and Human Services (HHS)
EXPIRED
CENTERS FOR AGRICULTURAL DISEASE AND INJURY RESEARCH, EDUCATION AND PREVENTION Release Date: January 29, 2001 RFA: RFA-OH-01-004 National Institute for Occupational Health and Safety Letter of Intent Receipt Date: February 16, 2001 Application Receipt Date: March 28, 2001 PURPOSE National Institute for Occupational Health and Safety (NIOSH), Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2001 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 (Ag Centers). The purposes of the Ag Centers are to conduct research, education, and prevention/intervention programs that address agricultural safety and health problems in the geographic region served (multi-state), as well as nationally. The mission of NIOSH 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 to lead a national effort in surveillance, research, and intervention. This program has had a "significant and measurable impact" on reducing adverse health effects among agricultural workers. As part of this program, nine Ag Centers were established nationally. These Ag Centers conduct research, education, and prevention projects to address the nation=s pressing agricultural safety and health problems. Geographically, the Ag 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 Ag Centers help to ensure that actions to prevent disease and injury in agriculture are taken based upon scientific findings. Additional information on NIOSH Agricultural Health and Safety activities can be found on the NIOSH web site at http://www.cdc.gov/niosh/agtopics.html. HEALTHY PEOPLE 2010 CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area of Occupational Safety and Health. For a copy of "Healthy People 2010" (Full Report: Stock No. 017-001-00547-9), write or call: Superintendent of Documents, Government Printing Office, Washington D.C. 20402-9325, telephone (202) 512-1800 or visit the internet site: http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Eligible applicants include State and private universities and university- affiliated, not-for-profit and for-profit medical centers within the United States (U.S.). Applications from minority and women investigators are encouraged. The restriction of eligible applicants is due to the FY 1990 appropriations language which initiated this program and states that centers for agricultural occupational safety and health will be established at universities. Because of programmatic and regional differences throughout agriculture in the U.S., Ag Centers will be established across the country to address this diversity, and geographic distribution of the Ag Centers will be an important factor in making awards. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U50), an "assistance" mechanism, in which substantial NIOSH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIOSH 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. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for an application submitted in response to this present RFA may not exceed five (5) years. The anticipated award date is September 1, 2001. The award and level of support depends on receipt of applications of high scientific merit. AVAILABILITY OF FUNDS Approximately $7,500,000 is available in FY 2001 to fund 7 to 9 awards. The maximum amount that may be requested is $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 that are of high scientific quality as judged by a peer-review merit evaluation and the actual 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 Ag 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 Ag 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. PREAPPLICATION CONFERENCE CALL Applicants are invited by NIOSH to participate in a preapplication technical assistance telephone conference call on February 12, 2001 at 1:00 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 1-800-311-3437. Interested parties will need the conference code (199814) to participate. RESEARCH 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 Ag 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 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. During 1993, approximately 201,000 work-related, lost-time injuries occurred on U. S. farms, nearly 10 injuries for every 100 farms. 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, power lines, manure pits, and livestock are among the many injury hazards workers are exposed to in the 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 research, education, and prevention 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 research, education, and prevention. Project Goals Note, for this RFA the term "projects" is defined as research, education or intervention/prevention 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 Ag 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 Ag Centers should be on addressing priority, regional (multi-state) occupational health and safety problems using a multi- disciplinary approach. Emphasis should also be given to populations not well represented in the current research 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. To guide NIOSH, a National Occupational Research Agenda (NORA) was created in 1996. 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.html. 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 Ag Center, applicants are encouraged to consult with regional (multi-state) stakeholders (e.g. agricultural organizations, advisory groups, workers, and other interested parties). Ag Centers should include the development, implementation and evaluation of model education, outreach, and intervention programs promoting 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, as appropriate, to reach the target agricultural populations within the Ag Center Districts. Emphasis should be given to reaching underserved agricultural populations such as hired farm laborers, migrant/seasonal workers, women and children. Ag 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. Ag Centers should include plans to develop linkages and communication with other governmental and non-governmental bodies involved in agricultural health and safety, with special emphasis on communications and collaborations with other CDC/NIOSH-sponsored agricultural health and safety programs. 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.html). The NIOSH 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 Agricultural Coordinator (name and contact information in the Inquiries Section). ESSENTIAL CHARACTERISTICS OF AN AGRICULTURAL CENTER COOPERATIVE AGREEMENT Overall Characteristics o The Ag Center cooperative agreement will support a broadly based multi- disciplinary research, education and prevention program. An Ag Center is expected to have the following components which together address the objectives of a center: 1. An Administrative and Planning Core. This component should not exceed 15% of the direct cost budget. 2. A Multi-Disciplinary Research Core. This component should be at least 40% of the direct cost budget. 3. An Education and Outreach Core. This component should be at least 10% of the direct cost budget. 4. A Prevention/Intervention Core. This component should be at least 10% of the direct cost budget. o There must be a demonstrated commitment of the applicant institution to the support and encouragement of the Ag Center. Such support could be demonstrated by release time of faculty, capital improvements that will facilitate the research, and/or assistance in the acquisition of scientific equipment and supplies. NON-ALLOWABLE COSTS FOR NIOSH AGRICULTURAL CENTER COOPERATIVE AGREEMENT The Ag Center mechanism should not be used as a substitute for individual research grant support. It is expected that investigators participating in Ag Centers will have a history of independent project support in addition to the Ag 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 Ag Center Cooperative agreement. ESSENTIAL ELEMENTS OF AN AGRICULTURAL CENTER ADMINISTRATIVE AND PLANNING CORE (SHOULD NOT EXCEED 15% OF THE ANNUAL DIRECT COST) The Administrative and Planning Core must have strong leaders committed to the project, who are capable of providing scientific leadership and who are willing to accept responsibility for the administration and integration of the program. Assessment of the ability of the program principal investigator to lead a tightly integrated program of collaborative research, education and prevention 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 the conduct of the research, education, training and intervention/prevention activities such as seminars, workshops, reference collection, computer support, etc. o An Internal Advisory Committee formed of the individual Center Core leaders that will assist the principal investigator in making scientific and administrative decisions in the operation of the program. o An External Advisory Committee comprised of at least three members who are recognized as leaders in agricultural health and safety and regional agricultural experts that will provide overall guidance and advice to the principal investigator and program investigators on program direction. MULTI-DISCIPLINARY RESEARCH CORE (SHOULD BE AT LEAST 40% OF THE ANNUAL DIRECT COSTS) Two types of projects (Pilot and Research) will be supported as part of the Ag Centers program, and both types must be present. It is important that each project (Pilot and Research) be of sufficient scientific merit to warrant independent support and that each project is an integral part of the Ag Center. To be funded, an Ag Center must have at least one Pilot project and two Research projects that are judged to have significant and substantial scientific merit on their own. Collaborative research is encouraged between Ag Centers and with the NIOSH intramural program. Research projects should be consistent with the R01-type projects that are typically awarded by NIOSH and NIH. The project period for a Research project is usually five years but may be less. These projects will adhere to the submission guidelines for a R01 application following the PHS 398 application instructions. Each research project should begin with a cover sheet that identifies the principal investigator, the title, and type of research project (pilot or R01). The next page is the form page BB of the 398 which provides the description, performance sites, and key personnel. The next pages are for the Research Plan which cannot exceed 25 pages for items d - g (see table of contents for an Ag Center Application section). The budget information, other support, etc. should be included in the appropriate sections of the application. Pilot projects are intended to provide Ag Center investigators an opportunity to obtain the preliminary research data needed to help direct and maintain ongoing research, education, and prevention/intervention programs and for the submission of a CDC, NIH, EPA, or other peer-reviewed Research Project Grant applications. The maximum project period for a Pilot project is 24 months. Each pilot research project should begin with a cover sheet that identifies the principal investigator, the title, and type of research project (Pilot). The next page is the form page BB of the 398 which provides the description, performance sites, and key personnel. The next pages are for the Research Plan. Follow the instructions for a NIOSH 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), and cannot exceed 15 pages for items d - g (see table of contents for an Ag Center Application section). The budget information, other support, etc. should be included in the appropriate sections of the application. NOTE: NIOSH will inform successful applicants of the procedures for adding Pilot, Research, Education/Outreach, or Prevention/Intervention projects in future years of support. Thus, the application should contain only projects for which funds are requested. EDUCATION AND OUTREACH CORE Applicants should include a well developed Education and Outreach Core to target the key agricultural health and safety needs in the Ag Center District. Projects should involve regional agricultural stakeholders in addressing educational needs and in the implementation of innovative strategies for meeting those needs. Partnerships and collaborative relationships are encouraged between Ag Centers and NIOSH intramural programs and other extramural partners including NIOSH Education and Research Centers (ERCs), Training Grant (TG) recipients, and other NIOSH funded agricultural programs. The Education and Outreach Core should begin with a cover sheet that identifies it as the beginning of the Core, and list the name of the Core leader. This page is then followed by as many subsections as there are education projects. Each subsection begins with a header page that identifies the project leader and title of the project. The next page is the form page BB of the 398 which provides the description, performance sites, and key personnel. The rest of the project description should follow the framework for the research projects which is described above. PREVENTION/INTERVENTION CORE. Applicants should include model programs, including intervention/intervention effectiveness research programs, for the prevention of illness and injury among agricultural workers and their families in the region. Programs should be designed to involve regional agricultural stakeholders in addressing regional needs and in the implementation of innovative strategies for meeting those needs. These programs should include the active participation of the involved target populations, and include an evaluation component. Partnerships and collaborative relationships are encouraged between Ag Centers and NIOSH intramural programs and other extramural partners, including NIOSH Education and Research Centers (ERCs), Training Grant (TG) recipients, and other NIOSH funded agricultural programs. The Prevention/Intervention Core should begin with a cover sheet that identifies it as the Prevention/Intervention Core, and list the name of the Core leader. This page is then followed by as many subsections as there are education projects. Each subsection begins with a header page that identifies the project leader and title of the project. The next page is the form page BB of the 398 which provides the description, performance sites, and key personnel. The rest of the project description should follow the framework for the research projects which is described above. TABLE OF CONTENTS FOR AN AG CENTER APPLICATION In order to facilitate the preparation and review of the Ag Center application, the following Table of Contents should be used. It is a minor modification of the 398 table of contents which should be followed as a guide. Face Page Ag Center Description, Performance Sites, and Personnel, Form page BB (use additional continuation pages as needed) Table of Contents Detailed Budget for the Initial Budget Period for the entire Ag Center Budget for the Entire Proposed Period of Support for the Entire Ag Center Detailed Budget for each Project for the Initial Budget Period Organized by Cores Budget for the Entire Proposed Period for each Project Organized by Cores Biographical Sketch- Principal Investigator/Program Director Other Biographical Sketches Other Support Overall Description of the Ag Center (2 page maximum) Past Performance/Accomplishments in Last Project Period (existing Ag Center) Past Performance/Accomplishments Relevant to Ag Center goals (new applicants) Statement on the Institutional Commitment to the Ag Center (1 page maximum) Identification of the States that will be involved with the project Research Project Core Cover Sheet Research Project Plan A Research Project Plan B (use as many headings as there are projects) Pilot Project Plan Education and Outreach Project Core Cover Sheet Education and Outreach Project Plans Prevention/Intervention Project Core Cover Sheet Prevention/Intervention Project Plans 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 BB) c. Highlights of Accomplishments for Past Project Period if it was part of an Existing Ag Center (1 page maximum) d. Specific Aims e. Background and Significance f. Preliminary Studies/Progress Report g. Research 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/Contractural Arrangements l. Consultants and Collaborators, including NIOSH Note: Type density and size of the entire application must conform to the limits provided in the 398 instructions on page 6. 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 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 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 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 Develop a research protocol(s) for agricultural disease and injury research, education, and prevention which would include collaboration with regional stakeholders as appropriate. 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 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 Serve as a center for consultation and/or training for agricultural safety and health professionals. o Develop linkages and communication with other governmental and non- governmental bodies involved in agricultural health and safety. o Disseminate research results and relevant health and safety education and training information. o Collaborate with other CDC/NIOSH Ag Centers, to develop and utilize a uniform evaluation scheme for Agricultural Center research, education/training, and outreach/intervention activities. o Establish an external advisory committee including expertise from agricultural experts in the region and the nation to guide the Ag Center and Center projects/activities. 2. NIOSH 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 CDC/NIOSH 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 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 Ag Centers Methods Committee. This multisite committee will provide a means to standardize the collection of evaluation materials/information across Ag Centers. It will also provide a means to collect information necessary to help address accomplishments on the NIOSH Agricultural Initiative. Information and materials may be collected at one repository location for common use by all Centers. If there are added costs associated with creating and maintaining this repository, NIOSH 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 to achieve a more integrated and effective program in agricultural health and safety. 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, August 2, 2000. It is also available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html. ANIMAL SUBJECTS REQUIREMENTS If the proposed project involves research on animal subjects, compliance with the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions" is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the Centers for Disease Control and Prevention (CDC) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES All applications 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by February 16, 2001, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NIOSH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Price Connor, Ph.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-30 Atlanta, GA 30333 Telephone 404-639-2376 Fax 404-639-0035 Email: spc3@cdc.gov APPLICATION PROCEDURES Although not a prerequisite for applying, applicants are encouraged to consult with NIOSH staff concerning the technical and substantive aspects of preparing the application. Applicants should contact NIOSH staff by phone early in the preparation process. However, applicants should understand that advice given by staff is independent from the review process. Applicants must use Form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: grantsinfo@nih.gov. Application kits are also available at: http://grants.nih.gov/grants/forms.htm. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed 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: Price Connor, Ph.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-30 Atlanta, GA 30333 Applications must be received by March 28, 2001. If an application is received after that date, it will be returned to the applicant without review. CSR and NIOSH will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. CSR and NIOSH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive, will undergo scientific merit review in accordance with the criteria stated below for scientific merit by an appropriate peer review group convened by NIOSH. 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. For these top applications, site visits may be included in the review process if it is deemed necessary in making the evaluation of scientific merit. Following the scientific merit review, applications will then be reviewed by NIOSH according to the programmatic review criteria below. Note: Type density and size of the entire application must conform to the limits provided in the 398 instructions on page 6. Applications which do not conform to these limits may be returned without review and consideration for this RFA. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the objectives of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the importance and timeliness of the proposed research, education and intervention studies, access to the agriculture population, and the interdisciplinary nature of the studies, will be part of the evaluation criteria. Following the scientific review, competitive applications will be reviewed for programmatic importance by a NIOSH Secondary Review Committee. REVIEW PROCEDURES SITE VISITS A site visit to the applicant institutions with the highest scientific merit 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 Scientific Review Administrator, and NIOSH staff observer(s). A site visit is not a prerequisite and is not assured, however, for consideration of an application by NIOSH. 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. REVIEW FACTORS The primary consideration for a Center cooperative agreement application is the ability of the Center program to bring together quality research, education and prevention activities into an interactive, multi-disciplinary operation addressing agricultural issues in the region. Quality scientific research is a prerequisite for the application, and without it, the application will fail. 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 design addresses the distinct characteristics, specific populations, and needs in agricultural research and education for the region. o Qualifications of core scientists 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 Research Core Projects are: o Significance - Does this project address an important problem related to the topical research issues outlined in this solicitation? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach - Are the conceptual framework, design (including composition of study population), methods, and analyses adequately developed, well-integrated and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation - Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator - Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers, if any? o Environment - Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there documentation of cooperation from stakeholders in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? Review Criteria for Education and Outreach Core Projects are: o Merit and significance of the proposed project as determined by such factors as content, originality, feasibility, potential long-term impact, transportability, and appropriateness for regional populations served by the Center. o Demonstration within the proposed project plan of current knowledge of education practices, outcomes, and standards, specifically those related to learning, attitudes, motivation, and educational strategies. o Qualifications and education experience of the principal investigator and staff, particularly but not exclusively in areas relevant to the mission of NIOSH Ag 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 settings. o Availability of resources necessary to perform project objectives. o Strength of commitment by the participating institution(s) as evidenced by provision of appropriate resources, services, technical support. o Appropriateness of the proposed budget and duration in relation to proposed objectives. o Plans for evaluation of factors contributing to the project"s effectiveness. o Plans for distribution of results and products in the educational arena. Review Criteria for Prevention/Intervention Core Projects are: o Merit and significance of the proposed project as determined by such factors as content, originality, feasibility, potential long-term impact, transportability, and appropriateness for regional populations served by the Center. o Demonstration within the proposed project plan of current knowledge of intervention practices and effectiveness. Does the applicant acknowledge potential problem areas and consider alternative tactics? o Qualifications and experience of the principal investigator and staff, particularly but not exclusively in areas relevant to the mission of NIOSH Ag 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 Availability of resources necessary to perform project objectives. o Appropriateness of the proposed budget and duration in relation to proposed objectives. o Plans for evaluation of factors contributing to the project"s effectiveness. o Plans for distribution of results and products. Other Review Criteria for all Projects The scientific review group will also examine the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. 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 technical knowledge for the prevention of agricultural occupational safety and health hazards on a national or regional basis (multi-state). AWARD CONSIDERATIONS Applications will be considered for award based upon (a) scientific and technical merit, (b) program importance, (c) program balance and geographic balance (including multi-state involvement), and (d) availability of funds. SCHEDULE Letter of Intent Receipt Date: February 16, 2001 Application Receipt Date: March 28, 2001 Anticipated Award Date: September 1, 2001 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to either: Roy M. Fleming, Sc.D. Office of Extramural Programs 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 Stephen Olenchock, Ph.D. Agriculture Coordinator National Institute for Occupational Safety and Health 1095 Willowdale Road, P04/1119 Morgantown, WV 26505-2888 Telephone: (304) 285-6271 FAX: (304) 285-6075 Email: solenchock@cdc.gov Direct inquiries regarding grants management to: Sheryl L. Heard, Grants Management Specialist Grants Management Branch, Procurement and Grants Office Centers for Disease Control and Prevention 2920 Brandywine Road, Room 3000 Atlanta, Georgia 30341 Telephone: (770) 488-2723 Email: slh3@cdc.gov PAPERWORK REDUCTION ACT Projects that involve the collection of information from 10 or more individuals and funded by cooperative agreement will be subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. AUTHORITY AND REGULATIONS The Catalog of Federal Domestic Assistance number is: 93.262 for the National Institute for Occupational Safety and Health (NIOSH). This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier 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 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 CDC mission to protect and advance the physical and mental health of the American people. 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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