DEVELOPMENT OF CORE STATE-BASED SURVEILLANCE MODEL PROGRAMS Release Date: MArch 15, 2000 RFA: OH-00-007 National Institute for Occupational Safety and Health Letter of Intent Receipt Date: April 2, 2000 Application Receipt Date: May 11, 2000 PURPOSE The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for cooperative agreement (U01) applications from a single State entity or consortia of State entities who are capable of, and interested in, participating in a State Occupational Surveillance Consortium (SOSC). The goal of the SOSC is to develop model surveillance systems that can strengthen state-based occupational surveillance programs for occupational diseases, injuries, and hazards. Applications are sought that develop and, through local implementation, validate new or enhanced model systems of surveillance for multiple occupational conditions (Core Program). These projects must have high potential for implementation in surveillance programs of other States. HEALTHY PEOPLE 2010 CDC is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area of Occupational Safety and Health. For information on the conference on Healthy People 2010, visit the internet site: http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by State health departments or other State health agencies or departments that direct and coordinate the State"s occupational surveillance program. This eligibility includes health departments or other official organizational authority (agency or instrumentality) of the District of Columbia, the Commonwealth of Puerto Rico, any territory or possession of the United States, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. Other official State and territorial agencies with occupational safety and health jurisdiction may also apply. Applicants other than health departments must apply in collaboration with and through their State and territorial health department. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism, in which substantial NIOSH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIOSH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period for an application submitted in response to this present RFA may not exceed four (4) years. The anticipated award date is September 29, 2000. The award and level of support depends on receipt of applications of high scientific merit. AVAILABILITY OF FUNDS Approximately $500,000 is available in fiscal year (FY) 2000 to fund 2-3 awards under this RFA. Awards are anticipated to range from $150,000 to $250,000 in total costs (direct and facilities and administrative (F&A) costs) per year. Awards will be made for a 12-month budget period within a project period up to 4 years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds in future years. USE OF FUNDS Recipient should allocate funds for travel for two project staff to attend an annual three day meeting to be held in conjunction with the Annual Meeting of the Council of State and Territorial Epidemiologists. PREAPPLICATION QUESTIONS AND ANSWERS Applicants are invited by NIOSH to attend a preapplication technical assistance conference on April 6, 2000 at 1:00 PM (Eastern time) to discuss: programmatic issues regarding this program, how to apply, and questions regarding the content of the RFA. This meeting is expected to last approximately three hours. The meeting will be held at the NIOSH Alice Hamilton Laboratory located at 5555 Ridge Avenue, Cincinnati, Ohio, 45213. Applicants may also participate by telephone. The conference name is NIOSH Surveillance. The telephone bridge number is (800)-713-1971 Interested parties will need the conference code, 662340, to participate. RESEARCH OBJECTIVES Background Occupational safety and health surveillance refers to the ongoing, systematic collection, analysis, and interpretation of relevant health and hazard data essential to the planning, implementation, and evaluation of industrial safety, industrial hygiene, occupational health, and/or public health practice, closely integrated with the timely dissemination of these data to those who need to know. The final link of the surveillance chain is the use of these data to develop prevention and control strategies. A surveillance system includes a functional capacity for data collection, analysis, and dissemination linked to industrial safety, industrial hygiene, occupational health, and/or public health programs. Surveillance systems can operate at one or more work organization or geo-political levels (e.g. plant, company, union, state or federal levels). Over the past quarter century, NIOSH has played a key role in the surveillance of occupational diseases, injuries, and hazards, complementing the important surveillance activities carried out by many States and several other Federal agencies, including the Bureau of Labor Statistics (BLS), the Occupational Safety and Health Administration (OSHA), the Mine Safety and Health Administration (MSHA), and the National Center for Health Statistics (NCHS). NIOSH began developing a program of national occupational health surveillance activities in the early 1970s. These initial efforts involved hazard surveillance and health effects surveillance. Collaboration between NIOSH and States related to occupational safety and health surveillance began with the Surveillance Cooperative Agreements between NIOSH and States (SCANS), a program intended to increase State health department capacities in the area of occupational safety and health. In addition to the Sentinel Event Notification Systems for Occupational Risks (SENSOR) Program operating in 13 States and the Fatality Assessment and Control Evaluation (FACE) Program operating in 20 States, current major collaborative surveillance-related activities between NIOSH and States include the Adult Blood Lead Epidemiology and Surveillance (ABLES) Program, a program that has grown from 4 States in 1987 to 28 States in 1999. The concept of a core (multiple activities) occupational surveillance program derives from NIOSH’s dialogue with its State partners and the mutual interests in integrating occupational health into mainstream public health practice. Building surveillance programs at the State level, that are actively linked with intervention efforts, provides an invaluable opportunity to integrate occupational health into mainstream public health. From a NIOSH perspective, the successes and lessons learned from the surveillance of targeted diseases, injuries, and hazards will be distilled to assist NIOSH and our State partners in developing models for core occupational surveillance program that should be undertaken in every State. The primary goal of these core surveillance activities is to increase, if only modestly, the level of prevention activity in the State, rather than to only provide data to estimate the magnitude and trend of the selected occupational conditions. An integral part of this initiative is the establishment of a State Occupational Surveillance Consortium (SOSC). One critical role of the SOSC is to ensure that the study designs and data collection protocols are uniform and compatible across recipients. Such coordination is needed if new/enhanced surveillance approaches are to be used across State agencies. In order to accomplish that goal, the SOSC 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 research program. In addition, the CC will serve as an advisory body for the common or shared protocols to be used in the studies. NIOSH staff will serve as non-voting members of the CC. Objectives and Scope Model core surveillance activities have been described in the peer reviewed literature that may aid applicants in developing model surveillance programs. Many of these programs have met the needs of local and State agencies responsible for public health surveillance. Core surveillance approaches must not only meet an applicants priorities, but must also have the potential for adoption by other States for core surveillance activities. Although the focus of the model(s) of core surveillance capacity should be state-based, applicants may also include approaches which permit neighboring States to work together to establish regional surveillance efforts. Based on an analysis of prior efforts to develop transferable State core surveillance approaches, a number of the common features that were identified included: o capacity to conduct a basic level of case finding for specific, priority occupational injuries, diseases, and hazards, o mandated lab-based reporting (e.g., blood lead levels exceeding 40 micrograms/deciliter) and case follow-up o periodic analysis of existing datasets (e.g., death certificate data, hospital discharge data) and selected case follow-up, o periodic surveys of workers and/or employers, o capacity for in-depth follow-up of new or unusual cases, o capacity to conduct periodic analysis and dissemination of relevant data, and o capacity for targeted prevention activities. This RFA seeks applications that develop core programs that can be used by multiple State surveillance programs. Such model programs should be conceptualized, implemented, evaluated, and revised to advance the development of a practical core surveillance model which may be adopted by multiple States. Although the focus of the model(s) of core surveillance capacity should be state-based, applicants may also include approaches which permit neighboring States to work together to establish regional surveillance efforts. Additional information on state based activities is available at the NIOSH web site http://www.cdc.gov/niosh/95-107.html. USEFUL REFERENCES National Institute for Occupational Safety and Health. National Occupational Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 (http://www.cdc.gov/niosh/nora.html). National Institute for Occupational Safety and Health, Guidelines for Minimum and Comprehensive State-based Activities in Occupational Safety and Health. 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. 95-107 (http://www.cdc.gov/niosh/95-107.html). COORDINATION COMMITTEE AND STATE SURVEILLANCE MEETINGS Principal investigators should include in their budget support for themselves and for at least one other person from their institutions integrally involved in the project to attend an annual program meeting of all members of the SOSC. The meeting will be of three days duration and will be held in conjunction with the Annual Meeting of the Council of State and Territorial Epidemiologists. The principal investigator should also budget for attendance at four Coordination Committee (CC) meetings of the SOSC 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 Cincinnati, Ohio. The CC will determine where and when recurring 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 research issues. 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 Grant Administration policy statements. 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 a. develop a case ascertainment system appropriate for the surveillance condition(s) including either a case definition for each surveillance condition or the description of the existing data system, b. provide study participants with individual notification letters when medical tests are performed, c. serve as a permanent member of the CC, d. develop and submit semiannual progress reports, e. disseminate the scientific findings, f. provide program management oversight for the project, and g. notify study participants of the overall study results, if applicable. 2. NIOSH Responsibilities NIOSH anticipates having substantial scientific programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination. NIOSH will: a. serve as a scientific liaison between the awardee and other program staff at NIOSH with experience in the occupational health issues of State surveillance programs, b. provide expert consultation in the area of surveillance and occupational epidemiology, if requested, c. provide technical advice on data collection, developing operating guidelines, quality control procedures, and developing policies/protocols for dealing with recurrent situations, if requested, d. facilitate collaborative efforts to compile and disseminate program results through presentations and publications, 3. Collaborative Responsibilities The CC will serve as the main governing board for the cooperative agreements making up the SOSC. NIOSH staff and one scientist from each recipient will have membership on the CC. One critical role of the CC is to ensure that the case definitions and data collection protocols are uniform and compatible across the SOSC. The CC may, when it deems it to be necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed. It is anticipated that there will be four CC meetings during the first year and two in each subsequent year, but the actual number and locations of the meetings will be determined by the CC itself. The initial planning meeting will be organized by NIOSH and held in Cincinnati soon after the award, but subsequent meetings will be organized by the CC. The committee chair will schedule the meetings and will be responsible for developing the meeting agenda, chairing the meetings, and producing CC reports. At the Planning Meeting, the CC may: o discuss and clarify program goals, o discuss and set initial recruiting targets and schedules At the second and subsequent meetings, the CC may: 1) make recommendations on the case definitions and data collection approaches, 2) identify and recommend solutions to unexpected problems and 3) recommend guidelines for minimum and ideal state-based occupational surveillance programs. HUMAN SUBJECTS REQUIREMENTS If a project involves research on human subjects, assurance (in accordance with Department of Health and Human Services Regulations, 45 CFR Part 46) of the protection of human subjects is required. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. Unless the grantee holds a Multiple Project Assurance, a Single Project Assurance is required, as well as an assurance for each subcontractor or cooperating institution that has immediate responsibility for human subjects. The Office for Protection from Research Risks (OPRR) at the National Institutes of Health (NIH) negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the Centers for Disease Control and Prevention (CDC) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. LETTER OF INTENT Prospective applicants are asked to submit, by April 2, 2000, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NIOSH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ann M. Cronin National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-40 Atlanta, GA 30333 Telephone 404-639-2277 Fax 404-639-0035 Email: axc2@cdc.gov APPLICATION PROCEDURES Applicants must use Form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: grantsinfo@nih.gov. Application kits are also available at: www.nih.gov/grants/forms.htm. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ann M. Cronin National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-40 Atlanta, GA 30333 Applications must be received by May 11, 2000. If an application is received after that date, it will be returned to the applicant without review. CSR and NIOSH will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. CSR and NIOSH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive, will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by NIOSH. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review. Following the scientific review, competitive applications will be reviewed for programmatic importance by a NIOSH Secondary Review Committee. Peer Review Criteria The review group will assess the scientific merit of the protocols and related factors as follows: Significance: Is the application relevant to the objectives outlined in the RFA? Has the proposed priority conditions or surveillance system been justified as important for the applicant’s State? Does the application describe the importance of the proposed surveillance activity in reducing occupational injuries, illnesses, or hazards? Is the proposed model likely to be useful for surveillance programs of other States? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the proposal? Does the proposal demonstrate the capacity or a plan to produce and disseminate case reports, data, and other information that promotes the goals of increasing prevention activities? Are the proposed schedule and personnel adequate for accomplishing the proposed activities? Does the applicant acknowledge potential problem areas and consider alternative approaches? Is the time line proposed for the project suitable? Innovation: Does the project employ novel concepts, approaches, or methods? Is the project original and innovative? Does the application address the feasibility of providing information needed to demonstrate how the model systems can be implemented in other States, including States with limited resources and experience in conducting occupational surveillance? Investigators: Are the principal investigator and her/his collaborators appropriately trained and well suited to carry out this work? Do they have adequate experience and competence in the design, implementation, and evaluation of public health surveillance and epidemiology activities? Is the work proposed appropriate to the experience level of the Principal Investigator and her/his collaborators? Environment: Are the applicant’s facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of institutional support generally, or specific agency commitment to development of occupational health surveillance activities? Does the applicant adequately document the commitment of the sponsoring agency to this project? In addition to the above criteria, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of plans to include both genders, and minorities and their subgroups, for the scientific goals of the research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Programmatic Review Criteria: o Magnitude and severity of the problem the worker population. o Likelihood of developing technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. AWARD CRITERIA Applications will be considered for award based upon (a) scientific and technical merit, (b) program importance, (c) program balance in terms of past and current funding of surveillance activities, and (d) availability of funds. SCHEDULE Letter of Intent Receipt Date: April 2, 2000 Application Receipt Date: May 11, 2000 Anticipated Award Date: September 29, 2000 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael J. Galvin, Jr. Ph.D. Research Grants Program National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: 404/639-3343 FAX: 404/639-4616 Email: mtg3@cdc.gov Direct inquiries regarding grants management to: Sheryl L. Heard, Grants Management Specialist Grants Management Branch, Procurement and Grants Office Announcement 00040 Centers for Disease Control and Prevention 2920 Brandywine Road, Room 3000 Atlanta, Georgia 30341 Telephone: (770) 488-2723 Email address: slh3@cdc.gov PAPERWORK REDUCTION ACT Projects that involve the collection of information from 10 or more individuals and funded by cooperative agreement will be subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. AUTHORITY AND REGULATIONS The Catalog of Federal Domestic Assistance number is: 93.262 for the National Institute for Occupational Safety and Health (NIOSH). This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. SMOKE-FREE WORKPLACE The CDC strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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