Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Human influenza pandemics continue to be a public health concern. Four human influenza pandemics have occurred in the past century. BARDA has recently completed the preparation and response to the 2009 H1N1 pandemic influenza virus. The WHO estimates approximately 59% case fatality of the currently circulating H5N1 avian influenza virus. At this time it is uncertain which influenza virus variant will cause the next pandemic.

The BARDA Strategic Plan 2011-2016 outlines the approach to enhance national MCM preparedness and response. BARDA plans to continue the programs for the development and procurement of MCM for pandemic influenza preparedness and response.

To accomplish this goal, BARDA intends to publish a Request for Proposals for the supply of the following items and/or services: pre-pandemic master/working virus seeds; pre-pandemic and pandemic pilot, clinical and commercial bulk vaccines and adjuvants; storage and stability studies of vaccines and adjuvants; formulation-fill-finish of vaccine and adjuvants; preclinical and clinical studies with pre-pandemic and pandemic vaccine; international shipping; storage services and stability program for vaccine and adjuvants, (bulk and final containers) from current contracts when applicable; and disposal of vaccine bulk and final containers.

The Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA) contemplates single or multiple awards of contracts to companies that meet the following mandatory criteria:

The offeror shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by:
• Holding a US influenza vaccine license OR
• Have developed an influenza vaccine as evidenced by:
o A complete final Phase 3 clinical study report AND
o A documented BLA in preparation.

The anticipated period of performance will be for a total of up to five (5) years or sixty (60) months with a potential for two (2) one (1) year option periods. Additional details and requirements will be described in the solicitation. A Request for Proposal (RFP) will be available electronically through the Federal Business Opportunities (FedBizOpps) website (www.fbo.gov) on or about February 14, 2012, with proposals being due on April 20, 2012.

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. It is the offeror's responsibility to monitor this website (www.fbo.gov) for the release of the solicitation as well as any amendments to the solicitation. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses and/or inquiries concerning this requirement MUST be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, fax number, email address and should be submitted to the primary and/or secondary point of contact identified in this notice.

Multiple awards may result from this solicitation with an estimated award date of August 2012.

THIS IS A PRESOLICITATION NOTICE ONLY.

Human influenza pandemics continue to be a public health concern. Four human influenza pandemics have occurred in the past century. BARDA has recently completed the preparation and response to the 2009 H1N1 pandemic influenza virus. The WHO estimates approximately 59% case fatality of the currently circulating H5N1 avian influenza virus. At this time it is uncertain which influenza virus variant will cause the next pandemic.

The BARDA Strategic Plan 2011-2016 outlines the approach to enhance national MCM preparedness and response. BARDA plans to continue the programs for the development and procurement of MCM for pandemic influenza preparedness and response.

To accomplish this goal, BARDA intends to publish a Request for Proposals for the supply of the following items and/or services: pre-pandemic master/working virus seeds; pre-pandemic and pandemic pilot, clinical and commercial bulk vaccines and adjuvants; storage and stability studies of vaccines and adjuvants; formulation-fill-finish of vaccine and adjuvants; preclinical and clinical studies with pre-pandemic and pandemic vaccine; international shipping; storage services and stability program for vaccine and adjuvants, (bulk and final containers) from current contracts when applicable; and disposal of vaccine bulk and final containers.

The Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA) contemplates single or multiple awards of contracts to companies that meet the following mandatory criteria:

The offeror shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by:
• Holding a US influenza vaccine license OR
• Have developed an influenza vaccine as evidenced by:
o A complete final Phase 3 clinical study report AND
o A documented BLA in preparation.

The anticipated period of performance will be for a total of up to five (5) years or sixty (60) months with a potential for two (2) one (1) year option periods. Additional details and requirements will be described in the solicitation. A Request for Proposal (RFP) will be available electronically through the Federal Business Opportunities (FedBizOpps) website (www.fbo.gov) on or about February 14, 2012, with proposals being due on or about April 2, 2012.

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. It is the offeror's responsibility to monitor this website (www.fbo.gov) for the release of the solicitation as well as any amendments to the solicitation. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses and/or inquiries concerning this requirement MUST be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, fax number, email address and should be submitted to the primary and/or secondary point of contact identified in this notice.

Multiple awards may result from this solicitation with an estimated award date of August 2012.