[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Rules and Regulations]
[Pages 32010-32013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13095]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol
AGENCY: Food and Drug Administration, HHS.
[[Page 32011]]
ACTION: Final rule.
-----------------------------------------------------------------------
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 April 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 May 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 protected].
SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine (CVM)
is adopting use of a monthly Federal Register document to codify
approval actions for new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs). CVM will no longer
publish a separate rule for each action. This approach will allow a
more efficient use of available resources.
In this document, FDA is amending the animal drug regulations to
reflect the original and supplemental approval actions during April
2012, as listed in table 1 of this document. FDA is also informing the
public of the availability, where applicable, of environmental review
documents 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.
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 April 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug
NADA/ANADA Sponsor product name Action 21 CFR Section FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-246.............. Intervet, Inc., 556 AQUAFLOR Supplemental 516.1215, 558.261.. yes................. EA/FONSI.\1\
Morris Ave., (florfenicol) Type approval to: (1)
Summit, NJ 07901. A medicated article. Increase the
permitted
concentrations in
Type C feeds; (2)
add an indication
for the control of
mortality due to
columnaris disease
associated with
Flavobacterium
columnare; (3) add
an indication for
the control of
mortality due to
streptococcal
septicemia
associated with
Streptococcus iniae
in freshwater-
reared warmwater
finfish; and (4)
increase the
withdrawal period
to 15 days. This
approval renders
Sec. 516.1215
obsolete.
200-456.............. Med-Pharmex, Inc., Dexamethasone Original approval of 522.540............ yes................. CE.\2\
2727 Thompson Creek Injectable Solution. a generic copy of
Rd., Pomona, CA NADA 012-559.
91767-1861.
200-481.............. Ceva Sante Animale, ALTRESYN Original approval of 520.48............. yes................. CE.\2\
10 Avenue de la (altrenogest) a generic copy of
Ballasti[egrave]re, Solution 0.22%. NADA 131-310.
33500 Libourne,
France.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Based on its review of an environmental assessment (EA) submitted by the sponsor, the Agency has concluded that this action will not have a
significant impact on the human environment and that an environmental impact statement is not required. A finding of no significant impact (FONSI) has
been prepared.
\2\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
[[Page 32012]]
21 CFR Parts 520 and 522
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 510,
516, 520, 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.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Ceva Sante Animale''; and in the table in paragraph
(c)(2), numerically add an entry for ``013744'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 013744
33500 Libourne, France.................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
013744.............................. Ceva Sante Animale, 10 Avenue de
la Ballasti[egrave]re, 33500
Libourne, France.
* * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for 21 CFR part 516 continues to read as
follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Sec. 516.1215 [Removed]
0
4. Remove Sec. 516.1215.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
6. In Sec. 520.48, revise paragraph (b) to read as follows:
Sec. 520.48 Altrenogest.
* * * * *
(b) Sponsors. See sponsor listings in Sec. 510.600(c) of this
chapter:
(1) No. 000061 for use as in paragraph (d) of this section.
(2) No. 013744 for use as in paragraph (d)(1) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
8. In Sec. 522.540, revise the section heading and paragraphs
(a)(2)(ii) and (a)(3)(iii) to read as follows:
Sec. 522.540 Dexamethasone.
(a) * * *
(2) * * *
(ii) Sponsors. See Nos. 054925 and 058005 for use as in paragraphs
(a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this
section.
(3) * * *
(iii) Do not use in horses intended for human food. 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
9. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
10. In Sec. 558.261, revise paragraphs (a)(2) and (c)(2)(i), and the
table in paragraph (e)(2) to read as follows:
Sec. 558.261 Florfenicol.
(a) * * *
(2) 500 grams per kilogram for use as in paragraph (e)(2) of this
section.
* * * * *
(c) * * *
(2) * * *
(i) For freshwater-reared finfish, must not exceed 15 days from the
date of issuance.
* * * * *
(e) * * *
(2) * * *
------------------------------------------------------------------------
Florfenicol in grams/ton of Indications for
feed use Limitations
------------------------------------------------------------------------
(i) 182 to 2,724............. Catfish: For the Feed as a sole ration
control of for 10 consecutive
mortality due to days to deliver 10 to
enteric 15 milligrams (mg)
septicemia of florfenicol per
catfish kilogram (kg) of
associated with fish. Feed containing
Edwardsiella florfenicol shall not
ictaluri. be fed for more than
10 days. Following
administration, fish
should be reevaluated
by a licensed
veterinarian before
initiating a further
course of therapy. A
dose-related decrease
in hematopoietic/
lymphopoietic tissue
may occur. The time
required for
hematopoietic/
lymphopoietic tissues
to regenerate was not
evaluated. The
effects of
florfenicol on
reproductive
performance have not
been determined.
Feeds containing
florfenicol must be
withdrawn 15 days
prior to slaughter.
------------------------------------------------------------------------
(ii) 182 to 1,816............ Freshwater-reared Feed as a sole ration
salmonids: For for 10 consecutive
the control of days to deliver 10 mg
mortality due to florfenicol per kg of
coldwater fish. Feed containing
disease florfenicol shall not
associated with be fed for more than
Flavobacterium 10 days. Following
psychrophilum administration, fish
and furunculosis should be reevaluated
associated with by a licensed
Aeromonas veterinarian before
salmonicida. initiating a further
course of therapy.
The effects of
florfenicol on
reproductive
performance have not
been determined.
Feeds containing
florfenicol must be
withdrawn 15 days
prior to slaughter.
------------------------------------------------------------------------
[[Page 32013]]
(iii) 182 to 2,724........... Freshwater-reared Feed as a sole ration
finfish: For the for 10 consecutive
control of days to deliver 10 to
mortality due to 15 mg florfenicol per
columnaris kg of fish for
disease freshwater-reared
associated with warmwater finfish and
Flavobacterium 10 mg florfenicol per
columnare. kg of fish for other
freshwater-reared
finfish. Feed
containing
florfenicol shall not
be fed for more than
10 days. Following
administration, fish
should be reevaluated
by a licensed
veterinarian before
initiating a further
course of therapy.
For catfish, a dose-
related decrease in
hematopoietic/
lymphopoietic tissue
may occur. The time
required for
hematopoietic/
lymphopoietic tissues
to regenerate was not
evaluated. The
effects of
florfenicol on
reproductive
performance have not
been determined.
Feeds containing
florfenicol must be
withdrawn 15 days
prior to slaughter.
------------------------------------------------------------------------
(iv) 273 to 2,724............ Freshwater-reared Feed as a sole ration
warmwater for 10 consecutive
finfish: For the days to deliver 15 mg
control of florfenicol per kg of
mortality due to fish. Feed containing
streptococcal florfenicol shall not
septicemia be fed for more than
associated with 10 days. Following
Streptococcus administration, fish
iniae. should be reevaluated
by a licensed
veterinarian before
initiating a further
course of therapy.
For catfish, a dose-
related decrease in
hematopoietic/
lymphopoietic tissue
may occur. The time
required for
hematopoietic/
lymphopoietic tissues
to regenerate was not
evaluated. The
effects of
florfenicol on
reproductive
performance have not
been determined.
Feeds containing
florfenicol must be
withdrawn 15 days
prior to slaughter.
------------------------------------------------------------------------
Dated: May 24, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-13095 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P