New Animal Drugs; Change of Sponsor

Federal Register, Volume 79 Issue 47 (Tuesday, March 11, 2014)

Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)

Rules and Regulations

Pages 13542-13546

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2014-04937

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

Docket No. FDA-2014-N-0002

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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.

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.

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.

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File No. Product name

------------------------------------------------------------------------

007-616...................... HISTOSTAT 50 (nitarsone) Type A Medicated

Article.

011-116...................... ZOAMIX (zoalene) Type A Medicated

Article.

012-375...................... ALBAMIX (novobiocin) Type A Medicated

Article.

012-680...................... PHARMASTATIN 20 (nystatin) Type A

Medicated Article.

013-747...................... Zoalene 90 Medicated Coccidiostat.

033-950...................... Sulfamerazine In Fish Grade.

034-085...................... LINCOMIX (lincomycin) Type A Medicated

Article.

034-254...................... MGA (melengestrol acetate) Type A

Medicated Article.

035-688...................... AUREOMIX Granular 500 (pen G, CTC,

sulfamethazine) Type A Medicated

Article.

035-805...................... AUREO S 700 Granular (CTC and

sulfamethazine) Type A Medicated

Article.

036-361...................... Amprolium and ethopabate/CTC

(chlortetracycline)/sodium sulfate.

039-077...................... CSP (chlortetracycline, sulfathiazole,

and penicillin G procaine) 250 and 500

Type A Medicated Articles.

039-402...................... MGA 500 (melengestrol acetate) Liquid

Type A Medicated Article.

039-417...................... DECCOX (decoquinate) Type A Medicated

Article.

040-209...................... ROFENAID 40 (sulfadimethoxine and

ormetoprim) Type A Medicated Article.

041-647...................... AUREOMIX S 700-A (CTC and sulfamethazine)

Type A Medicated Article.

041-648...................... AUREOMIX S 700-D (CTC and sulfamethazine)

Type A Medicated Article.

041-649...................... AUREOMIX S 700-G (CTC and sulfamethazine)

Type A Medicated Article.

Page 13543

041-650...................... AUREOMIX S 700-E (CTC and sulfamethazine)

Type A Medicated Article.

041-651...................... AUREOMIX S 700-F (CTC and sulfamethazine)

Type A Medicated Article.

041-652...................... AUREOMIX S 700-C-2 (CTC and

sulfamethazine) Type A Medicated

Article.

041-653...................... AUREOMIX S 700-B (CTC and sulfamethazine)

Type A Medicated Article.

041-654...................... AUREOMIX S 700-H (CTC and sulfamethazine)

Type A Medicated Article.

044-820...................... AMPROL PLUS (amprolium and ethopabate)/

LINCOMIX (lincomycin).

044-972...................... LINCOMIX (lincomycin)/COYDEN (clopidol).

045-348...................... ALBAC (bacitracin zinc)/DECCOX

(decoquinate).

045-444...................... CHLORMAX (chlortetracycline)/DECCOX

(decoquinate).

046-415...................... Tylosin Type A Medicated Articles.

046-592...................... BMD (bacitracin methylene disalicylate)

Type A Medicated Articles.

046-666...................... Penicillin G Procaine Type A Medicated

Articles.

046-699...................... CHLORMAX (chlortetracycline) Type A

Medicated Articles.

046-718...................... MGA (liquid) (melengestrol acetate)/

TERRAMYCIN (oxytetracycline).

046-719...................... MGA (dry) (melengestrol acetate)/

TERRAMYCIN (oxytetracycline).

046-920...................... BACIFERM (bacitracin zinc) Type A

Medicated Articles.

047-261...................... DECCOX (decoquinate)/LINCOMIX

(lincomycin).

047-262...................... DECCOX (decoquinate)/LINCOMIX

(lincomycin).

048-486...................... ROBENZ (robenidine) Type A Medicated

Article.

048-761...................... AUREOMYCIN (chlortetracycline) Type A

Medicated Article.

048-762...................... Chlortetracycline Type A Medicated

Article.

048-763...................... Chlortetracycline Type A Medicated

Article.

048-954...................... ZOAMIX (zoalene)/LINCOMIX (lincomycin).

049-287...................... PFICHLOR (chlortetracycline) Type A

Medicated Article.

055-040...................... SF Mix 66 (chlortetracycline) Type A

Medicated Article.

065-020...................... Micro CTC (chlortetracycline) 100 Type A

Medicated Article.

091-668...................... CHLORMAX SP (chlortetracycline) 250 and

500 Type A Medicated Articles.

091-749...................... TYLAN 40 Plus Sulfa-G.

092-482...................... COBAN (monensin)/LINCOMIX (lincomycin).

092-507...................... ROBENZ/Aureomycin 500 Gm.

092-522...................... COBAN (monensin)/LINCOMIX (lincomycin).

093-106...................... ROBENZ (robenidine)/LINCOMIX

(lincomycin).

096-298...................... AVATEC and BOVATEC (lasalocid) Type A

Medicated Articles.

096-933...................... ROBENZ (robenidine)/Bacitracin Zn.

097-085...................... Bacitracin MD/ROBENZ (robenidine).

097-505...................... LINCOMIX (lincomycin) Type A Medicated

Articles.

098-452...................... ALBAC 50 (bacitracin zinc) Type A

Medicated Article.

100-901...................... PFICHLOR (chlortetracycline) 100S Milk

Replacer Type A Medicated Article.

101-689...................... AVATEC (lasalocid)/LINCOMIX (lincomycin).

103-758...................... TERRAMYCIN (oxytetracycline) Type A

Medicated Article.

107-347...................... CHEQUE (mibolerone) Medicated Dog Food.

107-996...................... AVATEC (lasalocid)/FORTRACIN (lasalocid).

114-794...................... AMPROL HI-E (amprolium and ethopabate)/

BACIFERM (bacitracin zinc).

121-553...................... AUREOMYCIN (chlortetracycline)/COBAN

(monensin).

124-309...................... MGA 100 and 200 (melengestrol acetate)/

RUMENSIN (monensin).

125-476...................... MGA 500 (melengestrol acetate)/RUMENSIN

(monensin).

128-686...................... BIO-COX (salinomycin) Type A Medicated

Article.

133-334...................... Virginiamycin Type A Medicated Article.

134-284...................... BIO-COX (salinomycin)/FLAVOMYCIN

(bambermycins).

134-830...................... ALBAC (bacitracin zinc)/COBAN (monensin).

135-746...................... BIO-COX (salinomycin)/BMD (bacitracin

methylene disalicylate).

137-537...................... BIO-COX (salinomycin)/LINCOMIX

(lincomycin).

138-456...................... COBAN (monensin)/BMD (bacitracin

methylene disalicylate).

138-792...................... MGA 100 and 200 (melengestrol)/RUMENSIN

(monensin)/TYLAN (tylosin).

138-870...................... MGA 500 (melengestrol acetate)/BOVATEC

(lasalocid)/TYLAN (tylosin).

138-904...................... MGA (melengestrol acetate)/BOVATEC

(lasalocid)/TYLAN (tylosin).

138-941...................... LINCOMIX (lincomycin)/BANMINTH

(pyrantel).

138-992...................... MGA 200 (melengestrol acetate)/BOVATEC

(lasalocid)/TYLAN (tylosin).

138-995...................... MGA (melengestrol acetate)/TYLAN

(tylosin).

139-075...................... CYGRO (maduramicin) Type A Medicated

Article.

139-192...................... MGA 500 (melengestrol acetate)/TYLAN

(tylosin).

139-235...................... BACIFERM (bacitracin zinc)/BIO-COX

(salinomycin).

139-876...................... MGA 200 (melengestrol acetate)/BOVATEC

(lasalocid).

140-288...................... MGA 500 (melengestrol acetate)/BOVATEC

(lasalocid).

140-443...................... HYGROMIX 1.6 (hygromycin B) Premix.

140-579...................... BOVATEC (lasalocid)/TERRAMYCIN

(oxytetracycline).

140-853...................... BMD (bacitracin methylene disalicylate)/

MONTEBAN (naracin).

140-859...................... AUREOMYCIN (chlortetracycline)/BIO-COX

(salinomycin).

140-865...................... BACIFERM or ALBAC (bacitracin zinc)/

MONTEBAN (naracin).

141-025...................... CATTLYST (laidlomycin) Type A Medicated

Article.

141-059...................... BMD (bacitracin methylene disalicylate)/

CTC (chlortetracycline).

141-083...................... AVATEC (lasalocid)/BACIFERM (bacitracin

zinc).

Page 13544

141-085...................... BMD (bacitracin methylene disalicylate)/

ZOAMIX (zoalene).

141-088...................... HISTOSTAT (nitarsone)/BMD (bacitracin

methylene disalicylate).

141-102...................... BMD (bacitracin methylene disalicylate)/

DECCOX (decoquinate).

141-109...................... AVATEC (lasalocid)/BACIFERM (bacitracin

zinc).

141-124...................... BMD (bacitracin methylene disalicylate)/

MAXIBAN (naracin and nicarbazin).

141-132...................... HISTOSTAT (nitarsone)/ALBAC (bacitracin

zinc).

141-136...................... BMD (bacitracin methylene disalicylate)/

BIO-COX (salinomycin).

141-140...................... BMD (bacitracin methylene disalicylate)/

COBAN (monensin).

141-144...................... BMD (bacitracin methylene disalicylate)/

SAFE-GUARD (fenbendazole).

141-147...................... DECCOX (decoquinate)/CHLORMAX

(chlortetracycline).

141-148...................... DECCOX (decoquinate)/RUMENSIN (monensin).

141-149...................... DECCOX (decoquinate)/RUMENSIN (monensin)/

TYLAN (tylosin).

141-150...................... AVATEC (lasalocid)/STAFAC

(virginiamycin).

141-154...................... BMD (bacitracin methylene disalicylate)/

ROBENZ (robenidine).

141-156...................... BMD (bacitracin methylene disalicylate)/

AMPROL (amprolium).

141-179...................... BMD (bacitracin methylene disalicylate)/

AVATEC (lasalocid).

141-181...................... ALBAC (bacitracin zinc)/AVATEC

(lasalocid).

141-185...................... DECCOX (decoquinate)/AUREOMYCIN

(chlortetracycline).

141-201...................... CATTLYST (laidlomycin)/AUREOMYCIN

(chlortetracycline).

141-250...................... BOVATEC (lasalocid)/AUREOMYCIN

(chlortetracycline).

200-140...................... AUREOZOL (pen G, CTC, sulfathiazole) Type

A Medicated Article.

200-167...................... AUREOZOL 500 Granular (pen G, CTC,

sulfathiazole) Type A Medicated Article.

200-204...................... ALBAC (bacitracin zinc)/BIO-COX

(salinomycin).

200-205...................... ALBAC (bacitracin zinc)/AMPROL HI-E

(amprolium and ethopabate).

200-210...................... ALBAC (bacitracin zinc)/SACOX

(salinomycin).

200-212...................... ALBAC (bacitracin zinc)/ROBENZ.

200-213...................... ALBAC (bacitracin zinc)/DECCOX

(decoquinate).

200-218...................... ALBAC (bacitracin zinc)/COYDEN 25

(clopidol).

200-223...................... ALBAC 50 (bacitracin zinc) Type A

Medicated Article.

200-242...................... BMD (bacitracin methylene disalicylate)/

AUREOMYCIN (chlortetracycline).

200-261...................... CHLORMAX (chlortetracycline)/BIO-COX

(salinomycin).

200-262...................... CHLORMAX (chlortetracycline)/SACOX

(salinomycin).

200-263...................... CHLORMAX (chlortetracycline)/COBAN

(monensin).

200-478...................... ALBAC 50 (bacitracin zinc)/NICARB

(nicarbazin).

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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

List of Subjects in 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 part 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0

1. 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

2. In Sec. 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''.

   Sec. 558.78 Amended

   0

3. In Sec. 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''.

   Sec. 558.128 Amended

   0

4. Amend Sec. 558.128 as follows:

   0

   1. In paragraph (b)(1), remove ``046573'' and in its place add ``054771'';

      0

   2. 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'';

      0

   3. 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'';

      0

   4. In paragraph (e)(6)(iv), remove ``per head'' and in its place add ``per pound of body weight''; and

      0

   5. In paragraph (e)(6)(v), remove ``046573'' and in its place add ``054771''.

      Sec. 558.140 Amended

      0

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

   Sec. 558.140 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.

   Sec. 558.145 Amended

   0

6. In Sec. 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''.

   Page 13545

   Sec. 558.155 Amended

   0

7. In Sec. 558.155, in paragraphs (a)(1) and (2), remove ``046573'' and in its place add ``054771''.

   Sec. 558.175 Amended

   0

8. In Sec. 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''.

   Sec. 558.195 Amended

   0

9. In Sec. 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''.

   Sec. 558.198 Amended

   0

10. In Sec. 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''.

    Sec. 558.258 Amended

    0

11. In Sec. 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''.

    Sec. 558.305 Amended

    0

12. In Sec. 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''.

    Sec. 558.311 Amended

    0

13. In Sec. 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''.

    Sec. 558.325 Amended

    0

14. In Sec. 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''.

    Sec. 558.340 Amended

    0

15. In Sec. 558.340, in paragraph (a), remove ``046573'' and in its place add ``No. 054771''.

    Sec. 558.342 Amended

    0

16. In Sec. 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''.

    Sec. 558.348 Amended

    0

17. In Sec. 558.348, in paragraph (a), remove ``000009'' and in its place add ``No. 054771''.

    Sec. 558.355 Amended

    0

18. In Sec. 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:

    Sec. 558.355 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.

    * * * * *

    Sec. 558.363 Amended

    0

19. In Sec. 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''.

    Sec. 558.364 Amended

    0

20. In Sec. 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''.

    Sec. 558.366 Amended

    0

21. In Sec. 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''.

    Sec. 558.369 Amended

    0

22. In Sec. 558.369, in paragraph (a), remove ``046573'' and in its place add ``054771''.

    Sec. 558.415 Amended

    0

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

    Sec. 558.415 Novobiocin.

    0

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

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

    * * * * *

    0

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

    Sec. 558.430 Nystatin.

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

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

    * * * * *

    Sec. 558.460 Amended

    0

25. In Sec. 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''.

    Sec. 558.464 Amended

    0

26. In Sec. 558.464, in paragraphs (a)(1) and (2), remove ``000069'' and in its place add ``054771''.

    Page 13546

    Sec. 558.485 Amended

    0

27. In Sec. 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''.

    Sec. 558.500 Amended

    0

28. In Sec. 558.500, in paragraphs (e)(2)(viii) and (x), in the ``Limitations'' column, remove ``000009'' and in its place add ``054771''.

    Sec. 558.515 Amended

    0

29. In Sec. 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''.

    Sec. 558.550 Amended

    0

30. In Sec. 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''.

    Sec. 558.555 Amended

    0

31. In Sec. 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''.

    Sec. 558.575 Amended

    0

32. In Sec. 558.575, in paragraph (a)(1), remove ``046573'' and in its place add ``054771''.

    Sec. 558.582 Amended

    0

33. In Sec. 558.582, in paragraph (a), remove ``046573'' and in its place add ``054771''.

    Sec. 558.600 Amended

    0

34. In paragraph (e)(1)(iii) of Sec. 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''.

    Sec. 558.625 Amended

    0

35. In Sec. 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:

    Sec. 558.625 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.

    * * * * *

    Sec. 558.630 Amended

    0

36. In Sec. 558.630, in paragraph (b)(5), remove ``046573'' and in its place add ``054771''.

    Sec. 558.635 Amended

    0

37. In Sec. 558.635, in paragraph (a)(2), remove ``046573'' and in its place add ``054771''.

    Sec. 558.680 Amended

    0

38. In Sec. 558.680, in paragraph (b), remove ``046573'' and in its place add ``054771''.

    Dated: February 28, 2014.

    Steven D. Vaughn,

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

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

    BILLING CODE 4160-01-P