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PA NUMBER: PA-01-048 (superseded by PA-04-110)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 301/710-0267, 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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