PILOT AND FEASIBILITY TRIALS FOR OSTEOPOROSIS Release Date: January 31, 2002 NOTICE: NOT-AR-02-003 National Institute of Arthritis and Musculoskeletal and Skin Diseases RFP AVAILABLE: NIH-NIAMS-BAA-02-05 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 is to solicit proposals for small pilot and feasibility clinical trials and to encourage the adequate testing of novel and innovative potential therapies for osteoporosis. Projects supported would be phase I/phase II human trials to test basic safety and efficacy of treatments that would not be otherwise developed and pursued by private industry. The objectives of this initiative are to: 1) Identify and begin clinical testing of potential bone active agents; and 2) Perform initial dosing trials and select appropriate populations and endpoints for larger scale testing in appropriately powered clinical intervention trials. 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 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. It is anticipated that two to three cost reimbursement contract awards will be made for a period of three years beginning on or about September 30, 2002. The solicitation NIH-NIAMS-BAA-02-05 will be available electronically on or about February 11, 2002 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 May 1, 2002. 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. The North American Industrial Classification System (NAICS) code for this acquisition is 541710. This advertisement does not commit the Government to award a contract. Inquiries may be directed to: Eileen Webster-Cissel Chief, Contracts Management Branch, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS13A 45 Center Drive, MSC 6500 Bethesda, Maryland 20892-6500 Telephone: 301-594-2543 FAX: 301-480-5996 Email address: ew52c@nih.gov
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