the documentation of these influences.

Field Trials test adaptability, practicality and transportability in a variety 
of populations, contexts, and geographic locations of interventions shown to 
be effective in small-scale trials.  These studies focus on the explication of 
delivery and implementation features that lead to effective adoption, 
adaptation, outcomes and sustainability of interventions taken to scale. 

Characteristics of CMPT FTs:

Each study must:

o Select, in accordance with the Inclusion Criteria, a single prevention 
intervention to test, and provide documentation on availability of tools and 
training materials for replication and adaptation;

o Include both experimental communities and control communities;
o Establish and define roles and responsibilities for a Community 
Practitioner Advisory Board (CPAB), composed of representatives of local 
organizations that support drug abuse prevention programming, which will 
actively collaboration with scientific and site-specific implementation 
staff, in the design and implementation of the FT research. 


Applicants should document their ability to recruit a sufficient number of 
participants and implementation sites, and should demonstrate their ability 
and willingness to work collaboratively with the CPAB and implementation site 


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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 is 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 differences.


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.


As of the October 2000 receipt date, applicants must supply a general 
description of the Data and Safety Monitoring Plan for ALL clinical trials; 
this must be included in the application  For 
purposes of reviewing applications submitted to the NIH, a clinical trial is 
operationally defined as a prospective biomedical or behavioral research 
study of human subjects that is designed to answer specific questions about 
biomedical or behavioral interventions (drugs, treatments, devices, or new 
ways of using known drugs, treatments, or devices). The degree of monitoring 
should be commensurate with risk. NIH Policy for Data and Safety Monitoring 
requires establishment of formal Data and Safety Monitoring Boards for multi-
site clinical trials involving interventions that entail potential risk to 
the participants. The absence of this information will negatively affect the 
priority score.


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 PI, the identities of other key personnel and participating 
institutions, and the number and title of the RFA in response to which the 
application may be submitted.  Although a letter of intent is not required, 
is not binding, and does not enter into the review of a subsequent application, 
the information that it contains allows IC staff to estimate the potential 
review workload and plan the review.

The letter of intent is to be sent to: 

Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (express/courier service)
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 Grants Info, 
Telephone 301/710-0267, Email:


Specific content must be present in the application to document the technical 
and scientific merit of the applicant's plan for an FT that will be able to 
address the fundamental goals of the RFA.  Unlike the usual 25-page length 
limitation of the R01, applicants may use up to 35 pages to present their 
plans, as described below.  The use of tables, diagrams, organizational and 
flow charts is strongly encouraged and must be included within the 
page limitation.


Application package should include the following:

Scientific and community collaboration:

o The application must provide letters of commitment from implementation site 
officials, representing themselves, their facilities, and site-specific 

o Documentation must be provided about the formation, membership and 
responsibilities of a Community Practitioner Advisory Board (CPAB) including 
a description of how collaboration among the scientists, the CPAB, and site-
specific officials and intervention staff will be established and maintained. 
The CPAB is expected to be an active participant in the research process; 
letters of commitment must be included.

o Documentation shall describe how coordination and involvement of relevant 
state and local authorities will be achieved. 

Research concepts and planning: 

o The research plans for the proposed FT should include descriptions of: site-
specific selection criteria for and description of the intervention and tools 
and materials needed for implementation; study design and statistical 
considerations; access to appropriate subjects and sites; procedures for data 
management, quality control and follow-up; procedures for monitoring and 
reporting adverse events. 
o The plans must document the availability of appropriate expertise within the 
FT to design, implement, and analyze the results of the proposed trial. 

o The plans must describe the framework and procedures for training and 
supervision of implementation staff in the experimental condition. 

o The application must be specific about how the FT will recruit and retain 
sufficient subjects to participate in the ongoing trial and how subjects 
within sites or sites themselves will be randomly assigned to experimental or 
control condition.

o Applicants must describe how implementation site staff will function in 
partnership with the scientific staff in terms of study design, execution and 
administration. Applicants should anticipate problems and challenges related 
to this process, and propose mechanisms for collaborative resolutions. The 
NIH policy regarding consortium agreements should be considered in describing 
the relationship between the implementation site, implementation staff 
and scientists.

o The PI must describe his/her own qualifications and experiences and ability 
to access and utilize other professionals with specialized expertise needed to 
design and implement the proposed FT.

o The PI must demonstrate the ability to provide scientific commitment and 
leadership to the research agenda and the proposed trial (a minimum of 
30% time). 

o Justification for a FT to serve either a defined or diverse racial, ethnic 
or geographic population should be described. 

o Evidence of current or previous successful collaborations with community 
prevention programs and participation in collaboration with other research 
centers is desirable.

o Plans for data management and information management systems should 
be specified.


o The applicant should prepare a composite budget as well as separate 
detailed budget estimates for: 1) infrastructure including personnel, 
facilities, equipment, supplies, training costs, logistical support, travel, 
etc.; 2) support to conduct the FT; 3) study specific costs, such as training 
(of implementers, or data manager), data management, monitoring costs, 
publication costs, for the research project; and 4) travel to participate in 
an annual CMPT meeting.

o Composite budget:  Use page 4, "Detailed Budget for Initial Budget Period," 
of Form PHS-398 to present the total budget for all requested support for the 
first year.  For each category, such as "Personnel," "Equipment," etc., give 
the amount requested. Use page 5, "Budget for Entire Proposed Project 
Period," of Form PHS-398 to prepare a budget, by category that provides 
totals for each year of requested support.  Requests for any increases in 
succeeding years must be justified.

o Budget justifications and explanations:  First year--use page 4 of the PHS-
398; total project period Years 2-5--use page 5 of the PHS-398.  Describe the 
specific functions of all key personnel, consultants, collaborators, data 
management staff, training staff, and administrative and other support staff.  
For all years, explain and justify resources necessary for the operational 
management, data information systems, travel, and any unusual items such as 
major equipment.  For additional years of support requested, justify any 
significant increases or decreases in any category over the first 12-month 
budget period, identifying such changes with asterisks against the 
appropriate amounts.  If a recurring annual increase in personnel or other 
costs is anticipated, give the percentage; however, current NIH practice 
limits escalation to 3%.

Biographical sketches (as described in the Instructions for Form PHS-398) are 
required for all key personnel corresponding to personnel listed on page 2.  
Begin with PI, Co-PIs in alphabetical order, and thereafter other key staff 
in alphabetical order.

Page limits: The total length of the Research Plan, including the CMPT 
descriptions and research concepts, and administrative and management plan 
should not exceed 35 pages. No specific page limits apply to the Budget, 
Human Subjects, Literature Cited, or Consortium/Contractual 
Arrangements sections. 

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 courier/overnight services) 

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 Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier/overnight services)
Telephone:  (301) 443-2755 

Applications must be received by April 29, 2002. If an application is 
received after this date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application. The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique. 


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.

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 review criteria stated below.  As part of 
the initial merit review, all applications will receive a written critique.  
Those applications deemed to have the highest scientific merit will be 
discussed assigned a priority score, and receive a second level review by the 
National Advisory Council on Drug Abuse. 

Review Criteria

Applications will be reviewed for scientific and technical merit using the 
following criteria. Applicants should note that the criteria incorporate 
consideration of the quality and feasibility of the proposed activities as 
well as consideration of past performance. 

Significance.  Does this study address an important research problem related 
to the theme of the Community Multi-site Prevention Trials? Does the 
scientific merit and experimental design of the project adequately address 
issues of substantive importance for informing prevention trial development 
efforts. Will the study contribute to the overall goal of the CMPT through 
the acceleration of research on the processes and mechanism that contribute 
to the adoption, adaptation, and sustainability of research-based drug abuse 
prevention programming?
Approach.  Is the feasibility of the proposed trial supported by prior 
efficacy studies and small-scale effectiveness trials with demonstrated 
positive effects? Are the conceptual research framework, design, methods, and 
analyses adequately developed, well integrated and appropriate to the aims of 
the project?  Does the approach demonstrate knowledge of state-of-the-art 
prevention research designs and methodologies?  Are there adequate criteria 
for selecting community-based programs as implementation sites, balanced by 
the constraints of reasonable management?  Where feasible and appropriate to 
the research aims, does the application document the ability to accrue a 
demographically diverse population? Is there an adequate plan for subject 
recruitment, enrollment, retention and program evaluation, including the 
ability to accrue subjects at an adequate rate to support the FT?  Are there 
adequate plans for overall management and operations as well as for data 
management, including adequacy of the plan for implementing data standards, 
data collection, analysis and training?

Innovation.  Does the project develop new methodologies or technologies in 
the conduct of prevention field trials?    
Investigators.  Are the investigators appropriately qualified with 
demonstrated competence to conduct the proposed CMPT FT?  Is the proposed 
work appropriate to the experience level of the principal investigator and 
project researchers?  Does the PI have adequate time commitment,  
qualifications and research experience, including but not limited to, 
previous experience with design, administration and management of prevention 
intervention effectiveness studies or multi-site trials?  Are there 
appropriate qualifications among key personnel and scientific staff in their 
project-related research roles, including: statistical and data management, 
project administration, operational management, intervention implementation, 
and data information systems. Is there previous experience and adequate plans 
for training intervention implementers and research associates in 
implementing the FT?  
Environment.  Does the scientific environment in which the work will be done 
contribute to the probability of success?  Is there adequate documentation of 
on-going communication, coordination and involvement with relevant state and 
local practitioners and agencies?  Is there adequate documentation of the 
establishment of a Community Practitioner Advisory Board and the 
collaborative roles and responsibilities of the CPAB in the design and 
progression of the research?  Is there adequate documentation of commitment 
and intent to participate by implementation site officials, representing 
themselves, their facilities, and their staff?  
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, including requests for: 1) infrastructure including 
personnel, facilities, equipment, supplies, training costs, logistical 
support, travel, etc.; 2) support to conduct the field trial; 3) study 
specific costs, such as training (of implementers, or data manager), data 
management, monitoring costs, publications costs, for the research project and 
4) travel to participate in an annual CMPT meeting.
o The adequacy of the proposed plans for protection 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.


Applications recommended for further consideration by the National Advisory 
Council on Drug Abuse will be considered for funding based upon: (a) 
scientific and technical merit; (b) program balance; (c) applicant 
organization; and (d) availability of funds. 


Letter of Intent Receipt Date:  March 26, 2002
Application Receipt Date:       April 26, 2002
Scientific Review Date:         June/July 2002
Council Meeting Date:           September 2002
Earliest Award Date:            September 30, 2002


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

Direct inquiries regarding programmatic issues to: 

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

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

Direct inquiries regarding peer review issues to: 

Teresa Levitin, Ph.D.
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755

Direct inquiries regarding fiscal matters to: 

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


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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