DEVELOPMENT OF MOUSE PHENOTYPIC SCREENS FOR HEART, LUNG, AND BLOOD DISEASES Release Date: April 13, 1999 RFA: HL-99-010 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: August 1, 1999 Application Receipt Date: September 15, 1999 THIS RFA USE THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites research grant applications for the development of phenotypic screening methods in the mouse for heart, lung, and blood diseases and sleep disorders. The purpose of this initiative is to stimulate research on the phenotypic screening of mice for heart, lung, blood and sleep disorders in order to accelerate the pace at which mice with heritable disorders that are models of human disease produced through either targeted or random mutagenesis are made available to the research community for further investigation or application. This Request for Applications (RFA) will support investigators to (1) develop mouse screening and phenotype characterization protocols, particularly those that can be used for high throughput analysis of mouse phenotypes; (2) provide for the systematic validation of these screening protocols against normal inbred mouse strains and genetically altered mouse strains that approximate the disease of interest; and (3) provide for the timely dissemination of information and methodologies to the scientific community. The initiative is in response to the recommendations from the meeting on "Priority Setting for Mouse Genomics and Genetics Resources" on the development of phenotyping protocols in the mouse (see NIH Plan for Mouse Genomics and Genetics Resources at www.nih.gov/science/mouse). 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 RFA, Development of Mouse Phenotypic Screens for Heart, Lung, and Blood 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. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800) or at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, eligible agencies of the Federal Government, and small businesses. Applications may represent a single institution, or may involve several institutions or organizations. Applications from minority individuals, women, and persons with disabilities as principal investigators are strongly encouraged. Multiple applications from the same institution will not be considered unless each application is submitted by a different principal investigator, and is self-contained and independent of others from that institution. Overlap in the scientific scope of applications from the same institution will not be accepted. This does not preclude cooperation among participants after awards are made. If more than one application is envisioned from an institution, the investigators are encouraged to discuss their plans with the program administrator listed under INQUIRIES. Applications submitted in response to this RFA will only be considered as new applications. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) mechanism of support. However, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required in the application under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. Complete and detailed instructions and information on Modular Grants can be found at https://grants.nih.gov/grants/funding/modular/modular.htm Under the modular grant concept, funds must be requested in $25,000 direct cost modules and a maximum of ten modules ($250,000 direct costs) per year may be requested for four years. Any necessary escalation in future years must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. It is anticipated that larger than normal equipment costs may be incurred in the first year in order to implement new approaches. As such, applications may exceed the $250,000 direct cost maximum in the first year by up to 3 modules ($75,000) to cover the cost of new equipment. The need and cost of equipment must be well justified and must not be used to cover the cost of equipment already in place or for alteration and renovations. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS 398 application kit instructions. Application budgets will be simplified. Detailed categorical budget information will not be submitted with the application; budget form pages of the application kits will not be used. Instead, total direct costs requested for each year will be presented. Information, in narrative form, will be provided only for Personnel and, when applicable, for Consortium/Contractual Costs. See section on application instructions below. Additional narrative budget justification will be required in the application only if there is a variation in the number of modules requested. There will be no routine escalation for future years. In determining the total for each budget year, applicants should first consider the direct cost of the entire project period. Well-justified modular increments or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested. For example, purchase of major equipment in the first year may justify a higher overall budget in the first, but not in succeeding years. Other Support pages of the PHS 398 will not be submitted with the application. Information on research projects ongoing or completed during the last three years of the principal investigator and key personnel will be provided as part of the "Biographical Sketch." This information will include the specific aims, overall goals and responsibilities and should include Federal and non-Federal support. This information will be used by reviewers in the assessment of each individuals qualifications for a specific role in the proposed project. Following peer review, information about Other Research Support will be requested by NIH from the applicant for applications being considered for award. Additional budget information will be requested only under special circumstances. This RFA is a one time solicitation. Applications for continuation beyond this initial award period will compete with all investigator-initiated applications in the regular grant program and according to customary peer review procedures. FUNDS AVAILABLE It is anticipated that for fiscal year 2000, total costs of $4,500,000 will be available for this initiative. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. Approximately ten new grants requesting direct costs of up to $250,000 per year for four years are expected to be awarded under this program. The specific number of grants to be funded, however, depends on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap and other administrative adjustments. The earliest anticipated award date for successful grant applications is July 1, 2000. RESEARCH OBJECTIVES Background Cardiovascular, pulmonary, and hematologic diseases constitute a large morbidity and mortality burden on individuals. In 1996, cardiovascular, lung, and blood diseases accounted for 1,180,000 deaths, representing 51 percent of all deaths in the United States. The purpose of the biomedical research programs supported by the NHLBI is to contribute to the prevention and treatment of these diseases. Because many heart, lung, and blood diseases begin early in life, their detection and control can reduce the risk of disability and delay death. The identification of molecular and genetic factors contributing to the pathogenesis of cardiopulmonary, blood, and sleep disorders is essential for developing new preventive and treatment strategies. Objectives and Scope The mouse is an excellent model for defining mammalian gene function because mice exhibit extensive molecular, genetic, immunological, reproductive, physiological, and pathologic similarities to the human. Genetic manipulation, integrated with molecular, cellular, and organ level approaches in the mouse, can facilitate the investigation of potential pathogenic factors involved in cardiovascular, pulmonary, and blood syndromes. With the impending elucidation of the mouse genome and the availability of techniques to alter the expression and composition of genes in this species, the mouse offers an excellent model for determining the functional consequences of gene expression. Mutations introduced into the genome can be reflected in functional alterations in physiologic parameters that result in disorders resembling or modeling human disease. The systematic classification and characterization of phenotypes is essential for ultimately mapping the genes responsible for normal and abnormal development and physiology. In any search for mutations or altered functional expression, identification depends on phenotypic screening and its ability to detect variation from normal. The challenge is to develop efficient, systematic and comprehensive phenotypic screening procedures and tools that will permit comparison between laboratories, temporally, and between different strains of mice. This is a necessary step before utilizing chemical or other mutagenesis methods to produce large numbers of mutant mice for the investigation of normal and abnormal development and physiology. However, the technology for the functional analysis of genetically altered murine models has not kept pace with the rapid increase in the production of animals with mutant phenotypes. As a result, existing laboratory methods with respect to heart, lung, and blood measurements are inadequate to measure essential physiological parameters for screening and characterization purposes. For example, while a complete blood count with microscopic differential analysis is a standard clinical laboratory test that is used for disease diagnosis in humans, the application of such tests to mice is only now beginning to be utilized on a regular basis. The measurement of cardiovascular parameters in mice through imaging or electrophysiological characterization has been reported, but this technology is not readily available nor is it amenable to widespread and rapid screening of large numbers of mice. Likewise, current electroencephalographic methods to monitor sleep are not practical for testing large numbers of transgenic animals. Methods available for the measurement of pulmonary function and disease in the mouse are time consuming and often require manipulations or challenges over an extended period of time. This critically limits efforts to characterize mutant phenotypes and develop models with which to elucidate molecular pathways and map genes. Of particular interest to the National Heart, Lung, and Blood Institute are assays or tools that provide rapid measures of particular molecular parameters that specify, indicate, or point to dysfunctions or abnormalities in cardiovascular, pulmonary or hematologic systems. Thus, a primary focus of this program is the development of high throughput phenotyping assays or tests that could efficiently, rapidly, and systematically be used to screen anywhere from 5,000 to 20,000 mice per year for alterations in cardiovascular, pulmonary, hematologic or sleep physiology. This could include, but not be limited to, biochemical surrogate markers, noninvasive imaging modalities, microarray analysis, or indicator screens. Another goal is to develop new phenotyping techniques or methods for heart, lung, blood, and sleep disorders that would accelerate the emergence of new concepts and improve our understanding of structural, metabolic, and functional relationships in cardiopulmonary, and blood systems. The following are examples of studies that would be responsive to this program: Develop novel high throughput screening and phenotyping methods which would identify coagulation and fibrinolytic abnormalities, hemoglobinopathies, immunodeficiencies, platelet disorders, and bone marrow failure syndromes that are consequences of protein alterations/deficiencies. Identify genetic or cellular markers that are the result of dysregulated expression of genes that play a role in linage commitment, the progression of differentiation, and hematopoietic self-renewal. Identify and characterize genetic or cellular components that act as makers for high blood pressure, atherosclerosis, or cardiac abnormalities. Develop efficient, reproducible mouse hematology and blood chemistry analysis and define normal mouse parameters. Develop challenge assays that would identify increased risk of thrombosis, asthma, or alterations in the immune response that results from genetic manipulation. Develop a screening panel for cytokines associated with increased airway/lung reactivity. Develop screening methods which could be used to identify alterations in pulmonary function, pulmonary arterial pressure, blood gases, and ion channels. Development of new technologies for screening sleep and wakefulness in the mouse. Develop a screening panel for factors associated with pulmonary inflammatory response. Identify and develop rapid screens for early genetic or cellular markers predictive of aberrant lung or cardiovascular development or predisposition to lung or cardiovascular disease Develop assays that would be predictive of diurnal variations in cardiopulmonary function, endocrine function, immunological responses, and mechanisms that regulate sleep such as somnogenic factors. Develop methods of analyzing altered gene expression for cardiovascular, pulmonary or hematologic disease by novel technologies, such as DNA or protein microarray analysis. SPECIAL REQUIREMENTS FOR THE RFA In order to be considered responsive to this RFA, applications must propose studies that focus on the development of screening tools or methods, particularly high-throughput methods, for characterizing heart, lung, blood or sleep disorders in the mouse. Information should be provided on how the proposed new methodologies represent improvements over currently available methods and the levels of throughput that can be achieved (number of mice processed per day/week). Laboratories supported under this program will be required to: 1) Develop and validate cardiovascular, pulmonary, or hematologic phenotype characterization protocols, particularly high throughput methods, in the mouse. The development of phenotypic characterization protocols needs to provide for the systematic characterization of the normal physiological parameters of inbred mouse strains to provide a benchmark against which mutants can be compared. The validation of phenotypic screens or protocols must demonstrate the screens or protocols to be highly reliable and reproducible. 2) Implement mechanisms to rapidly disseminate information on phenotypic screening protocols and methodologies to the scientific community. This may include the development of databases, websites or detailed training manuals. PHS policy requires that investigators make unique research resources readily available to qualified individuals within the scientific community when they have been published (see PHS Grants Policy Statement in the July 12, 1996 issue of the NIH Guide to Grants and Contracts). The dissemination of information and the sharing of phenotypic methods as they are developed, are critical features of this program. Timely sharing of information and methods will enhance scientific discovery by permitting researchers access to the resources developed under this program as quickly as possible and is considered essential to stimulate rapid progress in the development of murine models of disease and avoid unnecessary duplication of scientific efforts. In order to ensure the timely sharing of information and materials, applicants will be requested to describe how, when, and in what manner methods and materials will be made available to the scientific community. This might include specific Internet based interfaces, newsletters, informational conferences, seminars, or workshops which may be held in association with relevant scientific society meetings. It is expected that the resources to be shared include all materials developed in projects funded under the RFA, including but not limited to, the following: phenotyping assays and protocols, detailed methods of procedure or training manuals that provide sufficient detail for scientists in multiple laboratories to employ the phenotypic methods or assays to phenotypically characterize animals reliably and reproducibly, and quantitative scores of reference animals on heart, lung, blood, and sleep disorder phenotyping assays. It is recognized that time may be required to validate methods or assays, perform initial analyses, and to protect intellectual property rights to ensure inventions are pursued and developed rapidly. Thus, a protected period, from the time data or materials are developed to the time they are made available to other qualified investigators, may be appropriate. The onset and duration of the period will vary, depending upon the nature of the research project, and applicants must justify the length of the protected period they specify in the application. The initial review group will comment on the proposed plan for sharing of methods and information dissemination. The adequacy of the plan will be considered by NIH staff as part of the criteria for award. The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. There will be an annual meeting of program participants. Travel funds for a two day meeting each year, most likely to be held in Bethesda, Maryland, must be included in the module calculation. Applicants must include a statement indicating their willingness to participate in these meetings. Production of inbred or transgenic mice is not a requirement. Transgenic mice already produced in other studies may be used to address the research goals of this RFA. Studies in mice must be the principal focus of the application. Applicants are encouraged to contact the program officials listed under INQUIRIES for further information. RESEARCH INVOLVING HUMAN SUBJECTS The primary objective of this RFA is to develop phenotypic screening methods in the mouse for heart, lung, blood and sleep and circadian research. There may be instances in which applicants must collect or use pathology specimens derived from human subjects, or clinical or epidemiological data from projects involving human subjects. In those instances, the NIH policies described below apply and must be addressed in the application. 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 research. This 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 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 28, 1994 (FR 59 14508-14513), in the NIH Guide for Grants and Contracts of March 18, 1994, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html 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 and Contracts, March 6, 1998, and is available at the following Internet address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by August 1, 1999 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 a subsequent application, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be mailed, or faxed, to: Dr. Ivan Baines Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 6213, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0277 FAX: (301) 480-3541 Email: [email protected] APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. These forms are available at most institutional offices of sponsored research and 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: [email protected]. Application kits also may be obtained electronically on the web at https://grants.nih.gov/grants/forms.htm The RFA label found in the PHS 398 (rev. 4/98) application form 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 (Development of Mouse Phenotypic Screens for Heart, Lung, and Blood Diseases) and number (HL- 99-010) must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and three signed, photocopies, making sure that the original application with the RFA label attached is on top, 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) APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. At the time of submission, two additional copies of the application must be sent to Review Branch Contact: Dr. Ivan Baines Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 6213, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0277 FAX: (301) 480-3541 Email: [email protected] 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). Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by 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. 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. The CSR will also 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. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/ contractual arrangement is included in the overall requested modular direct cost amount. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm Complete the educational block at the top of the form page; - List current position(s) and then previous positions; - List selected peer-reviewed publications, with full citations; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NHLBI. Incomplete and/or unresponsive applications 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. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and 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, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. (1) 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? (2) 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? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) 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 key personnel? (5) 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 Considerations (1) The development of high throughput phenotyping methods that could be utilized to screen anywhere from 5,000 to 20,000 mice per year for alterations in cardiovascular, pulmonary, hematologic or sleep physiology will be given primary consideration. (2) Potential of the proposed study to extend existing knowledge about heart, lung, blood and sleep disorders through the improved characterization of phenotypes using inbred or transgenic mouse strains. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. AWARD CRITERIA Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total costs of the proposed project and the availability of funds will be considered by NIH staff as well as Advisory Council in making funding recommendations. In circumstances in which applications have similar scientific merit, but vary in cost, NIH is likely to select the more cost competitive application for funding. Schedule Letter of Intent Receipt Date: August 1, 1999 Application Receipt Date: September 15, 1999 Date of Initial Review: February, 2000 Review by Advisory Council: May, 2000 Anticipated Award Date: July 1, 2000 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues to: John Fakunding, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 9200, MSC-7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0544 FAX: (301) 480-1454 Email: [email protected] Mary Ann Berberich, Ph.D. Division of Lung Diseases National heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10102, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: [email protected] Rebecca Link, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10178, MSC-7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0070 FAX: (301) 480-1046 Email: [email protected] Michael J. Twery, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: [email protected] Direct inquiries regarding the receipt and review of applications to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: [email protected] Direct inquiries regarding fiscal matters to: Marie Willett Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7156 Bethesda, MD 20892-7926 Telephone: (301) 435-0144 FAX: (301) 480-3310 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.839 and 93.848. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. 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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