CONTINUATION SUPPORT FOR STATE-BASED SENSOR PROGRAMS RELEASE DATE: March 21, 2002 RFA: OH-02-013 Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) (http://www.cdc.gov/niosh/homepage.html) LETTER OF INTENT RECEIPT DATE: May 3, 2002 APPLICATION RECEIPT DATE: June 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 Eligible Institutions o Individuals Eligible to Become Principal Investigations o Special Requirements 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 (NIOSH), Centers for Disease Control and Prevention (CDC) announces the availability of funds for fiscal year (FY) 2002 for cooperative agreement(U01) applications to support the continuation of the Sentinel Event Notification Systems for Occupational Risks (SENSOR), a state-based occupational surveillance program. The purpose of this announcement is to provide support for SENSOR programs for a condition(s) that is a high priority in the respective state and for which the state has developed a SENSOR model(s) through SENSOR funding. This RFA is consistent with Goal #2 of the NIOSH Surveillance Strategic Plan (to strengthen the capacity of state health departments and other state agencies to conduct occupational surveillance). PROGRAM OBJECTIVES Background A comprehensive approach to surveillance is vital to the prevention of occupational diseases, injuries, and hazards. Occupational safety and health surveillance entails the ongoing, systematic collection, analysis, interpretation, and dissemination of relevant health and hazard data. For surveillance to be effective, it must be actively linked to intervention and prevention activities. 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. Over the past quarter century, NIOSH has played a key role in the surveillance of occupational diseases, injuries, and hazards. The NIOSH program complements 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). In 1987 NIOSH, in conjunction with state health departments, initiated the SENSOR program to develop model surveillance systems based upon identification and follow-up of sentinel occupational disease and injury cases. During the first five-year funding period (1987 - 1992), 10 states received SENSOR funding for experimental case-based target conditions which included elevated blood lead, carpal tunnel syndrome, pesticide poisoning, occupational lung diseases (silicosis, work-related asthma and hypersensitivity pneumonitis), and work-related burns. SENSOR initially utilized a surveillance approach relying primarily on health provider reporting for case ascertainment and involving direct intervention at workplaces of reported cases. The second five-year funding period (1992-1997) resulted in 12 states receiving SENSOR awards for field testing model surveillance systems for specific conditions (silicosis, work- related burns, and work-related asthma) and developing new model surveillance systems for specific conditions (amputations, cadmium poisoning, carbon monoxide poisoning, carpal tunnel syndrome, dermatitis, noise-induced hearing loss, pesticide health effects, tuberculosis, and youth injury). The SENSOR model evolved over this period to include the utilization of existing data sources for case ascertainment and the implementation of alternative intervention approaches (information dissemination and consultation). The third five-year funding period (1997-2002) resulted in 13 states receiving SENSOR awards for field testing model systems (acute pesticide exposures (including EPA supplemental awards), burns, silicosis, and work-related asthma) and further development of experimental (new) models (amputations, carpal tunnel syndrome, dermatitis, noise-induced hearing loss, and youth injury). Many alternative data sources have been shown to be useful for case ascertainment. In addition to intervention activities at a particular work site, alternative intervention activities (information dissemination, education, consultation, enforcement, and research) have been shown to be feasible and effective. Evolution of the program has shown that SENSOR is not a single surveillance system and that it is far more than just surveillance with direct incorporation of active interventions. No single approach to case ascertainment or intervention is appropriate for all target conditions or for all state health departments. With the development of effective and integrated surveillance models for single and multiple conditions within states, support to sustain these surveillance models is needed. This RFA is intended to provide funds to sustain effective SENSOR programs in states, which have received or are currently receiving SENSOR awards. Objectives The objective of this announcement is to provide support to selected state agencies for sustaining SENSOR program activities for a condition(s) that is a high priority in their state and for which the state has developed a successful SENSOR model(s) through prior SENSOR funding. 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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The total requested project period for an application submitted in response to this RFA may not exceed three (3) years. The award and level of support depend on the receipt of applications of high scientific merit. Although this program is provided for in the financial plans of NIOSH, the award, pursuant to this RFA, is contingent upon the availability of funds for this purpose. This RFA uses just-in-time concepts. This RFA uses the detailed budget format rather than the modular budget format. Under the cooperative agreement award mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing and executing the proposed project with NIOSH staff being substantially involved as a partner with the Principal Investigator, as described under the section Cooperative Agreement Terms and Conditions of Award. FUNDS AVAILABLE NIOSH intends to commit approximately $1,000,000 in FY 2002 to fund five to eight cooperative agreement awards (U01). The maximum amount that may be requested is $150,000 in total costs (direct plus facilities). If a state has received or is currently receiving support for more than one condition, up to $250,000 in total costs in the first year may be requested. Awards will be made for a 12-month budget period within a project period up to three (3) years. A minimum of 25% of the funds must be retained and used by the State. USE OF FUNDS Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to provide an opportunity for the exchange of program and scientific information, to be held in Washington, D.C. ELIGIBLE INSTITUTIONS You may submit an application if your institution has the following characteristic: o unit of state government, which has received or is currently receiving support from SENSOR awards for condition-specific surveillance. You may only apply for the same condition that has previously been funded, and the expansion (adding new conditions) of existing SENSOR programs through this program is not allowed. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH programs. Note: Title 2 of the 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 Cooperative Agreement 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 do the following: o define SENSOR model program objectives and approaches, o use mechanisms to ensure that data collection and management procedures have necessary quality control and assure confidentiality of data, o identify and implement appropriate intervention activities, o collaborate with NIOSH, other states and state organizations about methods and findings, o develop any surveillance capacity using automated information technology tools and systems so that this capacity is in compliance with National Electronic Disease Surveillance System (NEDSS) architecture (http://www.cdc.gov/nedss)to enhance the opportunity for interoperability and to promote the use of standards across public health, o analyze data for case-based surveillance, and o publish results, interpretations, and conclusions pertaining to the SENSOR model program. 2. NIOSH Responsibilities NIOSH anticipates having substantial scientific programmatic involvement during conduct of this activity. However, the NIOSH role is limited to technical assistance, advice, and coordination. NIOSH will do the following: o serve as a scientific liaison between the awardee and other program staff at NIOSH with experience in the occupational health issues of State surveillance programs, o provide expert consultation in the area of surveillance and occupational epidemiology, if requested by the awardee, o provide technical advice on data collection, developing operating guidelines, quality control procedures, and developing policies/protocols for dealing with recurrent situations, if requested by the awardee, and o facilitate collaborative efforts to compile and disseminate program results through presentations and publications, 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 (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 Extramural Programs, Current Funding Opportunities. Preapplication Conference Call Applicants are invited by NIOSH to attend a pre-application technical assistance conference on April 18 at 1:30 PM (Eastern time) to discuss: programmatic issues regarding this program, how to apply, and questions regarding the content of this RFA. Applicants may participate by telephone. The conference name is NIOSH SENSOR and the telephone bridge number is 800-311-3437. Interested parties will need the conference code, 440353, to participate. 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: Joe Gilchrist Contracts Management Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 CDC Announcement Number 02064 Telephone: 412/386-6428 FAX: 412/386-6459 Email: jgilchrist@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by May 3, 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: Gwendolyn Cattledge, Ph.D., M.S.E.H. 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: 404/498-2508 FAX: 404/498-2571 Email: gcattledge@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. SPECIAL INSTRUCTIONS: Special instructions for defining proposed 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, (2) Why is the work important, (3) What has already been done, and (4)How are you going to do the work. Items a-d below should be organized to address these questions in detail. a. Specific Aims. Identify the broad, long-term objectives of the proposed project and expected accomplishments. b. Background and Significance. Briefly provide relevant background information related to this project, include a critique of existing knowledge on the subject and identify information gaps that the proposed project will address. Described the scope and the nature of target condition in the applicant"s State. Specifically address how this project is important and relevant to public health by relating the specific aims to the broad, long- term objectives. c. Preliminary Studies/Progress Report. Pertinent preliminary studies/activities conducted by the principal investigator/program director should be included to establish past experience and competence in the project area. Include a list of references to appropriate publications and manuscripts. Include a progress report providing a summary of the SENSOR project"s specific aims and the importance of the findings. Provide a statement of published and unpublished results and achievements, include a list of titles and references for all publications and manuscripts. d. Project Design and Methods. Describe in detail the project design and methods that will be used to achieve the specific aims of the project. Specifically describe how the project design and methodology will conduct timely surveillance of the target condition, identify cases for in-depth investigation, and pursue prevention activities at the state level, include new methodologies and expected advantages. Discuss potential limitations and anticipated difficulties of the proposed project and provide alternative approaches to be used to achieve the defined aims. Include a tentative timetable for the project. 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: Joe Gilchrist CDC Announcement Number: 02065 Contracts Management Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Telephone: 412/386-6428 FAX: 412/386-6459 Email: jgilchrist@cdc.gov At the time of submission, two additional copies of the application must also be sent to: Gwendolyn Cattledge, Ph.D., M.S.E.H. 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: 404/498-2508 FAX: 404/498-2571 Email: gcattledge@cdc.gov APPLICATION PROCESSING: Applications must be received by June 11, 2002. If an application is received after that date, it will be returned to the applicant without review. The CDC 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. CDC 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 CDC and responsiveness by NIOSH. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CDC staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited application at the next appropriate NIH review cycle. 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, and 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: Did the applicant communicate the public health importance of the selected condition in the state? Is the application relevant to the objectives outlined in the RFA? Have the broad, long-term objectives of the project and expected accomplishments been defined? Are the need and approaches to link surveillance and prevention activities well-described? Does the application describe the importance of the proposed surveillance and associated activities in evaluating and reducing occupational injuries, illnesses or hazards? If the aims of the application are achieved, how will state-based occupational safety and health capacity be advanced? (2) Approach: Does the application provide a summary report of the previously funded SENSOR program, including a synopsis of past related surveillance and intervention activities and accomplishments, including a list of reports, presentations, and education materials? Does the applicant communicate an approach for a SENSOR program that is comprehensive, including intervention activities linked to surveillance activities? Are the purpose and operation of the SENSOR program adequately described? Does the application provide a detailed plan (project design and methods) and a realistic schedule for accomplishing each of the activities to be carried out in this program? Are the conceptual framework and methods adequately developed and appropriate to the aims of the project? Are the resources used to operate the surveillance system and intervention activity identified? Are coordination and collaboration with relevant local and state agencies described adequately? Does the applicant acknowledge potential problem areas and consider alternative approaches? Is the time line proposed for the project suitable and realistic? (3) Innovation: Does the project employ concepts, approaches, or objectives for surveillance, intervention, dissemination and other associated activities that lead to enhanced efficiencies or cost- effectiveness? Does the project propose any relevant new activities or methodologies to enhance the developed SENSOR program? (4) Investigators: Are the principal investigator and collaborators appropriately trained and well-suited to carry out this work? Is the surveillance and intervention work proposed appropriate to the experience level of the principal investigator and other researchers? (5) Environment: Are the applicant"s facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of agency support generally, or specific agency commitment to support occupational surveillance and associated activities? Is there documentation of cooperation from relevant local agencies, state agencies, or other participants in the project, where applicable? (6) Other: Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the project. The adequacy of the proposed protection of humans to the extent that they may be adversely affected by the project proposed in the application. Does the applicant fully describe the involvement of human subjects and protections? PROGRAMMATIC REVIEW CRITERIA (1) Magnitude and severity of the condition (problem) in the worker population. (2) The potential to fill gaps in nationwide occupational injury and illness surveillance. (3) The potential impact of the surveillance program on the prevention of occupational safety and health hazards on a state- wide basis. (4) The commitment of the state to supporting an occupational safety and health surveillance program. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 3, 2002 Application Receipt Date: June 11, 2002 Anticipated Award Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit o Availability of funds o Programmatic priorities 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 performances 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 subject 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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