Optional ORA BIMO Survey

Office of Regulatory Affairs (ORA) logoThe Office of Regulatory Affairs (ORA) has notified NTEU that its Office of Policy and Risk Management (OPRM) will be issuing a survey to solicit feedback from investigators who conduct Bioresearch Monitoring Program (BIMO) inspections regarding their experience with Establishment Inspection Report (EIR)/inspection reclassification.

Responding to a surveyAccording to the notice, the objective of the survey is to solicit feedback from ORA field investigators who conduct BIMO inspections regarding their Official Action Indicated (OAI) EIR/inspection reclassification process and to learn more about the information they find useful in these communications.

Participation in the survey is optional and should take no more than 10 minutes.

The agency plans to use the survey feedback from both the Centers and ORA in order to develop recommendations for the OAI EIR/inspection reclassification process for BIMO inspections and the types of information to convey in these communications. The agency’s stated goal for this project is to improve the BIMO OAI EIR/inspection reclassification process and make these communications more meaningful for both ORA and the Centers.

Please let me know if you have any questions or comments on the survey.

Author: chapterpresident

I have worked in the FDA since 1990 in a variety of positions. I currently serve as chapter president of NTEU Chapter 254, representing FDA employees in Arkansas, Colorado, Iowa, Kansas, Missouri, Nebraska, New Mexico, Oklahoma, Texas, and Utah.