INCIDENCE OF NEEDLESTICK AND SHARPS INJURIES AND MEDICAL SAFETY DEVICE AVAILABILITY/USE AMONG NON-HOSPITAL HEALTH CARE WORKERS RELEASE DATE: November 18, 2003 RFA Number: RFA-OH-04-003 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Centers for Disease Control and Prevention (CDC) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute for Occupational Safety and Health (NIOSH) (http://www.cdc.gov/niosh/homepage.html) Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.262 LETTER OF INTENT RECEIPT DATE: December 17, 2003 APPLICATION RECEIPT DATE: January 23, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions 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), invites grant applications for studies that will contribute to the understanding of the risks of exposure to blood among health care workers employed in home health care settings. Such information will contribute significantly to an understanding not only of the risk for such exposures, but the development of effective intervention strategies. Because little is known about the incidence of blood exposures in home health care workers, this RFA has an emphasis on research that examines the incidence of exposures to blood, risk factors associated with such exposures, and the availability and use of medical safety devices. A special feature of this RFA is encouraging applications from researchers and from membership organizations comprised of health care workers, such as unions and professional organizations, and collaboration among these groups. RESEARCH OBJECTIVES Background There are nearly twelve million health care workers employed in the United States. It is estimated that there are approximately 20,000 home care providers (agencies) serving more than 7 million individuals each year. Health care workers are at risk of infection from blood-borne pathogens, particularly human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. As of December 2001, the CDC was aware of 57 health care workers in the U.S. who had been documented as having sero-converted to HIV following occupational exposures. Approximately 83% of exposures to blood reported by hospital-based health care workers are by percutaneous injury (i.e., needlestick and sharps injuries). Mucous membrane exposure accounts for about 13%, skin 3%, and bite 1%. Precise national data are not available on the annual number of needlesticks and other percutaneous injuries among health care workers since it has been estimated that about half of these injuries go unreported. Virtually all of the information on the occurrence of needlestick and sharps injuries is based on hospital workers. However, it has been estimated that 600,000 to 800,000 such injuries occur annually. In addition to the serious health consequences of this injury, the emotional impact of a needlestick injury can be severe and long lasting, even when a serious infection is not transmitted. In order to address this public health problem in the context of occupational injuries, past studies have shown that certain information about blood exposures need to be considered in a survey design, including relevant demographic information about survey respondents, general information about past exposures to blood, and details about the circumstances of recent exposures. For recent exposures to blood, at least eight critical areas of information have been shown to be important. These include: 1) route of exposure, 2) activity during and timing of exposure, 3) specific medical device being used, 4) relevant characteristics of the source patient, 5) reasons why the exposure either was or was not reported, 6) suggestions on how to improve reporting of injuries, 7) whether respondents obtained post- exposure prophylactic treatment, and 8) precautions that would have prevented the exposure. Another critical area for inclusion in such studies is an assessment of past exposures experienced by employees and, in order to assess under-reporting, the percentage of exposures reported to the worker=s employer via standard procedures. NIOSH has set a goal to describe the occurrence of exposure to blood among home health care workers in order to subsequently identify appropriate interventions to reduce the future incidence of exposure to blood-borne pathogens. This RFA is the first step to accomplish this goal. Research Objectives The objective of this RFA is to support research on the incidence of and risk factors for exposures to blood among home health care workers. Among the issues that need to be understood are the significant factors that affect blood exposures such as rate of exposure from needlestick and sharps injuries, other routes of exposure, and the prevalence and use of medical safety devices. Research projects should address this occupational issue in an integrated and comprehensive manner in order that the risk of these exposures in home health care workers can be understood. In designing their studies, applicants may consider the inclusion of these data elements in the study design: the incidence rate of exposure to blood from needlestick and sharps injuries and other routes of exposure among home health care workers; risk factors for these exposures; and the prevalence of medical safety device availability and usage. The applicant should justify the survey sample size. Investigators may wish to consider conducting either a retrospective or prospective survey of an entire or random sample of a population of home health care workers to estimate numbers of exposures and incidence rates by occupation, setting, medical device, and the availability and usage of medical safety devices. An important element that investigators may wish to include in the study design is a comparison of risk factors, rates of exposure, and availability/use of medical safety devices between these workers and hospital health care workers; however, the focus of this RFA is on non-hospital settings. Investigators may also wish to include in the study design approaches for estimating the availability and usage of medical safety devices in home care settings. Another element that investigators may wish to consider is the rate of vaccination against hepatitis B virus and compliance with recommendations for post-exposure prophylaxis for hepatitis B virus and human immunodeficiency virus. Applicants should also consider, study design methods for data collection that do not rely solely upon employers= or health services= records to reduce the potential for study bias due to under-reporting of needlestick injuries. However, an investigator may wish to supplement a survey of home health care workers with a review of injury records kept by employers. MECHANISM OF SUPPORT This RFA will use NIOSH 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. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the non-modular budgeting formats. Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIOSH intends to commit approximately $1,000,000 in FY 2004 to fund 2 to 4 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs of up to $400,000 per year. Applications exceeding $400,000 in direct costs in any year will be considered unresponsive and returned without further consideration. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIOSH provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBILITY 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 institutions/organizations o Foreign institutions/organizations are not eligible to apply o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH programs. Note: Title 2 United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan. SPECIAL REQUIREMENTS Applicants should fully describe the plan to recruit study sites across an industry (to characterize exposures in that industry) and to enroll workers willing to participate in the study. Letters of cooperation from employers and unions would provide some measure of the anticipated success of the plan. The following should be addressed in a clear and organized manner (see also peer review criteria section): o Timeline: a detailed timeline 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, conducting epidemiologic field studies of working populations, experience in traumatic injuries. o Access to a range of work sites varied enough to characterize the industry being studied, and to workers at those sites who are willing to participate in studies of needlestick and sharps injuries. o Expertise in assessing needlestick and sharps injuries along with contributing risk factors in individual job settings, as well as documentation of all non-hospital health care exposures. o Expertise in the clinical assessment of psychological factors associated with traumatic injuries, such as needlestick and sharps injuries. o Expertise in negotiating with work site management and unions in field settings. 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: o Direct your questions about scientific/research issues to: Adele M. Childress, Ph.D., M.S.P.H Scientific Program Administrator Office of Extramural Programs Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 1600 Clifton Road, N.E. Building 24, Room 1537, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2509 FAX: (404) 498-2571 Email: achildress@cdc.gov o Direct your questions about peer review issues to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov o Direct inquiries about financial or grants management matters to: Ms. Cynthia Mitchell, Contract Specialist Acquisition and Assistance Field Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Announcement Number OH-04-001 Telephone: (412) 386-6434 Email: CMitchell@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of an application, the information that it contains is used to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document and should be sent by mail to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. USING THE RFA LABEL: The RFA label, available in the PHS 398 (rev.5/2001) application form, must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE 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 and all copies of appendix material must also be sent to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a scientific review group convened by NIOSH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applicants deemed to have the highest scientific or technical merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a written critique. o Receive a second level of review by the NIOSH Secondary Review Committee. REVIEW CRITERIA The goals of NIOSH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, it may propose to carry out important work that by its nature is not innovative but essential to move a field forward. SIGNIFICANCE: Does the proposed research project satisfy an important public health, occupational health, or infection control need? 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 alternative approaches? Will the research project be able to provide reliable estimates of the incidence rate of exposure to blood, particularly needlestick and sharps injuries? Will the research project be able to identify risk factors for exposures to blood? Will the research project be able to estimate the availability and use of medical safety devices among the facilities employing the respondents? Does the applicant include health care workers in occupations (within-home-care settings) with potentially the highest incidence rates of needlestick injury? Does the applicant demonstrate access to health care workers who are at high risk of occupational exposure to blood, including letters of support from organizations facilitating access to these workers? Does the applicant justify the proposed sample size and statistical power calculations? INNOVATION: Does the project employ novel concepts, approaches, or methods? Is the project original and innovative? Does the project develop new methodologies? INVESTIGATORS: Are the principal investigator and her/his collaborators appropriately trained and well suited to carry out this work? Do they have adequate experience in the areas of occupational health, infection control, epidemiology, and project management to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and her/his collaborators? ENVIRONMENT: Are the applicant’s facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of institutional support? Are the methods for assuring privacy and maintaining confidentiality of participant records, including specific protections for Internet-based data systems adequate? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from all genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Scientific Review Criteria o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 17, 2003 Application Receipt Date: January 23, 2004 Earliest Anticipated Start Date: July 1, 2004 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website http://www.hhs.gov/ocr/ provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors)are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of the Centers for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered lobbying. That is lobbying for or against pending legislation, as well as indirect or grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training; and foster safe and healthful environments. Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and grassroots activities that relate to specific legislation, recipients of CDC funds should give attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law. HEALTHY PEOPLE 2010: The CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity for reducing morbidity and mortality and improving the quality of life. This RFA is related to one or more focus areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), the Occupational Safety and Health Act of 1970, Section 20(a)[29 USC 669(a)], and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.