PKD RESEARCH AND TRANSLATION CORE CENTERS RELEASE DATE: May 28, 2004 RFA Number: RFA-DK-04-012 Update: The following update relating to this announcement has been issued: December 22, 2009 - This RFA has been reissued as (RFA-DK-09-007). EXPIRATION DATE: March 16, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.849 LETTER OF INTENT RECEIPT DATE: February 15, 2005 APPLICATION RECEIPT DATE: March 15, 2005 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 of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Polycystic Kidney Disease (PKD) Research and Translation Core Centers to support both basic and clinical research on PKD. The goal of this program is to improve the lives of patients with polycystic kidney disease by improving therapies for this condition. Core Centers should provide shared institutional and national resources to facilitate basic and clinical research on PKD and improve its effectiveness in translating insights from basic biology to clinical practice. The Centers will also support pilot and feasibility studies to develop and test new approaches to therapy. RESEARCH OBJECTIVES A. Background PKD is the fourth leading cause of chronic kidney disease (CKD) in America, affecting approximately 500,000 people. A striking feature of PKD is the variability with which it affects the patient. Some develop only a modest number of renal cysts during their lifetime and may not be aware of being affected by this disorder. Others develop a massive number of renal cysts and may reach renal failure at an early age. It is not unusual for cysts to develop in the liver and within the systemic vasculature. Evidence also indicates that in addition to documented cyst enlargement and interstitial fibrosis, apoptotic loss of non-cystic nephrons is a significant component of the pathology of PKD and may contribute to the progressive loss of renal function. Much progress has been made since the initial solicitation for PKD centers in 1999. Examples include: improved animal models of disease due to increased understanding of the underlying molecular processes that result in cyst formation and growth; progress in understanding the role of the primary cilium in kidney tubule cyst formation; progress in understanding aneurysmal development in PKD. The NIDDK is now further enhancing the PKD Centers program to allow for regional, national and even international collaboration. The NIDDK has also funded two complementary multicenter clinical studies. In 1999, the NIDDK funded the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) (RFA-DK-99-003) to determine whether changes in anatomic characteristics of the kidneys of patients with PKD will be useful in providing surrogate measures for disease progression. Preliminary findings from this group over the next several years might inform the designs of clinical trials in patients with PKD in the near future. Then, in 2001, the NIDDK established the PKD Clinical Trials Network to design and implement clinical trials to determine which pharmacologic agents might slow the progressive loss of function in PKD. The first large interventional clinical trial in this network, called HALT-PKD, will be a randomized trial of renin-angiotensin axis blockade in patients with PKD. Despite the progress noted above, many challenges remain in determining the genetic and pathophysiologic mechanisms of PKD that could potentially be targeted for therapeutic interventions. B. Research Goals and Scope The goal of these PKD Research and Translation Core Centers is to provide resources for communication and collaboration between basic and clinical researchers in the field of polycystic kidney disease. Core Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of research on PKD. Centers may be located in a single institution or in multiple institutions with complementary research bases. Project Organization A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center. Each core should provide services to multiple funded research projects. Centers may propose either Institutional Cores or Regional/National/International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. A new category of research base for cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might expect to use the core in some way. This might include investigators who would be expected to fully compensate the core service through a charge-back, and thus would not be obtaining direct financial assistance from the Center. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, it should be evaluated as part of the core, in order to distinguish it from the local institutional research base. Examples of types of biomedical core resources that would be considered responsive to this Request for Applications include: o Collection, analysis, storage and distribution of data and samples; o Provision of specialized tools and technologies or access to specialized expertise; o Development, standardization and distribution of reagents and/or protocols; o Provision of technical assistance, training, and enrichment programs; o Recruitment of patients and coordination of patient studies; o Development, beta-testing and dissemination of specialty assays, methods, and services on an institutional level; o Increase interdisciplinary interactions at the institution through cross- project/laboratory exchange; o Sharing of specialized tools, technologies and expertise between collaborating investigators. In addition to biomedical cores, an administrative core must be described which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative core will also be responsible for planning the Educational Enrichment Program consisting of a seminar series, guest lectures, and workshops, and convening a Committee to oversee the solicitation, review and selection of the pilot projects. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members. Each Core Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of PKD research. A pilot and feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting. Each Core Center application must include a minimum of two up to a maximum of five pilot projects. Each pilot project may request a maximum of $50,000 direct costs per year (excluding Fiscal and Administrative costs) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html) for up to two years. A comprehensive description of the Pilot and Feasibility Program can be found in the Administrative Guidelines (http://www.niddk.nih.gov/fund/other/centers/P30guidelines.pdf). The National Center for Research Resources (NCRR) supports approximately 80 General Clinical Research Centers (GCRC) nationwide, which provide services and resources to enhance clinical research (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp). Research Centers supported by the NIDDK are encouraged to collaborate with GCRCs to avoid duplication of effort and enhance utilization of services and resources. MECHANISM OF SUPPORT This RFA will use NIH Core Center (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is October 2005. This RFA uses just-in-time concepts. It uses the non-modular budgeting formats. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDDK intends to commit approximately $1.5 million in FY 2005 to fund two new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $750,000 per year (excluding Fiscal and Administrative costs) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html ). 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 the IC(s) 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(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 are not eligible to apply as the applicant organization; however, consortia agreements with foreign institutions are permitted. 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. SPECIAL REQUIREMENTS An existing program of biomedical research in polycystic kidney disease is required. This research base must consist of NIH and other peer-reviewed funded research projects and be substantial to justify the requested Core support. A clinical research base is not required but would be considered a strength. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines. Successful applicants, during the second year of the award and each year thereafter, may be expected to attend a yearly meeting of PKD Centers Directors convened by the NIDDK. Funds for this activity may be requested in the budget proposed for the respective center. 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: Marva M. Moxey-Mims, M.D. Pediatric Nephrology & Renal Centers Programs Director National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 639 Bethesda, Maryland 20892-5458 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: firstname.lastname@example.org o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes, Digestive, and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, Maryland 20892-5452 Telephone: (301) 594-8897 Fax: (301) 480-3505 Email: email@example.com o Direct your questions about financial or grants management matters to: Carolyn Kofa Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 727 Bethesda, Maryland 20892-5452 Telephone: (301) 594-7687 FAX: (301) 480-3504 Email: firstname.lastname@example.org 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 a subsequent application, the information that it contains allows NIDDK 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 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 https://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: Applicants should consult the “Administrative Guidelines for PKD Research and Translation Core Centers” located at: http://www.niddk.nih.gov/fund/other/centers/P30guidelines.pdf. 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: https://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 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 the appendix material must be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 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. 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 the CSR and responsiveness by the NIDDK. Incomplete applications will not be reviewed. 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 the NIDDK 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 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 o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o The scientific excellence of the Center's research base (its strengths, its breadth and depth) as well as the relevance and interrelation of these separately funded research projects to the PKD focus of the Center and the likelihood for meaningful collaborations among Center investigators. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a PKD Core Center and is the most important component of the review. The results of previous peer reviews of its content will weigh heavily in the assessment of the application's overall strength. o The qualifications, experience, and commitment of the Center investigators responsible for the individual research projects, and their willingness to interrelate with each other and contribute to the overall objectives of the PKD Core Center. o The appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. Competing continuation applications must document the use, utility, quality control, and cost effectiveness of each Core requested to continue as part of the Center. Progress will be judged in part by the list of publications arising from the cores. At least two users are required to establish a core. However, a greater number of users will be considered to be more cost effective. o For all applications, two to five P&F studies should be submitted for evaluation as part of the review of the P&F program. In general for new applications, the proposed P&F projects will be examined to assess the eligibility of the P&F applicant and the adequacy of the selection process by which the individual studies were selected. For competing continuation applications, data should be supplied on the success of previously funded P&F projects in obtaining outside support. Applicants should refer to the Administrative Guidelines for PKD Research Core and Translation Centers for specific details regarding the P&F program and its review by the IRG. o The scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program. o The administrative organization proposed for the following: (a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring; (b) Establishment and maintenance of internal communication and cooperation among the Center investigators; (c) Mechanism for selecting and replacing professional or technical personnel within the Core Center; (d) Mechanism for reviewing the use of and administering funds for the P&F program; (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities; o The institutional commitment to the program, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center; o The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions; o Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center; o The appropriateness of the budgets for the proposed and approved work to be done in Core facilities, for P&F studies (these are restricted funds and are capped at $150,000), and for enrichment in relation to the total Center program. Total requested direct costs are limited to $750,000 (including the P&F program). For both new and competing continuation applications, total requested direct costs should not exceed the $750,000 cap. 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). 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. 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 must 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. https://grants.nih.gov/grants/policy/data_sharing BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 15, 2005 Application Receipt Date: March 15, 2005 Peer Review Date: June 2005 Council Review: September 2005 Earliest Anticipated Start Date: October 2005 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. 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: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $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. https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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. 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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://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. NIH has provided guidance at https://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). 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 https://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 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 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 https://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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