76 FR 62 pgs. 17776-17778 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine
Type: RULEVolume: 76Number: 62Pages: 17776 - 17778
Docket number: [Docket No. FDA-2011-N-0160]
FR document: [FR Doc. 2011-7560 Filed 3-30-11; 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, and 558
[Docket No. FDA-2011-N-0160]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendment.
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). In a notice published elsewhere in this issue of the Federal Register , FDA is withdrawing approval of these NADAs.
DATES:
This rule is effective April 11, 2011.
FOR FURTHER INFORMATION CONTACT:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The sponsors of the 13 approved NADAs listed in table 1 have requested that FDA withdraw approval because the products are no longer manufactured or marketed.
| Sponsor | NADA No. product (established name of drug) | 21 CFR section affected (sponsor's drug labeler code) |
|---|---|---|
| Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298 | NADA 093-029, UNITOP Cream (cuprimyxin) | 524.520 (063238). |
| Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318 | NADA 097-981, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine) | 558.630 (016968). |
| Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 | NADA 100-840, Chorionic Gonadotropin for Injection (chorionic gonadotropin) | 522.1081 (063323). |
| Furst-McNess Co., Freeport, IL 61032 | NADA 100-991, McNess Custom Premix L200 (tylosin phosphate) | 558.625 (010439). |
| Fort Dodge Animal Health, Division of Wyeth Holdings, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 | NADA 101-079 TRAMISOL-10% Pig Wormer (levamisole) | Not codified (000856). |
| Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 | NADA 101-905, Mill Co-Medicator TY-10 (tylosin phosphate) | 558.625 (017139). |
| Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 | NADA 101-906, Mill Co-Medicator TS-40 Premix (tylosin phosphate/sulfamethazine) | 558.630 (017139). |
| Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 | NADA 102-824,Phenylbutazone Tablets (phenylbutazone) | 520.1720a (055246). |
| Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 | NADA 108-487, DEC Tabs (diethylcarbamazine citrate) | 520.622a (015579). |
| Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 | NADA 108-863, DEC Chewable Tabs (diethylcarbamazine citrate) | 520.622c (015579). |
| Furst-McNess Co., Freeport, IL 61032 | NADA 140-820, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine) | 558.630 (010439). |
| Furst-McNess Co., Freeport, IL 61032 | NADA 140-825, BANMINTH Intermediate Premix (pyrantel tartrate) | 558.485 (010439). |
| Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511 | NADA 140-910, NFZ Wound Powder (nitrofurazone) | 524.1580c (050749). |
In a notice published elsewhere in this issue of the Federal Register , FDA gave notice that approval of NADAs 93-029, 97-981, 100-840, 100-991, 101-079, 101-905, 101-906, 102-824, 108-487, 108-863, 140-820, 140-825, and 140-910, and all supplements and amendments thereto, is withdrawn, effective April 11, 2011. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval and a current format.
Following these changes of sponsorship, Abraxis Pharmaceutical Products, Furst-McNess Co., Roche Vitamins, Inc., Waterloo Mills Co., and Wendt Laboratories, Inc., are no longer the sponsors of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms.
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, and 524
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, 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. In § 510.600, in the table in paragraph (c)(1), remove the entries for "Abraxis Pharmaceutical Products", "Furst-McNess Co.", "Roche Vitamins, Inc.", "Waterloo Mills Co.", and "Wendt Laboratories, Inc."; and in the table in paragraph (c)(2), remove the entries for "010439", "015579", "017139", "063238", and "063323".
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.
4. In § 520.622a, remove and reserve paragraph (a)(1); in paragraph (a)(5), remove "000081' and in its place add "No. 000061"; and revise paragraph (b)(2) to read as follows:
§ 520.622a Diethylcarbamazine citrate tablets.
(b) * * *
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
5. In § 520.622c, remove and reserve paragraph (b)(1); remove reserved paragraph (b)(7); and revise paragraph (c)(3) to read as follows:
§ 520.622c Diethylcarbamazine citrate chewable tablets.
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1720a [Amended]
6. In § 520.1720a, remove and reserve paragraph (b)(4).
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. In paragraph (b)(2) of § 522.1081, remove "Nos. 058639 and 063323" and in its place add "No. 058639".
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
9. The authority citation for 21 CFR part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 524.520 [Removed]
10. Remove § 524.520.
§ 524.1580c [Amended]
11. In paragraph (b) of § 524.1580c, remove "Nos. 000010, 000069, and 050749" and in its place add "Nos. 000010 and 000069".
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
12. The authority citation for 21 CFR part 558 continues to read as follows:
Authority:
21 U.S.C. 360b, 371.
§ 558.485 [Amended]
13. In § 558.485, in paragraph (b)(3), remove "010439".
§ 558.625 [Amended]
14. In § 558.625, remove and reserve paragraphs (b)(42) and (b)(45).
§ 558.630 [Amended]
15. In § 558.630, remove and reserve paragraph (b)(4); and in paragraph (b)(5), remove "010439," and "016968,".
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7560 Filed 3-30-11; 8:45 am]
BILLING CODE 4160-01-P