# [Amended]
**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/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 § 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**
Animal drugs.
Animal drugs, Animal feeds.
**21 CFR Part 522, 524, 558**
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.
§ 522.575
**21 CFR Part 522**
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:
**Authority:**
21 U.S.C. 360b.
§ 524.520
**21 CFR Part 524**
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.
§ 558.58
**21 CFR Part 558**
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.
§ 558.76
**21 CFR Part 558**
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:
§ 558.78
(a) * * *
(1) No. 046573: 10, 25, 40, and 50 grams per pound as in paragraph (d) of this section.
§ 558.95
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”.
§ 558.120
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:
§ 558.128
(a) *Approvals* . See sponsors in § 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.
§ 558.140
12. Section 558.140 *Chlortetracycline and sulfamethazine* is amended in paragraph (a) by removing “063238” and by adding in its place “046573”.
§ 558.145
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”.
§ 558.155
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”.
§ 558.195
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”.
§ 558.305
16. Section 558.305 *Laidlomycin propionate potassium* is amended in paragraph (a) by removing “063238” and by adding in its place “046573”.
§ 558.311
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”.
§ 558.340
18. Section 558.340 *Maduramicin ammonium* is amended in paragraph (a) by removing “063238” and by adding in its place “046573”.
§ 558.355
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”.
§ 558.363
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”.
§ 558.366
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”.
§ 558.515
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”.
§ 558.550
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)* ”.
§ 558.575
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”.
§ 558.582
25. Section 558.582 *Sulfamerazine* is amended in paragraph (a) by removing “063238” and by adding in its place “046573”.
§ 558.600
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.