The author is the only individual who was involved in the formulation and initiation of centralized regulatory review from its inception, Johnson Administration, to its development, Nixon and Ford Administrations, to its codification, Carter Administration and finally to its government-wide implementation, Reagan Administration. Centralized regulatory review consists of two major components, conducting benefit-cost analyses of proposed regulations and the OMB review of the proposed regulations before they are proposed in the Federal Register. The website of the Center for Regulatory Effectiveness titled “Centralized Regulatory Review: An Archive” is devoted to providing a comprehensive national library of the actions leading to the historical establishment of centralized regulatory review.
The author has been interested in the accuracy of LDT’s (Laboratory Developed Tests) on both a professional and personal basis for decades. Based upon this experience it is recommended that priority be accorded to the regulation of urological oncology with an emphasis on Laboratory Developed Tests (LDT’s) developed by private laboratories but excluding for the present time any immediate regulation of those procedures developed by academic or hospital based entities until the results of the regulation of private sector laboratories are vetted to determine the magnitude of the resultant problem, if one exits.
