[Federal Register Volume 66, Number 174 (Friday, September 7, 2001)]
[Rules and Regulations]
[Pages 46705-46707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522, 524, and 558


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 56 approved new 
animal drug applications (NADAs) and 3 approved abbreviated new animal 
drug applications (ANADAs) from Roche Vitamins, Inc., to Alpharma, Inc.

DATES: This rule is effective September 7, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., 
Parsippany, NJ 07054-1298, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following approved 
NADAs and ANADAs to Alpharma, Inc., One Executive Dr., P.O. Box 1399, 
Fort Lee, NJ 07024:

------------------------------------------------------------------------
                NADA No.                           Product Name
------------------------------------------------------------------------
33-950.................................  Sulfamerazine in Fish Grade
35-688.................................  Aureo SP-250; Aureomix 500
35-805.................................  Aureomix-S 700 Crumbles;
                                          Aureomix-S 700
36-361.................................  Amprolium Plus Ethopabate/
                                          CTC Sodium Sulfate
40-209.................................  Rofenaid 40
41-647.................................  Aureomix-S 700-A
41-648.................................  Aureomix-S 700-D
41-649.................................  Aureomix-S 700-G
41-650.................................  Aureomix-S 700-E
41-651.................................  Aureomix-S 700-F
41-652.................................  Aureomix-S 700-C-2
41-653.................................  Aureomix-S 700-B
41-654.................................  Aureomix-S 700-H
41-984.................................  Rofenaid Plus
                                          Roxarsone
46-920.................................  Baciferm 10, 25, 40,
                                          and 50 Type A Medicated
                                          Articles
48-486.................................  Robenz Type A
                                          Medicated Article
48-761.................................  Aureomycin Type A
                                          Medicated Article
49-287.................................  Chlorachel-50
55-040.................................  SF Mix 66
92-507.................................  Robenz With
                                          Aureomycin 500
95-546.................................  Robenz Plus Roxarsone
96-298.................................  Avatec and
                                          Bovatec Premixes
96-933.................................  Robenz Plus Zn
                                          Bacitracin
97-085.................................  Robenz Plus Bac MD
100-901................................  Pfichlor 100S Milk Replacer
                                          Type A Medicated Article
102-485................................  Avatec/3-
                                          Nitro
105-758................................  Zinc Bacitracin and Amprol HI-
                                          E
107-996................................  Avatec/
                                          Fortracin Premix
112-661................................  Avatec/
                                          Lincomix/3-
                                          Nitro
112-687................................  Avatec/
                                          Flavomycin/3-
                                          Nitro
114-794................................  Baciferm/Amprol HI-
                                          E Premix
121-553................................  Coban/
                                          Aureomycin
123-154................................  Coban/3-
                                          Nitro-10/
                                          Baciferm Premix
125-933................................  Romet-30
                                          (Sulfamerazine)
126-052................................  Avatec/
                                          Baciferm/3-
                                          Nitro
128-686................................  Bio-Cox Type A
                                          Medicated Article
131-894................................  Avatec/
                                          Fortracin/3-
                                          Nitro Broiler Premix
132-447................................  Bio-Cox Plus
                                          Roxarsone
134-185................................  Bio-Cox/3-
                                          Nitro/
                                          Flavomycin
134-284................................  Bio-Cox/
                                          Flavomycin
135-321................................  Bio-Cox/3-
                                          Nitro/BMD
135-746................................  Bio-Cox/BMD
136-484................................  Carb-O-Sep/
                                          Baciferm
137-536................................  Bio-Cox/3-
                                          Nitro plus
                                          Albac
137-537................................  Bio-Cox/
                                          Lincomix
139-075................................  Cygro Type A
                                          Medicated Article
139-190................................  Bio-Cox/3-
                                          Nitro/
                                          Baciferm
139-235................................  Bio-Cox/
                                          Baciferm
140-579................................  Bovatec/
                                          Terramycin
140-581................................  Bio-Cox/3-
                                          Nitro/
                                          Lincomix
140-859................................  Aureomycin/Bio-
                                          Cox
140-865................................  Monteban/
                                          Baciferm
140-867................................  Aureomycin/Bio-
                                          Cox/3-
                                          Nitro
141-025................................  Cattlyst Type A
                                          Medicated Article
141-109................................  Avatec/
                                          Baciferm
141-150................................  Avatec/
                                          Stafac
200-140................................  Aureozol Type A
                                          Medicated Article
200-167................................  Aureozol 500 Granular
200-242................................  Aureomycin-50, 70,
                                          80, 90, 100/BMD 25,
                                          30, 40, 50, 60, 75
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
558.58, 558.76, 558.78, 558.95, 558.120, 558.128, 558.140, 558.145, 
558.155, 558.195, 558.305, 558.311, 558.340, 558.355, 558.363, 558.366, 
558.515, 558.550, 558.575, 558.582, and 558.600 to reflect the transfer 
of ownership. Section 558.95 is also being amended to remove paragraph 
(d)(1)(x), an entry pertaining to NADA 112-687, which is redundant with 
Sec. 558.311(e)(1)(ii). Other nonsubstantive changes are being made to 
remove incorrect drug labeler codes.
    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

21 CFR Parts 522 and 524

    Animal drugs.

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 522, 
524, and 558 are amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec. 522.575  [Amended]

    2. Section 522.575 Diazepam injection is amended in paragraph (b) 
by removing ``000004'' and by adding in its place ``063238''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 524 continues to read as 
follows:


[[Page 46706]]


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


Sec. 524.520  [Amended]

    4. Section 524.520 Cuprimyxin cream is amended in paragraph (b) by 
removing ``000004'' and by adding in its place ``063238''.

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

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

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


Sec. 558.58  [Amended]

    6. Section 558.58 Amprolium and ethopabate is amended in the table 
in paragraph (d)(1)(iii), under the ``Limitations'' column in the 
entries for ``Bacitracin 4 to 50'', ``Bacitracin 5 to 35 plus roxarsone 
34 (0.00375%)'', and ``Bacitracin 10 to 50 plus roxarsone 15.4 to 45.4 
(0.0017% to 0.005%)'' by removing ``Nos. 046573 and 063238'' and by 
adding in its place ``No. 046573''; and under the ``Sponsor'' column by 
removing ``063238'' and ``and 063238'' wherever they appear.


Sec. 558.76  [Amended]

    7. Section 558.76 Bacitracin methylene disalicylate is amended in 
the table in paragraph (d)(1)(iv), under the ``Limitations'' column by 
removing ``Nos. 000004 and 046573'' and by adding in its place ``No. 
046573''; and under the ``Sponsor'' column by removing ``000004 and 
046573'' both times it appears and adding in its place ``046573''.
    8. Section 558.78 is amended by revising paragraph (a)(1), by 
removing paragraph (a)(2), and by redesignating paragraph (a)(3) as 
paragraph (a)(2); in the table in paragraphs (d)(1)(i) and (d)(1)(ii) 
under the ``Sponsor'' column by removing ``063238''; and in paragraphs 
(d)(1)(v) and (d)(1)(vi) under the ``Sponsor'' column, and in paragraph 
(d)(2)(ii) by removing ``063238'' and by adding in its place ``046573'' 
to read as follows:


Sec. 558.78  Bacitracin zinc.

    (a) * * * 
    (1) No. 046573: 10, 25, 40, and 50 grams per pound as in paragraph 
(d) of this section.
* * * * *


Sec. 558.95  [Amended]

    9. Section 558.95 Bambermycins is amended by removing and reserving 
paragraph (d)(1)(x); and in paragraphs (d)(1)(xi)(b), (d)(1)(xii)(b), 
and (d)(1)(xiv)(b) by removing ``063238'' and by adding in its place 
``046573''.


Sec. 558.120  [Amended]

    10. Section 558.120 Carbarsone (not U.S.P.) is amended in paragraph 
(d)(1)(iii)(b) by removing ``Nos. 046573 and 063238'' and by adding in 
its place ``No. 046573''.
    11. Section 558.128 is amended by revising paragraph (a); in the 
table in paragraph (d)(1) and in paragraph (d)(2) by removing ``00004'' 
or ``000004'' wherever they occur and by adding in their place 
``046573''; in paragraph (d)(1)(i) in entry 1, and in paragraphs 
(d)(1)(iv), (d)(1)(vi), and (d)(1)(viii) under the ``Sponsor'' column 
by removing ``063238'' and by adding in its place ``046573''; in 
paragraph (d)(1)(i) in entry 2, and in paragraphs (d)(1)(ii), 
(d)(1)(iii), (d)(1)(v), (d)(1)(vii), (d)(1)(x), and (d)(1)(xii) in 
entry 3, and in paragraphs (d)(1)(xiv), (d)(1)(xvi), and (d)(1)(xvii) 
under the ``Sponsor'' column by removing ``063238'' to read as follows:


Sec. 558.128  Chlortetracycline.

    (a) Approvals. See sponsors in Sec. 510.600(c) of this chapter for 
Type A medicated articles containing the following concentrations of 
either chlortetracycline calcium complex equivalent to 
chlortetracycline hydrochloride or, for products intended for use in 
milk replacer, chlortetracycline hydrochloride:
    (1) Nos. 000069, 046573, and 053389: 50 to 100 grams per pound.
    (2) No. 017519: 50 grams per pound.
* * * * *


Sec. 558.140  [Amended]

    12. Section 558.140 Chlortetracycline and sulfamethazine is amended 
in paragraph (a) by removing ``063238'' and by adding in its place 
``046573''.


Sec. 558.145  [Amended]

    13. Section 558.145 Chlortetracycline, procaine penicillin, and 
sulfamethazine is amended in paragraph (a)(1) by removing ``and 
063238'', and in paragraph (a)(2) by removing ``063238'' and by adding 
in its place ``046573''.


Sec. 558.155  [Amended]

    14. Section 558.155 Chlortetracycline, sulfathiazole, penicillin is 
amended in paragraph (a)(1) by removing ``000004 and 000010'' and 
adding in its place ``Nos. 000010 and 046573'', and in paragraph (a)(2) 
by removing ``000004 and 000010'' and by adding in its place ``000010 
and 046573''.


Sec. 558.195  [Amended]

    15. Section 558.195 Decoquinate is amended in the table in 
paragraph (d) in the entry for ``Roxarsone 11 to 45 (0.0012-0.005 pct.) 
plus Bacitracin 12 to 50'' under the ``Limitations'' column by removing 
``Nos. 011716, 046573, and 063238'' and by adding in its place ``No. 
046573''.


Sec. 558.305  [Amended]

    16. Section 558.305 Laidlomycin propionate potassium is amended in 
paragraph (a) by removing ``063238'' and by adding in its place 
``046573''.


Sec. 558.311  [Amended]

    17. Section 558.311 Lasalocid is amended in paragraphs (b) and (e) 
by removing ``000004'' or ``063238'' wherever they occur and by adding 
in their place ``046573''.


Sec. 558.340  [Amended]

    18. Section 558.340 Maduramicin ammonium is amended in paragraph 
(a) by removing ``063238'' and by adding in its place ``046573''.


Sec. 558.355  [Amended]

    19. Section 558.355 Monensin is amended in paragraphs (b)(8), 
(b)(9), (f)(1)(iv)(b), and (f)(1)(v)(b) by removing ``063238'' and by 
adding in its place ``046573''; in paragraphs (f)(1)(xiv)(b) and 
(f)(1)(xvi)(b) by removing ``Nos. 046573 and 063238'' and by adding in 
its place ``No. 046573''; and in paragraph (f)(1)(xv)(b) by removing 
``Nos. 063238 and 046573'' and by adding in its place ``No. 046573''.


Sec. 558.363  [Amended]

    20. Section 558.363 Narasin is amended in paragraphs (a)(7) and 
(d)(1)(x)(B) by removing ``063238'' and by adding in its place 
``046573''.


Sec. 558.366  [Amended]

    21. Section 558.366 Nicarbazin is amended in the table in paragraph 
(c) in the entry for the combination of nicarbazin at 113.5 grams per 
ton and bacitracin zinc at 4 to 50 grams per ton by removing ``063238'' 
in the ``Limitations'' column and by adding in its place ``046573''.


Sec. 558.515  [Amended]

    22. Section 558.515 Robenidine hydrochloride is amended in 
paragraph (a) by removing ``063238'' and by adding in its place 
``046573''; in the table in paragraph (d) in the entry for robenidine 
hydrochloride at 30 grams per ton as a single ingredient by removing 
``063238'' in the ``Sponsor'' column and by adding in its place 
``046573''; in the two entries for ``Bacitracin (as bacitracin zinc)'' 
by removing ``063238'' in the ``Sponsor'' column; and in the entry for 
``Chlortetracycline 500'' by removing ``063238'' from the ``Sponsor'' 
column and by adding in its place ``046573''.

[[Page 46707]]

Sec. 558.550  [Amended]

    23. Section 558.550 Salinomycin is amended in paragraph (a)(1) by 
removing ``063238'' and by adding in its place ``046573''; by removing 
paragraph (a)(3); in paragraph (d)(1)(xvii)(C) by removing ``000004'' 
and by adding in its place ``046573''; in paragraphs (d)(1) and (d)(3) 
by removing ``063238'' wherever it occurs and by adding in its place 
``046573''; in paragraph (d)(1)(viii)(c) by removing ``(b)(1)(iv)(c)'' 
and by adding in its place ``(d)(1)(iv)(c)''; and in paragraph 
(d)(1)(xi)(c) by removing ``(b)(1)(x)(c)'' and by adding in its place 
``(d)(1)(x)(c)''.


Sec. 558.575  [Amended]

    24. Section 558.575 Sulfadimethoxine, ormetoprim is amended in 
paragraphs (a)(1) and (a)(2) by removing ``000004'' and by adding in 
its place ``046573''.


Sec. 558.582  [Amended]

    25. Section 558.582 Sulfamerazine is amended in paragraph (a) by 
removing ``063238'' and by adding in its place ``046573''.


Sec. 558.600  [Amended]

    26. Section 558.600 Tiamulin is amended in paragraph (c)(4)(ii) by 
removing ``046573, 053389, and 063238'' and by adding in its place 
``046573 and 053389''.

    Dated: August 24, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-22470 Filed 9-6-01; 8:45 am]
BILLING CODE 4160-01-S