This Program Announcement expires on March 12, 2004 unless reissued. FUNCTIONAL TISSUE ENGINEERING FOR HEART, VASCULAR, LUNG, BLOOD and SLEEP DISORDERS AND DISEASES: SBIR/STTR INITIATIVE Release Date: October 25, 2000 PA NUMBER: PAR-01-006 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) Application Receipt Dates: March 13, 2001 and March 13, 2002 for Phase I and II applications. March 13, 2003 and March 12, 2004 for Phase II applications only. PURPOSE This announcement is to encourage small businesses to participate in the research and development of new approaches, technologies, tools, methods, devices, cells, biomolecules and biomaterials that can be used to engineer functional tissues in vitro for implantation in vivo as a biological substitute for damaged or diseased tissues and organs or to foster tissue regeneration and remodeling in vivo for the purpose of repairing, replacing, maintaining, or enhancing organ function. Applications should address a significant cardiovascular, pulmonary, hematologic, or sleep problem and propose research that will significantly improve clinical therapies for heart, vascular, lung, blood, and sleep disorders and diseases. In addition, research plans should emphasize rapidly transferring products and services to the patient and should integrate scientific disciplines such as bioengineering, biology, clinical medicine, materials science, chemistry, and physics. This program will use the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding mechanisms. The SBIR and STTR applications received in response to this program will undergo review by a Special Emphasis Panel (SEP) with the combined breadth of expertise necessary to review the broad range of proposals anticipated. Specific review criteria, which are included in this Program Announcement (PA), will be used in the review of all application received to ensure that the objectives of the solicitation are met. Because the length of time and cost of research involving advanced technology projects may exceed that normally awarded for SBIR/STTR grants, the NHLBI will allow well justified Phase I applications with a project period of up to two years and a budget not to exceed $100,000 per year direct costs (maximum of $200,000 direct costs for 2 years). Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The previously funded Phase I award need not have been awarded under this PA but the Phase II proposal must be a logical extension of the Phase I research. The NHLBI will consider Phase II projects with a project period up to three years and a budget not to exceed $400,000 per year direct costs. The March 13, 2001 and March 13, 2002 receipt dates will be for Phase I and Phase II applications. Only Phase II applications will be accepted on the last two receipt dates, March 13, 2003 and March 12, 2004. After the initial four receipt dates, this initiative will be evaluated and a decision will be made as to whether or not to continue the initiative. This PA must be read in conjunction with the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research Grant Applications (PHS 99-2), and the Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer Grant Applications (PHS 99-3). All of the instructions within the Omnibus Solicitations apply with the following exceptions: o Special Receipt Dates; o Additional review considerations; o Opportunity for two years of Phase I support with a budget not to exceed $100,000 in direct costs per year; o Opportunity for three years of Phase II support with a budget not to exceed $400,000 in direct costs per year. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA), Functional Tissue and Organ Engineering for Heart, Vascular, Lung, Blood, and Sleep Disorders and Diseases: SBIR/STTR Initiative , is related to the priority areas of cardiovascular, lung, blood, and sleep disorders and diseases as well as additional priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Eligibility requirements for SBIR and STTR are described in the NIH Omnibus Solicitation for SBIR/STTR grant applications which is available on the Internet at: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm. A limited number of hard copies of the NIH Omnibus SBIR/STTR Solicitation are available from: PHS SBIR/STTR Solicitation Office 13685 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX (301) 206-9722 Email: a2y@cu.nih.gov MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) SBIR/STTR award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. A. INDIVIDUAL PHASE I APPLICATIONS Phase I applications in response to this PA will be funded as Phase I SBIR Grants (R43) or Phase I STTR Grants (R41) with modifications as described below. Applications for Phase I grants should be prepared following the directions for Phase I SBIR/STTR applications as described in the Omnibus Solicitation which is available at: http://grants.nih.gov/grants/funding/sbirsttr1/11instructions.htm. Well-justified Phase I applications with a project period up to two years and a budget not to exceed $100,000 per year direct cost (maximum of $200,000 direct costs) will be allowed. B. INDIVIDUAL PHASE II APPLICATIONS Phase II applications in response to this PA will be awarded as Phase II SBIR Grants (R44) or STTR Grants (R42) with modifications as described below. Phase II applications will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II application must be a logical extension of the Phase I research and must be responsive to this PA. Applications for Phase II awards should be prepared following the instructions for NIH Phase II SBIR/STTR applications. The Phase II SBIR instructions and application may be found on the Internet at: http://grants.nih.gov/grants/funding/sbir2/index.htm The Phase II STTR instructions and application may be found on the Internet at: http://grants.nih.gov/grants/funding/sttr2/index.html Well-justified Phase II applications with a project period up to three years and a budget not to exceed $400,000 in direct costs per year will be allowed. RESEARCH OBJECTIVES Every day thousands of people of all ages are admitted to hospitals because of the malfunction of some vital organ. Estimates of the total U.S. health care costs for patients with tissue loss or end-stage organ failure exceed four hundred billion dollars annually. Moreover, because of the dearth of transplantable organs, many of these people die. As an example, the American Heart Association reports only 2,300 of the 40,000 Americans who needed a heart transplant in 1997 received one. Existing prosthetic replacements for diseased or damaged tissue and organs are imperfect and subject patients to one or more ongoing risks including thrombosis, limited durability, increased susceptibility to infection, and need for re- operations. Taken together, these points illustrate the need for long-term, safe, and cost-effective solutions. Until very recently, most scientists and clinicians believed that damaged or diseased human tissue could be replaced only by donor transplants or with totally artificial parts. Today, however, tissue and organ engineering promises to revolutionize the treatment of patients who need new vital structures. It applies the principles of engineering and the life sciences in an effort to reach a fundamental understanding of structure-function relationships in normal and pathological tissues and to develop biological substitutes that can grow and remodel to restore, maintain, or improve tissue and organ function. The field has already made headway in the synthesis of structural tissues such as skin, cartilage, and bone. Furthermore, bladders have been successfully bioengineered and implanted in dogs. Thus, progress to date predicts future success in the bioengineering of more complex internal organs such as hearts, blood vessels, lungs, and blood and the field is now poised for moving ahead in that direction. However, the development of enabling tissue engineering technologies in a few critical areas, and the application of those technologies through an integrated systems approach, could serve as a catalyst for engineering functional cardiovascular, lung, and blood tissue and help lay the foundation for success that could impact tremendously on human health. Although more than a decade of research may be required before an entire heart, lung, or blood cell system is available, laboratory grown components of these organs, such as vascular grafts, heart valves, alveoli, and hematopoietic stem cells are currently being developed. Vascular grafts are critical for the treatment of peripheral vascular and coronary artery disease. Grafts currently in use for bypass surgery are obtained from the patients own vessels or are constructed of synthetic materials. In either case, problems with vessel availability and complications due to thrombosis, infection, intimal hyperplasia, and occlusion make these grafts less than optimal. Efforts to develop tissue-engineered vascular grafts with improved long-term patency are needed. Another promising area for cardiovascular tissue engineering involves cardiac valves. Congenital and acquired diseases of the heart valves and great arteries are leading causes of morbidity and mortality. Current prosthetic or bioprosthetic replacement implants do not grow or remodel with the patient and are associated with risks including thrombosis, limited durability, infection, and the need for re-operations. Through a tissue-engineering approach, progress has been made in growing heart valves that function short- term in animals. These types of studies need to be expanded. Cell engineering and cell transplant procedures have the potential to treat heart failure. After a myocardial infarct, scar tissue might be replaced with muscle by transplanting cardiac cells or stem cells directly into the scar area. Another concept could be to grow a living tissue patch that could be applied to the scarred tissue or sewn into the heart after removal of the infarcted tissue. For the treatment of sleep disorders, transplantation of engineered cells to replace missing hypocretin/orexin-producing neurons in the brain may reverse some of the symptoms of narcolepsy. Growing blood and blood product-producing cells in the laboratory is another area of considerable interest. The ability to expand stem cells in culture would assure adequate reconstitution of patients, supply cells for gene therapy of blood diseases such as hemophilia, and allow for the production of patient-specific blood products or products with minimal antigenicity. To date, the expansion of transplantable stem cells in culture has not been possible. Additional studies to develop this field would be an important step forward in making stem cell technologies a therapeutic choice for more patients. Creating venous valves for the treatment of deep venous thrombosis is another area of opportunity. Acute and chronic anticoagulation are the only existing treatments for the valvular dysfunction associated with this disease. Bioengineering of functional replacements for diseased venous valves would provide an important treatment option in an area where no other options exist. Lung researchers have been able to propagate the lung bud in culture up to the stage of branching morphogenesis and have demonstrated augmentation and inhibition of alveolization with various compounds that function as morphogens and/or negative regulators. The implantation of a primitive lung bud that could grow in vivo might circumvent the existing problems of transplantation rejection and shortage of organs. In addition to laboratory grown tissues, more immediate returns may be realized in the area of regenerating functional structures in vivo. There is increasing evidence that lung may be capable of regeneration. Unilateral pneumonectomy in animals results in growth of new alveoli in the remaining lung tissue. Other studies have demonstrated that retinoic acid leads to lung growth and increased numbers of alveoli in neonatal animals and in a rodent model of emphysema. Future studies are needed to assess the functional significance of these changes in lung structure, and the potential of other agents to regenerate lung tissue in diseases such as emphysema or bronchopulmonary dysplasia. Another important goal for the future is to develop the ability to assemble extracellular matrix in emphysema or rebuild lung structure damaged by pulmonary fibrosis. Rebuilding lung regions or fostering repair of lung injury incurred in conjunction with inflammatory processes, interruption of normal development, or proteolytic degradation will significantly impact treatment for lung disease. In the quest to develop laboratory or in vivo grown tissues and organs, partners are needed in many disciplines including physics, mathematics, chemistry, computer sciences, engineering, biology and medicine. It is anticipated that the creativity of interdisciplinary teams will result in new understandings, novel products, and innovative technologies. It is thus the intention of this PA to encourage close interactions among researchers working in different fields. The NHLBI also recognizes that applications for tissue engineering projects may be either design-directed toward technology development, or hypothesis-driven and either type of application is acceptable under the SBIR/STTR mechanism. This PA was developed because of the nascence of this scientific area, and the need for the development of novel concepts and approaches to engineering functional tissues and organs, The primary purpose of the solicitation is to provide investigators with the opportunity to explore new approaches and test imaginative new ideas in areas that will have a significant impact on developing functional cardiovascular, lung, and blood tissues and organs. In addition, it is intended to encourage the development of substantial and meaningful changes to existing technology. The proposed research should be at the frontiers of tissue engineering and it must have the potential for an impact on current efforts directed at growing or regenerating tissues for repair or replacement. Cardiovascular, lung and blood tissuegenesis/organogenesis share some common scientific challenges and can all benefit from some common technological approaches. At the same time, each application area also presents its own challenges that relate to specific clinical problems and the unique biology and physiology of the tissue. Thus research should proceed along two parallel fronts: cross-cutting science and technology, and focused approaches aimed at well-defined clinical problems. This solicitation is open to all innovative approaches to engineering tissues and organs for heart, vascular, lung, blood, and sleep disorders and diseases. Possible applications, listed below for illustrative purposes only, are to develop: o functional heart, vascular, lung, or blood tissues or organs; o cell culture systems for optimal growth and maintenance of tissue- engineered constructs with differentiated cellular functions. These constructs might include vascular grafts, heart valves, myocardial patches, lung buds, or bone marrow; o techniques for creating scaffolds with the complex architecture and chemistry necessary to elicit differentiated phenotypes of cardiovascular, lung and blood cells and tissues grown in vitro; o bioreactors that simulate physiologically relevant biomechanical and biological environments for growing heart, vascular, lung and blood tissues; o ways to create vascular networks, ranging from capillaries to arteries/veins, that are capable of anastomosing with vessels at the site of implantation for those constructs grown in vitro; o ways to engineer immunologically-tolerant autologous tissue; o cellular markers to distinguish progenitor cells of the heart, blood vessels, lung and blood; o methods for cell sourcing including isolation, expansion and differentiation of stem and progenitor cells for cardiovascular, lung and blood tissues; o quantitative analyses and modeling of how signals are presented physically and temporally to cells and how cells integrate multiple signals to generate a response which could provide a design basis for the manipulation of the environment to achieve tissuegenesis; o quantitative methods for non-invasively assessing or monitoring the function of engineered tissues; o animal models for in vivo testing of engineered tissue or for in vivo tissue engineering; o techniques for in vivo regenerative medicine using cells and/or polymer delivery of genes, molecules or drugs; o technology for preservation of engineered tissues; o technology to support large-scale manufacturing of engineered tissues. 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 are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of 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 URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES OMNIBUS SOLICITATIONS for both the SBIR and STTR programs are available electronically through the NIH, Office of Extramural Research Small Business Funding Opportunities Web site at http://grants.nih.gov/grants/funding/sbir.htm. Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office at 301-206-9385 (phone); 301-206-9722 (fax); or a2y@cu.nih.gov (Email). Helpful information for preparing the application can be obtained on the Web at http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. Applications in response to the PA are to be submitted on the grant application form PHS 6246-1 (1/98) for SBIR Phase I (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm), PHS-6246-3 (1/98)for STTR Phase I (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm),PHS-6246-2 (1/98) for SBIR Phase II (http://grants.nih.gov/grants/funding/sbir2/index.htm), and PHS-6246-4 (1/98) for STTR Phase II (http://grants.nih.gov/grants/funding/sttr2/index.html) THE TITLE AND NUMBER OF THIS PA MUST BE TYPED IN LINE 2 ON THE FACE PAGE OF THE APPLICATION. For Phase I applications, applicants are strongly encouraged to highlight the innovation of their proposed research and to clearly state the milestones that will be used to demonstrate feasibility. For Phase II applications, the demonstration of feasibility accomplished in Phase I should be clearly indicated. The OMNIBUS SOLICITATIONS give the normal levels of support and period of time for SBIR and STTR Phase I and II awards. However, as stated under MECHANISM OF SUPPORT section, Phase I applications submitted in response to this PA can have a project period of up to two years and a budget not to exceed $100,000 per year direct costs. The second year of the Phase I budget should be included on the Budget Justification page, using categorical totals if costs deviate significantly from the first year of the budget, with narrative justifications for the increases (s). If the second year simply escalates due to cost of living factors, a statement to that effect with the escalation factor should be included rather than categorical totals. Phase II applications submitted in response to this PA can have a project period no longer than three years with a budget up to $400,000 in direct costs per year. The total duration (Phase I and Phase II application) cannot exceed five years. An annual meeting of all investigators funded through this program will be held to share progress and research insights that may further progress in the program. Applicants should request travel funds in their budgets for the principal investigator and one additional young investigator to attend this annual meeting. Submit a signed, typewritten original of the application, including the Checklist, and two 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) REVIEW CONSIDERATIONS Phase I and Phase II applications submitted under this PA will be accepted on the first two receipt dates. Only Phase II applications will be accepted on the last two receipt dates. Thereafter, this initiative will be evaluated and a decision will be made as to whether the initiative will be re- announced. Upon receipt, applications will be reviewed by the Center for Scientific Review for completeness and by the NHLBI program staff for adherence to the guidelines of this PA. Applications not adhering to application instructions described above, and those applications that are incomplete as determined by the Center for Scientific Review or by NHLBI program staff, will be returned to the applicant without review. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications, will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria Review criteria are described in the NIH Omnibus Solicitation and are available on the Internet at the following URL address: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? Does the proposed project have commercial potential to lead to a marketable product or process? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? (3) Milestones: For Phase I applications, how appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the R42/R44 development phase? For Phase II applications, to what degree was progress toward the Phase I objectives met and feasibility demonstrated in providing a solid foundation for the proposed Phase II activity? (4) Innovation: Does the project challenge existing paradigms or develop new methodologies, approaches, or technologies? Are the aims original and innovative? (5) Investigator: Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subawardees (if any)? (6) Environment: Is there sufficient access to resources (e.g. equipment, facilities)? Does the scientific and technical 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? In addition to the above criteria, the following additional criteria should be considered and addressed: Are the results of the study likely to enable research in this area of biomedical research? What will be the effect of these studies on the concepts or methods that drive this field? To what degree does the technology, tools, reagents, etc. support the needs for the targeted diseases? What is the time frame for developing the proposed technologies, methods, reagents, etc. and what is the suitability of this time frame for meeting the needs of this area of biomedical research? How easy will it be to use the developed technology, method, reagent, etc? Are the plans for dissemination of the proposed endpoints, tools, technologies, methods, reagents, etc. developed under this project adequate? If partnerships are proposed, how will they facilitate the development and integration of system components? Does the project adequately address end user needs? Will there be additional application opportunities for the approach, technology, tool, method, reagent, etc? What is the cost effectiveness of the proposed technology? Does the project team have adequate expertise in the areas of bioengineering and biomedical research? Is there evidence of institutional support? In accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended SBIR and STTR applications. Funding decisions for Phase I will be based on quality of the proposed project as determined by peer review, availability of funds, and program priority. Phase II applications will be selected for funding based on the above criteria as well as peer review assessment of attainment of Phase I goals. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Cardiovascular Christine A. Kelley, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 9142 Bethesda, MD 20892 Telephone: (301) 435-0513 FAX: (310) 480-1336 Email: kelleyc@nhlbi.nih.gov Blood Phyllis Mitchell, M.S. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Rockledge II, Room 10163 Bethesda, MD 20892-7950 Telephone: (301) 435-0481 FAX: (301) 480-1060 EMAIL: mitchelp@nhlbi.nih.gov Lung Mary Anne Berberich, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 10102 Bethesda, MD 20892 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: berberim@nhlbi.nih.gov Sleep Michael Twery, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, and Blood Institute Rockledge II, Room 10038 Bethesda, MD 20892 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: twery@nih.gov Direct inquiries regarding fiscal matters to: Mr. David Reiter Division of Extramural Affairs Grants Operations Branch National Heart, Lung, and Blood Institute Rockledge II, Room 7154 Bethesda, MD 20892 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: reiterd@nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the of Federal Domestic Assistance No. 93.837, 93.838, 93.839. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or 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, and 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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