Animal drugs, feeds, and related products: Alpharma, Inc.,

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Federal Register: September 7, 2001 (Volume 66, Number 174)Rules and RegulationsPage 46705-46707From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr07se01-2

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.

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/ CTCSodium Sulfate 40-209................................. Rofenaid40 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................................. RofenaidPlus Roxarsone 46-920................................. Baciferm10, 25, 40, and 50 Type A Medicated Articles 48-486................................. RobenzType A Medicated Article 48-761................................. AureomycinType A Medicated Article 49-287................................. Chlorachel-50 55-040................................. SF Mix 66 92-507................................. RobenzWith Aureomycin500 95-546................................. RobenzPlus Roxarsone 96-298................................. Avatecand BovatecPremixes 96-933................................. RobenzPlus Zn Bacitracin 97-085................................. RobenzPlus 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/ FortracinPremix 112-661................................ Avatec/ Lincomix/3- Nitro 112-687................................ Avatec/ Flavomycin/3- Nitro 114-794................................ Baciferm/Amprol HI- EPremix 121-553................................ Coban/ Aureomycin 123-154................................ Coban/3- Nitro-10/ BacifermPremix 125-933................................ Romet-30 (Sulfamerazine) 126-052................................ Avatec/ Baciferm/3- Nitro 128-686................................ Bio-CoxType A Medicated Article 131-894................................ Avatec/ Fortracin/3- NitroBroiler Premix 132-447................................ Bio-CoxPlus 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- Nitroplus Albac 137-537................................ Bio-Cox/ Lincomix 139-075................................ CygroType 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................................ CattlystType A Medicated Article 141-109................................ Avatec/ Baciferm 141-150................................ Avatec/ Stafac 200-140................................ AureozolType A Medicated Article 200-167................................ Aureozol500 Granular 200-242................................ Aureomycin-50, 70, 80, 90, 100/BMD25, 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. 01-22470Filed9-6-01; 8:45 amBILLING CODE 4160-01-S

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