SOURCES SOUGHT
65 -- Kryosure FEP bags
- Notice Date
- 2/2/2016
- Notice Type
- Sources Sought
- 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
- 3/3/2016
- 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 NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the government. This is NOT a Request for Proposal, Invitation for Bid, or an announcement of a solicitation. Response to this SOURCES SOUGHT is strictly voluntary and will not affect any firms' ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The purpose of this document is to identify potential sources. Any requests for a solicitation package will be disregarded. The Government does not intend to award a contract on the basis of this source sought or otherwise pay for the information solicited. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of preparing submissions in response to this sources sought and the Government's use of such information. Required Performance Capabilities: Information will be collected from Small or Large Manufactures and authorized distributors at this time to determine if the requirement can be met using a small business set-aside. All respondents are required to certify if they currently meet the small business requirements under the North American Industry Classification System (NAICS) code [326199], All Other Plastics Product Manufacturing, as of the date of their submittal. 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. Kyrosure TM 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*** CAPABILITY STATEMENT - Any potential Manufacturer must demonstrate the following: 1) The offeror shall submit product literature for the supplies it is proposing. Capability Statement(s) should clearly identify the following: a. Name of the Manufacturer, quantity and location where the units are produced (domestic and/or international); b. A signed statement to state, "We are the Manufacturer of the items and/or we are authorized distributors of company X"; c. Estimated Number of days, after receipt of order that is typical for delivery of such items; d. Any other relevant information that is not listed above which the Government should consider in developing its minimum specifications and finalizing its market research. 2) Provide the following business information: a. DUNS number b. Company Name c. Company Address (including point of contact, phone number and email address) d. Type/Size of company, NAICS code as validated in SAMS. Respondents will NOT be notified of the results of the evaluation. Responses must be submitted by email to POC, Milton.Dartoozos@nih.gov, within 15 calendar days (2/17/16) from the date of this synopsis.
- 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
- SN04007692-W 20160204/160202234916-686dc10b83421d8ccf9c2bd9227b7110 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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