SOLICITATION NOTICE
Q -- Medical Supplies
- Notice Date
- 7/12/2005
- Notice Type
- Solicitation Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- NOI5084
- Response Due
- 8/1/2005
- Archive Date
- 8/16/2005
- Description
- This is a combined/solicitation notice of intent for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are not being requested and a written solicitation will not be issued. The solicitation number for this acquisition is NOI-5084 and the solicitation is being issued as a notice of intent. This solicitation document and its incorporated provisions are those in effect through the Federal Acquisition Circular (FAC 2001-25). The National Institute of Allergy and Infectious Disease (NIAID) intends to procure, on a sole-source basis, using simplified acquisitions procedures, the production of 3 non-GMP grade master cell stocks of E. coli; containing plasmids, which express HIV gene products from Merck & Co., Inc. for use in NIAID Project #: 05-FR-009. The anticipated period of performance is 08/11/05-08/10/06. Also, NIAID will have the option to procure 3 additional master cell stocks with an anticipated period of performance of 08/11/06-08/10/07. This product will be used as starting materials in the manufacture of DNA vaccines used in FDA-regulated human clinical trials and must be manufactured under conditions meeting US regulatory requirements for raw materials and processing conditions. The Contractor will utilize their proprietary process for selecting clones which are capable of yielding high levels of plasmid DNA in a batch/fed-batch fermentation process. The Government will provide the following: A minimum of 20 ug of each plasmid; and the sequence of the gene insert of each plasmid and plasmid map for each plasmid. The Contractor will perform the following task 3 times- once for each of the 3 different plasmids provided by the VRC. An option will exist in FY06 for a second round of production of 3 additional cell stocks for each of 3 different VRC plasmids. Also, the contractor will transform a high yielding E. coli cell line with a VRC provided plasmid encoding an HIV gene product. Upon selection of a high-yielding clone using the Contractor?s selection process, the Contractor will prepare a Master Cell Stock. The cell stock, although not required to be manufactured under GMP conditions, should be acceptable for the future generation of master/working cell banks under GMP. Deliverables: 1. A minimum of 50 vials of master cell stock for each of the six plasmids provided by the VRC. 2. A testing report showing, at a minimum, the results of the following tests: a. Cell Stock Purity; b. Restriction enzyme analysis of plasmid DNA produced by the cell stock; and c. Any additional tests performed by the Contractor, will provide a report describing the transformation, clone selection and procedure for preparing the cell stocks or a letter authorizing the VRC to cross-reference the Contractor?s IND or BMF concerning cell selection and cell stock preparation. Merck has been identified as the only responsible source for this procurement and is a leader in the field of vaccine development. Merck possesses a proprietary screening process for the selection of high-yielding E. coli clones containing plasmids which express HIV gene products. They have successfully used this selection process to manufacture DNA plasmid vaccines against HIV which have been tested in FDA approved clinical trials. In addition, Merck has the in-house capabilities and capacity to begin work on this project immediately. Switching to another manufacturer would result in significant time delays and additional cost to the government as new technologies would need to be developed resulting in delayed arrival of the VRC HIV DNA vaccine into the clinic. This is not a Small-Business Set Aside. The North American Industry Classification System (NIACS) Code for this acquisition is 325412 and the small-business size standard is $11.5 million dollars. This is a firm fixed-price contract and the FOB terms are destination and Net 30. The anticipated period of performance will be 8/11/05- 8/10/06 with an option for one additional year. These items are to be shipped in specified quantities at the end-user?s request. FAR provisions and clauses that apply to this acquisition: FAR 52.212-1, Instructions to Offerors, Commercial Items; FAR 52.212-3, Contractor Terms and Conditions, Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders, Commercial Items; FAR 52.225-3, Buy American Act; FAR 52.204-7, Central Contractor Registration; and FAR 32.703-2, Availability of Funds. In order to be considered for an award, an offeror must have completed the online electronic Representations and Certifications located at http://orca.bpn.gov/ in accordance with FAR 4.1201(a). By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the CCR at www.ccr.gov/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation [Note: Lack of registration in the Central Contractor Registration will make an offeror ineligible for award.] Offers must be submitted no later than 5:00 P.M. Eastern Daylight Time on 8/01/05. For delivery of responses through the Postal Service, the address is NIH/NIAID/AMOB, 10401 Fernwood Drive, Suite/2NE70, Room/2N28F, MSC/2811 Bethesda, Maryland 20817-4812, Attention: Valerie Hankins. E-mail and Fax submissions are not authorized. Requests for information concerning this requirement must be submitted in writing, and can be faxed to 301-480-3695, or e-mailed to hankinsv@niaid.nih.gov . It is the vendor?s responsibility to confirm receipt of all quotations and/or questions by the closing date of this announcement by contacting Ms. Hankins at 301-402-5770. Collect calls will not be accepted. Point of Contact Valerie Hankins, Purchasing Agent, Phone 301-402-5770, Fax 301-480-3695, Email hankinsv@niaid.nih.gov - Linda Taylor, Contracting Officer, Phone 301-402-5770, Fax 301-480-3695, Email ltaylor@niaid.nih.gov
- Place of Performance
- Address: National Institutes of Health, NIAID Bethesda MD,
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00845131-W 20050714/050712211750 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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