SOLICITATION NOTICE
Q -- Intent to Sole Source for Clinical Grade AdhAQP1
- Notice Date
- 8/23/2005
- Notice Type
- Solicitation 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, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
- ZIP Code
- 20892-7663
- Solicitation Number
- 263-2005-P(BD)-0135
- Response Due
- 9/7/2005
- Archive Date
- 9/22/2005
- Description
- The National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR) plans to procure a 100 flask preparation of clinical grade materials from the GMP Core of the Belfer Gene Therapy Core Facility at Weill Medical College of Cornell University on a sole source basis as authorized by FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. The Gene Therapy and Therapeutics Branch (GTTB) at the NIDCR/NIH conducts research related to the diagnosis, prevention and management of salivary gland diseases. Primary efforts are directed at using gene transfer technology and are supported by basic research on virology, salivary secretion and function. The GTTB has been developing a replication deficient recombinant serotype 5 adenovirus (rAd5) vector, which is designed to transfer the cDNA encoding human (h)AQP1 to adult patients with reduced function of their parotid glands due to ionizing radiation (IR) received in the course of treatment for a head and neck cancer. hAQP1, the archetypal water channel, is a plasma membrane protein that facilitates water movement across lipid bilayers. AdhAQP1 is intended for administration to a single parotid salivary gland with a purpose of increasing salivary secretion from that gland. Acquisition of clinical grade, replication-deficient, serotype 5 adenovirus encoding human (h) AQP1 that is produced and packaged in a manner suitable for use in human clinical studies, including necessary quality control testing is essential and required. It is the NIH's belief that only the GMP Core of the Belfer Gene Therapy Core Facility at Weill Medical College of Cornell University should appropriately produce the 100 flask preparation of Clinical Grade AdhAQP1. Cornell University is the only know vendor to NIDCR that can meet the above requirements. This is not a solicitation for competitive quotations. However, if interested companies may identify to the Contracting Officer their interest and capability to satisfy the Government's requirements with a commercial product/service within 15 days of this notice. This acquisition will be processed under FAR Part 12, Acquisition for Commercial Items, and will be made pursuant to the authority in FAR 13.5, the Test Program for Certain Commercial Items.. A determination by the NIH not to compete this proposed contract based on responses to this notice is solely within the discretion of the NIH. Information received will normally be considered solely for the purpose of determing whether to conduct a competitive procurement. Address responses to the attention of Marcia Goldman at National Institutes of Health, 6011 Executive Blvd., Room 539A, MSC 7663, Bethesda, MD 20892-7663.
- Place of Performance
- Address: At contractor's facilicities
- Record
- SN00876806-W 20050825/050823211853 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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