CENTERS FOR CONSTRUCTION SAFETY AND HEALTH RELEASE DATE: October 30, 2003 RFA Number: RFA-OH-04-002 (This RFA has been reissued as RFA-OH-09-001) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention (NIOSH/CDC) (http://www.cdc.gov/niosh/homepage.html) NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.955 LETTER OF INTENT RECEIPT DATE: March 13, 2004 APPLICATION RECEIPT DATE: April 13, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Program Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Pre-Application Conference Call o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THE RFA The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2004 funds for cooperative agreement (U50) applications from single institutions or consortia of institutions to establish one or more Centers for Construction Safety and Health (Construction Centers). The purposes of the Construction Centers are to conduct exploratory, prevention/intervention, and translation projects that address priority construction safety and health problems and provide a national focus for construction health and safety issues. A key role for Construction Centers will be their leadership role in translational activities and research. Through this integrated approach to knowledge development and translation, Construction Centers are intended to have a significant and measurable impact on construction health and safety. PROGRAM OBJECTIVES Background The mission of NIOSH/CDC is to help assure safe and healthful working conditions for working men and women by providing research, information, and training in the field of occupational safety and health. NIOSH provides national and world leadership to prevent work-related illness, injury, disability, and death by gathering information, conducting scientific research, and translating the knowledge gained into products and services. One of the strategic goals is the conduct of a focused program of research to reduce injuries and illnesses among workers in high-priority areas and high- risk sectors, including mining, agriculture, construction, and health care. In 1996, a National Occupational Research Agenda (NORA), http://www.cdc.gov/niosh/nora/, was created to guide NIOSH. During the development of the Agenda, the importance of sector-specific research (including construction) was emphasized. The panel noted that sector-focused research has had much success and continues to hold great promise for gathering and translating knowledge and information into prevention. The Healthy People 2010 agenda, a national activity to reduce morbidity and mortality and improve the quality of life includes national objectives for high risk sectors. For example, it includes a 30% reduction goal for work- related injuries and deaths among construction workers by 2010. 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.healthypeople.gov/. This RFA builds upon an existing NIOSH program on construction safety and health that began in 1990. This program has developed a national infrastructure to address issues affecting workers in this industry. The program includes intramural and extramural research projects as well as collaborative surveillance activities with state health departments. These projects included a large Construction Center as well as investigator- initiated projects that addressed specific construction issues such as hearing loss, roof falls, and vibration injuries. The reduction in traumatic injury rates among construction workers since 1990 suggests that the program has had some impact. A compendium of NIOSH supported construction research can be found on the NIOSH web site http://www.cdc.gov/niosh/homepage.html, or it may be obtained by telephone (800-356-4674), email (firstname.lastname@example.org), or fax (513-533-8573). The NIOSH publication number is 2003-103. Additional information on the NIOSH construction program is available at http://www.cdc.gov/niosh/homepage.html. Despite these efforts, construction remains one of the industries with the highest rates of work-related injuries and deaths in the United States. From 1980 to 2001, approximately 1100 construction workers were killed on the job each year, more fatal injuries than any other industry. Furthermore, the construction fatality rate has not declined over the past decade. The construction environment presents a number of work settings and environments many of which vary across the United States. It can also involve a complex work organization, with multiple employers and trades at a worksite. Thus, construction safety and health research must not only address specific construction related safety and health problems, but also must examine their etiology in the context of the work environment. A significant challenge to improving the safety of the construction industry is the nature of the businesses. Of the approximately 600,000 companies, 90% employ fewer than 20 workers. Few small construction companies have formal safety programs. Thus, the adoption of new/improved construction safety and health is difficult to achieve, and innovative approaches to the translation of research knowledge to construction tools, practices, and environments are needed. While some employers utilize formal safety programs and training, others are less formal and many workers must learn how to work safely through on the job experiences. Additionally, there is an increasing need for construction worksites to communicate safety and health information in several languages. Construction workers are also at increased risk for occupational morbidity from musculoskeletal disorders, certain cancers, reproductive disorders, dermatological conditions; hearing loss, stress related mental disorders, and occupational lung diseases. In addition, the work environment such as construction vehicles, power lines, hazardous chemicals, and scaffolding failures present unique hazards for the construction worker. Thus, the construction environment represents a unique and multifaceted health and safety challenge. The health and safety issues in the construction sector are complex and evolving. Thus, there is a need for an integrated approach to the health and safety issues facing this sector and the construction centers are intended to address problems through a coordinated and integrated mix of exploratory, prevention/intervention, and translation projects. The goal of the Construction Center Program is to have a significant and measurable impact on construction safety and health. Goals This initiative is intended to assemble a cross-disciplinary, multi- institutional group to address the important issues in construction safety and health in a focused manner. To accomplish this objective, it is envisioned that a Construction Center would: 1. Conduct hypothesis driven (exploratory) research related to occupational safety and health of construction workers. 2. Develop, implement and evaluate model programs for the prevention of illness and injury among construction workers. 3. Develop, implement, and evaluate translation projects for the adoption of new and existing knowledge into construction settings. The emphasis of the Construction Centers should be on addressing priority occupational health and safety issues using a multi-disciplinary approach. Translation projects focus on the translation of extant knowledge (e.g. peer reviewed articles) into products or practices that meet construction “customer” needs so as to maximize the impact on industry practices. The NIOSH Construction Steering Committee has identified a number of priority topics in emerging areas of interest where research will most likely make a difference (see http://www.cdc.gov/niosh/homepage.html). These NIOSH identified topics can be grouped into three categories: o Health and injury outcome topics which target: 1. Leading types of fatal and non-fatal traumatic injuries in construction. 2. Low back injuries and other cumulative work-related musculoskeletal disorders among construction workers. 3. Occupational illness topics that focus on respiratory disease and hearing loss. Respiratory disease includes airways disease, asthma, chronic obstructive lung disease, and silicosis. o Chemical and physical exposure topics which target vibration, asphalt fumes, lead, and dust particles. o Approach and sector topics that target the following groups and issues within construction: 1. Small and self-employed contractors. 2. Special sub-populations at risk within construction such as Hispanic workers, day laborers, young workers, aging workers. 3. The role of design as a primary prevention tool for addressing construction hazards. 4. Addressing work organization in construction and improving understanding of how it affects health and safety. 5. Working with building owners and clients to promote and evaluate construction best practices. 6. Leveraging promising approaches from related high risk sectors such as agriculture and mining into construction. Other topics relevant to construction health and safety are also appropriate for this RFA. The significance of a project and relevance to the elimination of hazards in the construction industry must be fully described and developed in the application. Individual projects should identify the types and geographical distribution of the construction issue that will be addressed by a project. In addition, the size and characteristics of the population that will be impacted by the project results should be described. Intervention/prevention and translation 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. In the development and prioritization of the project topics for the Construction Center, applicants are encouraged to consult with stakeholders (e.g. construction organizations, construction unions, advisory groups, workers, safety and health professionals, and other interested parties). Construction Centers should include plans to develop linkages and communication with other governmental and non-governmental agencies involved in construction health and safety, with special emphasis on communications and collaborations with other NIOSH/CDC-sponsored construction health and safety programs. MECHANISM(s) OF SUPPORT This RFA will use the NIOSH U-54 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. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW investigator-initiated applications, using the standard receipt dates described in the instructions to the PHS 398 application. The NIOSH U-54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIOSH staff being substantially involved as a partner with the principal Investigator, as described under the section “Cooperative Agreement Terms and Conditions of Award”. This RFA uses just-in-time concepts. It does not use the modular budgeting formats. Follow the instructions for a detailed budget research grant application. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIOSH intends to commit approximately $5,000,000 in FY04 to fund one or more new or competing grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $3,600,000 per year. The total cost requested should not exceed $5,000,000. Applications exceeding $5,000,000 in total costs in any year will be considered unresponsive and returned without further consideration. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may also vary. Although the financial plans of NIOSH provide for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. In years two and four, an additional $100,000 will be provided to support a national construction meeting. This meeting will be planned jointly by NIOSH and the successful applicant(s). Use of Funds Applicants should allocate funds for travel for project staff (the Construction Center Director and the principal investigator for each project) to attend annual meetings held during each project year. Travel funds should also be planned for annual meetings of Construction Center Directors as a Coordinating Committee (see Collaborative Responsibilities under Terms and Conditions of Award) with NIOSH staff. For planning purposes, assume that the meetings will be held in Washington, DC. ELIGIBLE INSTITUTIONS You may submit (an) application (s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based or community-based organizations o 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 Construction Center cooperative agreement are: Overall Characteristics o The Construction Center cooperative agreement will support a broadly based multi-disciplinary exploratory, prevention/intervention, and translation program. A Construction Center is expected to have the following components that together address the objectives of a Center: 1. Administrative, Planning and Outreach Core. This component should NOT exceed 25% of the direct cost budget. 2. Multi-Disciplinary Exploratory Research Projects. These projects should be at least 20% of the direct cost budget. 3. Prevention/Intervention Projects. These projects should be at least 25% of the direct cost budget. 4. Translation Projects. These projects should be at least 20% of the direct cost budget. (Projects may overlap these arbitrary divisions. For example an intervention project may also fit as a translation project. Thus these are intended as guidelines to help the principal investigator balance the construction centers projects). o There must be a demonstrated commitment of the applicant’s institution to support and encourage the Construction Center. Such support could be demonstrated by release time of faculty, capital improvements that will facilitate the program, and/or assistance in the acquisition of scientific equipment and supplies. o The Construction Center’s program should be more than a collection of projects, but rather should include a process for the administrative integration and oversight of the projects. The projects should address construction issues in an integrated manner that contributes to the overall focus of the Center. Ideally, a Construction Center will address the entire continuum of a problem from identification/causation through translation. Therefore, under the Heading “OVERALL DESCRIPTION”, the principal investigator should clearly describe the theme or themes of the Center, how projects address the Center’s theme(s), and how the Center will function as an integrated program rather than simply a collection of projects. NON-ALLOWABLE COSTS FOR NIOSH CONSTRUCTION CENTER COOPERATIVE AGREEMENT The Construction Center funding mechanism should not be used as a substitute for individual research grant support. It is expected that investigators participating in Construction Centers will have a history of independent project support in addition to the Construction 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 Construction Center cooperative agreement. ESSENTIAL ELEMENTS OF A CONSTRUCTION CENTER ADMINISTRATIVE AND PLANNING CORE (SHOULD NOT EXCEED 25% OF THE ANNUAL DIRECT COST) The Administrative, Planning and Outreach Core must have strong leaders committed to the program, who are capable of providing scientific leadership for the administration and integration of the program. Assessment of the ability of the program’s principal investigator to lead a highly integrated program of exploratory, prevention/intervention, and translation projects will be a significant consideration in the evaluation of the application. The Administrative, Planning and Outreach Core supports the administrative infrastructure for the entire program and should not be duplicated within any other components. The responsibilities and activities for this core include: o Appropriate and adequate organization and facilities for activities such as seminars, workshops, reference collection, computer support, etc. The principal investigator should provide a minimum of 20% time commitment (direct and in-kind) and each member of the internal advisory committee (one exploratory, prevention/intervention, and translation project investigator) should provide a minimum of 5% time commitment for the Construction Center’s administration and coordination. o Feasibility Projects. Support of feasibility projects in the exploratory, prevention/intervention and translation project areas within the NIOSH Construction Center is considered fundamental to sustaining the quality, breadth, and dynamics of this program. Investigators should include between 5% and 10% of the annual direct cost for these projects. These projects are intended for the exploration and development of new and creative exploratory, prevention/intervention and translation projects, and are considered an important and integral part of the support provided to the Construction Center. Therefore, funds should be designated to provide support for short- term projects (maximum duration of 12 months and $20,000) to explore the feasibility of new projects in any of the Center’s program areas (exploratory, prevention/intervention, and translation). This will also enable investigators to collect sufficient data to pursue support through other funding mechanisms. Examples of feasibility projects may include but are not limited to: 1. Provide initial support to develop innovative approaches/lines of investigation in the program areas. 2. Allow exploration of possible innovative new directions representing a significant departure from ongoing funded projects in construction sciences (exploratory, prevention/intervention, and translation). 3. Stimulate investigators from other fields of study to apply their expertise to construction safety and health issues. 4. Develop new mechanisms for external or multi-Center collaborative partnerships to address emerging construction safety and health concerns. 5. Provide initial support for a translational activity. As a general rule, approximately 5% to 10% of the direct cost budget for each year should be allocated to the Feasibility Projects Program of a Center. While the administrative framework for management of the Center's Feasibility Projects Program is left to the Center Director's discretion, certain minimal requirements must be met. Management of the program must include provisions for: 1. A mechanism that ensures preparation and appropriate announcement of the availability of feasibility project funding. 2. A mechanism for merit review of feasibility project proposals. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the Center. These records must be available to reviewers in the event of a site visit. 3. A mechanism to maintain a record of subsequent results of each feasibility project study (abstract, RO1/R21 submission, etc.) recipient. This record must be available to reviewers in the event of a site visit for competing renewals. Input by both the Internal Advisory Committee and the External Advisory Committee into the management of the Feasibility Projects Program is strongly recommended. o The use of existing state and national databases is encouraged, however, a data center/statistical support activity may be included in the administrative core if needed for the Center. o Outreach Activities: Essential functions of the outreach component of the administrative core include but are not limited to, coordinating and collaborating with construction researchers, industry stakeholders, construction unions and other organizations to identify key issues and needs. They could also include ongoing construction communication efforts and convening consensus-development sessions to address complex and/or controversial issues with the aim of preventing construction injuries and illness. One topic that could be addressed through this activity would be working with building owners and clients (building managers) to develop strategies for identifying and adopting construction best practices. o An Internal Advisory Committee is formed from the individual project leaders, one from each type of project (exploratory, prevention/intervention and translation) that will assist the principal investigator in making scientific and administrative decisions in the operation of the program. These individuals should provide a minimum time commitment of 5%. o An External Advisory Committee, comprised of at least three members who are recognized leaders in construction health and safety and regional construction experts, will provide overall guidance and advice to the principal investigator and program investigators on program direction. TYPES OF PROJECTS Two types of exploratory, prevention/intervention, and translation projects may be included in the Construction Center, and both types are encouraged. The two types are pilot/short term projects (1 - 2 years, R21 type) and comprehensive projects (up to 5 years, R01 type). Each project (pilot and comprehensive) should be related to the overall goals established for the Center. To be funded, a Construction Center must have one project either pilot or comprehensive for each topic area (exploratory, prevention/intervention, and translation) that is judged to have significant and substantial merit. When appropriate, collaborative research is encouraged between Construction Centers and the NIOSH intramural program. Pilot research projects are intended to provide Construction Center investigators an opportunity to obtain the preliminary data needed for the submission of a NIOSH/CDC, NIH, EPA, or other peer-reviewed Project Grant application (R01 type). The maximum project period for a pilot project is 2 years. Follow the instructions for a NIOSH 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). Comprehensive research projects are intended to provide support for fully developed ideas that are ripe for study, and should be consistent with R01 projects that are typically awarded by NIOSH and NIH. The project period for this type of project is usually three to five years. These projects will follow the submission guidelines for a R01 application according to the PHS 398 application instructions. See NIH guide: http://grants.nih.gov/grants/guide/pa-files/PA-99-143.html, for additional information on R01 applications. EXPLORATORY PROJECTS (SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS) These projects are hypothesis driven projects focused on improving our understanding of construction issues. They may include but are not limited to projects involving surveillance, etiology, engineering, risk factor characterization, or development of analytical and exposure assessment approaches. They may be lab or field projects that provide the basis for creation or improvement of interventions. Exploratory projects should target priority topics and should be done as a part of multidisciplinary efforts to address important problems and avoid fragmentary efforts are encouraged. Other topics relevant to the construction environment are also appropriate. PREVENTION/INTERVENTION PROJECTS (SHOULD BE AT LEAST 25% OF THE ANNUAL DIRECT COSTS) This section is for projects in prevention and/or intervention. These studies are for testing promising approaches in actual construction settings. Prevention/intervention projects may include but are not limited to actions taken to eliminate or reduce exposure to safety and health hazards via practices or policies, or projects to demonstrate the value of screening or related approaches to detecting disorders and diseases in early stages. They can also examine the value of larger preventive systems (e.g., the workers compensation system) in reducing hazards and adverse outcomes. Prevention/intervention projects examine the utility and impact of new and existing measures in the workplace. They may include but are not limited to combinations of techniques such as control technologies, work practices, tools and materials, personal protective equipment, exposure guidelines and regulations, worker participation programs, contract language, design specifications, and changes in education and training. Projects should address significant construction problems and involve construction stakeholder input to maximize relevance. The development of strong partnerships with organizations that can facilitate the identification of project needs and culturally appropriate, prevention, and intervention activities is encouraged. These projects should include the active participation of target populations identified at the state and national level, and include an evaluation plan to determine the efficiency and effectiveness of these techniques and programs. TRANSLATION PROJECTS (SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS) These are projects that focus on the translation of extant knowledge (e.g. peer reviewed articles) into products or practices that meet construction “customer” needs so as to maximize the impact on industry practices. The Principal Investigator (Center Director) should view these projects as the tool to move the results from the research environment into the construction industry. As the goal for these projects is the adoption of new/improved knowledge in the construction sector, the principal investigator must include in the project plan how the study will accomplish this goal. Translation projects may include but are not limited to technology transfer projects or demonstration projects that expand the use of effective interventions by a construction trade or industry group. Projects may address diffusion research issues to improve understanding of what influences construction industry decision-makers, workers, contractors, building owners, or others to adopt new practices, tools, and methods to improve safety and health performance. Participatory research projects, where research subjects and researchers work as active co-partners on translation issues are encouraged. Social marketing projects and other approaches that target important topics such as reducing construction fatalities at the industry, state, or national level are also appropriate. Note to Principal Investigators Principal investigators are reminded that the intent of the Construction Center is not to support a collection of projects (exploratory, prevention/intervention, and translation). Rather, the goal for a NIOSH Construction Center is to support multi-disciplinary projects that are focused on a construction issue(s)in such a way as to have a meaningful and measurable impact on the problem. For example, a center may have as one focus fatal injury reduction and propose exploratory, prevention/intervention, and translation projects that address this problem in a multidisciplinary manner with a goal of reducing fatalities in construction workers. 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 inquiries regarding programmatic issues to: Michael J. Galvin Jr., Ph.D. Scientific Program Administrator Office of Extramural Programs National Institute for Occupational Safety and Health/CDC 1600 Clifton Road, N.E. Building 24, Room 1536, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2524 FAX: (404) 498-2571 Email: email@example.com Direct inquiries regarding peer review 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: firstname.lastname@example.org Direct inquiries regarding grants management to: Cynthia Mitchell Grants Management Branch, Procurement and Grants Office Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Announcement Number OH-04-002 Telephone: (412) 386-6434 FAX: (412) 386-6459 Email: email@example.com PRE-APPLICATION CALL Applicants are invited by NIOSH to participate in a pre-application technical assistance telephone conference call on December 17, 2003 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 “Construction” Centers program. The telephone bridge number is (888) 455- 3612. Interested parties will need the conference code (41162) to participate. If you experience difficulty connecting to the conference call, contact NIOSH staff at (404) 498-2530. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by the date listed at the beginning of the RFA 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 is used 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: firstname.lastname@example.org SUBMITTING AN APPLICATION Although not a prerequisite for applying, applicants are encouraged to consult with NIOSH program staff concerning the technical and other aspects of preparing the application. Applicants should contact NIOSH 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). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. SUPPLEMENTARY INSTRUCTIONS All projects (exploratory, prevention/intervention, or translation), should be consistent with the competitive/peer-reviewed applications that are typically awarded by NIOSH and NIH and adhere to the submission guidelines for a R01/R21 application following the PHS 398 application instructions. The R01 is an investigator initiated project that can request up to 5 years of support. The R21 is for projects that are short-term in nature or for pilot projects. PHS 398 form page 3 contains the section entitled “Research Plan” and although some projects are not hypothesis based research, this section should be used to describe the specific aims, background and significance, preliminary information or data, the project approach, for each project (prevention/intervention, or exploratory research/demonstration). This section should contain sufficient information to address the project’s 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 (see page 15 of the 398 instructions for additional guidance). Each project type section should begin with a cover sheet that identifies it as the beginning of the project section (administrative core, exploratory, prevention/intervention, or translation), 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 type. 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 a Construction Center Application, provided below. For each R01-type project, the application should not exceed 25 pages for items d - g for prevention/intervention, or comprehensive project (see the, Table of Contents for a Construction Center Application). For pilot research (R21-type) projects, 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. A 15 page maximum for items d - g should be followed. Refer to the, Table of Contents for a Construction Center Application, provided below. 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 exploratory, prevention/intervention, or translation projects in future years of support. Thus, the application should contain only projects for which funds are requested for support during year one. TABLE OF CONTENTS FOR A CONSTRUCTION CENTER APPLICATION In order to facilitate the preparation and review of the Construction Center application, the following Table of Contents should be used. It is a minor modification of the PHS 398 Table of Contents which should be followed as a guide. o Face Page o Construction Center Description, Performance Sites, and Personnel, Form page 2(use additional continuation pages as needed) o Table of Contents o Detailed Budget for the Initial Budget Period for the entire Construction Center o Budget for the Entire Proposed Period of Support for the Entire Construction Center o Detailed Budget for each Project for the Initial Budget Period Organized by areas (exploratory, prevention/intervention, or translation) 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 Construction Center (2 page maximum) o Past Performance/Accomplishments in Last Project Period (existing Construction Center) o Past Performance/Accomplishments Relevant to Construction Center goals (new applicants) o Statement on the Institutional Commitment to the Construction Center (1 page maximum) o Human Subjects summary table that lists all the projects and human subjects information (title, performance sites, FWAs, IRB approval date/status) o Administrative and Planning Core Cover Sheet o Administrative and Planning Core o Exploratory Projects Cover Sheet o Exploratory Plan A (use as many headings as there are projects) o Prevention/Intervention Projects Cover Sheet o Prevention/Intervention Project Plan A (use as many headings as there are projects) o Translation Projects Cover Sheet o Project Plan A (use as many headings as there are projects) Note: each project plan should use the following outline a. Header Page with Title, Principal Investigator's name, and type of project (comprehensive or pilot) b. Description, Performance Sites, and Personnel (form page 2) c. Highlights of Accomplishments for Past Project Period if it was part of an existing Construction Center (1 page maximum) d. Specific Aims e. Background and Significance f. Preliminary Studies/Progress Report g. Project Design and Methods Items d-g cannot exceed 25 pages (except pilot projects, which cannot exceed 15 pages) h. Human Subjects i. Vertebrate Animals j. Literature Cited k. Consortium/Contractual Arrangements l. Consultants and Collaborators, including NIOSH/CDC Note: Type density and size of the entire application must conform to the limits provided on page 3 in the PHS 398 instructions. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form, must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE CSR: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: 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: email@example.com APPLICATION PROCESSING: Applications must be received on or before 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) 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 an 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 from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH/CDC. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIOSH/CDC in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 written critique o Receive a second level of review by the NIOSH Secondary Review Committee. REVIEW CRITERIA The primary consideration for a Center cooperative agreement application is the ability of the Center’s program to bring together quality exploratory, prevention/intervention, and translation activities into an interactive, multi-disciplinary operation addressing construction issues. SITE VISITS A site visit to the applicant institutions may be made (but such site visits are not assured) to evaluate the overall merit of the application. The site visit team includes members of the Special Emphasis Panel 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 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. General Review Criteria The criteria that NIOSH will use to review applications for scientific merit and for meeting program objectives are provided below. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed project will have a substantial impact on the pursuit of these goals. The review group will address and consider each of these criteria in assigning your application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have a major impact and thus deserve a high priority score. For example you may propose to carry out important work that by its nature is not innovative but essential to move a field forward. Review Criteria for the Projects: o SIGNIFICANCE: Merit and significance of the proposed project as determined by such factors as content, originality, feasibility, potential long-term impact, transportability, and appropriateness. Does the project address an important construction problem? Does the project address a difficult construction problem that if successful would have significant impact? o APPROACH: Demonstration within the proposed project plan of current knowledge of intervention practices and effectiveness. Does the applicant acknowledge potential problem areas and consider alternative approaches. Is the project fully described and does it include a plan for the distribution of results? Has the investigator included appropriate methods for the analysis of the study results? o INNOVATION: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? The project does not have to be innovative but can use established methods to have a major impact and thus deserve a high priority score. o INVESTIGATOR: Qualifications and experience of the principal investigator and staff, particularly but not exclusively in areas relevant to the NIOSH’s mission of an Construction Center. Individuals with strong subject matter skills are expected to play key roles. Personnel should demonstrate knowledge of the needs of their target audience. o ENVIRONMENT: Availability of resources necessary to perform project objectives. Strength of commitment by the participating institution(s) as evidenced by provisions of appropriate resources, services, and technical support. Review Criteria for the Overall Program: 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 Involvement of key stakeholders (construction and construction contractor organizations, unions, and workers) 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 construction. o Qualifications of core investigators and the physical and intellectual environment of the group as a national resource for construction occupational health research and training. o Multidisciplinary scope of the program. o Degree of interrelationships, collaboration, and synergism of projects 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 projects. 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 Outreach Program that makes maximal use of the Center’s strengths in educating construction workers and others about reducing construction injuries and/or hazard exposure. o Institutional commitment to the Center. OTHER REVIEW CRITERIA FOR ALL PROJECTS The 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 goals of the project including 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 construction workplace and among construction populations in the region. o Likelihood of developing knowledge for the prevention/reduction of construction injuries and diseases on a national or regional basis. o Overall program addresses recognized construction priorities. o Program balance. o Appropriateness of the proposed budget and duration in relation to proposed objectives. 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 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 Serve as a center for consultation and partnership to coordinate work by researchers and to coordinate researcher/stakeholder relationships to facilitate an effective multidisciplinary program. o Conduct exploratory, prevention/intervention, and translation projects to improve construction health and safety. o Collaborate with other NIOSH funded Construction researchers. o Disseminate project results. o Participate in an annual meeting of project investigators. o Comprehensive Annual Center Report. In addition to the summary progress report required for continuation applications, the Center Director prepares and submits separately, following the conclusion of each budget period, a comprehensive annual report of all activities relating to the Center. This report is submitted electronically. Typically, this report includes: (a) An "Introduction and Summary" of the program. (b) Directors report on major accomplishments (highlights). (c) Detailed progress reports on each project, grouped according to type with appropriate references and a list of publications since the last annual report. (d) A progress report on feasibility projects. (e) A report on the Outreach Program. (f) A report on specific improvements in construction safety and health that resulted from center activities. (g) An administrative report, discussing relevant personnel and other matters. 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, if requested. o Provide scientific collaboration, if requested. o Assist in the reporting and dissemination of research results and relevant health and safety and training information to appropriate Federal, State, local agencies, health-care providers, the scientific community, construction workers, management and union representatives, and other NIOSH Construction Centers, if requested. 3. Collaborative Responsibilities If more than one Construction Center is awarded, 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 construction safety and health issues at a national level. 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 could be a Construction Centers Translation Committee. This multi-site committee would provide a means to share data that is ripe for translation to the construction sector. It is anticipated that critical issues for understanding and protecting construction workers from job risks will be better defined through the deliberations of the CC. The CC will combine the expertise and resources of the Centers with those of NIOSH/CDC to achieve a more integrated and effective program in construction health and safety. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-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 NIH 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. 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 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. 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 NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH 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. HEALTHY PEOPLE 2010: The CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity for reducing morbidity and mortality and improving the quality of life. This RFA is related to one or more focus 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 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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. 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 Center 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 healthy 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. SMOKE-FREE WORKPLACE: CDC strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which , library, day care, health care, and early childhood development services are provided to children. 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." AUTHORITY AND REGULATIONS 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.
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