SPECIALIZED CENTERS OF RESEARCH (SCOR) IN HEMOSTATIC AND THROMBOTIC DISEASES Release Date: July 29, 1999 RFA: HL-99-022 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 1, 1999 Application Receipt Date: January 14, 2000 PURPOSE This solicitation invites grant applications to enter a single open competition for Specialized Centers of Research (SCOR) in Hemostatic and Thrombotic Diseases. The goal of this initiative is to support quality basic research, facilitate transfer of the basic knowledge to the clinical setting and stimulate clinical studies in these areas. Such a program will involve innovative technology, a close interaction between the subprojects and contain one or more clinical components. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This initiative, Specialized Centers of Research (SCOR) in Hemostatic and Thrombotic Diseases, is related to the priority area of Heart Disease and Stroke. Potential applicants may obtain a copy of "Healthy People 2000," (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-01) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit institutions, public and private, such as universities, colleges, hospitals, and laboratories. This RFA is intended to support SCOR grants for basic and clinical investigations. Applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Foreign institutions are ineligible from receiving awards under this solicitation. Under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators or responsible project investigators. The Principal Investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The Principal Investigator must also be the project leader of one of the component research projects. If, through peer review, this project is determined to be of low scientific merit, the over all SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) specialized centers (P50) mechanism to support this research program. Responsibility for planning the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated start date of award is February 1, 2001. Although multidisciplinary approaches are required, it is not the intent of this announcement to solicit applications for large clinical trials or large epidemiologic studies. In general, funds will not be provided for the purchase and installation of expensive, new equipment. Upon initiation of the program, there will be required communications between SCORs, usually in the setting of a biennial combined meeting of SCOR participants. Applicants should request travel funds for this purpose in fiscal years 2002, 2004, and 2006 of the budget. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases relevant to the mission of the National Heart, Lung, and Blood, Institute (NHLBI). It is essential, therefore, that all applications include both basic and clinical research projects. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human patients/subjects, which is defined as research conducted with human patients/subjects or on material of human origin such as tissue or other specimens for which an investigator directly interacts with human patients/subjects. Support may be provided for human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions. Small population-based epidemiologic studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. Length of SCOR Programs Each NHLBI SCOR program is limited to ten years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. Only one five-year competing renewal is permitted, for a total of ten years of support, unless the SCOR program is recommended for extension. The SCOR program in Hemostatic and Thrombotic Diseases is in the initial five-year project period and this competition is for the second five-year competition. The comprehensive evaluation of this SCOR Program will be conducted during the second project period according to the following timetable: Announcement of SCOR renewal competition FY 1999 Project Period (Second Competition) FY 2001 to FY 2005 Letter to SCOR Directors FY 2002 (mid-way through year -02 of regarding SCOR evaluation plans the second project period) SCOR Evaluation Meeting FY 2002 (late in year -02 of the second project period) Notification of SCOR Directors FY 2003 (mid-way through year -03 of of NHLBI Decision of second project period) The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution provided there is a different SCOR principal investigator for each application and each application is self-contained and independent of the other(s). This does not preclude cooperation, planned or possible, among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application and can provide scientific expertise in areas and topics that may not be readily available at the applicant institution. However, the consortium projects must not constitute greater than 50 percent of the proposed projects. It is also imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. Applicants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. Facilities and Administrative costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Ms. Jane Davis of the Grants Operation Branch, NHLBI, (301) 435-0166. FUNDS AVAILABLE Applicants for new SCOR programs may request up to $1.28 million in direct costs, not including Facilities and Administrative costs for collaborating institutions, in the first year with a maximum increase of no more than three percent in each additional year requested in the application. Competing renewal applicants may request an increase in their budget in the first competing year (Year 06), not to exceed ten percent of the costs awarded in the last noncompeting award year (Year 05) or $1.28 million, whichever is greater (excluding Facilities and Administrative costs on subcontracts). Applicants may request up to a three percent increase for subsequent noncompeting years. NHLBI's FY 2001 plans for this initiative include a maximum of $5.0 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. Designated funding levels are subject to change at any time prior to final award, due to unforeseen budgetary, administrative, and/or scientific developments. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires justification. Final decisions will depend on the nature of the justification and the availability of funds. RESEARCH OBJECTIVES Background Nearly 50 percent of mortality in the United States is related to cardiovascular disease and amounts to about 1 million deaths per year. Thrombotic events precipitate myocardial infarction, deep vein thrombosis and pulmonary embolism, and stroke. Formation of a blood clot and the resulting ischemia cause the tissue damage and the associated disability or death. In spite of the seriousness of the disease and its impact, there has been significant improvements in our ability to combat thrombotic disorders and cardiovascular diseases. This improvement would not have been possible without major progress in research on thrombosis. The application of innovative technology in molecular biology, immunology, genetics and protein chemistry has led to the development of new tools in the following areas of emphasis and provide opportunities to further reduce the risk of thrombotic and hemostatic disorders. o Polygenic analysis of thrombotic disorders The pathogenesis of thrombosis is complex and its etiology is likely to involve both hereditary and acquired conditions. There are a number of proteins - antithrombin, protein C, protein S, clotting factor V, prothrombin, thrombomodulin, plasminogen activator inhibitor 1 - in which a genetic alteration may be prothrombotic. Significant progress has been made in establishing the structure-function and polymorphism of platelet membrane proteins. Some of the cytoplasmic proteins that are critical in the two-way signal transduction pathway in platelets have also been identified. However, heterozygosity for a particular mutant allele can be clinically silent in some individuals but not in others. These differences could be due to intergene interactions or the effect of environmental factors. The gene structure of many candidate proteins involved in hemostasis and thrombosis are known. The availability of knockout and transgenic animals and new information from human genome studies may allow genetic delineation of the causative factors and provide an objective definition of predisposition to thrombosis. Many human diseases are related to behavior, nutrition and other environmental factors. Recent developments on prevention of thrombosis by alterations in lifestyle or in nutritional elements offer exciting research opportunities. o Diagnosis, Assays, and Treatment of Venous Thrombosis Two million Americans develop deep vein thrombosis a year. About 600,000 of them will have pulmonary embolism and approximately ten percent will die. There are important issues involving diagnosis, anticoagulation therapy, laboratory assays, efficacy of thrombolytic therapy which need further studies. There is a need for more specific and better anticoagulant agents. Systematic, controlled studies on their efficacy and potential complications are critical for effective clinical application. Optimal therapy to prevent growth of thrombi at early stages and restoration of involved vessels to as normal a state as possible are likely to be beneficial. o Thrombosis in Special Populations Clinical research that addresses thrombosis in special population groups such as children, women, and minorities is needed. The incidence of established genetic risk factors, for example Factor V Leiden, is known to be different in minority populations. Studies in special population groups offer opportunities to identify unknown thrombophilic factors. Thrombotic disorders most commonly encountered in critically ill children and neonates is of the acquired type and genetic risk factors can rarely be identified. Antithrombotic therapy for the prevention and treatment of thrombosis in children is mostly based on modifications of recommendations for adults. The magnitude and seriousness of thrombotic problems in the pediatric population are only recently being recognized. The optimal diagnosis, management, treatment, dosing, duration of anticoagulation, efficacy of thrombolytic therapy all remain important questions to be answered. o Inflammation and Thrombosis Recent studies indicate a close relationship between inflammation and thrombosis. Monocytes may be a major source of tissue factor and initiate coagulation. Blood monocytes also stick to adhesive proteins translocated on the surface of activated platelets. This cell-cell contact may differentially affect monocyte gene expression and the secretion of chemokines in inflammatory lesions in vivo. Studies on the role of leukocytes in thrombosis and the contribution of markers of inflammation to thrombolytic resistance are needed. There seems to be an interplay between inflammation, cytokines and thrombosis. The role of adhesive proteins and receptors in leukocyte migration, and the interaction of the complement system with the coagulation and fibrinolytic processes need to be defined. Septic shock with attendant disseminated intravascular coagulation (DIC)annually affects 400,000 hospitalized patients and has a high mortality rate. Basic research on the pathogenesis of DIC, improved therapy and clinical management of the patients remains a challenge. o Immune Disorders Immune related disorders have been known to have serious hematologic and thrombotic consequences. A better understanding of the pathogenesis of heparin-induced thrombocytopenia (HIT) and thrombosis may allow improved diagnosis and treatment of the disorder. Activation of platelets by an antigen-antibody complex and their subsequent removal by the phagocytic system appears to be the basis of the thrombocytopenia although why certain patients with HIT develop thrombosis while others do not remain unexplained. The nature of the PF4 antigen, formation of the antigen-antibody complex, its effects on platelets, endothelial cells and the coagulation system require further studies. Treatment of HIT, particularly those associated with the use of low molecular weight heparin, are needed. Additional studies on immune disorders with thrombotic or hemostatic consequences such as systemic lupus erythematosus (SLE), neonatal alloimmune thrombocytopenia, autoimmune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP), paroxysmal nocturnal hemoglobinuria (PNH) may be proposed. o von Willebrand Factor The von Willebrand factor (vWF) is being increasingly recognized as a key player in hemostasis and thrombosis. vWF binds to platelet surface glycoprotein GP Ib and mediates their aggregation, especially at a high shear rate. Basic research on the initial steps of platelet adhesion and its application to the development of antithrombotic agents directed to GP Ib-vWF are needed. Moreover, von Willebrand disease is the most common familial bleeding disorder affecting both men and women. There is a need for additional basic and clinical studies on vWD, its treatment, products for therapy, assays and clinical correlation. o Protease-Activated Receptors A group of cell surface G-protein coupled receptors that are involved in the proteolytic activation of different cells has been identified. At this time four such receptors (PAR 1 to PAR 4) have been reported and cloned. Activation of human platelets by thrombin probably involves two such receptors. Thrombin may also activate endothelial cells through PAR(s) and regulate the adhesive protein expression on the surface. Leukocyte infiltration in inflammation, smooth muscle cell proliferation, angiogenesis are likely to involve these receptors. A better understanding of the unique mechanism of PAR-mediated activation of cells by thrombin seems essential for the identification of therapeutic targets and clinical applications in thrombosis, atherosclerosis and inflammation. o Vascular Diversity Vascular endothelial cells play a critical role in hemostasis and thrombosis. Vascular beds differ in structure, metabolic function and molecular diversity. Genetic approaches and phage display have revealed organ-specific molecular differences of the endothelium in different tissues. This diversity could be a determinant factor in the interaction of coagulation factors leading to the generation of thrombin, the interaction of platelets and formation or dissolution of thrombi in different organs. The molecular address of the endothelium in different tissues e.g. heart, brain, kidney and its regulation are important areas in the pathogenesis of thrombosis. Structure-function studies on the natural anticoagulant molecules on the endothelial surface and their genetic manipulation may be a productive research area. Proposed Research There are significant opportunities in basic thrombosis research and the application of the results to clinical situations. The following are examples only, one or more of which may constitute a multidisciplinary research approach to clinical problems. o Analysis of the multiple genetic factors involved in thrombosis and the effect of environmental interactions in precipitating disease. o Studies on the diagnosis, assays and treatment for venous thrombosis. o Investigations on the diagnosis, management and treatment of thrombosis in special population groups such as pediatric, women, minorities, elderly, and the obese. o Elucidation of the relationship between inflammation and thrombosis and studies on disseminated intravascular coagulation. o Research on immune disorders with thrombotic and hemostatic involvement.. o Studies on von Willebrand Factor and regulation of hemostasis and platelet function. o Investigations on genetic regulation of the synthesis, catabolism and function of fibrinolytic proteins o Studies on protease-activated receptors and their function in platelets and endothelial cells. o Examination of endothelial diversity and its implications in hemostasis and thrombosis. SPECIAL REQUIREMENTS Special features of SCOR grants are: o They provide opportunities for young and established investigators with mutual or complementary interests to engage in multidisciplinary basic and clinical research in a synergistic fashion such that major therapeutic advances will be realized. o A SCOR has a central theme to which all research projects pertain. In addition, a SCOR may include core units to provide services to the various research projects and to support the organizational and administrative aspects of the program. o Inherent in the SCOR program is a special interaction between the SCOR director, the grantee institution and the Division of Blood Diseases and Resources (DBDR). Upon initiation of the program, DBDR will hold periodic meetings to encourage exchange of information among investigators who participate in this program and to stimulate collaboration. Applicants should include travel funds for a two-day meeting every other year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. o The Division's overall SCOR program and each SCOR grant undergo periodic evaluation. The progress reports are prepared for the information of the National Heart, Lung, and Blood Advisory Council, the Division of Blood Diseases and Resources staff, and ad hoc members of SCOR evaluation groups. Requirements of SCOR grants: o The overall concept of a SCOR program focuses on scientific issues related to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. o Each SCOR must have a well-delineated organizational structure and administrative mechanism that foster interactions between investigators, accelerate the pace of research, and ensure a productive research effort. o Each SCOR grant application and award must include research involving human patients/subjects, which is defined as research conducted with human patients/subjects or on material of human origin such as tissue or other specimens for which an investigator directly interacts with human patients/subjects. Support may be provided for human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders, or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. Each component project requires a well-described hypothesis, preliminary data and a time-table for conducting the proposed investigations. A SCOR may also contain one or more core units that support the research projects. The relationship between each research project and one or more core units should be described. o Applications from institutions which have a General Clinical Research Center (GCRC) funded by the NIH, National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from the GCRC program director/principal investigator could be included with the application. o The principal investigator should be an established scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The principal investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. o Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. Investigators with minimal research experience, but promising credentials, may participate; however, it is expected that most of the project directors will be investigators with significant research experience. o If a project director transfers to another institution, support for the project will normally not be continued as a consortium. Because of the size and complexity of a SCOR, prospective applicants are urged to consult with the staff of the Division of Blood Diseases and Resources early in the preparation of the application (see Inquiries section). To provide opportunity for such interactions, the time frame for implementation of this program includes an ample interval between the release of this RFA and the receipt date for applications, January 14, 2000. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (F59 14508-14513), and in the NIH Guide for Grants and Contracts of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under Inquiries. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH 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 was published in the NIH Guide for Grants Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. LETTER OF INTENT Prospective applicants are asked to submit, a letter of intent, by December 1, 1999, that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it assists the NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. C. James Scheirer Chief, Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute 6701 Rockledge Drive, Suite 7093, MSC 7924 Bethesda, MD 20892-7924 Tel: (301) 435-0266 Fax: (301) 480-3541 Email: js110j@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research or may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone: (301) 710-0267; Email: GrantsInfo@nih.gov, and from the NIH program administrator listed under INQUIRIES. Specific instructions for preparing a SCOR application are also available from the program contact listed under INQUIRIES. The RFA label included in grant application PHS 398 (rev. 4/98) must be affixed to the bottom of the face page of the application. The RFA label and line 2 of the application should both indicate the RFA number. 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, SCOR in Hemostatic and Thrombotic Diseases and number, HL-99-022 must be typed on line 2 of the face page of the application form and the "YES" box must be marked. The sample RFA label available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Send or deliver 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) Send two additional copies of the application to the Chief, Review Branch, at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Center for Scientific Review (CSR). Applications must be received by January 14, 2000. If an application is received after that date, it will be returned to the applicant without review. The 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NHLBI staff. Incomplete applications or applications deemed not responsive to the RFA will be returned to the applicant without further consideration. 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. Applicants should submit the highest quality applications possible to CSR as no site visits or reverse site visits will be held. As part of the initial merit review, a streamlined process may be used by the initial review group in which the scientific merit of applications relative to other applications received in response to the RFA will be determined. Applications judged to be of high scientific merit will be discussed and be assigned a priority score, and will also receive a second level of review by the National Heart, Lung, and Blood Advisory Council. Applications determined to be of low scientific merit will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be notified. Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include overall proposed interactions among basic and clinical research projects. Major factors to be considered in the evaluation of applications include: o Scientific merit of the proposed basic and clinical research projects including significance, importance, and appropriateness of the theme; innovation, originality, and feasibility of the approach; and adequacy of the experimental design. o Leadership, scientific stature, and commitment of the program director; competence of the investigators to accomplish the proposed research goals and their time commitment to the program; and the feasibility and strength of consortium arrangements. o Collaborative interaction among basic and clinical research components, the balance between them, and plans for transfer of potential findings from basic to clinical studies. o Adequacy of the environment for performance of the proposed research including clinical populations and/or specimens; laboratory facilities; proposed instrumentation; quality controls; administrative structure; institutional commitment; and, when needed, data management systems. o Appropriateness of the budget for the proposed program. o Appropriateness of the central theme and coordination and interrelation of the research projects and core units. AWARD CRITERIA The anticipated date of award is February 1, 2001, for the SCORs in Hemostatic and Thrombotic Diseases. Awards will be made according to priority score, availability of funds, and programmatic priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Pankaj Ganguly , Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0070 FAX: (301) 480-1046 Email: gangulyp@nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung and Blood Institute 6701 Rockledge Drive, Suite 7174, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301)-435-0166 FAX: (301)-480-3310 Email: davisj@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.839, Blood Diseases and Resources. Awards will be made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or Health Systems Agency review. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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