SCREENING AND INTERVENTION FOR YOUTH IN PRIMARY CARE SETTINGS

RELEASE DATE:  December 16, 2003
 
RFA Number:  RFA-DA-04-006  

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)
Substance Abuse and Mental Health Services Administration (SAMHSA)
 (http://www.samhsa.gov)
Agency for Healthcare Research and Quality (AHRQ)
 (http://www.ahcpr.gov/)
Health Resources and Services Administration (HRSA)
 (http://www.hrsa.gov)

COMPONENT OF PARTICIPATING ORGANIZATIONS:
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279

LETTER OF INTENT RECEIPT DATE:   January 19, 2004
APPLICATION RECEIPT DATE:        February 19, 2004  

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

National Institute on Drug Abuse (NIDA) invites grant applications for the 
conduct of health services research to expand the role of primary care in the 
prevention and treatment of problem drug use, abuse, and related health problems 
among youth in the pre-dependency phase of drug abuse, with specific emphasis on 
marijuana use (alone or in combination with nicotine, alcohol, and other drugs 
of abuse).  This request for applications (RFA) seeks to build on recent efforts 
to address problematic alcohol and nicotine use in primary care settings in 
order to similarly expand the availability and delivery of efficacious drug 
abuse interventions.  Thus, applications are encouraged that propose to:  (a) 
develop, modify, or test efficacious drug use/abuse screens or assessments to be 
embedded into more comprehensive behavioral health screening/assessment 
instruments for use with youth in primary care settings; (b) develop, modify, or 
test brief behavioral prevention and treatment interventions for use with youth 
in primary care settings; and (c) test methods for integrating drug abuse 
screening, assessment, and brief prevention and treatment interventions into 
primary care.

For the purposes of this RFA, the term youth is intended to include all 
individuals within the age range of 12 to 24 years.  The term primary care 
setting is defined broadly to include all outpatient clinics (public and/or 
private) and private practices that offer office-based general medical care.  
These clinics and practices are staffed by allopathic or osteopathic physicians—
often with other health care providers such as physician assistants, nurse 
practitioners, nurses, social workers, or behavioral health practitioners—
typically within the following categories:  pediatrics, adolescent medicine, 
internal medicine, general medicine, family practice, obstetrics and gynecology.  
Not included in this RFA are the following care settings:  emergency rooms, 
acute care facilities, chronic care facilities, and addiction treatment 
facilities.  

RESEARCH OBJECTIVES

Background

Primary care and substance abuse prevention and treatment traditionally have 
been delivered through separate systems and in distinct settings.  New ways of 
coordinating primary care and drug abuse prevention and treatment services hold 
promise for the implementation of more holistic, integrated, and cost-effective 
approaches in the provision of health care for individuals with problem drug 
use, abuse, and related health problems.  Indeed, primary care settings are 
potentially one of the key points of access to screening, assessment, 
prevention, early intervention, referral, and treatment for youth with problem 
drug use and related health problems.  

Many young people who do not meet the diagnostic criteria for drug dependence 
use drugs in quantities and in ways that are unsafe for them—putting them at 
risk for interruptions in normative maturational processes; health problems, 
including HIV and other sexually-transmitted diseases; interpersonal 
complications with family and friends; difficulties at school or at work; and 
physical injuries such as motor vehicle accidents.  Marijuana is one of the 
three most commonly used drugs among youth.  Nearly 50 percent of 12th graders 
report having tried marijuana at least once, and one-quarter of 12th graders may 
be current users.  Marijuana use affects the brain and can impair short-term 
memory, perception, judgment and motor skills, and can lead to higher accident 
rates, mood fluctuation, and tolerance and cross-tolerance to other drugs.  
Marijuana use can contribute to social alienation and isolation, school 
problems, alliance with deviant peers, lack of bonding to prosocial 
institutions, behavioral problems and delinquency, and family conflict.  
Marijuana can also adversely affect the fetuses of pregnant users.  Many youth 
who use marijuana and/or other illicit drugs also misuse alcohol and nicotine 
products.  Often, these individuals do not seek help from drug abuse treatment 
specialists, but they do visit a primary care provider or come into regular 
contact with other medical caregivers.  In fact, about 70 percent of adolescents 
in the U.S. see a physician at least once a year.  

Despite this seemingly obvious connection, drug abuse prevention, screening, 
referral, brief behavioral treatment intervention, and aftercare treatment 
(e.g., monitoring relapse potential, medication management of methadone or 
buprenorphine) are rarely provided in primary care settings.  Primary care 
providers often fail to associate behavioral problems, psychosocial problems, 
dysfunctional eating, academic underachievement, sexually transmitted diseases, 
and other presenting problems with drug use and abuse in their adolescent and 
young adult clients.  Similarly, physicians routinely faced with the many 
medical consequences of drug abuse—such as, HIV/AIDS and other sexually 
transmitted diseases, hepatitis and other infectious diseases, heart attacks, 
and pulmonary problems—often do not consider the contribution of drug use and 
abuse to the medical symptoms and chronic diseases they see in clinical 
practice.  Primary care providers have begun to address the clinical symptoms 
and medical consequences of alcohol and tobacco abuse, but they seldom screen 
for, or even acknowledge, the problematic use and abuse of illicit drugs (e.g., 
marijuana, heroin, cocaine, methamphetamine, hallucinogens, club drugs, 
inhalants), let alone address problem drug use as an integral part of patient 
care.     

Furthermore, little research has examined effective ways to educate and 
encourage practicing primary care providers to address problem drug use, abuse, 
and related health conditions in their standard care routines.  Research has not 
yet systematically assessed the effectiveness and impact on practice behaviors 
of the limited post-graduate training related to drug abuse and addiction that 
is available to primary care providers and health care teams currently in 
practice.  Also lacking is research on practical incentives for primary care 
providers to focus on problem drug use as a treatment priority.  It is unclear 
the extent to which the current lack of attention to problem drug use in primary 
care settings is related to factors such as the stigmatized nature of drug use 
and its associated problems; lack of efficacious tools for screening, assessing, 
preventing, or treating problem drug use in primary care settings; lack of 
health care provider training in substance use disorders and associated medical 
and mental health consequences; and/or organizational, management, or financing 
issues, including limited reimbursement for care.  

Models of integrated care have begun to emerge, and those that currently exist 
hold promise for informing applications responding to this solicitation and for 
serving as research sites where study hypotheses can be tested in real-world 
settings.  For example, the Agency for Healthcare Research and Quality (AHRQ) 
supports a set of Primary Care Practice-Based Research Networks, a group of U.S. 
practices devoted to providing primary care for patients and investigating 
questions related to community-based practice.  In addition, the Health 
Resources and Services Administration (HRSA), in partnership with other federal 
agencies, implements the Health Disparities Collaboratives in health centers 
across the U.S., which involves a four-pronged strategy to improve health care 
and eliminate health disparities by developing leadership; implementing a model 
of change; building infrastructure to support and sustain improvement; and 
developing community partnerships.  Internationally, Australia, Canada, and 
Norway are among a number of countries that have been experimenting with 
comprehensive integrative and/or “shared care” models.  In these models, much of 
the medication monitoring, early intervention, and care management provided to 
patients with problem drug use and abuse occur within primary care offices.  To 
date, little is known about whether modification of these international models 
would work in the United States.  NIDA is interested in building on the advances 
in “shared care” found in other countries to integrate drug abuse services into 
primary care in the U.S.  

Research Areas of Interest

This RFA is designed to solicit grant applications for the conduct of behavioral 
health services, prevention, and treatment development research to expand the 
role of primary care in drug abuse intervention for youth (ages 12-24 years) in 
the pre-dependency phase of drug abuse, with specific emphasis on marijuana use 
(alone or in combination with nicotine, alcohol, and other drugs of abuse).  
NIDA encourages applicants to include developmentally appropriate, gender-
sensitive, and culturally-relevant approaches in designing their research.  
Furthermore, NIDA encourages applicants to conduct research on activities 
supported under SAMHSA’s initiative on Screening, Brief Intervention, Referral 
and Treatment (RFA No. TI 03-009), SAMHSA’s initiative on Targeted Capacity 
Expansion Program for Substance Abuse Treatment and HIV/AIDS Services (RFA No. 
TI 01-007, TI 02-009, TI 03-008), AHRQ’s Primary Care Practice-Based Research 
Networks, and HRSA’s Health Disparities Collaboratives. 
 
Screening and assessment instruments:  This announcement encourages research to 
develop screening and assessment instruments for problem drug use and related 
health problems in youth, ages 12-24 years, which can be self-administered or 
administered by a variety of health care providers.  There are several screening 
and assessment instruments geared toward adolescent substance abuse, but they 
tend to be stand-alone instruments and lacking in evidence of strong 
psychometric properties.  NIDA is interested only in screens and assessments 
that are or can be embedded into other more comprehensive behavioral health 
screening/assessment instruments, in order to maximize efficiency and likelihood 
of use in primary care settings.  Moreover, studies are needed to clarify 
instrument psychometrics, with particular attention given to validity.  
Instruments designed to screen for potential drug and related health problems 
should perform differently than instruments designed to provide a thorough 
assessment of drug problems, such as diagnostic instruments.  Two key dimensions 
of instrument performance are sensitivity and specificity.  Studies of 
instruments should describe optimal levels of sensitivity and specificity for 
the proposed purpose of the instrument within primary care settings. 

Research on the utility of screening instruments in improving clinical outcomes 
for adult populations, such as screening for depressive disorders in primary 
care settings, has yielded disappointing results.  Some studies suggest that 
screening instruments perform worse than chance at identifying patients who are 
in need of psychiatric services, and that even patients who are correctly 
identified do not have better outcomes than those who go unidentified.  Studies 
of screening for adolescent drug problems in primary care might benefit from 
building on the lessons learned from these earlier adult studies. 

The following research areas are illustrative of those that might be proposed:  

o Develop and test new, or refine existing, screening/assessment instruments to 
be embedded into comprehensive behavioral health assessments for use in primary 
care settings to screen for and assess problem drug use, with emphasis on tools 
that are simple, brief, easy-to-use (e.g., flash cards, online tools, manualized 
protocols), have optimum levels of sensitivity and specificity, and can be 
administered by a variety of health care providers. 

o Develop and test new, or refine existing, screens/assessments for use in 
primary care settings to screen for or assess health problems associated with 
problem drug use in youth, with an emphasis on sexually transmitted (HIV/AIDS, 
chlamydia, hepatitis B) and other infectious diseases. 

o Evaluate the effects of drug abuse screening tools on primary care providers’ 
ability to recognize patient problems and intervene accordingly. 

o Develop and evaluate screening or assessment instruments that are culturally 
or gender sensitive and relevant for diverse racial and ethnic minority 
populations as well as for females and males.

o Develop and test technological (e.g., hand-held technologies, touch-screen 
software, “expert systems models”) innovations to facilitate the implementation 
and adoption of screening and assessment for problem drug use in youth.

o Develop and test data management systems for gathering, maintaining, and 
sharing patient information to facilitate efficient implementation of problem 
drug use screening and assessment in primary care settings, with attention to 
patient confidentiality and HIPAA regulations. 

Brief prevention and treatment interventions:  This announcement encourages 
research to develop brief behavioral interventions for preventing and treating 
problem drug use and related health problems in youth.  Given the role of 
primary care in the overall health of youth, effective behavioral or combined 
behavioral and pharmacological interventions delivered in this setting have 
potential for initiating drug abuse treatment.  Existing brief interventions—
such as motivational interviewing, motivational enhancement therapy, and 
psychoeducational interventions—have potential for use in primary care settings, 
but their effectiveness for youth in primary care settings is unclear.  
Moreover, primary care settings present several challenges to delivering 
behavioral or combined interventions targeting problem drug use.  These 
challenges—including limited time with patients, competing demands during office 
visits, staff competence or confidence in delivering interventions—require 
innovative thinking about treatment interventions within primary care settings.  
NIDA encourages studies that develop new interventions, or modify interventions 
originally designed for different populations or different settings, to be 
applied effectively in primary care settings.  Investigators developing brief 
behavioral treatment interventions in response to this RFA are also encouraged 
to review NIDA’s Behavioral Therapy Development Program Announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html).

The following research areas are illustrative of those that might be proposed:  

o Develop and test brief universal, selective, and indicated prevention 
interventions for use in primary care settings to prevent initiation or 
escalation of problem drug use in youth.

o Develop and test new brief behavioral prevention and treatment interventions, 
or modify and test existing efficacious interventions for use with youth seen in 
primary care settings, especially for not-yet-chronic drug users—including 
minimal interventions such as brief check-ups, urine drug screening, etc.  
Modification and testing of existing efficacious interventions for use with this 
population may include changes in duration, content, and mode of presentation 
(from primary care provider presentation to book or computer-based expert 
systems presentation) for application in or concurrent with primary care.

o Develop and evaluate behavioral interventions to increase adherence to 
medication regimens for treating drug abuse, associated health consequences 
(e.g., HIV), or comorbid mental health problems.

o Develop and evaluate strategies for optimizing prophylactic regimens in at-
risk youth, such as hepatitis B vaccination.

o Develop and evaluate brief drug abuse prevention or treatment interventions 
and sexual risk reduction interventions that are gender and culturally sensitive 
and relevant for diverse racial and ethnic minority populations as well as for 
males and females.

o Develop and test caregiver-based interventions, including clinician strategies 
for educating parents and other adult caregivers on how to intervene with their 
adolescent and other children in order to prevent initiation or escalation of 
problem drug use.

o Develop and test new behavioral interventions to prevent and reduce risk 
behaviors associated with contracting or transmitting HIV and other infectious 
diseases among youth who are using all types of drugs. 

Methods for integrating drug abuse services into primary care practices:  This 
announcement encourages research to test methods for integrating drug abuse 
screening, assessment, and brief prevention and treatment interventions for 
youth into primary care systems.  Primary care providers are increasingly 
called upon to address a wider range of health problems at the same time that 
the structure of managed health care and other business practices have 
shortened patient contact time and limited reimbursement rates.  Consequently, 
the viable introduction of new drug abuse screening, assessment, and brief 
interventions for youth into primary care settings will require well-planned 
integration methods that acknowledge and accommodate the practice- and systems-
level constraints of primary care, including financing, organization and 
management practices, staffing, and staff training and supervision.  Such 
accommodation may involve embedding new clinical tools for addressing problem 
drug abuse within existing behavioral health assessments and interventions, 
modifying existing organizational and management procedures, and augmenting 
existing staff training and monitoring practices.  The following research areas 
are illustrative of those that might be proposed:

o Evaluate organizational and management processes for adopting and 
implementing brief behavioral prevention interventions or treatments (alone or 
in combination with pharmacotherapies) conducted within primary care networks 
or similar organizational structures.

o Identify types of organizational contexts within primary care settings that 
facilitate or hinder the prevention and/or treatment of problem drug use, 
abuse, and related health problems. 

o Develop and test models for introducing/transporting efficacious screening 
and brief behavioral prevention and treatment interventions (alone or in 
combination with pharmacotherapies)—including those developed under SAMHSA’s 
initiative on Screening, Brief Intervention, Referral and Treatment (RFA No. 
TI03-009)—into existing primary care settings.
 
o Develop and test tools and strategies for improving referral to more 
intensive treatments, when indicated, in order to facilitate patient adherence 
and increase cost efficiencies.

o Develop and test case management strategies for managing referrals and 
monitoring client participation in more intensive treatments.

o Determine effectiveness of currently existing “shared care” models, as well 
as internationally developed models that have experimented with comprehensive 
integrated care (i.e., medical monitoring, early intervention, and care 
management), modified as needed for the U.S. health care delivery system.

o Develop and test staff training, monitoring, and supervision practices that 
facilitate effective implementation of drug abuse services within primary care 
settings.

o Identify staffing patterns for effective implementation of integrated service 
models.

MECHANISMS OF SUPPORT

This RFA will use the NIH research project (R01), the small grant (R03) and the 
exploratory/development (R21) award mechanisms.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed project.  
This RFA is a one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer review 
procedures.  The anticipated award date is September 30, 2004.  Applications 
that are not funded in the competition described in this RFA may be resubmitted 
as NEW investigator-initiated applications using the standard receipt dates for 
NEW applications described in the instructions to the PHS 398 application.

This RFA uses just-in-time concepts.  It also uses the modular budgeting as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if you 
are submitting an application with direct costs in each year of $250,000 or 
less, use the modular budget format.  Otherwise follow the instructions for non-
modular budget research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE 
 
NIDA intends to commit approximately $3 million in FY 2004 to fund 6 to 8 new 
and/or competitive continuation grants in response to this RFA.  NIDA will 
commit $2,500,000 and SAMHSA will provide $500,000.  AHRQ is not providing any 
funds directly but has earmarked $100,000 to support at least one grant.  HRSA 
is interested in supporting research under this RFA pending (a) availability of 
funds, and (b) receipt of high quality applications relevant to HRSA's mission.  
Furthermore, NIDA may give funding priority within this RFA to applications to 
conduct research on activities supported under (a) SAMHSA’s initiative on 
Screening, Brief Intervention, Referral and Treatment (RFA No. TI03-009); (b) 
Primary Care Practice-Based Research Networks supported by AHRQ; or (c) Health 
Disparities Collaborative supported by HRSA. An applicant may request for the 
R01 a project period of up to 5 years.  For the R03, the project period is 2 
years and direct costs up to $50,000 for each of those years.  For the R21, the 
project period is 2 years and up to $275,000 in direct costs for the two-year 
period.  Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration of each 
award will also vary.  Although the financial plans of NIDA provide support for 
this program, awards pursuant to this RFA are contingent upon the availability 
of funds and the receipt of a sufficient number of meritorious applications.  At 
this time, it is not known if this RFA will be reissued.

The Agency for Healthcare Research and Quality (AHRQ) has a particular interest 
in funding under this announcement projects that will be conducted by primary 
care practice-based research networks (PBRNs). A PBRN is defined as a group of 
ambulatory practices devoted principally to the primary care of patients, 
affiliated with each other (and often with an academic or professional 
organization) in order to investigate questions related to community-based 
practice and to improve the quality of primary care 
(http://www.ahcpr.gov/research/primarix.htm).

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the following 
characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, and 
laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations

A variety of community-based primary care organizations and networks are 
eligible to participate in research supported by this announcement. 
In addition, consolidated health services organizations such as those supported 
by the Health Resources and Services Administration (HRSA) may be particularly 
well suited to serving as research sites for investigators studying real-world 
primary care settings. In addition, health care organizations such as HMOs, 
community health centers, large clinics or networks of community-based 
practices, are encouraged to participate in this research initiative 
(http://bphc.hrsa.gov/).

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry out 
the proposed research is invited to work with their institution to develop an 
application for support.  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are always encouraged to apply 
for NIH programs.    

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to answer 
questions from potential applicants.  Inquiries may fall into three areas:  
scientific/research, peer review, and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Jerry Flanzer, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4222, MSC 9565
Bethesda, Maryland 20892-9565
Telephone: (301) 443-4060
FAX: (301) 443-6815
Email: jflanzer@mail.nih.gov

Dorynne Czechowicz, M.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4231, MSC 9563
Bethesda, Maryland 20892-9563
Telephone: (301) 443-0107
FAX: (301) 443-8674
Email: dczechow@nida.nih.gov

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

o Direct your questions about financial or grants management matters to: 

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NIDA staff to estimate the potential review workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

DA-04-006
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal 
Identifier when applying for Federal grants or cooperative agreements. The DUNS 
number can be obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 
of the face page of the PHS 398 form. The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up 
to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants 
is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: 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.
 
SENDING AN APPLICATION TO THE NIH: 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/DHHS
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 and all 
copies of the appendix material must be sent to:

DA-04-006
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before 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.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignments within 8 
weeks.
 
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.  
However, when a previously unfounded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, it 
is to be prepared as a NEW application.  That is, the application for the RFA 
must not include an Introduction describing the changes and improvements made, 
and the text must not be marked to indicate the changes from the previous 
unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA.  Incomplete applications will not be reviewed.  If the 
application is not responsive to the RFA, NIH staff may contact the applicant to 
determine whether to return the application to the applicant or submit it for 
review in competition with unsolicited applications at the next appropriate NIH 
review cycle.
 
Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
NIDA in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o 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 assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Council on Drug Abuse  

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 evaluate the application in order 
to judge the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.  The scientific review group will address 
and consider each of the following criteria in assigning the application's 
overall score, weighting them as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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: Please assess the extent to which the study aims are 
consistent with the goals of the RFA.  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?  Does the study address an important problem 
consistent with the goals of this RFA?

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

(3) INNOVATION:  Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?  Innovation is 
particularly encouraged in conducting research on activities supported under 
SAMHSA’s SBIRT initiative, AHRQ’s primary care practice-based research networks, 
and HRSA’s Health Disparities Collaboratives. 

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

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

(6) APPLICABILITY:  How does the proposed work improve or advance current 
clinical practices and/or inform health policy?  How does the work address the 
identification and removal of barriers to improvements in clinical practice 
and/or health policy?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:  

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section on 
Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).

ADDITIONAL REVIEW CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    January 19, 2004 
Application Receipt Date:         February 19, 2004
Peer Review Date:                 May 2004
Council Review:                   September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against these 
risks, the potential benefits of the research to the subjects and others, and 
the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA SAFETY AND MONITORING PLAN:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding 
studies (phase I); efficacy studies (phase II); efficacy, effectiveness and 
comparative trials (phase III).  The establishment of data and safety monitoring 
boards (DSMBs) is required for multi-site clinical trials involving 
interventions that entail potential risk to the participants.  (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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:  The 
NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

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.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for Federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project description 
and elsewhere in the application as appropriate, the official NIH identifier(s) 
for the hESC line(s)to be used in the proposed research.  Applications that do 
not provide this information will be returned without review. 

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 PA 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
“Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002.  The Privacy Rule is a Federal regulation 
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 
that governs the protection of individually identifiable health information, and 
is administered and enforced by the DHHS Office for Civil Rights (OCR). Those 
who must comply with the Privacy Rule (classified under the Rule as “covered 
entities”) must do so by April 14, 2003 (with the exception of small health 
plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 service for persons at risk for HIV infection including 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.

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.   Furthermore, we caution 
reviewers that their anonymity may be compromised when they directly access an 
Internet site.

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 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.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under the authorization of Sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284 and under 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards are 
subject to the terms and conditions, cost principles, and other considerations 
described in the NIH Grants Policy Statement.  The NIH Grants Policy Statement 
can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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