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FBO DAILY ISSUE OF FEBRUARY 23, 2002 FBO #0083
SOLICITATION NOTICE

99 -- Production of Clinical/Grade Materials/FDA approved vectors

Notice Date

2/21/2002
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
 

ZIP Code

20892-7663
 

Solicitation Number

263-02-P-BD-0028
 

Point of Contact

Marcia Goldman, Sr. Contract Specialist, Phone 301-496-2302, Fax 301-402-3406,
 

E-Mail Address

goldmanm@od.nih.gov
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This notice constitutes the only solicitation; a written solicitation will not be issued. The solicitation, No. 263-02-P(BD)-0028, is issued as a RFP. The solicitation/contract will include all applicable provisions and clauses in effect through FAC 03. The North American Industrial Classification System Code is 541710, and the business size is 500 employees. The National Institutes of Health, has a requirement for production of Clinical Grade materials/FDA approved vectors. This includes production of a Clinical Grade, replication-deficient, recombinant type 5 adenovirus encoding human growth hormone (hGH). The NIH intends to contract with Cornell University Medical College, 100 Broadway Street 8th Floor, New York, New York 10005, under the authority of FAR 6-302-1 only one responsible source and no other supplies or services will satisfy agency requirements. Cornell University Medical College, is the only known source for this requirement. This manufacture of a 100 flask preparation of Clinical Grade materials shall be constructed, produced, and furnished, in accordance with the following. The virus to be constructed shall be a replication-deficient type 5 adenoviral vector and be driven by the cytomegalovirus promoter/enhancer. The virus shall be plaque-purified in certified 293 cells and amplified to a titer of ~10 to the 11th pfu/ml (=~10 to the 13th particles/ml). From this virus a clinical seed stock shall be prepared in a GMP laboratory facility. It shall be shown by immunologic and electrophoretic criteria (or equivalents) that following transduction of mammalian cells by the virus, production of hGH occurs. The virus shall be produced and packaged in a manner suitable for human clinical studies, including necessary quality control testing. It is the Government's belief that these requirements may only be met by the Cornell University Medical College. This is not a formal solicitation, however, concerns that respond to this notice must furnish concise responses directed specifically to the requirements mentioned above. Sources demonstrating the capability to accomplish the above shall supply pertinent information in sufficient detail to demonstrate their ability to perform. Respondents will not be notified of the evaluation results. Award will be made to the lowest, responsive responsible offeror meeting all the performance specifications specified herein. The Government anticipates the award of a Definite Delivery contract. Delivery shall be made FOB Destination within consignee's premises to the National Institutes of Health in Bethesda, Maryland. The manufacture of a 100 flask preparation of Clinical Grade biological materials shall be packaged and delivered in a manner appropriate for biological materials. The Government desires delivery on the production of Clinical Grade materials/FDA approved vectors within 2 months after award to the National Institute of Dental and Craniofacial Research in Bethesda, Maryland. The required delivery schedule shall be 120 calender days after award. If the offeror is unable to meet the desired delivery schedule, it may, without prejudicing evaluation of its offer, propose a delivery schedule. However, the offeror's proposed delivery schedule must not extend the delivery period beyond the Government's REQUIRED delivery schedule of (120) calender days after award of the contract. The Government will evaluate based on F.O.B. destination and acceptance at Bethesda, Maryland, and the requirements of FAR 52.214-21 descriptive literature apply. Proposals/Information provided must demonstrate the offeror's ability to met the specifications described herein. Invoice for payment shall be submitted after delivery and acceptance by the Institute. A completed copy of the provision 52-212-3, Offeror Representatives and Certifications-Commercial Items, is required as part of the offer. The contractor shall provide price for the manufacture of a 100 flask preparation of Clinical Grade Materials/ FDA approved vectors. The clause 52.212-4 Contract Terms and Conditions- Commercial Items applies to this acquisition. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders-Commercial Items applies to this acquisition. Invoice for payment should be submitted after delivery and acceptance by the Institute. The proposed contract is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirements with a commercial item within 15 days of this notice. A determination by the Government not 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. Address responses to the attention of Marcia Goldman at National Institutes of Health, 6011 Executive Blvd., Room 539A, MSC 7663, Bethesda, Maryland 20892-7663. CBD NUMBERED NOTE: Note 22 Not withstandiing the forty-five (45) day notice for receipt of capability statements all Capabilites must be received within fifteen (15) days from the publication of the Fedbizopps.
 

Place of Performance

Address: Bethesda, Maryland

Zip Code: 20892

Country: USA
 

Record

SN00029017-W 20020223/020221213041 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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