2013-16258. Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.

DATES:

This rule is effective July 15, 2013.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May 2013, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm.

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.

Table 1—Original and Supplemental NADAs and ANADAs Approved During May 2013

NADA/ANADA	Sponsor	New animal drug product name	Action	21 CFR section	FOIA summary	NEPA review
141-279	Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007	NICARB 25% (nicarbazin) and BMD (bacitracin methylene disalicylate) Type A medicated articles	Supplement revising nicarbazin dosage to a range consistent with dosage approved for use in combination feeds	558.366	No	CE 1
141-345	Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007	APOQUEL (oclacitinib tablet)	Original approval for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age	520.1604	Yes	CE 1
200-544	Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria	ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin) plus TYLOVET 100 (tylosin phosphate) plus MGA (melengestrol acetate) Type A medicated articles	Original aapproval as a generic copy of NADA 141-280)	528.665	Yes	CE 1
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.

List of Subjects

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 authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 558 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

2. Add § 520.1604 to read as follows:

§ 520.1604

Oclacitinib.

(a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.

(2) Indications for use. For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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.

4. In § 558.366, in paragraph (d), amend the table by:

a. Revising the entry for “90.8 to 181.6 (0.01 to 0.02 pct)”, and

b. Removing the entry for “Bacitracin methylene disalicylate 4 to 50” under the heading “113.5 (0.0125 pct)”; and

c. Removing the entry for “Bacitracin methylene disalicylate 50” under the heading “113.5 (0.0125 pct)”.

The additions and revisions read as follows:

§ 558.366

Nicarbazin.

* * * * *

(d) * * *

Nicarbazin in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
90.8 to 181.6 (0.01 to 0.02 pct)		Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis	Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton	066104
	Bacitracin methylene disalicylate 4 to 50	Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771
	Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to 45.4	Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Discontinue medication 5 days before marketing birds for human consumption. Do not feed to laying hens. Nicarbazin as provided by No. 066104; bacitracin methylene disalicylate and roxarsone as provided by No. 054771 in § 510.600(c) of this chapter	066104
	Bacitracin methylene disalicylate 30	Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter	066104
	Bacitracin methylene disalicylate 50	Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin	Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771
*         *         *         *         *         *         *

* * * * *

5. In § 558.665, in the table, in paragraphs (e)(2), (e)(4), and (e)(6), revise the last sentence in the “Limitations” column and revise the “Sponsor” column to read as follows:

§ 558.665

Zilpaterol.

* * * * *

(e) * * *

Zilpaterol in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(2)			* * * Melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter	000061 000986
*         *         *         *         *         *         *
(4)			* * * Monensin as provided by No. 000986; and melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter	000061 000986
*         *         *         *         *         *         *
(6)			* * * Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592; and melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter	000061 000986 016592

Dated: July 1, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.