Opinion ID: 64717
Heading Depth: 2
Heading Rank: 2

Heading: Proper Legal Framework

Text: Dr. Palazzo concedes that the FDA has authority to impose record-keeping requirements on clinical investigators through regulations and properly did so through 21 C.F.R. § 312.62. If the parties questioned whether § 355(i) provided sufficient guidance for the FDA to promulgate regulations requiring clinical investigators to adhere to certain record-keeping requirements, the nondelegation doctrine would be an issue in this case. See, e.g., Garfinkel, 29 F.3d at 453-54. Similarly, if the parties disputed whether § 355(i) authorized the FDA regulations at issue in this case, this Court would need to engage in a Chevron analysis to assess § 355(i)'s statutory construction. See, e.g., Id. The sole issue on appeal in the instant case, however, is whether 21 U.S.C. §§ 351(e) and 355(i) allow the imposition of criminal penalties on clinical investigators who violate the record-keeping requirements found in 21 C.F.R. § 312.62. This issue involves the scope of § 355(i), not the FDA's authority to promulgate regulations, and we must merely ascertain[ ] the scope of [§ 355(i)], which in turn requires us to construe the statute. See United States v. Kay, 359 F.3d 738, 740 (5th Cir. 2004). Thus, the issue on appeal requires this court to engage only in statutory interpretation. The starting point for interpreting a statute is the language of the statute itself. Id. at 742. (quotation omitted). We follow the plain and unambiguous meaning of the statutory language. Id. (quotation omitted). If the statute is ambiguous, we may look to the legislative history or agency interpretations for guidance. United States v. Orellana, 405 F.3d 360, 365 (5th Cir.2005) (citation omitted).