BEHAVIORAL THERAPY DEVELOPMENT AND BEHAVIORAL SCIENCE

Release Date:  December 23, 1998

RFA NUMBER:  

P.T.

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 29, 1999
Application Receipt Date:  April 29, 1999

THIS RFA USE THE JUST-IN-TIME CONCEPT.  IT INCLUDES DETAILED MODIFICATIONS TO
STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN
APPLICATION IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute on Drug Abuse (NIDA) requests applications for research
aimed at the development of behavioral therapies (Stage I research) for drug
addiction based upon basic behavioral and cognitive science.  The purpose of
this  Request for Applications (RFA) is to encourage innovative research on
the development of new and refinement of existing behavioral interventions for
the treatment of drug addiction.  The translation of ideas from basic
behavioral and cognitive science into novel behavioral interventions for drug
addicts is the ultimate goal of this program.  Research projects will be
considered that integrate basic behavioral and/or cognitive science with
behavioral therapy development research, with the aim of developing new or
refining existing behavioral therapies for individuals in drug abuse
treatment.

HEALTHY PEOPLE 2000

The Public Health Service 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 is related to the priority area
of alcohol and other drugs.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or Summary
Report:  Stock No. 017-001-00473-1) from the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800)
or electronically at http://odphp.osophs.dhhs.gov/pubs/hp2000

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and
nonprofit organizations, public and private; such as, colleges, universities,
hospitals, laboratories, units of state and local government, and eligible
agencies of the federal government.  Racial/ethnic minority individuals, women
and persons with disabilities are encouraged to apply as Principal
Investigators.  Awards to foreign institutions under other research (R-series)
mechanisms are generally limited to 3 years.

MECHANISM OF SUPPORT

Research support mechanisms under this RFA are the National Institutes of
Health (NIH) research project grant (R01) and the exploratory/developmental
grant (R21) mechanisms.

The total project period for an application submitted in response to this RFA
may not exceed five years.  The anticipated award date is September 30, 1999. 
This RFA is a one-time solicitation.  Future unsolicited competitive
supplement applications will compete with all investigator-initiated
applications and be reviewed according to standard peer review procedures.

Exploratory/Developmental (R21) applications are limited to three years and
$90,000 direct costs per year.  The R21 mechanism is intended to encourage
exploratory research projects with sound methodology and strong rationales in
underdeveloped research areas.  There are additional special requirements for
this mechanism; if an applicant intends to apply for R21 award under this RFA,
he or she should contact the program official listed under the INQUIRIES
section for further information.  Specific information on individual research
mechanisms can be obtained from the NIDA home page at:
www.nida.nih.gov/Funding.html.

Applications submitted in response to this RFA will use the Just-In-Time (JIT)
submission procedures.  These procedures were published in the NIH Guide, Vol.
25, No. 10, March 29, 1996, with additional instructions published in Vol. 25,
No. 16, May 17, 1996.  Copies of these two Guide publications are available
from the contact person listed under INQUIRIES and on the NIH Guide website
at: https://grants.nih.gov/grants/guide/

FUNDS AVAILABLE

A total budget for FY 1999 of $1.5 million will be committed to fund
applications submitted in response to this RFA.  This funding level is
dependent upon the receipt of a sufficient number of applications of high
merit.  It is anticipated that approximately five to eight awards will be made
in FY 1999.

RESEARCH OBJECTIVES

Behavioral therapy alone or in combination with medication remains the
mainstay of drug addiction treatment.  However, even though many forms of
behavioral therapy have been shown to be efficacious, some patients do not
succeed  in treatment and some have only limited success. In addition, drugs
of abuse and populations of drug abusers are continually changing.  Hence,
there is a need to develop new or modify existing behavioral therapies for
patients who do not respond or do not respond fully to currently available
treatments.

Basic behavioral and cognitive research has been useful in explicating basic
principles of  behavior and behavior change, and there exists the potential
for these principles to be applied in the treatment of addiction.  Similarly,
research paradigms used in the basic behavioral and cognitive sciences could
be adapted for use with patient populations, with the ultimate goal being the
development of behavioral therapies for drug addiction.

The objective of this announcement is to encourage "Stage I" behavioral
therapy research based on knowledge gained and/or research paradigms from
other areas of cognitive and behavioral science.  Stage I, the initial stage
of behavioral therapy development research, is an iterative process involving: 
1) identifying promising behavioral and cognitive theories and research
relevant to treatment; 2) generating and formulating new cognitive or
behavioral therapies (or modifying an existing therapy) based upon this theory
and research; 3) creating therapy manuals in which the therapies are
operationally defined and the principles underlying the therapies are
explicated; 4) pre- or pilot-testing of  the therapies; 5) refining and
modifying the therapies as needed.  Translational Stage I research integrates
theories, research findings, and paradigms from basic behavioral and cognitive
science into research aimed at the development of a new behavioral therapy, or
the modification of an existing therapy.  It also involves testing the theory
or hypothesis upon which the proposed new therapy or therapy modification is
based. Although some researchers conduct both behavioral therapy and basic
behavioral or cognitive research, many conduct one type of research or the
other.  Therefore, collaboration among investigators is encouraged where
appropriate.

Stage I research is encouraged that is based upon basic behavioral or
cognitive science and also integrates such research into the therapy
development process.  Such translational research may be based on ideas,
principles, and/or research paradigms in various areas of behavioral and
cognitive science including, but not limited to, the following areas:

Behavioral economics
Cognition and cognitive biases
Decision-making
Emotion
Memory and memory biases
Motivation
Psycholinguistics

Theoretically-driven research based in any of the above or other areas of
behavioral and cognitive science is encouraged.  Examples of translational
Stage I research proposals include:

o  A proposal to develop, utilizing a radical behavioral research paradigm, a
novel form of behavioral therapy for nicotine-addicted individuals.

o  A proposal to develop a more efficacious form of cognitive-behavioral
therapy for heroin-addicted, depressed individuals based upon research on
differential cognitive schemas in depressed versus normal individuals.

o  A proposal to develop an improved version of family therapy for poly-drug
abusing adolescents based upon research on the expression of hostility and
criticism within the family.

Applicants are not limited to the examples listed above and may propose to
develop any behavioral therapy/intervention that is based in behavioral or
cognitive science and is aimed at the treatment of any population of drug
addicted individuals.

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 subpopulations 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 research
involving human subjects should read the "NIH Guidelines for Inclusion of
Women and Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and
in the NIH Guide for Grants and Contracts, Vol. 3, No. 11, March 18, 1994.

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

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS

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 before submitting an
application that will administer compounds to human subjects.  The guidelines
are available on NIDA's Home Page at http://www.nida.nih.gov under "Funding"
or may be obtained by calling (301) 443-2755.

LETTER OF INTENT

Prospective applicants must submit, by March 29, 1999, a letter of intent that
includes a descriptive title of the proposed program, the name, address,
telephone, FAX, and E-mail numbers of the Program Director; the names 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  binding and does not enter into the review of subsequent
applications, the information that it contains permits the NIDA to estimate
the potential review workload.

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

APPLICATION PROCEDURES

Prospective applicants are encouraged to contact the staff person listed under
INQUIRIES early in the planning phase of the application.  NIDA program staff
can provide guidance and discuss responsiveness issues with prospective
applicants.

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most institutional
offices of sponsored research and 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, email:
GrantsInfo@nih.gov.

"Just-in-time" (JIT) is an initiative of the National Institutes of Health
(NIH) Extramural Reinvention Laboratory under the auspices of the National
Performance Review and government-wide efforts to create a government that
works better and costs less.  JIT postpones the collection of certain
information that currently must be included in all competing applications when
submitted.  The information for the applications with a likelihood of funding
is submitted "just-in-time" for awards to be made.  This program announcement
is incorporating JIT procedures as described below.  Some sections are
modified and others in the application do not need to be completed for the
submission of the application, but WILL be requested if your application
receives a priority score in the fundable range.

Form DD - Page 4 - DETAILED BUDGET PLAN FOR INITIAL BUDGET PERIOD
Do not complete this form on page 4 of the PHS 398 (rev. 5/95).  It is not
required nor will it be accepted at the time of the application.

Form EE - Page 5 - BUDGET FOR THE ENTIRE PROPOSED PROJECT

Do not complete the categorical budget table form on page 5 in the PHS 398
(rev. 5/95).  Only the requested total direct costs for each year and total
direct costs for the entire proposed period of support should be shown.  Begin
the budget justification in the space provided, using continuation pages as
needed.

Budget Justification

o  List the name, role on project, and percent effort for all project
personnel (salaried or unsalaried) and provide a narrative
justification for each person based on his/her role on the project and
proposed level of effort.

o  Identify all consultants by name and organizational affiliation and
describe the services to be performed.

o  Provide a narrative justification for any major budget items, other than
personnel, that are requested for the conduct of the project that would be
considered unusual for the scope of the research.  No specific costs for items
or categories should be shown.

o  Indirect costs will be calculated at the time of the award using the
institution's actual indirect cost rate.  Applicants will be asked to identify
the indirect cost exclusions prior to award.

o  If consortium/contractual costs are requested, provide the percentage of
the subcontract total costs (direct and indirect) relative to the total direct
costs of the overall project.  The subcontract budget justification should be
prepared following the instructions provided above.

Biographical Sketch - A biographical sketch is required for all key personnel,
following the modified instructions below.  Do not exceed the two-page limit
for each person.

o  Complete the education block at the top of the form page;

o  List current position(s) and those previous positions directly relevant to
the application;

o  List selected peer-reviewed publications directly relevant to the proposed
project, with full citation;

o  Provide information on research projects completed and/or research grants
participated in during the last five years that are relevant to the proposed
project.  Title, principal investigator, funding source, and role on project
must be provided.

Other Support - Do not complete the other support page (format page 7 of the
PHS 398 (rev. 5/95)).  Information on active support for key personnel will be
requested prior to award.

Checklist - Do not submit the checklist page.  For amended and competing
continuation applications, applicants must complete the block in the upper
right corner of the face page to indicate the previous grant number.  A
completed checklist will be required prior to award.

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 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.

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 Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547

Applications must be received by April 29, 1999.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDA.  Applications that are complete and responsive
will be evaluated for scientific and technical merit by a peer review group
convened by the NIDA in accordance with the standard NIH peer review
procedures.  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 Drug Abuse
Council.

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 the 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.  Relevance:  What is the extent the aims of the proposal are relevant to
the purpose and objectives of the RFA?

2.  Significance:  Does the proposal address an important problem?  If the
aims of the proposal are realized, how will scientific knowledge be advanced?

3.  Innovation:  Does the proposed clinical research involve theory, methods,
or concepts derived from basic behavioral science that are new to behavioral
therapy research?  Are the goals creative and original?  Does the proposal
challenge existing research paradigms or facilitate the development of new
methodologies?

4.  Integration:  Does the proposal successfully integrate basic behavioral
science theory, concepts and/or methods into research on the development of a
therapy?  Where collaboration is necessary to achieve this goal, is the
collaborative effort well-conceptualized?

5.  Approach:  Are the conceptual framework, design, methods, and analyses
satisfactorily developed and appropriate to the aims of the project?  Is the
project feasible?  Does the applicant acknowledge potential problem areas and
consider alternative approaches?

6.  Investigator:  Is the investigator well-qualified to conduct this
research?  If collaboration is proposed, are the co-investigators similarly
well-qualified?

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

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

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 above criteria apply to R01 applications, and there are additional
criteria for the R21 mechanism.  When applying under the R21 mechanism, the
applicants should obtain a copy of program announcement PA-98-004 from either
their office of sponsored research or from the NIH Guide website
(https://grants.nih.gov/grants/guide/pa-files/PA-98-004.html).  This program
announcement contains instructions for the preparation of R21 grant
applications.

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

Inquiries regarding programmatic issues may be directed to:

Lisa Onken, Ph.D.
Division of Clinical and Services Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4229, MSC 9563
Bethesda, MD  20892-9563
Telephone:  (301) 443-0107
Email:  lo10n@nih.gov

Direct inquires 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
Email:  gf6s@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.855 and 93.856.  Awards are made under the authority of Title III, Section
301, of the PHS Act as amended.  The Code of Federal Regulations, Title 42
Part 52 and Title 45 Part 74, are applicable to this program.  This program is
not subject to the intergovernmental review requirements of Executive Order
12372 to Health Systems Agency review.

The PHS strongly encourages all grant and contract 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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