[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Rules and Regulations]
[Pages 52852-52854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20538]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 524, 556, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol;
Tildipirosin; Zilpaterol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during June 2013. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable.
DATES: This rule is effective August 27, 2013.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during June 2013, 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 (Freedom of Information Summaries) under the
Freedom of Information Act (FOIA). These public documents may be seen
in the Division of Dockets Management (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 Center for Veterinary
Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, the animal drug regulations are being amended at 21
CFR 510.600 to correct a sponsor's name and at 21 CFR 556.733 to
correct the acceptable daily intake of total residues of tildipirosin.
This is being done to improve the accuracy of the regulations.
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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2013
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New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
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200-524.......... Putney, Inc., Mupirocin Original 524.1465 yes.......... CE.\1\
400 Congress Ointment 2%. approval as a
St., suite 200, generic copy
Portland, ME of NADA 140-
04101. 839.
200-517.......... Novartis Animal ZOBUXA Original 520.812 yes.......... CE.\1\
Health US, (enrofloxacin) approval as a
Inc., 3200 Flavored generic copy
Northline Ave., Antibacterial of NADA 140-
suite 300, Tablets. 441.
Greensboro, NC
27408.
200-519.......... Novartis Animal FLORVIO Original 520.995 yes.......... CE.\1\
Health US, (florfenicol) approval as a
Inc., 3200 2.3% generic copy
Northline Ave., Concentrate of NADA 141-
suite 300, Solution. 206.
Greensboro, NC
27408.
200-547.......... Huvepharma AD, ZILMAX Original 558.665 yes.......... CE.\1\
5th Floor, 3A (zilpaterol approval as a
Nikolay Haytov hydrochloride) generic copy
Str., 1113 plus RUMENSIN of NADA 141-
Sophia, (monensin USP) 276.
Bulgaria. plus TYLOVET
100 (tylosin
phosphate)
Type A
medicated
articles.
[[Page 52853]]
200-555.......... Piedmont Animal LIBREVIA Original 520.309 yes.......... CE.\1\
Health, 204 (carprofen) approval as a
Muirs Chapel Soft Chewable generic copy
Rd., suite 200, Tablets. of NADA 141-
Greensboro, NC 111.
27410.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the
requirement to submit an environmental assessment or an environmental impact statement because it is of a type
that does not individually or cumulatively have a significant effect on the human environment.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 510,
520, 524, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Purina Nutrition LLC'', and alphabetically add entries for
``Piedmont Animal Health'' and ``Purina Animal Nutrition LLC''; and in
the table in paragraph (c)(2), in the entry for ``017800'', remove
``Purina Nutrition'' and in its place add ``Purina Animal Nutrition'',
and numerically add an entry for ``058147'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * * * *
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Piedmont Animal Health, 204 Muirs Chapel Rd., suite 058147
200, Greensboro, NC 27410............................
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* * * * * * *
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Purina Animal Nutrition LLC, 1080 County Road F West, 017800
Shoreview, MN 55126-2910.............................
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* * * * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * * *
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058147....................... Piedmont Animal Health, 204 Muirs Chapel
Rd., suite 200, Greensboro, NC 27410
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* * * * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.309 [Amended]
0
4. In paragraph (b)(2) of Sec. 520.309, remove ``Nos. 000115, 055529,
and 062250'' and in its place add ``Nos. 000115, 055529, 058147, and
062250''.
0
5. In Sec. 520.812, revise paragraphs (a) and (b) to read as follows:
Sec. 520.812 Enrofloxacin.
(a) Specifications. Each tablet contains:
(1) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
(2) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (c) of this section.
(1) Nos. 000859 and 026637 for use of product described in
paragraph (a)(1) of this section.
[[Page 52854]]
(2) No. 058198 for use of product described in paragraph (a)(2) of
this section.
* * * * *
Sec. 520.955 [Amended]
0
6. In paragraph (b) of Sec. 520.955, remove ``No. 000061'' and in its
place add ``Nos. 000061 and 058198''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1465 [Amended]
0
8. In paragraph (b) of Sec. 524.1465, add ``026637,'' after
``025463,''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
9. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.733 [Amended]
0
10. In paragraph (a) of Sec. 556.733, remove ``10 micrograms'' and in
its place add ``50 micrograms''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
11. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
12. In Sec. 558.665, in the table, revise paragraph (e)(5) to read as
follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
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Combination in
Zilpaterol in grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
(5) 6.8 to provide 60 to 90 mg/ Monensin 10 to Cattle fed in As in paragraph 000061 016592
head/day. 40, plus tylosin confinement for (e)(1) of this
8 to 10. slaughter: As in section; see Sec.
paragraph (e)(1) of Sec. 558.355(d)
this section; for and 558.625(c) of
prevention and this chapter.
control of Monensin as provided
coccidiosis due to by No. 000986;
Eimeria bovis and E. tylosin as provided
zuernii; and for by Nos. 000986 or
reduction of 016592 in Sec.
incidence of liver 510.600(c) of this
abscesses caused by chapter.
Fusobacterium
necrophorum and
Arcanobacterum
(Actinomyces)
pyogenes.
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Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20538 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P