SPECIAL NOTICE: DEVELOPMENT OF VACCINES FOR SEVERE ACUTE RESPIRATORY SYNDROME (SARS) 266-02-SARSVAC RELEASE DATE: April 25, 2003 NOTICE: NOT-AI-03-025 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) RECEIPT DATE: May 16, 2003 DESCRIPTION The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), DHHS is seeking capability statements from organizations with the expertise to develop vaccines for Severe Acute Respiratory Syndrome (SARS). The purpose this effort is to identify commercial entities capable of the discovery, development and production of vaccines to prevent the disease caused by the newly recognized coronavirus that causes Severe Acute Respiratory Syndrome or SARS. The respondent should consider the following elements: 1. The U. S. government is mindful of the epidemiologic exigencies created by the emergence of this new virus and wishes to accelerate the development of appropriate interventions where possible. 2. The research and development needed to obtain a vaccine that will satisfy regulatory requirements of the FDA. 3. The possible need to provide substantial supplies of this vaccine. For purposes of this response the responder should consider the requirement for large-scale production of this material. 4. The ability to conduct preclinical and clinical testing of the product. 5. Documented history of successful development of a vaccine for human use in the United States is essential. 6. The U.S. government may also provide access to samples of the SARS virus. The research and development will require BSL-3 level facilities if work is proposed with the SARS virus in the laboratory. NIAID is interested in receiving letters of interest and capability statements from interested organizations. Interested organizations should submit their capability statements that contain descriptions of their potential development plans, their research and development capabilities and interests, summary results of pre-clinical and early clinical testing if available, and their potential or available manufacturing capabilities for large quantities of this vaccine. Any perceived barriers to the conduct of this research should also be indicated. The capability statements, along with any supporting documentations should not exceed 15 pages. It is also requested that interested organizations indicate their overall cost estimate for their proposed effort. The NIAID is not requesting a detailed cost proposal but rather an overall estimate of the effort per major line item. Capability statements and letters of interest will be kept confidential and will help in determining the need for an RFP to support research and development activities and in assembling a potential source list for distribution of any resultant RFP. This is not a Request for Proposals and does not commit the Government to award a contract now or in the future. Submission of any information based on this request for information is purely voluntary. Please specify, if applicable, the small business size status of your company (See Federal Acquisition Regulations, Part 19). No solicitation is available at this time. No collect calls will be accepted. Submit your responses to Sharon Kraft, Contract Specialist, at the address listed in this special notice. 266-02-SARSVAC will be available electronically on or about April 22, 2003 and may be accessed through the Internet on the Contract Management Branch Homepage, located at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps at http://www.eps.gov/servlet/Documents/R/634413. Responses to this Special Notice will be due on Friday, May 16, 2003. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Sharon Kraft, Contract Specialist, Phone 301-402-5825, Fax 301-402-0972, Email sk371c@nih.gov


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