NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION RELEASE DATE: April 3, 2003 RFA: OH-03-001 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 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 THIS RFA Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), announces the availability of funds in fiscal year 2003 to support a National Center for Childhood Agricultural Injury Prevention. The purpose of this program is to provide support for a national center for the prevention of childhood agricultural injury that 1) serves as a leader to facilitates prevention efforts and activities; 2) provide or enhance efforts to prevent injuries occurring to children who live on, work on, or visit farms, or are associated with other agricultural activities that pose a risk to children; 3) establish linkages and partnerships with the agricultural community to facilitate childhood agricultural injury prevention; 4) identifies, disseminates, and facilitates the use of state-of-the-art information and programs to prevent childhood agricultural injuries; 5) provide recommendations, utilizing input from the diverse stakeholders within childhood agricultural safety and health, for guiding childhood agricultural injury prevention efforts; and 6) conduct research to improve the safety and health of children who live on, work on, or visit farms. This announcement identifies program needs consistent with the National Occupational Research Agenda (NORA) developed by NIOSH and partners in the public and private sectors to provide a framework to guide occupational safety and health research in the new millennium towards topics which are most pressing and most likely to yield gains to the worker and the nation. The agenda identifies 21 research priorities. NORA priorities with specific relevance to this announcement are: traumatic injuries and special populations at risk, however, other relevant NORA priority areas are considered. Information about NORA is available through the NIOSH Home Page; http://www.cdc.gov/niosh/nora/. PROGRAM OBJECTIVES Background Agricultural production, which is most commonly identified with the occupation of farming, consistently ranks among the United States industries with the highest rates of work-related injuries and deaths, and is unique with respect to children and adolescents. Agriculture is the only major industry in which the workplace often encompasses the home. Exposures to agricultural production hazards are not confined to working adults. Children and adolescents may be exposed to agricultural production hazards not only through work activities, but also by virtue of living on a farm or ranch, accompanying their parents to work, or visiting farms. Children and adolescent involvement on farms is unique not only because they often begin to actively work on the farm at an early age, but because they also live and undertake recreational activities on the farm. An estimated 1.9 million youth less than 18 years of age lived or worked on a farm in 1998 (NIOSH pub. 2001- 154). In April 1996, the National Committee for Childhood Agricultural Injury Prevention (NCCAIP) published a National Action Plan to maximize the safety and health of all children and adolescents who may be exposed to agricultural hazards. The National Action Plan included 13 objectives and 43 recommended actions that called for funding of research and safety programs by the Federal government, foundations, agribusiness, and other public and private sector groups and nonprofit community-based organizations. The National Action Plan specifically calls for developing collaboration among researchers, public sector agencies and private sector foundations, corporations, associations, nonprofit community-based organizations, and other groups who can enact change; conducting efforts to ensure the public is aware of childhood agricultural safety and health issues; using consensus- building processes which involve interdisciplinary experts and stakeholders to arrive at guidelines and recommended standards for research and practices; and using state-of-the-art information and materials are essential for achieving the objectives set forth in this plan. In 2001, a summit on childhood agricultural injury prevention was convened with the goal to propose specific injury prevention strategies based on knowledge gained from research and interventions undertaken since implementation of the National Action Plan in 1996. Nearly 100 farmers, growers, professors, physicians, adolescents, and safety professionals, along with representatives of agricultural organizations and federal agencies, participated in the process of developing plans for a coordinated, comprehensive effort to prevent agricultural-related injuries among children and adolescents who live on, work on, or visit farms. The report, Childhood Agricultural Injury Prevention: Progress Report and Updated National Action Plan from the 2001 Summit, was released in April 2002. The Summit report provides an assessment of progress to date in implementing the National Action Plan, and includes three primary goals and twelve specific recommendations to generate strategies and priorities for future efforts related to childhood agricultural injury prevention. The Summit report builds upon the 1996 National Action Plan. Goal The goal of the National Center for Childhood Agricultural Injury Prevention will be to enhance the knowledge, attitudes, and practices of individuals, groups, and community-based organizations to protect children and adolescents from agricultural injuries. Useful References National Committee for Childhood Agricultural Injury Prevention. Children and Agriculture: Opportunities for Safety and Health. Marshfield, WI: Marshfield Clinic. 1996. http://research.marshfieldclinic.org/children/action/title.htm Lee, B. Gallagher, S. Marlenga, B. and Hard, D. (Eds.). 2002. Childhood Agricultural Injury Prevention: Progress Report and Updated National Action Plan for the 2001 Summit. Marshfield, WI: Marshfield Clinic. http://www.marshfieldclinic.org/research/children/childrensReport/. MECHANISM 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. This RFA uses just-in-time concepts. This RFA 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/part_i.htm#matchorcost. 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 AVAILABILE NIOSH intends to commit approximately $800,000 in FY 2003 to fund one award to support a National Center for Childhood Agricultural Injury Prevention. The amount of funding available may vary and is subject to change. The award will be made for a 12-month budget period within a project period not to exceed 5 years. Continuation awards within a project period will be made on the basis of satisfactory progress and the availability of funds. Use of Funds Applicants should include in their budget travel funds for one trip per year for an annual meeting with NIOSH/CDC scientists and other childhood agricultural principal investigators to be held in Morgantown, West Virginia. 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 The restriction of eligible applicants is due to the 1997 appropriations language which initiated this program and states that centers for agricultural occupational safety and health will be established at universities. Foreign institutions are not eligible to apply. 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 a National Center for Childhood Agricultural Injury Prevention program are: Overall Characteristics o The National Center for Childhood Agricultural Injury Prevention will support a broadly based national program of a coordinated outreach, prevention/intervention, education, and research projects. A National Center for Childhood Agricultural Injury Prevention is expected to have the following components which together address the objectives of the Center: 1. Administrative and Planning Core. This component should not exceed 25% of the direct cost budget. 2. Outreach Core This component should be at least 10% of the direct cost budget. 3. Prevention/Intervention Core. This component should be at least 10% of the direct cost budget. 4. Education Core. This component should be at least 10% of the direct cost budget. 5. Research Core. This component should be at least 10% of the direct cost budget. o There must be a demonstrated commitment of the applicant's institution to the support and encouragement of the National Center for Childhood Agricultural Injury Prevention. Such support could be demonstrated by release time of faculty, capital improvements that will facilitate the programs, and/or assistance in the acquisition of program equipment and supplies. o The National Center for Childhood Agricultural Injury Prevention 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 national child 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 a national integrated program rather than simply a collection of projects. NON-ALLOWABLE COSTS FOR THE NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION PROGRAM 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 National Center for Childhood Agricultural Injury Prevention program. ESSENTIAL ELEMENTS OF A NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION ADMINISTRATIVE AND PLANNING CORE (Should not exceed 25% of the annual direct cost) The Administrative and Planning Core must have strong leaders committed to the program, who are capable of providing leadership and who are willing to accept responsibility for the administration and integration of a national program. Assessment of the ability of the program's principal investigator to lead a highly integrated program of outreach, prevention/intervention, education, and research 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 core. The responsibilities and activities for the administrative and planning core include: o Appropriate and adequate organization and facilities for conducting outreach, prevention/intervention, education, training, and research activities such as seminars, workshops, reference collection, computer support, etc. The principal investigator should commit a minimum of 30% time (direct and in-kind) to the effort and each member of the internal advisory committee (one outreach, prevention/intervention, education, and research project investigator) should commit a minimum of 5% time for the National Center's administration and coordination. 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 formed from the individual core area program leaders, i.e., one each from outreach, prevention/intervention, education, and research. These individuals will assist the principal investigator in making programmatic and administrative decisions in the operation of the overall Center's program and should have a minimum time commitment of 5%. o An External Advisory Committee comprised of at least three members who are recognized leaders in child agriculture safety that will provide overall guidance and advice to the principal investigator and core program investigators on program direction. If not already included in the National Center for Childhood Agricultural Injury Prevention, one external advisory committee member should be from the Agriculture Extension community. o Feasibility Projects. Support of feasibility projects in the outreach, prevention/intervention, education, and research project areas within the National Center for Childhood Agricultural Injury Prevention is considered fundamental to sustaining the quality, breadth, and dynamics of this national injury prevention program. These projects encourage investigations and development of new and/or creative outreach, prevention/intervention, education, and research approaches, and are considered an important and integral part of the support provided to the National Center for Childhood Agricultural Injury Prevention. 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 core program areas (outreach, prevention/intervention, education, or research). This will also enable investigators to collect sufficient data to pursue support through other funding mechanisms. Examples of feasibility projects include but are not limited to: 1. Provide initial support for new investigators to develop new or innovative approaches/lines of investigation in any of the four core program areas. 2. Allow exploration of possible innovative or new directions representing a significant departure from ongoing funded projects in agricultural sciences (outreach, prevention/intervention, education, or research). 3. Stimulate investigators from other fields of study to apply their expertise to child agricultural safety and health issues. As a general rule, approximately 10%-15% of the direct cost budget for each year should be allocated to the Feasibility Projects Program of the 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 should be met. Management of the program should include provision for: 1. A mechanism that ensures preparation and appropriate announcement of the availability of funding for feasibility projects. 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 should 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 (abstract, RO1/R21 submission, etc.) recipient. This record should be available to reviewers in the event of a site visit for competing renewals. Both the Internal Advisory Committee and the External Advisory Committee are strongly encouraged to provide input into management of the Feasibility Projects program. OUTREACH CORE (Non-Research) (SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COST) This section is predominantly for non-research projects in outreach. Projects related to outreach research should not be included here, but rather in the pilot research project section below. The outreach core is an essential component of the National Center for Childhood Agricultural Injury Prevention, playing a key role in coalition building among organizations and groups that have the potential to reduce the childhood agricultural injury burden. Assessment of the ability of the core leader to develop and lead a highly integrated collaborative outreach program of prevention/intervention and educational/training activities will be a significant consideration in the evaluation of the application. There must also be a demonstrated commitment of the core leader for consensus development activities aimed at identifying issues and providing a course of action to reduce childhood agricultural injuries and engaging the private sector to become an acknowledged entity in childhood agricultural injury prevention. Annual meetings to bring these groups (or components of these groups) together to raise awareness of issues, promote action and achieve a "critical mass" of dedicated professionals to prevent childhood agricultural injuries are encouraged. 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 children who live on, work on, or visit 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 childhood agricultural injuries. PREVENTION/INTERVENTION CORE (Non-Research) (SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COSTS) This section is predominantly for non-research projects in prevention/intervention. Projects related to prevention/intervention research should not be included here, but rather in the pilot research project section below. Applicants should provide model programs, including prevention/intervention projects, for the prevention of injury among children who live on, work on, or visit farms. Prevention/intervention projects may include but are not limited to actions to prevent injury through combinations of techniques such as control technologies, exposure guidelines and regulations, worker participation programs, and training. Programs should be designed to involve direct input from national agricultural stakeholders in addressing national needs and in the implementation of relevant and culturally appropriate activities for meeting those needs. The development of strong partnerships with community organizations that can facilitate the identification of project needs and culturally appropriate prevention/intervention activities is encouraged. These programs 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 National Center for Childhood Agricultural Injury Prevention and the NIOSH/CDC Centers for Agriculture Disease and Injury Research, Education, and Prevention, NIOSH/CDC intramural programs, other extramural partners including NIOSH/CDC Education and Research Centers (ERCs), Training Project Grant (TPG) recipients, and other NIOSH/CDC funded agricultural programs. In addition, when possible, collaborations with Agricultural Extension units and Vocational Agricultural Programs are encouraged. In addition to national- level activities, projects should specifically identify: o The population of interest and relevant safety and health 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. EDUCATION CORE (Non-Research) (SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COSTS) This section is predominantly for non-research projects in education. Projects related to education research should not be included here, but rather in the pilot research project section below. Applicants should include well developed education project plans to target key agricultural safety and health needs. This Center core should include educational programs and a monitoring component to determine the success of these programs as a national public education approach to protect children who live on, work on, or visit farms. 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 children. These projects should be coordinated with the outreach core. Projects should involve agricultural stakeholders in addressing educational needs and in the implementation of a monitoring component to determine the success of these projects in meeting those needs. Partnerships and collaborative relationships are encouraged across states, as well as with the NIOSH/CDC Centers for Agriculture Disease and Injury Research, Education, and Prevention, NIOSH/CDC intramural programs, and other extramural partners including NIOSH/CDC Education and Research Centers (ERCs), Training Project Grant (TPG) recipients, and other NIOSH/CDC funded agricultural programs. In addition, when possible, collaborations with Agriculture Extension units and Vocational Agricultural Programs are encouraged. RESEARCH CORE (SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COSTS) Pilot research projects will be supported as part of the National Center for Childhood Agricultural Injury Prevention program. To be responsive to the RFA, a minimum of one pilot research project should be proposed. These pilot research projects can be in any of the core program areas, outreach, prevention/intervention, or education, but must be research in nature. Non- research projects in these core areas should be included in the relevant non- research core. Pilot (R21-type)research projects are intended to provide the National Center for Childhood Agricultural Injury Prevention investigators an opportunity to obtain the preliminary research data needed to help direct and maintain ongoing outreach, education, or 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 (R21-type) 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. 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 Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 1600 Clifton Road, N.E. Building 24, Room 1427, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2509 FAX: (404) 498-2571 Email: achildress@cdc.gov Direct your questions about the NIOSH agricultural program to: Stephen Olenchock, Ph.D. Agriculture Coordinator Centers for Disease Control and Prevention 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 your questions about peer review issues to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone: 304-285-5979 Fax: 304-285-6147 Email: pmajor@cdc.gov Direct questions about financial or grants business 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-03-001 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 6, 2003 at 1:00 PM (Eastern time) to discuss: programmatic issues, how to apply, and questions regarding the content of the RFA. The conference name is Child Agriculture Center program (CACP). The telephone bridge number is (404) 639-4100 (800- 713-1971, for Non-Federal Participants). Interested parties will need the conference code (233749) 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: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone: 304-285-5979 Fax: 304-285-6147 Email: pmajor@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 substantive 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 must contain both non-research and pilot research projects. Pilot research projects can be proposed in either one or several of the Center's core program areas (outreach, prevention/intervention, and/or education). Non-Research Core Projects (Outreach, Prevention/Intervention, Education) Each non-research core project section should begin with a cover sheet that identifies it as the beginning of the core project section (outreach, prevention/intervention, 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 NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION", provided below. PHS 398 form page 3 contains the section entitled "Research Plan" and although these projects are not research, this section should be used to describe the specific aims, background and significance, preliminary information or data, the project approach, 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, and 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 NOTE: NIOSH/CDC will inform successful applicants of the procedures for adding additional projects in subsequent years of support. Pilot Research Projects (Outreach, Prevention/Intervention, Education) Any pilot research project(s)(outreach, prevention/intervention, or education), 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 R21 application following the PHS 398 application instructions. The R21 is an exploratory/developmental funding mechanism which provides small short-term (2 year) awards used to explore the feasibility of an innovative basic or applied research question or approach. To be responsive to this RFA, a minimum of one pilot research project should be proposed. The pilot research core project section should begin with a cover sheet that identifies it as the beginning of the pilot research core project section, 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 pilot 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. 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 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. For further instructions refer to the "TABLE OF CONTENTS FOR THE NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION", provided below. NOTE: NIOSH/CDC will inform successful applicants of the procedures for adding additional projects in subsequent years of support. The budget information, other support, etc. should be included in the appropriate sections of the application. TABLE OF CONTENTS FOR THE NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION In order to facilitate the preparation and review of the National Center for Childhood Agricultural Injury Prevention 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 National Center for Childhood Agricultural Injury Prevention 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 National Center for Childhood Agricultural Injury Prevention. o Budget for the Entire Proposed Period of Support for the Entire National Center for Childhood Agricultural Injury Prevention. o Detailed Budget for each Project for the Initial Budget Period Organized by Cores. 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 National Center for Childhood Agricultural Injury Prevention(2 page maximum). o Highlights of Accomplishments for Past Project Period (for an existing Child Agricultural Center)(1 page maximum). o Highlights of Accomplishments Relevant to a National Center for Childhood Agricultural Injury Prevention Goals (new applicants). o Statement on the Institutional Commitment to the National Center for Childhood Agricultural Injury Prevention(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 Outreach Core Cover Sheet. o Outreach Project Plan A (use as many headings as there are projects). o Prevention/Intervention Core Cover Sheet. o Prevention/Intervention Project Plan A (use as many headings as there are projects). o Education Core Cover Sheet. o Education Project Plan A (use as many headings as there are projects). o Pilot Research Core Cover Sheet. o Pilot Project Plan A (R21-type)(use as many headings as there are projects). Note: each project plan (outreach, prevention/intervention, education, or research) 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 an existing NIOSH/CDC Center) (1 page maximum). Highlights of Accomplishments Relevant to a National Center for Childhood Agricultural Injury Prevention Goals (new applicants). d. Specific Aims. e. Background and Significance. f. Preliminary Studies/Progress Report. g. Project Design, Methods, or Approach. Items d-g cannot exceed 25 pages (except pilot research projects (R21), 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 in the PHS 398 instructions on page 3. 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 be sent to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone: 304-285-5979 Fax: 304-285-6147 Email: pmajor@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/CDC 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 program 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 of their peers 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 (SRC). REVIEW CRITERIA The primary consideration for a Center application is the ability of the Center's program to bring together quality outreach, prevention/ intervention, education, and research activities into a national interactive, multi-disciplinary operation addressing childhood agricultural injury issues in the nation. Since the programmatic core areas are not mutually exclusive, applicants will have latitude in determining the most appropriate core area(s) for each proposed project. Site Visits A site visit to 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 Special Emphasis Panel (SEP) who have expertise in major program 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, new projects, or investigators, for making major changes, or for delivering another edition of the application. Rather, it should be used by the principal investigator and associates to elaborate on the program and core units, cost effectiveness and quality control features of the core units, and on other Center activities for which funding is requested. It also serves 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 the 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 the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major program impact and thus deserve a high priority score. For example an investigator may propose to carry out important work that by its nature is not innovative but essential to move a field forward. Review Criteria for the Overall Program Are: o Responsiveness to the objectives of the RFA, including the applicant's understanding of the objectives of the national program for preventing childhood agricultural injuries and the relevance of the proposal to those objectives. o Feasibility of meeting the proposed objectives of the RFA and the national program for preventing childhood agricultural injuries, including the proposed schedule for initiating and accomplishing each of the activities within the core areas and the proposed method for evaluating the accomplishments. o Degree to which the overall Center's program addresses the distinct characteristics, specific populations, and needs in childhood agricultural injury prevention for the nation. o Qualifications of the technical, physical, and intellectual environment of key Center staff to serve as a national resource for childhood agricultural injury prevention efforts. o National multi-disciplinary scope of the program. o Degree of interrelationships, collaboration, and synergism of projects proposed for funding in this RFA. o Technical stature as well as leadership ability of the Center Director and his/her ability to meet the program's demands of time and effort. o Provisions for coordinating the programmatic cores. The applicant must have appropriate administrative arrangements and facilities that stimulate collaboration among constituent projects and personnel. o Effectiveness of the applicant in establishing or continuing an outreach and education program that makes maximum use of the National Center for Childhood Agricultural Injury Prevention strengths in educating the public with regard to preventing or reducing child and adolescent agricultural injuries and/or hazard exposure. o Institutional commitment to the National Center for Childhood Agricultural Injury Prevention Review Criteria for Outreach and Education Core (predominantly Non-Research) Projects Are: o SIGNIFICANCE: Merit and significance of the proposed projects as determined by such factors as content, originality, feasibility, potential long-term success, transportability, and appropriateness for 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 and plans, including a monitoring component to determine the success of these programs as a national public outreach and/or education approach for prevention/intervention of child and adolescent agricultural injuries. Plans for the distribution of results and products to appropriate stakeholders. 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 mission of the National Center for Childhood Agricultural Injury Prevention. 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 provisions of appropriate resources, services, and technical support. 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 populations served by the Center. o APPROACH: Demonstration within the proposed project plan of current knowledge of prevention/intervention practices and effectiveness. Does the applicant acknowledge potential problem areas and consider alternative approaches? Development of activities and plans, including a monitoring component to determine the success of these programs in the prevention/intervention of child and adolescent agricultural injuries. 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 mission of the National Center for Childhood Agricultural Injury Prevention. 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 Pilot Research Core (Outreach, Prevention/Intervention, and/or Education) Projects Are: o SIGNIFICANCE: Does this project address an important problem related to the research areas outlined in this announcement? If the aims of the application are achieved, how will scientific knowledge be advanced? 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 technical/scientific environment in which the work will be performed 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 (Research and Non-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 safety problems addressed in the proposal for children and adolescents who live on, work on, or visit farms. o Likelihood of developing knowledge (in the areas of outreach, prevention/intervention, or education for the prevention of childhood agricultural injuries. 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) for a National Center for Childhood Agricultural Injury Prevention. 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 a complex multidisciplinary project. Because of the nature of this award, NIOSH/CDC program staff may be more involved than in a usual research grant. NIOSH/CDC program staff may assist, as appropriate, the recipient's activity by working with the award recipient, but NIOSH/CDC will not 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, and NIOSH/CDC program staff will be available to collaborate where appropriate. In conducting activities to achieve the purpose of this program, the recipient will be responsible for activities under "Recipient Activities", and NIOSH/CDC will be responsible for the activities listed under "NIOSH/CDC Activities". 1. Recipient Activities The recipient will coordinate project activities, technically, scientifically, and administratively at the awarded institution and at other sites that may be supported by sub-contracts 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 program project award. The recipient will: o Establish and enhance a national Center for programs, research, and information which have been shown to be effective in preventing childhood agricultural injuries; o Establish and maintain contacts with organizations, groups, and individuals which supply childhood agricultural injury prevention information and data for use in targeting prevention efforts and prioritizing program needs; o Facilitate awareness and utilization of the Center through appropriate activities, including but not limited to involving minority-serving groups, community-based organizations, and other relevant organizations; o Coordinate and collaborate with established and ongoing health communication efforts, such as the National Safety Council's "Farm Safety and Health Week," "Farm Safety 4 Just Kids," and other relevant organizations as appropriate; o Organize and manage multi-perspective work groups which use consensus- building processes to arrive at recommendations for the protection of youth who work on farms and the protection of bystander children who are exposed to farm hazards. o Inform and facilitate the involvement of the private sector in childhood agricultural injury prevention activities; o Collaborate with public and private sector agencies, community-based organizations, researchers, and other groups who can enact change through prevention efforts and activities; o Conduct pilot research into the causes and prevention of childhood agricultural injuries; o Monitor the success of the National Center for the Prevention of Childhood Agricultural Injury on promoting actions to prevent childhood agricultural injuries. 2. NIOSH/CDC Activities NIOSH/CDC recognizes the potential need for assistance, when appropriate, in such a complex and diverse project. The following types of activities will be available from NIOSH/CDC program staff: o Provide technical assistance with program development, implementation, maintenance, priority setting, evaluation of efforts, enhancement of the Center, and information and dissemination activities. o Facilitate linkages with researchers and public and private sector agencies and organizations to plan, implement, and evaluate childhood agricultural injury prevention efforts. o Collaborate with the recipient in joint safety and health research, communication and dissemination efforts related to childhood agricultural injury prevention. o Communicate new findings from NIOSH/CDC supported research. 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.htm. 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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