DRUG ABUSE PREVENTION INTERVENTION RESEARCH

Release Date:  October 5, 1999

PA NUMBER:  PA-00-002 (This PA has been reissued, see PA-05-118)

National Institute on Drug Abuse

THIS PROGRAM ANNOUNCEMENT (PA) USES THE "MODULAR GRANT" CONCEPT. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

This Program Announcement (PA) replaces the following:  PA-91-73, Drug Abuse
Prevention Research, NIH Guide, Vol. 20, No. 26, July 5, 1992, PA-94-056,
Comprehensive Prevention Research in Drug Abuse, NIH Guide, Vol. 23, No. 15,
April 15, 1994, PA-94-061, School-Based Intervention Research, NIH Guide, Vol.
23, No. 16, April 29, 1994, PA-96-013, Drug Abuse Prevention Through Family
Intervention, NIH Guide, Vol. 25, No. 1, January 26, 1996, PA-96-018, Drug
Abuse Prevention Interventions for Women and Minorities, NIH Guide, Vol. 25,
No. 2, February 2, 1996.

The purposes of the National Institute on Drug Abuse"s (NIDA) prevention
research program are: to examine the efficacy and effectiveness of new and
innovative theory-based prevention approaches, to determine the components of
research-based intervention strategies and programs that account for
effectiveness of approaches, to clarify factors related to the effective and
efficient provision of prevention services, and to develop and test
methodologies appropriate for studying these complex aspects of prevention
science.  Prevention science takes a multi-disciplinary systems perspective in
examining interactions, transactions, and mechanisms within and across levels
of the human environment that deter the development of substance abuse
patterns and addiction.  To accomplish this, NIDA funds investigator-initiated
research focusing on developmentally appropriate universal, selective, and
indicated drug abuse prevention strategies for individuals, groups, and
specific populations.  Contexts of interest include the family, peer-group and
community (schools, workplace, neighborhood, media), and focus on these venues
as arenas for prevention from the intra-individual level through to the policy
level.

HEALTHY PEOPLE 2000

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 PA, "Drug Abuse Prevention
Intervention Research" is primarily related to the priority area of Healthy
Promotion/Alcohol and Other Drugs.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report: Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC 
20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, 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.  Foreign institutions are not eligible for
program projects or centers (P-series) awards.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
principal investigators.

MECHANISM OF SUPPORT

The mechanisms available for support of this PA are research project grants
(R01), small grants (R03), exploratory/developmental grants (R21), program
projects (P01), and research centers (P30, P50, and P60).  Application for
Research Centers must be in accordance with the NIDA guidelines for Research
Center applications.  More specific information about individual research
mechanisms can be obtained from the NIDA home page at: 
http://www.nida.nih.gov/funding.html.

Because the nature and scope of the research proposed in response to this PA
will vary, it is anticipated that the size of an award will vary also. 
Applications requesting direct costs of $500,000 or more in any one year must
obtain agreement from the assigned institute that the application will be
accepted for review and consideration of award, in accordance with the policy
of the National Institutes of Health (NIH), which is available at
https://grants.nih.gov/grants/guide/notice-files/not98-030.html.  Applicants
must identify in the cover letter sent with the application the specific NIH
office and staff member who agreed to accept assignment of the application.

"MODULAR GRANT APPLICATION AND AWARD" procedures will apply to all competing
individual research project grants (R01), small grants (R03), and
exploratory/developmental grants (R21) applications requesting up to $250,000
direct cost per year.  Complete and detailed information about modular grant
applications, including a sample budget narrative justification page and a
sample biographical sketch, is available via the Internet at URL:
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

Background and Significance

A priority of NIDA is to develop and disseminate science-based drug abuse
prevention knowledge.  Drug abuse prevention research applies theories and
empirical findings on the biologic, genetic, psychological, social, and
environmental origins of the onset and progression of drug abuse and addiction
to the design, development, and testing of prevention strategies and
interventions.  NIDA"s prevention research program is designed to identify and
test promising theory-based prevention practices, to examine program
components that account for effectiveness, and to promote the adoption of
effective prevention strategies.  Primary goals of prevention intervention
research are:  (1) to design, develop, and test innovative, theory-based
prevention strategies that build on research on the origins and pathways to
drug abuse and addiction, (2) to assess the effectiveness of efficacious
strategies and interventions under less controlled "real-world" conditions,
(3) to determine what components of effective strategies and programs account
for effectiveness and the processes involved in their success, (4) to clarify
organization, management, financing, delivery and other factors related to the
effective and efficient provision of prevention services in the U.S., and (5)
to improve prevention research methodology to assess the complex processes,
outcomes, and systemic impacts of prevention services.

NIDA recognizes that there are multiple pathways to and patterns of drug abuse
that may vary by geographic location, ethnicity, cultural group, lifestyle
choices, gender, and individual differences.  Thus, prevention research should
focus attention on (1) recognizing variations in community, ethnic, cultural,
lifestyle, gender, and individual issues, concerns, and risk factors, (2)
developing strategies that address these sub-population differences, and (3)
understanding the processes, mechanism, and reasons why some prevention
components may be universally effective whereas others must be adapted for
sub-groups.  NIDA"s drug abuse prevention research program is comprehensive in
nature and fully reflects the prevention research mission, objectives, and
study areas advanced by the Department of Health and Human Services and the
National Institutes of Health.

Specific Areas of Research Interest

The following sections address drug abuse prevention intervention, services,
and methodological research.  Under each research section, examples of topics
requiring further study are given.  However, many areas for future research
are not addressed, and investigators should not view the examples provided as
limiting the areas of research of interest to NIDA.

1.  Prevention Intervention Research

Research on prevention intervention programs and strategies should be theory-
based and focus on the manipulation of causal factors derived from studies on
the pathways and origins of drug abuse and addiction.  Historically,
prevention intervention research has included both efficacy and effectiveness
studies and emphasized audience and delivery context.  Efficacy studies are
the first step in designing, developing, and testing innovative theory-based
strategies and interventions.  These are randomized group design studies where
comparable groups are exposed to either an experimental or control condition. 
The theoretical basis of the intervention explains the role of moderating and
mediating variables and how various programmatic components have been designed
to address these elements.  Effectiveness trials replicate efficacious
strategies and interventions in real-world settings to test their translation,
barriers to implementation, and generalizability.  Both efficacy and
effectiveness studies generally incorporate a longitudinal design to allow for
the determination of the role of mediators and a variety of long-term effects.

Prevention research has now established that a number of strategies and
intervention programs are both efficacious and effective.  Prevention research
has also identified strategies and program components that are either counter
productive or have unintended negative effects.  Thus, a major new and
important emphasis of NIDA"s prevention research program is identifying and
determining content, implementation, audience, and context components that
account for strategy and program effectiveness.  Understanding these
components is key in both tailoring programs to meet the needs of specific
groups and, when appropriate, to generalizing strategies to other settings. 
This is a relatively unexplored area of research.  Thus, a complete
enumeration of intervention components and features that may account for
effectiveness is not possible.  However, prior research suggests that
components -- such as program duration, reinforcement of prevention messages
over time, consistency of messages across contexts, fidelity of
implementation, use of developmentally appropriate content and materials, use
of interactive teaching techniques, use of intermittent reinforcement, client-
facilitator fit, grouping of clients, and sub-population features -- should be
studied to improve the quality of programming and increase the potential for
translation into real-world settings.  Interactions between audience type,
audience features, intervention context and content, and implementation
strategies should be a major emphasis of this research.

a.  Audiences

Audiences or targets for prevention interventions are generally classified
into one of three types: universal, selective, or indicated.  Universal
prevention interventions are targeted to the general public or to a whole
population group, such as all children in a school.  Selective prevention
interventions are targeted to individuals or subgroups of the population with
well-defined risk factors for the development of substance abuse, such as
children of drug abusers.  Indicated prevention interventions are targeted to
individuals or subgroups who are identified as having non-clinical but
detectable signs or symptoms foreshadowing drug abuse, dependence, and
addiction, or with biological markers indicating predisposition to substance
use disorders, but who have not met diagnostic levels for drug abuse according
to DSM-III-R or DSM-IV.  The majority of the currently tested prevention
interventions are for universal populations. Thus, emphasis needs to be placed
on (1) adapting existing interventions and developing and testing new
interventions for selective and indicated audiences and (2) developing tiered
approaches to intervention that funnel individuals and groups from universal,
to selective, to indicated programming depending on need.

Developmental status of the target audience is also an important feature of
interventions, and research instruments must be tailored to the emotional,
social, and cognitive levels and abilities of the audience.  Currently, the
majority of efficacious interventions are for middle and high school aged
youth.  Thus, more emphasis needs to be placed on the early identification of
high risk youth and on the developing and testing of interventions for both
younger and older groups, such as pre-school and elementary school aged
children, young adults, older adults, and geriatric populations.  In addition,
gender and minority differences in the effectiveness of prevention programming
have not been examined in enough detail.  Examples of possible intervention
research topics are listed after the Audiences and Contexts sections. 
Applicants should be mindful of the natural intersection between audiences and
contexts.  Specific to the universal, selective, and indicated audience types,
examples of topics requiring further research include:

o  Developing universal-level strategies to establish and strengthen existing
group and environmental norms and characteristics that protect against drug
abuse and addiction and provide resources for positive development.

o  Using laboratory settings to test hypotheses about communication processes
that may account for variations in intervention facilitator success and
client-facilitator fit.

o  Conducting analyses of existing longitudinal prevention data to detect
variations in strategy or program effectiveness for sub-populations such as
those defined by developmental status, gender, race/ethnicity, and cultural
identification.

o  Testing models that facilitate early identification of biologically,
genetically, psychologically, or socially at-risk youth and developing
strategies that enhance academic and social skills development, self-
regulation and coping responses, and reframing of cognitive biases that may
prevent subsequent substance abuse.

o  Developing and testing the efficacy and effectiveness of prevention
strategies and interventions for individuals at-risk for the combined problems
of drug abuse, anti-social behavior, violence/aggression, high-risk sexual
behavior, and co-morbid psychiatric disorders.

b.  Contexts

Individuals and groups live and function in social contexts that provide
natural arenas for reaching audiences with prevention interventions.
Successful contexts for the implementation of prevention interventions are
those that targeted audiences naturally encounter.  Examples of contexts to be
considered include, but are not limited to, family, school, social networks,
work, social and religious organizations, community, and media.  Attention to
contexts is useful for at least two reasons.  First, some contexts provide
relatively easy access to prevention services for clients.  Second, changing
contextual features can directly impact mediators that are thought to be
causally related to the outcomes of drug abuse and drug-related behaviors. 
Additional research is needed to test theories and strategies designed to
alter context-related mediators to determine which are most effective in
reducing drug abuse and addiction, with what audiences, and under what
conditions.  Examples of topics requiring further research include:

o  Adapting proven intervention strategies for use in contexts that maximize
access to target audiences but have not been used to any great degree in the
past.  For example, accessing parents in the workplace with strategies and
programs that promote parenting skills know to protect children from substance
abuse.

o  Testing the impact of varying levels of implementation of environmental
change mechanisms, such as school drug policies, community underage smoking
and drinking laws, and workplace drug testing.

Contexts that have been successfully used for the implementation of prevention
programming are discussed in the following sections.  However, other
contexts -- especially existing service delivery context that could be adapted
for prevention delivery -- should be considered.

(1) Family - The family is the primary socializing unit.  Current research
indicates that strengthening parental and family functioning can reduce
precursors of youth substance abuse such as inadequate bonding to family and
institutions, poor family management, high levels of stress and conflict,
academic failure, and juvenile delinquency.  The goal of family-oriented
prevention interventions is to strengthen the family"s positive socialization
of the child through the use of developmentally appropriate strategies, such
as parental monitoring, consistency, and positive reinforcement.  Examples of
issues that warrant further research include:

o  Determining the extent to which research-based parenting strategies for
training high-risk parents -- such as those experiencing chronic poverty and
those in which abusive child-rearing strategies have been documented -- are
available through existing service delivery systems.

o  Examining variations in the acceptance and use of positive family
communications strategies and practices promoted through parent training
programs to better understand differences in the effectiveness of these types
of programs.

(2) School - Attendance in school is an almost universal experience, and after
the family, schools are the most important agent of socialization for
children. As they age, most children in grades K-12 tend to be more influenced
by the agents of socialization they encounter at school, particularly their
peers, than by family members.  There are both risk (e.g., academic failure,
lack of bonding) and protective factors (e.g., skills development, positive
involvement) associated with school attendance.  Moreover, transitions from
one school to another are viewed as critical periods for the onset drug abuse. 
For these reasons, as well as the fact that children in school are to a large
extent a captive audience, school-based prevention interventions are among the
oldest, best tested, and best understood interventions.  However, many gaps
remain in the area of school-based prevention intervention research.  Examples
of areas that need to be further explored include:

o  Testing the infusion of proven school-based strategies and interventions
into the existing curricula to determine the extent to which they can be
assimilated while preserving the positive effects of the program.

o  Determining the efficacy and effectiveness of untested, existing drug abuse
prevention program components -- such as case management, mentoring, job
training, and challenge activities -- for very high-risk delinquent
adolescents in specially designed educational settings.

o  Examining how school policy changes can influence mediators of drug use --
such as attitudes and norms -- and eventually substance abuse behaviors, with
particular attention to the pattern and duration of the change processes.

(3) Organizations - Community, civic, religious, and other youth serving
organizations are increasingly being called upon to provide prevention
services.  Large numbers of pre-adolescent and adolescent children are
unsupervised in the late afternoon, early evening, and weekend hours due to
economic demands placed on working couples and single parent families.  This
has led to increases in rates of substance abuse, violence, and other problem
behaviors during these hours.  Many organizations have been attempting to fill
this gap with programming, other organizations have been created to provide
services for high-risk youth.  Little is known about the nature and extent of
these activities or about their efficacy and effectiveness.  Thus, examples of
areas that need to be explored include:

o  Describing and testing the efficacy and effectiveness of existing drug
abuse prevention strategies and programs offered through large youth serving
delivery systems such as Boys and Girls Clubs, Girl and Boy Scouts, 4-H, and
so-forth.

o  Cataloging and describing the availability, content, supervision, and
context of after-school programming for students of different ages.

(4) Work - Relatively little research has been conducted on the workplace as a
context for drug abuse prevention.  However, like school programs, work
programs can offer easy access to clients.  Moreover, the broad demographics
of the workforce make it a viable programming context for a variety of
audiences.  Stage of career development, type of job, and competing life roles
are important in determining targets and content of prevention activities. 
Adolescent employment may give young people a great deal of expendable income,
providing the financial means through which to purchase illegal substances. 
Like other transitions, the transition to full-time work can be a period of
vulnerability as the strains of taking on new adult roles are realized and new
potentially risky social contexts are encountered.  Employees in high-risk
occupations--such as police officers, firefighters, construction workers,
truck drivers, and medical professionals--have documented higher than average
rates of substance abuse.  Work can also provide an easy access point for
assisting workers with other life roles related to substance abuse prevention,
such as the parenting role.  Thus, prevention programs for individuals at
different stages of career development, different types of jobs, and different
intervention targets are needed.  Examples of strategies that should be
examined include:

o  Determining the extent and effectiveness of drug screening and Employee
Assistance Programs as tools for preventing drug abuse and addiction.

o  The use of personnel orientation programs during the transition to work as
a point of contact for short, targeted prevention interventions that address
issues such as work-related stress, pressure to succeed, and social pressures
to abuse drugs.

(5) Media - Media messages can have a significant influence on attitudes,
expectancies, intentions, and behaviors that affect individual decisions about
illicit drug use.  Although some knowledge has been developed regarding
message salience and acceptance, there has been little systematic study of
optimal communication practices for preventing drug abuse. Theories and
research-based knowledge about the attributes of effective communications have
been applied to drug abuse prevention research and programming in a very
limited way.  Thus, research targeting the full spectrum of settings--from
communications research in the laboratory, to studies examining the elements
and impact of mass media, to applied studies using prevention communications
in the community--is needed.  Topics for further study include:

o  Assessment of existing media strategies for promoting community drug abuse
prevention programming and for establishing community anti-drug norms,
including an examination of the extent to which such efforts influence
individual norms and behavior.

o  Basic studies on social cognition, social-emotional development, and social
interaction styles and processes to characterize how individuals process
information under varying conditions and at different stages of development in
order to construct meaningful drug abuse prevention messages.

o  Examination of the interaction between emotional and cognitive responses to
messages to better understand how to construct messages to elicit appropriate
responses, such as triggering refusal behaviors when confronted with potential
drug use situations.

(6) Comprehensive Programs - The contexts for development previously discussed
do not operate in isolation.  Interactions and transactions take place across
these contexts and influences flow from one to another.  Therefore, systematic
study of multiple component substance abuse prevention interventions and other
educational, health, recreational, and social interventions implemented across
social environments are encouraged to determine any additive or multiplicative
effects in preventing drug abuse and addiction.  Comprehensive programs which
stress consistent anti-drug messages across settings have been shown to be
effective in promoting a community anti-drug social norm and in increasing
perceptions of risk associated with drug use.  Much has yet to be learned
concerning the validity of community change theories and practices concerning
organization, readiness and empowerment.  Examples include:

o  Decomposition studies that systematically examine the impact of
comprehensive program components, alone and together, to determine additive
and multiplicative effects.

o  Research that examines the initiation, development, and continuity of
community coalitions to prevent drug abuse and addiction, as well as their
impact on use of effective drug abuse prevention strategies.

o  Research on the application of models of community readiness and community
needs assessments to the selection and provision of tailored prevention
programming.

2.  Prevention Services Research

Prevention services research is encouraged to examine the nature and extent of
existing and potential substance abuse prevention delivery systems and the
impact of changes in management, organization, financing, and delivery on
those systems.  Research that describes the need for prevention services, and
the factors that affect their availability, adoption, adaptation,
sustainability, cost benefit and cost effectiveness, are needed.  While some
prevention services, primarily drug screening and short interventions, may be
offered through the health care system, the majority of prevention services
are offered through schools, worksites, community and youth organizations,
social welfare agencies, public housing affiliations, and the juvenile justice
system.  However, there is little empirical evidence for the efficacy and
effectiveness of the programming offered through many of these delivery
venues.  Moreover, little is known about the organization, management,
financing, sustainability, or impact of these services.  Possible research
foci include:

o  Assessments of prevention services delivery at the community, state,
regional, and national levels, including the interaction of the various
entities involved in a prevention services system.

o  Studies of the nature and extent of prevention services, including their
adoption, adaptation, funding, sustainability, and impact.

o  Evaluation of the cost-effectiveness of short-term drug abuse prevention
strategies that have been integrated into standard health, mental health,
school, and community settings.

3.  Methodological Research

Methodological research is needed in the field of drug abuse prevention on
promising data collection, data management, analysis, and reporting
techniques.  Special attention should be given to:  (a) the hierarchical
nature of most prevention data, (b) the adaptation of measures for
intervention cohorts over the course of time and development, (c) the
measurement and analysis of complex theoretical process models including
mediating and moderating variables, (d) the problem of missing data and
attrition when following intervention and control subjects over time, and (e)
the decomposition of existing data to determine variable effectiveness of
proven strategies and interventions.  NIDA supports the adaptation and
assessment of proven scientific procedures from other disciplines to determine
their applicability to drug abuse prevention research.  Specific areas of
research include:

o  The development of more powerful designs for detecting differences in
program effectiveness by attributes, such as subgroup membership, content
delivered, content exposure, and so forth.

o  The development and assessment of a variety of physiological and
biochemical measures for incorporation into prevention interventions in a
variety of settings.

o  The development of prevention audience profiles, including methodologies
appropriate for the identification of individuals at-risk for future drug
abuse and dependence.

Additional information about the prevention research program will be posted on
the Home Page of the Division of Epidemiology, Services and Prevention
Research, NIDA, located at:  
http://www.drugabuse.gov/about/organization/DESPR/DESPRHome.html.

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 is 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," that were published in the Federal Register on March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, 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.  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 website: 
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 the NIDA Home Page at http://www.nida.nih.gov/,
or may be obtained by calling 301-443-2755.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG
ABUSE

Researchers funded by NIDA who are conducting research in community outreach
settings, clinics, hospital settings, or clinical laboratories and have
ongoing contact with clients at risk for HIV infection, are strongly
encouraged to provide HIV risk reduction education and counseling.  HIV
counseling should include offering HIV testing available on-site or by
referral to other HIV testing services.  Persons at risk for HIV infection
include injection drug users, crack cocaine users, and sexually active drug
users and their sexual partners.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit.  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, Email: .  The title and number of the PA must be typed
in Section 2 on the face page of the application.

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 below.

BUDGET INSTRUCTIONS

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

o  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.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year.  This is not a Form page.

o  Under Personnel, List key project personnel, including their names, percent
of effort, and roles on 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 facilities and administrative) 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 on 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.

o  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: 
https://grants.nih.gov/grants/funding/modular/modular.htm

- 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
- List selected peer-reviewed publications, with full citations

o  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.

o  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 completed original application and five legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 -MSC 7710
BETHESDA, MD 20892-7710 (for U.S. mail)
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened in accordance with the
standard 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 applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate national
advisory council or board.

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.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

(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
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
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 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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications.  The following will be considered in making funding decisions:
quality of the proposed project as determined by peer review, availability of
funds, and program priority.

INQUIRIES

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

Direct inquiries regarding the programmatic issues to:

Elizabeth Robertson, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD  20892-9589
Telephone:  (301) 443-1514
FAX: (301) 443-2636
Email:  

Direct inquires regarding fiscal issues to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 443-6847
Email:  [email protected]

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

AUTHORITY AND REGULATIONS

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 78410), as amended by Public Law 99-158, 42 USC
241 and 285), and administered under PHS grant 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 Public Health Service strongly encourages all grant recipients to provide
a smoke-free workplace and promote the nonuse 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)