05-24104. Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications

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 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.

DATES:

This rule is effective December 27, 2005.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The following sponsors have requested that FDA withdraw approval of the 15 NADAs listed in table 1 of this document because the products are no longer manufactured or marketed:

Table 1.

Sponsor	NADA Number, Product (Drug)	21 CFR Section Affected (Sponsor Drug Labeler Code)
Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, OH 44333-2435	NADA 119-063, Pyrantel Tartrate Ton Pack (pyrantel tartrate)	558.485 (051359)
Farmland Industries, Inc., Kansas City, MO 64116	NADA 138-656, BN Wormer—19.2 BANMINTH Premix (pyrantel tartrate)	558.485 (021676)
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137	NADA 129-395, HYGROMIX 0.6 Premix (hygromycin B)	558.274 (050639)
	NADA 129-646, TYLAN 10 Sulfa-G (tylosin, sulfamethazine)	558.630 (050639)
	NADA 136-601, Swine Guard BN (pyrantel tartrate)	558.485 (050639)
J. & R. Specialty Supply Co., 310 Second Ave., SW., P.O. Box 506, Waseca, MN 56093	NADA 96-780, TYLAN 10; TYLAN 40 (tylosin)	n/a (049768)
Kerber Milling Co., Box 152, 1817 E. Main St., Emmetsburg, IA 50536	NADA 98-687, Hy-Test Hy-Boost TY 5 Medicated (tylosin)	558.625 (029341)
M & M Livestock Products Co., Eagle Grove, IA 50533	NADA 96-837, M & M Tylosin Premix (tylosin)	558.625 (026282)
Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850	NADA 129-161, Nutra-Blend TYLAN 10 Sulfa Premix (tylosin, sulfamethazine)	558.630 (050568)
	NADA 136-384, Swine Wormer-BN BANMINTH (pyrantel tartrate)	558.485 (050568)
South St. Paul Feeds, Inc., 500 Farwell Ave., South St. Paul, MN 55075	NADA 136-369, Custom Ban Wormer 9.6 (pyrantel tartrate)	558.485 (001800)
Stockton Hay & Grain Co.	NADA 49-462, Rainbrook Broiler Premix No. 1 (ampolium, arsanilic acid, ethopabate, penicillin G procaine, streptomycin)	n/a (036541)
	NADA 91-646, Rainbow Broiler Base Concentrate (ampolium, bacitracin zinc, ethopabate)	n/a (036541)
	NADA 91-647, Rainbow Broiler Base Concentrate (ampolium, chlortetracycline, ethopabate)	n/a (036541)
Triple “F”, Inc., 10104 Douglas Ave., Des Moines, IA 50322	NADA 131-146, FLAVOMYCIN 0.4 (bambermycins)	558.95 (011490)

Following the withdrawal of approval of these NADAs, Kerber Milling Co., M & M Livestock Products Co., Nutra-Blend Corp., and South St. Paul Feeds, Inc., are no longer sponsors of an approved application. Therefore, we are removing entries for these four sponsors from 21 CFR 510.600(c).

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 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 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 is amended in the table in paragraph (c)(1) by removing the entries for “Kerber Milling Co.”, “M & M Livestock Products Co.”, “Nutra-Blend Corp.”, and “South St. Paul Feeds, Inc.”; and in the table in paragraph (c)(2) by removing the entries for “001800”, “026282”, “029341”, and “050568”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.95

[Amended]

4. Section 558.95 is amended by removing and reserving paragraph (a)(3).

§ 558.274

[Amended]

5. Section 558.274 is amended in paragraph (a)(4) by removing “, 043733, and 050639” and by adding in its place “and 043733”; and in the table in paragraphs (c)(1)(i) and (c)(1)(ii) in the “Sponsor” column by removing “, 050639”.

§ 558.485

[Amended]

6. Section 558.485 is amended by removing and reserving paragraphs (b)(2) and (b)(4); and in paragraph (b)(3) by removing “, 049685, 050568, 050639, and 051359” and by adding in its place “and 049685”.

§ 558.625

[Amended]

7. Section 558.625 is amended by removing and reserving paragraphs (b)(22), (b)(31), (b)(52), and (b)(79).

§ 558.630

[Amended]

8. Section 558.630 is amended in paragraph (b)(10) by removing “, 050568, 050639”.

Dated: December 7, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.