SPECIAL NOTICE
B -- Manufacture of GLP and GMP Grade Retinal Pigment Epithelium Cells
- Notice Date
- 2/11/2016
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- NIH-OLAO-OD-NOI-4049724
- Archive Date
- 3/7/2016
- Point of Contact
- Van V. Holley, Phone: 301-594-9439
- E-Mail Address
-
holleyv@od.nih.gov
(holleyv@od.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The announcement number for this acquisition is NIH-OLAO-OD-4049724 and is being issued under the authority of FAR Subpart 5.101 under the conditions as described in 6.302-1, and 41 United States Code (U.S.C.), only one responsible source and no other supplies or services will satisfy agency requirements. The National Institute of Health, Office of the Director, Office of Logistics and Acquisition Operations intends to procure Reagents ( ACTIVIN A) to differentiate inducted pluripotent stem cells into retinal pigment epithelium on a sole source basis from R& D Systems, Inc. This notice of intent is not a request for competitive quotations; however, any quotation received within ten (10) calendar days of the issuance of this notice will be considered by the government. Justification Rationale: The specifications for the activity of ACTIVIN A to differentiate induced pluriopotent stem cells into retinal pigment epithelium. This is a cumbersome and lengthy protocol, takes 8-10 weeks of testing. The finding that R & D Systems ACTIVIN A has specific activity to differentiate 60-70% induced pluripotent stem cells into retinal pigment epithelium. This protocol for making retinal pigment epithelium is now part of a clinical protocol and is being used to generate retinal pigment epithelium for clinical use. It is necessary to acquire large amounts of the same product to prepare for this clinical product. Any change(s) in the manufacturing process would cause the entire clinical protocol to restart and cause delay in optimization of the clinical manufacturing process. A determination by the government not to compete this 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 a competitive procurement. Interested parties may submit their company's detailed capabilities statement, catalog price list and references. Interested parties shall include, in writing, the company name, address, point of contact, telephone number, and business size; a statement regarding their capabilities and qualifications; and any additional supporting literature. If no affirmative responses are received within ten (10) calendar days of this notice to determine whether a qualified source is more advantageous to the Government, the order will be issued to R & D Systems Inc. The North American Industry Classification System (NAICS) for this requirement is 4049724 and the size standard in number of employees is 500. Responses to this notice must be received no later than 12:00 PM, Eastern Standard Time, February 21, 2016. This notice of intent is not a request for competitive proposals, quotes or a solicitation of offers. The point of contact for this action is Ms. Van Holley, Contract Specialist, 6011 Executive Blvd., Room 537-B, Rockville, MD 20852, email: holleyv@od.nih.gov. The National Institutes of Health, Office of Logistics and Acquisition Operations, OLAO requires that all contractors doing business with OLAO must be registered with the Central Contractor Registry (CCR). No award can be made unless the vendor is registered in CCR. For additional information and to register in CCR please access the following website: http://www.sam.gov/. In order to register with the CCR and to be eligible to receive an award from this acquisition office, all offerors must have a Dun & Bradstreet Number. A Dun & Bradstreet number may be acquired free of charge by contacting Dun & Bradstreet on-line at https://www.dnb.com/product/eupdate/requestOptions.html. The government now encourages all contractors to submit their Certification and Representation (ORCA) thru the on-line System for Award Management (SAM). The SAM is the single source for vendor data for the federal government. Contractors should go on-line at www.sam.gov. Award will not be made to any contractor that is not registered in CCR and SAM. Responses should be sent to Ms. Van Holley, Contract Specialist, 6011 Executive Blvd., Room 537-B, Rockville, MD 20852. This procurement is to be processed using FAR Part 13 Simplified Acquisition Procedures in conjunction with FAR Part 12 Commercial Item Acquisition of Commercial Items. There is no solicitation package available.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/NIH-OLAO-OD-NOI-4049724/listing.html)
- Place of Performance
- Address: NIH MAIN CAMPUS, BUILDING 10 - CLINICAL CENTER, Bethesda, Maryland, 20814, United States
- Zip Code: 20814
- Zip Code: 20814
- Record
- SN04018514-W 20160213/160211235017-118c91f5ecaf054d4da5d749d48e0400 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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