NIDA'S NATIONAL PREVENTION RESEARCH INITIATIVE:  USING BASIC SCIENCE TO DEVELOP 
NEW DIRECTIONS IN DRUG ABUSE PREVENTION RESEARCH

Release Date:  December 17, 2001

RFA:  RFA-DA-02-010

National Institute on Drug Abuse
 (http://www.nida.nih.gov)

Letter of Intent Receipt Date:  March 29, 2002
Application Receipt Date:       April 29, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED 
IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute on Drug Abuse (NIDA) is committed to a comprehensive 
program of research on drug abuse prevention.  The purpose of this initiative 
is to: (1) support basic behavioral, cognitive, developmental, social and 
neurobiological research necessary to inform the development of innovative 
and novel prevention interventions; and (2) support translational research 
that would begin to apply basic science knowledge to the development and 
improvement of prevention interventions.  It is NIDA's intention to: (1) 
encourage new directions in prevention science, attract new investigators 
from diverse and multiple scientific disciplines to prevention research, 
foster creativity and novel approaches, and develop new, innovative 
prevention interventions; and (2) support scientifically sound, model or 
theory-driven research that will have the greatest impact upon the public 
health. This announcement is one initiative in NIDA's new National Drug Abuse 
Prevention Research Initiative (NNPRI). The NNPRI uses a conceptual model of 
research and development to provide comprehensive support for all aspects of 
prevention research, along a continuum ranging from basic science through 
efficacy testing of promising new interventions, to effectiveness testing to 
large-scale systems trials. 

This RFA focuses on basic and translational science and the critical 
knowledge gaps that must be filled to lay the groundwork for developing, 
testing, and expanding innovative interventions to prevent drug abuse and 
addiction. It exclusively targets: (1) basic science research with 
demonstrated application to the development of novel and innovative 
prevention interventions; and (2) preliminary prevention intervention 
development that is truly novel, and unique.  The research proposals 
submitted under this announcement do not need to conduct prevention research, 
but investigators need to demonstrate and provide a clear statement 
indicating how proposed research will advance the understanding of preventing 
drug abuse and addiction.  Research that proposes to modify, expand or test 
previously developed and existing drug abuse preventions programs would not 
be appropriate under this particular RFA.  Investigators interested in 
conducting this type of research should contact NIDA staff to discuss other 
support and opportunities for this research at NIDA. 

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 RFA, NIDA's National 
Prevention Research Initiative:  Using Basic Science to Develop New 
Directions in Drug Abuse Prevention Research, is related to one or more of 
the priority areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS 

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.  

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
award (R01) and exploratory/development award (R21)  
(http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) mechanism.  The 
R21 application is limited to a 3-year effort and a maximum of $100,000 in 
direct costs per year.  Applicants using the R21 mechanism should consult 
with NIDA staff before requesting budgets exceeding $100,000 in direct cost.  
Applicants are advised to contact NIDA program staff listed under INQUIRIES 
for additional information.  

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 
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE

NIDA intends to commit approximately $2 million in FY 2002 in total funds to 
fund five to ten new Basic Science or Preliminary Prevention Intervention 
Development awards.  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 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.

RESEARCH OBJECTIVES

Background and Rationale 

Despite significant progress in the field of drug abuse prevention, critical 
knowledge gaps need to be filled to improve ongoing prevention efforts and 
develop wholly new and innovative strategies.  There are exciting 
opportunities to build on recent advances in behavioral, developmental, 
cognitive, and social sciences and neuroscience by integrating basic science 
with prevention research.  For example, discoveries from the field of 
neuroscience might facilitate the identification of biological mediators or 
moderators as targets for intervention.  Behavioral scientists could provide 
important information on how environmental, neurobiological and/or genetic 
factors interact and/or can be manipulated to reverse or attenuate 
vulnerability to drug abuse behaviors.  Cognitive scientists might contribute 
through model-driven research aimed at processes that guide decision-making 
under different contexts associated with risk taking. Researchers studying 
human development could focus on cognitive, behavioral, social or 
neurobiological processes that lead to, or influence drug abuse and 
addiction.  This RFA invites qualified researchers from diverse and multiple 
scientific disciplines to consider unique and "out-of-the-box" research 
proposals that address critical knowledge gaps in drug abuse prevention 
research.

Epidemiological research and etiological research have identified numerous 
risk and resiliency factors that predict initiation of drug abuse.  However, 
many of these influences are distal to drug abuse behaviors, occurring well 
before the onset of drug abuse.  While the impact of some of these risk 
factors cannot be easily overcome with prevention interventions, many are 
malleable and can be modified with existing prevention interventions.  
However, many of these interventions may not be appropriate for 
implementation on a large-scale basis (e.g., intensive family interventions).  
Research on multiple determinants and pathways to drug abuse has advanced our 
understanding of factors that lead to drug abuse, but has had little impact 
in helping us to develop interventions to change these determinants and 
pathways, and to ultimately prevent drug abuse.  Additional research is 
needed to: (1) characterize distal factors in terms of their underlying 
mechanisms, processes, and critical components that predict future drug 
abuse; and (2) develop approaches to modify these critical components to 
prevent the initiation of drug abuse or the escalation to addiction. 

Also there have been relatively few studies of interventions that target 
proximal determinants of drug abuse initiation, but such research has great 
promise for preventing the initiation of drug abuse.  For example, research 
on decision-making (particularly the decision to use a drug of abuse) and 
cognitive expectancies (particularly concerning the expectation about the 
effects of drugs of abuse) might have some direct relevance to prevention 
interventions aimed at changing the actual decision to abuse drugs.  
Similarly, research examining biases in information processing and memory 
(of, for example, experiences with drugs of abuse) and the role of emotion as 
expressed in cognition and automatic cognitive operations, might hold 
potential for application to new prevention interventions. 

Areas of Interest:

This announcement focuses exclusively on supporting (1) basic research that 
will have direct application to the development of innovative and novel 
prevention interventions, and (2) preliminary prevention intervention 
development research that involves research to develop, refine, and pilot 
test new, innovative prevention interventions.  Preliminary prevention 
intervention development includes model-driven, theory-based research aimed 
at translating basic research findings into novel or improved prevention 
interventions.  This initiative targets for funding, in a systematic way, 
essential research needed for developing prevention interventions for drug 
abuse and dependence.  This includes, in particular, critical areas of 
research that have been overlooked in the past. 
 
This RFA will support model or theory-driven research involving human 
volunteers in laboratory-based or (where appropriate) field settings. 
Interdisciplinary research, as well as research that targets particular 
populations, including children and adolescents, is encouraged.  Research 
directly aimed at studying drug abuse prevention could target a specific drug 
of abuse (e.g., cigarettes, marijuana) or drugs of abuse, and/or related drug 
abuse behaviors more broadly defined.  Studies employing preclinical models 
that can directly inform our understanding on the development of drug abuse 
prevention interventions would also be appropriate under this RFA.  

And finally, given that there is growing evidence that (a) the risk and 
resiliency factors and the basic mechanisms of drug abuse may differ for 
males and females and that (b) cognitive, social, and developmental processes 
are often gender-sensitive, researchers are strongly urged to incorporate a 
gender-based approach in their research design.

This announcement does not support research that proposes to modify, expand, 
decompose or test previously developed and existing drug abuse preventions 
programs. Applicants interested in conducting this type of research are 
encouraged to contact NIDA staff to discuss other support and opportunities 
for this research at NIDA. 

Illustrative examples of research described below serves as a guide and are 
not meant to subsume all research topics that would be appropriate under this 
announcement.

-Basic Research- 

o Research on social cognition across development.

o Research on how the use of language and verbal representation of 
information influences thinking about drug abuse.

o Research on the psychobiology of normal cognitive development, as well as 
abnormal development (including the development of executive and motivational 
inhibitory processes).

o Studies of normal and impaired decision-making (including the study of 
decision making processes in adolescents or younger school-age children).

o Studies of the role of emotion in cognition as it relates to susceptibility 
and resistance to drug abuse.

o Studies of the development of controlled and automatic behaviors and their 
modification (including issues related to self-regulation, impulsive behavior 
and learned associations).

o Studies using animal models to determine if exposure to known risk factors 
(e.g., stress, maternal separation or neglect, environmental isolation) for 
drug abuse can be ameliorated or overcome to reduce vulnerability to drug 
abuse. 

-Preliminary Prevention Intervention Development Research-

o Studies that apply or translate what is known from, basic social or 
cognitive and neurobiological development to improve or develop novel, 
innovative prevention strategies.

o Studies aimed at developing prevention interventions to positively alter 
proximal motivators of drug-using behavior.

o Studies that adapt or modify existing non-drug abuse theory-driven, 
empirically-supported prevention interventions that have been used to address 
problems other than drug abuse (e.g., adolescent pregnancy). 

o Studies that use models of decision-making and executive function to 
develop novel prevention interventions.

o Studies of the training of inhibitory or self-regulation skills.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 

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 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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html).  
A complete copy of the updated Guidelines is 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

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:   
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

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:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this announcement 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.

LETTER OF INTENT

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 IC 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:  

Director
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

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html 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 301/435-0714, Email:  GrantsInfo@nih.gov.

This announcement focuses on Basic and Prevention Intervention Development 
Research. Applicants who respond to this announcement must clearly specify 
whether, how, and why their research falls under Basic and Prevention 
Intervention Development Research. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 
http://grants.nih.gov/grants/funding/phs398/phs398.html 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: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

Submit a signed, typewritten original of the application, including the 
Checklist, and three 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)

At the time of submission, two additional copies of the application must be 
sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier or express delivery)

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.

REVIEW CONSIDERATIONS

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 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:  Does this study address an important problem? Does this 
research target gaps in knowledge that can contribute to drug abuse 
prevention?  If the aims of the application are achieved, how will scientific 
knowledge in drug abuse prevention program development be advanced?  What 
will be the effect of these studies on the concepts or methods that drive 
this field?

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

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods that have not previously been applied to the design of drug abuse 
prevention interventions? Are the aims original and innovative in their 
application to drug abuse prevention?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

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

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

(6) The relevance of the proposed work to the purpose of the RFA.

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 
evaluated.

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.

Schedule

Letter of Intent Receipt Date:    March 29, 2002
Application Receipt Date:         April 29, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

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

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.  

Direct inquiries regarding programmatic issues to:

David Shurtleff, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 443-1887
FAX:  (301) 594-6043
Email:  dshurtle@mail.nih.gov


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
Email:  tl25u@nih.gov

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
Email:  gf6s@nih.gov

AUTHORITY AND REGULATIONS

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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