In the September 8, 2017, Federal Register, FDA sought comments and information from interested parties to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced. FDA is particularly interested in receiving comments and information on: (i) whether the regulation is still current or is outdated or unnecessary; (ii) whether regulated entities have had difficulties complying with the regulation; (iii) whether the regulation imposes requirements that are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International Organization for Standardization, Codex Alimentarius); (iv) whether the regulation contains redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, recordkeeping, or labeling requirements; (v) whether the goal of the regulation could be achieved by less-costly means that would provide the same level of public health protection; and (vi) what factors FDA should consider in selecting and prioritizing regulations and reporting requirements for reform. This request is part of the implementation of Executive Order 13771 titled "Reducing Regulation and Controlling Regulatory Costs," and Executive Order 13777 titled "Enforcing the Regulatory Reform Agenda." Comments are due December 7, 2017.
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