SOURCES SOUGHT
68 -- Request for Information (RFI) ORDC-06-02 for Domestic Influenza Vaccine Capacity Building and Advanced Development of Recombinant Influenza Vaccines
- Notice Date
- 1/30/2006
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
- ZIP Code
- 20201
- Solicitation Number
- Reference-Number-RFI-ORDC-06-02
- Response Due
- 2/21/2006
- Archive Date
- 3/8/2006
- Description
- *** BACKGROUND *** The National Pandemic Plan of 2005 designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response for pandemic preparedness and response. The HHS Pandemic Plan of 2005 appointed the Office of Public Health Emergency Preparedness (OPHEP) is responsible for the advanced development, establishment of surge capacity, and acquisition of medical countermeasures such as vaccines and antiviral drugs that may be used to contain, control, and mitigate the mortality and morbidity associated with influenza pandemics in the U.S. The tactical and logistical implementation of policies and decisions regarding these pandemic medical countermeasures is the responsibility of the Office of Research and Development Coordination (ORDC) in OPHEP. ***DESCRIPTION*** This is a Request for Information (RFI) only. It is not a request for proposals and does not commit the U.S. Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the U.S. Government and will not be returned. HHS/OPHEP/ORDC has an interest in identifying potential influenza vaccine manufacturers capable of providing expanded domestic pandemic influenza vaccine capacity using egg-based vaccine products. Additionally, there is further interest in identifying potential influenza vaccine manufacturers with active pandemic influenza vaccine programs using recombinant-based approaches and committed to U.S.-based manufacturing and licensure. The current domestic influenza vaccine manufacturing capacity is approximately 180 million doses at 15 ug HA per dose in nine (9) months using inactivated, egg-based vaccines. In order to achieve a goal of 600 million monovalent pandemic influenza vaccines doses manufactured in six (6) months, significant increases in surge capacity must be afforded by expanding existing egg-based influenza vaccine manufacturing facilities, erecting new influenza vaccine manufacturing facilities utilizing egg-based technologies as available and converting existing manufacturing facilities that produce FDA-licensed vaccines and biologics to influenza vaccines. Further to this end, advanced development of recombinant-based influenza vaccines towards U.S.-based manufacturing and licensure needs to accompany the HHS support of advanced development of cell-based influenza vaccines. Interested organizations that have potential candidate facilities, plans for facilities, or vaccine candidates are invited to submit a statement of capability, facility or product description, and development status to HHS/OPHEP/ORDC. Specifically, submitted information depending upon the stage of facility should provide the following: (1) U.S. facility location and description (i.e. sq. ft., systems, equipment, etc.); (2) a description of the facility?s potential pandemic influenza vaccine product yield and capacity (i.e. number of monovalent doses in six months following receipt of pandemic virus isolate or nucleotide sequence); (3) a description of the vaccine manufacturing process and biocontainment capability including waste products; and (4) a description of milestones, timelines, and cost estimates for the design, renovation (if applicable), construction, commissioning, and validation of the facility to address the urgency of a possible pandemic in the near future. Similarly, submitted information depending on the stage of recombinant influenza vaccine development should provide the following: (1) a description of the recombinant vaccine product and comparability to existing influenza vaccines; (2) description of the manufacturing process and lot release product assays; (3) results of preclinical and/or clinical studies; (4) a description of the proposed formulation, dosage and route of administration; (5) regulatory pathway, limitations, and possible obstacles; (6) an estimate of production capacity, U.S. manufacturing sites, and timelines and estimated retail costs; and (7) intellectual property accessibility. Data obtained from this RFI will be used by HHS in making recommendations and decisions on the development of an appropriate procurement strategy for National Pandemic Preparedness. All information submitted to HHS will be kept confidential as allowed by relevant federal law. A pre-solicitation meeting of interested companies will be scheduled at 10:30am to 12:00pm EST on February 7, 2006 in the Humphrey Building of the HHS located at 200 Independence Ave., SW, Washington, D.C. 20201. Information from the meeting will be posted on the website www.Fedbizopps.gov. Advance registration is required to attend the meeting. There is a limit of two attendees per organization. Email name of attendee, organization name, and telephone number to darrick.early@hhs.gov. Information must be submitted by 3:00 PM, EST, February 21, 2006. Responses to the facility or recombinant product requests should be limited to 25 pages in an electronic and hard copy formats and can be e-mailed to the attention of Darrick (Andre) Early, Contract Specialist, phone 202-205-5668, email address: darrick.early@hhs.gov. If information is sent by courier or mail service, please ensure that at least one electronic and TWO (2) HARD COPIES of all responses are submitted.
- Record
- SN00975949-W 20060201/060130212628 (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
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