New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol, 32010-32013 [2012-13095]
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32010
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Rules and Regulations
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
2012–11–07 Honeywell International, Inc.:
Amendment 39–17070; Docket No.
FAA–2012–0195; Directorate Identifier
2012–NE–08–AD.
(a) Effective Date
This AD is effective July 5, 2012.
(b) Affected ADs
None.
(c) Applicability
This AD applies to Honeywell
International, Inc. ALF502L–2C; ALF502R–3;
ALF502R–3A; ALF502R–5; LF507–1F; and
LF507–1H turbofan engines.
(d) Unsafe Condition
This AD was prompted by two reports of
engines experiencing uncontained release of
low-pressure (LP) turbine blades. We are
issuing this AD to prevent LP turbine
overspeed leading to uncontained release of
the LP turbine blades and damage to the
airplane.
(e) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
mstockstill on DSK4VPTVN1PROD with RULES1
(f) Initial Check of the Overspeed Trip
System
Within 30 operating hours after the
effective date of this AD, perform an initial
check of the overspeed trip system, in
accordance with the applicable paragraphs
for your engine as follows:
(1) ALF502L–2C Engines
(i) With engine operating at 65 percent NL
(N1) speed (28 to 30 percent if overspeed
controller 2–303–052–04 or later is installed),
pull toggle lever of cockpit OVERSPEED
TEST/RESET switch and hold in the
OVERSPEED TEST position.
(ii) Activation of the engine overspeed
system shall be verified by:
(A) Engine OVERSPEED TRIP light
illuminated in cockpit.
(B) Reduction of engine NH (N2) speed.
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(C) When engine NH (N2) speed begins to
decrease, retract engine power lever to fuel
cutoff position and turn off fuel boost pumps.
(D) Release lever of engine cockpit
OVERSPEED TEST/RESET Switch.
(E) When engine is completely shut down,
reset the engine Overspeed System by
momentarily holding the engine cockpit
OVERSPEED TEST/RESET switch on the
RESET position.
(F) If engine does not shut down, manually
shut down engine and perform a detailed
functional test of the overspeed system.
Guidance on performing a detailed functional
test of the overspeed system can be found in
the applicable engine maintenance manual
instructions.
(2) ALF502R–3; ALF502R–3A; ALF502R–5,
and LF507–1H Engines
(i) With engine operating at ground idle,
set engine NL (N1) speed to 30 to 35 percent.
(ii) Press cockpit OVERSPEED TEST
switch and hold.
(iii) Activation of the engine overspeed
system shall be verified by:
(A) Engine OVERSPEED TRIP light
illuminated in cockpit.
(B) Shutdown of the engine [zero NH (N2)
speed].
(iv) Release cockpit OVERSPEED TEST
switch and retract power lever to fuel cutoff
position.
(v) When the engine is completely shut
down, reset the engine overspeed system.
(vi) If engine does not shut down,
manually shut down engine and perform a
detailed functional test of the overspeed
system. Guidance on performing a detailed
functional test of the overspeed system can
be found in the applicable engine manual
instructions.
(3) LF507–1F Engines
(i) With engine operating at ground idle,
set engine NL (N1) speed to 30 to 35 percent.
(ii) Activate cockpit overspeed test circuit
(GRND TEST ENG OVSPD).
(iii) After NL (N1) speed begins to decay,
retard the throttle to the fuel cutoff position.
(iv) Verify the following conditions:
(A) Engine shutdown.
(B) Overspeed system light (ENG OVSPD)
is illuminated in cockpit.
(v) Reset overspeed system circuit power.
(vi) If engine does not shut down,
manually shut down engine and perform a
detailed functional test of the overspeed
system. Guidance on performing a detailed
functional test of the overspeed system can
be found in the applicable engine manual
instructions.
(g) Repetitive Checks of the Overspeed Trip
System
(1) For ALF502L–2C engines, perform
repetitive checks of the overspeed trip system
at 100-hour intervals of operation, as
specified in paragraph (f)(1) of this AD.
(2) For ALF502R–3; ALF502R–3A;
ALF502R–5; and LF507–1H engines, perform
repetitive checks of the overspeed trip system
once every flight day, as specified in
paragraph (f)(2) of this AD.
(3) For LF507–1F engines, perform
repetitive checks of the overspeed trip system
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once every flight day, as specified in
paragraph (f)(3) of this AD.
(h) Definition
For the purpose of this AD, a flight day is
a 24-hour period during which at least one
flight is indicated.
(i) Signing Off of Daily Repetitive Checks
Upon starting the daily repetitive checks,
only one sign-off is required attesting to the
daily check implementation.
(j) Alternative Methods of Compliance
(AMOCs)
The Manager, Los Angeles Aircraft
Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR
39.19 to make your request.
(k) Related Information
For more information about this AD,
contact Robert Baitoo, Aerospace Engineer,
Los Angeles Aircraft Certification Office,
FAA, 3960 Paramount Blvd., Lakewood, CA
90712; phone: 562–627–5245; fax: 562–627–
5210; email: robert.baitoo@faa.gov.
Issued in Burlington, Massachusetts, on
May 23, 2012.
Peter A. White,
Manager Engine & Propeller Directorate,
Aircraft Certification Service.
[FR Doc. 2012–13082 Filed 5–30–12; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 748
Applications (Classification, Advisory,
and License) and Documentation
CFR Correction
In Title 15 of the Code of Federal
Regulations, Parts 300 to 799, revised as
of April 1, 2012, on page 459, in
Supplement 7 to part 748, in the fourth
column of the table, the two entries for
‘‘National Semiconductor Hong Kong
Limited’’ are removed.
■
[FR Doc. 2012–13246 Filed 5–30–12; 8:45 am]
BILLING CODE 1505–01–D
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.
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31MYR1
32011
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Rules and Regulations
ACTION:
Final rule.
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.
SUMMARY:
DATES:
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,
SUPPLEMENTARY INFORMATION:
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,
george.haibel@fda.hhs.gov.
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: https://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
NADA/
ANADA
Sponsor
141–246 .......
Intervet, Inc., 556
Morris Ave.,
Summit, NJ
07901.
AQUAFLOR
(florfenicol) Type A
medicated article.
200–456 .......
Med-Pharmex,
Inc., 2727
Thompson
Creek Rd., Pomona, CA
91767–1861.
Ceva Sante
Animale, 10
Avenue de la
`
Ballastiere,
33500
Libourne,
France.
Dexamethasone
Injectable Solution.
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200–481 .......
New animal drug
product name
ALTRESYN
(altrenogest) Solution
0.22%.
Action
FOIA
summary
21 CFR Section
NEPA
review
Supplemental approval to: (1)
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 freshwaterreared warmwater finfish;
and (4) increase the withdrawal period to 15 days.
This approval renders
§ 516.1215 obsolete.
Original approval of a generic
copy of NADA 012–559.
516.1215,
558.261.
yes ...............
EA/FONSI.1
522.540 ..............
yes ...............
CE.2
Original approval of a generic
copy of NADA 131–310.
520.48 ................
yes ...............
CE.2
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
Reporting and recordkeeping
requirements.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
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21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
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31MYR1
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Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Rules and Regulations
21 CFR Parts 520 and 522
Drug labeler
code
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:
*
*
013744 .........
*
*
*
Ceva Sante Animale, 10 Ave`
nue de la Ballastiere,
33500 Libourne, France.
*
*
*
*
*
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for 21 CFR
part 516 continues to read as follows:
■
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 516.1215
2. In § 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:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■
■
[Removed]
4. Remove § 516.1215.
5. The authority citation for 21 CFR
part 520 continues to read as follows:
■
6. In § 520.48, revise paragraph (b) to
read as follows:
*
§ 520.48
*
Firm name and address
*
*
*
Ceva Sante Animale, 10 Av`
enue de la Ballastiere,
33500 Libourne, France ....
*
*
*
Altrenogest.
*
Drug labeler
code
*
*
013744
*
*
*
*
*
*
(b) Sponsors. See sponsor listings in
§ 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
7. The authority citation for 21 CFR
part 522 continues to read as follows:
■
(2) * * *
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
9. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
■
*
§ 522.540
Authority: 21 U.S.C. 360b.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
(c) * * *
(1) * * *
8. In § 522.540, revise the section
heading and paragraphs (a)(2)(ii) and
(a)(3)(iii) to read as follows:
■
■
PART 510—NEW ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
Firm name and address
10. In § 558.261, revise paragraphs
(a)(2) and (c)(2)(i), and the table in
paragraph (e)(2) to read as follows:
■
§ 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) * * *
Indications for use
Limitations
(i) 182 to 2,724 ..........
Catfish: For the control of mortality due
to enteric septicemia of catfish associated with Edwardsiella ictaluri.
Feed as a sole ration for 10 consecutive days to deliver 10 to 15 milligrams
(mg) florfenicol per kilogram (kg) of fish. 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. 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 .........
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Florfenicol in grams/
ton of feed
Freshwater-reared salmonids: For the
control of mortality due to coldwater
disease
associated
with
Flavobacterium psychrophilum and
furunculosis
associated
with
Aeromonas salmonicida.
Feed as a sole ration for 10 consecutive days to deliver 10 mg florfenicol per
kg of fish. 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. The effects of
florfenicol on reproductive performance have not been determined. Feeds
containing florfenicol must be withdrawn 15 days prior to slaughter.
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31MYR1
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Rules and Regulations
32013
Florfenicol in grams/
ton of feed
Indications for use
Limitations
(iii) 182 to 2,724 ........
Freshwater-reared finfish: For the control of mortality due to columnaris
disease
associated
with
Flavobacterium columnare.
Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg
florfenicol per kg of fish for freshwater-reared warmwater finfish and 10 mg
florfenicol per 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 warmwater finfish:
For the control of mortality due to
streptococcal septicemia associated
with Streptococcus iniae.
Feed as a sole ration for 10 consecutive days to deliver 15 mg florfenicol per
kg of fish. 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.
Dated: May 24, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–13095 Filed 5–30–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Part 658
[FHWA Docket No. FHWA–2012–0037]
RIN 2125–AF45
Truck Size and Weight; Technical
Correction
Federal Highway
Administration (FHWA), Department of
Transportation (DOT).
ACTION: Final rule; technical correction.
AGENCY:
This rule makes a technical
correction to the regulations that govern
Longer Combination Vehicles (LCV) for
the States of Oregon and Nebraska. The
amendments contained herein make no
substantive changes to FHWA
regulations, policies, or procedures.
DATES: This rule is effective July 2,
2012.
SUMMARY:
John
Nicholas, Truck Size and Weight
Program Manager, Office of Freight
Management and Operations, (202) 366–
2317; or Bill Winne, Office of the Chief
Counsel, (202) 366–1397. Both are
located at 1200 New Jersey Avenue SE.,
Washington, DC 20590. Office hours for
FHWA are from 8 a.m. to 4:30 p.m., e.t.,
Monday through Friday, except Federal
holidays.
mstockstill on DSK4VPTVN1PROD with RULES1
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
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Electronic Access
An electronic copy of this document
may be downloaded by accessing the
Office of the Federal Register’s home
page at: https://www.archives.gov or the
Government Printing Office’s Web page
at: https://www.gpoaccess.gov/nara.
Background
This rulemaking makes technical
corrections to the regulations in
appendix C of 23 CFR part 658 that
govern length of trailers in Oregon and
the length of permit duration in
Nebraska. The regulations on LCV’s
were frozen as of July 1, 1991, in
accordance with Section 1023 of the
Intermodal Surface Transportation
Efficiency Act (ISTEA) 1 but a provision
was made available in 23 CFR 658.23(f)
that requires the FHWA Administrator
to review petitions to correct any errors
in Appendix C. The States of Oregon
and Nebraska have petitioned the
Federal Highway Administrator to make
corrections to items they found to be
incorrect in accordance with 23 CFR
658.23(f), and certified those provisions
were in effect as of July 1, 1991.
Oregon Department of Transportation
petitioned the FHWA Administrator
that the section of Appendix C that
describes operational conditions for
triple trailers on Oregon’s Interstate
highways is not accurate. Oregon’s law
that was in effect at the time Appendix
C was adopted, June 1, 1991, required
only that the trailers be ‘‘* * *
reasonably uniform in length,’’ rather
than of ‘‘equal length’’ as stated in
1 Public Law 105–240, 105 Stat. 1914, 1951 (Dec.
18, 1991) (codified at 23 U.S.C. 127(d)).
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Fmt 4700
Sfmt 4700
Appendix C. The substitution of
language, ‘‘reasonably uniform in
length,’’ for the current ‘‘of equal
length,’’ will correct the language and
bring it into conformance with Oregon
statutes of that time.2
Nebraska Department of Roads
petitioned the FHWA Administrator to
change 120 days for the maximum
duration of a permit, as currently
written in Appendix C, to allow 150
days for the maximum permit time as
included in Nebraska Statutes in July
1991. The substitution of 150 days for
the current 120 days will correct the
language and bring it into conformance
with Nebraska statutes of that time.3
Rulemaking Analyses and Notice
Under the Administrative Procedure
Act (5 U.S.C. 553(b)), an agency may
waive the normal notice and comment
requirements if it finds, for good cause,
that they are impracticable,
unnecessary, or contrary to the public
interest. The FHWA finds that notice
and comment for this rule is
unnecessary and contrary to the public
interest because it will have no
substantive impact, is technical in
nature, and relates only to management,
organization, procedure, and practice.
The amendments to the rule are based
upon the explicit language of statutes
that were enacted subsequent to the
promulgation of the rule. The FHWA
does not anticipate receiving
meaningful comments. States, local
governments, motor carriers, and other
transportation stakeholders rely upon
the regulations corrected by this action.
These corrections will reduce confusion
2 Oregon
3 Neb.
E:\FR\FM\31MYR1.SGM
Vehicle Code 812.210 (1991–1992).
Rev. Stat. 39–6,181 (Cum. Supp. 1986).
31MYR1
]]>Agencies
[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Rules and Regulations]
[Pages 32010-32013]
From the Federal Register Online via the Government Printing 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,
george.haibel@fda.hhs.gov.
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: https://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
