76 FR 41 pgs. 11330-11331 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin
Type: RULEVolume: 76Number: 41Pages: 11330 - 11331
Docket number: [Docket No. FDA-2011-N-0003]
FR document: [FR Doc. 2011-4546 Filed 3-1-11; 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, and 558
[Docket No. FDA-2011-N-0003]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin
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 eight 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 March 14, 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 have requested that FDA withdraw approval of the three NADAs listed in table 1 of this document because the products are no longer manufactured or marketed:
| Sponsor | NADA No. product (established name of drug) | 21 CFR section affected (sponsor drug labeler code) |
|---|---|---|
| First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 | NADA 48-647; Phenylbutazone Boluses (phenylbutazone) | § 520.1720a (058829). |
| Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247 | NADA 96-161; Hy-Con TYLAN Premix (tylosin phosphate) | § 558.625 (035369). |
| Triple "F", Inc., 10104 Douglas Ave., Des Moines, IA 50322 | NADA 119-062; Cadco-BN-10 BANMINTH Premix (pyrantel tartrate) | § 558.485 (011490). |
Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow) has informed FDA that it is the owner of five feed premix NADAs previously owned by milling companies which it has purchased. NADA 100-352 was owned by NutriBasics Co., last doing business at P.O. Box 1014, Wilmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco, Inc., also last doing business at P.O. Box 1014, Wilmar, MN 56201. NADA 133-833 and NADA 135-243 were owned by Southern Micro-Blenders, Inc., last doing business at 3801 N. Hawthorne St., Chattanooga, TN 37406. Truow has requested that FDA withdraw approval of the five NADAs in table 2 of this document because they are no longer manufactured or marketed:
| Previous sponsor | NADA No. product (established name of drug) | 21 CFR section affected (sponsor drug labeler code) |
|---|---|---|
| NutriBasics Co., P.O. Box 1014, Wilmar, MN 56201 | NADA 100-352; Seeco T-10 Premix (tylosin phosphate) | § 558.625 (053740). |
| Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 | NADA 107-002; Seeco TYLAN-Sulfa 10 Premix (tylosin phosphate and sulfamethazine) | Not codified. |
| Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 | NADA 123-000; Super Swine Wormer B-9 BANMINTH(pyrantel tartrate) | § 558.485 (011749). |
| Southern Micro-Blenders, Inc., 3801 N. Hawthorne St., Chattanooga, TN 37406 | NADA 133-833; TYLAN 10 Premix (tylosin phosphate) | § 558.625 (049685). |
| Southern Micro-Blenders, Inc., 3801 N. Hawthorne St., Chattanooga, TN 37406 | NADA 135-243; Swine Guard-BN BANMINTH Premix (pyrantel tartrate) | § 558.485 (049685). |
In a notice published elsewhere in this issue of the Federal Register , FDA gave notice that approval of NADA 48-647, 96-161, 100-352, 107-002, 119-062, 123-000, 133-833, and 135-243, and all supplements and amendments thereto, is withdrawn, effective March 14, 2011. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval.
Following these changes of sponsorship, Yoder Feed, Division of Yoder, Inc., Triple "F", Inc., NutriBasics Co., Seeco, Inc., and Southern Micro-Blenders, Inc., are no longer the sponsor 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 Part 520
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 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 "Triple "F", Inc." and "Yoder Feed, Division of Yoder, Inc."; and in the table in paragraph (c)(2), remove the entries for "011490", "011749", "035369", "049685", and "053740".
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 § 520.1720a, revise paragraph (b)(6) to read as follows:
§ 520.1720a Phenylbutazone tablets and boluses.
(b) * * *
(6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
5. The authority citation for 21 CFR part 558 continues to read as follows:
Authority:
21 U.S.C. 360b, 371.
6. In § 558.485, revise the section heading and paragraph (b)(3) to read as follows:
§ 558.485 Pyrantel.
(b) * * *
(3) Nos. 010439, 012286, 016968, and 017790: 9.6 and 19.2 grams per pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.
§ 558.625 [Amended]
7. In § 558.625, remove and reserve paragraphs (b)(8), (b)(38), and (b)(80).
Dated: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-4546 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P