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New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address

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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 December 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.

DATES:

This rule is effective February 27, 2014.

Start Further Info

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, george.haibel@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during December 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 Center for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm.

In addition, West Agro, Inc., 11100 North Congress Ave., Kansas City, MO 64153 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 055-028 for QUARTERMASTER (penicillin G procaine and dihydrostreptomycin sulfate) Dry Cow Treatment to HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652. Following this change of sponsorship, West Agro, Inc., is no longer a sponsor of an approved NADA, and HQ Specialty Pharma Corp. is now the sponsor of an approved NADA. Also, Putney, Inc., 400 Congress St., Suite 200, Portland, ME 04101 has informed FDA of a change of address to One Monument Sq., Suite 400, Portland, ME 04101. Accordingly, the Agency is amending the regulations to reflect this change of sponsorship and change of sponsor's address.

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

NADA/ANADASponsorNew animal drug product nameAction21 CFR SectionFOIA summaryNEPA review
141-419Huvepharma AD, 5th Floor, 3A Nikolay Haytov St., 1113 Sophia, BulgariaCOYDEN 25 (clopidol) plus FLAVOMYCIN (bambermycins) Type A medicated articlesOriginal approval as an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiency in broiler chickens558.95, 558.175YesCE.1 2
200-523Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, IrelandSULFAMED (sulfadimethoxine) 40% Injectable SolutionOriginal approval as a generic copy of NADA 041-245522.2220YesCE.1 3
200-564Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640Ivermectin Paste 1.87%Original approval as a generic copy of NADA 134-3144 N/AYesCE.1 3
141-200Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007EAZI-BREED CIDR (progesterone intravaginal insert) Cattle InsertSupplemental approval for induction of estrous cycles in anestrous lactating dairy cattle529.1940YesEA/FONSI.5
141-320Novartis Animal Health US, Inc., 3200 Northline Ave., Suite 300, Greensboro, NC 27408ONSIOR (robenacoxib) TabletsSupplemental approval lowering age at treatment from 6 months to 4 months520.2075YesCE.1 6
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200-341Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215SPARMECTIN-E (ivermectin) LiquidSupplemental approval adding pathogens off exclusivity to labeling520.1195YesCE.1 3
1 The Agency has determined under § 25.33 (21 CFR 25.33) that this action is categorically excluded (CE) from the requirement to submit an environmental assessment (EA) 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.
2 CE granted under § 25.33(a)(2).
3 CE granted under § 25.33(a)(1).
421 CFR 520.1192 already contains a drug labeler code entry for this sponsor.
5 The Agency has carefully considered an EA of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).
6 CE granted under § 25.33(d)(1).

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.

Start List of Subjects

List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Parts 520, 522, 526, and 529

  • Animal drugs

21 CFR Part 558

  • Animal drugs
  • Animal feeds
End List of Subjects

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, 526, 529, and 558 are amended as follows:

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 510 continues to read as follows:

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for “HQ Specialty Pharma Corp.”, revise the entry for “Putney, Inc.”, and remove the entry for “West Agro, Inc.”; and in the table in paragraph (c)(2), revise the entry for “026637”, remove the entry for “033392”, and numerically add an entry for “042791” to read as follows:

End Amendment Part
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652042791
*    *    *    *    *
Putney, Inc., One Monument Sq., Suite 400, Portland, ME 04101026637
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
026637Putney, Inc., One Monument Sq., Suite 400, Portland, ME 04101.
*    *    *    *    *
042791HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652.
*    *    *    *    *
Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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4. In § 520.1195, revise paragraphs (b)(1) and (b)(2) to read as follows:

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Ivermectin liquid.
* * * * *

(b) * * *

(1) Nos. 000859, 050604, 054925, and 058005 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.

(2) No. 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.

* * * * *
[Amended]
Start Amendment Part

5. In § 520.2075, in paragraph (c)(2), remove “at least 6 months of age” and in its place add “at least 4 months of age”.

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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6. The authority citation for 21 CFR part 522 continues to read as follows:

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

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7. In § 522.2220, revise paragraphs (a)(1), (a)(2), and (a)(3)(iii) to read as follows:

End Amendment Part
Sulfadimethoxine.

(a)(1) Specifications. Each milliliter of solution contains 400 milligrams (mg) sulfadimethoxine.

(2) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for conditions of use as in paragraph (a)(3) of this section:

(i) No. 054771 for use as in paragraph (a)(3) of this section.

(ii) Nos. 000859, 057561, and 061623 for conditions of use as in paragraph (a)(3)(iii) of this section.

(3) * * *

(iii) Cattle—(a) Amount. Administer an initial dose of 25 mg per pound of body weight by intravenous injection followed by 12.5 mg per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.

(b) Indications for use. For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine.Start Printed Page 10965

(c) Limitations. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

* * * * *
Start Part

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

8. The authority citation for 21 CFR part 526 continues to read as follows:

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

9. In paragraph (b) of § 526.1696c, remove “033392” and in its place add “042791”.

End Amendment Part Start Part

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

10. The authority citation for 21 CFR part 529 continues to read as follows:

End Amendment Part Start Authority

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

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11. In § 529.1940, in paragraphs (b) and (e)(1)(iii), remove “000009” and in its place add “054771”; in paragraph (c), remove “§ 556.540(a)” and in its place add “§ 556.540”; and add paragraph (e)(1)(ii)(D) to read as follows:

End Amendment Part
Progesterone intravaginal inserts.
* * * * *

(e) * * *

(1) * * *

(ii) * * *

(D) For induction of estrous cycles in anestrous lactating dairy cows.

* * * * *
Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

13. In paragraph (d)(5) of § 558.95, redesignate paragraphs (d)(5)(iii) through (d)(5)(x) as paragraphs (d)(5)(iv) through (d)(5)(xi); and add new paragraph (d)(5)(iii) to read as follows:

End Amendment Part
Bambermycins.
* * * * *

(d) * * *

(5) * * *

(iii) Clopidol as in § 558.175.

* * * * *
Start Amendment Part

14. In § 558.175:

End Amendment Part Start Amendment Part

a. Redesignate paragraph (d)(9) as paragraph (d)(11).

End Amendment Part Start Amendment Part

b. Redesignate paragraphs (d)(5) through (d)(8) as paragraphs (d)(6) through (d)(9).

End Amendment Part Start Amendment Part

c. Add new paragraphs (d)(5) and (d)(10).

End Amendment Part

The additions read as follows:

Clopidol.
* * * * *

(d) * * *

Clopidol in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(5) 113.5Bambermycins 1 to 2Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration. Do not feed to chickens over 16 weeks of age016592
*         *         *         *         *         *         *
(10) 227Bambermycins 1 to 2Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration until 5 days before slaughter. Withdraw 5 days before slaughter or feed 113.5 g/ton clopidol and 1 to 2 g/ton bambermycins during those 5 days before slaughter. Do not feed to chickens over 16 weeks of age016592
*         *         *         *         *         *         *
Start Signature

Dated: January 27, 2014.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2014-01959 Filed 2-26-14; 8:45 am]

BILLING CODE 4160-01-P