DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor's Name and Address; Corrections
The Food and Drug Administration (FDA) published a document in theFederal Registerof April 20, 2010 (75 FR 20522) amending the animal drug regulations to reflect changes to a sponsor's name and address. That document contained errors in the regulatory text. FDA is correcting the tables listing sponsors of approved animal drug applications (NADAs) by adding a change to the sponsor's drug labeler code (DLC). Cross-references to the sponsor's DLC are amended in two sections of the Code of Federal Regulations (CFR) containing the conditions of use approved animal drug products. These corrections are being made to improve the accuracy of the animal drug regulations.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and Recordkeeping requirements.
21 CFR Part 529
Accordingly, 21 CFR parts 510 and 529 are corrected by making the following correcting amendments:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as follows:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. In § 510.600, in the table in paragraph (c)(1), revise the entry for “Piramal Critical Care, Inc.”; and in the table in paragraph (c)(2), remove the