PA-04-017: STUDIES OF THE ECONOMICS OF CANCER PREVENTION, SCREENING, AND CARE

Department of Health
and Human Services (HHS)

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STUDIES OF THE ECONOMICS OF CANCER PREVENTION, SCREENING, AND CARE RELEASE DATE: November 4, 2003 PA NUMBER: PA-04-017 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Replacement R21 (PA-06-304) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: November 2, 2006. (Expiration date extended, see NOT-CA-05-026) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Cancer Institute (NCI/NIH) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399 This Program Announcement (PA) replaces PA-02-005, which was published in the NIH Guide on October 5, 2001. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA It is estimated that the economic burden of cancer in the United States in 2002 was equivalent to $172 billion, including $61 billion in direct medical expenditures. As cancer survival improves and as the U.S. population ages, it is likely that the economic aspects of cancer will loom larger in policy discussions. Over the coming decades the U.S. health care system, including public sector programs such as Medicare and Medicaid, will face the challenge of covering an increasing array of health care procedures and services with fiscal resources that are limited by global budget constraints. Under these circumstances, there will be increased need for understanding how economic resources are used across the cancer continuum, from prevention through end- of-life care, and in the context of different organizational settings, for careful economic evaluation of conventional and innovative cancer control interventions and for a better understanding of how economic factors influence the welfare of cancer patients, and decision process about the use of cancer prevention, screening and treatment interventions. These are the types of issues addressed by this Program Announcement. The Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI), and the Agency for Health Care Research and Quality (AHRQ), invite investigator-initiated grant applications for research directed at increasing the knowledge base in the area of the economic aspects of cancer prevention, screening and care. The goal of this program announcement is to generate new economic knowledge that will promote the optimal design of cancer prevention and control trial studies and interventions and will facilitate the formulation of effective health care policy related to cancer prevention and control. NCI has an interest in economic and health services studies with particular emphasis on meeting the goals of the NCI Quality of Cancer Care Initiative (see http://plan.cancer.gov). This Program Announcement (PA) also relates to the general health services and outcomes and effectiveness research supported by the AHRQ for a wide range of clinical conditions, including cancer. The overall goal of this Initiative is to enhance the state-of-the-science on the quality of cancer care and inform federal decision making on care delivery, coverage, and regulation. This initiative requests research applications on new methods development, the synthesis and extension of existing methods, and innovative data gathering strategies. Applications that propose to implement actual data collection on a pilot or full-scale basis as well as analytical studies that use existing data and methodology may also be submitted. RESEARCH OBJECTIVES There is increasing interest in the collection and analysis of valid, accurate, and reliable economic data related to specific disease entities and preventive, screening, and treatment interventions related to specific disease entities. For example, the 2003 report of the Organization for Economic Co-operation and Development (OECD), A Disease-base Comparison of Health Systems, (Paris 2003) assesses economic resources, treatment processes, and health outcomes for the specific disease entities of breast cancer, heart disease, and stroke across twenty-one OECD countries. Scope of Activity This initiative supports research directed at increasing our understanding of studies of the economics of cancer prevention, screening, and care. Cancer is a heterogeneous chronic disease characterized by innovation in treatment and care approaches. Studies that cover the national population of all ages on an episodic basis fail to capture an adequate sample of cancer patients or the full scope and duration of cancer costs. Studies that focus on a convenience sample of cancer patients in a single health care delivery setting or community can be criticized as lacking external validity. Studies proposed in response to this PA will be expected to address these issues and propose innovative methods of overcoming these limitations. Examples of research topics that would be considered relevant to meeting the goals of this PA include but are not limited to: 1. The economic burden to the individual cancer patient, family, and society resulting from cancer and cancer treatment, including time costs, reduced employment opportunities, and reduced access to health and life insurance. 2. Economic factors at the individual, community and health system levels that effect access to and outcomes following the use of cancer-related prevention, screening, diagnostic, and treatment services. 3. The costs and organizational structures of delivering cancer prevention, screening, and treatment services in relation to various health care delivery settings and health care market structure conditions. 4. Cost-utility, cost-effectiveness, or cost-benefit of specific cancer prevention and screening trials and cancer prevention and control interventions. 5. The interactions of cost, cost-effectiveness, and other factors in decision-making processes related to the provision and delivery of cancer prevention, screening, and treatment at the physician-patient, health system, and health policy levels. 6. The roles of economic factors and financial incentives in determining the levels of participation of patients, physicians, and health care delivery systems in cancer prevention, screening, and treatment clinical trials. 7. The identification, development, and validation of data resources needed to support relevant and generalizable economic evaluation studies related to cancer prevention, screening, and treatment 8. Methodological studies on the measurement, evaluation, and presentation of data on cost and cost-utility/effectiveness/benefit in relation to cancer- specific issues. Examples of Research Funded by this PA Over forty research articles have been published since 1998, when the first version of this PA was issued, from grants funded by earlier issuances of this PA. Research topics include: - Descriptive studies of the economic burden of cancer - Cost-effectiveness analyses of cancer screening and treatment - The relationship between health care organization and the receipt of care - The influence of regulatory and taxation policies on health behaviors Selected examples of recently published research from PA-02-005 grants are: Bradley CJ, Bednarek HL, Neumark D. Breast cancer survival, work, and earnings. Journal of Health Economics 2002;21:757-79. Earle CC, Neumann PJ, Gelber RD, Weinstein MC, Weeks JC. Impact of referral patterns on the use of chemotherapy for lung cancer. Journal of Clinical Oncology 2002;20:1786-92. Gazelle GS, Hunink MG, Kuntz KM, et al. Cost-effectiveness of hepatic metastasectomy in patients with metastatic colorectal carcinoma: a state- transition Monte Carlo decision analysis. Annals of Surgery 2003;237:544-55. Haas JS, Phillips KA, Sonneborn D, et al. Effect of managed care insurance on the use of preventive care for specific ethnic groups in the United States. Medical Care 2002;40:743-51. Lee-Feldstein A, Feldstein PJ, Buchmueller T. Health care factors related to stage at diagnosis and survival among Medicare patients with colorectal cancer. Medical Care 2002;40:362-74. Mandelblatt JS, Lawrence WF, Gaffikin L, et al. Costs and benefits of different strategies to screen for cervical cancer in less-developed countries. Journal of the National Cancer Institute 2002;94:1469-83. O Malley AS, Lawrence W, Liang W, et al. Feasibility of mobile cancer screening and prevention. Journal of Health Care for Poor and Underserved. 2002;13:298-319. Plevritis SK. A mathemamtical algorithm that computes breast cancer sizes and doubling times detected by screening. Mathematical Bioscience 2001;171:155- 78. Taylor DH, Hasselblad V, Henley SJ, et al. Benefits of smoking cessation for longevity. American Journal of Public Health 2002;92:990-6. MECHANISM(S) OF SUPPORT This PA will use the NIH investigator-initiated research grants (R01) and exploratory/developmental (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed 5 years for an R01 application and 2 years for an R21 application. For R21 submissions, applicants may request up to $100,000 direct costs (four budget modules) per year unless the application includes consortium cost, in which case the limit is $125,00 direct costs (five budget modules)per year. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see 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 current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. Since AHRQ study sections require complete budget information in their review, all applications assigned, after initial submission, to AHRQ for review and funding considerations will be requested to submit detailed budget pages prior to the study section review. 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 institutions/organizations o Faith-based or community-based organizations 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Martin L. Brown, Ph.D. Health Services and Economics Branch Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, EPN Room 4005 Bethesda, MD 20892-7344 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-5716 FAX: (301) 435-3710 Email: mb53o@nih.gov Yen-pin Chiang, Ph.D. Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 540 Gaither Road Rockville, MD 20850 Telephone: 301-427-1493 Email: ychiang@ahrq.gov o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-4801 Email: wolfreyc@mail.nih.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. The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1. Contact the NCI program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2. Obtain agreement from the NCI staff that the NCI will accept your application for consideration for award; and, 3. Identify, in a cover letter sent with the application, the National Cancer Institute and the staff member who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-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 these 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 problem? 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? 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 tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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, 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 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 both 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 Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program 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. See 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). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/. 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. 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 PA 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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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.

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