66 FR 86 pgs. 22116-22118 - Animal Drugs, Feeds, and Related Products; Tylosin Tartrate for Injection, etc.; Withdrawal of Approval of NADAs
Type: RULEVolume: 66Number: 86Pages: 22116 - 22118
FR document: [FR Doc. 01-11070 Filed 5-2-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
Animal Drugs, Feeds, and Related Products; Tylosin Tartrate for Injection, etc.; Withdrawal of Approval of NADAs
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 13 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.
DATES:
This rule is effective May 14, 2001.
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.
SUPPLEMENTARY 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) |
|---|---|---|
| Elanco Animal Health, A Div. of Eli Lilly Co., Lilly Corporate Center, Indianapolis, IN 46285 | NADA 12-585 Tylan Injectable (tylosin tartrate) | 522.2640b (000986) |
| NADA 15-207 Hyferdex Injection (iron dextran complex) | 522.1183(c) (000986) | |
| NADA 30-330 Tylocine Sulfa Tablets (sulfadiazine, sulfamerazine, sulfamethazine, tylosin) | not applicable | |
| NADA 31-962 Tylan plus Neomycin Eye Powder (neomycin sulfate, tylosin) | 524.2640 (000986) | |
| NADA 40-123 Toptic Ointment (cephalonium, flumethasone, iodochlorhydroxyquin, piperocaine hydrochloride, polymyxin B sulfate) | 524.321 (000986) | |
| NADA 47-092 Tribodine (ticarbodine) | 520.2460a (000986) | |
| NADA 47-353 Ferti-Cept (chorionic gonadotropin) | 522.1081(b) (000986) | |
| NADA 92-602 Cephalothin Discs (cephaloridine) | 529.360 (000986) | |
| NADA 96-678 Tribodine Capsules (ticarbodine) | 520.2460b (000986) | |
| Bioproducts, Inc., 320 Springside Dr., suite 300, Fairlawn, OH 44333-2435 | NADA 93-518 Tylan® 10 Plus (tylosin phosphate) | 558.625(b)(2) (051359) |
| Young's, Inc., Roaring Spring, PA 16673 | NADA 96-162 Hog Grow-R-Mix-4000, Hog Grow-R-Mix-800 (tylosin phosphate) | 558.625(b)(13) (035393) |
| Veterinary Laboratories, Inc., 12340 Santa Fe Dr., Lenexa, KS 66215 | NADA 42-889 Oxytocin Injection (oxytocin) | 522.1680(b) (000857) |
| Webel Feeds, Inc., Pittsfield, IL 62363 | NADA 116-196 Webel Tylan Premix (tylosin phosphate) | 558.625(b)(73) (035098) |
Following the withdrawal of approval of these NADAs, Young's, Inc., is no longer the sponsor of any approved applications. Therefore, 21 CFR 510.600(c) is amended to remove the entries for the sponsor.
Elanco Animal Health's NADA 30-330 Tylocine Sulfa Tablets is not codified in 21 CFR part 520. Therefore, an amendment to the regulations for this withdrawal is 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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
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, 524, 529, and 558 are amended as follows:
PART 510-NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as follows:
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
§ 510.600 [Amended]
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 for "Young's, Inc.", and in the table in paragraph (c)(2) by removing the entry "035393".
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 520.2460 [Removed]
4. Section 520.2460 Ticarbodine oral dosage forms is removed.
§ 520.2460a [Removed]
5. Section 520.2460a Ticarbodine tablets is removed.
§ 520.2460b [Removed]
6. Section 520.2460b Ticarbodine capsules is removed.
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
7. The authority citation for 21 CFR part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 522.1081 [Amended]
8. Section 522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin suspension is amended by removing and reserving paragraph (b).
§ 522.1183 [Amended]
9. Section 522.1183 Iron hydrogenated dextran injection is amended by removing and reserving paragraph (c).
§ 522.1680 [Amended]
10. Section 522.1680 Oxytocin injection is amended in paragraph (b) by removing "000857,".
§ 522.2640b [Removed]
11. Section 522.2640b Tylosin tartrate for injection is removed.
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
12. The authority citation for 21 CFR part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 524.321 [Removed]
13. Section 524.321 Cephalonium, polymyxin B sulfate, flumethasone, iodochlorhydroxyquin, piperocaine hydrochloride topical-otic ointment is removed.
§ 524.2640 [Removed]
14. Section 524.2640 Tylosin, neomycin eye powder is removed.
PART 529-CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
15. The authority citation for 21 CFR part 529 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 529.360 [Removed]
16. Section 529.360 Cephalothin discs is removed.
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
17. The authority citation for 21 CFR part 558 continues to read as follows:
Authority:
21 U.S.C. 360b, 371.
§ 558.625 [Amended]
18. Section 558.625 Tylosin is amended by removing and reserving paragraphs (b)(2), (b)(13), and (b)(73).
Dated: April 23, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-11070 Filed 5-2-01; 8:45 am]
BILLING CODE 4160-01-S