68 -- recombinant protective antigen (rPA) anthrax vaccine for the Strategic National Stockpile

THIS IS A SOURCES SOUGHT NOTICE SEEKING RESPONSES FROM SMALL BUSINESSES ONLY. This sources sought notice is not a request for proposal (RFP). This notice does not constitute a commitment by the Government. The Government is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10 to identify small businesses that are capable of providing the requirement. All information submitted in response to this sources sought notice is voluntary and the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately. The Department of Health & Human Services has a future requirement for 25 million doses of an rPA anthrax vaccine that meets the specifications of the U.S. Food & Drug Administration/Center for Biologics Evaluation & Research (FDA/CBER) for potential use during a declared emergency under an EUA (Emergency Use Authorization). The rPA anthrax vaccine shall require a maximum of three (3) doses to show efficacy and shall have an expiry period no less than 24 months with a minimum of 20 months remaining when delivered to the SNS. A potential offeror must meet the following mandatory qualification criteria: 1. Obtained FDAs Current Thinking describing the minimum product information and data that shall be submitted to the FDA for review in order to potentially consider use of the product in a declared emergency under Emergency Use Authorization (EUA). It is anticipated that a solicitation will be announced in February, with proposals due in May. While the mandatory qualification criteria do not have to currently be met, all of the mandatory qualification criteria must be met by proposal submission. Proposals that do not meet the mandatory qualification criteria would not be considered for evaluation. Interested parties may identify their interest by submitting a capability statement including how they meet the mandatory qualification criteria, an anticipated delivery schedule of the product, primary contact information at the organization (name, email, address, and telephone number) for this sources sought in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 10 pages. Data sets (e.g., tables, charts, graphs) and documents which are pertinent to the response can be submitted as appendices to the primary submission. All respondents and comments to this announcement shall reference "DHHS-Sources Sought-rPA-February 2008" and be submitted to Brian K. Goodger, Contracting Officer, at Brian.Goodger@hhs.gov by COB on February 21, 2008. All submitted information shall remain with the U.S. Government and will not be returned.