SOLICITATION NOTICE
Q -- Laboratory Testing Services
- Notice Date
- 4/7/2011
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(DE)-2011-161-JML
- Archive Date
- 4/27/2011
- Point of Contact
- Jonathan M. Lear, Phone: 3014514470
- E-Mail Address
-
learj@nhlbi.nih.gov
(learj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA), on behalf of the National Institute of Dental and Craniofacial Research (NIDCR), intends to negotiate and award a purchase order on a noncompetitive sole source basis to WuXi Apptec, Inc., 2540 Executive Drive, St. Paul, MN 55120-1175 to provide the following laboratory testing services to the NIH/NIDCR Bone Marrow Stromal Cell Transplantation Center: -Virus Testing for Human Bone Marrow-Derived Stem Cells Background Before proceeding into human clinical trials, manufacturers of cell therapies are required by regulatory agencies worldwide to show that their products are free from adventitious agents. The Food and Drug Administration (FDA) requires a multilevel approach to thoroughly demonstrate product biosafety. The final product, as well as the material from the appropriate stages of the manufacturing process, must be tested to assure freedom from contamination. This process must be employed by the NIH Bone Marrow Stromal Cell Transplantation Center, which is assembling a Drug Master File for the preparation of these cells approved by the FDA. Specifically, the Transplantation Center must perform adventitious virus testing of bone marrow stromal cells that are banked. This testing must be done in accordance with the Good Laboratory Practice for Nonclinical Laboratory Studies as described in Title 21 Code of Federal Regulations Part 58. Appropriate controls are needed and specific validity criteria must be met for each assay. The initial work in preparation for submission of the Drug Master File (bacteriostasis and fungistasis testing, karyotyping, in addition to adventitious virus testing) was performed in conjunction with a number of companies on a trial basis. In all types of testing, WuXi Apptec, Inc. was the most responsive to the needs of the Transplantation Center. The sole source determination is based on the fact that WuXi Apptec has extensive experience and the expertise to meet these objectives in a reliable and rapid manner. This expertise and experience is derived from the performance of literally thousands of successful tests specifically for stem cells in support of clinical studies and regulatory applications for the FDA. This experience is unmatched by any other laboratory. Also, the Drug Master File was submitted to the FDA indicating that WuXi Apptec would be performing the testing, and switching to another company would require a change in the Drug Master File that would have to be resubmitted to the FDA. WuXi Apptec has demonstrated the ability to meet the FDA requirements by auditing data, and preparing final study reports by their Quality Assurance Group. These final reports are appropriately designed for incorporation into required regulatory submissions. Quality Assurance monitors compliance with regulatory guidelines through their internal standard operating procedures. The delivery point is the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), Bethesda, MD. The North American Industry Classification System (NAICS) Code is 541380 with a small business size standard of $12.0M. However, this requirement is not set aside for small businesses. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-50 (March 16, 2011). Interested parties may identify their interest and capabilities in response to this synopsis by April 12, 2011 at 3:00pm Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurements. Inquiries to this announcement, referencing synopsis number NHLBI-CSB-(DE)-2011-161-JML, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan Lear. Responses may be submitted electronically to learj@nhlbi.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(DE)-2011-161-JML/listing.html)
- Place of Performance
- Address: National Institute of Health/NIDCR, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02419785-W 20110409/110407234821-50a26518a2f1182e5e2d585be73138c6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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