Opinion ID: 510209
Heading Depth: 1
Heading Rank: 5

Heading: the subsequent petitions

Text: 63 Kanasco also seeks review of the FDA's denial of its Petition for Reconsideration, and of its Citizen Petition for Revocation, both filed September 1, 1987. The Petition for Reconsideration (1) elaborated upon the notice arguments made in Kanasco's motion for summary judgment; (2) took issue with the FDA's characterizations of Kanasco's replies to the Forms FDA-483; (3) responded for the first time to allegations in the NOOH regarding conditions at Kanasco during February 1987; and (4) argued that the FDA had erred in failing to consider Kanasco's recent corrective measures. The Citizens Petition submitted new evidence that Kanasco's facility was in compliance with CGMP requirements, including new validation data, verified statements regarding the import of that data, and evidence concerning Kanasco's CGMP training program. The Commissioner of Food and Drugs denied both petitions in a letter dated September 3, 1987. 64 We find that neither petition is appropriately before us for review. With respect to the Petition for Reconsideration, we note, as did the agency, that under FDA regulations, such a petition may not be based on views or information not contained in the administrative record on which the decision was made. 21 C.F.R. Sec. 10.33(e). To the extent that Kanasco's petition contained new information or arguments, therefore, it was properly denied by the agency. To the extent that Kanasco's petition elaborated upon arguments already in the record, however, the agency's decision, which merely denie[d] that petition, is not subject to judicial review. See ICC v. Brotherhood of Locomotive Engineers, --- U.S. ----, 107 S.Ct. 2360, 2366, 96 L.Ed.2d 222 (1987) ([W]here a party petitions an agency for reconsideration on the ground of 'material error,' i.e., on the same record that was before the agency when it rendered its original decision, 'an order which merely denies rehearing of ... [the prior] order is not itself reviewable.' ) (quoting Microwave Communications, Inc. v. FCC, 515 F.2d 385, 387 n. 7 (D.C.Cir.1974)). 65 As for the Citizen's Petition for Revocation, the government contends that Kanasco has not effectively sought review of its denial. Under Rule 15(a) of the Federal Rules of Appellate Procedure, a petition for review of an administrative agency order must designate ... the order or part thereof to be reviewed. Kanasco's petition for review in this court asked for relief only from the Commission's August 6, 1987, withdrawal order. Kanasco suggests that review of its subsequent petitions is nonetheless appropriate because the petitions and the FDA's letter denying them have the same docket number as the FDA's withdrawal order and are part of the administrative record before this court. In view of the plain language of Rule 15(a), however, we cannot agree that a petition for review designating one order in a proceeding suffices to obtain review of any other order that is part of the same administrative record. Thus, we conclude that the denial of Kanasco's Citizen's Petition is not before us for review.