RESEARCH AND DEMONSTRATION GRANTS OCCUPATIONAL SAFETY AND HEALTH Release Date: January 27, 1999 PA NUMBER: PAS-99-053 P.T. National Institute for Occupational Safety and Health PURPOSE The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is soliciting grant applications for research and demonstration projects related to occupational safety and health (see the section FUNDS AVAILABLE). The purpose of this grant program is to develop knowledge that can be used in preventing occupational diseases and injuries. Thus, NIOSH will support the following types of applied research projects: causal research to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries, methods research to develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries, control research to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards, and demonstrations to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system. HEALTHY PEOPLE 2000 CDC is 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 announcement is related to the priority area of Occupational Safety and Health. 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). ELIGIBLE APPLICANTS Applications may be submitted by 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. Exceptions: foreign organizations are ineligible to apply for the Special Emphasis Research Career Award (SERCA) Grant and Small Grant programs (additional guidance provided under these mechanisms). NOTE: An organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities shall not be eligible to receive Federal funds constituting an award, grant, contract, loan, or any other form. FUNDS AVAILABLE For fiscal year (FY) 1999, the budget is projected to be $19.8 million, which is a $2.0 million increase over the FY1998 budget. Of that amount, $13.6 million is committed to support 79 non-competing continuing awards. Therefore, $6.2 million is available for new and competing renewal awards. The overall budget includes funds for Small Business Innovation Research (SBIR) grants. Grant applications should be focused on the research priorities described in the section "FUNDING PRIORITIES" that include new research priorities developed in a process which resulted in defining a National Occupational Research Agenda. MECHANISM OF SUPPORT Grants are funded for 12-month budget periods in project periods up to five years for research project grants and demonstration project grants, two years for pilot study grants, three years for SERCA grants, and two years for small grants. Continuation awards within the project period are made on the basis of satisfactory progress and on the availability of funds. The types of grants NIOSH supports are as follow: 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 dealing with problems. These studies may generate information that is readily available to solve problems or 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, either on a pilot or full-scale basis, 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. Special Emphasis Research Career Award (SERCA) Grants (K01) The SERCA grant is intended to provide opportunities for individuals to acquire experience and skills while under the direction of at least one mentor, and in so doing, create a pool of highly qualified investigators who can make future contributions to research in the area of occupational safety and health. SERCA grants are not intended for individuals without research experience, or for productive, independent investigators with a significant number of publications and of senior academic rank. Moreover, the award is not intended to substitute one source of salary support for another for an individual who is already conducting full-time research, nor is it intended to be a mechanism for providing institutional support. Candidates must: (1) hold a doctoral degree, (2) have research experience at or above the doctoral level, (3) not be above the rank of associate professor, and (4) be employed at a domestic institution. For non-U.S. citizens who will be principal investigators, the grantee institution must indicate in the application that the individual"s visa will allow the person to remain in the country a sufficient length of time to complete the project. Also, a U.S. citizen must be identified who is a permanent staff member of the grantee institution and who, if the SERCA grant recipient is unable to stay in the U.S., will be responsible for seeing the project through to completion. This non-renewable award provides support for a three-year period for individuals engaged in full-time research and related activities. Awards will not exceed $50,000 per year in direct costs for salary support (plus fringe benefits), technical assistance, equipment, supplies, consultant costs, domestic travel, publications, and other costs. The indirect cost rate applied is limited to 8 percent of the direct costs, excluding tuition and related fees and equipment expenses, or to the actual indirect cost rate, whichever results in the lesser amount. A minimum of 60 percent time must be committed to the proposed research project, although full-time is desirable. Other work in the area of occupational safety and health will enhance the candidate"s qualifications but is not a substitute for this requirement. Related activities may include research career development activities as well as involvement in patient care to the extent that it will strengthen research skills. Fundamental/basic research will not be supported unless the project will make an original contribution for applied technical knowledge in the identification, evaluation, or control of occupational safety and health hazards (e.g., development of a diagnostic technique for early detection of an occupational disease). Research project proposals must be of the applicants" own design and of such scope that independent investigative capability will be evident within three years. At the completion of this three-year award, it is intended that awardees should be better able to compete for individual research project grants awarded by NIOSH. SERCA grant applications should be identified as such on the application form. Section 2 of the application (the Research Plan) should include a statement regarding the applicant"s career plans and how the proposed research will contribute to a career in occupational safety and health research. This section should also include a letter of recommendation from the proposed advisor(s). Small Grants (R03) The small grant program is intended to stimulate proposals from individuals who are considering a research career in occupational safety and health, as such, the minimum time commitment is 10%. It is expected that a recipient would subsequently compete for other grant mechanisms which are described above. The award is not intended to supplement ongoing or other proposed research, nor is it intended to be a mechanism for providing institutional support. Please note that fundamental/basic research is generally not supported. Small grant candidates are predoctoral students, post-doctoral researchers (within 3 years following completion of doctoral degree or completion of residency or public health training), or junior faculty members (no higher than assistant professor). If university policy requires that a more senior person be listed as principal investigator, it should be clear in the application which person is the small grant investigator. For non-U.S. citizens who will be principal investigators, the grantee institution must indicate in the application that the individual"s visa will allow the person to remain in the country a sufficient length of time to complete the project. Also, a U.S. citizen must be identified who is a permanent staff member of the grantee institution and who, if the small grant recipient is unable to stay in the U.S., will be responsible for seeing the project through to completion. Except for applicants who are assistant professors, there must be one or more named mentors to assist with the project. A biographical sketch is required for the small grant investigator, as well as for the supervisor and other key consultants, as appropriate. This non-renewable award provides support for project periods of up to two years to carry out exploratory or pilot studies, to develop or test new techniques or methods, or to analyze data previously collected. Awards will not exceed $25,000 per year in direct costs for salary support (plus fringe benefits), technical assistance, equipment, supplies, consultant costs, domestic travel, publications, and other costs. The indirect costs will be based upon the negotiated indirect cost rate of the applicant organization. An individual may not receive more than two small grant awards, and then, only if the awards are at different stages of development (e.g., doctoral student, post-doctoral researcher, or junior faculty member). RESEARCH OBJECTIVES Background 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. To identify and reduce hazardous working conditions, NIOSH carries out disease, injury, and hazard surveillance and conducts a wide range of field and laboratory research. Additionally, the Institute sponsors extramural research in priority areas to complement and expand its efforts. Funding Priorities NIOSH intends to support projects that facilitate progress in understanding and preventing adverse effects among workers. Of special interest are proposals addressing the priorities identified in the National Occupational Research Agenda (see below). Investigators may also apply in other areas related to occupational safety and health, the rationale for the significance of the research to the field of occupational safety and health must be presented in the grant application. The NIOSH program priorities are applicable to all of the types of grants listed under the section "MECHANISMS OF SUPPORT", above. 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. The agenda identifies 21 research priorities and reflects an attempt to consider both current and emerging needs. The priority areas are not ranked: each is considered to be of equal importance. The NORA priority research areas are grouped into three categories: Disease and Injury, Work Environment and Workforce, and Research Tools and Approaches. The NORA document is available through the NIOSH Home Page, http://www.cdc.gov/niosh/nora.html. NORA Priority Research Areas: Disease and Injury o Allergic and Irritant Dermatitis o Asthma and Chronic Obstructive Pulmonary Disease o Fertility and Pregnancy Abnormalities o Hearing Loss o Infectious Diseases o Low Back Disorders o Musculoskeletal Disorders of the Upper Extremities o Traumatic Injuries Work Environment and Workforce o Emerging Technologies o Indoor Environment o Mixed Exposures o Organization of Work o Special Populations at Risk Research Tools and Approaches o Cancer Research Methods o Control Technology and Personal Protective Equipment o Exposure Assessment Methods o Health Services Research o Intervention Effectiveness Research o Risk Assessment Methods o Social and Economic Consequences of Workplace Illness and Injury o Surveillance Research Methods Potential applicants with questions concerning the acceptability of their proposed work are strongly encouraged to seek programmatic technical assistance from the contact listed in this announcement under the section "INQUIRIES." APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted according to the deadlines indicated below. 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/ 435-0714, Email: GrantsInfo@nih.gov. The PHS Form 398 may be retrieved from http://www.nih.gov/grants/forms.htm. The title and number of the program announcement 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 of the application, including the checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) The timetable for receiving applications and awarding grants is given below. This is a continuous announcement, consequently, these receipt dates will be on-going until further notice. Research and Demonstration Project Grants: Receipt Initial Secondary Earliest Possible Date* Review Review Start Date February 1 June/July September December 1 June 1 Oct/Nov January April 1 October 1 Feb/Mar May August 1 *Deadlines for competing continuation applications or revised applications are 1 month later. SERCA and Small Grants Receipt Initial Secondary Earliest Possible Date Review Review Start Date March 1 June/July August November 1 July 1 Oct/Nov December March 1 November 1 Feb/Mar April July 1 Applications must be received by the above receipt dates. To prevent problems caused by carrier delays, retain a legible proof-of-mailing receipt from the carrier, dated no later than one week prior to the receipt date. If the receipt date falls on a weekend, it will be extended to Monday, if the date falls on a holiday, it will be extended to the following work day. The receipt date will be waived only in extenuating circumstances. To request such a waiver, include an explanatory letter with the signed, completed application. No request for a waiver will be considered prior to receipt of the application. OTHER 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. 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. 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 OPRR at the NIH. 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). REVIEW CONSIDERATIONS Applications will be reviewed for completeness by CSR. 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 will then 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. Awards will be made based on results of the initial and secondary reviews, as well as availability of funds. Review Criteria for Technical Merit are as follows: o Significance - Does this study address an important problem related to the topical research issues outlined in this solicitation? 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 approaches? 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 Principal Investigator - Is the investigator appropriately trained and well suited to carry out this work (particularly but not exclusively) in the area of the proposed project? 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, or other participants in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? o Gender and minority issues - Are plans to include both sexes and minorities and their subgroups adequately developed (as appropriate for the scientific goals of the project)? Are strategies included for the recruitment and retention of human subjects? o Human Subjects - Are the procedures proposed adequate for the protection of human subjects and are they fully documented? Are all procedures in compliance with applicable published regulations (see "OTHER REQUIREMENTS"). o Vertebrate animals - Are the procedures proposed adequate for the welfare of vertebrate animals and are they fully documented? Are all procedures in compliance with applicable published regulations? o Budget - Is the budget reasonable and appropriate for all direct costs and period/s of requested support and are all entries adequately justified? Additional consideration for technical merit of certain grant mechanisms is as follows: 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. SERCA grant applications will be reviewed additionally on the basis of the following criteria: o The review process will consider the applicant"s scientific achievements, the applicant"s research career plan in occupational safety and health, and the degree to which the applicant"s institution offers a superior research environment (supportive nature, including letter(s) of reference from advisor(s) which should accompany the application). Small grant applications will be reviewed taking the following into consideration: o Applicants for small grants do not have extensive experience with the grants process, so there is leniency in assigning priority scores. Review criteria for programmatic importance are as follows: o Relevance to occupational safety and health, by contributing to achievement of research objectives specified in Sections 20(a) and 22 of the Occupational Safety and Health Act of 1970 and Section 501 of the Federal Mine Safety and Health Act of 1977. o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o Potential contribution to applied technical knowledge in the identification, evaluation, or control of occupational safety and health hazards on a national or regional basis. The following will be considered in making funding decisions: o Technical merit of the proposed project as determined by the initial peer review. o Programmatic importance of the project as determined by secondary review. o Availability of funds. o Program balance among priority areas of the announcement. Questions regarding the above criteria should be addressed to the Programmatic Technical Information Contact listed under "INQUIRIES." INQUIRIES Inquiries concerning this program announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. This and other CDC Announcements can be found on the CDC homepage (http://www.cdc.gov) under the "Funding" section. This announcement can also be found on the NIOSH homepage (http://www.cdc.gov/niosh) under "Extramural Program." Direct inquiries regarding programmatic technical matters to: Roy M. Fleming, Sc.D. Director, Research Grants Program National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1600 Clifton Road, NE. Building 1, Room 3053, MS-D30 Atlanta, GA 30333 Telephone: (404) 639-3343 Fax: (404) 639-4616 Email: rmf2@cdc.gov Direct inquiries regarding fiscal matters to: Joanne Wojcik Grants Management Branch Procurement and Grants Office Centers for Disease Control and Prevention (CDC) 255 East Paces Ferry Road, NE., MS E-13 Atlanta, GA 30305 Telephone: (404) 842-6535 FAX: (404) 842-6513 Email: jcw6@cdc.gov. AUTHORITY AND CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER This program is authorized under the Public Health Service Act, as amended, Section 301 (42 U.S.C. 241), the Occupational Safety and Health Act of 1970, Sections 20(a) and 22 (29 U.S.C. 669(a) and 671), and the Federal Mine Safety and Health Act of 1977, Section 501 (30 U.S.C. 951). The applicable program regulations are in 42 CFR Part 52. The Catalog of Federal Domestic Assistance number is 93.262. 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.


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