This Program Announcement expires on February 2004 unless reissued. CAREER DEVELOPMENT GRANTS IN OCCUPATIONAL SAFETY AND HEALTH RESEARCH Release Date: December 13, 2000 PA NUMBER: PA-01-032 National Institute for Occupational Safety and Health Application Receipt Dates: March 1, July 1, and November 1 PURPOSE This Program Announcement (PA) supersedes all previous announcements of the National Institute for Occupational Safety and Health (NIOSH) Special Emphasis Research Career Award (SERCA) Grants (K01). The research must be related to the priority areas identified in the National Occupational Research Agenda (NORA) that are described in the RESEARCH OBJECTIVES section. Within the Centers for Disease Control and Prevention (CDC), NIOSH is the only Federal Institute responsible for conducting research and making recommendations for the prevention of work-related illnesses and injuries. NIOSH supports research to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries; 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; to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards; and to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system. HEALTHY PEOPLE 2010 NIOSH 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 program announcement is related to the focus area of Occupational Safety and Health and Injury and Violence Prevention. Potential applicants may obtain a copy of Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. 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 This program announcement will use the Special Emphasis Research Career Award (SERCA) grant (K01) award mechanism. 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, nor 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. 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 $75,000 per year in direct costs for salary support (plus fringe benefits), technical assistance, equipment, supplies, consultant costs, domestic travel, publications, and other costs. The facilities and administrative cost rate applied is limited to 8 percent of the direct costs, excluding tuition and related fees and equipment expenses, or to the facilities and administrative 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 (R01). 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). 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. Each day, an average of 9,000 U.S. workers sustain disabling injuries on the job, 17 workers die from an injury sustained at work, and 137 workers die from work-related diseases. The economic burden of this continuing toll is high. Data from a NIOSH-funded study reveal $171 billion annually in direct and indirect costs of occupational injuries and illnesses ($145 billion for injuries and $26 billion for diseases). These costs compare to $33 billion for AIDS, $67.3 billion for Alzheimer's Disease, $164.3 billion for circulatory diseases, and $170.7 billion for cancer. 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 "http://www.cdc.gov/niosh/nora.html". 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. Applicants should provide a statement about which NORA area is being addressed and a rationale for how the proposal is intended to contribute to the scientific knowledge base of the specified priority area (place this information in the "Background and Significance" section of the "Research Plan" of the application). Applicants are encouraged to contact individuals listed under INQUIRIES if they wish to discuss the relevance of their research ideas. NORA Priority Research Areas are: Disease and Injury 1. Allergic and Irritant Dermatitis 2. Asthma and Chronic Obstructive Pulmonary Disease 3. Fertility and Pregnancy Abnormalities 4. Hearing Loss 5. Infectious Diseases 6. Low Back Disorders 7. Musculoskeletal Disorders of the Upper Extremities 8. Traumatic Injuries Work Environment and Workforce 9. Emerging Technologies 10. Indoor Environment 11. Mixed Exposures 12. Organization of Work 13. Special Populations at Risk Research Tools and Approaches 14. Cancer Research Methods 15. Control Technology and Personal Protective Equipment 16. Exposure Assessment Methods 17. Health Services Research 18. Intervention Effectiveness Research 19. Risk Assessment Methods 20. Social and Economic Consequences of Workplace Illness and Injury 21. 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." HUMAN SUBJECTS REQUIREMENTS 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 of Human Research Protections (OHRP) negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services (Additional information is available at http://www.hhs.gov/ohrp/). All investigators proposing research involving human subjects should read the UPDATED "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 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). 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 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. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES All applications and proposals 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 comprised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the following receipt dates: March 1, July 1, and November 1. These forms are available at most institutional offices of sponsored research and 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: grantsinfo@nih.gov. Application kits are also available at: https://grants.nih.gov/grants/forms.htm. Specific K01 Instructions On the application Face Page item 2, check the "YES" box, indicating the application is in response to a Program Announcement, and type "PA-01-020" for the "Number" and "NIOSH SERCA Grant Program" for the "Title." Up to three publications, submitted manuscripts, or abstracts may be included in the Appendix material. Letters of support may also be included in the Appendix. For revised/amended applications, an introduction (not to exceed one and one- half pages) in addition to the research plan is required. This introduction should respond to comments and concerns of the Initial Review Group delineated in the summary statement. The Checklist 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. 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. 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. Furthermore, if the proposed research involves human subjects, it should be stated if such organizations or persons are to be engaged in the research with the applicant organization and how they will be obtaining IRB approvals prior to their participation in the research (but not prior to review of the proposed research). Submit a signed, typewritten original, including the checklist, and five 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) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive, will undergo a scientific merit review by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. 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. Following the scientific merit review, applications will then be reviewed by NIOSH according to the programmatic review criteria below. Scientific Review Criteria In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. The review process for SERCA applications 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). 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? What is the potential of this study to result in a full research project? 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Since applicants do not have extensive experience with the grants process, there is leniency in assigning priority scores. 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with HHS policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. 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. AWARD CONSIDERATIONS Applications will compete for available funds with all other applications. Funding decisions will be based on quality of the proposed project as determined by the scientific review, importance based on the programmatic review, and balance of awards among program research objectives. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. 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: rfleming@cdc.gov Direct inquiries regarding grants management matters to: Joanne Wojcik Procurement and Grants Office Centers for Disease Control and Prevention 2920 Brandywine Road, MS-E13, Suite 3000 Atlanta, GA 30341-4146 Telephone: (770) 488-2717 Email: jwojcik@cdc.gov 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. Executive Order 12372 is not applicable for this program announcement. LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS 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 instruct participants on how to lobby. In addition no part of 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. SMOKE-FREE WORKPLACE The CDC strongly encourages 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. ADDITIONAL REQUIREMENT 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.
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