and Human Services (HHS)
EXPIRED
NIOSH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM Release Date: October 22, 2001 RFA NUMBER: RFA-OH-02-001 National Institute for Occupational Safety and Health, (NIOSH) Letter of Intent: November 7, 2001 Application Receipt Date: December 27, 2001 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 http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Occupational Safety and Health (NIOSH) invites applications for Exploratory/Developmental Grants (R21) in research areas that are relevant to the research goals described in the National Occupational Research Agenda (NORA). The overall purpose of NORA is to provide a framework for research programs that provide the critical knowledge that can be used in preventing occupational diseases and injuries and foster our understanding of their underlying pathophysiology. For this RFA, research projects must address one of the following areas: 1) Work Organization: Cardiovascular Disease, 2)Work Organization: Depression, 3) Health Care Workers Including Violence, 4)Chronic Obstructive Pulmonary Disease (COPD)and Work, 5) Traumatic Injury, 6) Hearing loss, 7)Agricultural Injuries To Children, and 8) Intervention Effectiveness Research In Occupational Health. Applications for other areas should be submitted to the regular grants program of NIOSH. The objective of the exploratory/developmental mechanism (R21) is to encourage applications from institutions that are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of safety and occupational health. Another objective is to encourage necessary initial development to provide a basis for important future research. These are short-term awards (up to two years) with limited funding (maximum $75,000 per year for direct costs). Applicants are encouraged to use this mechanism to explore the feasibility of an innovative research question or approach, which may not qualify through existing research grant programs, or may not be competitive as a standard research project grant (R01). Potential applicants should also be aware of the program announcements for the NIOSH Small Grant (R03) Program PA-99-144. This small grant program is for pilot studies with funding requests for a maximum of $25,000 direct costs per year for up to two years. This program announcement is also available on the NIOSH Home Page, http://www.cdc.gov/niosh/norhmpg.html You may also refer to http://www.cdc.gov/funding.htm. HEALTHY PEOPLE 2010 CDC is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area of Occupational Safety and Health. The internet site is: http://www.health.gov/healthypeople/ 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, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations, and small, minority, and women-owned businesses that meet the above criteria. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Note: Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan. MECHANISM OF SUPPORT This mechanism of support will be the individual research project grant (R21). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for an application submitted in response to this RFA may not exceed two (2) years. This RFA is a one-time solicitation. FUNDS AVAILABLE Approximately $3,200,000 is available in FY 2002 to fund 32 awards under this RFA. The maximum amount that may be requested for an award is $75,000 direct cost. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. It is expected that the awards will begin on or about June 1, 2002 and will be made for a 12-month budget period within a project period of up to 2 years. Funding estimates may change. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds. Use of Funds Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to be held in Washington, D.C. The purpose of this meeting is to provide an opportunity for the exchange and dissemination of scientific information. RESEARCH OBJECTIVES In 1996, 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 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. 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 http://www.cdc.gov/niosh/nora.html While applications may involve a wide variety of biomedical, behavioral, clinical, socio-culture, or other disciplines, relevance to the mission of NIOSH must be clear. The Institute"s mission statement, extramural research program descriptions, list of special emphasis areas, and active program announcements may be found at NIOSH"s Internet web site: http://www.cdc.gov/niosh/homepage.html. This NIOSH Exploratory/Developmental Grant (R21) Program provides limited financial support for exploring the feasibility of innovative or creative research questions within the research interests of NORA. The overall purpose of this RFA is to stimulate investigations in eight priority areas (see below) that either have received few applications, have limited grant support from NIOSH, or have been identified as priority research needs. The Research Areas for this RFA are: o Work Organization: Cardiovascular Disease In the U.S., cardiovascular disease (CVD) is a health problem of staggering proportions. An estimated 58 million Americans have CVD, of whom 50 million have hypertension. Over 7 million Americans suffer from coronary heart disease which is responsible for more deaths each year in the U.S. than all forms of cancer combined. That occupational factors play a role in the etiology of CVD is undisputed. However, the nature and role of work organization as an etiologic factor is unclear. Types of research applications that are appropriate for this topic include but are not limited to the following areas: (1) role of work organization on CVD, and (2) work organization on worker groups such as miners, women etc. References Harlan WR, Sharret AR, Weill H, Turino GM, Berhani NO, Resnekow L. Impact of the environment on cardiovascular disease, report of the American Heart Association Task Force on environment and the cardiovascular system. Circulation 1981,63:243A-6A. Roseman KD. Cardiovascular disease and environmental exposure. Br J Ind Med 1979,36:85-97. o Work Organization: Depression Depression has been judged as one of if not the most disabling health condition worldwide, judged by sheer prevalence. Worker illness results in nearly 175 million lost workdays and productivity losses of $24 billion annually in the U.S. alone. However, unlike CVD and other health condition, there is limited information on the occupational aspects of depression. In the present environment, the rapid organizational changes expose workers to a broad range of stressors with suspected links to depression. Types of research applications that are appropriate for this topic include but are not limited to the following areas: (1) role of work organization on depression, and (2) work organization on worker groups such as miners, women etc. References Sauter, SL, Hurrell, JJ Jr, Roberts-Fox, H, Tetrick, LE, and Barling, J. 1999. Occupational health psychology: An emerging discipline. Industrial Health,37:199-211. Grosch, J and Murphy, LR. 1998. Occupational differences in depression and global health: Results from a national sample of US workers. Journal of Occupational and Environmental Medicine, 40:153-164. Revoke DA and May, HJ Occupational stress, social support, and depression. Health Psychology, 4 (1), 61-77. 1985 via George Wise, Missouri Extension Child and Family Development Specialist, July 1985 o Health Care Workers, Including Violence Currently, there are approximately 10 million health care workers in the U.S. performing in numerous professional and support positions in various work environments (hospitals, laboratories, home health care, and emergency services). This number is projected to increase to 13 million by 2006. Health care workers are at risk to injury or illness from occupational exposures for example, hazardous chemicals (solvents and chemotheraputic agents), infectious agents (viruses and bacteria), physical (violence and noise), biomechanical (lifting and standing), and psychological (stress and work shift). Approaches to reduce and prevent injury and illness seen in other industries and consistent with the concept of healthy work organizations have not been realized in the heath care system, particularly in the area of work-related violence. Types of research applications that are appropriate for this topic include but are not limited to: 1) identification of risk factors associated with injury or illness of health care workers, 2)innovative prevention strategies to reduce injury and illness among health care workers, and 3) role of work organizations on health care worker violence. References U.S. Department of Labor (OSHA): Guidelines for Preventing Workplace Violence for Health Care and Social Service Workers. Publication no. 3148, 1998. o Chronic Obstructive Pulmonary Disease (COPD) and Work COPD is one of the leading respiratory diseases in the U.S. and a major cause of morbidity and mortality. Many occupational exposures (both by themselves or in combination with smoking) are known to cause COPD. In addition, workplace exposures contribute to the development, persistence, and exacerbation of COPD brought about through non-occupational causes. The proportion of COPD attributable to occupational exposure in the general population is estimated to be 14 percent, providing a point estimate of 14,257 COPD deaths annually in the United States attributable to occupational dust exposure. The causal relationship between occupational exposures such as coal mine dust and COPD development has been well researched and now generally accepted. However, the evidence is either limited, suggestive, or non-existent, for other types of occupational exposures such as >nuisance dusts=, now called >particulate=. Further investigation is required to improve the 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 contribute to or result in lung dysfunction. Types of research applications that are appropriate for this topic include but are not limited to the following areas: 1) the assessment of the true extent of COPD associated with workplace exposures, including the contribution from exacerbation of non- occupationally caused COPD by workplace exposures, 2) the identification of exposures which cause COPD, including assessment of the group of dusts termed >particles not otherwise regulated or classified= (PNOR/PNOC) and study of the effects of mixed dust exposures, 3) the relationship between various work environments, symptom development, accelerated lung function loss, and the subsequent development of COPD, 4) documentation of the beneficial effects of substantially reducing or eliminating exposure to occupational respiratory hazards on the reduction or prevention of COPD, 5) evaluation of workplace medical screening/surveillance programs or data, obtained from on-going and completed population- based studies, to improve the understanding of the occupational contribution to COPD, and 6) animal models of occupational COPD. References American Lung Association. 1996. Trends in chronic bronchitis and emphysema: morbidity and mortality. New York, NY. pp.1-5. Frank E. Speizer. Occupational and environmental lung diseases: an overview. Environmental Health Perspectives Volume 108, Supplement 4, August 2000. Becklake MR.1994. The work relatedness of airways dysfunction. In: Proceedings of the 9th international symposium in epidemiology in occupational health. DHHS(NIOSH) Publication No.94-112:1-28. o Traumatic Injury The risk of occupational traumatic injuries affects all 130 million U.S. workers to some degree. In 1998, 2.6 million of the 5.5 million nonfatal occupational injuries in U.S. private sector industries resulted in lost work days, restricted duty, or both. Traumatic occupational injuries killed 6,026 Americans in 1998. The economic burden from traumatic occupational injuries has been estimated at approximately $145 billion (in 1992), in the same range as the costs ($160-170 billion) for cancer and circulatory diseases. Lack of a well coordinated or integrated approach has resulted in the inability of some previous research activities to reach a point of impacting the workplace, while others have been applied in only limited situations with no plans or mechanism for broad-based dissemination. The proposed projects should take advantage of existing knowledge regarding high-risk work activities and known and potential interventions. Intervention projects which assess the practical effectiveness of occupational injury prevention interventions (e.g., strategies, technologies, and programs) in reducing risks, exposures, injuries and their negative economic and social effects are of particular interest. Research should consider feasibility and cost effectiveness, as well as disincentives and other potential barriers to implementation. Topics for this project area include, but are not limited to: 1) systematic evaluation of the effectiveness of intervention methodologies, 2) practical and usefulness of specific control strategies, technologies, or personal protective equipment, 3) components of effective programs that reduce traumatic injuries, including worker participation, training, engineering solutions, and organization or administrative aspects, and 4) identification of critical factors( risk factors, prevention strategies, evaluation techniques, dissemination and technology transfer approaches) for implementing and conducting effective programs that reduce or prevent traumatic injuries. Dissemination and technology transfer mechanisms could be developed to inform at- risk populationsBemployers, safety and health practitioners, and workers of effective interventions, that would persuade them to implement new methods, policies, and partnerships to effect positive injury prevention changes in workplaces and companies. o Hearing Loss Work-related hearing loss from exposure to noise has long been recognized. However, job-related hearing loss from exposure to chemicals in combination with noise has been recognized only recently. Research from the 1990s showed that some workers exposed only to chemicals have more risk of occupational hearing loss than workers exposed to noise alone In addition, studies have found that workers exposed to both noise and chemicals were at much greater risk of hearing loss than workers exposed to either noise or chemicals alone. There is a need for studies that will support development of dose-response relationships so that exposure limits can be established to protect workers= hearing from combined noise and chemical exposures. Noise exposure parameters of interest include, but are not limited to steady state, fluctuating, intermittent and impulse/impact. The chemicals of interest include solvents, metals, insecticides, herbicides, pesticides, and asphyxiates. Populations of interest include, youths, miners, construction and agricultural workers. Types of research applications that are appropriate for this topic include but are not limited to the following areas: (1) systematic evaluation of the effectiveness of interventions (2) biological effects and biological responses induced by noise or other ototoxic agents including secondary risk factors such as hypertension, head trauma, diabetes, blood lipids, and clinical therapeutic drugs, (3) individual susceptibility to hearing loss induced by noise and/or chemicals and the role of free-radicals and antioxidants in the auditory system=s response to noise and ototoxic chemicals, (4) evaluation of the dose-response relationships between hearing loss and exposure to noise, chemicals, or noise and chemicals, and (5) laboratory studies that mimic work place noise/chemical exposures are appropriate as long as the results are directly applicable to the work place. o Agricultural Injuries To Children Agricultural production consistently ranks among industries with the highest rates of work-related injuries and deaths in the United States, and is unique with respect to children and adolescents. Projects are sought but not limited to research topics that develop new or enhance existing control technologies developed to reduce injury to youth exposed to agricultural production hazards. Other research topics related to the area of agricultural injuries to children are also allowed. Applications should identify the types and geographical distribution of agricultural production which will be addressed, and the size and characteristics of child and adolescent populations which can potentially be impacted by the research findings. Research topics of interest include but are not limited to: Develop New or Enhance Existing Control Technologies Control technologies, include any strategy which will control the exposure of children to agricultural hazards. Examples of research efforts which are appropriate under this priority area include, but are not limited to: a) engineering controlsBthese could include the development of new or the application and evaluation of existing equipment or devices which could prevent childhood agricultural injuries (for example, ensuring that agricultural structures have proper barriers and warnings, developing and evaluating play area designs to reduce child exposures to hazards, and developing and evaluating sensor technology to notify operators or automatically shut down machines when children are in harms way) and/or b) administrative controlsB these could include evaluating the impact of changes in work practices, such as limiting the type of work a youth does (i.e., not allowing youth under 16 to drive tractors), modification of work periods, (such as limiting the amount of time a youth works), limiting the exposure of the youth (ensuring equipment in the work environment is properly shielded), and the type and amount of training and supervision given to the young worker. References Myers JR, Hendricks K. 2001. Injuries Among Youth on Farms in the United States, 1998. NIOSH Publication No. 2001-154. Castillo DN, Adekoya N, Myers JR. 1999. Fatal Work-Related Injuries in the Agricultural Production and Services Sectors Among Youth in the United States, 1992-1996. Journal of Agromedicine 6:27-41. o Intervention Effectiveness Research In Occupational Health The purpose of this initiative is to stimulate research that evaluates the effectiveness of intervention techniques which have been implemented or proposed for reducing or preventing workplace injuries and illnesses. While many workplace interventions have been developed and implemented, there has been little research on the effectiveness of these activities. Before work place intervention strategies can be applied universally, there is a critical need for information on how effective are the currently used or planned strategies and approaches. The results of these investigations will contribute significantly to improving worker health and safety by identifying intervention strategies that are effective. Because the issue of intervention effectiveness is of importance to many membership groups (unions, professional associations, etc), industries, and state health departments, collaborative research projects between these organizations and academic researchers are particularly encouraged. Research applications are sought that focus on the systematic evaluation of the effectiveness of interventions that address but are not limited to any of the following disease or injury areas: 1) Traumatic Injuries including Violence 2)Allergic and Irritant Dermatitis, 3)Asthma and Chronic Obstructive Pulmonary Disease, 4)Fertility and Pregnancy Abnormalities, 5)Hearing Loss, 6)Infectious Diseases, and 7)Low Back Disorders. Fully-developed interventions either implemented or ready for implementation are of interest, as well as applications for comparative analysis of the effectiveness of alternate options (e.g., cost effectiveness). 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. Evaluations may address but are not limited to (1) the practicality and usability of specific control strategies, technologies and/or personal protective equipment in the elimination or reduction of hazards, (2) the identification of critical factors for implementing and conducting effective occupational safety and health programs, (3) the components of effective occupational safety and health programs, including worker participation programs, training or other organizational and administrative aspects, as well as engineering solutions, and (4) identification and elimination of barriers to the implementation of interventions, such as a lack of acceptance due to practicality, perception that cost is prohibitive, etc. Examples of potential health, economic, and social outcome measures may include but are not limited to, 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). References National Institute for Occupational Safety and Health. National Occupational Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 (http://www.cdc.gov/niosh/nora.html. National Institute for Occupational Safety and Health. A Model for Research on Training Effectiveness. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-142 (http://www.cdc.gov/niosh/99-142.html). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the 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. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 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. This policy will be followed by NIOSH for this announcement. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. HUMAN SUBJECTS REQUIREMENTS If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects. All awardees of CDC grants and cooperative agreements and their performances sites engaged in human subjects research must file an assurance of compliance with the regulations and have continuing reviews of the research protocol by appropriate institutional review boards. In order to obtain a federal-wide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application. OHRP will verify that the signatory official and the Human Subjects Protections Administrator have completed the OHRP Assurance Training/Education Module before approving the FWA. Existing Multiple Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project Assurances (SPAs) remain in full effect until they expire or until December 31, 2003, whichever comes first. To obtain a FWA contact the OHRP at: http://www.hhs.gov/ohrp/assurances/assurances_index.html or write to: Office for Human Research Protections (OHRP) Department of Health and Human Services 6100 Executive Boulevard, Suite 3B01, MSC 7501 Rockville, Maryland 20892-7507 (Note: For Express or Hand Delivered Mail, Use Zip Code 20852) Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also 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 the applicable portion of that project. 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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 of Laboratory Animal Welfare (OLAW) 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). Web page http://grants.nih.gov/grants/olaw/olaw.htm. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES All applications must be self-contained within specified page limitations. Unless otherwise specified, 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 By regulation (45 CFR 74.36), grantees that are institutions of higher education, hospitals, or non-profit organizations are required to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances (OMB Circular A-110). 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. For further information on this policy refer to page 52 in the PHS 398 grant application or access the NIH Guide for Grants and Contracts Announcement at: http://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, by November 7, 2001, a letter of intent that includes the number and title of the RFA, a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, and the identities of other key personnel and participating institutions. Although a letter of intent is not required, is not binding, and is not used in the review of an application, the information that it contains is used to estimate the potential review workload and plan the review. The letter of intent is to be submitted to: Pervis C. Major, Ph.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone: 304-285-5979 Fax: 304-285-6147 Email: [email protected] APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.pdf must be used in applying for these grants. This version of PHS 398 is available in an interactive, searchable format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIOSH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIOSH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: [email protected]. 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 http://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. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The RFA label available in the PHS 398 (rev. 5/2001) application form (http://grants.nih.gov/grants/funding/phs398/labels.pdf) 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. Submit a signed original of the application and three exact photocopies, including the checklist, 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: Pervis C. Major, Ph.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone: 304-285-5979 Fax: 304-285-6147 Email: [email protected] Applications must be received by December 27, 2001. If an application is received after that date, it will be returned to the applicant without review. CSR and NIOSH 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. CSR and NIOSH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Applications determined to be incomplete or unresponsive to this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be reviewed for technical merit by a scientific review group convened by NIOSH. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the research objectives of the RFA. As part of the scientific merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. The criteria that NIOSH will use to review applications for scientific merit and for meeting program objectives are provided below. Scientific Review Criteria o Significance - Does this study address an important problem related to the topical research issues outlined in this announcement? 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? o Approach - Are the conceptual framework, design (including composition of study population), 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? o Innovation - Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o 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? o 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 documentation of cooperation from industry, unions, communities, or other participants in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? o 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 adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. Programmatic Review Criteria o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o Likelihood of developing applied technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. SCHEDULE Letter of Intent Receipt Date: November 7, 2001 Application Receipt Date: December 27, 2001 Anticipated Award Date: June 1, 2002 AWARD CRITERIA Applications will be considered for award based upon (a) scientific merit, (b) program importance, (c) program balance of research areas, and (d) availability of funds. 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/NIOSH Announcements can be found on the CDC HomePage (http://www.cdc.gov) under the "Funding" section (see Grants and Cooperative Agreements scroll down to Occupational Safety and Health). This RFA can also be found on the NIOSH HomePage (http://www.cdc.gov/niosh) under "Extramural Programs, Current Funding Opportunities. Direct inquiries regarding programmatic issues to: Adele M. Childress, Ph.D. M.S.P.H. Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: 404/639-1493 FAX: 404/639-0035 Email: [email protected] Direct inquiries regarding grants business management matters to: Joanne Wojcik Grants Management Branch Procurement and Grants Office CDC Announcement Number CDC 02014 Centers for Disease Control and Prevention 2920 Brandywine Road, Suite 3000 Atlanta, GA 30341-4146 Telephone: 770/488-2717 FAX: 770/488-2777 Email: [email protected] AUTHORITY AND REGULATIONS The Catalog of Federal Domestic Assistance number is: 93.262 for the National Institute for Occupational Safety and Health (NIOSH). 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. LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of the Center for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention, collect and analyze data, publish and disseminate results of research and surveillance data, implement prevention strategies, conduct community outreach services, provide leadership and training, and foster safe and healthful environments. Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law. SMOKE-FREE WORKPLACE CDC strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children. SMALL, MINORITY, AND WOMEN-OWNED BUSINESS It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should: 1. Place small, minority, women-owned business firms on bidders mailing lists. 2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services. 3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms. 4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices. RESEARCH INTEGRITY The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science." The regulation places several requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity"s (ORI) Assurance Program. For examples: Section 50.103(a) of the regulation states: "Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant, and (2) Will comply with its own administrative process and the requirements of this Subpart." Section 50.103(b) of the regulation states that: "an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution"s assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe."
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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