Brief Fact Summary. Syncor International Corporation (Appellant) appealed from the District Court decision that the 1995 “Notice” issued by the Food and Drug Administration (FDA) regarding positron emission tomography (PET) was a “non- substantive” rule not subject to notice and comment rulemaking.
Synopsis of Rule of Law. APA Section:553(b)(3)(A) exempts from notice and comment interpretive rules or general statements of policy.
Issue. Was the 1995 publication an interpretive rule?
Held. No. Reversed and remanded to the district court with instructions to vacate the FDA’s rule and enter summary judgment in Syncor’s favor. The 1995 regulation was as far removed from the typical policy statement or interpretive rule. It did not purport to interpret anything; but rather, was a fundamentally new regulation. The sort of changes the FDA made in issuing the new regulation and making the Act applicable to PET drugs were exactly the sort of changes in fact and circumstance for which notice and comment are intended. Dissent. None. Concurrence. None.
The four factors are: (1) whether in the absence of the rule there would not be an adequate legislative basis for enforcement action or other agency action to confer benefits or ensure the performance of duties, (2) whether the agency has published the rule in the Code of Federal Regulations, (3) whether the agency has explicitly invoked its general legislative authority, or (4) whether the rule effectively amends a prior legislative rule.View Full Point of Law