Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to remove those portions that reflect approval of 11 new animal drug applications (NADAs) listed below. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.
This rule is effective May 21, 2001.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5593.End Further Info End Preamble Start Supplemental Information
The following sponsors have requested that FDA withdraw approval of the NADAs listed below because the products are no longer manufactured or marketed:
|Sponsor||NADA Number Product (Drug)||21 CFR Cite Affected (Sponsor Drug Labeler Code)|
|Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812||NADA 48-915 Purina® Bot Control (trichlorfon)||520.2520a (017800)|
|Golden Sun Feeds, Inc., 111 South Fifth St., Estherville, IA 51334||NADA 97-567 Tylan® 10 Premix (tylosin phosphate)||558.625(b)(17) (021780)|
|NADA 97-615 Swine Med-A-Mix TS 8000 Premix, Tylan® 5, 10, 20, 40 Sulfa-G (tylosin phosphate and sulfamethazine)||558.630(b)(4) and (b)(10) (021780)|
|Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318-1093||NADA 110-440 Hygromix Hygrowormer Hyanthelmix (hygromycin B)||558.274(a)(2), (a)(3), (a)(4), (c)(1)(i), and (c)(1)(ii) (016968)|
|Steris Laboratories Inc., 620 North 51st Ave., Phoenix, AZ 85043-4705||NADA 45-578 Lidocaine Hydrochloride With Epinephrine Injection 2%||522.1258 (000402)|
|NADA 44-585 Oxytocin Injection||522.1680 (000402)|
|NADA 45-737 Sodium Pentobarbital Injection||522.1704(b) (000402)|
|NADA 45-848 Phenylbutazone Injection||522.1720 (000402)|
|NADA 110-349 Dexamethasone Injection||522.540(c)(2) (000402)|
|NADA 110-350 Dexamethasone Injection||522.540(b)(2)(ii) (000402)|
|NADA 117-973 Prednisolone Sodium Succinate for Injection||522.1884(c) (000402)|
Following the withdrawal of approval of these NADAs, Golden Sun Feeds, Inc., is no longer the sponsor of any approved applications. Therefore, 21 CFR 510.600(c) is amended to remove entries for the sponsor.
Steris Laboratories currently has another approved application for dexamethasone injection (NADA 104-606). Therefore, the regulation is not amended to reflect the withdrawal of approval of NADA 110-349 (dexamethasone injection).
Steris Laboratories NADA 44-585 oxytocin injection is not codified under 21 CFR 522.1680 oxytocin injection. Also, Steris Laboratories NADA 45-848 phenylbutazone injection is not codified under 21 CFR 522.1720 phenylbutazone injection. Therefore, amendments of the cited regulations are not required.
As provided below, the animal drug regulations are amended to reflect the withdrawal of approvals.
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
21 CFR Parts 520 and 522
- Animal drugs
- Animal drugs
- Animal feeds
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, 21 CFR parts 510, 520, 522, and 558 are amended as follows: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 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraph (c)(1) by removing the entry “Golden Sun Feeds, Inc.”, and in the table in paragraph (c)(2) by removing the entry “021780”.Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part
3. The authority citation for 21 CFR part 520 continues to read as follows:
4. Section 520.2520a Trichlorfon oral is removed.Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part
5. The authority citation for 21 CFR part 522 continues to read as follows:
6. Section 522.1258 Lidocaine injection with epinephrine is removed.
7. Section 522.1704 Sodium pentobarbital injection is amended by removing and reserving paragraph (b).
8. Section 522.1884 Prednisolone sodium succinate injection is amended by removing the second sentence of Start Printed Page 23589paragraph (c) and by removing paragraph (d)(2)(iv).Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part
9. The authority citation for 21 CFR part 558 continues to read as follows:
10. Section 558.274 Hygromycin B is amended as follows:
a. In paragraph (a)(2) by removing “016968 and”;
b. By removing and reserving paragraph (a)(3);
c. In paragraph (a)(4) by removing “016968,”;
d. In the table in paragraph (c)(1) in the fifth column of the first entry in items (i) and (ii) by removing “016968,”.
11. Section 558.625 Tylosin is amended by removing and reserving paragraph (b)(17).
12. Section 558.630 Tylosin and sulfamethazine is amended by removing and reserving paragraph (b)(4), and in paragraph (b)(10) by removing “021780,”.Start Signature
Dated: May 2, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-11621 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S