This Program Announcement expires on December 31, 2003, unless reissued.

PRESCRIPTION DRUG ABUSE

Release Date:  February 12, 2001

PA NUMBER:  PA-01-048 (superseded by PA-04-110)

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

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

PURPOSE

This PA encourages research aimed at reducing prescription drug abuse while 
supporting appropriate medical use of therapeutic agents with abuse 
liability.  To promote the Nation’s health, research is needed to understand 
the factors contributing to prescription drug abuse, to characterize the 
adverse medical and social consequences associated with this abuse, and to 
develop effective prevention and service delivery approaches and behavioral 
and pharmacological treatments.  Applications to address this issue are 
encouraged across a broad range of experimental approaches including basic, 
clinical, and epidemiological studies.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project 
(R01), small grant (R03), and exploratory/developmental grant (R21) award 
mechanisms.  Because the nature and scope of the research proposed in 
response to this PA may vary, it is anticipated that the size of an award 
will vary also.  Responsibility for the planning, direction, and execution of 
the proposed project will be solely that of the applicant.

Applicants are advised to contact NIDA program staff listed under INQUIRIES for 
additional information.  Refer to the announcement for the specific eligibility 
requirements for the small grant (R03) at 
http://grants.nih.gov/grants/guide/pa-files/PAR-97-038.html and the 
developmental/exploratory grant (R21) at 
http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html.  
Because the nature and scope of the research proposed in response to this PA may 
vary, it is anticipated the size of an award will also vary.  Awards under the 
R01 mechanism may not exceed 5 years.  Awards under the R03 mechanism are 
limited to 2 years, and R21 awards are limited to 3 years.  Modular budgeting 
procedures apply for grants up to $250,000.  See 
http://grants.nih.gov/grants/funding/modular/modular.htm for further 
information about modular budgets.

RESEARCH OBJECTIVES

Background

Prescription drug abuse is on the rise (1999 National Household Survey on 
Drug Abuse).  In 1999, 3.5% of 18-25 year olds reported past month nonmedical 
use of any psychotropic medication compared to 1.6% in 1994.  An estimated 
1.6 million Americans used prescription pain relievers nonmedically for the 
first time in 1998.  This represents a significant increase in new users 
since the 1980s, when there were generally fewer than 500,000 initiates per 
year.  Between 1990 and 1998, increases in new users of prescription pain 
relievers were reported in youths age 12-17, as well as in young adults age 
18-25.  In addition, concerns have been raised about increasing substance 
abuse among older adults (age 60 and older) and the potential impact of the 
aging of the baby boom generation on this problem.  Alcohol and prescription 
drug misuse may affect as many as 17% of older adults [Substance Abuse Among 
Older Adults, SAMHSA/CSAT Treatment Improvement Protocol (TIP) Series 26].  
Yet, proper treatment of many medical conditions requires the use of 
medications that can be misused, abused, and or lead to dependency.

Applications are sought to define the extent of the problem of prescription 
drug abuse—to characterize the issue in terms of class of drug abused, 
etiology of abuse, and populations most affected.  Studies are needed on all 
classes of prescription drugs with abuse liability, including analgesics, 
stimulants, sedative/hypnotics/anxiolytics, and muscle building/performance 
enhancing drugs such as anabolic steroids.  Researchers are encouraged to 
study the relationship between the prescription medication, the indication 
for which the medication was prescribed (e.g., pain, sleep disorder, anxiety 
disorder), and the environmental and individual factors contributing to 
abuse.

Studies are also needed on the factors leading to diversion of prescription 
drugs into channels of illicit drug distribution and on measures to lessen 
this diversion, such as science-based education of health professionals.  
Research is needed to describe the populations most at risk for abuse of 
particular classes of drugs (including demographic factors and reasons for 
use), the source(s) of these drugs, and the consequences of drug use (e.g., 
adverse health outcomes such as drug overdose and drug interactions and 
behavioral and social consequences such as absenteeism and accidents).  To 
reduce prescription drug abuse, research is needed on prevention approaches, 
service delivery, and behavioral and pharmacological treatments targeted to 
particular populations (e.g. the elderly, health professionals, and those 
with comorbid substance abuse and mental health disorders).

Clinical studies are needed that take into account the patient’s age, gender, 
race/ethnicity, medical and psychiatric diagnoses, and current symtomatology 
and past and present treatments, as well as the clinical appropriateness or 
inappropriateness of prescribing practices.  Surveys are also necessary to 
determine how attitudes, knowledge, and patterns of prescribing vary across 
categories of patients and health care providers and how these contribute to 
inappropriate prescribing practices and disparities in health care.  For 
example, pharmacies may not stock opioid pain medications in racial and 
ethnic minority communities or low income communities, and there may be 
disparities in physicians’ prescribing practices to minority and low socio-
economic status (SES) patients.  Conversely, women are much more likely than 
men to be prescribed abusable prescription drugs, and prescription drug 
misuse/abuse among older women is a serious problem that has received little 
attention and often goes unrecognized by health professionals (CASA Report, 
June 1998).

In general, prescription drug abuse in older adults begins with misuse due to 
inappropriate prescribing or lack of patient compliance with medication 
regimens.  Continued misuse may progress to dependence.  Older adults may be 
more vulnerable to prescription drug abuse because of age-related 
physiological changes that may influence the metabolism and response to 
prescription drugs, greater likelihood of having undiagnosed psychiatric and 
medical comorbidities, and difficulties in compliance with complex multiple 
drug regimens that may increase the likelihood of drug interactions.  For 
example, benzodiazepines are frequently prescribed to older adults, but age 
related changes in drug metabolism, interactions with other prescription and 
over-the-counter medications, and use of alcohol may lead to increased 
use/misuse/abuse and adverse consequences such as impaired functional 
capacity and cognition.

Yet, older Americans, their families, and their health care and service 
providers are frequently uninformed about the potential problems with 
psychoactive prescription drugs and, therefore, do not recognize these 
problems when they occur.  The aging of the baby boom cohort may enhance the 
occurrence of substance abuse, including prescription drug abuse among older 
Americans because of this cohort’s prior use and abuse of psychoactive 
compounds.  There is a need for research to develop screening, assessment, 
and diagnostic instruments (especially for use by health professionals in 
primary care settings) and prevention and treatment approaches targeted to 
prescription drug misuse and abuse in older adults.

The increased use of prescription drugs among high school and college age 
youth is also of great concern.  Young people frequently mix prescription 
drugs with other drugs of abuse, such as marijuana and alcohol, putting them 
at risk for drug interactions and overdose.  When 12th graders were queried 
about use of specific amphetamines, methylphenidate use was widely reported; 
its use increased from 1992 (0.1%) to 1997 (2.8%) before leveling off 
(Monitoring the Future, Secondary School Students, 1999).  Prescription of 
methylphenidate and other stimulants to treat attention-deficit hyperactivity 
disorder (ADHD) has increased in recent years.  Studies are needed on the 
extent of misuse and abuse of those prescribed stimulant medications and on 
the extent to which youth prescribed these stimulants may provide these drugs 
to their peers.

In addition, some health professionals (doctors, nurses, dentists, 
veterinarians, etc.) may be at risk because of their ready access to 
prescription drugs with abuse liability.  Research is needed to identify the 
components of effective prevention and treatment approaches targeted toward 
health professionals.

Program Description

A range of research is needed to combat prescription drug abuse--from 
specifying the extent and nature of the problem (including health and social 
consequences) and identifying their determinants, to discovering effective 
clinical practices that identify those at risk and designing and 
disseminating prevention and treatment interventions.  Research on addiction 
risk factors associated with the chronic therapeutic use of analgesics, 
stimulants, and sedative-hypnotics for psychiatric and other medical 
illnesses is needed.  Studies that assess the risk of abuse or addiction to 
prescribed psychoactive medications for known therapeutic indications in 
patients with a history of polydrug abuse are also encouraged.  Improved 
means of identifying who is at high risk of abusing or becoming addicted to 
prescribed psychoactive medications are needed to develop more effective 
prevention and treatment approaches.  Basic, epidemiological, and clinical 
research is needed to identify interactions between abused prescription drugs 
and other abused drugs and alcohol.

Areas of research interest include, but are not limited to, the following:

Epidemiological, Prevention, and Clinical Research

o  Studies to evaluate whether non-compliance with prescription drug dosing 
regimens leads to sensitization that then increases the likelihood of 
transition from misuse to abuse.

o  Studies to evaluate the role of treatment with prescription drugs (for 
conditions such as sleep disorders, pain, etc.) in relapse to drug abuse.

o  Studies, by class of drug, on the nature and magnitude of prescription 
drug diversion from both licit and illicit sources.

o  Studies to identify patient populations who are under- or overmedicated or 
have difficulty obtaining adequate treatment with controlled substances.  
Studies on prescribing practices and attitudes of physicians (by specialty 
area, including primary care physicians) toward prescribing medications with 
abuse liability to different patient populations (such as women, the elderly, 
racial or ethnic minorities, uninsured) and patients with current or past 
substance abuse problems.

o  Studies to identify and to design prevention interventions for those 
adolescents and college-age youth at increased risk for prescription drug 
misuse and abuse.  Types of prescription misuse and abuse among youth 
include: 1) the mixing of prescription drugs with other drugs of abuse (e.g., 
marijuana, alcohol), which places them at risk for drug interactions and 
overdose; 2) misuse and abuse of prescribed stimulants and providing these 
drugs to their peers; 3) combining dextromethorphan (DXM), a drug commonly 
found in cough medicine, and ecstasy, which is found at rave parties; 4) use 
of stimulants on college campuses for appetite suppression, wakefulness, 
increased attention, and euphoria.

o  Studies to design prevention interventions for individuals who may be at 
increased risk for prescription misuse and abuse in the following 
populations: 1) individuals with illnesses, such as arthritis, back pain, 
cancer, insomnia, fatigue, obesity, anxiety, eating disorders, etc., who are 
prescribed abusable prescription drugs; 2) health care professionals; and 3) 
the elderly.  

o  Research on the factors that influence temporal trends in misuse and abuse 
of prescription drugs and how these relate to changes in the health care 
system, prescriptive practices, and sources of prescription medications 
(local pharmacy, mail order, other) and on the training of health care 
providers regarding prescription of medications with abuse liability.

o  Studies of the factors that predispose an individual to place over-
reliance on and misuse prescription and over-the-counter drugs (e.g., health 
beliefs and practices, health promotion behaviors, reliance on media, 
cultural practices).

o  Studies of the adverse behavioral and social consequences associated with 
prescription drug misuse, abuse, and dependence, such as impairment in 
driving, parenting, job performance, independent living for the elderly, etc.

o  Studies to determine incidence, prevalence, and underlying pathophysiology 
of medical and health consequences of prescription drug misuse and abuse.  Of 
particular interest are studies in those with HIV/AIDS and other infectious 
diseases that are prevalent in drug abusers.  The consequences may include 
developmental, psychiatric, metabolic (including nutritional), endocrine, 
pharmacokinetic/pharmacodynamic drug-drug interactions, or other 
physiological system effects caused by or associated with the misuse and 
abuse of prescription drugs.

Basic Research

Basic research to understand the neuropsychopharmacological basis of 
prescription drug abuse such as:

o  Research that compares the risk of addiction to prescribed medications as 
a function of whether the individual receiving the drug is or is not actually 
in need of this treatment.  For example, is the risk of addiction to opioids 
lessened when pain is present?  If having a particular illness lessens the 
potential of addiction, the mechanism of this protection needs to be 
examined.

o  Studies to examine behavioral cross sensitization and relapse.  Would, for 
example, a prescription with a mild stimulant action cause relapse in a 
former cocaine or amphetamine addict?

o  Studies to determine if the feelings of well-being induced by certain 
steroids (e.g., prednisone) are due to a direct or indirect mechanism.  Is 
the euphoria sufficient to maintain drug-seeking?  Will these steroids 
stimulate relapse under conditions of psychomotor stimulant abstinence?  Will 
they reduce the aversiveness of drug withdrawal in general?

o  Studies on the use of prescription drugs to self-medicate.  For example, 
fluoxetine is used in the treatment of depression and obsessive-compulsive 
disorder (OCD), but it is being misused/abused to protect from the neurotoxic 
action of methamphetamine, ecstasy, and other "club drugs."  Studies are 
needed to determine the degree of protection afforded by fluoxetine and/or 
compounds with similar action on the serotonin transport mechanisms.  Similar 
studies are indicated for dopamine uptake inhibitors.

Treatment and Services Research

o  Studies to develop and evaluate effective treatment approaches for the 
management of pain, anxiety, sleep disorders, etc., in substance abusing 
patients.

o  Research on effective treatments (behavioral, pharmacological, alternative 
or complementary therapies) for individuals who misuse/abuse or become 
dependent on prescribed analgesics, stimulants, anxiolytics, or sedative-
hypnotics.

o  Research on effective detoxification strategies for various classes of 
prescribed drugs with abuse liability.

o  Studies to develop and evaluate behavioral and pharmacological treatment 
approaches that maintain abstinence from prescription drug abuse and prevent 
relapse.

o  Studies to develop and test age-appropriate, gender sensitive, and 
culturally relevant treatment approaches for prescription drug abusing women, 
adolescents, older adults, racial and ethnic minorities, and individuals with 
comorbid substance abuse and mental disorders.  For example, studies are 
needed in women who misuse/abuse prescription drugs and have comorbid mental 
disorders, such as depression, anxiety disorders, postraumatic stress 
disorder, and eating disorders.

o  Studies to develop and evaluate behavioral treatments to improve 
medication adherence and prevent misuse of prescribed medications among 
substance abusing patients with comorbid medical illnesses or mental 
disorders.

o  Studies to improve the screening, assessment, and recognition of 
prescription drug misuse and abuse among patients being treated in health 
care settings for acute and chronic medical and/or psychiatric illnesses.

o  Studies of brief behavioral interventions for prescription drug misuse and 
abuse among patients seen in primary care settings.

o  Studies that evaluate the use of medications for new indications in the 
treatment of prescription drug abuse (e.g., buprenorphine for codeine abuse).

o  Studies to determine the factors that may affect access to treatment for 
prescription drug abuse and addiction, including treatment entry, readiness 
for treatment, retention in treatment, compliance with treatment, and 
treatment outcomes among prescription drug abusing women, adolescents, older 
adults, and racial/ethnic minorities.

o  Research on the organization, management, and financing of treatment for 
prescription drug abuse and addiction.  Studies on how linkages to other 
relevant treatment services, such as medical and psychiatric services, may 
improve access and improve treatment outcomes.

o  Research to develop and evaluate effective strategies/approaches for 
disseminating science-based information on the recognition, prevention, and 
treatment of prescription drug abuse to health professionals and community-
based health care providers.  Research to determine the most effective 
approaches for enhancing utilization of science-based information and whether 
these approaches actually change practice behaviors.

o  Research in pharmacoeconomics to study optimum drug therapy and health 
outcomes utilizing quality-of-life assessment and outcomes research.  Such 
studies would provide economic information to inform clinical prescribing 
decisions and allocation of healthcare resources.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report 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 these policies.

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.

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 the recommendations of the 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 Funding or may be obtained by calling (301) 443-2755.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application; 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute or Center who agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at  
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers, 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested in accordance with the program guidelines and the modifications 
made to the standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

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

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

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

Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and their role on the project.  Indicate whether the collaborating 
institution is foreign or domestic.  The total cost for a 
consortium/contractual arrangement is included in the overall requested 
modular direct cost amount.  Include the Letter of Intent to establish a 
consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years; and
- List selected peer-reviewed publications with full citations.

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

The title and number of the PA must be typed on line 2 of the face page of 
the application form and the YES box must be marked.

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

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines and will be reviewed for completeness by the Center for Scientific 
Review.  Applications will be evaluated for scientific and technical merit by 
an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, 
all applications will receive a written critique and undergo a process in 
which only those applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance the understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

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

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

(3) Innovation:  Does the project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

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

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

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

AWARD CRITERIA

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

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to clarify 
any issues or questions from potential applicants is welcome.

Direct programmatic inquiries to:

Dorynne Czechowicz, M.D.
Division of Treatment and Research Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4231, MSC 9551
Bethesda, Maryland 20892-9551
Telephone: (301) 443-2237
Fax: (301) 443-8674
e-mail: dc97d@nih.gov

Direct inquiries regarding fiscal matters to:

Jack Manischewitz, Ph.D.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, Maryland 20892-9541
Telephone: (301) 443-6710
Fax: (301) 594-6849
e-mail: jm198m@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 and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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