Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is updating the animal drug regulations to reflect changes to previously approved new animal drug applications (NADAs). Several sponsors currently listed as sponsors of approved applications and specified in the animal drug approval regulations are incorrect. This action is being taken to improve the accuracy of the regulations.
This rule is effective May 3, 2001.Start Further Info
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4567.End Further Info End Preamble Start Supplemental Information
FDA has found several errors in the agency's regulations concerning approval of animal drugs, feeds, and related products including the list of sponsors of approved applications. To correct those errors, FDA is amending 21 CFR 510.600(c)(1) and (c)(2) to remove 28 sponsor names and their corresponding drug labeler codes (DLCs) because the firms are no longer the holders of any approved NADAs. This document is also amending the animal drug approval regulations by correcting nonsubstantive DLC errors in 21 CFR 522.2120, 558.274, 558.625, and 558.630.
Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part
1. The authority citation for 21 CFR part 510 continues to read as follows:
2. Section 510.600End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part
3. The authority citation for 21 CFR part 522 continues to read as follows:
4. Section 522.2120 Spectinomycin dihydrochloride injection is amended in paragraph (b) by removing “Nos. 000033 and 059130” and adding in its place “No. 059130”.Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part
5. The authority citation for 21 CFR part 558 continues to read as follows:
6. Section 558.274 Hygromycin B is amended by removing and reserving paragraph (a)(5); by removing “011790 and” in paragraph (a)(7); and by removing “026186,” from the “Sponsor” column in the table in paragraphs (c)(1)(i) and (c)(1)(ii).
7. Section 558.625 Tylosin is amended by removing and reserving paragraphs (b)(16), (b)(19), and (b)(34), and in paragraph (b)(79) by removing “012286” and adding in its place “017519”.
8. Section 558.630 Tylosin and sulfamethazine is amended in paragraph (b)(8) by removing “, 026186”.Start Signature
Dated: April 23, 2001.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-11158 Filed 5-2-01; 8:45 am]
BILLING CODE 4160-01-S