BUS 410 Lecture Notes - Lecture 3: Rulemaking, Pharmaceutical Industry, Administrative Law Judge

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Delegation doctrine enabling legislation agency rules. Types of rules: (1) procedural (2) substantive legislative rules (the important things) (3) interpretive guidance/policy. Type of rulemaking: notice and comment, formal notice, comment, response, hearing (in front of the alj), unlimited cross-ex b. Informal notice, comment, response, [no cross-ex: hybrid notice, comment, response, limited cross-ex, negotiated notice, comment, response, negotiated at a round-table (parties must be reasonable for this to work, no notice and comment. The most common type of rulemaking is negotiated and hybrid. Ranking the types of rulemaking in order of due process: formal (most due process, hybrid/negotiated, informal, no notice and comment (least due process) The type of rule determines the type of rulemaking depending on how much due process should be applied. Substantive rules the most due process. If an agency doesn"t give enough due process, the regulation can be challenged as violating due process (regardless of the content of the rule)

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