PMA Operation Qualification

The purpose of this AMD01 is to update the serial numbers and new due date which will be on February 26 at 4pm. The instruments are integral components that support the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. The proposed instruments are needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products. The Contractor shall be capable of providing both the Service Agreement and Qualification Service for all systems specified in the Statement of Work to ensure uninterrupted performance within manufacturer’s specification. The Government intends to issue a firm fixed-price purchase order as result of this solicitation. Please see the attached RFQ for complete requirement details and quotation submission instructions.