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.
Discussion. An agency policy statement does not seek to impose, elaborate on or interpret a legal norm-it merely represents an agency’s position with respect to how it will treat the governing legal norm. An interpretive rule typically reflects an agency’s construction of a statute that has been entrusted to the agency to administer. A substantive rule has characteristics of both a policy statement and an interpretive rule; and is in part an exercise of policy and a rule. The distinction is that a substantive rule modifies or adds to a legal norm based on the agency’s own authority.