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FBO DAILY ISSUE OF NOVEMBER 05, 2005 FBO #1440
SOLICITATION NOTICE

68 -- Montanide ISA 51

Notice Date

11/3/2005
 

Notice Type

Solicitation Notice
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
 

ZIP Code

20852
 

Solicitation Number

NCI-60006-NG
 

Response Due

11/18/2005
 

Archive Date

12/3/2005
 

Description

The National Cancer Institute (NCI) Pharmaceutical Management Branch (PMB) plans to procure Montanide ISA-51 (NSC 675756), quantity: 1,500 ampules, from the sole manufacturer, Seppic, Inc. Suite 210, 30 Two Bridges Road, Fairfield, New Jersey 02004. The supplies and services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13. The North American Industry Classification System code is 325412 and the business size standard is 500 employees. The Pharmaceutical Management Branch currently provides Montanide ISA-51 Sterile Injection, 3 ml ampules (NSC 675756) for twenty-six studies involving hundreds of study participants. This is an investigational agent that is not approved for commercial distribution in the United States. The Montanide ISA 51 will no longer be manufactured by Seppic, Inc, it will be replaced with the new product formulation, Montanide ISA 51 VG to support ongoing and new clinical studies. This agent is being studied as an adjuvant to other agents in various types of cancer. There are no generic equivalents, nor are there therapeutically equivalent agents that could be used in its place. The product shall be manufactured in accordance with cGMP and ICH guidelines for suitability for human use and meet all required USP criteria for acceptability in relation to final drug product QC testing. The product should be delivered within 72 hours of ordering. The ampules must have a minimum expiration date of 12 months at the time of delivery to the NCI and all ampules in each shipment must be from the same lot. A Certificate of Analysis (CoA) must be provided and the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), NCI must have authority to reference the company?s Certificate of Analysis, quality control data and the company?s FDA Drug Master File for the DCTD-sponsored IND(s). Changing variables at this time, with respect to chemical consistency, will be detrimental to the experiments in progress. Seppic, Inc. is the only known source to the NCI that can provide the aforementioned substance. This substance is involved in patient care, therefore must remain consistent with ongoing treatment. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Capability statements must be received in the contracting office by 1:00 PM EST, on November 18, 2005. For further information please contact Malinda Holdcraft, Contract Specialist via electronic mail at holdcram@exchange.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Contractors must be registered in the Central Contractor Registration (CCR), www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov in order to receive an award. See FAR Part 4 for additional information. No collect calls will be accepted. Please reference NCI-60006-NG on all correspondence.
 

Place of Performance

Address: Bethesda, MD

Zip Code: 20892

Country: USA
 

Record

SN00925670-W 20051105/051103211733 (fbodaily.com)
 

Source

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

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