[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Rules and Regulations]
[Pages 19986-19987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07571]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin
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 and abbreviated new animal drug applications during
February 2013. FDA is also informing the public of the availability of
summaries the basis of approval and of environmental review documents,
where applicable.
DATES: This rule is effective April 3, 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 new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) during February
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 (FOI 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 (CVM) 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 the spelling of a street name in the sponsor's
address, and at 21 CFR 558.618 to clarify the dosage of tilmicosin
phosphate in medicated feeds for beef and non-lactating dairy cattle.
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.
[[Page 19987]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During February 2013
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New animal drug 21 CFR FOIA NEPA
NADA/ANADA Sponsor product name Action section Summary Review
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200-495........... Norbrook ENROFLOX 100 Original approval 522.812 yes......... CE \1\
Laboratories, (enrofloxacin) as a generic
Ltd., Station Injectable copy of NADA 141-
Works, Newry Solution. 068.
BT35 6JP,
Northern Ireland.
200-509........... Huvepharma AD, TILMOVET 90 Original approval 558.618 yes......... CE \1\
5th Floor, 3A (tilmicosin as a generic
Nikolay Haytov phosphate) Type copy of NADA 141-
Str., 1113 A medicated 064.
Sophia, Bulgaria. article.
200-531........... Huvepharma AD, TYLOVET 100 Original approval 558.355 yes......... CE \1\
5th Floor, 3A (tylosin as a generic
Nikolay Haytov phosphate) and copy of NADA 104-
Str., 1113 RUMENSIN 646.
Sophia, Bulgaria. (monensin) Type
A medicated
articles.
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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 Part 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feed.
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,
522, 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.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), in the entry for
``Huvepharma AD'', remove ``Haitov'' and in its place add ``Haytov'';
and in the table in paragraph (c)(2), in the entry for ``016592'',
remove ``Haitov'' and in its place add ``Haytov''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.812, revise paragraphs (b) and (e)(3)(ii); and add
introductory text to paragraph (e)(2) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter:
(1) No. 000859 for use of products described in paragraph (a) as in
paragraph (e) of this section; and
(2) No. 055529 for use of product described in paragraph (a)(2) as
in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i), and
(e)(3)(iii) of this section.
* * * * *
(e) * * *
(2) Cattle. Use the product described in paragraph (a)(2) of this
section as follows:
* * * * *
(3) * * *
(ii) Indications for use--(A) For the treatment and control of
swine respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma
hyopneumoniae.
(B) For the treatment and control of swine respiratory disease
(SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella
multocida, Haemophilus parasuis, and Streptococcus suis.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
6. In Sec. 558.355, remove and reserve paragraph (f)(3)(ix); and in
paragraphs (f)(3)(ii)(b) and (f)(3)(xii)(b), add a new last sentence to
read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) * * *
(ii) * * *
(b) * * * Tylosin provided by Nos. 000986 and 016592 in Sec.
510.600(c) of this chapter.
* * * * *
(xii) * * *
(b) * * * Tylosin provided by Nos. 000986 and 016592 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 558.618 [Amended]
0
7. Amend Sec. 558.618 as follows:
0
a. In paragraph (b), remove ``No. 000986'' and in its place add ``Nos.
000986 and 016592'';
0
b. In the table in paragraph (e)(1)(i), in the ``Sponsor'' column, add
``, 016592'' after ``000986'';
0
c. In the table in paragraph (e)(1)(ii), in the ``Sponsor'' column,
remove ``000986'';
0
d. In the table in paragraph (e)(2)(i), in the ``Limitations'' column,
in the first sentence, remove ``12.5 milligrams/kilogram/head/day'' and
in its place add ``12.5 mg tilmicosin/kg of bodyweight/day''; and
0
e. In the table in paragraphs (e)(2)(ii) and (e)(2)(iii), in the
``Limitations'' column, in the first sentence, remove ``12.5 milligrams
tilmicosin/kilogram/head/day'' and in its place add ``12.5 mg
tilmicosin/kg of bodyweight/day''.
Dated: March 26, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-07571 Filed 4-2-13; 8:45 am]
BILLING CODE 4160-01-P