New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin
Federal Register, Volume 78 Issue 83 (Tuesday, April 30, 2013)
Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)
Rules and Regulations
Pages 25182-25184
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-10152
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 558
Docket No. FDA-2013-N-0002
New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and 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 March 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 30, 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, george.haibel@fda.hhs.gov.
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 March 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 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 522.558 to add a new strength of dexmedetomidine hydrochloride injectable solution for use in dogs and cats. This change is being made 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 March 2013
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New animal drug product 21 CFR
NADA/ANADA Sponsor name Action section FOIA summary NEPA review
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200-532.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.342 yes........... CE \1\
Floor, 3A Nikolay phosphate) and MGA as a generic copy
Haytov Str., 1113 (melegestrone acetate) of NADA 139-192.
Sophia, Bulgaria. Type A medicated
articles.
200-533.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.195 yes........... CE \1\
Floor, 3A Nikolay phosphate) and RUMENSIN as a generic copy
Haytov Str., 1113 (monensin) and DECCOX of NADA 141-149.
Sophia, Bulgaria. (decoquinate) Type A
medicated articles.
Page 25183
200-535.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.342 yes........... CE \1\
Floor, 3A Nikolay phosphate) and BOVATEC as a generic copy
Haytov Str., 1113 (lasalocid) and MGA of NADA 138-992.
Sophia, Bulgaria. (melegestrone acetate)
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 (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant
effect on the human environment.
List of Subjects
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 522 and 558 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
-
The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
-
In Sec. 522.558, revise paragraph (a) to read as follows:
Sec. 522.558 Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains 0.5 or 1.0 milligrams dexmedetomidine hydrochloride.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
-
The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
0
-
In Sec. 558.195, in the table, in paragraph (e)(2)(v), revise the last sentence in the ``Limitations'' column and revise the ``Sponsor'' column to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
(2) * * *
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Combination in Indications for
Decoquinate in grams per ton grams per ton use Limitations Sponsor
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* * * * * * *
(v) * * *................... ................ ................ * * * Monensin as 016592, 046573
provided by No.
000986, and tylosin
as provided by Nos.
000986 and 016592
in Sec.
510.600(c) of this
chapter.
* * * * * * *
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* * * * *
0
-
In Sec. 558.342, in the table, in paragraphs (e)(1)(iv) and (e)(1)(ix), revise the last sentence in the ``Limitations'' column and revise the ``Sponsor'' column to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
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Melengestrol acetate Combination in mg/ Indications for
in mg/head/day head/day use Limitations Sponsor
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* * * * * * *
(iv) * * *............ .................. .................. * * * Lasalocid 000009, 000986, 016592
provided by No.
046573, and tylosin
provided by Nos.
000986 and 016592 in
Sec. 510.600(c) of
this chapter.
* * * * * * *
(ix) * * *............ .................. .................. Tylosin provided by 000009, 000986, 016592
Nos. 000986 and
016592 in Sec.
510.600(c) of this
chapter.
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Dated: April 25, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2013-10152 Filed 4-29-13; 8:45 am
BILLING CODE 4160-01-P
