INHALANT ABUSE:  SUPPORTING BROAD-BASED RESEARCH APPROACHES

Release Date:  November 26, 2001

RFA:  RFA-DA-02-002

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

Letter of Intent Receipt Date:  March 12, 2002
Application Receipt Date:       April 10, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN 
$250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN 
SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
https://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute on Drug Abuse (NIDA) requests applications to broaden 
the understanding of the epidemiology, social, behavioral, cognitive and 
neurobiological consequences, treatment, and prevention of inhalant abuse 
(i.e., solvents and gases often grouped as inhalants in nationwide surveys). 
Currently, there is little research on inhalant abuse and many issues remain 
to be explored. Prevalence data from both the National Household and 
Monitoring the Future Surveys indicates that inhalant abuse continues to be a 
major public health concern among grade school children, adolescents and some 
adults. According to the Monitoring the Future (MTF) 2000 Survey, 8th graders 
regularly report the highest rate of current (4.5 percent), past year (10.2 
percent) and lifetime (17.9 percent) inhalant abuse use; 10th and 12th graders 
report less abuse.  Furthermore, MTF lifetime prevalence figures indicate that 
the percentage of students who have tried inhalants remain at high levels.  
The National Household Survey on Drug Abuse, an annual survey of drug use 
among the Nation's non-institutionalized civilians, indicates that 
(http://www.samhsa.gov/oas/NHSDA/2kNHSDA/2kNHSDA.htm) lifetime use of inhalants 
is greater than for crack cocaine or heroin.  

Because of the paucity of research on all aspects of inhalant abuse, this 
announcement requests research focusing on developing targeted prevention and 
treatment interventions for inhalant abuse.  Basic epidemiological, 
behavioral, cognitive and neurobiological research is needed to determine the 
antecedent variables (e.g., impaired decision-making processes, impulsivity), 
consequences (e.g., neurological and physiological disorders, accidents, 
dropping out of school, impairments resulting from prenatal exposure, and 
cognitive deficits), and the underlying mechanisms associated with, or 
resulting from inhalant exposure.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This RFA, "Inhalant Abuse:  Supporting 
Broad-Based Research Approaches," is related to one or more of the priority 
areas.  Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.
 
ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of state and local governments, and eligible 
agencies of the Federal government.  Faith-based organizations are eligible to 
apply for these grants. Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This RFA 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 RFA 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.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
https://grants.nih.gov/grants/funding/modular/modular.htm.

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 
https://grants.nih.gov/grants/guide/pa-files/PAR-97-038.html and the 
developmental/exploratory grant (R21) at 
https://grants.nih.gov/grants/guide/pa-files/PA-01-012.html.  Because the 
nature and scope of the research proposed in response to this RFA 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.  

The anticipated award date is September 30, 2002.  This RFA is a one-time 
solicitation.  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  Applications judged to be 
nonresponsive to the RFA will be returned to the applicant.

FUNDS AVAILABLE

NIDA intends to commit approximately $2 million in FY 2002 to fund 5-7 
new/competitive continuation grants in response to the RFA.  Although the 
financial plans of the NIDA provide support for this program, awards pursuant 
to this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.  

RESEARCH OBJECTIVES

Background

Inhalants are volatile substances that produce chemical vapors that can be 
inhaled to induce a psychoactive or mind-altering effect.  Several 
subcategories of inhalants have been identified including: a) industrial or 
household products (e.g., paint thinners or solvents, degreasers or cleaning 
fluids, gasoline, and volatile substances in glues); b) art and office supply 
solvents (e.g., correction fluids, glues, and solvents in magic markers); c) 
gases such as butane and chlorofluorocarbons used in household or commercial 
products (e.g. butane lighters, whipped cream dispensers (nitrous oxide), 
electronic contact cleaners (dusters) and refrigerant gases); d) household 
aerosol propellants used in items such as hair, cooking, lubricant and fabric 
protector sprays; e) medical anesthetic gases such as ether, chloroform, 
halothane, and nitrous oxide; and f) aliphatic nitrites.

The practice of "sniffing," "huffing," "bagging," or inhaling to get high 
describes various forms of inhalation abuse. Inhalants are popular among 
adolescents and young adults.  They are appealing and abused for a variety of 
reasons, including: they are relatively inexpensive, can be purchased legally, 
and are readily accessible.  The "high" achieved with inhalants occurs rapidly 
and disappears relatively quickly, in comparison to other drugs of abuse.   
Several disorders have been associated with inhalant abuse including: toluene-
induced hearing loss, cerebellar ataxia, sensory-motor polyneuropathy 
resulting from nitrous oxide exposure, hexane- (e.g., methylethylketone) 
induced peripheral neuropathy, distal-renal acidosis, and cardiac arrhythmias. 

Prenatal exposure to inhalants can have potential adverse consequences, and 
additional research is needed to determine their acute and long-term effects 
on infant development. Deaths have been attributed to inhalant abuse, 
primarily resulting from anoxia and inhalant-abuse-related accidents.  While 
some of these disorders have been studied and documented, additional research 
should focus on understanding the underlying mechanism associated with these 
disorders and the development of interventions to treat these conditions.  
Additional research is needed to characterize addiction to inhalants and to 
compare inhalants with other abused substances, such as sedatives and alcohol.

Because inhalant abuse is an international public health concern, 
epidemiological research should examine regional and cultural differences in 
the pattern of use and substances abused among various populations.  Treatment 
and prevention interventions for inhalant abuse should consider regional 
differences and other variables in the development and testing of new 
interventions.  Additional research, therefore, is needed to address all 
aspects of inhalant abuse including research on the epidemiology, behavioral, 
cognitive, and neurobiological antecedents and consequences, as well as 
treatment and prevention of inhalant abuse.  

Specific research topics that would be appropriate for this initiative are 
described below.  These examples given are not meant to be inclusive of all 
the areas of research that would be appropriate under this announcement.  For 
further information about inhalant abuse and this area of research, please 
refer to:  Inhalant Abuse: A Volatile Research Agenda, NIDA Monograph 129, 
1992; Sharp and Rosenberg, Inhalants; and "Substance Abuse, a Comprehensive 
Textbook," 3rd ed. pp. 246-264, 1997; Balster, R., Neural Basis of Inhalant 
Abuse Drug Alcohol Depend, 51: 207-14, 1998.

Areas of Interest

I.  EPIDEMIOLOGY

Research is needed to characterize the nature and extent of the inhalant abuse 
for different classes of abused inhalants in relevant population subgroups.  
Studies are needed that focus on the initiation, experimentation, development, 
and cessation of inhalant abuse and the consequences of abuse of different 
classes of solvents and gases.  Inhalant abuse is widespread and affects 
diverse groups in domestic and international populations.  Because of this 
diversity, studies should consider socio-cultural, socio-economic, gender, and 
regional differences. Factors associated with risk, vulnerability, protection, 
and resiliency to inhalant abuse or its consequences require study.  Research 
is needed to determine how family support, role models, the extended family, 
pre-existing conditions (e.g., HIV/AIDS, mental health disorders, alcohol 
abuse), peer groups and socio-economic status affect initiation, continuation, 
escalation, and cessation of inhalant use. Data are needed on the incidence, 
prevalence, and trends in abuse of inhalants and on the health consequences, 
e.g., HIV/AIDS and behavioral and social consequences, e.g., automobile 
accidents, school dropout, etc., associated with inhalant abuse.  Topics 
needing further research include but are not limited to:  

o Investigate the abuse of different types of inhalants in different age 
groups (e.g., preadolescents, adolescents, college age youth) in different 
regions of the nation or world (e.g., rural and urban areas), in high 
prevalence areas with distinctive characteristics (e.g., U.S.-Mexico border), 
and in different ethnic and socioeconomic groups as well as in occupationally 
exposed groups.

o Explore the pathways and mechanisms to inhalant abuse during grade school 
and early adolescence (i.e., initiation, maintenance, cessation, progression).

o Study the patterns, prevalence, and incidence of inhalant use among high-
risk youth, including school dropouts, gang members, children of drug users, 
and homeless youth.

o Examine the roles of youth social networks, subcultures, and technology 
(e.g., the Internet) in the development and diffusion of inhalant abuse 
trends. Study the association between inhalant abuse and other substance abuse 
(e.g., investigate family substance abuse histories, assess contextual factors 
in which substances are abused, study the possible progression of substance 
abuse, and describe the patterns of social interaction associated with the 
abuse of these substances).

o Identify extent and patterns of use, reasons for use and attitudes toward 
use, knowledge of potential short- and long-term consequences of use (e.g., 
accidents due to inhalant intoxication, health effects such as CNS toxicity) 
and reasons for continued use or cessation of use.

o Study the developmental trends in inhalant abuse to understand the dynamics 
of inhalant abuse.  Are there cohort effects or secular trends?

o Study the underlying risk factors for inhalant abuse, including 
developmental risk factors, comorbidity with emotional distress, psychiatric 
disorders (e.g., depression) and psychosocial stressors (e.g., family 
discord).  Assess these risk factors considering gender, ethnicity, and 
socioeconomic factors.

o Determine the adverse behavioral and social consequences related to inhalant 
abuse such as household, occupational, and driving accidents/deaths, poor 
performance in school and school dropout, and difficulty securing/maintaining 
a job.

o Explore the relationship between inhalant abuse and use and abuse of alcohol 
and other drugs.  To what extent and for whom does availability of alcohol and 
other drugs lead to decreased inhalant abuse?  Why do some inhalant abusers 
continue to abuse inhalants despite availability of other drugs and alcohol?

o Study unique factors associated with abuse of particular inhalants.   
Studies in certain regions or foreign countries may be particularly useful 
because it may be possible to study selective, high exposure abuse of a 
particular inhalant (for example, selective toluene abuse is prevalent in 
Japan).

II. PREVENTION INTERVENTION

Inhalants are widely abused by youngsters due to their easy accessibility 
through household products, as well as their low cost.  Unfortunately, 
inhalant abuse poses definite dangers to the health of young children, 
including cognitive, neurological and physiological disorders, and the threat 
of sudden death. Inhalant abuse is often associated with behavioral problems 
such as dropping out of school, delinquency and crime in young people. In fact 
inhalants are considered to be the precursors to later substance abuse and 
related psychosocial problems. 

Current inhalant prevention strategies focus on increasing young people's 
awareness and information regarding the dangers of inhalant abuse.  Since the 
average age of inhalant initiation is relatively young, prevention strategies 
should target not only young people, but their parents and teachers as well.  
Therefore, inhalant abuse prevention strategies should be multicomponent and 
comprehensive, and include family-based and school-based components.  

Prevention programs should begin in the primary grades where many young 
people's beliefs and attitudes about drug use are formed.  However, care must 
be exercised in developing interventions which avoid unnecessary sensitization 
of youth to the issue of inhalant abuse, in order to avoid unintended 
consequences.  In fact media and public information interventions must be 
developed according to guidelines, which on one hand reduce unnecessary 
sensitization of youth to the presence of inhalants in certain materials, and 
on the other hand succeed in educating youth, parents, teachers and other 
adults about the hazards of inhalants.   Inhalant prevention strategies should 
include comprehensive approaches that meld carefully constructed and 
developmentally appropriate media, training, technical assistance, information 
dissemination, and local community action efforts.

The field of prevention research should develop a scientifically sound 
knowledge base concerning the efficacy and effectiveness of existing inhalant 
abuse prevention strategies and policies, as well as develop and test 
innovative intervention strategies.  The development of sex-based prevention 
interventions are needed that is based on the differential etiologic factors 
found in males and females. The following are examples of research topics that 
address important gaps in our knowledge of inhalant prevention:

o Develop and test the efficacy and effectiveness of inhalant prevention 
strategies for youth at high-risk for inhalant abuse in different cultural 
(e.g., Hispanics, Native American, etc.), geographic (e.g., urban, rural, 
etc.) and socioeconomic (e.g., poor, affluent) settings.

o Develop population or context-specific universal, selective, and/or 
indicated prevention approaches that can be implemented and administered 
easily, efficiently and at low cost.  

o Compare and contrast the efficacy and effectiveness of family-based, school-
based, and multiple-component prevention strategies.

o Develop and test the efficacy and effectiveness of age-specific inhalant 
prevention strategies.

III. TREATMENT

There is a paucity of research on the behavioral or pharmacotherapeutic 
approaches to treatment of inhalant abusers.  Inhalant abusers are often 
excluded from studies on drug abusers, and there have been no NIDA-funded 
studies focusing exclusively on treating inhalant abusers.  Research is needed 
on behavioral treatments focusing on different populations of inhalant 
abusers.  Stage I or early behavioral treatment development research focusing 
on the development, refinement, and pilot testing of behavioral interventions 
are also encouraged under this RFA.  For a description of Stage I research, 
please see PA-99-107, A Behavioral Therapies Development Program at:  
https://grants.nih.gov/grants/guide/pa-files/PA-99-107.html.

This includes research that seeks to develop new therapeutic approaches, or 
refine or modify existing behavioral or psychosocial therapeutic approaches, 
(e.g., forms of cognitive-behavioral therapy, family therapy, motivational 
enhancement, drug counseling, group therapy, motivational incentives, etc.).  
Stage I also involves the pilot testing of these therapies.  Pilot testing 
that seeks to clarify the mechanisms by which behavioral treatments produce 
change in inhalant use, including identification of mediators and moderators 
that influence abuse of inhalants and other drugs, is encouraged.  Such pilot 
testing may utilize a variety of designs, including but not limited to single-
case designs, dismantling, additive, and nonparametric designs, where 
appropriate.  Specific areas of Stage I interest include:

o Stage I research that addresses the unique characteristics and problems of 
specific populations of inhalant abusers, including but not limited to young 
male and female adolescents, women, men who have sex with men, individuals 
with HIV/AIDS, persons in professions with extended exposure to inhalants, 
individuals with comorbid mental or physical disorders, chemically dependent 
pregnant women, adolescents who are abusing another drug or multiple other 
drugs, adolescents living in impoverished areas, individuals in the criminal 
justice system or other populations abusing inhalants. This research may 
include the development of treatment modules that address the unique 
characteristics of particular populations of inhalant abusers and integration 
of these modules into other therapeutic approaches.

o Development and pilot testing of treatments for specific populations of 
inhalant abusers based upon recent advancements in the behavioral, social, or 
cognitive sciences.  Where appropriate, outcome measures may include, in 
addition to measures of substance abuse, other measures of functioning (e.g., 
behavioral, social, etc.) and also measurements of brain functioning (e.g., 
MRI, PET-scan, etc.).

o Development and pilot testing of behavioral treatments tailored to people 
who have inhalant-related cognitive impairments.  This may include research 
that focuses on behavioral therapies aimed at cognitive rehabilitation, based 
upon recent advancements and theories in cognitive neuroscience, and also may 
include measurements of changes in brain function associated with therapeutic 
intervention.

o Development and pilot testing of behavioral treatments that have a 
particular focus on the initial stage of treatment engagement, including the 
development of "treatment modules" that can be incorporated into other 
therapeutic approaches to improve engagement and retention.

o Development and pilot testing of brief behavioral treatment interventions 
(e.g., for use in primary care settings).

o Other studies should identify pre-existing and co-existing neurobiological, 
psychosocial and environmental factors that significantly impact treatment 
outcomes. 

o Determine and examine the physiology of withdrawal from inhalants, including 
the study of potential treatments to ameliorate any withdrawal syndrome and 
determine if different classes of inhalants induce different withdrawal 
syndromes.

o Develop and improve methods for diagnosing, treating, and increasing 
physician awareness of inhalant abuse, overdose and poisoning, including 
research aimed at developing and improving analyses for inhalants that can be 
used in medical emergency care or other settings.

o Develop and/or test medications currently used or under development for 
other drug dependencies (e.g. alcohol, sedatives).

IV. BASIC LABORATORY RESEARCH 

Several medical sequelae have been associated with inhalant abuse, including 
hearing loss, neurological degeneration, metabolic acidosis, loss of 
cerebellar function, and cardiac arrhythmia.  Additional research is needed to 
determine and characterize the neuropsychological, neuropsychiatric, 
cognitive, behavioral, cellular and physiological consequences of inhalant 
abuse using clinical, animal and in vitro investigations. Additionally, 
research is needed to develop and test possible pharmacotherapies to treat the 
medical and other related conditions associated with inhalant abuse including 
addiction.

Investigators need to be aware of pattern of use and how inhalants are abused 
in order to develop valid models of inhalant abuse and addiction. Studies 
should also consider measuring and modeling acute and long-term administration 
of solvent/gas mixtures, their pharmacodynamic properties, and the 
bioavailability of abused solvents and their metabolites.

Illustrative examples of research described below serve as a guide and are not 
meant to subsume all laboratory research topics that would be appropriate 
under this RFA.

o Study the cellular and systemic changes involved in single and repeated 
inhalant exposure, e.g. measures of central neurotransmitter systems, renal 
metabolic processes, cobalamin systems related to N20.

o Define the mechanisms of the acute and long-term toxic effects of inhalants 
on, for example, central nervous, cardiovascular, renal, pulmonary and immune 
systems.   Research could focus on known inhalant-induced toxicities (e.g. 
high-frequency hearing loss, renal acidosis, cerebellar ataxia).

o Characterize the acute subjective, reinforcing and cognitive effects of 
inhalant abuse.

o Correlate the pharmacokinetic and pharmacodynamic parameters of inhalants 
with their behavioral, cognitive and/or physiological effects.

o Compare and contrast the behavioral, cognitive and neurobiological effects 
of different types of inhalants or other abused substances (e.g., alcohol, 
benzodiazepines, dissociative anesthetics or sedatives).

o Characterize the relative abuse potential of inhalant compounds.

o Study tolerance and/or sensitization to inhalants and determine the 
underlying neurobiological mechanisms associated with these phenomena.

o Develop animal models to study motivational processes, environmental, and 
genetic factors that influence the acquisition and maintenance of inhalant 
self-administration, and identify the associated neural substrates involved.

o Identify consequences of acute and chronic inhalant administration on 
sensory/perceptual, motor, behavioral and cognitive processes in known abusers 
or with the use of appropriate animal models.

o Study the short- and long-term developmental consequences of prenatal 
exposure to inhalants.  Possible ontogenetic consequences of inhalant exposure 
could be examined at various stages of development using animal models or in 
individuals known to be exposed to inhalants perinatally.  Determine the 
nature and characteristics of a possible Fetal Solvent Syndrome (FSS).

o Identify relative reinforcing and subjective properties, including possible 
aversive properties of inhalants, in comparison with other, better-
characterized drugs of abuse with the use of self-administration, drug 
discrimination or other animal behavioral approaches.

o Study potential neurotoxic effects of inhalants in the CNS in humans (and 
animals) using neuroimaging techniques and with use of post mortem tissue 
analyses.

o Study various cognitive functions in inhalant abusers with an emphasis on 
investigations employing longitudinal or prospective designs and those 
relating patterns of abuse with cognitive ability (e.g., inhibitory processes, 
executive function, attention, learning and memory).

o Use neuroimaging techniques (i.e., PET, fMRI and other technologies) to 
attempt to relate neural integrity and changes in metabolic function with 
patterns of inhalant use and/or prior abuse.

o Use behavioral, psychological and cognitive measures to characterize those 
individuals who are regular inhalant abusers (e.g., delay discounting, risk-
taking, self-monitoring, etc.).

o Study the etiology, diagnosis, progression, and treatment of HIV/AIDS in 
inhalant abusers, as well as complications associated with HIV therapy for 
inhalant users (e.g., drug-drug interactions).

o Study the short- and long-term consequences of inhalant abuse as a function 
of age or developmental period (e.g., adolescence).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided indicating 
that inclusion is inappropriate with respect to the health of the subjects or 
the purpose of the research. This policy results from the NIH Revitalization 
Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.   
The amended policy incorporates: the use of an NIH definition of 
clinical research; updated racial and ethnic categories in compliance with the 
new OMB standards; clarification of language governing NIH-defined Phase III 
clinical trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in 
Research Involving Human Subjects that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:   
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows NIDA staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to the address shown under INQUIRIES by the 
letter of intent receipt date listed.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable format.  For further assistance contact GrantsInfo, 
Telephone 301/710-0267, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 NIH staff. 
The research grant application form PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  

The RFA label available in the PHS 398 (rev. 5/2001) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked. The RFA label is also available at: 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier or express delivery)

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA.  Incomplete and/or non-responsive applications will be 
returned to the applicant without further consideration.  Applications that 
are complete and responsive to the RFA will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by NIDA in 
accordance with the review criteria stated below.  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 the applications under review, will be 
discussed, assigned a priority score, and receive a second level review by the 
National Advisory Council on Drug Abuse.

Review Criteria 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to 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 method? 
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.

Schedule

Letter of Intent Receipt Date:    March 12, 2002
Application Receipt Date:         April 10, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:  scientific 
merit (as determined by peer review), availability of funds, and programmatic 
priorities.

INQUIRIES

Potential applicants are strongly encouraged to contact the appropriate staff 
for additional information and specific application procedures or to clarify 
any issues.  

Direct inquiries regarding programmatic issues related to basic behavioral and 
cognitive antecedents and consequences of inhalant abuse and addiction should 
be addressed to:

Dr. Charles Sharp
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4260, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 443-1887
FAX:  (301) 594-6043
Email:  cs107m@nih.gov

A list of additional staff members for other areas of research may be found at 
http://www.drugabuse.gov/Funding/resfundslist.html.

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tl25u@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.279.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.