C -- ENGINEERING & DESIGN SERVICES FOR VACCINE PRODUCTION FACILITY

Notice Date

May 15, 2001

Contracting Office

NCI Frederick Cancer Research and Development Center (NCI-FCRDC), P.O. Box B, Frederick, Maryland 21702-1201

ZIP Code

21702-1201

Solicitation Number

A01-537

Response Due

June 4, 2001

Point of Contact

Marilyn Buchen 301-846-1527

E-Mail Address

click here to contact the Contract Specialist via (mbuchen@mail.ncifcrf.gov)

Description

SAIC Frederick, Operations and Technical Support contractor for the National Cancer Institute (NCI) at Frederick under contract number NO-1-CO-56000 requires engineering and design services, including limited construction administration support and validation services for a cGMP Vaccine Research Center Pilot Plant at the Frederick, MD facility. The proposed project will be a two-story, slab on-grade laboratory building with full height mechanical attic space and on-grade mechanical room. The plant will be designed to operate as a cGMP pilot production facility for the production of HIV vaccines for Phase I/II human trials. The facility will perform scale-up and final development of selected manufacturing processes. The pilot plant will house or be supported by Quality Control and Quality Assurance Laboratories. The estimated construction range is greater than $10,000,000.00. Design effort shall include preparation of plans, specifications and equipment purchase specifications based upon process requirements of the scientific program and sufficient as documentation of audit supporting validity of the design. Support during construction will include review of shop drawings and submittals, responses to Requests for Information, construction site visits and determination of substantial completion. Project completion support will include as-built drawing from construction mark-ups. Validation services will include preparation of a Validation Master Plan, preparation and execution of validation protocols (IQ, OQ and PQ) including summary reports, preparation of building systems and equipment SOP's including maintenance, operation, calibration and cleaning and preparation of FDA documentation. It is anticipated that design work will start by August 15, 2001 and be complete by April 26, 2002 with construction completed by April 15, 2003. A firm-fixed-price contract will be awarded. Significant selection criteria in relative order of importance are: (1) Specialized, recent experience of the firm in the type of work required; (2) Professional qualifications, registration and specialized experience of the team members and staff proposed for the project; (3) Professional capacity of the firm/team to accomplish the work within the required time limits; (4) Past performance ratings of Government agencies and private industry contracts in terms of : a) cost accuracy and control; b) quality of work; c) compliance with performance schedules; d) responsiveness to customer; e) project team effectiveness.; (5) A geographic location of the firm to ensure timely response to needs for on-site support; (6) Quality Control Program. A/E firms which meet the requirements described in this announcement are invited to submit original and five (5) copies of completed SF254 and 255 by June 4, 2001. In order to assist the Selection Board in review of all applications, please include the following: (1) Summarize at least 3 cGMP facility designs within the last 5 years; for each project presented, provide the following information: a) bid results as compared to your estimate and the owner's programmed amount; b) project team members and firm; c) owner point of contract with title and telephone number; d) number and dollar value of design error and/or design omission related changes; e) original design submission schedule, owner approved time extensions and final execution schedule (in bar chart format).; (3) Summarize proposed team with the following data: a) firm name; b) individuals's name; c) work history with individual or consultant firm; d) office location; e) professional degree(s) and date(s); f) professional registrations(s) dates(s) and state(s); g) assigned team responsibility; h) percent of time committed to this team; i) synopsis of design experience including firm names(s) years with each firm and type of design experience with each firm. (4) Design Quality Assurance Plan including an explanation of management and design team components, specific quality control processes and use of interdisciplinary design reviews.

Record

Loren Data Corp. 20010517/CSOL010.HTM (W-135 SN50M1X2)