Loren Data's SAM Daily™

FBO DAILY ISSUE OF SEPTEMBER 16, 2004 FBO #1025
SOLICITATION NOTICE

99 -- DHHS and CDC has a requirement for 200,000 Doses of Heptavalent Botulinum Immune Globulin

Notice Date

9/14/2004
 

Notice Type

Solicitation Notice
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

2004-N-01183
 

Response Due

10/3/2004
 

Archive Date

10/18/2004
 

Description

The Centers for Disease Control and Prevention (CDC) intends to negotiate a sole source procurement with Cangene Corporation under the authority of FAR 6.302-1, Only responsible source and 6.302-2, Unusual and compelling urgency. A contract was awarded, to Cangene Corporation, in January 2003, as a result of a competitive procurement for the production of botulinum antitoxin. To date the contractor has developed Assays and conducted the necessary Pilot Runs (4). As a direct result of the Sept. 1, 2001 tragedy and the increase in threat of bioterrorist activities against the United States (U.S.), the Department of Health and Human Services (DHHS) and the Centers for Disease Control and Preventon (CDC) has a need to contract for additional botulinum antitoxin in addition to the botulinum antitoxin that will be produced under the contract described above. The DHHS and CDC has a need to contract with an experienced firm that possesses the capability and capacity for the production, licensure, and delivery of up to 200,000 doses of Despeciated Heptavalent Botulinum Immune Globulin (BIG) for use as a Heptavalent investigational product under an Investigational New Drug Application (IND) and to develop a strategy to license the product that is produced. The contractor will also be responsible for monitoring the potency of the BIG product for an extended period of time. At the time of award, the prospective contractor must possess the necessary capability and capacity required for cGMP production and licensure and all FDA validation production requirements. The FDA has now determined that both sets of plasma (the January 2003 Cangene contract and the resulting contract for an additional 200,000 doses as described above) can go under one license.
 

Place of Performance

Address: 26 Henlow Bay, Winnipeg Manitoba

Zip Code: R3Y 1G4

Country: Canada
 

Record

SN00672698-W 20040916/040914211739 (fbodaily.com)
 

Source

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

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