[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Rules and Regulations]
[Pages 5713-5715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01647]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Cefpodoxime; Meloxicam
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
[[Page 5714]]
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during December 2012. 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 January 28, 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 several original ANADAs during December
2012, 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 FOIA
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
Table 1--Original ANADAs Approved During December 2012
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New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
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200-485........... Accord Meloxicam Original 522.1367 yes......... CE\1\
Healthcare, Injection. approval as a
Inc., 1009 generic copy of
Slater Rd., NADA 141-219.
suite 210-B,
Durham, NC 27703.
200-491........... Norbrook LOXICOM Original 522.1367 yes......... CE\1\
Laboratories, (meloxicam) approval as a
Ltd., Station Solution for generic copy of
Works, Newry Injection. NADA 141-219.
BT35 6JP,
Northern Ireland.
200-543........... Putney, Inc., 400 Cefpodoxime Original 520.370 yes......... CE\1\
Congress St., Proxetil Tablets. approval as a
suite 200, generic copy of
Portland, ME NADA 141-232.
04101.
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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.
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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
Animal drugs.
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, and 522 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]
2. In Sec. 510.600, in the table in paragraph (c)(1),
alphabetically add an entry for ``Accord Healthcare, Inc.'' and revise
the entry for ``Jurox Pty. Ltd.''; and in the table in paragraph
(c)(2), numerically add an entry for ``016729'' and revise the entry
for ``049480'' to read as follows:
(1) * * *
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Drug labeler
Firm name and address code
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* * * * *
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, 016729
Durham, NC 27703.......................................
* * * * *
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, 049480
Australia..............................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
016729.............................. Accord Healthcare, Inc., 1009
Slater Rd., suite 210-B, Durham,
NC 27703
* * * * *
049480.............................. Jurox Pty. Ltd., 85 Gardiner St.,
Rutherford, NSW 2320, Australia
* * * * *
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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. 520.370 [Amended]
0
4. In paragraph (b) of Sec. 520.370, remove ``No. 000009'' and in its
place add ``Nos. 000009 and 026637''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
[[Page 5715]]
Sec. 522.1367 [Amended]
0
6. In paragraph (b) of Sec. 522.1367, remove ``No. 000010'' and in its
place add ``Nos. 000010, 016729, and 055529''.
Dated: January 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-01647 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-01-P