STATE-BASED OCCUPATIONAL SAFETY AND HEALTH SURVEILLANCE RELEASE DATE: May 25, 2004 PA NUMBER: PAR-04-106 Updates: July 6, 2009 - This PAR has been reissued as (PAR-09-184). April 20, 2007 - See Notice (NOT-OH-07-003) The purpose of this notice is to notify potential applicants of changes. -May 26, 2006 (NOT-OH-06-004) - see Notice regarding FY 2007 funding and supplemental applications -Conference call, see NOT-OH-05-004 -See clarification, NOT-OH-05-003 and NOT-OH-04-106 EXPIRATION DATE: August 7, 2007, unless reissued. APPLICATION DUE DATE: Annually on August 6th Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute for Occupational Safety and Health (NIOSH) (http://www.cdc.gov/NIOSH) 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): 93.957 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA NIOSH invites applications for cooperative agreements from state agencies to establish, maintain or expand state occupational health surveillance capacity. This program is intended to provide state agencies the resources to collect data from existing systems that capture information on occupational safety and health hazards and effects on workers, to identify new sources of occupational safety and health data, to perform occupational health and safety surveillance and to develop interventions for reducing worker injuries and illnesses in the state. The purpose of this announcement is two-fold. The first is to provide states an opportunity to conduct a Fundamental Occupational Safety and Health Surveillance Program in their state. The second purpose is to provide states with an established Fundamental Program the opportunity to expand the Fundamental Program to address one or more additional priority health conditions in the state (Expanded Program). Because of the need for a national scope of surveillance on occupational safety and health concerns, the collaboration of NIOSH and the states through a consortium is needed if the objectives of the program are to be achieved. Thus, a Consortium of Occupational State-based Surveillance (COSS) will be created to guide efforts to improve worker safety and health through assessments of conditions and translation of results into the workplace. This program announcement is intended to continue initiatives and programs developed under one or more of the following announcements: Development of Core State-Based Surveillance Model Programs (OH-00-007), Development of New or Enhanced Models for State-Based Occupational Surveillance (OH-00-008), Program for the Initiation and Development of State-Based Surveillance Capacity in Occupational Safety and Health (OH-02-007). OBJECTIVES Purpose of the NIOSH Surveillance Program Tracking occupational injuries, illnesses, and hazards has been an integral part of the NIOSH since its creation by the Occupational Safety and Health Act of 1970. In collaboration with many of its partners, NIOSH has established surveillance programs to help describe the magnitude of occupational hazards, diseases, injuries and deaths in the U.S. These surveillance activities have often documented the Nation’s progress in reducing the burden of work-related diseases and injuries. They have also identified many old and new problems that require additional research and prevention efforts. Such efforts include translation into the workplace of successful intervention approaches. PROGRAM OBJECTIVES The intended benefit of supporting surveillance programs is to increase the level of prevention activity in the state. This outcome has as a prerequisite the collection of data to estimate the magnitude and trend of the selected occupational conditions. Although significant accomplishments have been made in occupational health and safety surveillance in the U.S., there are still data gaps. To address these gaps, NIOSH and collaborators have developed strategic goals for a surveillance program. These are: o Advance the usefulness of surveillance information at the Federal and state level for the prevention of occupational illnesses, injuries, and hazards. o Strengthen the capacity of state agencies to conduct occupational surveillance. o Strengthen surveillance of high-risk industries and occupations, and of populations at high risk, including special populations. o Promote effective occupational health and safety surveillance conducted by employers, unions, and other non-governmental organizations. This program announcement will most directly help advance the second goal to strengthen state-based occupational surveillance, and to a lesser extent, other goals, including strengthening surveillance of populations at high risk. As noted in the NIOSH Strategic Plan, “states have a critical role to play in a comprehensive nationwide surveillance system. State agencies with unique and independent state-based health data systems, can provide essential information for nationwide occupational surveillance. State-based surveillance can target intervention efforts at the local and state level. Finally, there is a need to increase the capacity of states to carry out surveillance and related prevention activities.” The concept of a state-based occupational health and safety surveillance program involving multiple activities was developed from dialogue between NIOSH and its state partners and the mutual interests in integrating occupational health into mainstream public health practice. Guidelines for the planning and development of surveillance activities and associated policy, intervention, and infrastructure activities are described in the publication, Minimum and Comprehensive State-based Activities in Occupational Safety and Health (NIOSH, 1995; see references at end). The role of state- based occupational safety and health surveillance in worker safety and health, and the identification of priority occupational safety and health conditions are further described in The Role of States in a Nationwide Comprehensive Surveillance System for Work-related Diseases, Injuries and Hazards. More recently, the Council of State and Territorial Epidemiologists (CSTE, 2003) and NIOSH have completed a set of occupational health indicators that provide information about a population’s health status with respect to workplace factors that can influence health, along with a companion guide on how to access data for each indicator. Thus, NIOSH believes there is a comprehensive vision for occupational safety and health surveillance and it is now time to initiate a program which will facilitate the implementation of this vision by the states. Although NIOSH has provided support for single-condition and multiple- condition surveillance programs, many states have yet to develop the critical infrastructure needed to support fundamental occupational health and safety surveillance programs. There is ongoing need to foster the initiation of state occupational surveillance. This program announcement provides support for fundamental surveillance and for expanded surveillance program(s). It also provides for surveillance-linked intervention recommendations. An expanded program must include fundamental activities. As part of this program, all awardees are expected to participate in a Consortium of Occupational State-based Surveillance (COSS) that will meet twice annually to share and learn from experiences within the group, work through issues of common interest, and work to refine state occupational safety and health surveillance activities to maximize impact on worker safety and health. It is important that data elements which will be shared between awardees are managed in a uniform and compatible format. In addition, for the detailed field observations, the methods and data should have sufficient commonality to allow for analyses across the states as well as development of prevention recommendations. The COSS will establish a Coordination Committee (CC), comprised of one voting representative from each member of the consortium, to serve as the main governing board for the conduct of this program. The CC will serve as an advisory body for common or shared protocols that may be used. NIOSH staff will serve as non-voting members of the CC. FUNDAMENTAL PROGRAM State agencies interested in conducting a base level of occupational safety and health safety surveillance need the ability to conduct population-based surveillance of specified occupational health indicators using existing data systems. The Fundamental Program is intended to provide state agencies the resources to initiate or continue activities for a state-based surveillance program for occupational injuries, diseases, and hazards. This Fundamental Program will contribute to state and local prevention efforts as well as to national data concerning magnitude, trend, and distribution of occupational health conditions. Based on the availability of the data, the public health importance, and the opinion that these conditions should be prevented, the following health conditions have been identified for the Fundamental Program. 1. Non-fatal work related injuries and illnesses reported by employers 2. Work-related hospitalization 3. Fatal work-related injuries 4. Work-related amputations with days away from work reported by employers 5. Amputations filed with the state workers’ compensation system 6. Hospitalization for work-related burns 7. Work-related musculoskeletal disorders with days away from work reported by employers 8. Carpal tunnel syndrome cases filed with the state workers’ compensation system 9. Hospitalization from or with pneumoconiosis 10. Mortality from or with pneumoconiosis 11. Acute work-related pesticide-associated illness and injury reported to poison control centers 12. Incidence of malignant mesothelioma 13. Elevated blood lead levels among adults Additional information about the Fundamental health indicators can be found at http://www.cste.org/ under the occupational health indicators. Activities for the Fundamental Program will include but are not limited to the following: o Collect and analyze surveillance data for occupational health indicators, information on this process has been developed by NIOSH (NIOSH, 1995) and CSTE (CSTE, 2003). At a minimum, the thirteen health indicators identified above must be included in the Fundamental Program. o Identify and interact with appropriate state partners, local public health agencies, and other stakeholders to obtain input on the priority conditions for their state. o Participate in the COSS and attend their biannual meetings, o Prepare an annual performance review of the accomplishments and impact of their surveillance program. EXPANDED PROGRAM To be eligible for an Expanded Program award, an applicant must have a Fundamental Program or demonstrate prior public assistance support equivalent to this program within the last three years for state-based surveillance. The Expanded Program is intended to support Fundamental Program activities as well as provide states the resources to obtain more in-depth information about a priority health condition(s). Such information is frequently required to understand the circumstances and contributors for an occupational health condition in order to develop effective preventive measures. It is envisioned that the Expanded Program awards will continue the Fundamental Program activities and expand the program to include focused surveillance effort(s) on a state priority health condition(s). These focused efforts may involve more in-depth analysis and dissemination of information using existing data sets, and/or new case finding and case follow-up. Priority health conditions selected should address significant and compelling worker health and safety problems, and consider opportunities amenable to guide intervention efforts to improve worker health and safety, and to monitor progress in improving worker health and safety. Priority occupational safety and health conditions or worker groups may be identified through the collection and analysis of key occupational indicators, other state data and input of key stakeholders. An important feature of the Expanded Program is the identification of opportunities for intervention and prevention activities, the evaluation of these efforts and the translation of effective efforts to the state and national workplace. The effectiveness of an Expanded Program is meeting these goals may be facilitated through collaboration with other states and NIOSH. These collaborations will be enhanced through participation in the COSS and regional surveillance efforts with neighboring states. The ultimate goal for in-depth surveillance activities is to reduce occupational fatalities, injuries and disease within the states and throughout the nation. Thus, Expanded applications should not only include the Fundamental activities, but should also assist in building state capacity for conducting in-depth occupational surveillance, for performing walk- through visits and making recommendations regarding hazard abatement, and for developing and disseminating hazard prevention strategies. The objectives of the state-based Expanded projects are to (1) identify work environments that place workers at high risk occupational disease or injury, (2) identify potential risk factors, and (3) formulate and disseminate prevention strategies to those who can intervene in the workplace. Expanded applications must demonstrate a high potential for implementing a balanced program that includes occupational surveillance, field observation of the state priority conditions, and the development and dissemination of preventive strategies. Applications for the Expanded Program should include additional detailed surveillance activity plans in areas such as the following: o A surveillance system to be used at the state level. This surveillance system should enable the identification of all the occupational incidents related to the condition identified by the state. o Development and evaluation of prevention strategies for reducing the incidence of occupational disease, injuries and fatalities at the state level. o Conduct in depth analysis of data on interactions of the worker, the work environment, and work processes, prevention/intervention strategies aimed at reducing occupational injuries in the workplace. o Identify one or more priority occupational health and safety conditions or worker groups for focused surveillance efforts. o Conduct in-depth analysis of occupational health conditions using existing data sets, and/or new case findings and case follow-up. These surveillance results may be used by states to develop and implement intervention and prevention activities. o Identify one or more priority conditions or worker groups for focused occupational health and safety surveillance. o Establish or maintain procedures and policies for performing case follow-up of selected condition(s) or worker populations, including methods for identifying associated worksites. o Establish and implement plans to undertake targeted occupational prevention activities suggested by the focused surveillance (this may include promoting the use of data by others for intervention through dissemination of findings or establishing working relationships with enforcement agencies for referrals). o Establish an evaluation plan to assess effectiveness and impact of the focused surveillance activity, including case follow-up and intervention and/or prevention procedures and outcomes. o Conduct periodic analysis, interpretation, and dissemination of surveillance data (which may include a data sources assessment, comprehensive occupational disease/injury data analysis or strategic planning). o Conduct periodic surveys as needed to ascertain reporting compliance, surveillance or intervention needs, and surveillance program impact. o Collaborate with neighboring states to establish regional surveillance opportunities and enhancement. o Prepare an annual report of the accomplishments and impact of their surveillance program appropriate for public release, included as part of non- competing continuation application to NIOSH. Expanded projects must include the Fundamental occupational injuries and illnesses surveillance program (Fundamental Program) as well as new or established occupational health indicator surveillance. If intervention studies are proposed, the study plan should contain an evaluation component to determine the significance, worth, or circumstances under which the intervention is successful. CONSORTIUM OF OCCUPATIONAL STATE-BASED SURVEILLANCE An integral part of this initiative is the establishment of a COSS. The goal for this consortium is to have an integrated state-based surveillance program that builds on the results of previous projects which were independent state- based surveillance programs. A critical role of the COSS will be to assure that the data are uniform and comprehensive in order to achieve consistency across state assessments. In addition, for the detailed investigations, the methods and data should have sufficient commonality to allow for analyses across the states, as well as development of prevention recommendations. In future years a Data Coordination Center (DCC) may be established for this program through a competitive, peer-reviewed process. If the DCC is established, each recipient will be responsible for providing data to the DCC in a uniform fashion. This center would serve as the data resource for the analysis by the consortium investigators of the pooled data from all work sites in collaboration with the COSS, and these combined data will be available for all members of the COSS. The DCC and the COSS members would work together to establish an integrated occupational safety and health state-based surveillance consortium. The COSS will establish a Coordination Committee (CC), comprised of one voting representative from each member of the consortium, to serve as the main governing board for the conduct of this program. The CC will serve as an advisory body for the common or shared protocols that may be developed for use by the members. Voting members of the Coordination Committee (CC) will include the Principal Investigator (PI) for each occupational safety and health state-based surveillance award and the PI of the DCC. NIOSH staff will serve as non-voting members of the CC. The Chairperson will oversee its functions and conduct the Coordination Committee meetings. The CC will develop and ensure compliance with policies and procedures, identify and prioritize topics for observation, and evaluate protocols proposed by the successful applicants. The CC will ensure that studies are properly conducted and monitored, that data are appropriately analyzed and interpreted, and that study results are reported in the scientific literature in a timely manner and disseminated. Through the COSS, it is anticipated that critical risk factors for condition- specific projects will be better defined at both the state and national level, so that prevention and intervention strategies can be developed and translated into the workplace. It is anticipated that practitioners in occupational safety and health will be able to use the results from this project to more quickly and reliably discriminate job tasks that elevate risks for condition-specific projects. With such knowledge, effective job design changes or interventions can be developed that reduce occupational injuries. The COSS will combine the expertise and resources of NIOSH staff with those of external collaborators. Individual investigators are encouraged to analyze and publish data on their work as soon as feasible. MECHANISM(S) OF SUPPORT This PA will use the U01 award mechanism, which is a cooperative agreement. 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 PA uses “just-in-time” concepts. This announcement uses the detailed budget format that is described in the 398 application kit. 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_2003/ FUNDS AVAILABLE NIOSH intends to make two types of awards with the following general limits: Fundamental awards may have direct costs up to $100,000 per year for three years; Expanded awards may have direct costs up to $400,000 per year for up to five years. If an applicant has special circumstances for requesting more than these general limits, they must take the following steps: (1) Submit a letter to the NIOSH scientific program contact under “Where to Send Inquiries”, which must be received by that person at least six weeks prior to the application deadline, (2) Obtain agreement that NIOSH will accept the application for consideration, and (3) Identify, in a cover letter sent with the application, the NIOSH contact staff member who agreed to accept the application. Because the nature and scope of a surveillance project may vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIOSH provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS State Health and/or Labor Departments or their Bona Fide Agents. A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility, in lieu of a state application. If you are applying as a bona fide agent of a state government, you must provide a letter from the state as documentation of your status. Place this documentation behind the second page of your application form. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed project 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 programs. SPECIAL REQUIREMENTS COSS AND COORDINATION COMMITTEE (CC) MEETINGS Applicants should include in their budget support for the PI and one other person from their institution integrally involved in the project to attend an annual program meeting of the COSS. The meeting will be of two or three days duration and will be held at a site mutually acceptable to study collaborators. The initial meeting will be in Atlanta, Georgia. The applicant should also budget for attendance by the PI at two CC meetings during the first year and two in each subsequent year. For budget preparation and project planning purposes, it should be assumed that these meetings will be held in Atlanta, Georgia. However, the CC will determine later where and when future CC meetings will be held. The CC chair will coordinate the meetings to review and assess overall progress and provide the opportunity for investigators to exchange information and discuss surveillance issues. TERMS AND CONDITIONS OF AWARD Cooperative Agreement Terms and Conditions of Award The cooperative agreement is an award instrument establishing an "assistance" relationship (in contrast to an "acquisition" relationship) between NIOSH and a recipient, in which substantial NIOSH scientific and/or programmatic involvement with the recipient is anticipated during performance of the activity. The purpose of NIOSH involvement is to support and/or stimulate the recipient's activity by acting as a "partner", while avoiding a dominant role, direction, or prime responsibility. The awardee agrees to the provisions of this cooperative agreement mechanism which involve collaborative actions with the NIOSH Scientific Program Administrator to achieve the project objectives. It is anticipated that these terms and conditions will enhance the relationship between the NIOSH staff and the principal investigator(s), and will facilitate the successful conduct and completion of the awards. These agreements will be in addition to, and not in lieu of, the relevant NIOSH procedures for grants administration. 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 (state office that administers the award) and at the other sites that may be supported by sub- contractors to this award. The applicant will have primary authority and responsibility to do the following: o establish and maintain a scientific advisory committee to identify relevant state-specific issues and priorities for occupational surveillance; o define objectives and approaches for establishing and enhancing a state- based occupational surveillance program; o establish and maintain contacts with appropriate organizations, groups and individuals who may provide or use appropriate surveillance data; o conduct a review and analysis of existing surveillance data; and o publish surveillance results, interpretations, and conclusions under the terms and conditions of the cooperative agreement award. 2. NIOSH Responsibilities NIOSH anticipates having substantial scientific programmatic involvement during conduct of this activity. However the NIOSH role is limited to technical assistance, advice, and coordination. NIOSH will do the following: o serve as a scientific program administrator between the awardee and other program staff at NIOSH with experience in the occupational health issues of state surveillance programs; o provide expert consultation in the area of surveillance and occupational epidemiology, if requested by the awardee; o provide technical advice on data collection, developing operating guidelines, quality control procedures, and developing policies/protocols for dealing with recurrent situations, if requested by the awardee; and o facilitate collaborative efforts to compile and disseminate. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific, peer review, and financial or grants management issues: o Direct your questions about scientific issues to: Susan B. Board, M.S. 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 1415, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2512 FAX: (404) 498-2571 Email: firstname.lastname@example.org o Direct your questions about peer review issues to: Price Connor, Ph.D. Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Executive Park Building 24, Room 1618, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2511 FAX: (404) 498-2571 Email: email@example.com o Direct inquiries about financial or grants management matters to: Mr. David Staudt, Contract Specialist Acquisition and Assistance Field Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Telephone: (412) 386-4458 Email: firstname.lastname@example.org SUBMITTING AN APPLICATION 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 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: mailto:GrantsInfo@nih.gov SUPPLEMENTARY INSTRUCTIONS Special instructions for defining proposed project plans are included in the public health service grant guidelines (PHS 398) and should address 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. Items a-d below should be organized to address these questions in detail. a. Specific Aims. Identify the broad, long-term objectives of the proposed project and expected accomplishments. What are the surveillance activities that will be established, continued or expanded? b. Background and Significance. Briefly provide relevant background information related to this project, include a critique of existing knowledge on the subject and identify information gaps that the proposed project will address. Describe the scope and the nature of target condition(s) in the applicant’s state. Specifically address how this project is important and relevant to public health by relating the specific aims to the broad, long- term objectives. c. Preliminary Studies/Progress Report. Pertinent preliminary studies/activities conducted by the principal investigator/program director should be included to establish past experience and competence in the project area. Include a list of references to report providing a summary of the surveillance project’s specific aims and the importance of the findings. Provide a statement of published and unpublished results and achievements, include a list of titles and references for all publications and manuscripts. d. Project Design and Methods. Describe in detail the project design and methods that will be used to achieve the specific aims of the project. Specifically describe how the project design and methodology will conduct timely surveillance of the target condition, identify cases for in-depth observations, and pursue prevention activities at the state level, including new methodologies and expected advantages. Discuss potential limitations and anticipated difficulties of the proposed project and provide alternative approaches to be used to achieve the defined aims. Include a tentative timetable for the project. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement must be received or mailed on or before August 6 of each year and must include the program announcement number on the application face page. SENDING AN APPLICATION TO NIOSH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/dates.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned to NIOSH. An appropriate scientific review group convened by NIOSH in accordance with the standard NIH peer review procedures http://www.csr.nih.gov/refrev.htm will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Be discussed and assigned a priority score o Receive a written critique o Receive a programmatic review by the NIOSH Secondary Review Committee REVIEW CRITERIA The goals of NIOSH-supported projects are to advance our understanding of the occurrence of adverse health and safety outcomes from occupational hazards, improve the prevention of disease and injury, and enhance health and safety. 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment Criteria for Fundamental Applications SIGNIFICANCE: Does the project address an important occupational problem? If the aims of the project are achieved, how do they advance scientific knowledge? Did the applicant communicate the public health importance of the selected condition/indicator in the state? Is the application relevant to the objectives outlined in this announcement? Does the application describe the importance of the proposed surveillance and associated activities in evaluating and reducing occupational injuries, illnesses or hazards? If the aims of the application are achieved, how will state-based occupational health and safety capacity be advanced? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, and appropriate to the aims of the project? Does the Principal Investigator acknowledge potential problem areas and consider alternative tactics? Are the purpose and operation of the state-based surveillance program adequately described? Does the application provide a detailed plan (project design and methods) and a realistic schedule for accomplishing each of the activities to be carried out in this program? Are the conceptual framework and methods adequately developed and appropriate to the aims of the project? Are the resources used to operate the surveillance system and intervention activity identified? Are coordination and collaboration with relevant local and state agencies described adequately? Does the applicant acknowledge potential problem areas and consider alternative approaches? Is the time line proposed for the project suitable and realistic? INNOVATION: Does the project employ concepts, approaches, or objectives for surveillance, intervention, dissemination and other associated activities that lead to enhanced efficiencies or cost-effectiveness? Does the project propose any relevant new activities or methodologies to enhance the developed state-based surveillance program? INVESTIGATOR: Is the work proposed appropriate to your experience level as the principal investigator and to that of other investigators (if any)? Are the principal investigator and collaborators appropriately trained and well- suited to carry out this work? Is the surveillance and intervention work proposed appropriate to the experience level of the principal investigator and other investigators? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Are the applicant's facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of agency support generally, or specific agency commitment to support occupational surveillance and associated activities? Is there documentation of cooperation from relevant local agencies, state agencies, or other participants in the project, where applicable? BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed project. Criteria for Expanded Applications SIGNIFICANCE: Does the project address an important problem(s)? If the aims of the application are achieved, how do they advance scientific knowledge? Did the Principal Investigator communicate the public health importance of the selected condition in the state? Is the application relevant to the objectives outlined in this announcement? Have the broad, long-term objectives of the project and expected accomplishments been defined? Are the need and approaches to link surveillance and prevention activities well- described? Does the application describe the importance of the proposed surveillance and associated activities in evaluating and reducing occupational injuries, illnesses or hazards? If the aims of the application are achieved, how will state-based occupational health and safety capacity be advanced? Has the applicant described an effective and established surveillance program? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant demonstrate the ability to maintain the Fundamental occupational health and safety surveillance? Has the applicant done a critical review of the past efforts, and made appropriate changes? Does the applicant build on past efforts? Does the application provide a summary report of the previously funded state-based surveillance program, including a synopsis of past related surveillance and intervention activities and accomplishments, including a list of reports, presentations, and education materials? Has the applicant established a state-based surveillance program that is comprehensive, including intervention activities linked to surveillance activities? Are the purpose and operation of the state-based surveillance program adequately described? Does the application provide a detailed plan (project design and methods) and a realistic schedule for accomplishing each of the activities to be carried out in this program? Does the intervention work have an evaluative component? Are the conceptual framework and methods adequately developed and appropriate to the aims of the project? Are the resources used to operate the surveillance system and intervention activity identified? Are coordination and collaboration with relevant local and state agencies described adequately? Has the applicant provided evidence of successful interactions? Does the applicant acknowledge potential problem areas and consider alternative approaches? Is the time line proposed for the project suitable and realistic? INNOVATION: Does the project improve or develop methodologies or technologies? Does the project employ state of the art concepts, approaches, or objectives for surveillance, intervention, dissemination and other associated activities that may lead to enhanced efficiencies or cost- effectiveness? Does the project propose any relevant new activities or methodologies to enhance the developed state-based surveillance program? INVESTIGATOR: Is the work proposed appropriate to your experience level as the principal investigator and to that of other investigators (if any)? Are the principal investigator and collaborators appropriately trained and well- suited to carry out this work? Is the surveillance and intervention work proposed appropriate to the experience level of the principal investigator and other investigators? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support? Are the applicant's facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of agency support generally, or specific agency commitment to support occupational surveillance and associated activities? Is there documentation of cooperation from relevant local agencies, state agencies, or other participants in the project, where applicable? BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed project. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed project will be assessed (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN SURVEILLANCE PROJECT: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH (if applicable): 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. PROGRAMMATIC REVIEW CRITERIA (1) Magnitude and severity of the condition (problem) in the worker population. (2) The potential to fill gaps in nationwide occupational injury and illness surveillance. (3) The potential impact of the surveillance program on the prevention of occupational health and safety hazards on a state-wide basis. (4) The commitment of the state to supporting an occupational health and safety surveillance program. (5) The overall balance in types of awards and in geographic location of the awards. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to surveillance program priorities and program balance 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 of 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. Because public health surveillance is the ongoing systematic collection, analysis and interpretation of health data for improving worker health and safety, applicants should be aware of the HHS human subjects requirements. The web site for HHS human subjects protections is 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 Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. 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. 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: NIOSH policy requires education on the protection of human subject participants for al 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). 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 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. LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or state legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition no part of PHS 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, NIOSH/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 NIOSH/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 NIOSH/CDC grants and cooperative agreements need to be careful to prevent NIOSH/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and “grass roots” activities that relate to specific legislation, recipients of NIOSH/CDC funds should give attention to isolating and separating the appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds. NIOSH/CDC also cautions recipients of NIOSH/CDC funds to be careful not to give the appearance that NIOSH/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law. HEALTHY PEOPLE 2010: 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 improve the quality of life. This RFA is related to one or more focus areas. Potential applicants may obtain a copy of "Healthy People 2010" 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 Section 301 of the Public Health Service Act as amended (42 USC 241 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. And under the Occupational Safety and Health Act of 1970, Section 20(a) (29 USC 669(a)). 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. USEFUL REFERENCES NIOSH . Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 (http://www.cdc.gov/niosh/nora.html). Morbidity and Mortality Weekly Report (MMWR). A Framework for Assessing the Effectiveness of Disease and Injury Prevention. March 27, 1992/Vol.41/Jn. The MMWR can be accessed through the world-wide Web at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00016403.htm NIOSH FACE Program: National Institute for Occupational Safety and Health website at: http://www.cdc.gov/niosh/face/faceweb.html Stanbury M., Rosenman K., and Anderson H . Guidelines: Minimum and Comprehensive State-based Activities in Occupational Health and safety. Occupational and Environmental Health Committee. Council of State and Territorial Epidemiologists. Association of State and Territorial Health Officials. Cincinnati, OH: US Department of Health and Human Services Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Health and safety, DHHS (NIOSH) Publication No. 95-107. NIOSH-CSTE Surveillance Planning Working Group . The Role of States in a Nationwide Comprehensive Surveillance System for Work-related Diseases, Injuries and Hazards. Council of State and Territorial Epidemiologists. Available at: http://www.cste.org/pdffiles/FINREP.pdf. NIOSH . Tracking Occupational Injuries, Illnesses, and Hazards: The NIOSH Surveillance Strategic Plan. Cincinnati, OH: US Department of Health and Human Services Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Health and Safety, DHHS (NIOSH) Publication No. 2001-118. CDC . Notice to Readers: Occupational Health Indicators for Tracking Work-Related Health Effects and Their Determinants. MMWR, November 29, 2002/51(47):1073-1074. CDC . Assessment of the Epidemiologic Capacity in State and Territorial Health Departments – United States, 2001. MMWR, October 31, 2003/52(43): 1049-1051.
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