and Human Services (HHS)
EXPIRED
OCCUPATIONAL RADIATION AND ENERGY-RELATED HEALTH RESEARCH GRANTS RELEASE DATE: February 28, 2002 RFA: OH-02-002 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: April 19, 2002 APPLICATION RECEIPT DATE: May 13, 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 Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), announces the availability of fiscal year (FY) 2002 funds for the acceptance of grant applications for research projects relating to occupational safety and health concerns associated with occupational exposures to radiation and other hazardous agents at nuclear facilities and in other energy-related industries. Studies in the nuclear power industry and deliberate exposure of human subjects in radiation experiments are outside the scope of this announcement. RESEARCH OBJECTIVES Background The Secretary, Department of Health and Human Services (DHHS) and the Secretary, Department of Energy (DOE) signed a Memorandum of Understanding (MOU) transferring the authority and resources to manage and conduct energy- related analytic epidemiologic research from DOE to DHHS. This includes the authority, resources, and responsibility for the design, implementation, analysis, and scientific interpretation of analytic epidemiologic studies of the following populations: workers at DOE facilities, other workers potentially exposed to radiation, and workers exposed to potential hazards resulting from non-nuclear energy production and use. The Comprehensive Epidemiologic Data Resource (CEDR) was established by DOE to serve as a repository for data from epidemiologic studies they had sponsored prior to transferring this responsibility to CDC. These data (without personal identifiers) are available to investigators who wish to conduct additional analyses on these completed studies in response to this announcement. The CEDR is maintained by DOE and, to access the data, an investigator should make an application to the DOE"s Office of Health Studies. Much of the epidemiologic research on nuclear workers conducted at nuclear facilities and other sites has emphasized retrospective studies. More recent activities involve environmental restoration, waste management and other work that is not related to the design and production of nuclear weapons. Workers may be exposed to radiation and other hazardous agents under conditions and in processes not previously encountered. Exposure assessment, epidemiology and related studies are needed to evaluate these new conditions and processes and the impact on worker health. NIOSH will support applied field research projects to identify and investigate the relationships between health outcomes and occupational exposure to radiation and other hazardous agents, epidemiologic methods research relevant to energy-related occupational health research, and research related to assessing energy-related occupational exposures. Objectives Types of research applications that are appropriate for this topic include but are not limited to the following areas, emphasizing field research: epidemiologic analysis of the health effects of radiation, statistical modeling, retrospective exposure assessment, meta-analysis and combined analysis methodologies, uncertainty analysis, and effects of measurement error on risk estimates. o Epidemiologic Analysis of the Health Effects of Radiation Risks for cancer and non-cancer health effects associated with ionizing and non-ionizing radiation exposures have been estimated through epidemiology studies and related research. Most analytical epidemiologic research of energy-related occupational and environmental exposures has focused historically on the association between cancer mortality and exposure to ionizing radiation. Relationships among radiation exposures and cancer mortality continue to be an important area for investigation. Other potential adverse health effects, as well as other possible energy-related exposures, should be thoroughly evaluated. Among these would be the possible effects of radiation and chemical exposures on the respiratory, reproductive, neurologic and immune systems, among others. o Statistical Modeling Analytical methods to detect and adjust for effect modification and confounding in radiation epidemiology studies may be advanced through application of Gaussian, Bayesian and Berksonian statistical models, among others. Simultaneous occupational exposures to photons, neutrons, and internal emitters along with chemical exposures and lifestyle factors lead to possibly complex interactions which may be appropriately analyzed with advanced methods. Time-related factors such as age-at-exposure and intermittent or fractionated exposure conditions may also be factors subject to adjustments in appropriate statistical models. o Retrospective Exposure Assessment Epidemiologic studies of occupational cohorts frequently involve, and can generally benefit from, retrospective exposure assessment to provide estimates of exposure or categorize groups of workers by common exposure. Exposure assessment in energy-related occupational epidemiology requires evaluating exposures to various hazards including ionizing and non-ionizing radiation, metals, acids, and solvents. Grant opportunities encompass the fields of industrial hygiene, health physics and retrospective exposure assessment. Research areas of general interest include: methods to use limited data to the best advantage, adjustment of exposure levels based on sampling strategy design to yield representative estimates, decision logic to select and use the most appropriate exposure metric for epidemiologic and risk assessment analysis, and, development of approaches to identify similarly exposed groups and the advantages and limitations for epidemiologic use. Research opportunities of specific interest include: reconstruction of radiation exposure for neutrons and internal emitters based on personal and area measurement data, examination of use and utility of internal dosimetry, external dosimetry, occupationally-required medical exposures and the combination thereof for use in epidemiologic analyses, exposure assessment for acid mists, solvents, metals and other chemicals, and evaluation of biomarkers of exposure. o Meta-Analysis and Combined Analysis Methodologies Many of the cohorts at nuclear facilities are not individually large enough to detect statistically significant increases in mortality or incidence for rare cancer types. Methods and/or analyses for combining data across studies, whether in summary form or individual data, are valuable to energy- related health research. o Uncertainty Analysis Measures of occupational exposure are inherently uncertain. Even when measures of external radiation exposure are generally available, the models used to estimate organ dose, shallow versus deep dose, and neutron dose are subject to error. Measures of dose derived from biological monitoring of urine, feces, and blood are even less precise. Methods for assessing the degree of error in various estimates of exposure to both ionizing radiation as well as chemical agents are desirable. o Effects of Measurement Error on Risk Estimates Estimation of both bias and imprecision introduced into risk analyses through exposure measurement error have recently received considerable attention. Many of the suggested approaches are computer intensive. Practical solutions to this problem with regard to the spectrum of epidemiologic designs (cohort, case-control, cross-sectional, etc.) are needed, with particular attention to the nature of exposure measurement in radiation epidemiology. MECHANISM OF SUPPORT This RFA will use NIOSH individual research project grant (R01)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. The total requested project period for an application submitted in response to this RFA may not exceed three (3) years. This RFA uses the detailed budget format, rather than the modular grant budget format. FUNDS AVAILABLE NIOSH intends to commit approximately $500,000 in fiscal year (FY) 2002 to fund approximately 2 to 4 research project grants (R01). The amount of funding available is subject to change. Awards are expected to range from $100,000 to $250,000 in total costs (direct and indirect) per year. These awards are expected to begin on or about September 1, 2002 and will be made for a 12-month budget period within a project period not to exceed 3 years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds. Use of Funds Applicants should include in their budgets funds for one trip per year for an annual meeting of energy-related researchers to be held in Washington, D.C. The purpose of this meeting is to provide an opportunity for the exchange and dissemination of scientific information. ELIGIBLE INSTITUTIONS You may submit (an) application (s) if your institution 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 Domestic or foreign 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 underreprested 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 Participation in the Comprehensive Epidemiology Data Resource (CEDR) The scientific community and the general public have a longstanding interest in health effects that may result as a consequence of radiation exposure. The Comprehensive Epidemiologic Data Resource (CEDR) was established by the Department of Energy (DOE) to ensure public access to data collected for occupational epidemiologic studies they have sponsored, primarily of workers involved in nuclear weapons production. Investigators without DOE funding are invited to submit radiation study data to CEDR as well. CEDR contains the epidemiologic data but not personal identifiers (because of restrictions in the Privacy Act). Access to these data allows outside researchers, primarily at universities and public interest groups, to independently investigate potential health effects due to radiation exposure. The government has no direct benefit from the collection of these data. CEDR only provides a resource to the public to ascertain the validity of published government-funded research reports or to test their own hypotheses. However, since these funds are from DOE, successful applicants will be required to participate in the CEDR, and should submit their study data set, with appropriate documentation, to NIOSH no later than six months after completion of the study or upon expiration of the grant. This data set should include analysis files and separate analytic files for all relevant study data, including demographic variables, radiation dosimetry, industrial hygiene, work history, and/or medical records data, as appropriate. A written report describing each data set and a code book for each data set should also be submitted to NIOSH. NIOSH will prepare and process the submission of the appropriate data files to CEDR. Further information can be obtained at http://www.hanford.gov/safety/healthstudies/mou.html and http://tis.eh.doe.gov/health/hstudies.html Useful References NIOSH Occupational Energy Research Program agenda booklet and/or The DOE Access Handbook: Conducting Health Studies at Department of Energy Sites available at the web site : http://tis.eh.doe.gov/health/epi/docs/access.pdf 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". Direct your questions regarding programmatic issues to: Adele M. Childress, Ph.D., M.S.P.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 1427, MS E-74 Atlanta, GA 30333 Telephone: 404/498-2509 FAX: 404/498-2571 Email: ahc0@cdc.gov Direct your questions about financial or grants management business matters to: Joe Gilchrist Contracts Management Branch Centers for Disease Control and Prevention CDC Announcement Number CDC 02013 626 Cochrans Mill Road Pittsburgh, PA 15236-0070 Telephone: 412/386-6428 Email: jgilchrist@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by April 19, 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: Pervis C. Major, Ph.D. 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). 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 301/710-0267, 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: Pervis C. Major, Ph.D. 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 April 19, 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. And, if the application is not responsive to the RFA, CSR 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 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. o SIGNIFICANCE: Does this study address an important problem related to the topical research issues outlined in this announcement? If the aims of the application 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? o APPROACH: Are the conceptual framework, design (including composition of study population), methods, and analyses adequately developed, well- integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? o INNOVATION: Does your 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? o INVESTIGATOR: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers, if any? o ENVIRONMENT: Does the scientific environment in which your work will be done 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 documentation of cooperation from industry, unions, communities, or other participants in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o INCLUSIONS: Adequacy of plans to include subject from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (Refer to inclusion criteria located in the section on Federal Citations, below). o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. Programmatic Review Criteria o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o 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: April 19, 2002 Application Receipt Date: May 13, 2002 Anticipated Award Date: September 1, 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. ANIMAL SUBJECTS REQUIREMENTS: If the proposed project involves research on animal subjects, compliance with the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions" is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). Information is available at http://grants.nih.gov/grants/olaw/references/phspol.htm 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 and NIH GRANT APPLICATIONS OR APPENDICES: All applications 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. 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 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 the conference 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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