National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

A -- HIV VACCINE PRODUCTION, PRECLINICAL TESTING, FDA SUBMISSIONS SOL NIH-NIAID-DAIDS-01-06 DUE 050100 POC Mr. Lawrence Butler, Contracting Officer, 301-496-0192 The Preclinical Research Branch (PRB), Vaccine and Prevention Research Program (VPRP), Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has a requirement for HIV Vaccine Production. It is anticipated that multiple contracts will be awarded for a period of five years. The development of vaccines to prevent the spread of HIV infection is a national goal of the highest priority. To help accomplish this goal, the Division of AIDS of the National Institute of Allergy and Infectious Diseases plans to establish a pool of prequalified contractors with experience in vaccine development and production. The contract will provide the NIAID with the ability to achieve: 1) process development and cGMP production of pilot lots of candidate HIV vaccines; and 2) a rapid response mechanism for funding high priority, targeted developmental research. The NIAID, in consultation with its advisory groups, will establish the priorities for all research and development. The purpose of this contract is to facilitate developmental HIV vaccine research by performing tasks in three areas. Offers may submit proposals for one or more of the Parts A-C of this solicitation. PART A: VACCINE PRODUCTION. The first area will require a process development team with the expertise to develop candidate vaccine products including scale-up and production of GLP/GMP lots suitable for human use. In some cases, a Task Order may support work on well-developed products that need only final steps in production and formulation. Other Task Orders may involve very early and iterative steps in the development process and require several years of effort. Under Part A, four (4) categories of vaccine concepts will be developed based on (1) Synthetic peptides, (2) Recombinant subunits, (3) Vector based vaccines [viral or bacterial], or (4) Virus-like particles/Replicons. Offerors may submit proposals based on scale-up and production of any one or more vaccine categories and will only be considered for work under the categories selected. PART B: SAFETY AND IMMUNOGENICITY TESTING. The second activity area to be supported under this contract is the testing of vaccine preparations as required prior to release for initial clinical evaluation. This includes testing candidate products for safety and immunogenicity (both cellular and humoral) in small animals and, if appropriate, in non-human primates. PART C: FDA SUBMISSIONS. The third area to be supported by this contract is the development of the Master File, Investigator's Brochure, and compilation of an IND including a vaccine trial protocol provided by the clinical trials group appropriate for submission to CBER, FDA for Investigational New Drug Application (IND). RFP NIH-NIAID-01-06 will be available electronically on or about 2/4/00 and may be accessed through the NIAID Contracts Management Branch (CMB) Home Page using the following address and instructions: NIAID CMB Home Page (via the World Wide Web) may be accessed using http://www.niaid.nih.gov/cgi-shl/cmb/rfps.cfm. Once you are at the NIAID Contracts RFP Page, select "RFP-NIH-NIAID-01-06." Please note that the RFP for this acquisition has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualifications, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on 5/1/00. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Posted 01/21/00 (W-SN417484). (0021)

Loren Data Corp. http://www.ld.com (SYN# 0002 20000125\A-0002.SOL)