Facilities

In addition to collaborative resources located at NIST, the NCL laboratory facilities will initially be located in Building 469 on the NCI-Frederick campus. This facility is adjacent to, and will integrate with, other relevant NCI-Frederick laboratories such as the electron microscopy laboratory and the animal care facility. The laboratories in Building 469 are outfitted with a tissue culture room, an isotope laboratory, research bays, a cold room, a chromatography and electrophoresis area, microscopy rooms, a spectroscopy area, a synthetic lab with chemical fume hoods, and open floor space for freestanding instrumentation and equipment.

Relationship to SAIC-Frederick

The NCL is a government-owned, contractor-operated (GOCO) facility under NCI's federally funded research and development center (FFRDC) and will fall under NCI-Frederick's Operations and Technical Support (OTS) contract. SAIC-Frederick, Inc., a subsidiary of SAIC, is the OTS contractor for NCI-Frederick. The mission of SAIC-Frederick, Inc., is to provide scientific, technical, management, administrative, and logistical support to NIH intramural laboratory research and development related to the causes of and cures for cancer and AIDS.

SAIC-Frederick, Inc., is one of four related NCI contracts on site and serves as the infrastructure support for the entire center. The contract is the largest single research contract awarded by the U.S. Department of Health and Human Services (DHHS) and it is the Department's only government-owned, contractor-operated facility contract. SAIC-Frederick, Inc. employs over 1,500 staff including scientists, research assistants, technicians, engineers, administrative, maintenance, and support personnel.

SAIC-Frederick operates under a variety of regulatory, performance, and quality standards.
These include:

• SAIC-Frederick operates the NCI's Biopharmaceutical Development Program and the NIAID/Vaccine Research Center's Vaccine Pilot Plant. Both programs manufacture pharmaceuticals for use in human clinical trials. These products are manufactured in accordance with FDA requirements for Current Good Manufacturing Practices 21CFR Chapter 1 Parts 210 and 211 and Biological Products Requirements 21 CFR Chapter 1 Parts 600 and 610.
• SAIC-Frederick clinical testing laboratories in accordance with 42 CRF Part 493 "Clinical Laboratory Improvement Amendments (CLIA)."
• SAIC-Frederick research laboratories are operated in accordance with 21 CFR Part 58 "Good Laboratory Practice for Nonclinical Laboratory Studies."
• NCI-Frederick laboratory animal science programs, operated by SAIC-Frederick, are AAALAC accredited (Association for Accreditation and Assessment Laboratory Animal Care) and operated in accordance with the Guide for the Care and Use of Laboratory Animals and Public Health Service Policies. NCI-Frederick maintains an Assurance through the NIH Office of Animal Care and Use.