Building Domestic Cell-Based Influenza Vaccine Manufacturing Facilities

Added: Aug 13, 2008 2:48 pm Modified: Aug 13, 2008 5:48 pmTrack Changes The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) requires the services of a contractor(s) to design, construct, validate and perform regulatory activities that will lead to FDA-licensure of new U.S.-based bulk influenza vaccine manufacturing facilities. The requirement will include pre-construction document development, land use and zoning licensure, construction, commissioning, validation and licensing of the facility, and the licensure, manufacture and release of a least one (1) lot of pandemic and/or pre-pandemic vaccine product.



The successful offeror(s) will have vaccine manufacturing facilities located in the U.S. or have partnerships with companies owning vaccine-manufacturing facilities in the U.S. In addition, the successful offeror(s) will: 1) have unencumbered rights to an influenza vaccine manufacturing process that is scalable; 2) have completed a Phase I clinical trial for safety and immunogenicity of an influenza strain; 3) provide written evidence of a firm commitment to establish and maintain the necessary facilities in the U.S. to manufacture bulk and final container mammalian cell-based pandemic influenza virus vaccine with a manufacturing surge capacity of at least 150 million doses within six months; 4) provide a comprehensive development plan and timeline for U.S. licensure of a mammalian cell-based pandemic-like influenza vaccine; and 5) agree to enter into a cost-sharing contract (40% Government; 60% Contractor) with the USG.



The anticipated period of performance for this requirement is sixty (60) months. It also contains provisions for 20, 1-year option periods. In accordance with FAR 36.204, the estimated price for this requirement is more than $10,000,000. Multiple awards may be made as a result of this RFP. The anticipated date of award is on or about December 15, 2008.



The solicitation (RFP-HHS-BARDA-08-09) will be available electronically through FedBizOpps on or about August 28, 2008 with a proposal submission date of September 29, 2008. Any responsible offeror may submit a proposal that will be considered by the USG. Questions concerning this notice may be submitted in writing to Paquetta Myrick-Hancock, Contracting Officer, at Paquetta.Hancock@hhs.gov. Please include the RFP number and title of the requirement in the subject line of your email. No telephone calls or facsimile transmission requests for information will be accepted.



A pre-proposal conference is scheduled for Friday, September 12, 2008 from 9:00AM -11:00AM (EST) at the following address:



Department of Health and Human Services

Office of the Assistant Secretary for Preparedness and Response

Biomedical Advanced Research and Development Authority

Herbert H. Humphrey Building

200 Independence Avenue Room 325A

Washington, DC 20201



Please arrive 15 minutes early to allow time to clear security and remember to bring personal identification. If you are riding Metro, the nearest stop is Federal Center SW. Attendance is limited to a maximum of (3) individuals per organization. Please email your attendee list and any questions that you would like to have addressed to the Contracting Officer no later than Monday, September 8, 2008 at 3:00 p.m. Voice recorders and camcorders (video) are prohibited. The minutes of the conference will be posted on FedBizOpps in an amendment to the RFP approximately one week after the pre-proposal conference. If you plan to bring a laptop, please notify the Contracting Officer no later than September 8, 2008 to obtain a property pass.



See numbered note 26.

Added: Aug 13, 2008 2:48 pm The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) requires the services of a contractor(s) to design, construct, validate and perform regulatory activities that will lead to FDA-licensure of new U.S.-based bulk influenza vaccine manufacturing facilities. The requirement will include pre-construction document development, land use and zoning licensure, construction, commissioning, validation and licensing of the facility, and the licensure, manufacture and release of a least one (1) lot of pandemic and/or pre-pandemic vaccine product.



The successful offeror(s) will have vaccine manufacturing facilities located in the U.S. or have partnerships with companies owning vaccine-manufacturing facilities in the U.S. In addition, the successful offeror(s) will: 1) have unencumbered rights to an influenza vaccine manufacturing process that is scalable; 2) have completed a Phase I clinical trial for safety, immunogenicity of an influenza strain or a Phase I clinical trial for safety, immunogenicity and cross-reactivity or cross-neutralization of a antigenically drifted influenza strain; 3) provide written evidence of a firm commitment to establish and maintain the necessary facilities in the U.S. to manufacture bulk and final container cell-based pandemic influenza virus vaccine with a manufacturing surge capacity of at least 150 million doses within six months; 4) provide a comprehensive development plan and timeline for U.S. licensure of a cell-based pandemic-like influenza vaccine; and 5) agree to enter into a cost-sharing contract (40% Government; 60% Contractor) with the USG.



The anticipated period of performance for this requirement is sixty months. It also contains provisions for 20, 1-year option periods. In accordance with FAR 36.204, the estimated price for this requirement is more than $10,000,000. Multiple awards may be made as a result of this RFP. The anticipated date of award is on or about December 15, 2008.



The solicitation (RFP-HHS-BARDA-08-09) will be available electronically through FedBizOpps on or about August 28, 2008 with a proposal submission date of September 29, 2008. Any responsible offeror may submit a proposal that will be considered by the USG. Questions concerning this notice may be submitted in writing to Paquetta Myrick-Hancock, Contracting Officer, at Paquetta.Hancock@hhs.gov. Please include the RFP number and title of the requirement in the subject line of your email. No telephone calls or facsimile transmission requests for information will be accepted.



A pre-proposal conference is scheduled for Friday, September 12, 2008 from 9:00AM -11:00AM (EST) at the following address:



Department of Health and Human Services

Office of the Assistant Secretary for Preparedness and Response

Biomedical Advanced Research and Development Authority

Herbert H. Humphrey Building

200 Independence Avenue Room 325A

Washington, DC 20201



Please arrive 15 minutes early to allow time to clear security and remember to bring personal identification. If you are riding Metro, the nearest stop is Federal Center SW. Attendance is limited to a maximum of (3) individuals per organization. Please email your attendee list and any questions that you would like to have addressed to the Contracting Officer no later than Monday, September 8, 2008 at 3:00 p.m. Voice recorders and camcorders (video) are prohibited. The minutes of the conference will be posted on FedBizOpps in an amendment to the RFP approximately one week after the pre-proposal conference. If you plan to bring a laptop, please notify the Contracting Officer no later than September 8, 2008 to obtain a property pass.



See numbered note 26.