BARDA is seeking responses from qualified small business sources only (e.g., small business, 8(a), Small Disadvantaged Business, Historically Underutilized Business Zone, Veteran-Owned, and Service Disabled Veteran Small Businesses).  Responses from large businesses will not be reviewed under this sources sought notice.

*** BACKGROUND *** The National Pandemic Influenza Plan (Nov. 1, 2005) designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response for pandemic preparedness. Following the issuance of this plan, the office of the Assistant Secretary for Preparedness and Response (ASPR) was charged with gathering information, developing policies and issuing recommendations on specific medical countermeasures may be used to contain, control, and mitigate the mortality and morbidity associated with an influenza pandemic in the U.S. The office of Biomedical Advanced Research and Development Authority (BARDA) is responsible for the tactical and logistical implementation of policies and decisions regarding these countermeasures, including the establishment of a stockpile of supplies to prevent or control the spread of pandemic influenza disease. This is a Sources Sought Notice seeking small businesses with the interest and capabilities to perform certain testing of vaccine components in the BARDA pandemic preparedness stockpile. 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.

*** OBJECTIVE *** As part of its preparations, HHS/ASPR/BARDA has established a stockpile of avian influenza vaccine antigens to be administered in a pandemic or pre-pandemic situation for the prevention of avian influenza disease. In order to extend the number of effective doses that can be provided from the stockpile, BARDA is also working with manufacturers to develop antigen-sparing technologies such as components that can be added to the vaccine to enhance its immune response, known as adjuvants. In the event of a pandemic emergency, HHS would like to be able to extend the available stockpile of antigens by administering them with adjuvants depending on availability. In order to have this ability, BARDA, in conjunction with NIH, CDC, and the antigen and adjuvant manufacturers, is planning to conduct clinical testing of possible antigen:adjuvant combinations, the results of which would be submitted to U.S. regulatory agencies as support for an Emergency Use Authorization. Evaluation of these investigational formulations will be made by serological testing for immunogenicity by appropriate assays for influenza vaccines. BARDA seeks qualified, small business contract research organizations having the necessary capabilities and willingness to conduct this testing. This is a request for such organizations to make themselves known to BARDA and provide information concerning their capabilities to perform the testing. Please provide information concerning the following required capabilities.

1. Conducting immunological testing of sera from human clinical trials

2. Assessment of sera for the presence of antibodies reactive with influenza antigens by Inhibition of Hemagglutination (HAI) and Microneutralization (MN) assays, using reagents specific for the vaccine (homologous) or other (heterologous) influenza strains.

3. Must possess the necessary facilities, capabilities, and expertise to conduct GLP human serology analysis in compliance with all applicable codes and regulations.

4. Capacity for up to 10,000 samples for the duration of the testing

5. Availability to start in January 09-June 09 timeframe

6. Both HAI and MN assays must be fully qualified (recognized by FDA) for testing human clinical trial samples. Also, both HAI and MN assays must be qualified for at least one pandemic flu strain for testing human sera from clinical trials

Data obtained from this sources sought notice 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 and will be eligible for additional special protections under the conditions of the Protected Critical Infrastructure Information (PCII) Program outlined in the Critical Infrastructure Information Act of 2002.

Information must be submitted by 9:30 a.m. (EST) on November 10, 2008. Include the name, email address and telephone number of a primary contact point at your organization for this sources sought in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 2 pages.

All questions and your responses to this sources sought notice must be submitted electronically in Adobe Acrobat (.pdf) or Microsoft Word format and emailed to kevin.nilles@hhs.gov. The type of business submitting the response (i.e., small business, hub-zone, small and disadvantaged business, etc.) must be identified in your response. If the service can be acquired on a GSA schedule, VA schedule, or other Government-wide acquisition vehicle, please supply the contract title and number, contract point of contact information and the name of the awarding agency.