SPECIAL NOTICE
A -- Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathies
- Notice Date
- 6/8/2004
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, One Democracy Blvd., 6701 Democracy Blvd., Suite 800, Bethesda, MD, 20892-4872
- ZIP Code
- 20892-4872
- Solicitation Number
- NIH-NIAMS-04-05
- Response Due
- 7/24/2004
- Archive Date
- 8/8/2004
- Point of Contact
- Eileen Webster-Cissel, Chief Contracting Officer, Phone 301-594-2543, Fax 301-480-5996, - Eileen Webster-Cissel, Chief Contracting Officer, Phone 301-594-2543, Fax 301-480-5996,
- E-Mail Address
-
ew52c@nih.gov, ew52c@nih.gov
- Description
- The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to negotiate on a sole source basis with the University of Pittsburgh, Pittsburgh, Pennsylvania, to carry out a study to assess the efficacy of intravenous Rituximab in a multi center 6-month randomized, double-blind, placebo-controlled trial of refractory myositis in adults and children. The trial will be conducted among adult and pediatric rheumatologists and neurologists implementing the newly defined disease activity and damage measures (developed by the International Myositis Assessment and Clinical Study Group (IMACS) in childhood and adult inflammatory myopathy. The goal is to examine the efficacy of Rituximab as a potentially important new therapeutic advance for these diseases. Rituximab is a monoclonal antibody directed against the CD20 antigen that results in elimination of circulating B cells and is currently FDA-approved for use in B cell lymphomas. A determination for the use of other than full and open competition has been made in accordance with 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1. The University of Pittsburgh is determined to be the only responsible source for the following reasons: (1) They have organized the effort to conduct the study in full collaboration with the majority of myositis research centers in the U.S. and internationally; 2) They have obtained approval and collaboration of the drug manufacturer to conduct the study; 3) They were awarded and carried out a planning grant to organize the study and to develop and test the primary outcomes instrument in collaboration with the IMACS. Therefore, the University of Pittsburgh has the unique capability to perform this work. This is not an announcement of the availability of a Request for Proposals. Inherent duplication of cost to the Government and unacceptable delays in performance make competition for this work unfeasible. All responsible sources may submit a proposal which will be considered by the NIAMS. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. The North American Industry Classification System (NAICS) Code is 541710. This notice of intent is not an announcement of the availability of a Request for Proposals (RFP), nor is an RFP available. See Numbered Note 22.
- Record
- SN00599920-W 20040610/040608211809 (fbodaily.com)
- Source
-
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