Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.
This rule is effective November 18, 2008.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Tiffany J. Brown, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.End Further Info End Preamble Start Supplemental Information
FDA has discovered that an error appeared in the agency's codified regulations for part 601 (21 CFR part 601). In the Federal Register of December 28, 2007 (72 FR 73589), FDA published an interim final rule that inadvertently revised § 601.12(f)(3)(i)(D) (21 CFR 601.12(f)(3)(i)(D)) instead of adding a new paragraph, § 601.12(f)(3)(i)(E). Accordingly, § 601.12(f)(3)(i)(D), which was added in the Federal Register of January 24, 2006 (71 FR 3922), is being reincorporated into the regulations to replace current § 601.12(f)(3)(i)(D); current § 601.12(f)(3)(i)(D) is being redesignated as § 601.12(f)(3)(i)(E). This document corrects the errors described previously. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive.Start List of Subjects Start Printed Page 68333
List of Subjects in 21 CFR Part 601End List of Subjects Start Amendment Part
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs,End Amendment Part Start Part
PART 601—LICENSINGEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 601.12, redesignate paragraph (f)(3)(i)(D) as paragraph (f)(3)(i)(E) and add new paragraph (f)(3)(i)(D) to read as follows:End Amendment Part
(f) * * *
(3)(i) * * *
(D) A change to the information required in § 201.57(a) of this chapter as follows:
(1) Removal of a listed section(s) specified in § 201.57(a)(5) of this chapter; and
(2) Changes to the most recent revision date of the labeling as specified in § 201.57(a)(15) of this chapter.
Dated: November 10, 2008.
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27254 Filed 11-17-08; 8:45 am]
BILLING CODE 4160-01-S