The purpose of amending this notice is to correct the due date and email address for submissions.

*** 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 Request for Information (RFI) about parties with the interest and capabilities to perform certain pre-clinical 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. A prerequisite for performing these clinical studies is the completion of GLP general toxicology testing of the investigational vaccine formulations to enable the filing of an IND to FDA. To conduct this testing, BARDA seeks qualified contract research organizations having the necessary capabilities and willingness to perform the studies. This is a request for such organizations to make themselves known to BARDA and provide information concerning their capabilities to perform the studies. Please provide information concerning the following required capabilities.





1. Designing and conducting standard GLP general toxicology safety testing in rabbits according to protocols and standards sufficient to support the filing of an IND for clinical testing in humans



a. Protocol design and execution

b. Housing of animals in accredited facilities, administration of vaccine,

c. Observation and recording of animal welfare

d. Collection of sera

e. Clinical chemistry and immunological testing of sera

f. Euthanasia by approved methods

g. Post-mortem histopathological analysis of test subject tissues



2. Mixing ad hoc of two vaccine components just prior to immunization according to procedure to be provided



3. Compliance with all applicable local, state, and federal regulations for housing and experimental testing with lab animals



4. Capacity for up to 90 rabbits for the duration of the study



5. Availability to start in Dec07-Jan08 timeframe





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 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 3:00 p.m. (EST) on Oct. 26, 2007. Include the name, email address and telephone number of a primary contact point at your organization for this RFI in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 2 pages.

Your response to this RFI must be submitted electronically in .pdf format and emailed to schuyler.eldridge@hhs.gov. The type of business submitting the response (i.e., small business, large 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.