The President has repeatedly stated his goal of achieving a regulatory system that is balanced, flexible, and maintains freedom of choice. Thus, it is essential that agencies reduce burdens, redundancy, and conflict, and at the same time promote predictability, certainty, and innovation in their rulemaking activities. Two things are important to achieve this goal:
- Establishing clear guidelines for the selection of candidate regulations subject to review and reform; and
- The sound, robust analysis of candidate regulations to determine whether and how the regulation might be improved or whether viable alternatives exist.
Several commenters stated strong views about the guidelines for selecting candidate regulations subject to review. Some suggested that review should occur only after sufficient time has elapsed for meaningful evaluation of a rule’s performance or whether changed circumstances, scientific advances, or technology warrant review of a rule. Others suggested fixed time periods for review ranging from every four to every 10 years. One commenter cautioned that HHS should be careful not to schedule the review of existing rules so early as to reduce the ability or incentive for the industry to adapt. While agencies did not necessarily factor in the length of time a regulation has been in effect in developing the list of initial candidates for review, HHS will take these suggestions into account as it moves forward with its ongoing retrospective review process.
Fundamentally, however, retrospective review priorities are guided by the goals of protecting the public health, welfare, safety, and environment based on the best available science, while using best efforts to promote economic growth, innovation, competitiveness, and job creation, to the extent permitted by law. The analysis applied to the retrospective review of regulations should inform decision makers of the consequences of any proposed action and its alternatives, in order to help those decision makers determine the least burdensome and most effective approach (e.g., maximizing net benefits) to achieving the desired result.
HHS agencies already understand the importance of setting priorities in the retrospective review process. Agencies routinely take into account the following factors when reviewing regulations under existing retrospective review frameworks:
- Whether an action will have a positive impact on innovation in an area of public health, safety, or delivery of or access to care;
- Whether the public health benefits of an action have not been realized;
- Whether the public or regulated community view modification or revocation of the regulations as important and have offered useful comments and suggestions for change;
- Whether the impact and effectiveness of a regulation has changed or been superseded by changes in conditions or advances in scientific or technological information; and
- Whether there are significant, unresolved issues with implementation or enforcement
- How long the regulation has been in effect and whether it has been subject to prior reviews.
Agencies will continue to use and refine these factors as they implement the retrospective review called for in Executive Order 13563and the requirements of Section 610 of the Regulatory Flexibility Act. In particular, agencies will pay careful attention to the costs and benefits of rules; to choosing the least burdensome approaches and reducing administrative burdens on the private sector as well as state, local, and tribal governments; to the need to simplify rules and harmonize overlapping rules, both within HHS or between HHS and other federal departments; to the importance of promoting flexibility for the private sector; and to scientific integrity and the development of rules based on the best available science.