RESYNTHESIS OF POTENTIAL THERAPEUTIC AGENTS FOR TREATMENT OFINFECTIOUS DISEASES NIH GUIDE, Volume 22, Number 41, November 12, 1993 RFP AVAILABLE: NIH-NIAID-DAIDS-95-05 P.T. 34 Keywords: Chemotherapeutic Agents Chemical Synthesis Infectious Diseases/Agents National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports a number of programs designed to identify and develop promising therapeutic agents active against a wide spectrum of infectious agents, including HIV, tuberculosis, and viral and non-viral opportunistic infections associated with the Acquired Immune Deficiency Syndrome (AIDS). Many of these research endeavors require pharmaceutical research and development resources such as chemical resynthesis, pharmaceutical analysis, and preparation of pharmaceutical dosage forms to provide therapeutic agents of sufficient quantity and quality to permit a proper evaluation of their efficacy and safety. The purpose of this solicitation is to provide a contract for resynthesis and acquisition of chemicals for testing as anti-infective agents. These chemicals will be used to prepare dosage forms for clinical evaluation and for use in animal models of infectious diseases, toxicological studies, as required to support the Government's ongoing evaluation of these agents. The Division of AIDS (DAIDS), NIAID previously awarded a contract to provide a chemical resynthesis capability on a scale of 1-1000g to support the drug discovery effort for infectious diseases. The current contract will expire in October 1994. The anticipated contract will be a set-aside for small business concerns. The Government's requirements specify the following two mandatory qualification criteria that must be met: (1) Neither the Offeror nor a proposed subcontractor may be a pharmaceutical company, defined as an organization that sells drugs or other therapeutic agents to the general public for profit and (2) The Offeror must be able to manufacture pharmaceutical materials in compliance with current Good Manufacturing Practice regulations (21 CFR 210-211) at time of Best and Final Offers. Documentation of this capability is required. This is an announcement for an anticipated Request for Proposals (RFP). RFP NIH-NIAID-DAIDS-95-05 was issued on November 1, 1993 and proposals will be due the close-of-business February 15, 1994. It is anticipated that one (1) level-of-effort type cost-reimbursement contract will be awarded for a five year period to carry out requested scale up and/or modify the synthetic procedure to yield increasingly larger batches as required for the further evaluation on new agents. A short-form version of the RFP will be available, for informational purposes, which includes the background information, full Statement of Work and Evaluation Criteria, and the Reporting Requirements. There is sufficient information in this document to enable prospective offerors to determine if they have the experience/capability to meet the Government's requirements. A full- text version is also available, which includes all the necessary information, business forms, etc., to submit a proposal. There are a limited number of full-text versions available. Therefore, request the short-form RFP first, then the full-text version only if you intend to submit a proposal. Telephone inquiries will not be honored. Specify if you are requesting the short-form or full-text version of the RFP (if no distinction is made, the short-form version will be sent). FAX responses are acceptable, but it is preferred that requests be submitted in writing with two self-addressed mailing labels attached to ensure proper delivery. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. INQUIRIES Requests for the RFP are to be directed in writing to: Ms. Merilee Rahe-Stoline Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-0972 .
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