MODIFICATION
65 -- 65/6505 - Acquisition of Licensed Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile (SNS)
- Notice Date
- 3/11/2004
- Notice Type
- Modification
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Ofc. of the Assistant Secretary for Public Health Emergency Preparedness, Ofc. of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
- ZIP Code
- 20201
- Solicitation Number
- RFP-DHHS-ORDC-04-01
- Response Due
- 4/16/2004
- Archive Date
- 5/1/2004
- Point of Contact
- Jacqueline Holden, Contracting+Officer, Phone 202-401-3693, Fax null, - Jacqueline Holden, Contracting+Officer, Phone 202-401-3693, Fax null,
- E-Mail Address
-
Darrick.Early@hhs.gov, Darrick.Early@hhs.gov
- Description
- THE DUE DATE HAS BEEN CHANGED TO APRIL 16, 2004. The SubProduct Service Code for this aquisition is 6505; Drugs & Biologicals. The Federal Response Plan of the Department of Homeland Security designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response to Intentional or natural disasters. In 2002, the U.S. Congress established the Office of the Assistant Secretary for Public Health Emergency Preparedness (OASPHEP). This office holds responsibility for implementation of a comprehensive HHS strategy to prevent, prepare for, and respond to acts of bioterrorism and other public health emergencies threatening the civilian population. The Office of Research and Development Coordination (ORDC) in OASPHEP has the responsibility within HHS to contract with industry for large-scale manufacturing and delivery of medical countermeasures to the Strategic National Stockpile (SNS) in preparation for response to a public health emergency. Description The nature and degree of the threat posed by the use of infectious agents as weapons of biological warfare have generated increased concern for the safety of the general American populace. With the deliberate exposure of citizens of the United States including postal workers, and other U.S. Government (USG) employees to Bacillus anthracis (B. anthracis) spores in 2001, there is an urgent need to stockpile appropriate and effective countermeasures to protect those living in the United States from the harmful effects of B. anthracis spores when used as instruments of terror. Thus, this enduring threat requires an accelerated pace of anthrax recombinant protective antigen (rPA) vaccine development, testing, manufacturing, and acquisition to provide a sufficient stockpile for emergency preparedness and response. Abundant preclinical evidence is available to indicate that vaccination with native protective antigen (PA) and the rPA of B. anthracis adsorbed to aluminum salts generates long-lasting protective immunity in animal models against inhalational spore challenge of the disease. This immunity is mediated by antibody directed at PA, and preclinical and clinical testing to date indicates that rPA will be an effective vaccine against anthrax exposure. Although future anthrax vaccines may be formulated to include antigens other than rPA and adjuvants other than aluminum salts, these novel components are not requested because their consideration could complicate and delay approval of the vaccine sought in this solicitation. The primary purpose of this Request for Proposal (RFP) is the acquisition and maintenance of 75 million doses of licensed anthrax rPA vaccine for the SNS to protect U.S. citizens against inhalation anthrax. The contractor will also be required to provide an FDA approval letter and accompanying issuance of appropriate license for a BLA for pre-exposure prophylaxis use of the anthrax rPA vaccine in the SNS; provide an FDA approval letter for a BLA supplement for post-exposure prophylaxis use of anthrax rPA vaccine in combination with antibiotics; maintain ongoing quality control/quality assurance monitoring of the SNS stored product and ongoing stability testing over the life of the contract or the expiration date of the vaccine, whichever comes first; conduct special population trials including pediatric and geriatric populations; and produce a minimum of one (1) lot of bulk product per year to maintain cGMP capacity (a warm base) for the production of the anthrax rPA vaccine for the life of the contract. It is anticipated that multiple indefinite delivery, indefinite quantity contracts for a maximum quantity of 75 million doses of rPA vaccine for the SNS to protect U.S. citizens against inhalation anthrax will be awarded. However, the Government reserves the right to make one award. RFP-DHHS-ORDC-04-01 will be available electronically through the FedBizOpps on or about February 23, 2004. Responses will be due on or about March 23, 2004. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26. All responses should be identified with RFP No. DHHS-ORDC-04-01 and should be submitted to the Contracting Office Address identified in this notice. . Points of Contact Jacqueline C. Holden, Contracting Officer, or Darrick A. Early, Contract Specialist, Phone 202-401-3693, e-mail: Darrick.Early@HHS.gov, Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, 200 Independence Avenue, SW, Room 636G, Washington, DC 20201.
- Record
- SN00542443-W 20040313/040311222249 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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