National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Natcher Building, Room 5AS-13A, 45 Center Drive, MSC 6500, Bethesda, Maryland 20892-6500

A -- PILOT TRIALS ON INNOVATIVE THERAPIES FOR RHEUMATIC AND SKIN DISEASES SOL NIH-NIAMS-BAA-99-02 DUE 041299 POC Valerie Syed, Contracting Officer, 301/594-2543 WEB: NIH-NIAMS-BAA-99-02, http://www.nih.gov/niams/grants/rfp/rfplist.htm. E-MAIL: Valerie Syed, syedv@mail.nih.gov. This announces the availability of a Broad Agency Announcement (BAA) which describes in general terms a research topic and outlines proposal preparation requirements. The purpose of this BAA is to solicit proposals for small, pilot, and feasibility clinical trials of innovative therapies for the treatment of rheumatic and skin diseases. The goal of this initiative is to accelerate the application of new drugs, biologicals and other non-behavioral interventions for the short and long term management of symptoms, signs, systemic and structural changes in patients with established disease and for the development of strategies for prevention of disease onset, progression or structural damage to target organs in patients at high risk. New and emerging agents for the treatment of lupus, rheumatoid arthritis, scleroderma, myositis, Sjogren's and other rheumatic diseases are included. In the skin diseases area, inflammatory, autoimmune and genetic skin diseases are included as are small trials for innovative therapies on wound healing. In addition, Human Immunodeficiency Virus (HIV)-associated skin and rheumatic diseases are included as appropriate responses to this solicitation. To achieve the main goal of this BAA, the NIAMS seeks to support small, pilot and feasibility trials. The trials should be designed so that the preliminary data obtained would be sufficient to either design the next phase (for example, Phase II/III), for which the investigators will have to seek separate funding or obtain evidence of efficacy where a large, double blind-placebo-controlled trial is not feasible. Also appropriate will be proposals that include a short initial phase to complete pre-clinical testing of highly promising products/approaches. Another goal of this BAA is to improve understanding of disease pathogenesis and the underlying mechanism of action of new therapies. In the context of the clinical trials, ancillary studies are being sought. It is anticipated that six cost reimbursement contract awards will be made for a period of four years beginning on or about September 30, 1999. The solicitation NIH-NIAMS-BAA-99-02 will be available electronically on or about February 8, 1999 and may be accessed through the Internet at the following address: http://www.nih.gov/niams/grants/rfp/rfplist.htm. Proposals will be due on or about April 12, 1999. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendments that may be issued by the Government. All responsible sources may submit proposals which will be considered by the Government. This advertisement does not commit the Government to award a contract.***** Posted 01/21/99 (W-SN290219). (0021)

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