Report to the Secretary of Health, Education, and Welfare on Fundamental Improvements Needed for Timely Promulgation of Health Program Regulations

HRD-77-58: Published: May 5, 1977. Publicly Released: May 5, 1977.

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The Chairman of the House Subcommittee on Health and the Environment, Committee on Interstate and Foreign Commerce, requested a review of the Department of Health, Education, and Welfare's (HEW) system for developing and promulgating health program regulations. Fourteen regulations were studied, 12 initiated as a result of legislation and 2 instituted to change the administration of current programs.

No final regulations were published within the deadline time of 6 months after enactment of enabling legislation, and, instead, are being published up to 3 years late. Delays in publishing regulations were primarily caused by weaknesses in HEW policies and procedures for developing and processing proposed regulations, but sometimes the delays were caused by HEW conscientiousness in resolving policy issues and encouraging public participation. Limited staff and resources, diffused responsibilities and lack of authority, low priority assigned regulations by some officials, and failure to monitor and take effective measures, also delay publication. Recently announced changes to policies and procedures will help somewhat, but additional changes are needed. Compliance with Office of Management and Budget Circular A-85 is not required, and the policies for forwarding proposed regulations to the Advisory Committee on Intergovernmental Relations (ACIR) are interpreted differently by the health agencies.

Recommendation for Executive Action

  1. Status: Closed

    Comments: Please call 202/512-6100 for additional information.

    Recommendation: HEW staff and resources should be developed to levels that are sufficient to participate in developing and processing regulations, and the need for public comment should be reevaluated. Comments from appropriate congressional committees on proposed and final regulations should be requested. The computerized system for monitoring the processing of regulations within the Office of the Secretary should be modified to include both developing and processing of all regulations. Preclearance policies and procedures to expedite final processing should be formalized, and revisions, unresolved issues, or questions on program criteria and proposed regulations should be highlighted. The Commissioner of the Food and Drug Administration should establish developing and processing limits. The policy and procedures for forwarding regulations to ACIR, obtaining comments from state and local government associations, and resolving differences of opinion should be clarified.

    Agency Affected:


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