A -- Clinical Site Monitoring Project [Request for Capability Statements]

The Division of AIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate with Pharmaceutical Product Development (PPD) under the Authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(b)(1), Unique Capabilities, for a modification to increase the volume of activity under Contract N01-AI-05405 through the completion of the existing contract that ends 06/30/2005. This contract was awarded under a full-and-open competition under SIC C ode 8741; Size Standard $5 Million, for the period 07/01/2000 through 06/30/2005. As the sponsor of federally funded clinical trials research, DAIDS has an on-going regulatory responsibility for oversight of some 200 studies conducted at over 800 sites in 41 countries, and PPD has assumed a significant part of this responsibility through the contract. PPD currently provides domestic and international on-site monitoring and training services for the Adult AIDS Clinical Trials Group (AACTG), the Pediatric AIDS Clinical Trials Group (PACTG), the Acute Infection Early Disease Research Program (AIEDRP), the Community Programs for Clinical Research on AIDS (CPCRA), the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), and a large non-network trial - ESPRIT. In responding to the scientific priorities of the evolving HIV/AIDS epidemic larger and more complex studies have been implemented at more sites than originally planned. These new sites are both domestic and in resource poor settings in the developing world that require the same level of monitoring and training as currently provided by the contract. The negotiated modification will provide for an increase in the activity itself to continue to provide support to the on-going clinical trial monitoring and training operations of DAIDS Clinical Site Monitoring Project. PPD is uniquely qualified to continue to fulfill these requirements by virtue of their performance under the current contract. If this portion of PPD's requirement were awarded to another contractor at this time, the consequences would mean an interruption and/or inconsistency in the normal monitoring operations of DAIDS. Therefore, no other service will satisfy Agency requirements. If there are responsible sources who feel that they are able to perform the requirement, they must respond by submitting the information required by Numbered Note 22 on/before the closing date noted in this announcement. Organizations that submit capability statements in response to this announcement must demonstrate their ability to assume the work without unnecessary delay and duplication of cost and effort. You are directed to Government-Wide Numbered Notes 22 and 26. No collect calls will be accepted.