TITLE

RULEMAKING WITHOUT RULES: AN EMPIRICAL STUDY OF DIRECT FINAL RULEMAKING

AUTHOR(S)
Kolber, Michael
PUB. DATE
February 2009
SOURCE
Albany Law Review;2009, Vol. 72 Issue 1, p79
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
In an effort to improve efficiency, several administrative agencies have adopted a procedure known as "direct final rulemaking" (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act (APA), but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the Food and Drug Administration (FDA), is the first of this kind. The results are surprising, and suggest DFR deserves more attention than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, the FDA has often used direct final rulemaking for the opposite: regulations that may be expected to be controversial. Far from generating few comments, forty percent of DFRs have had to be withdrawn due to significant opposition. These findings suggest greater limits should be placed on the use of direct final rulemaking and that its legality be reevaluated in light of how the procedure is actually used. As it is presently practiced, direct final rulemaking could increase cynicism about government.
ACCESSION #
41995304

 

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