CENTERS FOR AGRICULTURAL DISEASE AND INJURY RESEARCH, EDUCATION AND PREVENTION RELEASE DATE: April 3, 2003 RFA: OH-03-002 (This RFA has been modified, see PAR-06-057) National Institute for Occupational Safety and Health, (NIOSH), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) (http://www.cdc.gov/niosh/homepage.html) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.956 LETTER OF INTENT RECEIPT DATE: May 20, 2003 APPLICATION RECEIPT DATE: June 12, 2003 EXPIRATION DATE: June 13, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Program Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Pre-Application Conference Call o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THE RFA The National Institute for Occupational Safety and Health (NIOSH/CDC), Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2003 funds for cooperative agreement (U50) applications from single institutions or consortia of institutions to establish Centers for Agricultural Disease and Injury Research, Education and Prevention (Agricultural Centers). The purposes of the Agricultural Centers are to conduct prevention/intervention, education/outreach, and research programs that address agricultural safety and health problems in the geographic region served (multi-state), as well as nationally. The mission of NIOSH/CDC is to support research and research training relating to the etiology, mechanisms, diagnosis, treatment, and prevention of human diseases and disorders caused by occupational factors including those found in agriculture. To assist in this mission, in 1990, Congress established a National Program for Occupational Safety and Health in Agriculture within NIOSH/CDC to lead a national effort in surveillance, research, intervention/prevention, education, and outreach. This program has had a significant and measurable impact on reducing adverse health effects among agricultural workers. As part of this program, ten Agricultural Centers were established nationally. These Agricultural Centers conduct outreach, prevention/intervention, education, and research projects to address the nation's pressing agricultural safety and health problems. Geographically, the Agricultural Centers are distributed throughout the nation to be responsive to the agricultural safety and health issues unique to the different regions. Through these efforts, the Agricultural Centers help to ensure that actions to prevent disease and injury in agriculture are taken based upon scientific findings. Additional information on NIOSH/CDC Agricultural Health and Safety activities can be found on the NIOSH web site at http://www.cdc.gov/niosh/topics/agriculture/default.html. PROGRAM OBJECTIVES Background Agriculture consistently ranks among the industries with the highest rates of work-related injuries and deaths in the United States. The agricultural environment presents a number of unique work settings which vary across the United States. This is the only industry in which the workplace is often also a home. The Agricultural Centers were established to address the unique occupational challenges of the agricultural environment. Agriculture consistently ranks as one of the most hazardous industries in the United States. Acute traumatic injury and accidental death are among the most significant and striking occupational hazards in agriculture. There were approximately 26 deaths per 100,000 workers in the agricultural sector [Agriculture, forestry, and fishing] during 1999. The average annual fatality rate for the United States civilian working population for this same time period was approximately 5 deaths per 100,000 workers. Of special concern are the children (over 100) killed each year while involved in farm activities. Each day approximately 500 agricultural workers suffer lost-work-time injuries, and about 5% of these result in permanent impairment. Those who work in agriculture are also at increased risk for occupational morbidity from musculoskeletal disorders, certain cancers, reproductive disorders, dermatological conditions, zoonotic diseases, hearing loss, stress related mental disorders, and occupational lung diseases. Farm tractors, farm machinery, stored grain silos, power lines, manure pits, and livestock are among the many hazards workers are exposed to in agricultural workplaces. This cooperative agreement program is designed to strengthen the occupational and public health infrastructure by building on a decade of Agricultural Center accomplishments aimed at integrating resources for occupational safety and health research and public health prevention programs at the State and local levels. It is designed to address the outreach, prevention/intervention, education, and research activities that are unique to agriculture in all geographic regions. To achieve this objective, the program will support Agricultural Centers that integrate disease and injury prevention/intervention, outreach, education, and research. Goals Note, for this RFA the term "projects" is defined as prevention/intervention, education/outreach, or research projects. This initiative is intended to assemble a cross-disciplinary, multi- institutional and geographically diverse group to address the current issues in agricultural safety and health. To accomplish this objective, it is envisioned that an Agricultural Center would: 1. Conduct research related to the prevention of occupational disease and injury among agricultural workers and their families. 2. Develop, implement, and evaluate education and outreach programs for promoting health and safety for agricultural workers and their families. This would include providing consultation and/or training to researchers, health and safety professionals, graduate/professional students, and agricultural extension agents, and others in a position to improve the health and safety of agricultural workers. 3. Develop, implement and evaluate model programs for the prevention of illness and injury among agricultural workers and their families. 4. Develop linkages and communication with other governmental and non- governmental bodies involved in agricultural health and safety with special emphasis on communications with other agricultural health and safety programs. The emphasis of the Agricultural Centers should be on addressing priority, regional (multi-state) occupational health and safety issues including emerging issues applicable to agricultural safety and health (such as new technologies, stress, depression, and others), using a multi-disciplinary approach. Emphasis should also be given to underrepresented populations such as hired farm laborers, migrant/seasonal workers, women, and children. The significance of a project and application to the development and/or implementation of intervention efforts must be fully developed in the proposal. Individual projects should identify the types and geographical distribution of the agricultural issue which will be addressed by a project. Finally, the size and characteristics of populations which can potentially be impacted by the research findings should be described. In 1996, a National Occupational Research Agenda (NORA) was created to guide NIOSH. NORA is a vision of the Institute to conduct occupational safety and health research to adequately serve the needs of workers in the United States. During the development of the Agenda, the importance of sector-specific research (including agriculture) was emphasized: Sector-focused research has had much success and continues to hold great promise for gathering and translating knowledge and information into prevention. A cross-cutting, matrix approach for targeting research in some or all of the 21 NORA priority areas has been recommended for the agricultural sector. See: http://www.cdc.gov/niosh/nora/ Intervention/prevention and to the extent possible, education projects should include process and outcome measures. Process measures must be detailed enough to allow for replication in other areas. Outcome measures of interest include, but are not limited to: exposure to injury hazards, knowledge of safety and health hazards, documenting safety and health behavior change, and changes in the incidence of disease, injury, or fatality. Evaluation of the results of these projects will guide future decisions to implement programs which have demonstrated success in reducing injury and disease. In the development and prioritization of the project topics for the Agricultural Center, applicants are encouraged to consult with regional (multi-state) stakeholders (e.g. agricultural organizations, advisory groups, workers, and other interested parties). Agricultural Centers should include the development, implementation, and evaluation of model intervention, education, and outreach programs that promote health and safety for agricultural workers and their families. These programs should include culturally-appropriate materials (such as, consideration of language) and multi-media presentations to reach the identified agricultural populations within the Agricultural Center Districts. Emphasis should be given to reaching under served agricultural populations such as hired farm laborers, migrant/seasonal workers, women, and children. Agricultural Centers should include plans to provide assistance and direction to community-based groups in the region (e.g. farm youth or adult associations, extension services, schools, local government groups, migrant worker groups, medical clinics or treatment centers, worker associations, etc.) for the development and implementation of community projects, including intervention research and prevention demonstration projects for preventing work-related injuries and illness among farm workers and their families. Agricultural Centers should include plans to develop linkages and communication with other governmental and non-governmental agencies involved in agricultural health and safety, with special emphasis on communications and collaborations with other NIOSH/CDC-sponsored agricultural health and safety programs. Refer to the following web sites for more information; http://www.cdc.gov/niosh/topics/agriculture/default.html and http://www.cdc.gov/niosh/agctrhom.html. Useful 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/ The NIOSH/CDC Agricultural program is a multi-faceted program. For information on programs supported in the past, discussions of the vision, or future direction of the program, contact the NIOSH/CDC Agricultural Coordinator (name and contact information in the Inquiries Section). MECHANISM(s) OF SUPPORT This RFA will use NIOSH (U50) cooperative agreement award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 1, 2003 and will be made for a 12-month budget period. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds. Applications that are not funded in the competition described in this RFA may be submitted as NEW investigator- initiated applications using the standard receipt dates for NEW applications described in the instructions on the PHS 398 application. This RFA uses just-in-time concepts and requires the detailed budget format, rather than the modular grant budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. The NIOSH (U50)is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIOSH/CDC staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". FUNDS AVAILABLE NIOSH intends to commit approximately $1,000,000 in FY 2003 to fund 1 to 2 awards. An applicant may request a project period not to exceed three (3) years and a budget of up to $1,000,000 total cost (direct and indirect) per year. This level of expenditure is contingent upon the receipt of a sufficient number of applications directly relevant to the objectives of this RFA, the program merit as judged by a peer-review evaluation, and the availability of funds. 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 allocate funds for travel for two project staff (the Agricultural Center Director and one other person) to attend annual meetings held during each project year. Travel funds should also be planned for semi-annual meetings of Agricultural Center Directors as a Coordinating Committee (see Collaborative Responsibilities under Terms and Conditions of Award). For planning purposes, assume that the meetings will be held in Washington, DC. ELIGIBLE INSTITUTIONS You may submit (an) application (s) if your institution has any of the following characteristics: o Domestic public or private universities. o Domestic for-profit or non-profit medical centers Foreign institutions are not eligible to apply. The restriction of eligible applicants is due to the 1990 appropriations language which initiated this program and states that centers for agricultural occupational safety and health will be established at universities. Because of the programmatic and regional differences throughout agriculture in the U.S., Agricultural Centers will be established across the country to address this diversity, and geographic distribution of the Agricultural Centers will be an important factor in making awards. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH/CDC programs. Note: Title 2 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. SPECIAL REQUIREMENTS The essential characteristics of an Agricultural Center cooperative agreement are: Overall Characteristics o The Agricultural Center cooperative agreement will support a broadly based multi-disciplinary outreach, prevention/intervention, education, and research program. An Agricultural Center is expected to have the following components which together address the objectives of a Center: 1. Administrative and Planning Core. This component should not exceed 20% of the direct cost budget. 2. Prevention/Intervention Core. This component should be at least 20% of the direct cost budget. 3. Education and Outreach Core. This component should be at least 20% of the direct cost budget. 4. Multi-Disciplinary Research Core. This component should be at least 20% of the direct cost budget. o There must be a demonstrated commitment of the applicant's institution to support and encourage the Agricultural Center. Such support could be demonstrated by release time of faculty, capital improvements that will facilitate the program, and/or assistance in the acquisition of scientific equipment and supplies. o The Agricultural Center's program should be more than a collection of projects, but rather should include a process for the administrative integration and oversight of the projects. The projects should address agricultural issues in an integrated manner with well defined goals that contribute to the overall focus of the Center. Therefore, under the Heading "OVERALL DESCRIPTION", the principal investigator should clearly describe the theme of the Center, how projects address the Center's focus, and how the Center will function as an integrated program rather than simply a collection of projects. NON-ALLOWABLE COSTS FOR NIOSH/CDC AGRICULTURAL CENTER COOPERATIVE AGREEMENT The Agricultural Center funding mechanism should not be used as a substitute for individual research grant support. It is expected that investigators participating in Agricultural Centers will have a history of independent project support in addition to the Agricultural Center support. Generally, funds for renovation of existing facilities or to purchase substantial amounts of equipment will not be allowed. If such requests are made, they must be justified in terms of the critical nature of the equipment/renovations for the success of the overall objectives of the Agricultural Center cooperative agreement. ESSENTIAL ELEMENTS OF AN AGRICULTURAL CENTER ADMINISTRATIVE AND PLANNING CORE (SHOULD NOT EXCEED 20% OF THE ANNUAL DIRECT COST) The Administrative and Planning Core must have strong leaders committed to the program, who are capable of providing scientific leadership and willing to accept responsibility for the administration and integration of the program. Assessment of the ability of the program's principal investigator to lead a highly integrated program of collaborative prevention/intervention, education, outreach, and research projects will be a significant consideration in the evaluation of the application. The Administrative and Planning Core provides the administrative infrastructure for the entire program and should not be duplicated within any other components. The responsibilities and activities for the administrative and planning core include: o Appropriate and adequate organization and facilities for conducting intervention/prevention, education/outreach, training, and research activities such as seminars, workshops, reference collection, computer support, etc. The principal investigator should provide a minimum of 30% time commitment (direct and in-kind) and each member of the internal advisory committee (one prevention/intervention, education/outreach, and research project investigator) should provide a minimum of 5% time commitment for the Agricultural Center's administration and coordination. o Feasibility Projects. Support of feasibility projects in the prevention/intervention, education/outreach, and research project areas within the NIOSH/CDC Agricultural Center is considered fundamental to sustaining the quality, breadth, and dynamics of this program. These projects encourage exploration and development of new and creative prevention/intervention, education/outreach, and research approaches, and are considered an important and integral part of the support provided to the Agricultural Center. Therefore, funds should be designated to provide support for short-term projects (maximum duration of 12 months and $15,000) to explore the feasibility of new projects in any of the Center's program areas (prevention/intervention, education/outreach, and research). This will also enable investigators to collect sufficient data to pursue support through other funding mechanisms. Examples of feasibility projects may include but are not limited to: 1. Provide initial support to develop innovative approaches/lines of investigation in the program areas. 2. Allow exploration of possible innovative new directions representing a significant departure from ongoing funded projects in agricultural sciences (prevention/intervention, education/outreach, or basic research). 3. Stimulate investigators from other fields of study to apply their expertise to agricultural safety and health issues. 4. Develop new mechanisms for external or multi-Center collaborative partnerships to address emerging agricultural safety and health concerns. As a general rule, approximately 5% to 10% of the direct cost budget for each year should be allocated to the Feasibility Projects Program of a Center. While the administrative framework for management of the Center's Feasibility Projects Program is left to the Center Director's discretion, certain minimal requirements must be met. Management of the program must include provisions for: 1. A mechanism that ensures preparation and appropriate announcement of the availability of feasibility project funding. 2. A mechanism for merit review of feasibility project proposals. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the Center. These records must be available to reviewers in the event of a site visit. 3. A mechanism to maintain a record of subsequent results of each feasibility project study (abstract, RO1/R21 submission, etc.) recipient. This record must be available to reviewers in the event of a site visit for competing renewals. Input by both the Internal Advisory Committee and the External Advisory Committee into the management of the Feasibility Projects Program is strongly recommended. o The use of existing state and national databases is encouraged, however, a data center/statistical support activity may be included in the administrative core if needed for the Center. o An Internal Advisory Committee is comprised of one senior individual from each core area that will assist the principal investigator in making scientific and administrative decisions in the operation of the program. These individuals should commit 5% of their effort serving on this committee. o An External Advisory Committee, comprised of at least three members who are recognized leaders in agricultural health and safety and regional agricultural experts, will provide overall guidance and advice to the principal investigator and program investigators on program direction. If not already included in the Agricultural Center, one member should be from the Agriculture Extension community. PREVENTION/INTERVENTION CORE (Non-Research) (SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS) This section is predominantly for non-research projects in prevention and/or intervention. Projects related to prevention/intervention research should not be included here, but rather in the multi- disciplinary research projects section below. Applicants should provide model programs in prevention/intervention that address injury and illness among people who work on, live, or visit farms. Prevention projects may include but are not limited to actions taken to reduce susceptibility or exposure to health problems, to detect and treat disease in early stages, or to alleviate the effects of disease and injury. Intervention projects may include but are not limited to actions to prevent disease or injury through combinations of techniques such as control technologies, exposure guidelines and regulations, worker participation programs, and training. Projects should be designed to involve direct input from agricultural stakeholders in addressing national needs and in the implementation of relevant and culturally appropriate innovative strategies for meeting those needs. The development of strong partnerships with community organizations that can facilitate the identification of project needs and culturally appropriate education, prevention, and intervention activities is encouraged. These projects should include the active participation of target populations identified at the state and national level, and include a monitoring component to determine the success of these techniques and programs. Partnerships and collaborative relationships are encouraged among the Agricultural Center and NIOSH/CDC intramural programs, other extramural partners including NIOSH/CDC Education and Research Centers (ERCs), Training Grant (TG) recipients, and other NIOSH/CDC funded agricultural programs. A central role of the Agricultural Centers is to provide leadership in the evaluation of agricultural injury and disease programs implemented by agricultural extension programs, State health departments, Federal agencies and others. Projects that address this priority area are particularly encouraged. The project should specifically identify: o The population of interest and relevant health and safety needs; o Mechanisms for establishing communication and active partnerships with local organizations, health care providers, educators, and community leaders; o Appropriate community-driven projects and approaches to inform the community of potential risk factors; and o Describe the project approach and time frame to monitor the success of these prevention/intervention approaches in mitigating agriculture- related injury and disease. EDUCATION AND OUTREACH CORE (Non-Research) (SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS) This section is predominantly for non-research projects in education and/or outreach. Projects related to education/outreach research should not be included here, but rather in the multi-disciplinary research projects section below. Applicants should include well developed education and outreach projects to target the key agricultural health and safety needs in the Agricultural Center region. These programs should be model educational and outreach projects on safety and health for workers in agriculture. This core should include educational projects and a monitoring component to determine the success of this program as a public education approach to protect people who live, work on, or visit farms. The translation of promising prevention or intervention findings into applied safety programs or demonstration programs through community services is a key role of the outreach core. This would include providing consultation and/or training to health and safety professionals, researchers, graduate/professional students, and agricultural extension agents and others in a position to improve the safety and health of people who work on farms. Essential functions of the outreach core include but are not limited to, coordinating and collaborating with established ongoing health communication efforts and convening consensus-development sessions to address complex and/or controversial issues with the aim of preventing agricultural injuries and illness. Projects should involve regional agricultural stakeholders in addressing educational needs and in the implementation of innovative approaches for meeting those needs. Partnerships and collaborative relationships are encouraged between Agricultural Centers and NIOSH/CDC intramural programs and other extramural partners including NIOSH/CDC Education and Research Centers (ERCs), Training Grant (TG) recipients, and other NIOSH/CDC funded agricultural programs. In addition, when possible, collaborations with Agriculture Extension Services are encouraged. MULTI-DISCIPLINARY RESEARCH CORE (SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS) Two types of projects, pilot(2 years) and integral (up to 3 years)research projects, will be supported as part of the Agricultural Center's program, and both types are encouraged. Each project (pilot and integral research) should be an important component of the Center's program. These projects can be in any of the program areas, outreach, prevention, intervention, education, or exploratory, but for this core, must be research in nature. Non-research projects in these areas should be included in the relevant non-research core. To be funded, an Agricultural Center must have one pilot project and one integral research project that are judged to have significant and substantial scientific merit. Collaborative research is encouraged between Agricultural Centers and the NIOSH/CDC intramural program. Pilot research projects are intended to provide Agricultural Center investigators an opportunity to obtain the preliminary research data needed to help direct and maintain ongoing prevention/intervention education, and research programs and for the submission of a NIOSH/CDC, NIH, EPA, or other peer-reviewed Research Project Grant application. The maximum project period for a pilot project is 2 years. Follow the instructions for a NIOSH/CDC Exploratory/Developmental (R21)grant (see NIH guide: http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html), for additional information on R21 applications. Integral research projects should be consistent with R01 projects that are typically awarded by NIOSH/CDC and NIH. The project period for this type of project is usually five years but may be less. These projects will follow the submission guidelines for a R01 application according to the PHS 398 application instructions. See NIH guide: http://grants.nih.gov/grants/guide/pa-files/PA-99-143.html, for additional information on R01 applications. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. Direct your questions about scientific/research issues to: Adele Childress, Ph.D., MSPH Scientific Program Administrator Office of Extramural Programs National Institute for Occupational Safety and Health/CDC 1600 Clifton Road, N.E. Building 24, Room 1427, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2509 FAX: (404) 498-2517 Email: achildress@cdc.gov Direct your questions about agricultural program issues to: Stephen Olenchock, Ph.D. Agriculture Coordinator National Institute for Occupational Safety and Health/CDC 1095 Willowdale Road, P04/1119 Morgantown, WV 26505-2888 Telephone: (304) 285-6271 FAX: (304) 285-6075 Email: solenchock@cdc.gov Direct your questions about peer review issues to: Cattledge, Gwen, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health/CDC Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 24, Room 1423, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2508 Fax: (404) 498-2571 Email: gcattledge@cdc.gov Direct your questions about financial or grants management matters to: Larry Guess Acting Chief Acquisition and Assistance Field Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Announcement Number OH-03-002 Telephone: (412) 386-6826 Email: lguess@cdc.gov PRE-APPLICATION CONFERENCE CALL Applicants are invited by NIOSH/CDC to participate in a pre-application technical assistance telephone conference call on May 7, 2003 at 1:OO PM (Eastern time) to discuss: programmatic issues regarding this program, how to apply, and questions regarding the content of the RFA. The conference name is "Agriculture" Centers program. The telephone bridge number is 404-639-3277 [(800-311-3437), for Non-Federal Participants]. Interested parties will need the conference code (457136) to participate. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed program o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of an application, the information that it contains allows NIOSH staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Cattledge, Gwen, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health/CDC Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 24, Room 1423, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2508 Fax: (404) 498-2571 Email: gcattledge@cdc.gov SUBMITTING AN APPLICATION Although not a prerequisite for applying, applicants are encouraged to consult with NIOSH/CDC program staff concerning the technical and other aspects of preparing the application. Applicants should contact NIOSH/CDC program staff by phone early in the preparation process. However, applicants should understand that advice given by staff is independent from the review process. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Information to prepare a detailed budget is provided in the instructions. 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. SUPPLEMENTAL INSTRUCTIONS Applications may contain both non-research and research projects in either one or several of the Center's program areas (prevention, intervention, outreach, education). Non Research Projects Each project section should begin with a cover sheet that identifies it as the beginning of the project section (outreach, prevention, intervention, and/or education), and the name of a project investigator who will be a member of the internal advisory committee should be listed. This page is then followed by as many subsections as there are projects under that area. Each subsection begins with a header page that identifies the project investigator and title of the project. The next page is the form page 2 of the PHS 398 which provides the description, performance sites, and key personnel. For further instructions, refer to the TABLE OF CONTENTS FOR THE "CENTERS FOR AGRICULTURAL DISEASE AND INJURY RESEARCH, EDUCATION, AND PREVENTION", provided below. PHS 398 form page 3 contains the section entitled "Research Plan" and although these projects are not research, this section can be used to describe the specific aims, background and significance, preliminary information or data, the project design and methods, for each non- research project (outreach, prevention, intervention, or education). This section should contain sufficient information to address the projects goals and plan to achieve those goals, it should answer the following questions; 1)What do you intend to do?, 2)Why is the work important?, 3)What has already been done?, and 4)How are you going to do the work? This section should not exceed 25 pages for items d-g for outreach, prevention, intervention, and education project plans Research Projects All research projects (outreach, prevention, intervention, and/or education), integral or pilot, should be consistent with the competitive/peer-reviewed funding applications that are typically awarded by NIOSH/CDC and NIH and adhere to the submission guidelines for a R01/R21 application following the PHS 398 application instructions. The R01 is a competitive, standard applied or basic research project funding mechanism and the R21 is an exploratory/developmental funding mechanism which provides small short- term awards used to explore the feasibility of an innovative basic or applied research question or approach. Each project section should begin with a cover sheet that identifies it as the beginning of the project section (pilot or integral research), and the name of a project investigator who will be a member of the internal advisory committee should be listed. This page is then followed by as many subsections as there are research projects under that area. Each subsection begins with a header page that identifies the project investigator and title of the project. The next page is the form page 2 of the PHS 398 which provides the description, performance sites, and key personnel. For further instructions refer to the, Table of Contents for an Agricultural Center Application, provided below. PHS 398 form page 3 contains the section entitled "Research Plan" and can be used to describe the specific aims, background and significance, preliminary data, the research project design and methods, for each research project (outreach, prevention, intervention, or education). For the integral (R01-type) research projects, the application should not exceed 25 pages for items d - g for outreach, prevention, intervention, or education project plans(see the, Table of Contents for an Agricultural Center Application). For pilot research (R21-type) projects, follow the instructions for a NIOSH/CDC Exploratory/Developmental grant (R21), see NIH guide: http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html for additional information on R21 applications. A 15 page maximum for items d - g should be followed. Refer to the, Table of Contents for an Agricultural Center Application, provided below. The budget information, other support, etc. should be included in the appropriate sections of the application. NOTE: NIOSH/CDC will inform successful applicants of the procedures for adding prevention/intervention, education, pilot, or research projects in future years of support. Thus, the application should contain only projects for which funds are requested for support during year one. TABLE OF CONTENTS FOR AN AGRICULTURAL CENTER APPLICATION In order to facilitate the preparation and review of the Agricultural Center application, the following Table of Contents should be used. It is a minor modification of the PHS 398 Table of Contents which should be followed as a guide. o Face Page o Agricultural Center Description, Performance Sites, and Personnel, Form page 2(use additional continuation pages as needed) o Table of Contents o Detailed Budget for the Initial Budget Period for the entire Agricultural Center o Budget for the Entire Proposed Period of Support for the Entire Agricultural Center o Detailed Budget for each Project for the Initial Budget Period Organized by Cores (prevention/intervention, educational/outreach, research), o Budget for the Entire Proposed Period for each Project Organized by Cores o Biographical Sketch-Principal Investigator/Program Director o Other Biographical Sketches o Other Support o Overall Description of the Agricultural Center (2 page maximum) o Past Performance/Accomplishments in Last Project Period (existing Agricultural Center) o Past Performance/Accomplishments Relevant to Agricultural Center goals (new applicants) o Statement on the Institutional Commitment to the Agricultural Center (1 page maximum) o Identification of the States that will be involved with the project o Administrative and Planning Core Cover Sheet o Administrative and Planning Core o Prevention/Intervention Core Cover Sheet o Prevention/Intervention Project Plan A (use as many headings as there are projects) o Education and Outreach Core Cover Sheet o Education and Outreach Project Plan A (use as many headings as there are projects) o Research Core Cover Sheet o Pilot Project Plan A (use as many headings as there are projects) o Research Project Plan A (use as many headings as there are projects) Note: each project plan should use the following outline a. Header Page with Title and Principal Investigator's name b. Description, Performance Sites, and Personnel (form page 2) c. Highlights of Accomplishments for Past Project Period if it was part of an existing Agricultural Center (1 page maximum) d. Specific Aims e. Background and Significance f. Preliminary Studies/Progress Report g. Project Design and Methods Items d-g cannot exceed 25 pages (except pilot projects, which cannot exceed 15 pages) h. Human Subjects i. Vertebrate Animals j. Literature Cited k. Consortium/Contractual Arrangements l. Consultants and Collaborators, including NIOSH/CDC Note: Type density and size of the entire application must conform to the limits provided on page 3 in the PHS 398 instructions. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review (CSR) 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: Cattledge, Gwen, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health/CDC Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 24, Room 1423, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2508 Fax: (404) 498-2571 Email: gcattledge@cdc.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to this RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH/CDC. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for merit by a review group convened by NIOSH/CDC in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applicants deemed to have the highest merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level of review by the NIOSH/CDC Secondary Review Committee. REVIEW CRITERIA The primary consideration for a Center cooperative agreement application is the ability of the Center's program to bring together quality prevention/intervention, education, outreach, and research activities into an interactive, multi-disciplinary operation addressing agricultural issues in the region. SITE VISITS A site visit to the applicant institutions may be made (but such site visits are not assured) to evaluate the overall merit of the application. The site visit team includes members of the SEP who have expertise in major research areas, facilities, and outreach activities of the proposed Center, the NIOSH/CDC Scientific Review Administrator, and NIOSH/CDC staff observer(s). A site visit is not a prerequisite and is not assured for consideration of an application by NIOSH/CDC. Therefore, the application is considered a complete document for review purposes. Furthermore, the applicant should not use the site visit as an occasion for adding core units, research projects, or investigators, for making major changes, or for delivering another exposition of the application. Rather, it should be used by the principal investigator and associates to elaborate on the research program and core units, cost effectiveness and quality control features of the core units, and on other Center activities for which funding is requested, as well as to answer reviewers' questions. The site visit team will not consider any component core unit that is presented for evaluation at the site visit which has not been included in the application. Budgetary changes also will not be considered at the time of a site visit. The findings of the site visit team are reported and discussed by the members of the SEP, which makes the final peer review recommendations and assigns the priority score. General Review Criteria The criteria that NIOSH/CDC will use to review applications for merit and for meeting program objectives are provided below. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed project (non-research or research) will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have a major impact and thus deserve a high priority score. For example you may propose to carry out important work that by its nature is not innovative but essential to move a field forward. Review Criteria for the Overall Program Are: o Responsiveness to the objectives of the cooperative agreement program, including the applicant's understanding of the objectives of the proposed cooperative agreement and the relevance of the proposal to the objectives. o Feasibility of meeting the proposed goals of the cooperative agreement program including the proposed schedule for initiating and accomplishing each of the activities of the cooperative agreement and the proposed method for evaluating the accomplishments. o Degree to which the program designs addresses the distinct characteristics, specific populations, and needs in agricultural research and education for the region. o Qualifications of core investigators and the physical and intellectual environment of the group as a national resource for agricultural occupational health research and training. o Multidisciplinary scope of the program. o Degree of interrelationships, collaboration, and synergism of research that might be expected to derive from Center support. o Leadership ability and scientific stature of the Center Director and his/her ability to meet the program's demands of time and effort. o Provisions for coordinating project cores. The Center must have appropriate administrative arrangements and facilities that stimulate collaboration among constituent projects and personnel. o Effectiveness of the Center in establishing or continuing a Community Education and Outreach Program that makes maximal use of the Center's strengths in educating the public and surrounding community with regard to reducing agricultural injuries and/or hazard exposure. o Institutional commitment to the Center. Review Criteria for Prevention/Intervention Core (predominantly Non- Research) Projects Are: o SIGNIFICANCE: Merit and significance of the proposed project as determined by such factors as content, originality, feasibility, potential long-term success, transportability, and appropriateness for regional populations served by the Center. o APPROACH: Demonstration within the proposed project plan of current knowledge of intervention practices and effectiveness. Does the applicant acknowledge potential problem areas and consider alternative approaches? Development of activities, plans, and including a monitoring component to determine the success of these programs. Plans for the distribution of results and products. 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? The project does not have to be innovative but can use established methods to have a major impact and thus deserve a high priority score. o INVESTIGATOR: Qualifications and experience of the principal investigator and staff, particularly but not exclusively in areas relevant to the NIOSH/CDC's mission of an Agricultural Center. Individuals with strong subject matter skills are expected to play key roles. Personnel should demonstrate knowledge of the needs of their target audience. o ENVIRONMENT: Availability of resources necessary to perform project objectives. Strength of commitment by the participating institution(s) as evidenced by provisions of appropriate resources, services, and technical support. Review Criteria for Education and Outreach Core (predominantly Non- Research) Projects Are: o SIGNIFICANCE: Merit and significance of the proposed project as determined by such factors as content, originality, feasibility, potential long-term success, transportability, and appropriateness for regional populations served by the Center. o APPROACH: Demonstration within the proposed project plan of current knowledge of education practices, outcomes, and standards, specifically those related to learning, attitudes, motivation, and educational approaches. Development of activities, plans, and including a monitoring component to determine the success of these programs. Plans for the distribution of results and products within the community and educational settings. 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? The project does not have to be innovative but can use established methods to have a major impact and thus deserve a high priority score. o INVESTIGATOR: Qualifications and education experience of the principal investigator and staff, particularly but not exclusively in areas relevant to the mission of NIOSH/CDC Agricultural Center. Individuals with strong subject matter skills are expected to play key roles. Personnel should demonstrate knowledge of the needs of their target audience in educational and outreach settings. o ENVIRONMENT: Availability of resources necessary to perform project objectives. Strength of commitment by the participating institution(s) as evidenced by provision of appropriate resources, services, technical support. Review Criteria for Research Core Projects Are: o SIGNIFICANCE: Does this project 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 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? The project does not have to be innovative but can use established methods to have a major impact and thus deserve a high priority score. 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 stakeholders in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? ADDITIONAL REVIEW CRITERIA FOR ALL PROJECTS (Non-Research and Research): In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o PROTECTIONS OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). o INCLUSIONS OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subject from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). o CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001 will be assessed). ADDITIONAL CONSIDERATIONS o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. PROGRAMMATIC REVIEW CRITERIA: o Magnitude and severity of the occupational health or safety problems addressed in the proposal for the agricultural workplace and among agricultural populations in the region. o Likelihood of developing knowledge (in the areas of science, education, prevention, intervention, or outreach) for the prevention of agricultural occupational safety and health hazards on a National or regional basis (multi-state). o Appropriateness of the proposed budget and duration in relation to proposed objectives. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 20, 2003 Application Receipt Date: June 12, 2003 Anticipated Award Date: September 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Program merit o Availability of funds o Programmatic priorities o Balance of program areas and geographic balance (including multi- state involvement). TERMS AND CONDITIONS OF AWARD The Terms and Conditions of Award, below, will be incorporated in all awards issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. These special terms of award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and PHS Grants Policy Statement. Under the cooperative agreement, the NIOSH/CDC purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIOSH/CDC collaborators where appropriate, including the following: 1. Recipient Responsibilities The recipient will coordinate project activities, scientifically and administratively at the awardee institution and at the other sites that may be supported by sub-contractors to this award. The applicant will have primary authority and responsibility to define objectives and approaches; to plan, conduct, and analyze data; and to publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. Recipient will: o Serve as a center for consultation and/or training for agricultural safety and health professionals. o Provide assistance and direction to community-based groups in the area for the development and implementation of community projects including intervention research and prevention demonstration projects for preventing work-related injuries and illness among farm workers and their families. o Develop, implement, and evaluate model educational, outreach, and intervention programs promoting health and safety for the targeted populations. o Develop, implement, and evaluate model programs including control technologies for the prevention of illness and injury among agricultural workers and their families. o Develop a research protocol(s) for agricultural disease and injury research, education, and prevention which would include collaboration with regional stakeholders as appropriate. o Collaborate with other NIOSH/CDC Agricultural Centers, to develop and utilize a uniform evaluation scheme for Agricultural Center research, education/training, and outreach/intervention activities. o Develop linkages and communication with other governmental and non- governmental bodies involved in agricultural health and safety. o Develop and conduct research related to the prevention of occupational disease and injury of agricultural workers and their families, with an emphasis on multi-disciplinary research and the development and evaluation of control technologies. o Disseminate research results and relevant health and safety education and training information. o Establish an external advisory committee including expertise from agricultural experts in the region and the nation to guide the Agricultural Center and Center projects/activities. 2. NIOSH/CDC Responsibilities o Provide technical assistance through site visits and correspondence in the areas of program development, implementation, maintenance, and priority setting related to the cooperative agreement. o Provide scientific collaboration where needed. o Assist in the reporting and dissemination of research results and relevant health and safety education and training information to appropriate Federal, State, local agencies, health-care providers, the scientific community, agricultural workers and their families, management and union representatives, and other NIOSH/CDC Centers for agricultural disease and injury research, education, and prevention. o Assist in the development of human subjects protocols for the CDC Institutional Review Board (if required) and in the preparation of OMB (and other) clearances that may be required during the conduct of the study. 3. Collaborative Responsibilities Part of this initiative will be the establishment of a Coordinating Committee (CC) that will facilitate sharing of information about activities and accomplishments among the Centers. This CC will also provide leadership and work collaboratively to address occupational safety and health issues at a national level such as combined Center efforts to reduce tractor-related injury and fatality. The CC will be comprised of the principle investigators from the Centers. NIOSH/CDC representatives will participate in CC meetings where appropriate but will not have voting privileges. The CC may designate working groups for specific purposes, made up of staff members from their Centers. One such working group would be an Agricultural Centers Methods Committee. This multi-site committee will provide a means to standardize the collection of evaluation materials/information across Agricultural Centers. It will also provide a means to collect information necessary to help address accomplishments on the NIOSH/CDC Agricultural Initiative. Information and materials may be collected at one repository location for common use by all the Centers. If there are added costs associated with creating and maintaining this repository, NIOSH/CDC may determine that a contract or other mechanism could be used to fund it. It is anticipated that critical issues for understanding and protecting agricultural workers from job risks will be better defined through the deliberations of the CC. The CC will combine the expertise and resources of the Centers with those of NIOSH/CDC to achieve a more integrated and effective program in agricultural health and safety. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the CDC that women and members of minority groups and their sub-populations must be included in all CDC-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research, - amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html) a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of CDC staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.html HUMAN SUBJECT REGUIREMENTS: 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 are strongly recommended to 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 can 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 The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-00-039.html. This policy will be followed by NIOSH for this announcement. 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 PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-025.html. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIOSH funding must be self-contained within specified page limitations. Unless otherwise specified in a NIOSH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 Centers 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. 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." HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301(a) [42 U.S.C. 241(a)], the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)] [number: 93.956, Agricultural Health and Safety Program of the National Institute for Occupational Safety and Health (NIOSH)], and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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