Animal Husbandry Services and Vivarium Management

Background
The Food and Drug Administration (FDA) is the United States Government regulatory agency responsible for the safety of foods, cosmetics, drugs, biological products, medical devices and radiological products. The FDA Centers at White Oak protect and promote public health by the regulation and oversight of pharmaceutical products, supplements, biologic products, and medical devices, including devices that emit electromagnetic radiation. The Center for Biologics Evaluation and Research (CBER)’s mission includes the regulation of biological products for human use such as vaccines, blood-derived and tissue-derived products, including xenografts, allergenic extracts, and cellular/gene therapy products. CBER conducts animal studies to support regulatory review and understanding of these diverse and innovative products, their safety, effectiveness, and potency. The Center for Drug Evaluation and Research (CDER)’s mission includes helping ensure that human drugs are safe and effective for their intended use and that these products meet established quality standards. Animal studies in CDER are focused on improving scientific standards for the composition, quality, safety and effectiveness of human drugs and protein therapeutic products. The Center for Devices and Radiological Health (CDRH)’s mission includes providing the public with understandable science-based information about the products they oversee. CDRH animal studies often focus on the stability and reliability of implanted devices and product materials. Current use of laboratory animals and development of new animal models support regulatory review and understanding of diverse medical products, as well as provide guidance to the regulated industry. These Centers maintain a consolidated on-site animal research program in support of these regulatory activities.

Work Details
The contract is for animal husbandry services and vivarium management for CBER/CDER and CDRH for a 5 year ordering period. The contractor will be responsible for managing animal based research performed by CBER, CDER, and CDRH at Building 10 (52/72) Vivarium of the Federal Research Center in Silver Spring MD 20993. This includes housing laboratory animals such as mice, rats, hamsters, guinea pigs, rabbits, ferrets, voles, gerbils, swine non-human primates, frogs in an environmentally controlled animal vivarium that utilizes a single corridor system. The contractor will also manage eight laboratory animal biosafety level three (ABSL-3) room suites capable of BSL2 practices.

Period of Performance
The contract is expected to be performed over a 5 year ordering period.

Place of Performance
The contract will be performed at Building 10 (52/72) Vivarium of the Federal Research Center in Silver Spring MD 20993.