INTERNATIONAL MASTER CONTRACT FOR HIV VACCINE EFFICACY TRIALS NIH GUIDE, Volume 22, Number 1, January 8, 1993 RFP AVAILABLE: NIH-NIAID-DAIDS-93-21 P.T. 34 Keywords: AIDS Clinical Trial Data Management/Analysis+ Vaccine Epidemiology National Institute of Allergy and Infectious Diseases The Vaccine Trials and Epidemiology Branch (VTEB), Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals from organizations with the capacity to serve as the International Master Contractor (IMC) for: (1) preparation of sites for efficacy trials, (2) Phase I/II trials, and (3) Phase III trials of HIV vaccines and other methods for preventing HIV infection in high-risk populations in countries outside of the United States and its territories. The proposed contract requires expertise in the following areas: coordination and management of multicenter, longitudinal epidemiologic studies, coordination of Phase I/II and Phase III trials; coordination, training and site monitoring of Phase III vaccine trials; experience with populations at high risk of HIV infection; and solicitation and management of subcontracts. Specifically, the selected contractor will be responsible for the operation and maintenance of a master contract that will provide: (1) subcontracts to sites that are currently conducting baseline epidemiologic studies to ascertain the feasibility of conducting future Phase III HIV vaccine trials; (2) solicitation of proposals from, and monitoring of, additional sites to conduct baseline/feasibility studies; (3) solicitation of proposals from, and monitoring of, sites to conduct Phase I/II and Phase III HIV vaccine trials; (4) development of protocols to test HIV vaccines and other biomedical interventions in high risk seronegative individuals; and (5) an orderly and efficient transition of the proposed contract to a successor, if necessary at the expiration of the contract. This is an announcement for an anticipated Request for Proposals (RFP). RFP NIH-NIAID-DAIDS-93-21 will be issued on or about January 20, 1993, with a closing date tentatively set for March 19, 1993. INQUIRIES Requests for the RFP are to be directed in writing to: Cyndie Cotter Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C-07 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-0972 Requests sent via overnight mail service should use Rockville, MD 20852 instead of the Bethesda zip code To receive a copy of the RFP, supply this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided first. It includes only the Statement of Work and Evaluation Criteria to be used for selection of the awardee. After examining this, a full text version of the RFP must be requested, in writing for those offerors interested in responding. Fax requests are acceptable for the full-text version only. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the government to award a contract. .
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