Source: https://www.federalregister.gov/documents/2007/01/10/E7-118/new-animal-drugs-change-of-sponsor
Timestamp: 2018-03-22 10:49:38
Document Index: 268568889

Matched Legal Cases: ['§\u2009510', '§\u2009520', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558']

This rule is effective January 10, 2007.
72 FR 1173
1173-1174 (2 pages)
https://www.federalregister.gov/d/E7-118 https://www.federalregister.gov/d/E7-118
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 14 approved new animal drug applications (NADAs) from ADM Animal Health & Nutrition Division to ADM Alliance Nutrition, Inc.
ADM Animal Health & Nutrition Division, 1000 North 30th St., Box 1C, Quincy, IL 62305-3115 has informed FDA that it has transferred ownership of, and all rights and interest in, the following 14 approved NADAs to ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115:
048-480 Chloratet 50
065-256 Chlortet-Soluble-O
091-582 Gilt Edge TYLAN Mix
107-957 TYLAN 20 Sulfa-G, TYLAN 40 Sulfa-G
108-484 HFA Tylosin-10 Plus Sulfa
110-045 Good-Life TYLAN 10 Premix
110-439 HFA Hygromix 2.4 Medicated Premix
118-877 Ban-A-Worm Pyrantel Tartrate Ton Pack
128-411 TYLAN 5 Sulfa Premix
131-956 TYLAN Sulfa-G
131-957 TYLAN 10, TYLAN 20, TYLAN 40, TYLAN 5
132-448 FLAVOMYCIN
133-490 Ban-D-Wormer II BANMINTH
140-842 Hygromix 2.4 Premix
Accordingly, the agency is amending the regulations in 21 CFR 520.445b, 558.95, 558.128, 558.274, 558.485, 558.625, and 558.630 to reflect the transfer of ownership and a current format.
In addition, ADM Animal Health & Nutrition Division is no longer a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove entries for the firm.
2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “ADM Animal Health & Nutrition Division”; and in the table in paragraph (c)(2), remove the entry for “017519”.
4. In § 520.445b, revise the section heading, and paragraphs (b) and (d)(4)(iii)(C) to read as follows:
(1) No. 048164 for use as in paragraph (d) of this section.
(2) No. 053501 for use as in paragraph (d)(4) of this section.
(3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (iv) of this section.
(4) Nos. 021930 and 059130 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.
(C) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 5 days. For Nos. 000010 and 021930, do not slaughter animals for food within 5 days of treatment; for No. 053501, do not slaughter animals for food within 24 hours of treatment.
6. In paragraph (a)(4) of § 558.95, remove “016968, 017519, and 017790” and in its place add “Nos. 016968, 017790, and 021930”.
7. In § 558.128, in paragraph (b)(2), remove “017519” and in its place add “021930”; and in the tables in paragraphs (e)(1) through (e)(4), in the “Sponsor” column remove “017519” wherever it occurs and in its place add “021930”.
8. In § 558.274, in paragraph (a)(7), remove “017519” and in its place add “021930”; and in the table in paragraphs (c)(1)(i) and (c)(1)(ii), in the “Sponsor” column remove “017519” and in numerical sequence add “021930”.
9. In paragraph (b)(3) of § 558.485, remove “017519” and in numerical sequence add “021930”.
10. In paragraph (b)(10) of § 558.625, remove “017519” and in its place add “021930”.
11. In § 558.630, remove and reserve paragraphs (b)(3) and (b)(8); and in paragraph (b)(10) remove “017519”.
[FR Doc. E7-118 Filed 1-9-07; 8:45 am]