IMPROVED THERAPY FOR HEMOPHILIA AND HEREDITARY BLEEDING DISORDERS RELEASE DATE: June 18, 2004 RFA Number: RFA-HL-04-032 EXPIRATION DATE: January 16, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) National Hemophilia Foundation (NHF) (http://www.hemophilia.org) COMPONENT OF PARTICIPATING ORGANIZATIONS: National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.839 LETTER OF INTENT RECEIPT DATE: December 15, 2004 APPLICATION RECEIPT DATE: January 14, 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 Heart, Lung, and Blood Institute (NHLBI) and the National Hemophilia Foundation (NHF) invite applications for studies that will lead to improved treatment of hemophilia, von Willebrand disease, and other hereditary bleeding disorders with the ultimate goal of finding a cure for bleeding disorders. The objectives of this program are to stimulate research to improve therapy, and enhance understanding of immune response and safety issues related to novel therapeutics, gene transfer or cell based therapies for bleeding disorders. RESEARCH OBJECTIVES Background Hemophilia is a hereditary bleeding disorder that results from a functional deficiency in either blood coagulation factor VIII (hemophilia A) or factor IX (hemophilia B). The severity of the disease is related to the levels of circulating functional clotting protein. Standard hemophilia treatment involves infusion of plasma derived or recombinant coagulation factor. About 25% of individuals with severe hemophilia develop neutralizing antibodies requiring higher doses or alternative therapy. The current therapeutic options for these patients are recombinant factor VIIa (rfVIIa), plasma derived prothrombin complex concentrate (PCC) or porcine factor VIII. Often more than one approach is tried before the bleeding is arrested. One of the most common hereditary bleeding disorders is von Willebrand Disease (VWD), which is associated with mucosal or trauma related bleeding. It results from a quantitative or qualitative defect in von Willebrand factor (VWF). Approximately 80% of VWD patients have a mild to moderate form of the disease and are treated with desmopressin (DDAVP), which stimulates the release of stored VWF into the circulation. However, tachyphylaxis occurs with repeated doses. Plasma derived factor VIII products that contain a significant amount of VWF are an alternate therapy. Bleeding disorders may also be related to deficiencies in other coagulation factors: fibrinogen, prothrombin, factor V, factor VII, factor X, factor XI and factor XIII. The incidence of a deficiency in any one of these factors is about 1 in 1 million. The available treatment options for a bleeding episode for someone with one of the clotting factor deficiencies is generally a plasma derived product such as; fresh frozen plasma, cryoprecipitate, or prothrombin complex concentrates. Research Objectives This initiative would support research on the discovery and development of improved therapeutics with a goal of finding a cure for hemophilia, VWD and other hereditary bleeding disorders. The focus is on controlling the bleeding complications, the development of novel therapeutic agents, and reducing the immunogenicity or safety challenges of the products for the treatment of bleeding disorders. The introduction of recombinant factor VIII (fVIII) and factor IX (fIX) provided an alternative to plasma derived products and increased the supply of therapeutic agents. Recombinant DNA technology also provides the ability to design fVIII and fIX molecules with specific properties, such as increased activity, longer half- life, or reduced antigenicity. An inactivation resistant fVIII (IR8) had increased activity and corrected prolonged bleeding in the hemophilia A mouse model. The time fVIII remains in the circulation may be prolonged by simultaneous blocking the receptors, which are low-density lipoprotein receptor-related protein (LRP) and cell-surface heparan sulfate proteoglycans (HSPGs). Specific fVIII residues that mediate binding to these receptors have been identified and are potential mutagenesis targets for an improved fVIII. These or other protein modifications could lead to products that would require a reduced dose or less frequent administration. It may also be possible to design fVIII molecules with reduced antigenicity. Bioengineering of fVIII or fIX to improve expression may benefit the production of recombinant proteins and gene transfer applications. Recombinant fVIII with the B domain deleted (BDD) retains activity and has about a 20-fold higher expression level than wild type. The safety and efficacy of this modified fVIII was demonstrated in clinical studies, which led to the introduction of the BDD-rfVIII product. FIX has complex post-translational modifications and poses different challenges for efficient expression. The presence of intron 1 in fIX cDNA or the inclusion of three ATG triplets as a translation initiation signal results in increased production of fIX. The introduction of recombinant fVIIa provided a safe and effective therapy for many hemophilia patients with inhibitors. However, some patients have shown low clinical responsiveness to rfVIIa, which may not be detected for several days. Sequential by-pass therapy with PCC, followed by rfVIIa, has been found to be effective for some patients. The potential to develop novel by-pass agents needs to be further explored. Another possible area for exploration is the identification and development of agents that stimulate the release or increase expression of coagulation proteins. DDAVP, which can be administered as a nasal spray, works by stimulating the release of stored VWF and is an effective therapy for mild VWD. Interleukin-11 (IL 11) increases plasma levels of VWF and fVIII. A report of heterozygous VWD and normal dogs treated with IL 11 or DDAVP showed that IL11 produced a gradual and sustained elevation of VWF and fVIII and DDAVP gave a rapid unsustained elevation of these factors. In addition, the DDAVP releasable pool of VWF was maintained after IL 11 treatment. Treatment of bleeding disorders generally requires intravenous infusion. The use of venous access devices has increased the ability to treat small children several times a week, but such devices induce significant risk of infection. Studies have shown that fIX administered subcutaneously reaches the circulation but there may be an increased risk of an immune response. FIX has been produced in porcine milk and has been shown to enter the circulation of hemophilia B mice when taken orally. Studies in hemophilia B mice showed that oral tolerance to human fIX could protect against an immune response when mice were challenged with an injection of hfIX or underwent intramuscular gene transfer with AAV-hfIX. Further research is needed on tolerance induction for replacement therapy and gene transfer approaches. Additional research is also needed for development of improved delivery systems for therapeutic agents or cell/gene transfer technologies. The pursuit of novel pharmacologic agents should include consideration for the safety of the potential new therapy. In particular new therapies must not increase risk of development of antibodies to the coagulation factor or other pathologic complications. Examples for research topics The emphasis of this program is on the therapy of inherited bleeding disorders and related safety issues. Areas of investigation that would be appropriate for this RFA include but are not limited to: o Development of modified factor VIII or factor IX proteins with improved biological activity and/or functional half life o Identification of modifications that increase factor VIII or factor IX production of recombinant proteins or use in gene transfer applications o Development of pharmacologic agents that would improve the release, activity or biological availability of coagulation factors, thereby improving the effectiveness of a hemostatic response o Development of novel hemostatic agents, design of small molecules that promote hemostasis, or factor VIII/IX analogues o Identification of the processes that regulate potential for inhibitor formation, or the genetic and phenotypic signatures that affect immune response o Development of novel ways to avoid immune response, evaluation of risks/benefits of immunosuppressive agents Basic studies on von Willebrand Factor not related to von Willebrand Disease or vector development research for gene transfer will not be considered appropriate for support by this program. MECHANISM OF SUPPORT This RFA will use NIH R01 award mechanism. National Hemophilia Foundation support of the RFA will be provided by monies collected under its It’s Time for a Cure campaign (http://www.hemophilia.org/programs/timeforacure/timeforacure.htm). Applications submitted in response to this RFA, whether supported by the NHLBI or the NHF, may have a project period of up to four years. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The NHLBI intends to commit approximately $1.5 million in FY 2005 to fund 4 to 5 new and/or competitive continuation grants in response to this RFA. The NHF intends to commit approximately $1.5 million in FY 2006 (NHF fiscal year runs from July 1 through June 30) to fund 4 to 5 new grants relevant to their mission. The NHLBI intends to commit approximately $6 million for this program from FY 2005 to FY 2008. The NHF intends to commit approximately $6 million for this program from FY 2006 to FY 2009. The NHF funded grants will be awarded with the NHF indirect cost rate. NHF will make the award of grants for meritorious applications of interest to them. Applicants who wish to have their projects considered for funding by NHF should include with their application a letter stating that their application and summary statement may be shared with NHF. An applicant may request a project period of up to 4 years and a budget for direct costs of up to $250,000 per year. Facilities and administrative costs (F&A) for consortia are not included in this direct cost ceiling. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html for more information on the exclusion of the facilities and administrative (F&A) costs requested by consortium participants or contact the Grants Management Specialist listed under where to send inquiries , below. 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 NHLBI and the NHF 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 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. SPECIAL REQUIREMENTS Grantee’s Meeting The NHLBI and the NHF will sponsor annual meetings to encourage exchange of information among investigators who participate in this program. In their budgets, applicants should include funds for annual one-day grantees meetings. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. CONSIDERATION BY NHF Applicants who wish to have their projects considered for funding by NHF should include with their application a letter stating that their application and summary statement may be shared with NHF. The Research Department at the National Hemophilia Foundation, with counsel from scientific and lay leaders, is responsible for the administration of it’s grant programs. Grantees are not employees of NHF but of their grantee institution and are subject to the policies and regulations of the grantee institution. Only noncommercial institutions and investigators associated with a noncommercial institution are eligible for NHF funding. NHF is a nonprofit organization and all grants are offered based on fundraising efforts; therefore, all grants and fellowships are contingent on funds available. Please see http://www.hemophilia.org/research/pol_proc_2003.pdf for further information and specific requirements. 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: Rebecca P. Link, Ph.D. Division of Blood Diseases and Resources National Heart, Lung and Blood Institute 6701 Rockledge Drive Rockledge II, Room 10178, MSC 7950 Bethesda, MD 20892 Telephone: (301) 435-0070 FAX: (301) 480-1046 Email: linkr@nhlbi.nih.gov o Direct your questions about peer review issues to: Valerie Prenger, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive Room 7214, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: PrengerV@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Patricia Reyes Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge II, Room 7140 Bethesda, MD 20892 Telephone: (301) 435-0187 FAX: (301) 480-3310 Email: reyesp@nhlbi.nih.gov Direct any questions regarding NHF to: Steven Humes, MPH Director of Research National Hemophilia Foundation Telephone: (212) 328-3752 FAX: (212) 328-3788 Email: shumes@hemophilia.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 IC 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 Dr. Valerie Prenger at the address listed under WHERE TO SEND INQUIRIES. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: 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 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 Dr. Valerie Prenger at the address listed under WHERE TO SEND INQUIRIES. 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 NHLBI. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below. This peer review group may include members recommended by the NHF. 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 NHLBI National Advisory Council o Receive a second level review by a NHF Review Board for applications considered for NHF funding 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 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 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 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: December 15, 2004 Application Receipt Date: January 14, 2005 Peer Review Date: June/July 2005 Council Review: September 2005 Earliest Anticipated Start Date: September 30, 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: (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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. 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. 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). 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 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 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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