Full Text HL-94-008 SPECIALIZED CENTERS OF RESEARCH IN PATHOBIOLOGY OF FIBROTIC LUNG DISEASE, PATHOBIOLOGY OF LUNG DEVELOPMENT, AND CELLULAR AND MOLECULAR MECHANISMS OF ASTHMA NIH GUIDE, Volume 23, Number 20, May 27, 1994 RFA: HL-94-008 P.T. 04 Keywords: Asthma Pulmonary Diseases Biology, Molecular Pathophysiology National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 15, 1994 Application Receipt Date: July 14, 1995 PURPOSE The primary objective of the Specialized Centers of Research (SCORs) programs supported by the Division of Lung Diseases is to foster multidisciplinary basic and clinical research enabling basic science findings to be more rapidly applied to clinical problems. The basic and clinical research to be supported through this RFA will be related to one of the above three categories. It is expected that results from these SCOR grants will have an impact on the prevention, diagnosis, and treatment of fibrotic lung disease, pulmonary diseases in infants and children, and asthma. 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 Request for Applications (RFA), SCORs in Pathobiology of Fibrotic Lung Disease, Pathobiology of Lung Development, and Cellular and Molecular Mechanisms of Asthma, is related to the priority areas of occupational safety and health, environmental health, maternal and infant health, diabetes and chronic disabling diseases and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic 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. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. 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 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. 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 Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. All applications received in response to this solicitation will be considered as new applications. Applications submitted by current SCOR groups must be sufficiently changed to meet the objectives of one of the three programs described in this RFA. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under the RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases relevant 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. Each SCOR grant application and award must include research involving 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. 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 10 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 10 years of support, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the Pathobiology of Fibrotic Lung Disease, Pathobiology of Lung Development, and Cellular and Molecular Mechanisms of Asthma SCOR programs will be conducted during the second project period according to the following timetable: Program Announced FY 1994 Project Period (First Competition) FY 1997 through FY 2001 Program Reannounced FY 2000 Project Period (Second Competition) FY 2002 through FY 2006 Letter to SCOR Directors Regarding FY 2003 (mid-way through year 02 of SCOR Evaluation Plans 2nd project period) SCOR Evaluation Meeting FY 2004 (late in year 02 of 2nd project period) Notification of SCOR Directors FY 2004 (mid-way through year 03 of of NHLBI Decision 2nd project period) The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution nor does it limit the number of applications in the three SCOR programs described in this RFA from one institution. However, there must be a different SCOR principal investigator for each application and each application must be 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 in a given program is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator. FUNDS AVAILABLE Applicants may request up to $1,170,000 direct costs, not including indirect costs for collaborating institutions, in the first year, with a maximum increase of no more than four percent in each additional year requested in the application. Award of grants pursuant to this RFA is contingent upon availability of funds for this purpose. It is estimated that a total of $28,000,000 will be available for the first year of support for the three programs, and it is anticipated that 14 awards will be made. 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 requests require in-depth justification. Final decisions will depend on the nature of the justification and the NHLBI's fiscal situation. 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, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. 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 Mr. Ray Zimmerman, Grants Operations Branch, NHLBI, 301/594-7420. Applicants of SCOR grants 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 the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. RESEARCH OBJECTIVES Background The SCOR program was initiated within the Division of Lung Diseases in 1971 as a "Pulmonary SCOR." Since then, several modifications and changes in program direction have been made. In the 1975 and 1980 competitions, the Division's SCOR program was announced in four disease categories: Chronic Airways Diseases, Fibrotic and Immunologic Lung Diseases, Pediatrics, and Pulmonary Vascular Diseases; in the 1985 competition the disease categories were: Chronic Diseases of the Airways, Occupational and Immunologic Lung Diseases, Respiratory Disorders of Neonates and Children, and Pulmonary Vascular Diseases. The SCOR program expanded in 1977 with the solicitation for applications in Adult Respiratory Failure. This program was reannounced in 1982 and 1987, with the latter competition resulting in four awards. As a result of a Congressional mandate, two new SCOR programs, Cardiopulmonary Disorders During Sleep and Cystic Fibrosis, were announced in 1988, resulting in a total of five awards. Following an evaluation, a SCOR competition was announced in 1989 and the following awards were made in FY 1992: three in Chronic Diseases of the Lung and seven in Lung Biology and Disease in Infants and Children. In October 1992, a competition was announced in Acute Lung Injury, Cardiopulmonary Disorders of Sleep, and Cystic Fibrosis. In FY 1993, a total of six awards were made for centers in Cardiopulmonary Disorders of Sleep and Cystic Fibrosis and six awards were made in FY 1994 for centers in Acute Lung Injury. In response to the new NHLBI policy that each SCOR program is limited to 10 years of support, unless a programmatic evaluation indicates that further support is warranted, the Division convened a committee, composed of Pulmonary Diseases Advisory Committee members and ad hoc consultants, to evaluate the SCOR programs in Occupational and Immunologic Lung Diseases, Lung Biology and Disease in Infants and Children, and Chronic Diseases of the Airways. As a part of the evaluation process, written and oral comments were received from the current SCOR directors of these three programs. As a result of this evaluation, new SCOR programs were recommended in Pathobiology of Fibrotic Lung Disease, Pathobiology of Lung Development, and Cellular and Molecular Mechanisms of Asthma. Proposed Research Applications must be addressed to only one of the three disease categories identified below to be acceptable for this competition. A SCOR grant is a five-year program, therefore, an applicant should submit a five-year plan for all the projects. If a project can be completed in less than five years, it should not be included in the application. Examples of research topics of interest for each SCOR program under competition are listed below. These research topics are intended to provide a perspective of the scope of research that would meet the objectives of this program. It is not required that all or any of these topics be included; investigators are encouraged to consider other topics that are relevant to the goals of these programs. Pathobiology of Fibrotic Lung Disease The SCOR program in Pathobiology of Fibrotic Lung Disease will focus on cellular and molecular mechanisms involved in the transition from the inflammatory events associated with early disease to the later processes involving wound healing, repair, and fibrosis. It will offer the opportunity for in vitro, animal, and human studies on diseases such as idiopathic pulmonary fibrosis, sarcoidosis, and autoimmune-, occupational- and environmentally-induced lung disease. Research aimed at identifying and characterizing prognostic factors and molecular biomarkers of progression of disease is an important aspect of this program. Studies designed to obtain phenotypic information that might be used to uncover the genetic basis of susceptibility for developing pulmonary fibrosis would also contribute significantly toward progress on understanding these diseases. Basic research on molecular/cell signalling, cell/cell interactions such as those between epithelial cells and fibroblasts, and the molecular basis for progression from the later stages of inflammatory disease to fibrosis is a prime objective of this program. The most prominent manifestation of fibrotic pulmonary disease is the abnormal accumulation of extracellular matrix components that results in severe malfunctioning of the lungs. The events that lead to an exaggerated accumulation of these components in fibrotic lesions involve a number of complex cellular and molecular processes, which explains why the nature of both the inflammatory responses and the triggering mechanism that induces the fibrotic response in the lung remain poorly understood. Cytokines and other factors are currently recognized to play an important part in stimulating cells to overproduce extracellular matrix components. Following their initial contact with the cell surface, these molecules are postulated to activate intracellular signalling pathways, which in turn lead to activation of a pleiotropic genetic program characteristic of the fibrotic response. This activation is thought to bring about changes in the expression of specific genes that determine the phenotype of cells involved in the healing of lung injury. Research on specific mechanisms that determine progression to aberrant healing of injury and development of fibrotic lesions are an important area of interest within this program. Emphasis on molecular biologic and molecular genetic technology is highly desirable to gain information on how the transition from inflammation to normal healing and to fibrosis is regulated in the lung. During the past two decades, much information has been obtained at the cellular and molecular level on the biology of connective tissue formation and the pathophysiology of connective tissue diseases. The knowledge that pharmacologic interventions can be specifically targeted at varying strategic points in the life cycle of fibroproliferative processes has broadened considerably the realm of therapeutic modalities that might be investigated to control these processes. Numerous approaches designed to control collagen deposition remain untested in the lung. Ways to overcome the toxicity associated with collagen inhibitors through delivery methods that exploit the unique aspects of the lung might be developed. Experimentation that addresses collagen degradation, use of steroidal and non-steroidal anti-inflammatory drugs, interferons and their inducers, calcium and calmodulin antagonists, and cyclic nucleotides also offers opportunities for continued development as ways to control the accumulation of extracellular matrix in the lung. The SCOR program offers the opportunity for a multidisciplinary effort to conduct in vitro studies, animal studies, and human studies aimed at developing new ways to prevent and/or control fibrosis in the lung. The SCOR program in the Pathobiology of Fibrotic Lung Disease also offers the potential to compare and contrast mechanisms involved in the fibroproliferative processes in diseases such as acute lung injury and chronic obstructive lung disease with those of the chronic interstitial lung diseases. Pathobiology of Lung Development The objective of this SCOR program is to expedite the acquisition and application of new knowledge essential for improving clinical care of infants and children with respiratory disorders. The program will be focused on delineating the sequence of events which occurs during normal lung development and will include studies on the role of genetic determinants as well as that of other factors that regulate lung growth and repair. An important goal of this program will be to discern how the process of lung development is altered in several important lung diseases of infants and children such as: bronchopulmonary dysplasia (BPD), lung hypoplasia, persistent pulmonary hypertension of the newborn, viral diseases in infancy and early childhood and chronic bronchiolitis. Although new clinical strategies, such as surfactant therapy, have improved the outcome for infants born prematurely, the application of the therapies has generated a hidden cost in the survival of lower and lower birth weight infants. Along with the ability to keep low birth weight infants alive, the incidence of chronic lung diseases in infants, such as BPD, has increased dramatically by being able to include that group. The need to address the problems of this group of infants presents a significant new challenge. Because of the limitations in our knowledge, it is necessary to focus upon an in-depth exploration of the pathobiology of early lung development. Currently available technologies of molecular embryology should be utilized to ascertain the factors that control growth and differentiation in the primitive lung bud and that determine the repair options available to the developing lung in models of lung injury. Areas of specific research interest will include: lung molecular embryology; determinants of lung growth and repair; genetic sequence of cell differentiation events; and the etiology, prevention and management of clinical manifestations of disordered lung growth. Molecular embryology approaches may also be applied to the ontogeny of the pulmonary vasculature and the etiology, prevention, and management of clinical conditions such as persistent pulmonary hypertension of the newborn. Likewise, similar information on the ontogeny of pulmonary defense mechanisms would be expected to translate into the prevention and more effective management of childhood pulmonary infections and bronchiolitis. A systematic investigation of the molecular and cellular variables defining the disordered growth observed in childhood lung disease states, such as BPD, is required. Of special interest will be the identification of the complex of molecular variables involved in normal lung development. It is expected that a better understanding of the process of lung development will lead to new interventions to prevent arrested development of the lung via the translation of this information into new clinical strategies. Studies to elucidate the relationship of early insults to lung development and subsequent lung disease in childhood, adolescence and adulthood are encouraged. Follow-up studies as well as the development of appropriate models of injury or aberrant lung development are also encouraged. Because the purpose of the program is to provide an opportunity for the expeditious transmission of basic research results to the bedside, the clinical problem should generate the research questions within each SCOR program on Pathobiology of Lung Development. Applicants will be encouraged to develop a comprehensive program of well-integrated, mechanistic, basic research with high relevance to the clinical focus of the SCOR grant. For example, studies on the efficacy and/or comparison of lung surfactant treatments in RDS will not be considered responsive to this solicitation, whereas studies concerned with the possible regulatory influence of the surfactant proteins on early lung development could be considered responsive. Cellular and Molecular Mechanisms of Asthma The objective of this SCOR program is to better define the cellular and molecular mechanisms underlying acute and chronic asthma through multidisciplinary basic and clinical investigations. Understanding the interaction and integration of various inflammatory, immunologic, and neural processes and how they cause the clinical syndrome of asthma is an important goal. Cell activation and cell-cell and cell-matrix interactions are poorly understood in asthma, particularly as they relate to altered airway function. The role of specific inflammatory cells in the pathogenesis of asthma requires further study. The relationship between influx of inflammatory cells and alterations in resident airway cell function and tissue matrix is likely critical to this process. The influence of cytokines, adhesion molecules, and growth factors also needs to be investigated. Epidemiologic data strongly suggest that asthma results from the combined effects of genetic and environmental factors, but the nature of the gene or genes that contribute to this predisposition remains to be established. Molecular genetic studies of asthma require an understanding of the complexity of phenotype and of the interactions between genotype and the environment. The availability of longitudinal databases provides an essential component upon which to base these types of studies. Moreover, advances in molecular genetics have produced useful systems that could be exploited to test specific hypotheses that relate to asthma. For example, transgenic mice with specific alterations in protein expression may be useful to determine the importance of individual factors (e.g., cytokines, adhesion products, growth factors, membrane ion channels) in this complex disorder. While it is unlikely that any single genetic manipulation would produce an animal with asthma-like disease, the response of such model systems to airway inflammation might yield important and specific information about normal host defenses and pivotal regulatory molecules. Use of these techniques provides the possibility of determining how altered cell biology relates to airway inflammation and asthma. Mechanisms underlying the development and persistence of asthma, as well as the processes resulting in the reemergence of active asthma remain poorly understood. Potential areas of investigation include basic studies of the nature of the repair process in the airway wall and of remodelling of the airway epithelium, connective tissue, and airway smooth muscle; examination of potential sources of long-term airway "memory", and development of in vivo systems demonstrating persistent airway hyperresponsiveness. Asthma changes with age yet little is known about the influence of growth and development on lung physiology, immune function, and features of bronchial hyperresponsiveness. Investigations are needed to better define the ontogeny of airway function (including airways responsiveness), immune function, and inflammatory and neural control mechanisms of potential relevance to asthma. There is little doubt that inflammation is a component of asthma, but the role of inflammation in the pathogenesis of the disease requires further investigation. The use of inhaled corticosteroids as first-line treatment is likely to increase, and, although this therapy has proven to be consistently efficacious, little is known about the cellular and molecular mechanisms that contribute to the clinical response. This information is essential to the development of therapeutic agents that possess the beneficial effects of inhaled steroids without the undesirable side effects. Another important area of investigation is neural and immunologic mechanisms of nocturnal asthma. There is a need to better understand the circadian aspects of physiology, bronchial reactivity, and inflammation. Development and use of animal models, tissues, and cells derived from the lung may be appropriate for certain studies, but, when feasible, human lung materials should be employed. In the case of studies with non-human tissues or cells, the relationship of the proposed studies to the improved understanding of human asthma and human airway function relevant to asthma should be addressed. SPECIAL REQUIREMENTS Special features of SCOR grants are: o They provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research focusing on a specific respiratory disorder. o Inherent in the SCOR program is a special interaction between the SCOR director, the grantee institution and the Division of Lung Diseases. Funds are specifically allocated in a SCOR grant for investigators from different SCORs to meet and discuss problems of mutual interest and to participate in workshops addressing common research areas. 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 Lung Diseases staff, and ad hoc members of SCOR evaluation groups. Requirements of SCOR grants: o Research conducted at the individual centers must include both basic science and clinical research to ensure that advances in the basic sciences are translated rapidly into clinical applications and that clinical needs will provide a direction for the basic sciences. Therefore, each SCOR grant application and award must include one or more research projects involving human subjects/patients. The basic research projects should clearly relate to the disease focus and contribute to elucidation of mechanisms underlying the disease, or to improved diagnosis or management of the disease. o Each component project requires a well-described hypothesis, preliminary data and a time-table for conducting the proposed investigations. o If core facilities are included, the relationship of each component project to each core should be described. 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 Each SCOR must have a well-delineated organizational structure and administrative mechanisms that foster interactions between investigators, accelerate the pace of research, and ensure a productive research effort. 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 Lung Diseases 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, May 1994 and the receipt date for applications, July 14, 1995. STUDY POPULATIONS 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) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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 9, 1994 (F 59 11146-11151), and reprinted 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 below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 15, 1994, a letter of intent 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: Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) 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 Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267 and from the NIH program administrator named below. Specific instructions for preparing a SCOR application are available by contacting Director, Division of Lung Diseases, as indicated under INQUIRIES. The RFA label included in grant application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the "YES" box must be marked. Send or deliver a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to 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 Division of Research Grants (DRG); otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by July 14, 1995. If an application is received after that date, it will be returned to the applicant without review. The DRG 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 Division of Research Grants 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 application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG 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 DRG as no site visits nor reverse site visits are planned. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive 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 non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly 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. AWARD CRITERIA The anticipated date of award is December 1, 1996. Awards will be made according to priority score, availability of funds, and programmatic priorities. INQUIRIES Written and telephone inquiries concerning the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Special supplemental instructions for the preparation of grant applications for SCORs may be obtained by contacting Director, Division of Lung Diseases, as indicated below. Direct inquiries regarding programmatic issues to: Suzanne Hurd, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A16 Bethesda, MD 20892 Telephone: (301) 594-7430 FAX: (301) 594-7408 Direct inquiries regarding fiscal matters to: Raymond Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 2241 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 requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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