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A -- REQUEST FOR PROPOSALS AND NOTICE OF PUBLIC MEETING SOL 97-07 DUE 061197 POC Customer Representativ 1-800-ATP-FUND; Fax (301) 926-9524 E-MAIL: Advanced Technology Program, atp@nist.gov. Department of Commerce Technology Administration National Institute of Standards and Technology (NIST) Advanced Technology Program Administration Building 101, Rm. A407 Gaithersburg, MD 20899-0001 February 12, 1997 REQUEST FOR PROPOSALS AND NOTICE OF PUBLIC MEETING: The NIST Advanced Technology Program (ATP) is soliciting proposals under its focused program competition 97-07, Tissue Engineering, and announces a public meeting (Proposers' Conference) for all interested parties. This notice provides general information for this focused program competition 97-07. An estimated $12 million in first-year ATP funding is available under this focused program competition. The ATP reserves the right to utilize for this competition more or less funding than the amount stated above. The actual number of proposals funded will depend on the quality of the proposals received and the amount of funding requested in the highest ranked proposals. Outyear funding is contingent on the approval of future Congressional appropriations and satisfactory project performance. This is the first year of three competitions planned for this ATP focused program. Award recipients will be required to share non-proprietary information at workshops to be held throughout the duration of the project. The ATP operates under program procedures published as Part 295, Title 15, Code of Federal Regulations. The ATP Proposal Preparation Kit dated November 1996 (containing proposal cover sheets, other required forms, background material, and instructions for submission of proposals) and the 97-07 focused program booklet (containing a paper describing the scope of this focused program) may be obtained by phone: 1-800-ATP-FUND); fax: 301-926-9524 or 301-590-3053; e-mail: atp@nist.gov; or letter at the address shown below. Note that those individuals whose names are currently on the ATP mailing list should have already received the new November 1996 version of the ATP Proposal Preparation Kit. The 97-07 focused program booklet is available on ourWorld Wide Web site (http://www.atp.nist.gov) and printed copies are available upon request from ATP. Only FULL proposals are being solicited under this focused program competition 97-07. Abbreviated proposals (pre-proposals) WILL NOT be accepted. Proposals submitted by facsimile or electronic mail WILL NOT be accepted. If a proposer's proposal is judged to be of high enough quality to be invited in for an oral review, ATP reserves the right to submit a list of questions to the proposer that must be addressed at the oral review. The due date for submission of full proposals is 3 p.m. Eastern time on Wednesday, June 11, 1997. Should the NIST facility be closed on the specified due date. ATP proposals will be due at 3 p.m. Eastern time on the next business day that the NIST facility is open. Proposals received after this deadline WILL NOT be considered. Send proposals to: Advanced Technology Program, National Institute of Standards and Technology, Administration Building 101, Rm A407, Quince Orchard and Clopper Roads, Gaithersburg, MD 20899-0001. Mark envelope Focused Program 97-07. The goal of the Tissue Engineering Focused Program is to promote U.S. economic growth by focusing on the development of a tissue engineering industry that would have global preeminence and thus provide jobs, result in high market revenues and significantly reduce the total national healthcare costs which now exceeds $1 trillion annually. Furthermore, development of new treatment modalities with the use of tissue engineered devices will have significant societal benefits by improving the quality of life for the physically and mentally afflicted population. The acute and chronic shortage of donor tissues and organs, will make these devices life-saving in many instances. To be in scope, business plans of proposals must contribute to the overall goal of reducing direct hospital and medical costs as well as those costs associated with the long-term care of the ill or disabled. Technical plans must address one or more aspects of the design and development of tissue engineered devices for diagnostic and/or therapeutic use including A) biomaterials, B) cellular components, C) manufacturing processes, and D) implantation/transplantation technologies. A) In the area of biomaterials, proposals are sought that address innovations with respect to scaffolding materials to promote cell growth or, when implanted without cells, evoke specific cellular responses in the host. These materials may be synthetic, naturally derived or hybrids of such, and should have evidence of biocompatibility. In order to achieve the desired physical and chemical features, these materials may be used individually or in composites. Biocompatible materials also are sought that either coat implantable structures or encapsulate living cells or groups of cells for transplantation. For coating purposes, biomaterials that prevent adhesion of circulating proteins on the implants are needed. Technologies that would provide more cost effective sources of biomaterials from novel sources such as genetically altered plants or animals also would fit within the biomaterials scope. B) In the realm of cellular components, proposals are solicited that describe technological advances in proliferation of stem and differentiated cells for use in replacement or genetic therapies. The retention of the desired genotypic and phenotypic expressions through many passages is of particular importance. Proposed technologies that would lead to optimization of target-determined biological and physical properties of cells either through genetic or environmental manipulation also are within scope of this solicitation. C) Since tissue engineered products need be available to large patient populations at reasonable costs, technologies are sought that will result in improved manufacturing processes. Innovative methods to enhance automation and scale-up of bioreactors for cell growth without compromising cellular integrity are sought. To ensure uniformity of products and retention of functionality through multiple in vitro manipulations, proposed technologies may address improved manufacturing processes for use of biomaterials as encapsulating agents or use as scaffolds as well as better sterilization, storage and transport methods for tissue engineered products, including diagnostic tools and transplantable composites. D) To ensure that tissue engineered devices can be diffused broadly in a multitude of different environments, creative solutions are sought to advance transplantation/implantation technologies. Thus, enabling technologies are needed that aid in the design of easily available devices and cost-effective tests to monitor transplantation/implantation procedures and subsequent functional/structural integration by the host system. A public meeting (Proposers' Conference) for potential proposers and other interested parties under this focused program competition 97-07 will be held on Monday, March 17, 1997, at the Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD. The conference will begin at 9:30 a.m.Eastern time and end at approximately 3 p.m. and will provide general information regarding the ATP, hints on preparing good proposals (covering the same material presented at previous ATP Proposers' Conferences), and will provide an opportunity for attendees to ask questions on the scope and technical and business goals of the focused program. Attendance at this public meeting is not required. No registration fee will be charged To register for this public meeting or for further information, contact ATP, by phone: 1-800-ATP-FUND; fax: 301-926-9524 or 301-590-3053; or e-mail: atp@nist.gov. (0043)

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