Source: https://www.federalregister.gov/documents/2001/09/17/01-23043/new-animal-drugs-change-of-sponsor-technical-amendment
Timestamp: 2020-07-04 02:58:38
Document Index: 481541508

Matched Legal Cases: ['arts 520', 'arts 510', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009510', '§\u2009520', '§\u2009520', '§\u2009520', 'art 522', '§\u2009522', '§\u2009556', '§\u2009510', 'art 558']

Federal Register :: New Animal Drugs; Change of Sponsor; Technical Amendment
New Animal Drugs; Change of Sponsor; Technical Amendment
A Rule by the Food and Drug Administration on 09/17/2001
This rule is effective September 17, 2001.
66 FR 47959
47959-47962 (4 pages)
01-23043
https://www.federalregister.gov/d/01-23043
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 16 approved abbreviated new animal drug applications (ANADAs) from Hoechst Roussel Vet to Intervet, Inc. Technical amendments are also being made. This action is being taken to improve the accuracy of the agency’s regulations.
Hoechst Roussel Vet, Perryville Corporate Park III, P.O. Box 4010, Clinton, NJ 08809-4010, has informed FDA that it has transferred ownership of, and all rights and interest in, the following NADAs and ANADAs to Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE 19966.
34-478 LASIX® Injection
34-621 LASIX® Tablets and Boluses
44-759 FLAVOMYCIN® Type A Medicated Article
45-188 LASIX® Packets
95-543 AMPROL HI-E®/FLAVOMYCIN®
95-547 AMPROL HI-E®/FLAVOMYCIN®/3-NITRO®
95-548 AMPROL®/3-NITRO®/FLAVOMYCIN®
95-549 AMPROL®/3-NITRO®/FLAVOMYCIN®
98-340 FLAVOMYCIN®/Monensin
98-341 FLAVOMYCIN®/3-NITRO®/COBAN®
101-628 FLAVOMYCIN®/3-NITRO®/ZOALENE®
101-629 FLAVOMYCIN®/ZOALENE®
102-380 LASIX® Syrup
104-494 PANACUR® 10% Suspension
111-278 PANACUR® Granules 22%
120-648 PANACUR®/SAFE-GUARD® Paste
121-473 PANACUR® Granules 22%
128-620 PANACUR®/SAFE-GUARD® 10% Suspension
130-185 FLAVOMYCIN®/Amprolium
130-661 FLAVOMYCIN®/CARB-O-SEP®
130-951 STENOROL® Type A Medicated Article
131-310 REGU-MATE® Solution
131-675 SAFE-GUARD® Type A Medicated Article
132-872 PANACUR®/SAFE-GUARD® 10% Paste
137-483 FLAVOMYCIN®/STENOROL®
137-600 SAFE-GUARD® Type A Medicated Article
138-612 FINAPLIX®-S; FINAPLIX®-H Implants
139-189 SAFE-GUARD® ENPROAL Feedblocks
139-473 STENOROL®/STAFAC®
140-339 FLAVOMYCIN®/NICARB®
140-340 STENOROL®/LINCOMIX®
140-533 STENOROL®/3-NITRO®/BMD®
140-584 STENOROL®/BMD®
140-824 STENOROL® Type A Medicated Article
140-843 MONTEBAN®/FLAVOMYCIN®/3-NITRO®
140-845 FLAVOMYCIN®/MONTEBAN®
140-897 REVALOR®-S; REVALOR®-G Implants
Start Printed Page 47960
140-918 STENOROL®/FLAVOMYCIN®
140-919 STENOROL®/BMD®
140-954 SAFE-GUARD® Type A/LINCOMIX®
140-992 REVALOR®-200; REVALOR®-H Implants
141-034 GAINPRO® Type A Medicated Article
141-129 AVATEC®/FLAVOMYCIN®
200-075 SACOX® Type A Medicated Article
200-080 SACOX®/3-NITRO®/FLAVOMYCIN®
200-081 SACOX®/3-NITRO®/BMD®
200-082 SACOX®/BMD®
200-083 SACOX®/FLAVOMYCIN®
200-086 SACOX®/ALBAC®/3-NITRO®
200-089 SACOX®/BACIFERM®
200-090 SACOX®/LINCOMIX®/3-NITRO®
200-091 SACOX®/3-NITRO®/AUREOMYCIN®
200-092 SACOX®/STAFAC®
200-093 SACOX®/LINCOMIX®
200-094 SACOX®/STAFAC®/3-NITRO®
200-095 SACOX®/AUREOMYCIN®
200-096 SACOX®/TERRAMYCIN®
200-097 SACOX®/3-NITRO®
200-143 SACOX®/3-NITRO®/BACIFERM®
Accordingly, the agency is amending the regulations in 21 CFR 520.48, 520.905a, 520.905b, 520.905c, 520.905d, 520.905e, 520.1010a, 520.1010b, 520.1010c, 522.1010, 522.2476, 522.2477, 558.55, 558.58, 558.95, 558.198, 558.258, 558.265, 558.355, 558.363, 558.366, and 558.550 to reflect the transfers of ownership. In addition, the sections in 21 CFR parts 520 and 522 are being revised to reflect current format.
Following the change of sponsor of these NADAs, Hoechst Roussel Vet is no longer the sponsor of any approved applications. Therefore, 21 CFR 510.600(c) is amended to remove the entries for this sponsor.
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 510, 520, 522, and 558 are amended as follows:
2. Section 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraph (c)(1) by removing the entry for “Hoechst Roussel Vet” and in the table in paragraph (c)(2) by removing the entry for “012799”.
4. Section 520.48 is revised to read as follows:
(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.
(d) Conditions of use—(1) Amount. 1.0 mL per 110 pounds body weight (0.044 mg per kilogram) daily for 15 consecutive days.
(2) Indications for use. For suppression of estrus in mares.
(3) Limitations. For oral use in horses only; avoid contact with the skin. Do not administer to horses intended for use as food.
§ 520.905a
5. Section 520.905a Fenbendazole suspension is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.
6. Section 520.905b Fenbendazole granules is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.
7. Section 520.905c Fenbendazole paste is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.
§ 520.905d
8. Section 520.905d Fenbendazole powder is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.
§ 520.905e
9. Section 520.905e Fenbendazole blocks is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.
10. Section 520.1010 is revised to read as follows:
§ 520.1010
(a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams (mg) furosemide.
(2) Each bolus contains 2 grams (g) furosemide.
(3) Each packet of powder contains 2 g furosemide.
(4) Each milliliter of syrup contains 10 mg furosemide.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use of dosage forms and strengths listed in Start Printed Page 47961paragraph (a) of this section for uses as in paragraph (d) of this section.
(1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section.
(2) No. 000093 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(B) of this section.
(3) No. 057926 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this section for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).
(d) Conditions of use. It is used as follows:
(1) Cattle—(i) Amount. 1 to 2 mg per pound (/lb) body weight using powder, or one 2-g bolus per animal, per day.
(ii) Indications for use. For treatment of physiological parturient edema of the mammary gland and associated structures.
(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.
(2) Dogs—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
(ii) Indications for use—(A) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
(B) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency.
(3) Cats—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
(ii) Indications for use. For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
§ 520.1010a
11. Section 520.1010a Furosemide tablets or boluses is removed.
§ 520.1010b
12. Section 520.1010b Furosemide powder is removed.
§ 520.1010c
13. Section 520.1010c Furosemide syrup is removed.
14. The authority citation for 21 CFR part 522 continues to read as follows:
15. Section 522.1010 is revised to read as follows:
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of furosemide diethanolamine.
(1) No. 000010 for use as in paragraphs (d)(1) and (d)(2)(ii) of this section.
(2) No. 000864 for use as in paragraph (d)(2)(ii) of this section.
(3) No. 057926 for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.
(B) Limitations. Do not use in horses intended for food.
16. Section 522.2476 is revised to read as follows:
§ 522.2476
(1) No. 021641 for use as in paragraphs (d)(1) and (d)(2) of this section.
(2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(ii), and (d)(2)(iii) of this section.
(c) Related tolerances. See § 556.739 of this chapter.
(d) Conditions of use—(1) Steers fed in confinement for slaughter—(i) Amount. Use 126 days prior to slaughter; should be reimplanted once after 63 days.
(A) 140 milligrams (mg) trenbolone acetate (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.
(B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.
(ii) Indications for use. For improved feed efficiency.
(iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals.
(2) Heifers fed in confinement for slaughter—(i) Amount. Use last 63 days prior to slaughter.
(A) 200 mg trenbolone acetate (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.
(B) 200 mg of trenbolone acetate (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 1 pellet containing 29 mg of tylosin tartrate) per implant dose.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.
17. Section 522.2477 is amended by revising paragraph (b) to read as follows:
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.
(1) No. 021641 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), Start Printed Page 47962(d)(1)(ii), (d)(1)(iii), and (d)(3) of this section.
(2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of this section.
18. The authority citation for 21 CFR part 558 continues to read as follows:
19. Section 558.55 Amprolium is amended in the table in paragraphs (d)(2)(iii) by removing “012799” wherever it appears under the “Limitations” and “Sponsor” columns and by adding in its place “057926”.
20. Section 558.58 Amprolium and ethopabate is amended in the table in paragraphs (d)(1)(ii) and (d)(1)(iii) by removing “012799” wherever it appears in the “Limitations” column and by adding in its place “057926”.
21. Section 558.95 Bambermycins is amended in paragraphs (a)(1), (a)(2), (a)(5), (d)(1)(vi)(b), and (d)(1)(vii)(b) by removing “012799” and by adding in its place “057926”; and in paragraphs (d)(1)(xi)(b), and (d)(1)(xii)(b) by removing “012799 and 046573” and by adding in its place “046573 and 057926”.
22. Section 558.198 Diclazuril is amended in the table in paragraphs (d)(1)(iii) by removing “012799” under the “Limitations” column and by adding in its place “057926.”
23. Section 558.258 Fenbendazole is amended in paragraph (a) by removing “012799” and by adding in its place “057926”.
24. Section 558.265 Halofuginone hydrobromide is amended in paragraph (a) by removing “012799” and by adding in its place “057926”.
25. Section 558.355 Monensin is amended in paragraphs (b)(10), (f)(2)(v)(b), and (f)(2)(vi)(b) by removing “012799” and by adding in its place “057926”.
26. Section 558.363 Narasin is amended in paragraphs (a)(4), (a)(5), (d)(1)(vii)(B), and (d)(1)(xii)(B) by removing “012799” and by adding in its place “057926”.
27. Section 558.366 Nicarbazin is amended in the table in paragraph (c) in the entry for “Bambermycins 1 to 2” under the “Sponsor” column by removing “012799” and by adding in its place “057926”.
28. Section 558.550 Salinomycin is amended in paragraph (a)(2) by removing “012799” and by adding in its place “057926”; and in paragraphs (d)(1)(xv)(c) and (d)(1)(xvi)(c) by removing “012799 and 046573” and by adding in its place “046573 and 057926”.
[FR Doc. 01-23043 Filed 9-14-01; 8:45 am]