Formal Rulemaking (Recommendations)

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The present recommendation implements, and somewhat expands, the statement of principle adopted by the Conference in June 1973 with respect to the American Bar Association’s Resolution No. 10 concerning proposed amendments to the Administrative Procedure Act. It speaks only to the issue of subpena authority in formal proceedings under the Administrative Procedure Act, and...

The Federal Food, Drug and Cosmetic Act requires the Food and Drug Administration (FDA) to hold a formal evidentiary hearing in connection with promulgation of certain types of rules of general applicability. Detailed findings of fact based solely on the record must accompany the regulations, and such findings are subject to judicial review on a substantial evidence test....