NIDA NATIONAL PREVENTION RESEARCH INITIATIVE (NNPRI):  TRANSDISCIPLINARY 
PREVENTION RESEARCH CENTERS

Release Date:  December 31, 2001

RFA:  RFA-DA-02-005

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

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

PURPOSE

The National Institute on Drug Abuse (NIDA) is accepting applications under a 
new National Drug Abuse Prevention Research Initiative (NNPRI) for (1) 
expanding the knowledge base of basic research with strong translational 
potential for informing the design of drug abuse prevention interventions; 
(2) accelerating the development of new prevention interventions arising from 
transdisciplinary research interactions; and (3) testing research-based 
interventions in large-scale field trials.  The NNPRI is formulated on a 
conceptual model that encourages translational research along a continuum of 
basic research, to preliminary prevention intervention development, 
effectiveness testing and large-scale program implementation.  The model also 
recognizes the potential contributions of service delivery providers, even in 
very early stages of basic research, for facilitating the ultimate 
translation of research to practice.  This Request for Applications (RFA) 
invites grant applications (P50) to support the creation of transdisciplinary 
prevention research centers (TPRCs) that will accelerate the development of 
new and innovative preventive interventions for drug abuse.  For purposes of 
the present RFA, transdisciplinary research is defined as a cooperative 
effort by a team of investigators, each expert in different methods and 
concepts, collaborating in an organized research endeavor to address a 
specific scientific problem.  It is expected that a transdisciplinary 
approach will bring diverse and multiple scientific perspectives to catalyze 
new thinking about prevention research questions.  The scientific 
interactions and collaborations supported by this center model are intended 
to maximize scientific creativity and stimulate new developments in the field 
of drug abuse prevention research more rapidly than would be possible by 
depending on individual investigators working in relative isolation. It is 
the intent of this RFA to support centers that can demonstrate reciprocal 
interactions between basic and applied research components to enhance 
creative and innovative research along this continuum of prevention research. 

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 National 
Prevention Research Initiative (NNPRI): Transdisciplinary Prevention Research 
Centers 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 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 P50 grants.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.  Competitive continuation 
applications will not be accepted under this solicitation.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) center grant award 
(P50) mechanism (see 
http://www.nida.nih.gov/Funding/GrantGuidelines.html#Purpose).  NIDA provides 
support for research center grants to foster a synergistic approach to drug 
abuse and addiction research and to enable studies that would not occur 
without the climate, facilities and research resources that a research center 
can uniquely provide.  Research supported at a NIDA research center must be 
thematically focused and must reflect in clear ways interdependence of 
components of the research program that would not occur simply from the mere 
collection of the individual components. Taken as a whole, then, a NIDA 
center is expected to enable a level of achievement which exceeds that 
expected on the basis of "the sum of its parts."  In addition, NIDA research 
centers are expected to serve as national research resources. They are 
expected to attract established and promising investigators into drug abuse 
research and to provide opportunities for research training, career 
development, and mentoring.  

The present RFA will support the integration of basic and prevention 
research, along a continuum ranging from basic research studies with 
potential application to the development of innovative prevention 
interventions, through efficacy testing and small scale effectiveness trials 
of promising interventions. PIs will be responsible for the planning, 
direction, and execution of the proposed TPRC program.  Awards will be 
administered under NIH grants policy as stated in the new NIH Grants Policy 
Statement (http://www.nih.gov/grants/policy/policy.htm).

Under this RFA, requested budgets will be subject to the following limits: A 
new P50 application may request a maximum annual direct cost of $1.0 million 
and maximum annual total cost of $1.5 million.  Future year budgets may 
include annual increases up to three percent, but cannot exceed the annual 
cap of $1.5 million in total costs.  In complying with the direct cost cap of 
$1.0 million, the indirect costs related to subcontracts to other 
institutions or organizations will not apply toward the direct cost cap, but 
the total dollar request may not exceed $1.5 million.  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, 2002.

FUNDS AVAILABLE

NIDA intends to commit approximately $4,000,000 in FY 2002 to fund up to four  
P50 awards in response to this RFA.  Additional awards will be considered 
based on availability of funds.  An applicant may request up to five years of 
support.  Funding in response to this RFA is dependent upon the receipt of a 
sufficient number of applications of high scientific merit.  Although this 
program is provided for in the financial plans of NIDA, the award of grants 
pursuant to this RFA is contingent upon the anticipated availability of funds 
for this purpose.  This RFA is a one-time solicitation.

RESEARCH OBJECTIVES

Background

Previous research has identified significant risk and protective factors that 
influence the development of drug abuse and addiction.  Discoveries from the 
behavioral and social sciences, and from neuroscience, cellular, genetic and 
molecular biology, have elucidated individual vulnerabilities to initiate 
drug use, and to some extent, the changes associated with progression from 
occasional use to chronic, uncontrollable patterns of abuse. Over two decades 
of prevention research have produced drug abuse prevention programs with 
proven efficacy and effectiveness, based on a general set of science-based 
prevention principles.  However, there are many important research questions 
and opportunities remaining for drug abuse prevention research.  For example, 
findings from research on the underlying biological, cognitive, 
psychological, social and behavioral processes involved in drug abuse and 
addiction have not been fully exploited for purposes of developing innovative 
prevention interventions.

Research Goals and Scope

The NIDA recognizes the need to encourage the development of new, innovative 
preventive interventions targeting both the initiation and escalation of drug 
abuse.  Preventing escalation of abuse, and the transition to compulsive, 
uncontrollable use (e.g., an integration of prevention and early intervention 
models) is of particular interest in this initiative.  The overall goal for 
this RFA is to stimulate the development and testing of prevention 
interventions that can ultimately be demonstrated to produce long-lasting and 
broad-based reductions in the initiation and progression of drug abuse 
behaviors.  NIDA is especially interested in the development of new 
prevention paradigms (e.g., peer-to-peer interventions, brief motivational 
interventions, internet delivery systems, etc.) and in novel research on the 
delivery, receipt, processing and outcome of drug abuse messages and 
communications.  In addition, the underlying mechanisms that contribute to 
the effectiveness of existing interventions need to be more fully elucidated 
so that these approaches can be strengthened, and new programs developed to 
target critical mechanisms of behavioral change or to re-direct developmental 
trajectories.  As it is recognized that even the most effective interventions 
have not benefited all who have been exposed to those interventions, 
remaining challenges in drug abuse prevention research include better 
characterization of subgroups or individuals who are refractory to existing 
interventions, and the development of new paradigms for targeting resistant 
populations.  Finally, given growing evidence that (a) 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.

It is the intent of this RFA to support transdisciplinary collaborations 
along a continuum of research, ranging from basic science that can inform or 
guide the development of novel prevention interventions, through preliminary 
program development, efficacy testing, and small-scale effectiveness trials 
of promising new interventions.  Studies at the following levels along a 
continuum of basic science to prevention research are appropriate and centers 
should incorporate more than one level in the transdisciplinary proposal: (a) 
Theory-based or model-driven basic research studies, with potential 
application to the development of innovative prevention interventions;(b) 
Research on the development, refinement and pilot testing of new 
interventions, including studies aimed at translating discoveries from basic 
behavioral, cognitive, social or neuroscientific research into novel or 
improved interventions; (c) Efficacy testing of interventions that show 
promise; including research on the hypothesized mechanisms through which 
these interventions produce their effects; (d) Small scale effectiveness 
trials of prevention interventions.

A transdisciplinary approach is best suited for developing a research 
environment conducive to a reciprocal exchange of scientific information and 
ideas between projects and between prevention centers.  Transdisciplinary 
collaborations in these TPRCs should: (1) stimulate the translation of basic 
science discoveries (from both preclinical and human laboratory-based or 
field investigation) into the design of novel preventive interventions, and 
(2) capitalize on opportunities from drug abuse prevention research to inform 
the design of basic science investigations on vulnerability to drug abuse and 
addiction. For example, collaborative interactions between neuroscientists 
and prevention specialists may facilitate the identification of biological 
mediators or moderators as targets for intervention.  Behavioral scientists 
studying individual differences can develop models of how environmental and 
neurobiological or genetic risk factors interact and can be manipulated to 
reverse or attenuate vulnerability to acquire drug abuse behaviors.  
Cognitive scientists can contribute through model-driven research aimed at 
processes that guide decision-making under different parameters of risk and 
consequences.  Epidemiologists working with drug abuse prevention researchers 
can investigate clusters of trajectories, patterns of abuse or changes in 
patterns of abuse, and population-, community-, or context-specific factors 
that may be amenable to tailored interventions.  Developmental specialists 
may characterize maturation factors and processes that can be targets for 
intervention activities, such as changing profiles of cognitive, emotional 
and behavioral capabilities or strategies (e.g., information processing).

The focus on different aspects of drug abuse prevention research will vary 
from center to center, but each center must focus thematically on an area of 
research in which (1) there are significant gaps in our knowledge; (2) there 
is potential for contributing to the development of new approaches to drug 
abuse prevention or the prevention of escalation; and (3) there is evidence 
that the thematic focus can benefit from transdisciplinary collaborations 
among scientists from diverse methodological and theoretical disciplines.  
Applicants are encouraged to include the study of racial, ethnic minority 
group membership, sexual orientation, and effects of gender and culture.

Following are examples of scientific themes in drug abuse prevention research 
that might benefit from transdisciplinary collaborations within the context 
of a P50 center.  However, the list is not intended to be all-inclusive, and 
many other significant topics of scientific inquiry may be appropriate:

o Processes and mechanisms in adolescent decision making about drug abuse, 
and research aimed at modifying these processes and their behavioral 
outcomes; e.g., calculation of presumed risk; influence of predicted outcomes 
and consequences on decisions; impact of short- and long-term consequences; 
context variables as proximal mediators in decision making; interactions 
between cognitive processes and emotional states.

o Developmental trajectories in cognitive functioning and studies addressing 
how such trajectories might be influenced or altered; development of dis-
inhibition, attributional biases, expectancies and impulsivity; as well as 
developmental transitions as periods of plasticity and vulnerability that may 
provide targets for intervention.

o Cognitive, affective and behavioral characteristics of target populations 
that may be addressed as malleable targets for intervention; for example,  
individual factors that influence the impact of prevention messages and 
materials.

o Biological, genetic, behavioral, environmental, cognitive and emotional 
variables that contribute to, or are modified as a result of, dynamic 
processes in the escalation to uncontrollable drug use; research to identify 
interventions that can re-direct behavioral outcomes resulting from the 
influence of these variables.

O Characterization of changes in neurobiological, psychological or social 
processes resulting from efficacious drug abuse prevention interventions, 
including study of the processes through which these changes occur; e.g., 
identification of markers or indicators in stress reactivity, neuronal 
activation, affect, or information processing that correlate with or predict 
positive outcomes of drug abuse prevention interventions.

o Neurobiological development during adolescence and young adulthood; 
research to examine how neurobiological indices are related to the impact of 
interventions at critical or transition periods; e.g., examinations of 
changing patterns of activation in cortical and subcortical circuits 
underlying emotional and cognitive processes in the reaction to prevention 
messages, or recruited in the context of making drug abuse decisions.

o Exploration and development of behavioral change models from arenas of 
prevention research outside of the area of drug abuse; processes involved in 
the impact of changing attitudes and values, or influence of contextual 
variables, on behavioral choice, as exemplified by interventions from other 
fields of health and behavioral medicine.

O Studies to examine processes and mechanisms by which family interactions, 
peer dynamics, social networks and other contextual variables confer 
vulnerability or resiliency for drug abuse; (e.g., identifying features of 
peer interactions that account for their influence on drug abuse in 
adolescents); including the development of interventions to modify these 
processes and mechanisms.

o Self-regulation and regulation failure in modulating drug abuse behavior; 
the role of conscious (controlled) and unconscious (automatic) mental 
processes in self-regulation and research aimed at strengthening self-
monitoring and self-regulation in intervention paradigms.

o Social interaction, affiliative and antagonistic behaviors; bonding and 
attachment; research on neurobiological substrates of these processes as 
moderators or mediators of behavioral consequences that may provide targets 
for intervention strategies.

SPECIAL REQUIREMENTS

1.  TPRC Requirements

Each center must develop an infrastructure that ensures transdisciplinary 
communication and reciprocal interaction between basic and applied prevention 
researchers.  The Center's infrastructure will consist of core elements, 
including at minimum an administrative core, with other core elements to 
provide shared resources as deemed necessary such as, for example, a 
statistical/data management core, or a recruitment core, etc.  In addition, 
each TPRC must initiate a minimum of 3 projects with demonstrated 
translational potential; thus applicants must describe the potential 
contributions of three of more interacting projects, for leading to promising 
new drug abuse prevention approaches.  Because it is intended that the these 
prevention research centers will provide ideal settings for training future 
generations of drug abuse prevention researchers in transdisciplinary 
sciences and translational perspectives, TPRC applications must have strong 
career development objectives.  TPRCs supported by this initiative must have 
input from local and state prevention practitioners in the design of the 
proposed investigations.  Centers also will be expected to develop plans for 
rapid implementation of future pilot projects  to capitalize on especially 
promising discoveries, and to respond to emerging trends from epidemiological 
data.  Lastly, it is expected that each center will participate in a national 
drug abuse prevention network to share information, assess scientific 
progress in the field, identify new research opportunities, and promote 
inter-center collaborations.

The center application must clearly articulate:

(a) Center integrity that provides for thematic integration, synergy and 
ensures transdisciplinary interactions between basic and applied prevention 
researchers; an overall scientific theme with clear potential for informing 
innovative drug abuse prevention efforts; evidence for interdependency of 
proposed projects; translational potential of the projects for informing the 
subsequent design of novel drug abuse prevention research, or for prevention 
research studies to generate testable hypotheses at the basic science level; 
explanation of how a transdisciplinary approach will accelerate the pace in 
this area of investigation (i.e., to bring new prevention interventions to be 
subsequently tested in field and systems trials); and plans for ensuring that 
translation is facilitated (when appropriate) in a logical progression of 
research projects;

(b) An administrative core structure to ensure effective and synergistic 
functioning among projects; to promote the conduct of innovative, 
transdisciplinary research by supporting interactions and collaborations 
between co-investigators and investigative teams; to provide for effective 
administration and organization of the center, effective long-range planning, 
evaluation of center activities, quality control, and effective budget 
management; 

(c) Other core structures as deemed necessary, such as shared statistical, 
clinical, data sharing, equipment or recruitment resources;

(d) A scientifically and administratively qualified principal investigator 
who has responsibility for scientific, administrative, budgetary and 
operational aspects of the center; who can provide direction to the TPRC, 
ensure a transdisciplinary research emphasis, and build a career development 
program; the principal investigator should demonstrate an adequate commitment 
of time and effort (35% effort at the minimum); 

(e) A cadre of experienced and productive investigators that represent a 
breadth of transdisciplinary expertise; and administrative support sufficient 
for the effective administration of the center including a minimum of one 
full-time administrative assistant to the principal investigator; 

(f) Evidence of institutional commitment, such as adequacy of facilities, 
equipment and space to promote transdisciplinary research objectives; 

(g) Evidence that an advisory board representing local and state drug abuse 
prevention practitioners is in place and has provided input to the design of 
the proposed research, for purposes of ultimately facilitating the 
translation of research to practice; also, plans for this board to continue 
to provide guidance on issues of practical applicability, and make 
recommendations for future research priorities; the board must be comprised 
of at least three drug abuse prevention practitioners who represent programs 
at the state and local level, selected on the basis of their expertise in the 
thematic scientific area of the TPRC; other local and/or state practitioners 
may be included as needed; each board must also have representation from two 
researchers from outside of the TPRC, representing areas of basic science 
and/or drug abuse prevention, with appropriate expertise for the projects 
proposed in the application; budget should include bi-annual meetings of the 
full board to evaluate progress from the projects and advise on 
future directions;  

(h) A strong commitment to career development in transdisciplinary and 
translational research perspectives, especially at the level of the early 
career investigator, with a plan included as part of the application; plan 
may also include a provision for established investigators who wish to cross-
train in a new discipline; recruitment must include qualified women and 
minorities; there must be a clear policy and plan for recruitment of career 
development candidates; the application should state the number of trainee 
positions proposed, the criteria for eligibility and for selection of 
candidates, and describe the selection process; the application should 
indicate potential mentors who are already in place at the proposed TPRC, 
briefly describe their research programs, and describe complementary 
activities that contribute to the transdisciplinary environment for career 
development (e.g., existing training grants, other career development 
mechanisms, established collaborators within and outside of the center, and 
relevant programs); 

(i) A budget for supporting future pilot studies to capitalize on 
opportunities arising from new scientific discoveries, or to rapidly respond 
to shifting or emerging drug abuse trends from epidemiologic data; 
applications should propose an institutional review process that selects 
pilot projects for funding which represent the most innovative ideas and 
which are likely to have the greatest impact on the development of new and 
innovative drug abuse prevention programs;

(j)  Plans to foster intra- and inter-center collaborations  including 
interactions among TPRCs; may be in the form of research collaborations, 
exchange of scientists on a visiting basis, exchange of resources and 
materials, and other innovative mechanisms; budget must accommodate travel 
for all TPRC PIs and co-investigators to participate in two meetings per year 
as part of the National Drug Abuse Prevention Research Initiative; and

(k) A budget justification for all core elements and projects.

In addition applications should include description of a minimum of three 
proposed research projects that focus on different aspects of a common 
scientific theme or problem in the area of drug abuse prevention, (along the 
continuum of basic research to prevention intervention development, through 
efficacy testing and small-scale effectiveness trials);  evidence must be 
presented for transdisciplinary interaction and collaboration across 
projects.  Included in these project proposals should be:

- a clear description of the project's translational potential; that is, 
evidence provided that basic science discoveries (from both preclinical and 
human laboratory-based or field investigation) can be incorporated into the 
design of novel preventive interventions, and/or that findings from drug 
abuse prevention research will be used to inform the design of basic science 
investigations on vulnerability to drug abuse and addiction;

- evidence that the project addresses a research question or problem that is 
appropriate for the  scientific theme of the center;

- a description of the project's contribution to the overall synergy of 
the TPRC;

- evidence that these projects are exemplary in scientific innovation.

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 clinical research 
projects unless a clear and compelling justification is 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 are 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 RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

DATA AND SAFETY MONITORING PLAN

As of the October 2000 receipt date, applicants must supply a general 
description of the Data and Safety Monitoring Plan for ALL clinical trials; 
this must be included in the application 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  For 
purposes of reviewing applications submitted to the NIH, a clinical trial is 
operationally defined as a prospective biomedical or behavioral research 
study of human subjects that is designed to answer specific questions about 
biomedical or behavioral interventions (drugs, treatments, devices, or new 
ways of using known drugs, treatments, or devices). The degree of monitoring 
should be commensurate with risk. NIH Policy for Data and Safety Monitoring 
requires establishment of formal Data and Safety Monitoring Boards for multi-
site clinical trials involving interventions that entail potential risk to 
the participants. The absence of this information will negatively affect the 
priority score.

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, clinical, 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 injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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 of Council 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 the Funding, or may be obtained by calling (301) 443-2755.

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

PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to 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.

Applicants submitted under this solicitation must conform to the SPECIAL 
REQUIREMENTS described above.  Because of the multi-project nature of a TPRC 
grant and the special requirements in this RFA, additional instructions 
regarding format are listed below:

Applicants are encouraged to organize their application by initially 
presenting the face page, the abstract page with key personnel, a table of 
contents, summary budget pages for the entire TPRC, and other documentation 
pertaining to the entire TPRC.  This should be followed by an Introductory 
Section of no more than three pages.  It should be written for the proposed 
TPRC application describing it as a whole with respect to the overall theme, 
goals, objectives, and overall research plan.  The Introductory Section should 
contain information on i) the overall research theme, ii) timelines and 
milestones for each projects in a graphic outline to clearly lay out the 
sequence of research events and how each project of the TPRC relates to each 
other, iii) the capacity of the TPRC to conduct the research as proposed iv) 
the capability of the proposed Principal Investigator and his/her institution 
to carry out the scientific and administrative duties required in this RFA.

After the introductory section, each core and research project should be
presented with its accompanying individual budget, budget justification,
biographical sketches, and other support information and research plan.  For 
each core and research project component, there is a 25 page limit for the 
sections of the research plan (i.e., specific aims, background and 
significance, preliminary studies/progress report, and research design and 
methods) as indicated in the form PHS 398.  Appendix material limits apply to 
each component separately; each component's appendix may include up to 10 
publications, manuscripts, abstracts, patents, or other printed material 
directly related to the project.  Surveys, questionnaires, data collection 
instruments, and clinical protocols may also be submitted in the appendix.  
Original glossy photographs or color images may be included, provided that a 
photocopy (that may be reduced in size) is included within the 25 pages of 
the research plan.  Applications exceeding page limits, font limits, or 
appendix limits will be returned to the applicant without review.  Appendices 
should not be placed within the body of the application when submitting, but 
should be bundled separately, component by component.

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)
Telephone:  (301) 443-2755

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 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 the NIDA in accordance with the review criteria stated below.  
Applications receive a written critique as part of the initial merit review.  
They may 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 and be 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.  The 
reviewers will comment on the following aspects of the application in their 
written critiques 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 by the reviewers 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 a major scientific impact, and thus, have high scientific merit.

In reviewing Core Components, reviewers will be asked to address:

o synergy of the projects around an overarching theme or topic and its 
relationship to drug abuse prevention; innovativeness and transdisciplinary 
nature of the proposed research activities; demonstration of collaborations 
and communication between basic and applied prevention researchers; 
likelihood of a significant impact on the field; and plans to effectively 
pursue translational research objectives; 

o administrative and organizational structure and support conducive to 
successful research coordination; an organizational structure that allows for 
efficient and cost-effective management and allocation of funds;

o plans for the development and maintenance of shared resources that promote 
the highest quality of research;

o scientific qualifications and demonstrated scientific and administrative 
leadership capabilities of the Principal Investigator;

o quality of the cadre of investigators and evidence of research 
productivity; breadth of expertise represented among investigators; quality 
of interactions and nature of collaborations;

o evidence of the institution's substantial commitment to the center; 

o plans for the establishment of an outside advisory structure that includes 
scientific expertise relative to both the thematic area, and the proposed 
research projects, and community and state level prevention provider input on 
research design and priorities;

o appropriate plans for cross-disciplinary training of new and established 
investigators, including adequacy of facilities for workshops, seminars and 
other educational activities; capacity to train predoctoral and/or 
postdoctoral students in transdisciplinary drug abuse research; career 
development plans for current drug abuse researchers; demonstrated success in 
mentoring and career development activities; 

o internal process that allows for priority setting; including an internal 
process for the assessment and approval of future pilot projects;

o evidence of  plans to interact with other TPRCs and members of the NNPRI, 
including participation in two meetings per year with other TPRC directors 
and co-Investigators; adequate planning for intra-center interaction, 
communication and collaborations;

o appropriateness of the proposed budget and duration in relation to the 
proposed research;

In reviewing individual projects, reviewers will be asked to address:

Significance.  Does this study address an important research problem related 
to the theme of the TPRC? Does the scientific merit and experimental design 
of the project adequately address issues of substantive importance for either 
informing prevention development efforts or formulating novel questions in 
basic science that can shape prevention directions?

Approach.  Are the conceptual research 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 approaches? Are translational linkages between sequences 
of investigations apparent where appropriate?

Innovation.  Does the project develop new methodologies or technologies in 
the area of basic science that have the potential of informing the 
development of prevention programs, or from the area of drug abuse prevention 
research that provide new hypotheses for basic science investigations? Does 
the experimental design reflect sufficient originality, novelty, and 
innovation to make it highly relevant to the overall translational goals and 
objectives of the TPRC?

Investigators.  Are the investigators appropriately qualified with 
demonstrated competence to conduct the proposed research?  Is the proposed 
work appropriate to the experience level of the principal investigator and 
project researchers?  Are the proposed time commitments for all key 
laboratory and clinical researchers reasonable and adequately associated with 
the project?

Environment.  Does the scientific environment in which the work will be done 
contribute to the probability of success?  Do the proposed projects take 
advantage of unique and multidisciplinary features in the scientific 
environment and reach out to useful collaborative arrangements? Is there 
evidence of adequate institutional support? Is the project interactive with 
other components of the TPRC, conceptually, experimentally, and 
translationally?

Context.  How well does this project contribute to/or benefit from other 
projects in the center.  How is the scientific merit enhanced by being part 
of a center?  To what extent does this project seem to be an essential part 
of the center's goals?

Other aspects of individual pilot projects include: the appropriateness of 
proposed project budget and duration; the adequacy of plans to include both 
genders and minorities and their subgroups as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of 
subjects; the adequacy of plans for including children as appropriate for the 
scientific goals of the research, or justification for exclusion; the 
provisions for the protection of human and animal subjects; and the safety of 
the research environment.

AWARD CRITERIA

Awards will be based upon scientific and technical merit reflected in the 
priority score or percentile, which will be used to make award decisions.  
Staff may consider other criteria such as the geographical location of the 
applicant organization as well.  The most common award criteria are 
scientific merit as determined by peer review, availability of funds and 
programmatic priorities.

Schedule

Letter of Intent Receipt Date:  March 26, 2002
Application Receipt Date:       April 26, 2002
Peer Review Date:               June/July 2002
Review by NIDA Advisory Board:  September 2002
Anticipated Award Date:         September 30,2002

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Minda Lynch, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard
Bethesda, MD  20892-9547
Telephone:  (301) 443-1887
FAX:  (301) 594-6043
Email:  mlynch@nida.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, Maryland  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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