Pharmaceutical Vial Manufacturing for Influenza Vaccine Products

Summary This is a Sources Sought Notice. The purpose of this notice is to obtain information from all qualified U.S. manufacturing sources that manufacture pharmaceutical vials, stoppers or seals for use with influenza vaccine products. It is not a solicitation for proposals, proposal abstracts, or quotations. The Government will evaluate information received to: (1) Obtain product listings of pharmaceutical multi-dose and single dose vials, stoppers and seals used with FDA approved influenza vaccine products, (2) Obtain information on current manufacturing processes, capabilities, capacities, constraints and limitations in the manufacturing and availability of these products, (3) Utilize this information to inform acquisition strategies that may be used to support preparedness and response to public health emergencies, and (4) Conduct site visits. Background Within the Federal Government, the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases. To accurately estimate the capability and limitations to deploy medical countermeasures, HHS requires information on the manufacturability and availability of multi-dose and single dose vial products, which would be critical to the rapid deployment and administration of medical countermeasures during a public health emergency. Purpose and Objectives To accurately assess the capability to deploy medical countermeasures in a timely manner, HHS is seeking information on product availability, current manufacturing processes for routine and surge manufacturing requirements, resource constraints, and other limitations of these products, which may impact the availability and distribution of vaccine and drug products during a public health emergency. Submission Instructions To respond to this Sources Sought Notice, manufacturers must be able to manufacture pharmaceutical vial, elastomer stoppers, or seals for use with FDA approved vaccine and/or other drug products. Respondents (manufacturers) are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents (manufacturers) are asked to provide a cover page that contains the following information: 1. All point of contact information (email addresses, phone numbers and mailing address). 2. Identification as a large or small business. If small, indicate the classification. 3. Identification of products/services on Federal Supply Schedules, if any, and the relevant schedule numbers. Respondents (manufacturers) are asked to provide the following information: 1. Product literature and specification sheets for pharmaceutical vials, stoppers and seals. 2. Sufficient information on the topics below for discussion during a potential site visit: a) U.S. based manufacturing capabilities and plant locations (city, state) b) Non U.S. based manufacturing capabilities and plant locations (city, country) c) Manufacturing processes and current manufacturing capacities d) Manufacturing surge capacities that can be achieved in 30, 60 and 90 day timeframes e) Raw/starting materials and long lead-time components that may impact production f) Supply and manufacturing constraints, limitations or other pertinent information Small Business manufacturers who meet the requirements are encouraged to respond. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. Please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. This Sources Sought Notice is in accordance with FAR 52.215-3, Request for Information or Solicitation for Planning Purposes (Oct 1997); as such, any information received will be for the purpose of planning only. Responses to this Sources Sought Notice, along with a firm's capability statement referencing "Sources Sought Notice - Pharmaceutical Vial Manufacturing for Influenza Vaccine Products" shall be submitted electronically via email to the points of contact listed in this notice, NO LATER THAN 3:00 PM ET, THURSDAY, JANUARY 10, 2019. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. RESPONSES TO THIS NOTICE WILL NOT BE CONSIDERED ADEQUATE RESPONSES TO A SOLICITATION.