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“Federal Regulations: Development, Review, and Approval Processes” by Mary Ann Troanovitch Executive Summary External forces such as statutes, Executive Orders, and Administration initiatives impact on the development, review, clearance, and approval of Federal government regulations. The external forces are not unique to any single Federal agency that is responsible for regulatory activities. What often differs is the process various agencies follow when developing regulations. The significance of the regulatory review process to central authority, i.e., the Executive Office of the President (EOP), has grown since the Nixon Administration. Some, such as Members of Congress, view this increased EOP involvement as pre-emption of authority that is vested by law directly to the heads of departments and agencies. The growth of central authorities over agency regulations is discussed in the paper from the perspective of one former executive in the Centers for Medicare & Medicaid Services, an Operating Division in the Department of Health and Human Services, to illustrate the complexity of meeting new requirements. At times, what has been alleged to be ideological or political reasons, instead of scientific and technical findings, will overrule federal agencies on the policy content of a regulation. This may be an unavoidable circumstance that some federal agencies and stakeholders need to face. In this author’s experience, it was not the case with CMS regulations. However, there is always the possibility for contention when involved in a process that affects the lives of people, budget, and resources. The positive experience of the CMS regulatory process points to six major principles of effective rulemaking: 1) Information on developing regulations should be part of the orientation process for newly elected officials for a clear understanding of regulation “how” and “why”, 2) All participants in the process must be willing adapt, 3) The paper discusses the ways in which CMS follows these principles. This evolutionary process within CMS has resulted in a fairly good regulatory review process albeit some problems remain such as delays by political appointees in reviewing and approving a rule, and limited staff at OMB. The federal government has a responsibility to the public to issue sound regulations that are cost effective, not unduly burdensome, and easy to understand, and reflect the concerns of all parties. Presidential initiatives or new statutes often require new processes and some restructuring in the agency. Regulations are a good way for the President and Members of Congress to meet their political agenda. Interestingly, no matter what the hurdles are, agencies do adapt and work hard to streamline and meet new requirements. However, careful consideration must be given to the cost of the effort in terms of resources vs. the end return. And, Federal agencies need to be allowed flexibility and not be subjected to aggressive intrusion. The key is to find a healthy balance of agency creativity and thoughtful, responsible oversight and review. Related Resources EOM Panel Minutes: Associated Presentation Materials: Other Related NAPA Materials:
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