A -- Safety Evaluation of Anti-Infective Agents

The Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), NIH, DHHS, maintains a portfolio of drug development contracts to assist academic investigators and small pharmaceutical firms by providing the preclinical resources necessary to support submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). NIAID is conducting a market survey to determine the availability and capability of small business firms to support us in our mission to develop safe and effective therapies and preventives for the treatment of infectious diseases caused by Human Immunodeficiency Virus (HIV) and other infectious disease agents, including tuberculosis and malaria. Sources Sought Notice Information: Type of Requirement Re-competition (Contract No.:N01-AI-05417) Place of Performance Place of performance is unknown at this time. We are soliciting the availability and capability of small business firms that are able to conduct simultaneously multiple and complex preclinical toxicology and pharmacokinetic studies in a timely and efficient manner. The studies must be conducted in compliance with 21 CFR 58, Good Laboratory Practices regulations and will be submitted to the U.S. Food and Drug Administration (FDA) as a component of an Investigational New Drug Application. Products for study will be either small organic new chemical entities, or complex biologics for the treatment of or prophylaxis against infectious diseases. It is expected that the Contractor shall have experience and expertise conducting preclinical safety and pharmacokinetic studies using biologics (e.g. DNA plasmids, therapeutic vaccines, antibodies, and/or proteins) in addition to organic chemical molecules. There also will be the need to develop and validate bioanalytical methods, and develop experimental formulations, as needed for GLPcompliant IND enabling studies. The work will require the development of protocols and conduct and evaluation of studies for the evaluation of : (1) acute and subchronic systemic toxicities, and pharmacokinetics, in multiple and diverse experimental animal species, including dogs and non-human primates; (2) target organ toxicities, such as central nervous system, immune system, cardiovascular system, etc; (3) in vitro genetic toxicity and in vitro metabolic potential. In addition it will be expected that the contractor will develop test systems and models in cutting-edge scientific subdisciplines such as toxicogenomics. Potential sources must demonstrate and document the ability to perform multiple required studies simultaneously in a timely manner in relevant animal and in vitro models, and to promptly and efficiently evaluate the data and promptly prepare reports suitable for submission to FDA. The following legend shall be added to the bottom of all Sources Sought announcements: Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Written capability statements should be received by the NIAID Contracting Officer at 3:30 PM Eastern time by June 8, 2006. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. No facsimile transmissions will be accepted. This notice is for information and planning purposes only and does not commit the Government to award a contract now or in the future. This is not a request for proposals. The Government does not intend to award a contract based on responses under this announcement. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Point of Contact Joshua LaVine, Contact Specialist, Phone 301-496-2509 via Video Phone number 1-866-410-5787 and use extension 27149, Fax 301-480-4675, Email JLaVine@niaid.nih.gov - Lawrence Butler, Contracting Officer, Phone 301-496-0192, Fax 301-402-0972, Email lb13t@nih.gov