IMPLEMENTATION OF THE NATIONAL OCCUPATIONAL RESEARCH AGENDA Release Date: March 4, 1999 RFA: OH-99-002 P.T. National Institute for Occupational Safety and Health National Cancer Institute National Heart, Lung, and Blood Institute National Institute on Aging National Institute on Deafness and Other Communication Disorders National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 19, 1999 Application Receipt Date: June 10, 1999 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), announce the availability of fiscal year (FY) 1999 funds for grant applications for research related to some of the priority areas identified in the National Occupational Research Agenda (NORA) that is described in the RESEARCH OBJECTIVES section. Two types of grants will be supported: traditional research projects and demonstration projects. The overall purpose of this grants program is to develop knowledge that can be used in preventing occupational diseases and injuries and to better understand their underlying pathophysiology. Thus, the following types of applied research projects will be supported: causal research to identify and investigate the relationships between hazardous working conditions and associated occupational disease and injury, the nature and magnitude of special risk factors experienced by older and/or minority workers, methods research to develop more sensitive means of evaluating hazards at work sites, and evaluations of the effectiveness of prevention and intervention programs, including new approaches or combinations of techniques such as control technologies, personal protective equipment and changes in work organization factors, which have been developed and implemented in workplaces. This Request for Applications (RFA) is jointly sponsored by several Institutes, with varying interest in the topics given in the listed under RESEARCH OBJECTIVES. The National Institute for Occupational Safety and Health (NIOSH) in CDC is interested in all eight topics. The National Cancer Institute (NCI) in NIH is interested in exposure assessment (4) and surveillance research methodology (5). The National Heart, Lung, and Blood Institute (NHLBI) in NIH is interested in asthma and chronic obstructive pulmonary disease (7) and organization of work - sleep disorders (8). The National Institute on Aging (NIA) in NIH is interested in special populations at risk - aging workforce (6). The National Institute on Deafness and Other Communication Disorders (NIDCD) in NIH is interested in hearing loss (3). The National Institute of Environmental Health Sciences (NIEHS) in NIH is interested in exposure assessment (4). HEALTHY PEOPLE 2000 CDC and NIH are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a national activity to reduce morbidity and mortality and improve the quality of life. This RFA is related to the priority areas of occupational safety and health and unintentional injuries. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report, Stock No. 017-001-00474-0 or Summary Report, Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, public and private nonprofit and for-profit organizations and by governments and their agencies, that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations Note: Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant (cooperative agreement), contract, loan, or any other form. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and demonstration project grant (R18). The total requested project period for an application submitted in response to this RFA may not exceed three years. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. Complete and detailed instructions and information on Modular Grants can be found at Applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. A typical modular grant application will request the same number of modules in each year. Application budgets will be simplified. Detailed categorical budget information will not be submitted with the application, budget form pages of the application kits will not be used. Instead, total direct costs requested for each year will be presented. Information, in narrative form, will be provided only for Personnel and, when applicable, for Consortium/Contractual Costs. See section on APPLICATION PROCEDURES below. Additional narrative budget justification will be required in the application only if there is a variation in the number of modules requested. There will be no routine escalation for future years. In determining the total for each budget year, applicants should first consider the direct cost of the entire project period. Well-justified modular increments or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested. For example, purchase of major equipment in the first year may justify a higher overall budget in the first, but not in succeeding years. Other Support pages of the PHS 398 will not be submitted with the application. Information on research projects ongoing or completed during the last three years of the principal investigator and key personnel will be provided as part of the "Biographical Sketch." This information will include the specific aims, overall goals and responsibilities and should include Federal and non-Federal support. This information will be used by reviewers in the assessment of each individuals qualifications for a specific role in the proposed project. Following peer review, information about Other Research Support will be requested from the applicant for applications being considered for award. Additional budget information will be requested only under special circumstances. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Research Project Grants (R01) - A research project grant application should be designed to establish, discover, develop, elucidate, or confirm information relating to occupational safety and health, including innovative methods, techniques, and approaches for addressing problems. These studies may generate information that is immediately useful to solve problems or that will contribute to a better understanding of the causes of work-related diseases and injuries. Demonstration Project Grants (R18) - A demonstration project grant application should address the technical or economic feasibility of implementing a new/improved innovative procedure, method, technique, or system for preventing occupational safety or health problems. The project should be conducted in an actual workplace where a baseline measure of the problem will be defined, the new/improved approach will be implemented, a follow-up measure of the problem will be documented, and an evaluation of the benefits will be conducted. FUNDS AVAILABLE Approximately $7.5 million is available in FY 1999 to fund approximately 30-32 grants under this RFA. The approximate amounts that are expected to be available by each Institute are as follows, but the amounts may vary: NIOSH - $5.5 million for all areas (including CDC Prevention Research funds for intervention effectiveness research),NCI - $0.5 million, NHLBI - $1.0 million, and NIEHS - $0.5 million. Target amounts for the NORA priority areas are as follows: 1. Intervention Effectiveness Research ($1.5M) 2. Fertility and Pregnancy Abnormalities ($0.5M) 3. Hearing Loss ($0.5M) 4. Exposure Assessment ($1.0M) 5. Surveillance Research Methodology ($1.0M) 6. Special Populations at Risk - Aging Workforce ($1.0M) 7. Asthma and Chronic Obstructive Pulmonary Disease ($1.0M) 8. Organization of Work: Demanding Work Schedules, Sleep Disorders, and Risk of Occupational Illness and Injury ($1.0M) Awards are anticipated to range up to $250,000 in total costs (direct and indirect) per year and are expected to begin in September 1999. Awards will be made for a 12-month budget period within a project period not to exceed 3 years. Only applications that are found to be of high scientific merit will be considered for funding, and not all of the funds will be spent if there are not enough highly meritorious applications. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds in future years. RESEARCH OBJECTIVES In today"s society, Americans are working more hours than ever before. The workplace environment profoundly affects health, each of us, simply by going to work each day, may face hazards that threaten our health and safety. Risking one"s life or health should never be considered merely part of the job. In 1970, Congress passed the Occupational Safety and Health Act to ensure Americans the right to "safe and healthful working conditions," yet workplace hazards continue to inflict a tremendous toll in both human and economic costs. Employers reported 5.8 million work injuries in 1996 and 439,000 cases of occupational illness. An average of 16 American workers die each day from injuries on the job. Moreover, even the most conservative estimates find that about 137 additional workers die each day from workplace diseases. Additionally, in 1996 occupational injuries and deaths cost $121 billion in wages and lost productivity, administrative expenses, health care and other costs. This does not include the cost of occupational disease. These occupational injuries and diseases create needless human suffering, a tremendous burden upon health care resources, and an enormous drain on U.S. productivity. In 1996, the National Institute for Occupational Safety & Health (NIOSH) and its partners in the public and private sectors developed the National Occupational Research Agenda (NORA) to provide a framework to guide occupational safety and health research into the next decade not only for NIOSH, but also for the entire occupational safety and health community. Approximately 500 organizations and individuals outside NIOSH provided input into the development of the National Occupational Research Agenda (NORA). This attempt to guide and coordinate research nationally is responsive to a broadly perceived need to address systematically those topics that are most pressing and most likely to yield gains to the worker and the nation. Fiscal constraints on occupational safety and health research are increasing, making even more compelling the need for a coordinated and focused research agenda. Potential applicants may obtain a copy of the "National Occupational Research Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National Institute for Occupational Safety and Health, telephone (800) 356-4674. It is also available on the internet at "". The research needs identified in this RFA are consistent with the NORA but are limited to the targeted areas below. Potential applicants with questions concerning the acceptability of their proposed work are encouraged to contact program staff listed under INQUIRIES. Applications responding to this RFA will be reviewed for their responsiveness to the following program interests and their potential for developing knowledge that can be used in preventing occupational diseases and injuries. Applicants should provide a statement about which NORA area is being addressed and a rationale for how the proposal will contribute to the specified priority area (this information should be placed in the "Background and Significance" section of the "Research Plan" of the application). Targeted NORA Priority Areas for this RFA are: 1. Intervention Effectiveness Many workplace prevention and intervention programs have been developed and implemented, yet few have undergone systematic evaluation to determine their impact on health and safety outcomes. Evaluations of the effectiveness of intervention efforts can provide crucial guidance and corrective feedback for current and future occupational safety and health intervention efforts. Research applications are sought that focus on the systematic evaluation of the effectiveness of interventions. Of interest are fully-developed interventions which are ready for implementation as well as evaluations of the effectiveness of interventions which have already been implemented. Proposals for comparative analyses of the effectiveness of alternate options (e.g., cost-effectiveness) are also solicited. The interventions to be evaluated could be defined at any level of complexity, and range from a regulatory or voluntary occupational safety or health standard to the change of a single, specific work process, control technology, training program, or informational campaign. Encouraged are interdisciplinary proposals which include, as appropriate, the fullest complement possible of outcome measures. These measures could include health and safety outcomes (e.g., reductions in injury, disability, stress, or hazard exposure), economic outcomes (e.g, the effect of the intervention on productivity, employee turnover, income, medical, and or societal costs), and/or social outcomes (e.g., social roles and relationships at work and in the family and other aspects of the work-family interface.) These examples of potential health, economic, and social outcome measures, are provided only to illustrate the range of outcomes of interest, not to represent an exclusive listing. Encouraged are proposals to evaluate interventions in any industry sector but special consideration will be given to proposals to evaluate interventions in agriculture, construction, services (especially health care), and mining. 2. Fertility and Pregnancy Abnormalities While more than 1,000 workplace chemicals have shown reproductive effects in animals, for the vast majority, nothing is known about the effects in humans. In addition, most of the 4 million other chemical mixtures in commercial use remain untested. Although the total number of workers exposed to potential reproductive hazards is difficult to estimate, three-quarters of employed women and an even greater proportion of employed men are of reproductive age. More than half of U.S. children are born to working mothers. The vast number of workers of reproductive age together with the substantial number of workplace chemical, physical, and biological agents suggest that a considerable number of workers are potentially at risk for adverse reproductive outcomes. The inadequacy of current knowledge coupled with the ever-growing variety of workplace exposures pose a potentially serious public health problem. Research applications are sought which will investigate the relationships between occupational exposures and adverse reproductive/developmental effects in humans. Applicants are strongly encouraged to design studies that employ improved exposure assessment methodologies such as biomarkers, utilize existing data bases, and include non-occupational risk factors, such as existing medical conditions, lifestyle factors and genetic susceptibility to teratogens. Effects of interest include: (1) Reduced fertility in male and females or other indications of altered reproductive function such as changes in hormone levels or poor semen quality, (2) Pregnancy outcomes, pre- and postnatal development of offspring and, (3) Evidence of effects on male reproduction such as testicular cancer, hypospadias and cryptorchidism. 3. Hearing Loss NIOSH estimates that over 30 million American workers are exposed to occupational hazards to hearing including noise and ototoxic chemicals. Hearing loss is the most common of occupational diseases and it is the most preventable. In 1995 the National Institute on Deafness and other Communication Disorders estimated that of the 28 million Americans with hearing loss, nearly half had workplace-related noise-induced hearing loss. The goal of the "Healthy People 2010" is to reduce by half the incidence of significant threshold shift due to exposure to noise at work. To aid in achieving this national health objective, further research in Occupational Hearing Loss is needed. Research applications are sought in the following areas: (1) Biological effects of and biological response to noise and other ototoxic agents including relationship of first- or second-hand smoke to noise induced hearing loss, relationship of noise-induced hearing loss to secondary risk factors such as hypertension, head trauma, diabetes, blood lipids, and clinical therapeutic drugs, role of genetics in determining individual susceptibility to noise-induced hearing loss, as well as the role of free-radicals and antioxidants in noise-induced hearing loss, (2) Investigation of new noise control and personal protective equipment technologies such as utilization of active noise reduction control noise at the source, incorporation of electroacoustic systems in hearing protectors, as well as development of methods for determining the actual noise reduction workers receive from hearing protectors, (3) Issues for hearing-impaired workers including susceptibility to noise-induced hearing loss for persons with pre-existing noise- or age-related hearing loss, personal protective equipment used for noise reduction and as hearing aids, aural rehabilitation for the hearing-impaired worker who must continue to work in noise, as well as defining audiometric and performance specifications for hearing-critical jobs, (4) Effects of noise on speech communication including accuracy of communication in terms of expected outcomes or need to repeat messages, safety of workers who must work and communicate in noise, (5) Health communications research including methods for delivering training and motivation to noise-exposed workers, and (6) Surveillance and intervention research including evaluation methods to study existing compliance-driven hearing conservation programs to determine their effectiveness in preventing noise-induced hearing loss, as well as development and study of longitudinal audiometric databases for persons not exposed to hearing hazardous agents such as noise and other chemical and physical agents. 4. Exposure Assessment A primary research focus for both occupational and environmental health concerns is to better understand the health effects associated with exposures to toxic and hazardous substances in the environment. Precise methods for exposure assessment are critical to measuring body burden of environmental exposures in environmental and occupational epidemiologic studies and risk assessment. Exposure assessment is a rapidly evolving, multi-disciplinary research activity central not only to defining exposure - response relationships in epidemiologic studies but also to deciding whether, and how, to use resources for reducing workplace and environmental exposures. Methods for substances that may have high dose exposures in the workplace, but are also found, possibly at lower levels, in the general environment are of interest as are methods for determining take-home exposures (which may be important for children and spouses), and other environmental sequellae of chemicals and other exposures. Research applications are sought which address: (1) Development of sufficiently precise exposure assessment methodologies to support valid epidemiologic studies in complex environments. This includes considerations related to the structure and content of occupational safety and health exposure assessment databases (e.g., types of data included, the functionality and relationships necessary to complement typical industrial hygiene work flows, and data collection and analysis), characterizations of individual work practices and tasks, development of modeling strategies and statistical methods for data analysis, and research which addresses the utility of these data bases in understanding community risks from occupational exposures, (2) Development of practical and valid measurement techniques that can be applied at reasonable cost for assessing workplace chemical, biological, and physical hazards. Of particular interest are methods addressing microbial contamination and worker exposure to microbes and microbial toxins (both non- aerosolized microbes and bioaerosols) which consider issues such as sample transport, stability and viability, real-time (on-site) determination of microbial contamination, and issues related to the identification of exposures of bioaerosol mixtures, (3) Development and/or evaluation of methods for appropriate biomarkers of exposure and total dose using samples obtained by relatively noninvasive methods. These would include methods to evaluate dermal exposures, and methods that can measure exposure to heterogeneous mixtures or classes of compounds (e.g., chlorinated solvents, mixtures of PCB congeners). Use of occupationally exposed cohorts to validate biomarkers of exposure to environmentally relevant chemicals is encouraged, (4) Development and evaluation of portable, direct-reading instrumentation for on-site determinations of chemical, biological and physical hazards. Of particular need are devices for measuring low level exposures which could provide data useful in addressing dose-response aspects of occupational risk, and (5) Transfer of strategies from workplace assessment to environmental assessment, i.e., the application of methods which measure worksite exposures at high concentration levels for the determination of lower level exposures to environmental air pollutants. 5. Surveillance Research Methodology Occupational safety and health surveillance programs collect, analyze, and disseminate information about hazards, illnesses, and injuries in the workplace. Surveillance systems describe the presence of hazards and where occupational injuries or illnesses are occurring, how frequently they occur, whether they are increasing or decreasing, and whether prevention efforts have been effective. The occupational and public health community rely on surveillance information to set research and prevention priorities. Gaps in knowledge, inadequate hazard/exposure assessment methods, and untimely recognition and reporting are barriers to effective occupational safety and health. Surveillance methods research applications are sought in the following areas: (1) Development and/or evaluation of methods to characterize workplace hazards, exposures, and risk factors to promote the early recognition and prevention of workplace illness or injury, (2) Methods for effective exposure monitoring, medical screening, and disease and injury surveillance of worker populations at risk for important work-related conditions and injuries, such as musculoskeletal disorders, irritant contact dermatitis, asthma, pesticide poisoning, hearing loss, bladder cancer, heat stress, and radiation effects, (3) Methods to evaluate the prevalence of and estimate the impact of under- recognition and under-reporting of workplace illness and injury, (4) Methods to improve enumerating the "population-at-risk" for illness and injury surveillance, and methods estimating "exposure time" concerning machine use hazards and other time-dependent injury risks, (5) Methods to identify, evaluate, and monitor workplace hazards, exposures, illness, injury, and related-risk factors among small scale businesses, independent contractors, service sector part-time or occasional labor, and vulnerable (e.g., workers less than 16 years or the legal age of consent, and migrant labor) working populations, (6) Methods to adapt the use of insurance industry data (e.g., workers" compensation, health and medical care) to promote the early recognition, reporting, and prevention of workplace illness and injury, and (7) Methods for utilizing information technologies for the development of active injury, illness, and hazard surveillance systems for use at the employer level. 6. Special Populations at Risk - Aging Workforce This announcement targets a subset, older workers, of the special populations included in this NORA priority area. The median age of the US workforce is increasing as a result of the aging of the post World War II "baby boom" generation. This combined with a gradual increase in life expectancy has led to an increasing percentage of older workers either remaining in the workforce or reentering the workforce as contingent or part-time workers. The aging of the workforce raises several important public health questions including how working affects the aging process, how aging affects working capacity and occupational disease susceptibility, and how the health of older employees is affected by the recent changes in the nature of work, including the introduction of new technologies, adoption of new forms of work organization and other organizational changes such as downsizing and restructuring. Research proposals are invited which address the following areas: (1) Demographics of work and the health of workers by age. Of interest are proposals which address the development and validation (using either new or existing databases) of methods of determining where older workers are employed and the occupational risk factors to which they are exposed, including parameters such as the distribution by industry and jobs classification, geographic regions and nature of employment (full-time, part-time, contingent) as well as their demographic distribution such as by age group, gender, race/ethnicity and workforce size. Analyses of these data might also address the distribution of important work-related and non work-related diseases by age group, gender/ethnicity and employment with a focus on determining priority areas where the impact of the aging workforce will be most significant. Also of interest are proposals which address methods of generating priority areas for future intervention and research based upon the analysis of this statistical data. (2) The characteristics of work/workplace that facilitate or impede the productivity of older workers and their ability to stay in the workplace. Prior research has focused mainly on measuring changes in work capacity as workers age, the ability of aging workers to remain in a job or workplace also depends upon a combination of physical, mental, and social characteristics. Of interest are proposals which develop and utilize an integrated approach to examining the relationships between these characteristics and the aging worker"s ability to remain in the workforce. Also of interest are proposals which focus on the interdependence between work organizations and individuals and the consequences of adapting work to the needs and characteristics of the older worker, as well as the health and safety implications for older workers of recent workplace changes such as technological innovation, downsizing, and new forms of work organization. 7. Asthma and Chronic Obstructive Pulmonary Disease (COPD) Concurrent with the rise in asthma in the general U.S. population, work- related asthma has become the most commonly reported occupational lung disease, resulting in considerable disability, economic loss, and human costs. Further investigation is required to improve the understanding of asthma that develops in response to exposures in work environments. Specific areas of interest include, but are not limited to, definition of the relationships between respiratory, skin, and mucous membrane exposures (to sensitizers, irritants, and other adjuvant conditions) and health outcomes of relevance to asthma (immunologic sensitization, airway hyper-responsiveness, airway inflammation, broncho-constriction, and asthma symptoms). Of interest are proposals that address: (1) Relationships between occupational exposures and asthma-related responses, including the inflammatory and immunologic mechanisms and possible related genetic markers, relevant to development, progression, regression of, or protection from asthma in relation to work exposures, such as cellular migration and proliferation, cellular functions, and cytokine cascades, (2) Development and/or application of novel approaches to characterizing and evaluating exposures and/or exposure kinetics using methodologies that may be applicable to exposure assessment, health screening, or epidemiologic studies in the workplace, (3) Methods for prospectively identifying substances that are likely to pose a risk of asthma (prior to their introduction into the workplace) and characterizing their immunotoxicology. Many occupational exposures (both by themselves or in combination with smoking) are known to cause COPD. One estimate of the proportion of COPD attributable to occupational exposure in the general population is 14 percent. Further investigation is required to improve understanding of the contribution of work exposures to the overall population burden of COPD, as well as to better understand the types, severity, and distribution of the occupational exposures that accelerate lung function loss. Specific areas of interest include, but are not limited to, the relationship between various work environments, accelerated lung function loss, and the subsequent development of COPD, documentation of beneficial effects of substantially reducing or eliminating exposure to occupational respiratory hazards, evaluation of workplace medical screening/surveillance programs or data from on-going and completed population-based studies, mechanisms by which certain occupational exposures cause COPD, and animal models of occupational COPD. 8. Organization of Work: Demanding Work Schedules, Sleep Disorders, and Risk of Occupational Illness and Injury This announcement targets a part of the NORA priority area Organization of Work. Demanding work schedules involving night and rotating shift work, extended workdays, overtime, and irregular work schedules affect 20% of U.S. workers. The most immediate detrimental effect of such schedules is disturbed sleep and disrupted circadian rhythms leading to excessive fatigue, reduced performance and loss of alertness. Health and safety outcomes potentially associated with these disruptions include: accidents and injuries, operational errors, miscarriage, and cardiovascular and gastrointestinal morbidity. However, additional information is needed to link work schedule parameters to sleep and circadian rhythm disruption, and to examine how these factors interact with other work demands and workplace stressors to compromise health and safety. Research applications are sought in the following areas: (1) Broad epidemiologic studies to determine the association of sleep disorders with work-related health and safety risks, (2)Applied research to evaluate the scope and consequences of sleepiness and to develop new approaches to prevent impaired performance in the workplace and during waking hours, (3) Focused workplace demonstration projects aimed at improving the quality and quantity of sleep and decreasing circadian rhythm disruption by re-designing work schedules, minimizing workplace stressors, and improving other aspects of work organization, (4) Approaches for shift workers to reduce the likelihood of excessive sleepiness and drowsy driving using a combination of alertness management approaches, (5) The biological and behavioral factors that may contribute to individual tolerance to shift work, (6) Studies to better understand and evaluate the utility of various interventions (e.g., bright light treatments and melatonin) to prevent and manage sleepiness to help shift workers adapt and overcome circadian phase disruption and improve productivity and safety, (7) Understanding of the role of sleep deficits resulting from lifestyle and work schedules, (8) The degree and nature of sleepiness associated with different amounts and rates of sleep loss and appropriate countermeasures to increase productivity and safety in a variety of work settings, and, (9) Development of new pharmacological agents to increase alertness and advanced technologies to objectively detect and monitor sleepiness. SPECIAL REQUIREMENTS Human Subjects If a project involves research on human subjects, assurance (in accordance with Department of Health and Human Services Regulations, 45 CFR Part 46) of the protection of human subjects is required. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. Unless the grantee holds a Multiple Project Assurance, a Single Project Assurance is required, as well as an assurance for each subcontractor or cooperating institution that has immediate responsibility for human subjects. The Office for Protection from Research Risks (OPRR) at the National Institutes of Health (NIH) negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services. Animal Subjects Requirements If the proposed project involves research on animal subjects, compliance with the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions" is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office for the Protection from Research Risks (OPRR) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the Centers for Disease Control and Prevention (CDC) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. 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: LETTER OF INTENT Prospective applicants are asked to submit, by April 19, 1999, 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 staff of the participating Institutes to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Roy M. Fleming, Sc.D. Research Grants Program National Institute for Occupational Safety and Health 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-4616 Email: APPLICATION PROCEDURES Applicants must use Form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: Application kits are also available at: BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See for sample pages.) At the top of the page, enter the total direct costs requested for each year. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/ contractual arrangement is included in the overall requested modular direct cost amount. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page, - List current position(s) and then previous positions, - List selected peer-reviewed publications, with full citations, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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. Submit a signed, typewritten original, including the checklist, and three signed, clear, and single sided 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 also be sent to Dr. Roy M. Fleming at the address under LETTER OF INTENT. Applications must be received by June 10, 1999. 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 and responsiveness (applicants should clearly indicate which priority area of this RFA is being addressed by their proposal) and will be assigned to the appropriate sponsoring federal agency or institute for funding consideration. Applications determined to be incomplete or unresponsive to this RFA will be returned to the applicant without further consideration. If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. Applications that are complete and responsive to the RFA will be reviewed for scientific and technical merit by an initial review group convened by NIOSH. Reviewers will identify those applications with the highest scientific merit, which generally comprise the top half of applications reviewed. Those applications will be discussed fully and assigned a priority score between 100 and 300 (100 is the best possible score). For all other applications, there will be a limited discussion and they will not be scored. Notification of the scientific review results will be sent to the applicants after the initial review. Following the initial review, applications will receive a secondary review for programmatic importance (for applications assigned to NIH Institutes, the review will be conducted by the appropriate Council). Review Criteria 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 or advance 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? The initial review group will also examine the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Demonstration grant applications will be reviewed additionally on the basis of the following criteria: o Degree to which the project will document baseline measures and evaluate the benefits of an intervention approach. o Degree to which the project can be expected to yield or demonstrate results that will be useful and desirable on a national or regional basis. o Documentation of cooperation from industry, unions, or other participants in the project. Review Criteria for Programmatic Importance are as follows: o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o Usefulness to applied technical knowledge in the identification, evaluation, or control of occupational safety and health hazards on a national or regional basis. o Propensity to improve understanding of the pathophysiology (includes biomechanics), diagnosis, treatment, and prevention of adverse health or safety outcomes caused by occupational exposures. AWARD CRITERIA Final funding decisions are based on the recommendations of the initial (technical merit) and secondary (programmatic importance) reviews, balance of awards across areas of programmatic interest in this RFA, and availability of funds. Awards are expected to begin in September 1999, although some awards may not begin until FY 2000. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. This RFA and other CDC Announcements can be found on the CDC HomePage ( under the "Funding" section. This RFA can also be found on the NIOSH HomePage ( under "Extramural Program." Direct inquiries regarding programmatic issues to: Roy M. Fleming, Sc.D. Research Grants Program National Institute for Occupational Safety and Health 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-4616 Email: Kumiko Iwamoto, M.D., Dr.P.H. Epidemiology and Genetics Research Program National Cancer Institute 6130 Executive Boulevard, Room 535 Bethesda, MD 20892-7395 Telephone: (301) 435-4911 FAX: (301) 402-4279 Email: Gail Weinmann, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: Sidney M. Stahl, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Room 533 Bethesda, MD 20892 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Amy Donahue, Ph.D. Hearing and Balance/Vestibular Sciences Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Suite 400C, MS-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: Gwen W. Collman, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-4937 Email: Direct inquiries regarding grants management matters to: Joanne Wojcik Procurement and Grants Office Centers for Disease Control and Prevention 2920 Brandywine Road, MS-E13 Atlanta, GA 30341-4146 Telephone: (770) 488-2717 FAX: (770) 488-2777 Email: Mr. William Wells Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 250 FAX: (301) 496-8601 Email: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7128 Bethesda, MD 20892-7128 Telephone: (301) 435-0144 FAX: (301) 480-3310 Email: Mr. David Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-22 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-1373 FAX: (919) 541-2860 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.262 NIOSH, 93.393 NCI, 93.837, 93.838, and 93.839 NHLBI, 93.866 NIA, 93.173 NIDCD, and 93.113 and 93.115 NIEHS. This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. The CDC and NIH strongly encourage all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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