PRESCRIPTION DRUG ABUSE
RELEASE DATE: June 16, 2004
PA NUMBER: PA-04-110
December 8, 2006 - The R01 portion of this funding opportunity has been
replaced by PA-07-123, which now uses the electronic SF424 (R&R)
application for February 5, 2007 submission dates and beyond.
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission.
Replacement R03 (PA-06-340) and R21 (PA-06-339) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates
for AIDS and non-AIDS applications thereafter.
EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279
THIS PROGRAM ANNOUNCEMNT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF PA
This PA supersedes PA-01-048, "Prescription Drug Abuse," issued on February
12, 2001 in the NIH Guide for Grants and Contracts at
http://grants.nih.gov/grants/guide/pa-files/PA-01-048.html. In revising and
reissuing this PA, NIDA continues to encourage research aimed at
understanding and 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,
behavioral, 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, epidemiological, prevention, and treatment studies.
RESEARCH OBJECTIVES
Background
Prescription drug abuse is a major public health concern. The 2002 National
Survey on Drug Use and Health (formerly known as the National Household
Survey on Drug Abuse) reports that 6.2 million Americans age 12 and older are
current users of prescription drugs for nonmedical purposes. An estimated
4.4 million used pain relievers, 1.8 million used tranquilizers, 1.2 million
used stimulants, and 0.4 million used sedatives. Lifetime nonmedical pain
reliever prevalence among youths aged 12 to 17 increased from 2001 (9.6%) to
2002 (11.2%), continuing an increasing trend from 1989 (1.2%). Among young
adults aged 18 to 25, the rate increased from 19.4% in 2001 to 22.1% in 2002.
The young adult rate had been 6.8% in 1992. Lifetime nonmedical use of
stimulants increased steadily from 1990 to 2002 for youths aged 12 to 17 (0.7
to 4.3%). For young adults aged 18 to 25, rates declined from 1981 to 1994
(from 10.9 to 5.9%), then increased to 10.8% in 2002. Rates increased
between 2001 and 2002 for both youths (3.8 to 4.3%) and young adults (10.2 to
10.8%).
The number of new initiates to nonmedical pain reliever use increased from
628,000 in 1990 to 2.7 million in 2000. About half (52%) of the new users in
2001 were females. In 2001, the number was 2.4 million, not significantly
different from 2000. First use of stimulants increased during the 1990s from
270,000 in 1991 to 983,000 in 2000 and 808,000 in 2001. Initiation of
tranquilizer use increased steadily during the 1990s, from 373,000 initiates
in 1990 to 1.3 million in 2000 and 1.1 million in 2001. The number of
sedative initiates has remained below 300,000 per year since 1981.
Drug Abuse Warning Network (DAWN) data show that rates per 100,000 of
emergency room mentions of narcotic analgesics/combinations (category
consists of drugs containing narcotic analgesics alone as well as narcotics
in combination with other drugs) have increased 138.7% from 1995 to 2002 and
18.5% from 2001 to 2002. In 2002, the Monitoring the Future study added new
questions on the nonmedical use of Vicodin and OxyContin. In both 2002 and
2003, past year use of Vicodin (hydrocodone) and OxyContin (oxycodone
hydrochloride) by 12th graders has been about 4% while past year use of
Vicodin has been about 10%, raising serious concern about prescription opioid
abuse among youth.
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 the need for substance abuse treatment (Gfroerer et
al., Drug Alcohol Depend. 69, 127-135, 2003). 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 this problem in terms of class of drug abused,
etiology of abuse, and populations most affected (including racial/ethnic
minority and gender analyses). 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,
obesity), 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. The
recent proliferation of internet sites offering controlled substances for
sale without a prescription (Forman, JAMA, 290, 889, 2003) requires further
investigation. 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 social norms and social contexts associated with 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 cognitive impairment, absenteeism, and
accidents). To reduce prescription drug abuse, research is needed on
prevention approaches, service delivery, and behavioral and pharmaco-
therapies targeted to particular populations (e.g., the elderly, women,
adolescents, health professionals, and those with comorbid substance abuse
and mental health disorders and/or medical disorders).
Clinical studies are needed that take into account the patient’s age, gender,
race/ethnicity, medical and psychiatric diagnoses, and current symptomatology
and past and present treatments, as well as the clinical appropriateness or
inappropriateness of prescribing practices. Clinical neurobiological
investigations using a variety of brain imaging methods also can allow for a
better understanding of how these prescription drugs affect brain processes
and systems over the life span. Studies 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 socioeconomic 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 abuse and 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. In the 2003 Monitoring the Future study,
among twelfth graders, annual prevalence of Vicodin use was second only to
marijuana use. 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. Prescription of methylphenidate and other
stimulants to treat attention-deficit hyperactivity disorder (ADHD) has
increased in recent years. A new, stand-alone question on nonmedical
Ritalin (methylphenidate) use was added to the Monitoring the Future survey
in 2001, (Secondary School Students, 2002). Using this new question, annual
prevalence rates among twelfth graders was 4.0%; about half (1.9%) reported
using only once or twice in the past year, but 0.9% reported using 10 or more
times during the year. Studies are needed on the extent of misuse and abuse
of prescribed stimulant medications and on the extent to which youth share
prescribed stimulants with their peers. There is also a need for
developmentally appropriate therapies that can engage and retain adolescents
in treatment for prescription drug abuse.
In addition, doctors, nurses, dentists, pharmacists, veterinarians, and other
health professionals are 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. Furthermore, while some health professionals may
contribute to the misuse and abuse of prescription drugs because of
inappropriate prescribing behaviors, others may provide inadequate
pharmacotherapy for pain and other conditions because of fear that their
patients will become addicted or that they will incur regulatory scrutiny.
There is a need to develop and evaluate innovative science based education
approaches for health professionals. Best practices and training protocols
for health care workers require research not only on approaches, but also on
methods to transfer science into the field.
Program Description
A range of research is needed to combat prescription drug abuse--from
specifying the extent and nature of the problem (including health,
behavioral, and social consequences) to developing, evaluating, and
disseminating effective prevention and treatment approaches. Research is
needed to identify addiction risk factors, including those associated with
the chronic therapeutic use of analgesics, stimulants, and sedative-hypnotics
for psychiatric and other medical illnesses. Improved means of screening,
assessing, and diagnosing those at high risk of abusing or becoming addicted
to prescribed psychoactive medications are needed. Research is needed to
examine the interaction of patient behavior, social and physical environment,
and medical and drug abuse treatment practice to improve prescribing,
screening, referral, and treatment processes in the health care system.
Treatment studies are needed to develop and evaluate behavioral therapies and
combined behavioral and pharmaco-therapies for prescription drug abuse, with
particular attention to populations at highest risk (adolescents, women,
patients with comorbid psychiatric and/or physical illness, the elderly, and
those with a history of polydrug abuse). Basic preclinical and clinical
research is needed to understand the neurobiological, behavioral,
pharmacological, and genetic basis of prescription drug abuse. Research is
needed to identify interactions between abused prescription drugs and other
abused drugs and alcohol. Across levels of analysis and research domains,
there is also an interest in stimulating development and integration of
technologies (for example, from genetic, imaging, proteomic, metabolomic
information and approaches) to observe and understand the etiology and
biological and behavioral mechanisms associated with prescription drug abuse.
Areas of research interest include, but are not limited to, the following:
Epidemiology and Prevention Research
o Studies, by class of drug, on the nature and magnitude of prescription drug
diversion from both licit and illicit sources. Research to identify sources
of illicit prescription drugs in different population subgroups. Studies of
the demographics of populations abusing each class of prescription drugs,
including regional variations and rural-urban gradients. Studies should
consider the methodological aspects of measuring prescription drug abuse such
as the nomenclature for prescription drugs used in various population groups
and the accuracy of recall and reporting of medication names and dosing
regimens.
o Research on the factors that influence temporal trends in abuse of
prescription drugs such as changes in the health care system, prescriptive
practices, and sources of prescription medications (local pharmacy, mail
order, internet, other) and in the training of health care providers
regarding prescribing medications with abuse liability.
o Studies on the role of the internet as both a source of prescription drugs
and a source of information about these drugs. Studies on the role of the
internet and direct-to-consumer advertising in shaping attitudes and in
influencing beliefs about the risks associated with prescription drugs.
o Studies to identify patient populations who are under- or over-medicated 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 children and
adolescents, women, the elderly, racial/ethnic minorities, uninsured) and
patients with current or past substance abuse problems.
o Studies to evaluate whether prolonged treatment with prescription
psychoactive drugs for conditions such as ADD/ADHD, sleep disorders, pain,
obesity, anxiety disorders, etc. contributes to drug abuse or relapse to drug
abuse in vulnerable individuals.
o Studies to evaluate whether noncompliance with prescription drug dosing
increases the likelihood of transition from misuse to abuse, possibly by
inducing sensitization.
o Studies to determine how prescription drug misuse and abuse, particularly
by pregnant women, children, and adolescents, might increase the risk of
abuse/addiction of illicit drugs over the life span.
o Studies of the factors that predispose an individual to over-rely on and to
misuse psychoactive prescription and over-the-counter drugs (e.g., health
beliefs and practices, health promotion behaviors, reliance on media, family
and cultural practices).
o Studies of the adverse behavioral and social consequences associated with
prescription drug misuse, abuse, and dependence, such as impairment in school
performance, driving, parenting, job performance, independent living for the
elderly, etc.
o Studies to determine incidence and prevalence of medical and health
consequences of prescription drug misuse and abuse. Of particular interest
are studies in those with HIV/AIDS, hepatitis, and other infectious diseases
that are prevalent in drug abusers.
o Studies to identify, design, and evaluate 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) abuse of dextromethorphan (DXM), an over-the-counter
drug, alone and in combination with other drugs of abuse; 4) use of
stimulants on college campuses for appetite suppression, wakefulness,
increased attention, and euphoria.
o Studies to design and evaluate 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,
insomnia, fatigue, obesity, anxiety, eating disorders, etc., who are
prescribed abusable prescription drugs; 2) health care professionals; and 3)
the elderly.
o Studies that theoretically and empirically explore the impact of existing
evidence-based drug abuse prevention approaches, or variants of existing
approaches, on prescription drug abuse patterns.
Basic Preclinical and Clinical Research
o Employ basic studies using animal models to probe the effects of
prescription drugs on neurobiological, neurochemical, and neurobehavioral
processes.
o Study possible associations between physical dependence, produced by either
medical or nonmedical prescription drug use, and the development of
addiction.
o Study the pharmacokinetics, pharmacodynamics, and pharmacogenetics of drug-
drug interactions between abused prescription drugs and other illicit drugs,
as well as between prescription drugs and dietary supplements and drugs for
treatment of infections (e.g., antiretrovirals).
o Conduct pharmacogenetic studies examining the genetic variation in
physiological homeostasis, neurocognitive processes, biological systems
and/or metabolic effects of prescription drugs and vulnerability to
addiction.
o Conduct studies to determine the health consequences of prescription drug
abuse and their underlying pathophysiology in diverse populations, e.g.,
those with HIV/AIDS and other infectious diseases, adolescents, the elderly,
women. 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 abuse of prescription drugs.
o Research is needed to determine the extent and mechanisms by which abused
prescription drugs affect neurobiological mechanism and behavioral processes
during development (including prenatal exposure), adolescence and adulthood,
including older adulthood.
o Determine how prescription drug abuse has a differential effect on brain
processes across adulthood, particularly in elderly populations. For
example, what are the effects of prescription drugs on normal aging processes
in the brain, and do they place individuals at increased risk (or earlier
expression) of neurodegenerative diseases such as Parkinson’s disease,
Alzheimer’s disease, and other neurocognitive disorders?
o Assess the risk of addiction to prescribed medications as a function of the
medical condition for which the drug is prescribed. For example, is the risk
of addiction to opioids lessened as a function of the degree of pain present?
If so, the mechanism responsible for this variation needs to be examined.
o Cross-sensitization and relapse. In animal models determine if exposure to
prescription drugs can precipitate relapse or lead to cross-sensitization to
other drugs.
o Determine the mechanism responsible for feelings of well-being induced by
certain steroids (e.g., prednisone). Is the euphoria sufficient to maintain
drug-seeking? Do steroids stimulate relapse under, for example, conditions
of psychomotor stimulant abstinence? Determine if steroids reduce the
aversive effects of drug withdrawal.
o Assess whether prescription drugs affect the toxicity of other abused
substances. For example, fluoxetine is used in the treatment of depression
and obsessive-compulsive disorder (OCD), but it is being misused/abused in an
attempt to protect from the neurotoxic action of methamphetamine, ecstasy,
and other "club drugs." Studies are needed to determine the consequences of
these drug combinations on neural mechanisms and behavioral.
o Study the acute and chronic interactions between prescription drugs and
illicit substances at the behavioral and cognitive level of analysis. Most
notably, what are reinforcing characteristics of drug combinations?
o Develop and apply interoperable and scalable analytic, modeling and other
computation and information tools (such as those for dynamic semantic
profiling, social and other network analysis, and data integration and
management) to enable pattern recognition and analysis to facilitate
understanding of emerging patterns of use, vulnerabilities, drug use and
disease relationships, economic relationships, and other factors related to
prescription drug abuse.
Treatment and Services Research
o Research on the development and testing of effective and comprehensive
treatment approaches that may include behavioral, pharmacological,
alternative or complementary therapies for individuals who abuse or become
dependent on prescription analgesics, stimulants, anxiolytics, or sedative-
hypnotics. Behavioral treatment and combined behavioral and pharmacological
studies should be informed by the stage model of therapy development,
described in detail in the Behavioral Therapies Development Program
Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html).
Treatment studies are encouraged to include tests of the mediators,
moderators, key ingredients, and/or mechanisms of action at all stages of
therapy development.
o Studies to develop and evaluate treatment approaches that maintain
abstinence from prescription drug abuse and prevent relapse.
o Studies of brief behavioral treatment interventions for prescription drug
misuse and abuse in primary care settings.
o Studies to develop and test age-appropriate, gender-sensitive, and
culturally-relevant treatment approaches for prescription drug abusing
individuals.
o Studies to adapt existing treatments for other drugs of abuse, or for other
conditions, for use with individuals who abuse prescription drugs.
o Studies to develop and evaluate new and innovative therapies to treat
prescription drug abuse that are based on promising findings from basic
behavioral and cognitive research.
o Studies to develop and test, or to adapt, developmentally-appropriate
behavioral treatments for adolescents who abuse prescription drugs, with
particular attention to the types and patterns of drug use among adolescents
and the challenges to engaging adolescents in treatment.
o Studies to develop and evaluate therapies for individuals who abuse
prescription drugs and have comorbid mental disorders, such as depression,
anxiety disorders, post-traumatic stress disorder, and eating disorders or
comorbid physical disorders such as sickle cell anemia, HIV/AIDS,
musculoskeletal disease, etc. associated with chronic pain.
o Studies which utilize e-health tools such as computers and portable digital
and wireless devices to improve access to treatment for prescription drug
abuse and/or augment provision of treatment by health care providers.
o Studies to develop and evaluate effective treatment approaches for the
management of pain, anxiety, sleep disorders, obesity etc., in substance
abusing patients and people with a history of substance abuse. Therapies are
needed for patients who are self-medicating in an attempt to manage comorbid
medical and/or psychiatric problems.
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 Research on effective detoxification strategies for various classes of
prescribed drugs with abuse liability.
o Pharmacotherapy studies to evaluate the use of medications for new
indications in the treatment of prescription drug abuse (e.g., buprenorphine
for oxycodone abuse).
o Studies to improve the screening, assessment, and recognition of
prescription drug misuse, abuse, and dependence among patients being treated
in health care settings for medical and/or psychiatric illnesses, especially
those which are chronic in nature.
o Studies to improve the recognition and referral for intervention of
employee prescription drug misuse and abuse in the workplace to ensure timely
and appropriate referral for treatment. Research is needed on educational
approaches to increase workforce awareness of prescription drug misuse and
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 Studies to identify organizational characteristics (e.g., climate, culture,
age, and size), financing, and managerial approaches to providing the most
accessible and effective treatment for prescription drug abuse and addiction,
including factors that enhance motivation to participate and remain in
treatment, compliance with treatment, and relapse avoidance. Research to
identify the value added by linkages to relevant treatment services such as
psychiatric, wellness, and social services is also welcome.
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 to develop and evaluate innovative health professional
prescription drug education programs using new technologies, e.g. palm pilot,
interactive computer based programs, virtual reality, etc.
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.
MECHANISMS OF SUPPORT
This PA will use the NIH research project (R01), small research grant (R03)
(PA-03-108: NIH SMALL RESEARCH GRANT PROGRAM (R03), and
exploratory/developmental research grant (R21) PA-03-107: NIH
EXPLORATORY/DEVELOPMENTAL RESEARCH GRANT AWARD (R21) award mechanisms. As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project.
This PA 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.
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
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 your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Dorynne Czechowicz, M.D.
Division of Clinical Neurobiology, Development and Behavioral Treatment
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4231, MSC 9551
Bethesda, Maryland 20892-9551
Rockville, Maryland 20852 (for express/courier service)
Telephone: (301) 443-2237
Fax: (301) 443-8674
E-mail: dc97d@nih.gov
Lynda Erinoff, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Blvd., Room 5153 MSC 9589
Bethesda, MD 20892-9589
Rockville, Maryland 20852 (for express/courier service)
Telephone: 301-402-1972
Fax: 301-480-2543
E-mail: le30q@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 270, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: gf6s@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 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget 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.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the IC staff member
who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: 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, NIH, DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. Appropriate scientific review groups
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate national advisory council
or board.
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 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.
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?
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?
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?
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)?
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?
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)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
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 will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane Care
and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
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 AND SAFETY 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 and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek
guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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 "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.
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.
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.
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).
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.
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 PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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