HHS Seeks Comments on Its Plan to Review Existing Regulations

(HHS represents 12 agencies, including the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), Agency for Toxic Substances and Disease Registry (ATSDR), etc., to among other things, assure the safe and effectiveness of drugs and other medical products, protect the nation's food supply.)

Overall Review Framework for Each Agency to be Established

Although many agencies of HHS currently conduct periodic retrospective reviews, until now there has been no single HHS-wide plan for ongoing review of HHS regulations. HHS’ goal is to establish a framework for each HHS agency to undertake a periodic analysis of its significant existing regulations, resulting in a more streamlined, flexible, less burdensome regulatory structure. HHS has determined that the plan called for by the EO 13563 should reflect HHS’ overall approach to regulatory review, leaving implementation of that plan to each individual regulatory agency.

Comments Sought on How to Make Its Regulatory Program More Effective

HHS seeks public comments on the following elements to be considered as HHS develops its preliminary plan to make its regulatory program more effective or less burdensome. HHS notes that responses to this request for information do not bind HHS to any further actions related to the response and that HHS will not respond to individual comments, but will consider them as it formulates its preliminary plan.

1. Schedule for Ongoing Review: The public is first asked to comment on how HHS should determine a schedule for review. Comments might address how best to schedule periodic reviews that will be meaningful, yet not unduly burden individual agencies within HHS, or how best to integrate mandatory reviews of HHS regulations.

2. Process for Setting Priorities: HHS solicits comments about factors it should consider and the process it should use in setting priorities and selecting rules for review.

3. Public Participation:HHS solicits comments on ways to further engage and increase public comment in its rulemaking. HHS also welcomes comments on how it can remain informed on new technologies, events or processes that may render significant rules potentially obsolete, outdated, or require modification.

4. Analysis of Costs and Benefits: HHS invites public comment on how it ought to develop its analysis of costs and benefits of those rules under consideration for retrospective review.

5. Coordination with Other Departments: HHS is interested in public comment on ways that HHS can consider the combined effects of regulations (together with those of other agencies) on particular sectors and industries, particularly small businesses, and state, local and tribal governments; and ways to promote greater coordination across agencies, harmonization of regulatory requirements, and the identification of regulations that are redundant, inconsistent or overlapping.

6. What the Plan Should Include: HHS seeks comment on how best to structure its framework for conducting ongoing retrospective reviews, and other criteria that should be considered in preparation of its preliminary plan

¹EO 13563 directs each federal agency to develop a preliminary plan, consistent with law and its resources and regulatory priorities, under which the agency will periodically review its existing significant regulations to determine whether such regulations should be modified, streamlined, expanded or repealed to make the agency’s regulatory program more effective and or less burdensome in achieving its regulatory objectives. (See ITT’s Online Archives or 01/19/11 news, 11011915, for BP summary.)

HHS Contact -- Oliver Potts (202) 690-6392

(FR Pub 04/13/11)