Collaborative Program for the Identification and Prevention of Work-related Musculoskeletal Disorders RELEASE DATE: May 2, 2002 RFA: OH-02-010 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute for Occupational Safety and Health (NIOSH) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov/niosh/homepage.html) LETTER OF INTENT RECEIPT DATE: June 11, 2002 APPLICATION RECEIPT DATE: July 11, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism(s)of Support o Funds Available o Use of Funds o Eligibility Considerations and Requirements o Special Requirements o Terms and Conditions of Award 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 The National Institute for Occupational Safety and Health invites applications for Cooperative Agreements (U01s) from single institutions or consortia of institutions who are capable of, and interested in, conducting research to quantify the risk for upper limb and low back musculoskeletal disorders at varying levels of exposure to physical job stressors (repetitive motion, forceful exertion, awkward postures, manual handling, etc.). RESEARCH OBJECTIVES Background Work-related Musculoskeletal Disorders (MSDs) remain a large and costly disease to our society even though there have been many advances in understanding the ergonomics of work. In 1996, a total of 600,390 work-related musculoskeletal injury cases resulting in work absence or restriction were reported to be caused by overexertion and repetitive motion by the Bureau of Labor Statistics (BLS). Because the BLS annual survey does not cover approximately one-third of workers, this figure significantly underestimates the overall incidence of MSDs in the American workforce. Of all MSD cases, sixty-nine percent were low back or distal upper limb disorders. The magnitude of the problem in today=s workforce is confirmed by workers= compensation data. For instance, in Washington State between 1990 and 1997, 27% of all workers= compensation claims and 46% of the cost of all claims resulted from non-traumatic musculoskeletal disorders of the neck, upper extremity or back. The results from this research program will provide practitioners in occupational health critical data that will facilitate their identification of job tasks that represent low, moderate and high risk for MSDs, and that will provide a knowledge base for effective job design changes or interventions. Past studies primarily have been cross sectional or retrospective, the limitations of these approaches for determining exposure response relationships have been widely discussed in the scientific literature. This RFA builds on an initial effort (see http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-003.html) in 2000 to begin a Collaborative Program for the Identification and Prevention of Work-related Musculoskeletal Disorders. The current RFA expands this program by making available additional funds to meet the objective of collecting sufficient data to better understand exposure response relationships between physical stressors and MSDs. An integral part of this initiative is participation in a Work-related Musculoskeletal Disorders Consortium (MSDC). In order to achieve the goals of this program, it is important to have common data elements shared among awardees that are managed in a uniform and compatible format. In addition, because much of the shared data elements are centered on job tasks and workers, a critical role of the MSDC is to assure that job tasks are studied using uniform exposure assessment methods and that workers undergo standard health tests to identify MSDs. Etiology is a critical element in meeting the RFA objective of studying MSD. In order to accomplish that goal, the initial awardees established a Coordination Committee (CC), to serve as the main governing board for the conduct of this research program. The CC is comprised of one voting representative from each member of the MSDC. New awardees under this current RFA will also have one voting member on the CC. The CC will continue to serve as an advisory body for the common or shared protocols to be used in the studies. The NIOSH liaison serves as a non-voting member of the CC. Research Goals An anticipated outcome of this research program will be better defined exposure-response relationships between job physical stressors and musculoskeletal disorders across industries. Information regarding the utility of practical methods that could be readily employed by occupational safety and health practitioners, such as the American Conference of Governmental Industrial Hygienists Threshold Limit Value for Hand Activity and the NIOSH Lifting Equation, is another anticipated outcome. With such knowledge, effective job design changes or interventions can be developed that reduce the burden of work-related MSDs. The MSDC will combine the expertise and resources of NIOSH research staff with those of external collaborators. It is anticipated that up to four new extramural partners that demonstrate expertise in 1) upper limb MSDs (CTS, hand-wrist tendinitis, epicondylitis) at varying levels of hand activity, exertion, and other physical stressors in job tasks, and/or 2) low back pain in relation to physical demands of lifting and manual handling tasks will be awarded cooperative agreements and will participate in the MSDC. Individual investigators will be free to analyze and publish data from the work sites they study. In addition, each investigator will be responsible for providing data to a data coordinating center in a uniform fashion. The intent of this initiative is to assemble a cross-disciplinary, multi-institutional consortium to define exposure response relationships among physical job stressors and upper limb and low back MSDs. To accomplish this objective, it is envisioned that the following research areas be examined: 1) upper limb MSDs at varying levels of hand activity, exertion, and other physical stressors in job tasks, and 2) low back pain in relation to physical demands of lifting and manual handling tasks. USEFUL REFERENCE 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). MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01). 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 30, 2002. The award and level of support depends on receipt of applications of high scientific merit. The award pursuant to this RFA is contingent upon the availability of funds. An applicant may only submit applications that are limited in scope to one of the two research areas defined in this RFA. On the face page of the application, line two, the applicant must indicate the proposed research, either 1) upper limb MSDs (CTS, hand-wrist tendinitis, epicondylitis) at varying levels of hand activity, exertion, and other physical stressors in job tasks, or 2) low back pain in relation to varying levels of physical demand due to lifting and manual handling tasks. If an applicant wishes to apply for more than one research area, you must submit a separate and independent application. Applications which address more than one of the RFA topics will be returned as non- responsive. This RFA is a one time announcement. If by the end of the fourth year of the award NIOSH has not determined whether or how this program will be continued, awardees should contact NIOSH program staff and consider submitting investigator-initiated (R01) application which will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1,000,000 is available in FY 2002 to fund two to four awards. The maximum amount that may be requested is $500,000 total cost (direct and indirect) per year. Awards will be made for a 12-month budget period within a project period up to four(4) years. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds. USE OF FUNDS Recipient should allocate funds for travel for two project staff to attend two MSDC meetings held during each project year. ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private nonprofit and for-profit organizations and by governments and their agencies, that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents, including small, minority and/or women-owned businesses. Applications from minority and women investigators are encouraged. SPECIAL CONSIDERATIONS AND REQUIREMENTS Applicants with established resources and facilities to recruit study sites and to enroll workers willing to participate in the study in a cost effective manner are encouraged. The following should be addressed in a clear and organized manner (see also peer review criteria section): o Time line: a detailed time line for the proposed study must be included in the application. o In a separate section labeled, Participant Notification of Study Results, the applicant should describe plans for notifying participants about their individual results and the overall results of the study. Applicants should highlight unique expertise and/or unusual opportunities as related to the purpose of this RFA. Examples include, but are not limited to: o Expertise in specialized areas with potential applications to the issues/questions considered in this RFA, such as health effects assessment for the upper extremities, field studies of working populations experiencing work-related MSDs and experience utilizing the NIOSH lifting equation, o Access to specific work sites and working populations that are willing to participate in studies of work-related MSDs, o Expertise in assessing work situations and individual job tasks in relation to the development of work-related MSDs, and/or o Expertise in interviewing workers and negotiating with work site management in field settings. Coordination Committee and Annual MSDC Meetings Applicants 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 two Coordination Committee (CC) meetings of the MSDC each year. For budget preparation and project planning purposes, it should be assumed that these meetings will be of one or two days duration and will be held in Cincinnati, Ohio. The CC will determine later 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 in 45 CFR Parts 74 and 92, and PHS Grants Policy Statement. The administrative and funding instrument used for this program is a cooperative agreement (U01), an assistance mechanism (rather than an acquisition 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, 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. In addition, the applicant is responsible for coordination of the individual study with the CC. It is anticipated that recipients will utilize common approaches as agreed upon by the CC so that data can be combined. Recipient will: a. develop an appropriate data collection instrument, b. enroll and follow the study participants and establish and maintain mechanisms to ensure that data collection and management procedures have necessary quality control and assure confidentiality of data, c. provide study participants with individual notification letters when medical tests are performed, d. serve as a permanent member of the CC, e. develop and submit semiannual progress reports in a standard format that is agreed upon after an award is made, f. collaborate in the scientific reporting of findings, g. provide program management oversight for the project, and h. notify study participants of the overall study results. 2. NIOSH Staff Responsibilities NIOSH will have substantial scientific programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination. NIOSH staff will: a. Serve as a scientific liaison between the awardee and other program staff at NIOSH with experience in the occupational health issues of MSDs and epidemiology, b. provide expert consultation in the area of occupational epidemiology, c. provide technical advice on monitoring of field data collection, developing operating guidelines, quality control procedures, and developing policies/protocols for dealing with recurrent situations, d. facilitate collaborative efforts to compile and disseminate program results through presentations and publications, e. assist in the development of human subjects protocols for the CDC Institutional Review Board (if required) and in the preparation of OMB (and other) clearances that may be required during the conduct of the study. 3. Collaborative Responsibilities The Coordination Committee will serve as the main governing board for the cooperative agreements making up the MSDC. One external scientist from each award will have membership on the Coordination Committee, the NIOSH liaison will be a non-voting member. One critical role of the CC is to ensure that the study designs and data collection protocols are uniform and compatible across the MSDC. The CC may, when 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 two CC meetings each year. Locations of the meetings will be determined by the CC. The committee chair (NIOSH representatives will not serve in this position) will schedule the meetings and will be responsible for developing the meeting agenda, chairing the meetings, and producing CC reports. At the Coordination Committee meetings, the Coordination Committee will: 1) make recommendations on the study protocols and data collection approaches, 2) discuss the study populations that have been/will be recruited, 3) identify and recommend solutions to unexpected study problems and 4) discuss ways to efficiently coordinate and combine common study 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 two areas: scientific/research and financial or grants management issues. This RFA and other CDC Announcements can be found on the CDC HomePage (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 (www.cdc.gov/niosh) under Funding Opportunities. Direct inquiries regarding programmatic issues to: Lee M. Sanderson, 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 1429, MS E-74 Atlanta, GA 30333 Telephone: 404/498-2546 FAX: 404/498-2571 Email: lsanderson@cdc.gov Direct inquiries regarding grants management business matters to: Mildred Garner or Robert Williams Announcement Number OH-02-010 Grants Management Branch, Procurement and Grants Office Centers for Disease Control and Prevention (CDC) 2920 Brandywine Road, Suite 3000 Atlanta, Georgia 30341 Telephone: 770-488-2745 or 770-488-2656 Email: mgarner@cdc.gov or rww8@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by June 11, 2002, 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 should be sent 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 1423, MS E-74 Atlanta, GA 30333 Telephone 404-498-2511 Fax 404-498-2569 Email: pconnor@cdc.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov. Information to prepare a detailed budget is provided in the instructions. If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. 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 NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent 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 1423, MS E-74 Atlanta, GA 30333 Telephone 404-498-2511 Fax 404-498-2569 Email: pconnor@cdc.gov APPLICATION PROCESSING: Applications must be received by July 11, 2002. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific 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 include an introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by 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 Receive a written critique. 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 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 your 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 your application"s overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that, by its nature, is not innovative but essential to move a field forward. (1) SIGNIFICANCE: Does this study address an important problem in the area of work-related musculoskeletal disorders? If the aims of the applications are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Will the proposed research contribute to the overall aim of better defining the exposure-response relationships between job physical stressors and musculoskeletal disorders? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternatives? Are the plans for the recruitment and retention of subjects adequate? Is there adequate consideration of follow up of study participants? For example, is the plan for follow up of participants adequate? Is the plan for tracking drop outs adequate? Is the plan for assembling work sites and participants suitable for this study? Is the time line for the studies appropriate and well described? Are the methods for assuring privacy and maintaining confidentiality of participant records, including specific protections for computerized data systems adequate? Does the project employ standardized, comparable approaches for exposure assessment such as the American Conference of Governmental Industrial Hygienists Threshold Limit Value for Hand Activity and the NIOSH Lifting Equation. (3) INNOVATION: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATORS: Are the Principal Investigator, Co-Principal Investigators and their teams appropriately trained and have adequate experience to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and his/her collaborators? (5) ENVIRONMENT: Does the scientific environment in which the work will be done significantly contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Does the proposed project utilize an existing resource or constitute a new one? (6) OTHER: In addition to the above criteria, all applications will also be reviewed with respect to the following. The reasonableness of the proposed budget and duration in relation to the proposed research. The adequacy of plans to include both genders, minorities and their subgroups, for the scientific goals of the research. 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 (1) Magnitude and severity of the condition (problem) in the worker population. (2) Likelihood of developing applied technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 11, 2002 Application Receipt Date: July 11, 2002 Anticipated Award Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific and technical merit o Availability of funds o Programmatic priorities o Program balance for the two study areas (priority for funding at least one for each area, low back and upper limb) provided applications are of sufficient scientific merit. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of the 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. All investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research-Amended, October 9, 2001, published in the NIH Guide for Grants and Contracts on October 9, 2001, http://grants.nih.gov/grants/funding/women_min/women_min.htm.,a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. This policy will be followed by NIOSH for this announcement. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines, on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects. All awardees of CDC grants and cooperative agreements and their performance sites engaged in human subjects research must file an assurance of compliance with the regulations and have continuing reviews of the research protocol by appropriate institutional review boards. In order to obtain a federal-wide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application. OHRP will verify that the signatory official and the Human Subjects Protections Administrator have completed the OHRP Assurance Training/Education Module before approving the FWA. Existing Multiple Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project Assurances (SPAs) remain in full effect until they expire or until December 31, 2003, whichever comes first. To obtain a FWA contact the OHRP at: http://www.hhs.gov/ohrp/assurances/assurances_index.html or write to: Office for Human Research Protections (OHRP) Department of Health and Human Services 6100 Executive Boulevard, Suite 3B01, MSC 7501 Rockville, Maryland 20892-7507 (Note: For Express or Hand Delivered Mail, Use Zip Code 20852) Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve the applicable portion of that project. Note: Investigators in states with existing statutes covering guidance for the protection of humans, will be asked to submit documentation detailing fully the state authority. If a state does not have statutory authority for all the human subjects activities proposed in the application, the awardee must obtain human subject clearances as described above. The project plan in the application must fully describe the involvement of human subjects and protections. This information should be included in the Human Subjects Research Section of PHS 398. 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-(45 CFR 74.36) 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. Guidance is provided at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this 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. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals must be self-contained within specified page limitations. Unless otherwise specified, 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. Reviewers are cautioned 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 Center for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered lobbying. That is lobbying for or against pending legislation, as well as indirect or grass roots, lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly, there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention, collect and analyze data, publish and disseminate results of research and surveillance data, implement prevention strategies, conduct community outreach services, provide leadership and training, and foster safe and 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. SMOKE-FREE WORKPLACE: CDC strongly encourages all grant recipients to provide a smoke-free workplace and promote the non- use of all tobacco products, and Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children. SMALL, MINORITY, AND WOMEN-OWNED BUSINESS: It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should: 1. Place small, minority, women-owned business firms on bidders mailing lists. 2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services. 3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms. 4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices. RESEARCH INTEGRITY: The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science. The regulation places several requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity"s (ORI) Assurance Program. For examples: Section 50.103(a) of the regulation states: Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS- sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant, and (2) Will comply with its own administrative process and the requirements of this Subpart. Section 50.103(b) of the regulation states that: an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution"s assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe. 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. For a copy of Healthy People 2010, visit the internet site: http://www.health.gov/healthypeople/default.htm AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Number 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review.


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