Loren Data's SAM Daily™

FBO DAILY ISSUE OF FEBRUARY 14, 2008 FBO #2271
SOLICITATION NOTICE

68 -- recombinant Protective Antigen (rPA) anthrax vaccine for the strategic national stockpile

Notice Date

2/12/2008
 

Notice Type

Solicitation Notice
 

NAICS

325414 — Biological Product (except Diagnostic) Manufacturing
 

Contracting Office

Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, UNITED STATES
 

ZIP Code

00000
 

Solicitation Number

RFP-BARDA-08-15
 

Response Due

5/29/2008
 

Archive Date

6/13/2008
 

Point of Contact

Brian Goodger, Contracting Officer, Phone 202-260-0333, Fax 202-205-4520, - Brian Goodger, Contracting Officer, Phone 202-260-0333, Fax 202-205-4520
 

E-Mail Address

Brian.Goodger@hhs.gov, Brian.Goodger@hhs.gov
 

Description

The United States Government (USG) has a need to acquire and supply the Strategic National Stockpile (SNS) with 25 million doses of Final Drug Product (FDP) of recombinant protective antigen (rPA) anthrax vaccine. The FDP shall be packaged as single dose units or multi-dose vials with a minimum expiry period of 24 months manufactured in accordance with current Good Manufacturing Practice (cGMP). The rPA anthrax vaccine will initially be accepted into the SNS once the successful Offeror has supplied sufficient safety, efficacy, and stability data to support FDA (Food & Drug Administration)/CBER (Center for Biologics Evaluation & Research) Current Thinking for the potential use under a declared emergency under Emergency Use Authorization (EUA) for a post exposure prophylaxis indication (PEP), concurrent with antibiotics indication. The successful Offeror will be required to seek and achieve licensure for their rPA anthrax vaccine. Initial licensed product will be used in a pre-exposure general use prophylaxis (GUP) indication in adults. The Contractor shall also seek label extension for PEP plus antibiotic indication in adults in the base contract.
 

Place of Performance

Address: TBD

Zip Code: 00000

Country: UNITED STATES
 

Record

SN01506545-W 20080214/080212223535 (fbodaily.com)
 

Source

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

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