National Institute of Environmental Health Sciences, Contracts and Procurement Management Branch, OM, P.O. Box 12874, Research Triangle Park, NC 27709

A -- QUALITY ASSURANCE AUDIT AND INSPECTION SUPPORT RESOURCE SOL NIH-ES-97-27 DUE 041197 POC Contract Specialist, Jacqueline A. Osgood, 919-541-7596, Contracting Officer, Elizabeth B. Ford, 919-541-0415 The purpose of this contract is to obtain independent quality assurance monitoring and retrospective auditing support resources. Through these support resources, the NTP will be better informed to take action to assure the high quality of studies, ascertain areas of vulnerabilities in the conduct and documentation of studies, and develop acceptance standards for the performance of high quality studies. The tasks will be carried out based on priorities established by the Project Officer. The base contract will provide NIEHS with a resource for auditing various materials and reports from toxicological and carcinogenicity studies. The base contract will encompass 6 tasks: Task 1- Audit of NTP Technical Report (A/TR); Task 2 -- Audit of Laboratory Study Report (A/LR); Task 3 -- Audit of Final Pathology Tables (A/FT); Task 4 -- Audit of Pathology Specimens (A/PS), Task 5 -- Audit of Necropsy and TDMS Information (A/NT), and Task 6 -- Option -- Site Visit Inspection and Audit. Two options will expand the effort in the contract pending the need for additional assessments and the availability of funds. Option 1, which may be exercised once per contract year, will provide support for site visit inspections at two designated laboratory facilities. Option 2, which may only be exercised in years 3, 4, and/or 5, will provide support for additional audits of study reports, data, and materials beyond the level in the base contract. All work will be handled confidentially and reported by the Project Officer. All work will be handled confidentially and reported for review to the Project Officer or as otherwise directed by the Project Officer. Award of one cost-reimbursement, term form, level of effort type of contract with an estimated period of performance of five years is contemplated as a result of this solicitation. This is a 100% set aside for Small Business. The Government estimates that the project will require approximately 0.87 senior professional person years, 1.92 technical per years, and 0.63clerical person years will be required on an annual basis for this award. All interested organizations should request either a streamlined for full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverables and reporting requirements, special requirements and mandatory qualification (if any), and technical evaluation criteria. After examination of these documents, any organization interested in responding to the RFP must request the entire RFP in writing or by telephone (919) 541-7596 or by telefax request (919) 541-2712. All responsible sources may submit a proposal which shall be considered by the Agency. Expected release date of the RFP is April 11, 1997. See Numbered Note 1. (0069)

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