The FDA has provided NTEU with a courtesy notice announcing that the Office of Regulatory Affairs’ Office of Policy and Risk Management (OPRM) will issue a voluntary and anonymous survey monkey questionnaire to Office of Regulatory Affairs (ORA) field investigators who conduct inspections that have combination products. The notice states that the objective of the survey is to solicit feedback from ORA field investigators to identify inspectional challenges as well as gaps in the current training regimen for combination products in order to improve the quality of inspections. Depending on the information obtained from the survey, it will be used to either develop a new Compliance Program Guidance Manual (CPGM) or update the current CPGM to include information specific to combination products.
The FDA anticipates distributing the survey electronically to bargaining unit employees on or about Wednesday, November 2, 2016.
The agency has stated that if the FDA/ORA decides to make any changes to bargaining unit employees’ conditions of employment based on the survey results, it will provide NTEU with notice and an opportunity to bargain consistent with applicable law and its obligations under the HHS-NTEU Collective Bargaining Agreement.