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.
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