FDA Requests Input on Reducing Regulations
In response to Presidential Executive Orders aimed at reducing regulatory burdens, the U.S. Food and Drug Administration (FDA) is seeking comments to help the Agency “identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.” FDA’s call for public comments appeared in seven, separate Federal Register Notices published on September 8, 2017, one directed to each of the FDA Centers, as well as one applicable to general regulatory and information collection requirements that affect multiple FDA Centers. The Federal Register notices explain that input from the public is intended to assist the Agency in implementing Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), issued on January 30, 2017, and Executive Order 13777 (“Enforcing the Regulatory Reform Agenda”), issued on February 24, 2017.
In each Notice, FDA provides a list of questions to help the public in providing comments. These include:
- Is the regulation still current, or is it outdated or unnecessary in some way? (This could be due to scientific advances, duplicate regulation, etc.)
- Have regulated entities had difficulties complying with the regulation?
- Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius)?
- Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records?
- Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?
- What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
More information, including how to submit comments, is available at the links below:
- General regulatory requirements (82 Fed Reg 42506)
- Center for Food Safety and Applied Nutrition (CFSAN) requirements (82 Fed Reg 42503)
- Center for Drug Evaluation and Research requirements (82 Fed Reg 42499)
- Center for Biologics Evaluation and Research requirements (82 Fed Reg 42492)
- Center for Devices and Radiological Health requirements (82 Fed Reg 42494)
- Tobacco Products requirements (82 Fed Reg 42501)
- Veterinary Medicine requirements (82 Fed Reg 42497)
Comments are due by December 7, 2017.