A -- Epidemiologic Studies of Adverse Effects of Marketed Drugs

The Food and Drug Administration anticipates awarding a sole source contract modification to Contract number HHSF223200510012C with Harvard Pilgrim Health Care, Inc., Wellesley, Massachusetts. Harvard Pilgrim is the incumbent contractor and is the only source capable of meeting the Government's requirements for this contract. The statutory authority for other than full and open competition is 41 U.S.C. 253 (c)(1) implemented by Federal Acquisition Regulation 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. The basic contract, awarded on a full and open competition basis, was to gain access to data resources that can be used to conduct drug safety analyses to the benefit of the public's health; to respond expeditiously to urgent public safety concerns; to provide a mechanism for collaborative pharmacoepidemiological research designed to test hypotheses, particularly those arising from suspected adverse reactions reported to FDA, and to enable rapid access to U.S. population-based data sources to ensure public safety when necessary. The purpose of this contract modification is to perform the increasing number of drug safety studies needed within the contract's statement of work. The original completion date for this contract, September 2010, will not change. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. NO SOLICIATIONS WILL BE ISSUED. All questions regarding this posting must be in writing and can be sent via email to contact@example.gov. Only email responses will be accepted. Questions must be received by no later than 12:00pm (noon) EST, June 21, 2006. A modification to the contract will be issued on or after June 21, 2006.