Source: https://www.federalregister.gov/articles/2013/11/05/2013-26473/new-animal-drugs-afoxolaner-carprofen-ceftiofur-hydrochloride-monensin
Timestamp: 2015-07-03 17:23:09
Document Index: 343285541

Matched Legal Cases: ['§ 510', 'ART 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 510', '§ 520', '§ 520', 'ART 522', 'art 522', '§ 522', '§ 510', '§ 558']

Federal Register | New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin
Dates: This rule is effective November 5, 2013.
-66265 (3 pages)
Shorter URL: https://federalregister.gov/a/2013-26473 Related Topics
FREEDOM OF INFORMATION SUMMARY NADA 141-246 AQUAFLOR
Table 1—Original and Supplemental NADAs and ANADAs Approved During September 2013
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during September 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, Piedmont Animal Health, 204 Muirs Chapel Rd., suite 200, Greensboro, NC 27410 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-555 for LIBREVIA (carprofen) Soft Chewable Tablets to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. Accordingly, the Agency is amending the regulations to reflect this change of sponsorship.
Following this change of sponsorship, Piedmont Animal Health is no longer a sponsor of an approved NADA. Accordingly, FDA is amending 21 CFR 510.600 to remove the entries for this firm.
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 September 2013 Back to Top
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.
4 CE granted under 21 CFR 25.33(a)(3).
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640
NEXGARD (afoxolaner), Chewable Tablets
Original approval for the treatment and prevention of flea infestations, and the treatment and control of American dog tick infestations in dogs.
CE 1 2.
095-735
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285
RUMENSIN (monensin) Type A medicated article
Supplement extending the lower dose limit of monensin medicated feed for pasture cattle from 25 grams per ton (g/ton) to 15 g/ton.
CE 1 3.
141-288
EXCENEL RTU EZ (ceftiofur hydrochloride), Injectable Suspension
Supplemental approval of a reformulated product for use in cattle and swine, addition of an intramuscular route of injection in cattle, change in withdrawal period for cattle, and addition of a warning statement.
522.313b
CE 1 4.
2.In § 510.600, in the table in paragraph (c)(1), remove the entry for “Piedmont Animal Health”; and in the table in paragraph (c)(2), remove the entry for “058147”. PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Back to Top
§§ 520.44, 520.45, 520.45a, and 520.45b [Redesignated as §§ 520.28, 520.38, 520.38a, and 520.38b]
4.Redesignate §§ 520.44, 520.45, 520.45a, and 520.45b as §§ 520.28, 520.38, 520.38a, and 520.38b, respectively. 5.Add § 520.43 to read as follows: § 520.43 Afoxolaner.
(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.
(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)).
(2) Indications for use. For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month.
§ 520.309 [Amended]
6.In paragraph (b)(2) of § 520.309, remove “Nos. 000115, 055529, 058147, and 062250” and in its place add “Nos. 000115, 000859, 055529, and 062250”. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Back to Top
7.The authority citation for 21 CFR part 522 continues to read as follows: Authority:
8.In 522.313b, revise paragraphs (b), (d), (e)(2)(i), and (e)(2)(iii) to read as follows: § 522.313b Ceftiofur hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(i) Amount. Administer by subcutaneous or intramuscular injection as follows:
(iii) Limitations. Treated cattle must not be slaughtered for 4 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
10.In § 558.355, in the introductory text in paragraph (f)(3)(iii), remove “Monensin, 25 to 400 grams” and in its place add “Monensin, 15 to 400 grams”. end regulatory text
Bernadette Dunham ,
[FR Doc. 2013-26473 Filed 11-4-13; 8:45 am]