SPECIAL NOTICE
66 -- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. X VIVO 20
- Notice Date
- 6/20/2016
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 16-012758
- Archive Date
- 7/6/2016
- Point of Contact
- Andre M. Moody, Phone: 3014022677
- E-Mail Address
-
moodya@cc.nih.gov
(moodya@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The government intends to award a fixed price purchase order to Sartorius Stedim North America, Inc., Bohemia, NY 11716. The Department of Transfusion (DTM) at National Institutes of Health (NIH) Clinical Center (CC), Bethesda, MD has a requirement to procure the below supply and quantity: Item Number: 08-608A Description: X-VIVO 20 TM, 4L with Phenol Red, and Gent.5L Media Bag CTC-11. 08-608A Unit of Issue: EA Quantity: 70 The government reserves the right to increase quantities pursuant to FAR 52.217-6, Option for Increased Quantity. The total value of the contract will not exceed the simplified acquisition threshold. The CC is a clinical research hospital providing medical services for patients participating in human research protocols of the NIH. The CC provides patient care facilities and services for clinical investigations by the NIH Institutes, research in related areas, and other training programs. The CPS is responsible for the manufacture of human cells and tissue-based products utilized in phase Ml clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. Sartorius Stedim North America, Inc. is the only US distributor of X-VIVO 20 TM. This media is used to expand autologous and allogeneic Natural Killer (NK) cell products that are used to treat cancer patients. The autologous NK cells are used as the primary treatment of cancer and hematologic malignancies. The allogeneic NK cells products are given to patients after a hematopoietic stem cell transplant to treat cancer and hematologic malignancies. Many of these patients have already begun a series of NK cell treatments that would be interrupted if this were not available. This media must come from the same vendor so as not to affect the processing of cells and patient treatment plans. Sartorius Stedim Biotech is the trademark holder additionally, this co. provides Good Manufacturing Practice (GMP) grade media packaged in 4 liter bags. GMP is the following per Wikipedia: "Good Manufacturing Practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMP are guidance that outline the aspects of production and testing that can impact the quality of a product. Receiving media in these large bags rather than bottles prevents microbial contamination that could occur when media bottles are pooled to provide the large quantities needed for the protocols. In addition, the media in GMP grade is required for the production of cells used for clinical purposes. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b). Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on 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 a competitive procurement. Each response should include the following Business Information: a. DUNS. b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, HubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement, referencing this posting number, may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Andre Moody, Contract Specialist, amoody@cc.nih.gov by the due date and time marked in this notice.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/16-012758/listing.html)
- Place of Performance
- Address: National Institutes of Health, 10 Center Drive, Room 3C720, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04155898-W 20160622/160620234911-6200cd4a003cd50712278f1b7f4ac389 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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