2025-14203: Regulatory Hearing Before the Food and Drug Administration

Federal Register, Volume 90 Issue 142 (Monday, July 28, 2025) [Federal Register Volume 90, Number 142 (Monday, July 28, 2025)] [Rules and Regulations] [Page 35407] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-14203] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 16 Regulatory Hearing Before the Food and Drug Administration CFR Correction This rule is being published by the Office of the Federal Register to correct an editorial or technical error that appeared in the most recent annual revision of the Code of Federal Regulations. 0 In Title 21 of the Code of Federal Regulations, Parts 1 through 99, revised as of April 1, 2025, reinstate paragraph Sec. 16.1(b)(1) to read as follows: Sec. 16.1 Scope. * * * * * (b) * * * (1) Statutory provisions: Section 304(g) of the act relating to the administrative detention of devices and drugs (see Sec. Sec. 800.55(g) and 1.980(g) of this chapter). Section 304(h) of the act relating to the administrative detention of food for human or animal consumption (see part 1, subpart k of this chapter). Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to the modification or revocation of a variance from the requirements of section 419 (see part 112, subpart P of this chapter). Section 515(e)(1) of the act relating to the proposed withdrawal of approval of a device premarket approval application. Section 515(e)(3) of the act relating to the temporary suspension of approval of a premarket approval application. Section 515(f)(6) of the act relating to a proposed order revoking a device product development protocol or declaring a protocol not completed. Section 515(f)(7) of the act relating to revocation of a notice of completion of a product development protocol. Section 516(b) of the act regarding a proposed regulation to ban a medical device with a special effective date. Section 518(b) of the act relating to a determination that a device is subject to a repair, replacement, or refund order or that a correction plan, or revised correction plan, submitted by a manufacturer, importer, or distributor is inadequate. Section 518(e) of the act relating to a cease distribution and notification order or mandatory recall order concerning a medical device for human use. Section 520(f)(2)(D) of the act relating to exemptions or variances from device current good manufacturing practice requirements (see Sec. 820.1(d)). Section 520(g)(4) and (g)(5) of the act relating to disapproval and withdrawal of approval of an application from an investigational device exemption (see Sec. Sec. 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of this chapter). Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products. Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act relating to the establishment of good manufacturing practice requirements for tobacco products. Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a new tobacco product to be introduced or delivered for introduction into interstate commerce. Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a modified risk tobacco product to be introduced or delivered for introduction into interstate commerce. * * * * * [FR Doc. 2025-14203 Filed 7-25-25; 8:45 am] BILLING CODE 0099-10-P