A -- Clinical Research Operations and Monitoring Contract

The Division of AIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate with Westat 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-15445 through the completion of the existing contract that ends 06/14/2006. This contract was awarded using full-and-open competition under SIC Code 8731 (currently NAICs 541710); for the period 06/15/2001 through 06/15/2006. 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 Westat has assumed a significant part of this responsibility through this contract. Westat currently provides domestic and international on-site monitoring, site management, regulatory support, protocol development, operations support and training services for a large portfolio of investigator-initiated trials as well as all trials funded and pending funding within the Comprehensive International Program of Research on AIDS (CIPRA). In responding to the scientific priorities of the evolving HIV/AIDS epidemic and also in response to the growth of the CIPRA program to increasing numbers of countries and sites, more studies as well as more complex trials 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, training, protocol development support, operations support and regulatory support as currently provided by the contract. The negotiated modification will provide for an increase in the current activity to continue to provide support to the on-going clinical trial monitoring, training, protocol development support and regulatory support of the Westat contract. Westat is uniquely qualified to continue to fulfill these requirements by virtue of their performance under the current contract and through their establishment of relationships with developing international sites. If this portion of Westat's requirement were awarded to another contractor at this time, interruptions and/or inconsistencies in the normal monitoring operations of DAIDS would result. In addition, a transition would delay protocol development for a multitude of CIPRA funded studies. Training efforts tailored specifically to CIPRA requirements would cease, causing extensive delays in trial implementation and negatively impacting on the operations of current studies. Therefore, no other services 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.