About the Office of Regulatory Science (ORS)
The Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), is comprised of four main offices:
- The Office of Business and Safety Operations (OBSO) is located within ORS’s immediate office. OBSO provides quantitative and qualitative studies to improve processes, planning systems, and decision models in ORS programs, including productivity, cost estimation, and workload measurement analyses. It also leads in the creation of outcome-based measures that facilitate the development of various ORS strategic plans. The Office is responsible for developing and implementing national safety policies and programs in ORA laboratories, ensuring conformance with federal safety standards. The office oversees budgets and equipment purchases for ORS laboratories.
- The Office of Research Coordination and Evaluation (ORCE) provides strategic leadership and support for high quality, collaborative, scientific research conducted at ORA laboratories that advances regulatory science and addresses important public health issues concerning FDA-regulated products. This research is aimed at supporting ORA’s regulatory mission and targets development of methods that assess conformance of FDA-regulated products with the agency regulations. The Office also includes laboratory quality management oversight. ORA laboratories are regulatory laboratories and operate under an ISO-17025 accredited status.
- The Office of Food and Feed Laboratory Operations (OFFLO) oversees eight laboratories and associated programmatic staff. OFFLO provides oversight on scientific issues and laboratory analysis related to the chemical and microbiological analysis of human and animal food. It works with appropriate FDA centers and other stakeholders to establish and execute strategic and tactical plans for the effective use of science resources in ORA.
- The Office of Medical Products, Tobacco, and Specialty Laboratory Operations (OMPTSLO) oversees eight laboratories and associated programmatic staff. OMPTSLO provides oversight on scientific issues and laboratory analysis related to pharmaceuticals, tobacco, medical devices, radiochemistry, and forensic chemistry. It works with appropriate FDA centers and other stakeholders to establish and execute strategic and tactical plans for the effective use of science resources in ORA.