[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Rules and Regulations]
[Pages 76862-76864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31397]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 529, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam;
Pradofloxacin; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 November 2012. 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 December 31, 2012.
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:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect original and supplemental approval actions during November
2012, as listed in table 1 of this document. 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
[[Page 76863]]
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 FOIA Electronic Reading
Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
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 November 2012
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New animal drug FOIA
NADA/ ANADA Sponsor product name Action 21 CFR Section summary NEPA review
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141-344........................ Bayer HealthCare VERAFLOX Original approval for 520.1860 Yes CE \1\
LLC, Animal (pradofloxacin) the treatment of skin
Health Division, Oral Suspension infections (wounds and
P.O. Box 390, for Cats. abscesses) in cats
Shawnee Mission, caused by susceptible
KS 66201. strains of Pasteurella
multocida,
Streptococcus canis,
S. aureus, S. felis,
and S.
pseudintermedius.
141-346........................ Abbott OROCAM (meloxicam) Original approval for 529.1350 Yes CE \1\
Laboratories, Transmucosal Oral the control of pain
Inc., North Spray. and inflammation
Chicago, IL 60064. associated with
osteoarthritis in dogs.
141-068........................ Bayer HealthCare BAYTRIL 100 Supplemental approval 522.812 Yes CE \1\
LLC, Animal (enrofloxacin) adding treatment and
Health Division, Injectable control of swine
P.O. Box 390, Solution. respiratory disease
Shawnee Mission, associated with
KS 66201. Bordetella
bronchiseptica and
Mycoplasma
hyopneumoniae.
200-534........................ Huvepharma AD, 5th TYLOVET 100 Original approval as a 558.342 Yes CE \1\
Floor, 3A Nikolay (tylosin generic copy of NADA
Haitov St., 1113 phosphate) and 138-870.
Sophia, Bulgaria. RUMENSIN
(monensin) and
MGA
(melengestrone
acetate) liquid
and dry,
combination drug
Type C medicated
feeds.
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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 Parts 520, 522, and 529
Animal drugs.
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 520,
522, 529, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 520.1860 to read as follows:
Sec. 520.1860 Pradofloxacin.
(a) Specifications. Each milliliter of suspension contains 25
milligrams (mg) pradofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian. Federal law prohibits
the extralabel use of this drug in food-producing animals.
(d) Conditions of use in cats--(1) Amount. Administer 3.4 mg/lb
(7.5 mg/kg) body weight once daily for 7 consecutive days.
(2) Indications for use. For the treatment of skin infections
(wounds and abscesses) in cats caused by susceptible strains of
Pasteurella multocida, Streptococcus canis, Staphylococcus aureus,
Staphylococcus felis, and Staphylococcus pseudintermedius.
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 paragraph (e)(3)(ii) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(e) * * *
(3) * * *
(ii) Indications for use. 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.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
6. Add Sec. 529.1350 to read as follows:
Sec. 529.1350 Meloxicam.
(a) Specifications. Each milliliter of solution contains 5
milligrams (mg) meloxicam.
(b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter.
[[Page 76864]]
(c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per
kilogram of body weight once daily using the metered dose pump.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
7. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.342 [Amended]
0
8. In Sec. 558.342, in the table, in paragraph (e)(1)(xi), in the
``Limitations'' column, revise the last sentence to read ``Monensin
provided by No. 000986 and tylosin provided by Nos. 000986 and 016592
in Sec. 510.600(c) of this chapter.''; and in the ``Sponsor'' column,
add ``016592''.
Dated: December 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31397 Filed 12-28-12; 8:45 am]
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