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New Animal Drugs; Change of Sponsor

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 110 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for new animal drug for use in animal feed from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc.

DATES:

This rule is effective March 11, 2014.

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FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855; 240-276-8300, steven.vaughn@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Pfizer, Inc., 235 E. 42d St., New York, NY 10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have informed FDA that they have transferred ownership of, and all rights and interest in, the 110 approved NADAs and 14 approved ANADAs in Table 1 to Zoetis, Inc., 333 Portage St., Kalamazoo, MI 4900.

Table 1—NADAs and ANADAs Transferred From Pfizer, Inc., to Zoetis, Inc.

File No.Product name
007-616HISTOSTAT 50 (nitarsone) Type A Medicated Article.
011-116ZOAMIX (zoalene) Type A Medicated Article.
012-375ALBAMIX (novobiocin) Type A Medicated Article.
012-680PHARMASTATIN 20 (nystatin) Type A Medicated Article.
013-747Zoalene 90 Medicated Coccidiostat.
033-950Sulfamerazine In Fish Grade.
034-085LINCOMIX (lincomycin) Type A Medicated Article.
034-254MGA (melengestrol acetate) Type A Medicated Article.
035-688AUREOMIX Granular 500 (pen G, CTC, sulfamethazine) Type A Medicated Article.
035-805AUREO S 700 Granular (CTC and sulfamethazine) Type A Medicated Article.
036-361Amprolium and ethopabate/CTC (chlortetracycline)/sodium sulfate.
039-077CSP (chlortetracycline, sulfathiazole, and penicillin G procaine) 250 and 500 Type A Medicated Articles.
039-402MGA 500 (melengestrol acetate) Liquid Type A Medicated Article.
039-417DECCOX (decoquinate) Type A Medicated Article.
040-209ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Medicated Article.
041-647AUREOMIX S 700-A (CTC and sulfamethazine) Type A Medicated Article.
041-648AUREOMIX S 700-D (CTC and sulfamethazine) Type A Medicated Article.
041-649AUREOMIX S 700-G (CTC and sulfamethazine) Type A Medicated Article.
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041-650AUREOMIX S 700-E (CTC and sulfamethazine) Type A Medicated Article.
041-651AUREOMIX S 700-F (CTC and sulfamethazine) Type A Medicated Article.
041-652AUREOMIX S 700-C-2 (CTC and sulfamethazine) Type A Medicated Article.
041-653AUREOMIX S 700-B (CTC and sulfamethazine) Type A Medicated Article.
041-654AUREOMIX S 700-H (CTC and sulfamethazine) Type A Medicated Article.
044-820AMPROL PLUS (amprolium and ethopabate)/LINCOMIX (lincomycin).
044-972LINCOMIX (lincomycin)/COYDEN (clopidol).
045-348ALBAC (bacitracin zinc)/DECCOX (decoquinate).
045-444CHLORMAX (chlortetracycline)/DECCOX (decoquinate).
046-415Tylosin Type A Medicated Articles.
046-592BMD (bacitracin methylene disalicylate) Type A Medicated Articles.
046-666Penicillin G Procaine Type A Medicated Articles.
046-699CHLORMAX (chlortetracycline) Type A Medicated Articles.
046-718MGA (liquid) (melengestrol acetate)/TERRAMYCIN (oxytetracycline).
046-719MGA (dry) (melengestrol acetate)/TERRAMYCIN (oxytetracycline).
046-920BACIFERM (bacitracin zinc) Type A Medicated Articles.
047-261DECCOX (decoquinate)/LINCOMIX (lincomycin).
047-262DECCOX (decoquinate)/LINCOMIX (lincomycin).
048-486ROBENZ (robenidine) Type A Medicated Article.
048-761AUREOMYCIN (chlortetracycline) Type A Medicated Article.
048-762Chlortetracycline Type A Medicated Article.
048-763Chlortetracycline Type A Medicated Article.
048-954ZOAMIX (zoalene)/LINCOMIX (lincomycin).
049-287PFICHLOR (chlortetracycline) Type A Medicated Article.
055-040SF Mix 66 (chlortetracycline) Type A Medicated Article.
065-020Micro CTC (chlortetracycline) 100 Type A Medicated Article.
091-668CHLORMAX SP (chlortetracycline) 250 and 500 Type A Medicated Articles.
091-749TYLAN 40 Plus Sulfa-G.
092-482COBAN (monensin)/LINCOMIX (lincomycin).
092-507ROBENZ/Aureomycin 500 Gm.
092-522COBAN (monensin)/LINCOMIX (lincomycin).
093-106ROBENZ (robenidine)/LINCOMIX (lincomycin).
096-298AVATEC and BOVATEC (lasalocid) Type A Medicated Articles.
096-933ROBENZ (robenidine)/Bacitracin Zn.
097-085Bacitracin MD/ROBENZ (robenidine).
097-505LINCOMIX (lincomycin) Type A Medicated Articles.
098-452ALBAC 50 (bacitracin zinc) Type A Medicated Article.
100-901PFICHLOR (chlortetracycline) 100S Milk Replacer Type A Medicated Article.
101-689AVATEC (lasalocid)/LINCOMIX (lincomycin).
103-758TERRAMYCIN (oxytetracycline) Type A Medicated Article.
107-347CHEQUE (mibolerone) Medicated Dog Food.
107-996AVATEC (lasalocid)/FORTRACIN (lasalocid).
114-794AMPROL HI-E (amprolium and ethopabate)/BACIFERM (bacitracin zinc).
121-553AUREOMYCIN (chlortetracycline)/COBAN (monensin).
124-309MGA 100 and 200 (melengestrol acetate)/RUMENSIN (monensin).
125-476MGA 500 (melengestrol acetate)/RUMENSIN (monensin).
128-686BIO-COX (salinomycin) Type A Medicated Article.
133-334Virginiamycin Type A Medicated Article.
134-284BIO-COX (salinomycin)/FLAVOMYCIN (bambermycins).
134-830ALBAC (bacitracin zinc)/COBAN (monensin).
135-746BIO-COX (salinomycin)/BMD (bacitracin methylene disalicylate).
137-537BIO-COX (salinomycin)/LINCOMIX (lincomycin).
138-456COBAN (monensin)/BMD (bacitracin methylene disalicylate).
138-792MGA 100 and 200 (melengestrol)/RUMENSIN (monensin)/TYLAN (tylosin).
138-870MGA 500 (melengestrol acetate)/BOVATEC (lasalocid)/TYLAN (tylosin).
138-904MGA (melengestrol acetate)/BOVATEC (lasalocid)/TYLAN (tylosin).
138-941LINCOMIX (lincomycin)/BANMINTH (pyrantel).
138-992MGA 200 (melengestrol acetate)/BOVATEC (lasalocid)/TYLAN (tylosin).
138-995MGA (melengestrol acetate)/TYLAN (tylosin).
139-075CYGRO (maduramicin) Type A Medicated Article.
139-192MGA 500 (melengestrol acetate)/TYLAN (tylosin).
139-235BACIFERM (bacitracin zinc)/BIO-COX (salinomycin).
139-876MGA 200 (melengestrol acetate)/BOVATEC (lasalocid).
140-288MGA 500 (melengestrol acetate)/BOVATEC (lasalocid).
140-443HYGROMIX 1.6 (hygromycin B) Premix.
140-579BOVATEC (lasalocid)/TERRAMYCIN (oxytetracycline).
140-853BMD (bacitracin methylene disalicylate)/MONTEBAN (naracin).
140-859AUREOMYCIN (chlortetracycline)/BIO-COX (salinomycin).
140-865BACIFERM or ALBAC (bacitracin zinc)/MONTEBAN (naracin).
141-025CATTLYST (laidlomycin) Type A Medicated Article.
141-059BMD (bacitracin methylene disalicylate)/CTC (chlortetracycline).
141-083AVATEC (lasalocid)/BACIFERM (bacitracin zinc).
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141-085BMD (bacitracin methylene disalicylate)/ZOAMIX (zoalene).
141-088HISTOSTAT (nitarsone)/BMD (bacitracin methylene disalicylate).
141-102BMD (bacitracin methylene disalicylate)/DECCOX (decoquinate).
141-109AVATEC (lasalocid)/BACIFERM (bacitracin zinc).
141-124BMD (bacitracin methylene disalicylate)/MAXIBAN (naracin and nicarbazin).
141-132HISTOSTAT (nitarsone)/ALBAC (bacitracin zinc).
141-136BMD (bacitracin methylene disalicylate)/BIO-COX (salinomycin).
141-140BMD (bacitracin methylene disalicylate)/COBAN (monensin).
141-144BMD (bacitracin methylene disalicylate)/SAFE-GUARD (fenbendazole).
141-147DECCOX (decoquinate)/CHLORMAX (chlortetracycline).
141-148DECCOX (decoquinate)/RUMENSIN (monensin).
141-149DECCOX (decoquinate)/RUMENSIN (monensin)/TYLAN (tylosin).
141-150AVATEC (lasalocid)/STAFAC (virginiamycin).
141-154BMD (bacitracin methylene disalicylate)/ROBENZ (robenidine).
141-156BMD (bacitracin methylene disalicylate)/AMPROL (amprolium).
141-179BMD (bacitracin methylene disalicylate)/AVATEC (lasalocid).
141-181ALBAC (bacitracin zinc)/AVATEC (lasalocid).
141-185DECCOX (decoquinate)/AUREOMYCIN (chlortetracycline).
141-201CATTLYST (laidlomycin)/AUREOMYCIN (chlortetracycline).
141-250BOVATEC (lasalocid)/AUREOMYCIN (chlortetracycline).
200-140AUREOZOL (pen G, CTC, sulfathiazole) Type A Medicated Article.
200-167AUREOZOL 500 Granular (pen G, CTC, sulfathiazole) Type A Medicated Article.
200-204ALBAC (bacitracin zinc)/BIO-COX (salinomycin).
200-205ALBAC (bacitracin zinc)/AMPROL HI-E (amprolium and ethopabate).
200-210ALBAC (bacitracin zinc)/SACOX (salinomycin).
200-212ALBAC (bacitracin zinc)/ROBENZ.
200-213ALBAC (bacitracin zinc)/DECCOX (decoquinate).
200-218ALBAC (bacitracin zinc)/COYDEN 25 (clopidol).
200-223ALBAC 50 (bacitracin zinc) Type A Medicated Article.
200-242BMD (bacitracin methylene disalicylate)/AUREOMYCIN (chlortetracycline).
200-261CHLORMAX (chlortetracycline)/BIO-COX (salinomycin).
200-262CHLORMAX (chlortetracycline)/SACOX (salinomycin).
200-263CHLORMAX (chlortetracycline)/COBAN (monensin).
200-478ALBAC 50 (bacitracin zinc)/NICARB (nicarbazin).

Accordingly, the Agency is amending the regulations in 21 CFR part 558 to reflect these transfers of ownership. In addition, the regulations are being amended to make minor corrections. This is being done to increase the accuracy and readability of the regulations.

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

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List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds.

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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 part 558 is amended as follows:

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

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2. In § 558.76, in paragraph (a), remove “046573” and in its place add “054771”; and in the table in paragraph (d)(1), in the “Limitations” column and in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”.

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3. In § 558.78, in paragraph (b), remove “046573” and in its place add “054771”; and in the table in paragraph (d)(1), in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”; and in paragraph (d)(2)(ii), remove “046573” and in its place add “054771”.

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4. Amend § 558.128 as follows:

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a. In paragraph (b)(1), remove “046573” and in its place add “054771”;

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b. In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(5), in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”;

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c. In the table in paragraph (e)(4), in the “Limitations” column and in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”;

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d. In paragraph (e)(6)(iv), remove “per head” and in its place add “per pound of body weight”; and

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e. In paragraph (e)(6)(v), remove “046573” and in its place add “054771”.

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5. In § 558.140, in paragraph (a), remove “046573” and in its place add “054771”; and revise paragraph (c)(3) to read as follows:

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Chlortetracycline and sulfamethazine.
* * * * *

(c) * * *

(3) Limitations. Feed for 28 days, withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

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6. In § 558.145, in paragraph (a)(1), remove “046573” and in its place add “054771”; and in paragraph (a)(2) remove “046573 and 048164” and in its place add “Nos. 048164 and 054771”.

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7. In § 558.155, in paragraphs (a)(1) and (2), remove “046573” and in its place add “054771”.

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8. In § 558.175, in the table in paragraph (d), in the “Limitations” column and in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”; and in paragraph (d)(6), in the “Sponsor” column, remove “000009” and in its place add “054771”.

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9. In § 558.195, in paragraph (b), remove “046573” and in its place add “054771”; in the tables in paragraphs (e)(1), (e)(2), and (e)(3), in the “Limitations” column and in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”; and in the table in paragraph (e)(1), in the “Limitations” column and in the “Sponsor” column, remove “000009” wherever it occurs and in its place add “054771”.

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10. In § 558.198, in the tables in paragraphs (d)(1) and (2), in the “Limitations” column, remove “046573” wherever it occurs and in its place add “054771”.

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11. In § 558.258, in the tables in paragraphs (e)(2)(vi) and (vii), in the “Limitations” column and in the “Sponsor” column, remove “046573” and in its place add “054771”; and in paragraphs (e)(2)(ii) through (v), in the “Limitations” column, remove “000009” and in its place add “054771”.

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12. In § 558.305, in paragraph (b), remove “046573” and in its place add “054771”; and in the table in paragraph (e) in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”.

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13. In § 558.311, in paragraphs (b)(1) through (4) and (6) and (7), remove “046573” and in its place add “054771”; in the table in paragraph (e)(1), in the “Limitations” column and in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771”, in the “Limitations” column, remove “000009” where it occurs and in its place add “054771”, in the “Limitations” column, remove “000004” where it occurs and in its place add “054771”; and in paragraphs (e)(2)(v), (e)(3)(v), and (e)(4)(v), remove “046573” and in its place add “054771”.

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14. In § 558.325, in paragraphs (a)(1) and (c)(3)(i), remove “000009” and in its place add “054771”; and in the tables in paragraphs (d)(1) and (2), in the “Sponsor” column, remove “000009” wherever it occurs and in its place add “054771”.

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15. In § 558.340, in paragraph (a), remove “046573” and in its place add “No. 054771”.

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16. In § 558.342, in paragraph (b)(1), remove “000009” and in its place add “054771”; in the table in paragraph (e)(1), in the “Limitations” column and in the “Sponsor” column, remove “000009” wherever it occurs and in its place add “054771”, and in the “Limitations” column, remove “046573” wherever it occurs and in its place add “054771”.

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17. In § 558.348, in paragraph (a), remove “000009” and in its place add “No. 054771”.

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18. In § 558.355, in paragraphs (b)(8), (b)(9), and (b)(11), remove “046573” and in its place add “054771”; in paragraphs (f)(1)(iii)( b), (f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(vii)(b), (f)(1)(xiv)(b), (f)(1)(xxv)(b), (f)(1)(xxix)(b), (f)(1)(xxx)(b), (f)(2)(ii)(b), (f)(2)(iii)(b), (f)(4)(ii)(b), (f)(4)(iii)(b), (f)(4)(iv)(b), (f)(4)(v)(b), remove “046573” and in its place add “054771”; and revise paragraph (f)(1)(i)(b) to read as follows:

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Monensin.
* * * * *

(f) * * *

(1) * * *

(i) * * *

(b) Limitations. Feed continuously as the sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens.

* * * * *
[Amended]
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19. In § 558.363, in paragraphs (a)(6) and (a)(7), remove “046573” and in its place add “054771”; in paragraph (d)(1)(vi)(B) and (d)(1)(x)(B), remove “046573” and in its place add “054771”.

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20. In § 558.364, in paragraph (a), remove “000009” and in its place add “054771”; and in the table in paragraph (d), in the “Sponsor” column, remove “000009” wherever it occurs and in its place add “054771”.

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21. In § 558.366, in the table in paragraph (d), in the “Limitations” column and in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771” and in paragraph (d), in the “Limitations” column, remove “000009” wherever it occurs and in its place add “054771”.

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22. In § 558.369, in paragraph (a), remove “046573” and in its place add “054771”.

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23. In § 558.415, redesignate paragraphs (b) and (c) as paragraphs (c) and (d); revise paragraph (a); and add new paragraph (b) to read as follows:

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Novobiocin.
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(a) Specifications. Type A medicated article containing 25 grams of novobiocin activity per pound.

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

* * * * *
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24. In § 558.430, redesignate paragraphs (b) and (c) as paragraphs (c) and (d); revise paragraph (a); and add new paragraph (b) to read as follows:

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Nystatin.

(a) Specifications. Type A medicated article containing 20 grams of nystatin activity per pound.

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

* * * * *
[Amended]
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25. In § 558.460, in paragraph (b), remove “046573” and in its place add “054771”; and in the table in paragraph (d)(1)(i), in the “Sponsor” column, remove “000069, 046573” and in its place add “054771, 066104”; and in paragraphs (d)(1)(ii) and (iii), in the “Sponsor” column, remove “Do.” and in its place add “054771, 066104”.

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26. In § 558.464, in paragraphs (a)(1) and (2), remove “000069” and in its place add “054771”.

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27. In § 558.485, in paragraph (b)(7), remove “000069 and 017135” and in its place add “017135 and 054771”; and in paragraph (e)(1)(xii)(C), remove “000009” and in its place add “054771”.

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28. In § 558.500, in paragraphs (e)(2)(viii) and (x), in the “Limitations” column, remove “000009” and in its place add “054771”.

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29. In § 558.515, in paragraph (a), remove “046573” and in its place add “054771”; in the table in paragraph (d), in the “Sponsor” column, remove “046573” wherever it occurs and in its place add “054771” and in the “Sponsor” column, remove “000009” where it occurs and in its place add “054771”.

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[Amended]
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30. In § 558.550, in paragraphs (b)(1), (d)(1)(iii)( c), (d)(1)(vi)(c), (d)(1)(vii)(c), (d)(1)(xvi)(c), (d)(1)(xx)(C), (d)(1)(xxi)(C), (d)(1)(xxii)(B), (d)(1)(xxiii)(b), (d)(3)(ii)(B), (d)(3)(iii)(B), (d)(3)(v)(B), (d)(4)(i)(b), remove “046573” and in its place add “054771”; and in paragraph (d)(1)(xiii)(c), remove “000009” and in its place add “054771”.

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31. In § 558.555, in paragraphs (d)(2), (d)(3), (d)(4), and (d)(8), in the “Limitations” column, remove “046573” and in its place add “054771”.

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32. In § 558.575, in paragraph (a)(1), remove “046573” and in its place add “054771”.

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33. In § 558.582, in paragraph (a), remove “046573” and in its place add “054771”.

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34. In paragraph (e)(1)(iii) of § 558.600, in the “Indications for use” column, remove “susceptible” wherever it occurs and in its place add “sensitive”; in the “Limitations” column, add “Use as only source of tiamulin.”; and in the “Limitations” column, remove “046573” and in its place add “054771”.

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35. In § 558.625, remove and reserve paragraphs (b)(57) and (83); in paragraph (b)(54), remove “046573” and in its place add “054771”; and add paragraph (b)(10) to read as follows:

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Tylosin.
* * * * *

(b) * * *

(10) To No. 012286: 0.4, 0.8, and 1.6 grams per pound, paragraph (f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, paragraphs (f)(1)(i) through (vi) of this section.

* * * * *
[Amended]
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36. In § 558.630, in paragraph (b)(5), remove “046573” and in its place add “054771”.

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37. In § 558.635, in paragraph (a)(2), remove “046573” and in its place add “054771”.

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38. In § 558.680, in paragraph (b), remove “046573” and in its place add “054771”.

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Dated: February 28, 2014.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 2014-04937 Filed 3-10-14; 8:45 am]

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