Document ID: FDA-2014-N-0002-0005
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor
Posted Date: 2014-03-11T04:00Z

[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]

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

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.

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

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.
------------------------------------------------------------------------
           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).
------------------------------------------------------------------------

    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
a. In paragraph (b)(1), remove ``046573'' and in its place add 
``054771'';
0
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'';
0
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'';
0
d. In paragraph (e)(6)(iv), remove ``per head'' and in its place add 
``per pound of body weight''; and
0
e. 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