MINING SAFETY AND HEALTH TRAINING AND TRANSLATION CENTER RELEASE DATE: November 20, 2003 RFA Number: RFA-OH-04-005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: Centers for Disease Control and Prevention (CDC) PARTICIPATING INSTITUTES AND CENTERS: National Institute for Occupational Safety and Health, (NIOSH), (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): CFDA 93.262 LETTER OF INTENT RECEIPT DATE: December 18, 2003 APPLICATION RECEIPT DATE: January 23, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA 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 grant applications for mining safety and health training and translation research to address mining operations in the Western United States. Applications are sought that provide an integrated approach for training mine workers and for translational research in order to improve safety and health of the mining environment. Research projects that are focused on topics other than translational research are not responsive to this RFA. PROGRAM OBJECTIVES Background Despite many technological and work environment advances, mining remains one of the most dangerous occupations in the United States. The fatality rate in mining is six times higher than the national average for other industries. Additionally, the severity of injuries for mining exceeds all other industries with the highest percentage of lost work days per incident. Between 1987 and 1996, black lung disease caused the deaths of over 18,000 U.S. coal miners. In addition, more than 65 percent of miners experience occupational hearing loss by the time they retire. With the increased demand for coal to meet the nation’s energy needs, many of the health and safety problems associated with mining will be increased such as noise levels, methane gas levels, respirable dust levels etc. As a result, mining training and translation research interests span a wide range of disciplines. In addition, the objective of any translation project must explicitly address a mining issue and not be a project that would only contribute to mining safety and health as a secondary outcome. Goals This grant will support mining occupational health and safety education and translational research projects that are developed to enhance the training of mine workers and to foster the transfer of research findings to the mining environment. Objectives The goal of this grant is to reduce the number of injuries to workers who are involved in mining operations through an integrated program of training and translational research. This grant is intended to support a Western United States (referred to as Western in this document) program that 1) identifies the training needs of mining personnel, 2) develops and conducts a Western training program, 3) provides qualified instructors and faculty to train mining personnel, 4)evaluates the effectiveness and impact of the training program on reducing injuries to mining personnel, and 5) conducts translational projects that convert mining occupational health research into information, resources or tools. The training provided by this program should satisfy current Occupational Safety and Health Administration (OSHA) and Mine Safety and Health Administration (MSHA) recommendations and guidelines. See Useful References After AUTHORITY AND REGULATIONS (Below). MECHANISM OF SUPPORT This RFA will use the education project grant (R25) 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 NOT be resubmitted as NEW investigator-initiated applications as this is a not a recurring NIOSH program. For this RFA, the Facilities and Administration (F&A) Costs are limited to eight percent (8%) of the direct cost for the training activities. For the translation projects, the established institutional rate will be used. Approximately $450,000 of the direct costs for each year of the project must be used for the training activities. 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 $1,000,000 in fiscal year (FY) 2004 to fund one new and/or competitive continuation grant in response to this RFA. An applicant may request a project period of up to five years and a budget for total costs (direct costs, and facilities and administration (F&A)) of up to $1,000,000 in the first year. In the second through fifth years, the total costs that may be requested may not exceed $600,000. Applications exceeding $1,000,000 in total costs in the first year or $600,000 in the subsequent years will be considered unresponsive and returned without further consideration. The F&A for the administrative and training components is limited to an eight percent (8%) rate. The F&A rate for the translation projects will be based on the established institution rate at the time of award. Although the financial plans of NIOSH provide support 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application (s) if your institution is a domestic organization and 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 Faith-based organizations o Federally recognized Indian Tribes, Tribal Governments, Colleges, and/or Organizations Because the focus of this training is on western mining operations, ease of access is a significant consideration. Therefore, eligibility is limited to institutions whose principal location is west of the Mississippi River. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions 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. 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 Mining Safety and Health Training and Translations Research Center are: 1. Administrative, Planning and Outreach Core. 2. Training Core. 3. Translation Projects ESSENTIAL ELEMENTS OF A WESTERN TRAINING AND TRANSLATION CENTER ADMINISTRATIVE AND PLANNING CORE The Administrative, Planning and Outreach Core must have a leader who is capable of providing training and translation research 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 training and translation projects will be a significant consideration in the evaluation of the application. The Administrative, Planning and Outreach Core is intended to support 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 10% time commitment (direct and in-kind) for the Mining Center’s administration and coordination. o An External Advisory Committee, comprised of at least three members who are recognized leaders in mining health and safety and regional mining experts, will provide overall guidance and advice to the principal investigator on program direction. o Outreach Activities: Essential functions of the outreach core include but are not limited to, coordinating and collaborating with mining researchers and industry stakeholders to identify key issues and needs. The principal investigator may also include ongoing mining communication efforts and convening consensus-development sessions to address complex and/or controversial issues with the aim of preventing mining injuries and illness. o First year funds for program initiation. NIOSH recognizes that there may be significant costs associated with the initiation of a Western States Training Program. Therefore, in the first year of the project an investigator may include up to $200,000 in direct costs for startup expenses. Items that may be appropriate for these funds include computer work stations, classroom modifications/supplies, web site development, distance learning equipment, etc. The request for these funds must be well justified in the application. TRAINING PROJECTS This should be the major focus of the program. These projects should focus on the training of Western miners. The activities should be well described and sufficient details provided to enable a peer review panel to assess the quality of the proposed training. A well defined evaluation component is considered an essential element for the training projects. The recipient should coordinate project activities, academically, scientifically and administratively, at the awarded 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 identify and train the target populations; to plan and conduct a Western program for mine safety and health training, to analyze and evaluate the training impact; and to publish results, interpretations, and conclusions of activities conducted. TRANSLATION PROJECTS (These projects CANNOT exceed $200,000 in direct cost in the first year, and $100,000 in direct costs in the out years. Applications exceeding $200,000 in direct costs for translation projects in the first year or $100,000 in the subsequent years will be considered unresponsive and returned without further consideration.) These are projects that focus on the translation of extant knowledge (e.g. peer reviewed articles) into products or practices that meet mining 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 results from the research environment into the mining industry. As the goal for these projects is the adoption of new/improved knowledge in the mining 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 mining trade or industry group. Projects may address research issues that affect the diffusion of results to the work setting. Such research could include projects to improve understanding of what influences mining industry decision-makers, workers, contractors, or others to adopt new practices, tools, and methods to improve safety and health performance. PROJECT PLANS Special instructions for defining project plans are included in the public health service grant guidelines (PHS 398, page 15) and should address the following questions 1) What do you intend to do to address the problem, 2) Why is the work important, 3)What has already been done to address this need, and 4)How are you going to do the work to address the needs of the program. Items a-d should be organized to address these questions in detail. a. Specific Aims: Identify the broad, long-term objectives of the proposed training and translation projects and expected accomplishments. b. Background and Significance: Briefly provide relevant background information related to the project; include a critique of existing training programs for mining workers. Identify training gaps that the proposed project will address. Describe the need for a comprehensive Western United States Mining training program and how this project will satisfy this need. Describe the needs for translational projects. c. Preliminary Studies: 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 appropriate publications and training materials. d. Project Design and Methods: Describe in detail the project design and methods that will be used to achieve the objectives of the project, the steps to be undertaken in planning, implementing and evaluating this project, and the respective responsibilities of the applicant and other personnel for carrying out those steps. The project design and methods should specifically address how the goals of the program will be met to include 1) assessing the needs for the Western training program, 2) developing and conducting a five year training and translation project plan to meet those needs, 3) providing qualified instructors and faculty to train mining personnel, 4) evaluating the training program and the impact on mining safety and health, and 5) fully describing the translation project. A schedule for accomplishing each of the tasks to be carried out during the project period (include a time-line for activities) and a method for evaluating the accomplishments should be provided. In addition, describe the names and qualifications of the proposed staff and time allocated for them to accomplish program activities; the support staff available for the project; the instructors for the program; and audio-visual support, the facilities, space, and equipment available for the project. Letters of support from professional/community organizations, agencies and worker groups whose participation is essential for program success (such as mining groups, potential trainees, etc.) should be included. Submit a plan for evaluating the Western training program and its impact on mining safety and health, including tracking trainee activities. 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. This RFA and other CDC Announcements can be found on the CDC HomePage at http://www.cdc.gov, under the Funding Section (see Grants and Cooperative Agreements, scroll down to Occupational Safety and Health). This RFA can also be found on the NIOSH HomePage http://www.cdc.gov/niosh/homepage.html, under Funding Opportunities. Direct your questions about scientific/research issues to: Michael J. Galvin Jr., Ph.D. 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 1536, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2524 FAX: (404) 498-2571 Email: mtg3@cdc.gov Direct your questions about peer review issues to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov Direct inquiries about financial or grants management matters to: Mr. John Columbia, 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: JColumbia@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research 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 and should be sent to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov SUBMITTING AN APPLICATION 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) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. 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 NIOSH: 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 and all copies of appendix material 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: pmajor@cdc.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of the 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 eight weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or nonresponsive 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 a scientific review group convened by NIOSH 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 scientific or technical 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 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example it may propose to carry out important work that by its nature is not innovative but essential to move a field forward. SIGNIFICANCE: If the aims of the application are achieved, how will knowledge be advanced? Will the proposed project contribute to the overall aims of improving mine safety and health? o Did the applicant communicate the needs and objectives of providing a comprehensive Western United States training program for miners? o Is the application responsive and relevant to the objectives outlined in the RFA? Have the broad, long-term objectives of the project and expected accomplishments been defined? o Did the applicant provide a needs assessment for training for Western United States miners to identify specific areas of training needed? o Did the applicant provide a strong rationale for the translation project(s)? APPROACH: o Does the project identify and target necessary personnel to be trained, including the types of trainees, amount of training, and specific levels of training? o Does the applicant provide a detailed and well conceived plan for the translation project(s)? o Does the application provide a detailed plan (project design and methods) and a proposed schedule for accomplishing each of the activities to be carried out in this project? o Does the project provide a plan to conduct training programs for mine workers? o Does the project meet current OSHA or MSHA guidelines and other recommendations for training mine workers? o Does the application clearly define the strengths, limitations, and comprehensiveness of the Western training program plan to address the distinct characteristics and needs of the target audience, including the essential program elements for planning, conducting, and evaluating training programs? o Does the project provide a mechanism to evaluate the knowledge and skills of miners before and after training in order to ensure consistency in delivering training programs for target worker populations? o Are the proposed training materials and personnel adequate for accomplishing the proposed activities? o Is the time-line proposed for the project suitable? o Is there a method for evaluating the knowledge, the effectiveness of training, and impact of the training on mine workers? INNOVATION: o Does the applicant propose innovative concepts, approaches, or methods for training mine workers? o Does the applicant propose innovative concepts, approaches, methods for establishing a five year Western training program, including collaboration with the mining communities? INVESTIGATOR: o Does the training and experience of the Program Director and staff meet the needs of the proposed project? o Does the training personnel have appropriate expertise in the mining field and experience in developing curricula? o Is the investigator(s) for the translation project(s) qualified and appropriate? o Are the proposed course materials current? o Does the project provide a method for selecting and training faculty to conduct training classes? ENVIRONMENT: o Are the applicant’s facilities, equipment, and other resources adequate for the performance of this project? o Is there evidence of institutional support or other documentation that demonstrated the applicant’s ability to work with diverse groups, establish collaborations, and facilitate emergency response information? 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 research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. PROGRAMMATIC REVIEW CRITERIA o Number of mining personnel to be trained. o Appropriateness of the target population. o The likelihood of mining personnel and trainees developing technical knowledge for the prevention of injury or disease from mining operations. o The likelihood of the translation projects impacting the mining environment. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit o Availability of funds o Programmatic priorities o Population studied 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 NIOSH application will follow the NIH policy. Applicants seeking $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 NIOSH and NIH that women and members of minority groups and their sub- populations must be included in all NIOSH-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. NIOSH has adopted this policy 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. NIOSH has adopted this policy. 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/RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIOSH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIOSH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of the Centers for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered lobbying. That is lobbying for or against pending legislation, as well as indirect or grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training; and foster safe and healthful environments. Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and grassroots activities that relate to specific legislation, recipients of CDC funds should give attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law. 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. SMOKE FREE WORKPLACE: The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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