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Executive Summary

FDA INTERPRETIVE RULES NOTICE-AND-COMMENT REQUIREMENT should be retained because it gives industry the opportunity to provide its view as well as more time to make changes needed to comply with new agency policies, the Pharmaceutical Manufacturers Association recommended in Sept. 27 written comments to FDA. "Current procedure enhances the regulatory process by allowing the open expression of all points of view prior to the establishment of agency policies," PMA suggested. "While the agency has a very high level of expertise on food and drug matters, it can still benefit from input from regulated industries and other members of the public." The federal Administrative Procedures Act requires agencies to follow formal rulemaking procedures for rules that implement or proscribe law. The APA exempts interpretive rules, rules of agency practice and general statements of policy from that requirement. In 1975, FDA waived the exemption and said it would follow an informal notice-and-comment requirement for interpretive rules. In the July 31 Federal Register, FDA proposed to rescind that waiver and no longer require notice and comment ("The Pink Sheet, Aug. 13, T&G-13). PMA also observed that FDA has previously "recognized the difficulty in distinguishing between legislative and interpretive rules." In publishing the proposed change, FDA said it is concerned about a trend in judicial opinions interpreting agency pronouncements as having the force of more formal rules, even though they were not intended as such. The agency said it could still "voluntarily follow such [notice-and-comment] procedures for any FDA pronouncement." FDA has said it does not intend to alter current agency practice regarding public comments, but rather intends to clarify FDA's legal responsibilities for the courts. In comments submitted Oct. 1, the American Bar Association's Section of Administrative Law and Regulation Practice also opposed the change. While a voluntary approach would allow "public participation in particular instances, which instances are left unspecified," the group stated. "The current regulation follows a more rigorous and reasonable policy."

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