CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE INVESTIGATOR INITIATED RESEARCH (R01) RELEASE DATE: April 22, 2004 RFA Number: RFA-CD-04-002 EXPIRATION DATE: June 23, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: Office of the Director (OD), Office of Science Policy and Technology Transfer, Office of Public Health Research, (OPHR) (http://www.cdc.gov/od/ads) 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): 93.062 LETTER OF INTENT RECEIPT DATE: May 24, 2004 APPLICATION RECEIPT DATE: June 22, 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 Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Centers for Disease Control and Prevention (CDC), Office of Public Health Research (OPHR) announces the availability of fiscal year (FY) 2004 public health research funds to support innovative public health research that addresses priority health protection issues. Health protection should be interpreted to include activities that 1) promote health and/or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats. This RFA focuses specifically on health promotion in the workplace. RESEARCH OBJECTIVES Background The large discrepancies between what Americans spend on health and the outcomes they experience may stem from how the nations health knowledge and resources are deployed within the health system and other sectors of society. Most resources are deployed when people seek care for specific diseases and health conditions; health protection, health promotion, and prevention activities account for less than 3% of the nation’s investment for health services. A major obstacle to prioritizing health promotion is the fact that there is insufficient evidence to support specific programs, practices, and policies that affect health decisions made by people and those responsible for health policies and programs in the public health, health care delivery, and educational systems, as well as their counterparts in businesses and other private sector enterprises, governments, and governmental agencies. Development of this evidence is hampered by the lack of support for public health research investigations that encompass the relevant disciplines across all academic environments. CDC has initiated this RFA to support investigator-initiated research as one key component of its public health research agenda to address this gap in health promotion. CDC has aligned its priorities and investments with those of the Department of Health and Human Services to achieve 2 overarching health protection goals: 1) Health promotion/Disease, injury and disability prevention: All people will achieve their optimal lifespan with the best possible quality of health in every life stage. The strategies to accomplish this goal include developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on health evolving in life stages over a lifetime (infants, children, adolescents, young adults, middle-age adults, and older adults, and in all situations (at work, in communities, in school, at home). Integral to the successful accomplishment of this goal is the elimination of health disparities that afflict many people in our society. 2) Preparedness: People in all communities will be protected from infectious, environmental, and terrorist threats. The strategies to accomplish this goal include developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on exposure prevention, rapid detection and diagnosis, investigation, containment, and recovery from health threats. CDC’s health protection research initiative is designed to support achievement of these goals, and will help develop and disseminate the knowledge and tools that can be used by individuals, public health professionals, health care providers, educators, policy makers, businesses, private sector organizations, and others to protect and measurably improve the health of Americans and reduce health disparities at all life stages and in all settings. CDC’s intent is to ensure that a diverse pool of highly trained and creative scientists are supported and encouraged to accomplish the nation’s public health research agenda. The objective of this RFA is to support innovative investigations that address CDC’s health promotion research priorities. The proposed research should add substantially to the body of knowledge necessary to have a significant impact on the health status of Americans in one or more life stages. Objectives and Focus Areas Applicants should focus their investigations, which will ultimately make a substantive contribution to CDC’s overarching goals (above) and a significant impact on people’s health status. Specifically, the research outcomes should ultimately translate into extended lifespan or improved quality of health at any or all of the life-stages as defined in the background portion of this section, and/or should substantively contribute to people’s protection from non-occupational infectious, environmental, or terrorist threats. Public health research should help close the gap between fundamental scientific knowledge and the information and motivators needed by individuals, families, communities, or the sectors that serve them to effectively use new knowledge and tools for making or supporting health decisions. In addition, the knowledge gained should be useful to public health practitioners, policy-makers, or even to the self-help or self- management of diseases, risk factors, or risk conditions by individuals, communities, and populations. This first RFA for the health protection research initiative will give priority to research that identifies innovative cost-effective health promotion policies, programs, and activities in the workplace or affecting the workplace. Although important to worker health, this RFA is not intended to cover research on occupational safety and health programs, policies, and activities. If resources allow, future RFAs will expand the scope of this initiative to address health protection research relevant to other populations and sectors. The knowledge base needed for successful implementation of health promotion programs in the workplace needs to be greatly expanded. This RFA will support investigations with a high probability of identifying cost-effective interventions that improve the health of the American workforce and the determinants of their successful implementation. A desired outcome would be the identification of critical success factors that could be used to motivate adaptation and implementation of evidence-based interventions to promote workers health across the business sector. These might be best processes to complement best practices derived from clinical or other efficacy studies. A successful approach to health promotion in the workplace must be economically sustainable to achieve widespread impact, and investigations that address this issue are needed. There are many strategies that could be used to address this RFA, but this first RFA will give priority to those applications that emphasize the design and evaluation of interventions and identification of determinants affecting the successful implementation of evidence-based cost-effective health promotion interventions in the workplace or that have impact on the workplace. Hence, the application should address at least one of the following issues: 1. Identification of cost-effective interventions that improve the health of employees as measured by: a. mortality, morbidity, and disability, b. quality of life (e.g., satisfaction with daily functioning, energy level, attentiveness), c. productivity (e.g., increase in on-the-job-productivity, decrease of absenteeism), d. employer and/or employee health-related costs. 2. Identification of the determinants of successful implementation and dissemination of evidence-based health promotion, interventions among individual employees, or groups of employees, or employers. 3. Identification of the determinants of successful translation of evidence-based health promotion interventions to special employee populations to reduce health disparities. 4. Evaluation of the impact of employee health policy alternatives on the health of individuals or groups of employees and their families. 5. Determinants of the economic drivers of health and health decisions for employers and employees. 6. Identification and evaluation of public health informatics and communication strategies and tools to improve health decisions, health alerting, health literacy, or health assessment among employees and employers. 7. Identification of strategies to improve the workforce’s protection from urgent non-occupational infectious, environmental, or terrorist threats. Because effective health promotion/prevention interventions often require a trans-disciplinary and trans-sector approach, projects that include close and ongoing collaborations with business leaders and affected employees and their representatives in the design, conduct, interpretation, communication, dissemination, and implementation of the research are encouraged. Likewise, linkages with experts from the public health and healthcare delivery system sectors may be critical to the success of many projects. MECHANISM OF SUPPORT This RFA will use the RO1 award mechanism. The applicant is responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Awards are not renewable. This RFA uses the modular budgeting as well as the non-modular budgeting formats, as described on the website: http://grants.nih.gov/grants/funding/modular/modular.htm. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise, follow the instructions for non-modular budget research grant applications. This program does not require cost sharing, as defined in the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm . FUNDS AVAILABLE The CDC intends to commit up to $14,000,000 in FY 2004 funds for 20 to 40 new grants in response to this RFA. The award provides up to three consecutive 12-month budget periods within a project period of up to 3 years with a budget for direct costs of up to $300,000 per year. Direct costs include salary support (plus fringe benefits), technical assistance, equipment, supplies, consulting fees, domestic travel, publications, and other costs. 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 CDC 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. ELIGIBLE INSTITUTIONS You may submit an application if your institution is a(n): o Public or private academic institution o Eligible agency of the federal government o Unit of state, county, local, or tribal government o Healthcare organization o Research institution The institution must be located in the United States or its territories and have, or be affiliated with, a well-established research or public health program, with qualified faculty in public health, basic, or other research to serve as mentors. The institution must be able to demonstrate a commitment to adequately supporting the investigator to ensure successful accomplishment of the research. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Principal Investigator must have a research or a health- professional doctorate or its equivalent. Principal investigators must be established in their field with expertise appropriate to the purpose of this RFA and have specific authority and responsibility to carry out the proposed project. Examples of appropriate career appointments could include faculty positions at academic institutions or similar research positions at other eligible institutions. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs. SPECIAL REQUIREMENTS The following are applicant requirements: 1) Applicant should demonstrate effective and well defined working relationships within the performing organization and with outside entities which will ensure implementation of the proposed activities. 2) Principal Investigators are encouraged to submit only one proposal in response to this program announcement. With few exceptions, only one application per Principal Investigator will be funded under this announcement. WHERE TO SEND INQUIRIES CDC encourages inquiries concerning this RFA and welcomes 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: Tanja Popovic, M.D., Ph.D., F.A.A.M. Acting Associate Director for Science Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road, N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (404) 639-7240 Email: TPopovic@cdc.gov o Direct your questions about peer review issues to: Catherine Spruill Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (404) 639-7240 Email: CSpruill@cdc.gov o Direct your questions about financial or grants management matters to: Sylvia Dawson Procurements and Grants Office Centers for Disease Control and Prevention Koger Office Park, Colgate Building, Mail-Stop E-14 2920 Brandywine Road, Atlanta, Georgia, 30341-5539 Telephone: (770) 488-2771 Email: SDawson@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, telephone number, and e-mail address 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 a subsequent application, the information that it contains allows OPHR staff 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. The letter of intent should be sent to: Heidi Steele Office of Public Health Research Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (770) 488-8612 Email: HSteele@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. Instructions provided with this RFA supercede instructions provided in PHS 398. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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 Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier services) At the time of submission, two additional copies of the application and the appendix material must be sent to: Heidi Steele Office of Public Health Research Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (770) 488-8612 Email: HSteele@cdc.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this 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. Upon receipt, applications will be reviewed for completeness by Center for Scientific Review, NIH, and for responsiveness by the Office of Public Health Research, CDC. Incomplete applications and applications that are not responsive to the eligibility criteria will not be reviewed. Applicants will be notified that their applications did not meet submission requirements. PEER REVIEW PROCESS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CDC in accordance with the review criteria stated below. CDC uses a peer review process modeled after that of the NIH, including a streamlined review process, essentially as spelled out in the website located at: http://www.csr.nih.gov/REVIEW/streamln.htm As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique Applications in the upper half will receive a secondary review by the secondary review committee. REVIEW CRITERIA The goal of this award is to fund research that identifies innovative cost-effective health promotion policies, programs, and activities in the workplace or affecting the workplace. Although important to worker health, this RFA is not intended to cover research on occupational safety and health programs, policies, and activities. If resources allow, future RFAs will expand the scope of this initiative to address health protection research relevant to other populations and sectors. FIRST LEVEL OF REVIEW: 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, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. SIGNIFICANCE: Does this study address an important health promotion issue? 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? What is the potential impact on the individuals, health care providers, educators, policy makers, businesses, private sector organizations, and others engaged in protecting health and promoting healthy environments? Does this study address any other CDC priorities such as reducing racial and ethnic health disparities? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Are the measures of effectiveness well defined, objective, quantitative and relevant to the intended outcome? Are the measures of effectiveness related to the performance goals stated in the Purpose section of this announcement? Does the applicant acknowledge potential problem areas and consider alternative tactics? Do the proposed methods include the participation and involvement of the affected population? Does the proposed project include a trans- disciplinary and trans-sector approach? INNOVATION: Innovation as applied to health promotion includes entirely new ideas for intervention activities, new approaches to replication or applicability research (e.g., adapting previously used intervention or policy ideas to include new areas of consideration, such as the impact of obesity on absenteeism), new approaches to achieve dissemination or implementation of programs or policies previously shown to be effective, and new approaches to identify factors that contribute to the success or failure of implementation or to sustaining interventions. Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Has the investigator demonstrated experience in an area relevant to health protection research? Has the investigator experience with teams that include various scientific disciplines and skill in contributing to the confluence of their research findings? ENVIRONMENT: Does the scientific environment in which the 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 evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, at least one of the following strategies must be employed. The extent to which one or more of the strategies are employed in the proposed research will be considered in the determination of scientific merit and priority score: 1. Cost-effective interventions that improve the health of employees as measured by: a. mortality, morbidity, and disability, b. quality of life (e.g., satisfaction with daily functioning, energy level, attentiveness) c. productivity (e.g., increase in on-the-job-productivity, decrease of absenteeism), d. employer and/or employee health-related costs. 2. Identification of the determinants of successful implementation and dissemination of evidence-based interventions among individual employees, or groups of employees, or employers. 3. Identification of the determinants of successful translation of evidence-based interventions to special employee populations to reduce health disparities. 4. Evaluation of the impact of employee health policy alternatives on the health of individuals or groups of employees and their families. 5. Determinants of the economic drivers of health and health decisions for employers and employees. 6. Identification and evaluation of public health informatics and communication strategies and tools to improve health decisions, health alerting, health literacy, or health assessment among employees and employers. 7. Identification of strategies to improve the workforce’s protection from urgent infectious, environmental, or terrorist threats. SECONDARY REVIEW LEVEL: Applications will receive a programmatic review that will consider the following 1) the potential impact of the research outcome on workplace or workforce conditions 2) severity of the problem, and 3) likelihood of rapid application of research results to known issues in health protection strategies. 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. This will not be scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES IN RESEARCH: The adequacy of plans to address the CDC policy requirements regarding the inclusion of women, racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Review criteria include: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits. 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 SHARING RESEARCH DATA: CDC expects researchers who are supported by CDC funding to make their data available for analysis by other public health researchers and include a data sharing plan in their application. CDC requires that mechanisms for, and costs of, data sharing be included in contracts, cooperative agreements, and applications for grants. CDC reviewers must check whether applications for CDC funds include mechanisms for, and costs of, sharing data. The costs of sharing or archiving data may be included in the amount of funds requested in applications for first-time or continuation funds. Applicants for CDC funds who incorporate data release into their study designs can (1) readily and economically set up procedures for protecting the identities of research subjects and (2) produce useful data with appropriate documentation. Awardees who fail to release data in a timely fashion will be subject to procedures normally used to address lack of performance (e.g., reduction in funding, restriction of funds, or grant termination). Researchers who contend that the data they collect or produce are not appropriate for release must justify that contention in their applications for CDC funds. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. CDC’s policy is available at: http://www.cdc.gov/od/ads/pol-385.htm BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT SCHEDULE Letter of Intent Receipt Date: May 24, 2004 Application Receipt Date: June 22, 2004 Earliest Anticipated Award Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities (as determined by the secondary review). 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 INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of CDC to ensure that individuals of both sexes and the various racial and ethnic groups will be included in all CDC-supported studies involving human subjects, whenever feasible and appropriate. Furthermore, it is CDC policy to identify significant gaps in knowledge about health problems that affect women and racial and ethnic minority populations and to encourage studies which address these problems. Policy available in the Federal Register volume 60 number 179, September 15, 1995, page 47948-51. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. Guidance is available 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. 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). 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 CDC GRANT APPLICATIONS OR APPENDICES: All applications and proposals for CDC funding must be self-contained within specified page limitations. Unless otherwise specified in a CDC 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. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority 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 Section 301 of the Public Health Service Act as amended (42 USC section 241). 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.


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