SOLICITATION NOTICE
65 -- Kryosure FEP bags and pouches
- Notice Date
- 2/22/2016
- Notice Type
- Presolicitation
- NAICS
- 326199
— All Other Plastics Product 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
- 16-000100
- Archive Date
- 3/23/2016
- Point of Contact
- Milton Dartoozos, Phone: 3015945919
- E-Mail Address
-
MILTON.DARTOOZOS@NIH.GOV
(MILTON.DARTOOZOS@NIH.GOV)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute of Health Office of Purchasing and Contracts intends to negotiate and 1 year plus 4 option year contract to SAINT-GOBAIN, MD 20877 to provide KyroSure® FEP bags and pouches for which the government intends to solicit and negotiate with only one source under the authority of 13.106-1. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-84, September 3, 2015. This acquisition is conducted under 41 U.S.C. 1903, the simplified acquisition procedures authorized in this subpart may be used for acquisitions that do not exceed $13 million when the acquisition will be treated as an acquisition of commercial items in accordance with 12.102(f)(1). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.500 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplifeid Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements The North American Industry Classification System (NAICS) code for this acquisition is 326199, and the size standard is 750 employees This notice of intent to award is not a request for competitive quotations. 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. No solicitation is available. 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. STATEMENT OF WORK The Dept. of Transfusion Medicine Our Mission The mission of the Department of Transfusion Medicine (DTM) is to provide high quality patient care and hospital services in support of NIH clinical research programs, to pursue research that contributes to our knowledge and practice of transfusion medicine and related technologies, and to provide advanced training in transfusion medicine. On behalf of the NIH Clinical Center, It provides 24/7 transfusion support for patient care and research. The Cell Processing Section (CPS) is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II 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. Also, regarding Institute research support it: Collects, manufactures and distribute blood components for in vitro research use Collaboration in the design, planning, execution and data analysis of clinical studies Develops biologics collection and manufacturing processes to support clinical trials Collects and manufacture specialized cellular products to support clinical trials Develops and evaluate assays for clinical application and biologics safety testing and cellular characterization The purpose of this procurement is to obtain specific FDA registered FEP cryofreezer bags which the Cell Processing Section uses once the blood products are drawn from the patients in the Apheresis area, DTM. The cancer patients' blood/blood products are then manufactured and frozen for later infusion. The latter step requires the CPS to later thaw the blood/blood products so that the patient may be re-infused. In the past, DTM was using EVA bags that would shatter and break as the bags could not restrain the freezing temperatures of our Liquid Nitrogen levels. The bags must also have FEP overwraps. These overwraps are helpful in insuring that if any leak in a bag does occur, it will contained within the FEP overwrap. KyrosureTM is manufactured from FEP and this material remains flexible at liquid nitrogen storage temperatures. These bags and pouches provide the flexibility and durability required for both freezing and thawing. The bags are manufactured using a proprietary laser welding process, permitting a wide range of shapes and sizes of bags, as well as allowing vendor to make bags with an internal volume as small as 1ml, and as large as 50 liters. The FEP film used in the bags and overwraps---the film is made from a unique, very high molecular weight FEP resin and uses proprietary film extrusion processes. The bags are considered Class I Medical Devices and are made at an FDA registered and inspected facility. Period of performance Base plus four (4) option years on a scheduled shipment They are to be shipped once every other month beginning approximately April 2016. The specific quantities will be as follows: 100 of 2PF-0060 (bags) and qty. of 150 of OP-0061 (pouches) shipped accordingly. Yearly Items sought: Qty Catalog # Description 600 Ea. 2PF-0060 Kryosure FEP bags with 2 ports, 1AFC spike 900Ea OP-0061 Kryo Vue FEP pouch, overwraps for 2P-0060 ***Terms and Conditions are dictated by the government*** Comments to this announcement, referencing this posting number, may be submitted to the CC Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Milton Dartoozos, Contract Specialist, Milton.Dartoozos@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/16-000100/listing.html)
- Place of Performance
- Address: 10 CENTER DRIVE, BETHESDA, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04027524-W 20160224/160222235144-40d5dee1977b5020d3f3ebd657f07358 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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