NDA-Enabling Development for ST-246: A Smallpox Antiviral Drug.

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services (HHS), intends to negotiate with SIGA Technologies (SIGA), Inc., Corvallis, Oregon for a two-year continuation of Contract HHSN266200600014C for increased support of development activities for SIGA-246 to allow for full evaluation and development of ST-246, in support of NIH Biodefense Research Agenda and HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan. The contract was part of multiple awards made under Broad Agency Announcement NIH-NIAID-DMID-06-35 entitled - Development of Therapeutic Agents for Selected Viral Diseases. The SIGA contract is entitled - NDA-Enabling Development for ST-246: A Smallpox Antiviral Drug. The scope of the contract is to conduct advanced product development activities to enable a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) of a smallpox antiviral compound ST-246 (also known as SIGA-246). The Office of the Biomedical Advance Research and Development Authority (BARDA), HHS, has delegated its funding to and collaborated with NIAID to advance research and development of biodefense products inclusive of SIGA-246. Since the award in 2006, additional regulatory requirements are now requested by the FDA based on study results recently obtained. The NIAID and BARDA intend to further the process development of ST-246 for commercial scale validation, which is required for supplemental NDA submission. The NIAID intends to negotiate and award the modification under the authority of 41 USC 253(c)(1), as set forth in FAR 6.302-1. NIAID and BARDA wish to capitalize on the current development capability of the Contractor to accomplish the additional effort anticipated. This is not a request for competitive proposals. However, interested parties who believe that they are capable of fulfilling this requirement may identify their interest by providing clear and comprehensive information supporting their claim. Please include contact person(s) and phone number(s), and identify the type of business, e.g. educational institution, small business, large for profit, research non-profit, etc. The Government will consider any such information received within 45 days of the publication date of this notice. A determination by the Government not to compete this requirement is solely within its discretion. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If no responses are received within 45 days, the Government shall negotiate and modify the contract listed above. See Government-wide Numbered Note 22. No collect calls will be accepted.