Source: https://www.federalregister.gov/documents/2017/09/18/2017-19602/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsors-address
Timestamp: 2018-09-21 14:32:54
Document Index: 759577919

Matched Legal Cases: ['§\u2009510', 'art 558', '§\u2009510', '§\u2009520', '§\u2009520', 'art 522', '§\u2009522', '§\u2009510', '§\u2009522', '§\u2009522', '§\u2009522', '§\u2009522', '§\u2009524', '§\u2009524', 'art 558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558']

Federal Register :: New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
A Rule by the Food and Drug Administration on 09/18/2017
43482-43485 (4 pages)
https://www.federalregister.gov/d/2017-19602 https://www.federalregister.gov/d/2017-19602
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.
Start Further Info Start Printed Page 43483
FDA is amending the animal drug regulations to reflect approval actions for a NADA and ANADAs during March and April 2017, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Dockets Management Staff Office (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/​AnimalVeterinary/​Products/​ApprovedAnimalDrugProducts/​default.htm.
Table 1—Original and Supplemental NADAs and ANADAs Approved During March and April 2017
April 24, 2017 141-269 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 REVALOR-XH (trenbolone acetate and estradiol extended-release implant) Cattle Supplemental approval of a new implant for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation in beef heifers fed in confinement for slaughter FOI Summary, EA/FONSI.1
April 19, 2017 200-593 Accord Healthcare, Inc., 1009 Slater Rd., Suite 210-B, Durham, NC 27703 Carprofen Injection Dogs Original approval as a generic copy of NADA 141-199 FOI Summary.
April 28, 2017 200-595 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland CARPRIEVE (carprofen) Chewable Tablets Dogs Original approval as a generic copy of NADA 141-111 FOI Summary.
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405, has informed FDA that it has changed its address to 1800 Sir Tyler Dr., Wilmington, NC 28405. Accordingly, we are amending § 510.600(c) to reflect this change.
We are making several technical amendments in part 558, which was amended on December 27, 2016 (81 FR 94991), and February 24, 2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. We are also making several technical amendments to the regulations for dosage form drugs. These actions are being taken to improve the accuracy of the regulations.
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.
Start Printed Page 43484 Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. In § 510.600, in the table in paragraph (c)(1), revise the entry for “Pharmgate LLC”; and in the table in paragraph (c)(2), revise the entry for “069254” to read as follows:
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 069254
069254 Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405
4. In § 520.88g, in paragraphs (c)(1)(ii) and (c)(2)(ii), in the first sentence, remove “nonbeta-lactamase” and in its place add “non-beta-lactamase”.
5. In § 520.304, remove paragraph (b)(3) and revise paragraphs (b)(1) and (2) to read as follows:
(1) Nos. 054771, 026637, 055529, and 062250 for use of products described in paragraph (a) as in paragraph (d) of this section.
(2) No. 000859 for use of product described in paragraph (a)(1) as in paragraph (d) of this section.
6. The authority citation for part 522 continues to read as follows:
7. In § 522.304, revise paragraph (b) to read as follows:
(b) Sponsors. See Nos. 016729, 026637, 054771, and 055529 in § 510.600(c) of this chapter.
8. In § 522.970, revise paragraph (b)(1); remove paragraphs (b)(3), (e)(2)(ii)(B), and (e)(2)(iii); and add two sentences after the italic heading of paragraph (e)(2)(ii), to read as follows:
(1) See Nos. 000061, 000859, 055529, 057561, and 061623 for use as in paragraph (e) of this section.
(ii) Limitations. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. * * *
9. In § 522.1002, revise paragraph (b)(1) to read as follows:
10. In § 522.1660a, revise the first sentence of paragraph (e)(1)(ii) to read as follows:
(ii) Limitations. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in adult beef and dairy cattle may result in antibiotic residues beyond the withdrawal time. * * *
11. In § 522.2477, revise paragraph (b)(2) and the first sentence in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii); and add paragraph (d)(5) to read as follows:
(iii) Limitations. Administer implant subcutaneously in the ear only. * * *
(iii) Limitations. Administer implant subcutaneously in the ear only. Do not use in lactating dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Do not use in calves to be processed for veal. A withdrawal period has not been established for this product in pre-ruminating calves. Effectiveness Start Printed Page 43485and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (beef heifers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated.
13. In § 524.998, add paragraph (c)(2) to read as follows:
§ 524.998
14. The authority citation for part 558 continues to read as follows:
15. In § 558.4, in paragraph (d), in the “Category II” table, revise the row entries for “Neomycin” and “Oxytetracycline” to read as follows:
Assay limits percent Type A 1
Assay limits percent Type B/C 2
Neomycin 80-120 20 g/lb (4.4%) 70-125
Oxytetracycline 80-120 20 g/lb (4.4%) 65-135
16. In § 558.128, in paragraphs (e)(4)(iii) and (xii) and (e)(5)(ii) and (iii), in the “Sponsor” column, add “069254” after “054771”; in paragraphs (e)(4)(xi) and (xiii), in the “Limitations” column, remove the third sentence “Withdraw 24 hours prior to slaughter.”; and in paragraph (e)(6)(v), remove “ Sponsor. See No. 054771” and in its place add “Sponsors. See Nos. 054771 and 069254”.
17. Amend § 558.625 as follows:
a. In paragraphs (e)(1)(vii) and (ix), in the “Tylosin grams/ton” column, remove “40 to 100” and in its place add “40 or 100”;
b. In paragraph (e)(2)(ii), in the “Limitations” column, add “See §§ 558.311(d) and 558.342(d) in this chapter.” after the last sentence;
c. In paragraph (e)(2)(iii), in the “Limitations ” column, add “See § 558.342(d) in this chapter.” after the last sentence;
d. In paragraph (e)(2)(vi), in the “Limitations” column, remove “See § 558.355(d) in this chapter” and in its place add “See §§ 558.311(d) and 558.355(d) in this chapter.”;
e. In paragraph (e)(2)(vii), in the “Limitations” column, remove “See § 558.355(d) in this chapter” and in its place add “See §§ 558.342(d) and 558.355(d) in this chapter.”;
f. In paragraphs (e)(2)(viii), (ix), and (x), in the “Limitations” column, remove “See § 558.355(d) in this chapter” and in its place add “See §§ 558.355(d) and 558.500(d) in this chapter.”
g. In paragraph (e)(2)(xi) in the “Limitations” column, remove “See § 558.355(d) in this chapter.” and in its place add “See §§ 558.342(d), 558.355(d), and 558.500(d) in this chapter.”;
h. In paragraphs (e)(2)(xii) and (xiii), in the “Limitations” column, remove “See § 558.355(d) in this chapter.” and in its place add “See §§ 558.355(d) and 558.665(d) in this chapter.”; and
i. In paragraphs (e)(2)(xiv) and (xv), in the “Limitations” column, remove “See § 558.355(d) in this chapter.” and in its place add “See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter.”
[FR Doc. 2017-19602 Filed 9-15-17; 8:45 am]