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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