New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
Federal Register, Volume 80 Issue 49 (Friday, March 13, 2015)
Federal Register Volume 80, Number 49 (Friday, March 13, 2015)
Rules and Regulations
Pages 13226-13232
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2015-05644
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
Docket No. FDA-2014-N-0002
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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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 November and December 2014. 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 eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.
DATES: This rule is effective March 13, 2015.
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.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 2014, 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. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
In addition, Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, has transferred ownership of, and all rights and interest in, the following approved applications to Pharmgate LLC, 161 North Franklin Turnpike, Suite 2C, Ramsey, NJ 07446:
------------------------------------------------------------------------
File No. Product name 21 CFR Cite
------------------------------------------------------------------------
065-480............ Chlortetracycline Soluble Powder 520.441.
138-934............ PENNCHLOR SP (chlortetracycline, 558.145.
sulfamethazine, penicillin)
Type A medicated articles.
138-935............ PENNCHLOR (chlortetracycline) 558.128.
Type A medicated articles.
138-938............ PENNOX (oxytetracycline) Type A 558.450.
medicated articles.
138-939............ NEO-OXY (neomycin sulfate and 558.455.
oxytetracycline) Type A
medicated articles.
140-680............ TYLAN (tylosin phosphate) Type A 558.625.
medicated articles.
140-681............ TYLAN Sulfa-G (tylosin phosphate 558.630.
and sulfamethazine) Type A
medicated articles.
141-137............ PENITRACIN (bacitracin Not codified.
methylenedisalicylate) 50 Type
A medicated article.
200-026............ PENNOX 343 (oxytetracycline).... 520.1660d.
200-154............ PENNOX 200 (oxytetracycline).... 558.450.
200-295............ PENNCHLOR 64 (chlortetracycline) 558.128.
200-314............ PENNCHLOR S (chlortetracycline). 558.140.
200-354............ PENNCHLOR (chlortetracycline)/ 558.355.
COBAN (monensin).
200-356............ PENNCHLOR (chlortetracycline)/ 558.600.
DENAGARD (tiamulin).
Page 13227
200-357............ PENNCHLOR (chlortetracycline)/ 558.550.
BIO-COX (salinomycin).
200-358............ PENNCHLOR (chlortetracycline)/ 558.76.
BMD (bacitracin MD).
200-359............ PENNCHLOR (chlortetracycline)/ 558.195.
DECCOX (decoquinate).
------------------------------------------------------------------------
At this time, the regulations are being amended to reflect these changes of sponsorship. Following these changes of sponsorship, Pharmgate LLC will now be the sponsor of an approved application while Pennfield Oil Co. will no longer be the sponsor of an approved application. Also, Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has informed FDA that it has changed its name to Hikma International Pharmaceuticals LLC. Accordingly, Sec. 510.600 (21 CFR 510.600) is being amended to reflect these changes. In addition, FDA is amending Sec. 510.600 and several sections of part 520 to reflect a correct drug labeler code for Akorn Animal Health, Inc. FDA is also amending the regulations in 21 CFR parts 520, 522, 556, and 558 to redesignate several sections to reflect alphabetical order and to make minor technical amendments. These corrections and technical amendments are being made to improve the accuracy of the animal drug regulations.
Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2014
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New animal drug product 21 CFR FOIA NEPA
NADA/ ANADA Sponsor name Action Sections Summary Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-575................ Putney, Inc., One Monument Carprofen Chewable Original approval as a generic 520.309 yes CE \1\ \2\
Sq., suite 400, Portland, Tablets. copy of NADA 141-111.
ME 04101.
141-232................ Zoetis Inc., 333 Portage SIMPLICEF (cefpodoxime Supplemental approval of chewable 520.370 yes CE \1\ \3\
St., Kalamazoo, MI 49007. proxetil) Chewable tablet dosage form for dogs.
Tablets.
200-512................ Zoetis Inc., 333 Portage TRIAMULOX (tiamulin Original approval as a generic 520.2455 yes CE \1\ \2\
St., Kalamazoo, MI 49007. hydrogen fumarate) copy of NADA 140-916.
Liquid Concentrate.
200-573................ Putney, Inc., One Monument Dexmedetomidine HCl...... Original approval as a generic 522.558 yes CE \1\ \2\
Sq., suite 400, Portland, (dexmedetomidine copy of NADA 141-267.
ME 04101. hydrochloride).
Injectable Solution......
141-068................ Bayer HealthCare LLC, BAYTRIL 100 Supplemental approval adding 522.812 yes CE\1\ \4\
Animal Health Division, (enrofloxacin). administration by intramuscular
P.O. Box 390, Shawnee Injectable Solution...... injection in swine and an
Mission, KS 66201. indication for control of
colibacillosis in groups or pens
of weaned pigs.
141-349................ Zoetis Inc., 333 Portage DRAXXIN 25............... Supplemental approval for 522.2630 yes CE \1\ \4\
St., Kalamazoo, MI 49007. (tulathromycin).......... treatment of bovine respiratory
Injectable Solution...... disease (BRD) in suckling
calves, dairy calves, and veal
calves.
141-437................ Novartis Animal Health US, OSURNIA.................. Original approval for the 524.955 yes CE \1\ \3\
Inc., 3200 Northline (florfenicol, treatment of otitis externa in
Ave., suite 300, terbinafine, dogs.
Greensboro, NC 27408. betamethasone acetate)
Otic Gel.
034-267................ Intervet, Inc., 556 Morris GENTOCIN DURAFILM........ Supplemental approval of 524.1044i yes CE \1\ \3\
Ave., Summit, NJ 07901. (gentamicin sulfate and additional safety information.
betamethasone).
Ophthalmic Solution......
141-034................ Huvepharma AD, 5th Floor, GAINPRO.................. Supplemental approval of a free- 558.95 yes CE \1\ \2\
3A Nikolay Haytov Str., (bambermycins)........... choice Type C medicated loose
1113 Sophia, Bulgaria. Type A medicated article. mineral feed without selenium
for pasture cattle.
200-510 \5\............ Pharmgate LLC, 161 North DERACIN.................. Original approval as a generic 558.128 yes CE \1\ \2\
Franklin Turnpike, suite (chlortetracycline)...... copy of NADA 048-761.
2C, Ramsey, NJ 07446. Type A medicated articles
141-258................ Intervet, Inc., 556 Morris ZILMAX (zilpaterol Supplemental approval to provide 558.665 yes CE \1\ \2\
Ave., Summit, NJ 07901. hydrochloride) Type A for component feeding of Type C
medicated article. medicated feeds.
Page 13228
141-276 \5\............ Intervet, Inc., 556 Morris ZILMAX (zilpaterol Supplemental approval to provide 558.665 yes CE \1\ \6\
Ave., Summit, NJ 07901. hydrochloride) plus for component feeding of
RUMENSIN (monensin) plus combination drug Type C
TYLAN (tylosin medicated feeds.
phosphate) Type C
medicated feeds.
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\1\ The Agency has determined 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 have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).
\5\ This application is affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on
Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI
\6\ CE granted under 21 CFR 25.33(a)(2).
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
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, 520, 522, 524, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
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.
0
2. Amend Sec. 510.600 as follows:
0
-
In the table in paragraph (c)(1), in the entry for ``Akorn Animal Health, Inc.'', in the ''Drug labeler code'' column, remove ``053599'', and in its place add ``059399'';
0
-
In the table in paragraph (c)(1), in the entry for ``Hikma Pharmaceuticals LLC'', in the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma International Pharmaceuticals LLC'';
0
-
In the table in paragraph (c)(1), remove the entry for ``Pennfield Oil Co.'' and add an entry, in alphabetical order, for ``Pharmgate LLC'';
0
-
In the table in paragraph (c)(2), remove the entries for ``000008'', ``048164'', and ``053599'' and add entries, in numerical order, for ``059399'' and ``069254''; and
0
-
In the table in paragraph (c)(2), in the entry for ``059115'', in the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma International Pharmaceuticals LLC''.
The additions and revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, 069254
Ramsey, NJ 07446.......................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
059399...................... Akorn Animal Health, Inc., 1925 West Field
Ct., suite 300, Lake Forest, IL 60045
* * * * * * *
069254...................... Pharmgate LLC, 161 North Franklin
Turnpike, suite 2C, Ramsey, NJ 07446
Page 13229
* * * * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. Sec. 520.310 and 520.312 Redesignated as Sec. Sec. 520.301 and 520.302
0
4. Redesignate Sec. Sec. 520.310 and 520.312 as Sec. Sec. 520.301 and 520.302, respectively.
Sec. 520.309 Redesignated as Sec. 520.304 and Amended
0
5. Redesignate Sec. 520.309 as Sec. 520.304 and revise newly redesignated Sec. 520.304 by adding paragraph (b)(3) to read as follows:
Sec. 520.304 Carprofen.
* * * * *
(b) * * *
(3) No. 026637 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section.
* * * * *
0
6. In Sec. 520.370, revise paragraphs (a) and (b) and in paragraph (c)(2), remove ``intermedius'' and in its place add ``pseudintermedius'' to read as follows:
Sec. 520.370 Cefpodoxime tablets.
(a) Specifications. (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.
(2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for uses as follows:
(1) No. 026637 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section.
(2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section.
* * * * *
Sec. 520.441 Amended
0
7. In Sec. 520.441, in paragraph (b)(1), remove ``048164'' and in its place add ``069254''.
0
8. Amend Sec. 520.1660d as follows:
0
-
In paragraph (b)(6), remove ``048164'' and in its place add ``069254''.
0
-
In paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3), revise the last sentence.
The revisions read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(3) * * * Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254.
(B) * * *
(3) * * * Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254.
(C) * * *
(3) * * * Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254.
* * * * *
0
9. In Sec. 520.2455, revise paragraphs (b)(3) and (c) to read as follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(3) No. 054771 for the product described in paragraph (a)(3) of this section.
(c) Related tolerances. See Sec. 556.732 of this chapter.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.246 Amended
0
11. In Sec. 522.246, in paragraph (b)(3), remove ``053599'' and in its place add ``059399''.
0
12. In Sec. 522.558, revise paragraphs (a) and (b) to read as follows:
Sec. 522.558 Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains:
(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or
(2) 0.5 mg dexmedetomidine hydrochloride.
(b) Sponsors. See sponsors in in Sec. 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) No. 026637 for use of product described in paragraph (a)(2) of this section;
(2) No. 052483 for use of products described in paragraph (a) of this section.
* * * * *
0
13. Amend Sec. 522.812 as follows:
0
-
Revise paragraph (b)(2);
0
-
Remove paragraph (e)(3)(i);
0
-
Redesignate paragraphs (e)(3)(ii) and (e)(3)(iii) as paragraphs (e)(3)(i) and (e)(3)(ii), respectively; and
0
-
Revise newly redesignated paragraph (e)(3)(i).
The revisions read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(2) No. 055529 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section, and use of product described in paragraph (a)(2) of this section as in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii) of this section.
* * * * *
(e) * * *
(3) * * *
(i) Amounts and indications for use. (A) Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae.
(B) Administer, by subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
(C) Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.
* * * * *
0
14. In Sec. 522.1222, revise paragraph (b) to read as follows:
Sec. 522.1222 Ketamine.
* * * * *
Page 13230
(b) Sponsors. See Nos. 000859, 026637, 054628, 054771, 059399, and 063286 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 522.2474 Amended
0
15. In Sec. 522.2474, in paragraph (b), remove ``053599'' and in its place add ``059399''.
0
16. In Sec. 522.2630, revise paragraphs (b)(1), (b)(2), (d)(1)(ii)(A), (d)(1)(ii)(B), and (d)(1)(iii) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(1) Product described as in paragraph (a)(1) of this section for use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section.
(2) Product described as in paragraph (a)(2) of this section for use as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) Beef and non-lactating dairy cattle. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
(B) Suckling calves, dairy calves, and veal calves. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
(iii) Limitations. (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) Calves intended for human consumption must not be slaughtered within 22 days from the last treatment. Not for use in ruminating cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
* * * * *
Sec. 522.2662 Amended
0
17. In Sec. 522.2662, in paragraph (b)(4), remove ``053599'' and in its place add ``059399''.
Sec. 522.2670 Amended
0
18. In Sec. 522.2670, in paragraph (b)(1), remove ``053599'' and in its place add ``059399''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
20. Add Sec. 524.955 to read as follows:
Sec. 524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel.
(a) Specifications. Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
0
21. In Sec. 524.1044i, revise paragraph (c)(2) to read as follows:
Sec. 524.1044i Gentamicin and betamethasone ophthalmic solution.
* * * * *
(c) * * *
(2) Indications for use. For treatment of external eye infections and inflammation.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
22. The authority citation for 21 CFR part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.738 Redesignated as Sec. 556.732
0
23. Redesignate Sec. 556.738 as Sec. 556.732.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
24. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.76 Amended
0
25. In Sec. 558.76, in paragraph (d)(1)(iv), in the ``Limitations'' and ``Sponsor'' columns, remove ``048164'' and in its place add ``069254''.
0
26. In Sec. 558.95, add paragraph (d)(4)(v) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(4) * * *
(v) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) as follows:
(A) Specifications.
------------------------------------------------------------------------
International
Ingredient feed No. Percent
------------------------------------------------------------------------
Deflorinated phosphate (20.5% 6-01-080 42.50
calcium, 18.5% phosphorus).........
Sodium chloride (salt).............. 6-04-152 20.10
Calcium carbonate (38% calcium)..... 6-01-069 15.45
Corn distillers dried grains w/ 5-28-236 9.57
solubles...........................
Magnesium oxide..................... 6-02-756 5.15
Vitamin and trace mineral premix *.. ................ 3.72
Mineral oil......................... ................ 1.00
Yeast (primary dehydrated yeast).... 7-05-533 0.75
Bambermycins Type A article (10 g/ ................ 0.60
lb)................................
Iron oxide.......................... 6-02-431 0.50
Magnesium sulfate (67%)............. 6-02-758 0.32
Copper sulfate...................... 6-01-720 0.18
Page 13231
Potassium sulfate (0.33%)........... 6-06-098 0.16
------------------------------------------------------------------------
* Content of vitamin/trace mineral premix may be varied. However, they
should be comparable to those used for other free-choice feeds.
Formulation modifications require FDA approval prior to marketing.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
Policy Guides Sec. 651.100 (CPG 7125.18).
(B) Amount per ton. 120 grams.
(C) Indications for use. For increased rate of weight gain.
(D) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers). Feed a non-medicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.
* * * * *
0
27. Amend Sec. 558.128 as follows:
0
-
In paragraph (b)(1), remove ``Nos. 054771, 048164, and 066104'' and in its place add ``Nos. 054771, 066104, and 069254'';
0
-
In paragraphs (e)(4)(ii) and (iv), in the ``Limitations'' column, remove ``048164'' wherever it occurs and in its place add ``069254'';
0
-
In paragraphs (e)(1)(i), (ii), and (iii), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i), (ii), (iii), and (iv), (e)(4)(i), (ii), (iv), (vii), and (viii), and (e)(5)(i) and (ii), in the ``Sponsor'' column, remove ``048164'' wherever it occurs and in its place in numerical order add ``069254''; and
0
-
Revise paragraphs (e)(1)(iv), (e)(4)(v), and (e)(4)(ix).
The revisions read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 500 g/ton......................... Chickens: For the 1. Feed for 5 d. To sponsor 054771,
reduction of mortality No. 054771 under NADA 048-761 069254.
due to E. coli infections and No. 069254 under ANADA
susceptible to 200-510: zero withdrawal time.
chlortetracycline.
2. Feed for 5 d; withdraw 24 h 012286,
prior to slaughter; do not 054771,
feed to chickens producing 066104,
eggs for human consumption. 069254.
----------------------------------------------------------------------------------------------------------------
* * * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) 500 to 4,000 g/ton................. Calves, beef and Feed continuously for not more 054771
nonlactating dairy than 5 days to provide 10 mg/ 069254
cattle; treatment of lb body weight per day. To
bacterial enteritis sponsor No. 054771 under NADA
caused by E. coli and 046-699: 24-h withdrawal time.
bacterial pneumonia To sponsor No. 054771 under
caused by P. multocida NADA 048-761 and No. 069254
susceptible to under ANADA 200-510: Zero
chlortetracycline. withdrawal time.
* * * * * * *
(ix) 350 mg/head/day................... 1. Beef cattle: For Withdraw 48 h prior to 012286,
control of bacterial slaughter. To sponsor No. 054771,
pneumonia associated with 054771 under NADA 046-699: 48- 066104,
shipping fever complex h withdrawal time. To sponsor 069254.
caused by Pasteurella No. 054771 under NADA 048-761
spp. susceptible to and No. 069254 under ANADA
chlortetracycline. 200-510: Zero withdrawal time.
2. Beef cattle (under 700 Withdraw 48 h prior to 012286,
lb): For control of slaughter. To sponsor No. 054771,
active infection of 054771 under NADA 046-699: 48- 066104,
anaplasmosis caused by A. h withdrawal time. To sponsor 069254.
marginale susceptible to No. 054771 under NADA 048-761
chlortetracycline. and No. 069254 under ANADA
200-510: zero withdrawal time.
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.140 Amended
0
28. In Sec. 558.140, in paragraph (b)(1), remove ``048164'' and in its place add ``069254''.
Sec. 558.145 Amended
0
29. In Sec. 558.145, in paragraph (a)(2), remove ``048164'' and in its place add ``069254''.
Sec. 558.195 Amended
0
30. In Sec. 558.195, in paragraph (e)(2)(iv), in the ``Limitations'' and ``Sponsor'' columns, remove ``048164'' and in its place add ``069254''.
Sec. 558.355 Amended
0
31. In Sec. 558.355, in paragraph (f)(1)(xiv)(b), remove ``048164'' and in its place add ``069254''.
Page 13232
Sec. 558.450 Amended
0
32. Amend Sec. 558.450 as follows:
0
-
In paragraph (a)(2), remove ``048164'' and in its place add ``069254'';
0
-
In paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(4)(ii), in the ``Limitations'' column, remove ``048164'' wherever it occurs and in its place add ``069254''; and
0
-
In paragraphs (d)(1)(i), (ii), (iii), and (iv), (d)(2)(i), (ii), (iii), and (iv), (d)(3)(i) and (ii), (d)(4)(i), (ii), (iii), (iv), and (v), and (d)(5)(i), (ii), and (iii), in the ``Sponsor'' column, remove ``048164'' and in its place add ``069254''.
Sec. 558.455 Amended
0
33. Amend Sec. 558.455 as follows:
0
-
In paragraph (b), remove ``Nos. 048164 and 066104'' and in its place add ``Nos. 066104 and 069254''; and
0
-
In paragraphs (e)(1)(i), (ii), (iii), and (iv), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i) and (ii), and (e)(4)(i), (ii), (iii), (iv), (v), and (vi), in the ``Sponsor'' column, remove ``048164'' and in its place in numerical order add ``069254''.
Sec. 558.550 Amended
0
34. In Sec. 558.550, in paragraphs (b)(3) and (d)(1)(xvi)(c), remove ``048164'' and in its place add ``069254''.
Sec. 558.600 Redesignated as Sec. 558.612 and Amended
0
35. Redesignate Sec. 558.600 as Sec. 558.612 and amend newly redesignated Sec. 558.612 as follows:
0
-
In paragraph (c), remove ``Sec. 556.738'' and in its place add ``Sec. 556.732''; and
0
-
In paragraph (e)(1)(iii), in the ``Limitations'' and ``Sponsor'' columns, remove ``048164'' and in its place in numerical order add ``069254''.
Sec. 558.615 Redesignated as Sec. 558.600
0
36. Redesignate Sec. 558.615 as Sec. 558.600.
Sec. 558.625 Amended
0
37. In Sec. 558.625, in paragraph (b)(5), remove ``048164'' and in its place add ``069254''.
Sec. 558.630 Amended
0
38. In Sec. 558.630, in paragraph (b)(2), remove ``No. 054771'' and in its place add ``Nos. 054771 and 069254''.
0
39. Amend Sec. 558.665 as follows:
0
-
Revise paragraphs (d)(1) and (e)(1);
0
-
Redesignate paragraph (d)(2) as paragraph (d)(4); and
0
-
Add paragraphs (d)(2), (d)(3), (e)(7), and (e)(8).
The revisions and additions read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(d) * * *
(1) Labeling shall bear the following caution statements: ``Zilpaterol hydrochloride is not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves.''
(2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statements in paragraph (d)(3) of this section.
(3) Labeling of complete Type C medicated feeds shall bear the following caution statements: ``Not to be fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.''
* * * * *
(e) * * *
----------------------------------------------------------------------------------------------------------------
Combination grams/
Zilpaterol in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8......................... ................... Cattle fed in Feed continuously 000061
confinement for as the sole ration
slaughter: For during the last 20
increased rate of to 40 days on feed
weight gain, improved to provide 60 to
feed efficiency, and 90 mg/head/day.
increased carcass Withdrawal period:
leanness in cattle fed 3 days.
in confinement for
slaughter during the
last 20 to 40 days on
feed.
* * * * * * *
(7) 6.8 to 24................... ................... Cattle fed in Feed continuously 000061
confinement for to cattle during
slaughter: For the last 20 to 40
increased rate of days on feed to
weight gain, improved provide 60 mg
feed efficiency, and zilpaterol
increased carcass hydrochloride per
leanness in cattle fed head per day.
in confinement for Withdrawal period:
slaughter during the 3 days.
last 20 to 40 days on
feed.
(8) 6.8 to 24................... Monensin 10 to 40, Cattle fed in Feed continuously 000061
plus tylosin 8 to confinement for to cattle during
10. slaughter: For the last 20 to 40
increased rate of days on feed to
weight gain, improved provide 60 mg
feed efficiency, and zilpaterol
increased carcass hydrochloride per
leanness in cattle fed head per day. See
in confinement for paragraphs Sec.
slaughter during the Sec. 558.355(d)
last 20 to 40 days on and 558.625(c).
feed; for prevention Monensin and
and control of tylosin as
coccidiosis due to provided by No.
Eimeria bovis and E. 000986 in Sec.
zuernii; and for 510.600(c) of this
reduction of incidence chapter.
of liver abscesses Withdrawal period:
caused by 3 days.
Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------
Dated: March 9, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2015-05644 Filed 3-12-15; 8:45 am
BILLING CODE 4164-01-P
