[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Rules and Regulations]
[Pages 21126-21127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08445]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
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 March 2014. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect a change of sponsorship for an ANADA.
DATES: This rule is effective April 15, 2014.
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 March 2014, 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. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Also, the regulations are being amended to reflect the previous
approval of revised food safety warnings for ceftiofur sodium powder
for injection. This amendment 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.
[[Page 21127]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2014
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New animal drug 21 CFR
NADA/ ANADA Sponsor product name Action Section FOIA Summary NEPA Review
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200-468........ Cross Vetpharm GENTAMED-P for Original 522.1044 yes........... CE.1 2
Group Ltd., Poultry approval as a
Broomhill Rd., (gentamicin generic copy of
Tallaght, sulfate) NADA 101-862.
Dublin 24, Injection.
Ireland.
200-529........ Cross Vetpharm XYLAMED Original 522.2662 yes........... CE.1 2
Group Ltd., (xylazine) approval as a
Broomhill Rd., Injection. generic copy of
Tallaght, NADA 047-956.
Dublin 24,
Ireland.
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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.
\2\ CE granted under 21 CFR 25.33(a)(1).
List of Subjects in 21 CFR Part 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 part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In 522.313c, revise paragraph (d) to read as follows:
Sec. 522.313c Ceftiofur sodium.
* * * * *
(d) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian. Federal law prohibits
extra-label use of this drug in cattle, swine, chickens, and turkeys
for disease prevention purposes; at unapproved doses, frequencies,
durations, or routes of administration; and in unapproved major food-
producing species/production classes.
* * * * *
Sec. 522.1044 [Amended]
0
3. In Sec. 522.1044, in paragraph (b)(4), remove ``No. 000859'' and in
its place add ``Nos. 000859 and 061623''.
Sec. 522.2662 [Amended]
0
4. In Sec. 522.2662, in paragraph (b)(2), remove ``No. 000010'' and in
its place add '' Nos. 000010 and 061623''.
Dated: April 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-08445 Filed 4-14-14; 8:45 am]
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