NIH GUIDE, Volume 22, Number 1, January 8, 1993


P.T. 34



  Clinical Trial 

  Data Management/Analysis+ 



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.


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



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