The Food and Drug Administration intends to award a non-commercial, type contract on a non-competitive, sole source basis to the National Institute for Biological Standards and Control (NIBSC) for the delivery of Pandemic Influenza Potency Antiserum. The vendor will be required to ship the supplies to the following FDA location, 8800 Rockville Pike, Bethesda, Md 20892.

This request is for a contractor to produce a potency antiserum for a candidate pandemic influenza vaccine virus. The antiserum standard will be generated in sheep to purified hemagglutinin from a pandemic influenza virus vaccine generated by one of the World Health Organization (WHO) Essential Regularitory Laboratories or WHO Collaborating Centers for influenza. The potency antiserum will be used to determine the potency of influenza vaccines produced by various liscensed manufactorers.

A major effort in the Department of Health and Human Services (HHS) Pandemic Influenza Preparedness planning is to stockpile influenza vaccines and the reagents necessary to evaluate them for use should a pandemic influenza virus emerge into the population. Standardized reagents are required to measure the potency of the stockpiled influenza strain-specific antigen standard and a strain-specific antigen standard. Antiserum standards are currently made for each new strain for which there is a vaccine. Since HHS has contracted for pilot lots of several pandemic vaccines for the national stockpile, we are responsible for procuring and storing the potency antiserum standards required for the testing of the vaccine potency.

This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than 15 days from the date of this announcement and reference Sources Sought No. 11-223-SOL-00129 . The applicable North American Industry Classification System (NAICS) Code is 325414. A determination the Government not to compete the proposed work based on the responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be sent via email to the Contract Specialist/Officer listed. No phone calls will be accepted. The FDA intends to make an award immediately after the response date of this notice.