New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin, 29216-29218 [2012-11937]
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Federal Register / Vol. 77, No. 96 / Thursday, May 17, 2012 / Rules and Regulations
(ii) Model G58, serial numbers TH–2125
through TH–2281, TH–2283, and TH–2284.
(d) Subject
Joint Aircraft System Component (JASC)/
Air Transport Association (ATA) of America
Code 28; fuel.
(e) Unsafe Condition
This AD was prompted by installation of
oversized clamps on fuel vapor return and/
or fuel vent lines in the outboard sections of
the left and right wings. We are issuing this
AD to correct the unsafe condition on these
products.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Inspection
Within the next 50 hours time-in-service
after June 21, 2012 (the effective date of this
AD) or within the next 6 calendar months
after June 21, 2012 (the effective date of this
AD), whichever occurs first, inspect the fuel
hose clamps for oversized or deformed
clamps following Hawker Beechcraft
Mandatory Service Bulletin No. SB 28–4039,
Revision 1, dated October 2011.
Note 1 to paragraph (g) of this AD: If you
have a scheduled inspection before the
compliance time of this AD, the FAA
recommends you comply with this AD at that
time.
(h) Replacement
If any oversized or deformed clamps are
found during the inspection required in
paragraph (g) of this AD, before further flight,
replace the clamps following Hawker
Beechcraft Mandatory Service Bulletin No.
SB 28–4039, Revision 1, dated October 2011.
(i) Alternative Methods of Compliance
(AMOCs)
srobinson on DSK4SPTVN1PROD with RULES
16:15 May 16, 2012
Jkt 226001
(k) Material Incorporated by Reference
(1) You must use Hawker Beechcraft
Mandatory Service Bulletin No. SB 28–4039,
Revision 1, dated October 2011, to do the
actions required by this AD, unless the AD
specifies otherwise. The Director of the
Federal Register approved the incorporation
by reference (IBR) under 5 U.S.C. 552(a) and
1 CFR part 51.
(2) For service information identified in
this AD, contact Hawker Beechcraft
Corporation, B091–A04, 10511 E. Central
Ave., Wichita, Kansas 67206; telephone:
(800) 429–5372 or (316) 676–3140; fax: (316)
676–8027; email:
tmdc@hawkerbeechcraft.com; or Internet:
https://www.hawkerbeechcraft.com/
customer_support/
technical_and_field_support/.
(3) You may review copies of the
referenced service information at the FAA,
Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information
on the availability of this material at the
FAA, call (816) 329–4148.
(4) You may also review copies of the
service information that is incorporated by
reference at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030, or go
to: https://www.archives.gov/federal-register/
cfr/ibr-locations.html.
Issued in Kansas City, Missouri, on May 9,
2012.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 2012–11812 Filed 5–16–12; 8:45 am]
(1) The Manager, Wichita Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in the
Related Information section of this AD.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
VerDate Mar<15>2010
(j) Related Information
For more information about this AD,
contact Thomas Teplik, Aerospace Engineer,
Wichita ACO, FAA, 1801 Airport Road,
Room 100, Wichita, Kansas 67209; phone:
(316) 946–4196; fax: (316) 329–4090; email:
thomas.teplik@faa.gov.
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Ceftiofur Sodium;
Lincomycin Powder; Naracin; Tylosin
AGENCY:
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 March 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:
This rule is effective May 17,
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:george.haibel@fda.hhs.gov.
FDA’s
Center for Veterinary Medicine (CVM) is
adopting use of a monthly Federal
Register document to codify approval
actions for NADAs and abbreviated
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 March 2012, as listed in
table 1 of this document. FDA is also
informing the public of the availability
of environmental review documents
required under the National
Environmental Policy Act (NEPA),
where applicable. For actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA) 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.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
PO 00000
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Federal Register / Vol. 77, No. 96 / Thursday, May 17, 2012 / Rules and Regulations
29217
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2012
NADA/
ANADA
Sponsor
New animal drug product name
118–980 ...
Elanco Animal Health, A
Division of Eli Lilly &
Co., Lilly Corporate
Center, Indianapolis,
IN 46285.
Pharmacia & Upjohn
Co., a Division of
Pfizer, Inc., 235 East
42d St., New York,
NY 10017.
Hospira, Inc., 275 N.
Field Dr., Lake Forest,
IL 60045.
Cross Vetpharm Group,
Ltd., Broomhill Rd.,
Tallaght, Dublin 24,
Ireland.
Huvepharma AD, 33
James Boucher Blvd.,
Sophia 1407, Bulgaria.
MONTEBAN (narasin)
Type A medicated article.
Supplement increasing
the upper dose limit
for narasin in broiler
feed.
LINCOMIX (lincomycin
hydrochloride) Soluble
Powder.
Ceftiofur for Injection
(ceftiofur sodium)
Sterile Powder.
TYLOMED–WS (tylosin
tartrate) Soluble Powder.
111–636 ...
200–421 ...
200–455 ...
200–473 ...
TYLOVET Soluble
(tylosin tartrate).
FOIA
summary
21 CFR
Section
Action
NEPA review
558.363
Yes ......
Environmental assessment (EA)/Finding of
no significant impact
(FONSI).
Supplement adding an
indication for control
of American foulbrood
in honey bees.
520.1263c
Yes ......
Categorically excluded
(CE).1
Original approval of generic copy of NADA
140–338.
Supplement adding an
indication for control
of porcine proliferative
enteropathies.
Supplement adding an
indication for control
of porcine proliferative
enteropathies.
522.313c
Yes ......
CE.
520.2640
Yes ......
CE.1
520.2640
Yes ......
CE.1
1 The Agency has determined under 21 CFR 25.33 that this action is 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.
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.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
List of Subjects
Firm name and address
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
*
*
Hospira, Inc., 275 North Field
Dr., Lake Forest, IL 60045
21 CFR Parts 520 and 522
*
Animal drugs.
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, 520, 522, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
000409
*
*
*
*
*
*
*
000409 ........ Hospira Inc., 275 North Field
Dr., Lake Forest, IL 60045.
*
*
*
*
*
■
§ 520.2640
4. In § 520.1263c, revise paragraph (b)
and add paragraph (d)(3) to read as
follows:
■
§ 520.1263c
*
PO 00000
*
Lincomycin powder.
*
Frm 00011
*
Fmt 4700
5. In § 520.2640, revise paragraph (b)
introductory text to read as follows:
Tylosin.
*
Authority: 21 U.S.C. 360b.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Hospira, Inc.’’; and in the
table in paragraph (c)(2), numerically
add an entry for ‘‘000409’’ to read as
follows:
Jkt 226001
Firm name and address
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
■
Drug labeler
code
3. The authority citation for 21 CFR
part 520 continues to read as follows:
1. The authority citation for 21 CFR
part 510 continues to read as follows:
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*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■
16:15 May 16, 2012
*
*
(2) * * *
21 CFR Part 558
VerDate Mar<15>2010
*
Drug labeler
code
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 000009 for use as in paragraph
(d) of this section.
(2) Nos. 046573, 054925, 061623, and
076475 for use as in paragraphs (d)(1)
and (d)(2) of this section.
*
*
*
*
*
(d) * * *
(3) Honey bees—(i) Amount. Mix 100
milligrams lincomycin with 20 grams
confectioners’/powdered sugar and dust
over the top bars of the brood chamber
once weekly for 3 weeks.
(ii) Indications for use. For the control
of American foulbrood (Paenibacillus
larvae).
(iii) Limitations. The drug should be
fed early in the spring or late in the fall
and consumed by the bees before the
main honey flow begins to avoid
contamination of production honey.
Complete treatments at least 4 weeks
before main honey flow.
*
*
*
*
(b) Sponsors. See Nos. 000986,
016592, and 061623 in § 510.600(c) of
this chapter.
*
*
*
*
*
*
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29218
Federal Register / Vol. 77, No. 96 / Thursday, May 17, 2012 / Rules and Regulations
Dated: May 7, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
[FR Doc. 2012–11937 Filed 5–16–12; 8:45 am]
6. The authority citation for 21 CFR
part 522 continues to read as follows:
■
BILLING CODE 4160–01–P
Authority: 21 U.S.C. 360b.
7. In § 522.313c, revise paragraphs (b),
(e)(2)(ii), (e)(3)(ii), (e)(4)(ii), and (e)(8)(i)
to read as follows:
■
§ 522.313c
40 CFR Part 82
Ceftiofur sodium.
*
*
*
*
*
(b) Sponsors. See Nos. 000009,
000409, and 068330 in § 510.600(c) of
this chapter.
*
*
*
*
*
(e) * * *
(2) * * *
(ii) Indications for use. For treatment
of bovine respiratory disease (shipping
fever, pneumonia) associated with
Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni. Also,
for the treatment of acute bovine
interdigital necrobacillosis (foot rot,
pododermatitis) associated with
Fusobacterium necrophorum and
Bacteroides melaninogenicus.
*
*
*
*
*
(3) * * *
(ii) Indications for use. For treatment
of sheep respiratory disease (sheep
pneumonia) associated with
Mannheimia haemolytica and
Pasteurella multocida.
*
*
*
*
*
(4) * * *
(ii) Indications for use. For treatment
of caprine respiratory disease (goat
pneumonia) associated with
Mannheimia haemolytica and
Pasteurella multocida.
*
*
*
*
*
(8) * * *
(i) Amount. 1.0 mg/lb (2.2 mg/kg)
body weight by subcutaneous injection.
Treatment should be repeated at 24hour intervals for 5 to 14 days.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
8. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
9. In § 558.363, revise paragraph
(d)(1)(i) introductory text to read as
follows:
srobinson on DSK4SPTVN1PROD with RULES
■
§ 558.363
Narasin.
*
*
*
*
*
(d) * * *
(1) * * *
(i) Amount per ton. Narasin, 54 to 90
grams.
*
*
*
*
*
VerDate Mar<15>2010
16:15 May 16, 2012
ENVIRONMENTAL PROTECTION
AGENCY
Jkt 226001
[EPA–HQ–OAR–2009–0277; FRL–9668–3]
RIN 2060–AQ83
Protection of Stratospheric Ozone: The
2012 Critical Use Exemption From the
Phaseout of Methyl Bromide
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is authorizing uses that
qualify for the 2012 critical use
exemption and the amount of methyl
bromide that may be produced,
imported, or supplied from existing prephaseout inventory for those uses in
2012. EPA is taking this action under
the authority of the Clean Air Act to
reflect a recent consensus decision by
the Parties to the Montreal Protocol on
Substances that Deplete the Ozone
Layer at the Twenty-Second Meeting of
the Parties.
DATES: This rule is effective on May 17,
2012.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OAR–2009–0277. All
documents in the docket are listed on
the www.regulations.gov web site.
Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and is publicly available
only in hard copy form. Publicly
available docket materials are available
either electronically through
www.regulations.gov or in hard copy at
the Air and Radiation Docket, EPA/DC,
EPA West, Room 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the Air
and Radiation Docket is (202) 566–
1742).
SUMMARY:
For
further information about this rule,
contact Jeremy Arling by telephone at
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
(202) 343–9055, or by email at
arling.jeremy@epa.gov or by mail at U.S.
Environmental Protection Agency,
Stratospheric Protection Division,
Stratospheric Program Implementation
Branch (6205J), 1200 Pennsylvania
Avenue NW., Washington, DC 20460.
You may also visit the methyl bromide
section of the ozone layer protection
Web site at www.epa.gov/ozone/mbr for
further information about the methyl
bromide critical use exemption, other
stratospheric ozone protection
regulations, the science of ozone layer
depletion, and related topics.
SUPPLEMENTARY INFORMATION: This rule
concerns Clean Air Act (CAA)
restrictions on the consumption,
production, and use of methyl bromide
(a Class I, Group VI controlled
substance) for critical uses during
calendar year 2012. Under the Clean Air
Act, methyl bromide consumption and
production were phased out on January
1, 2005, apart from allowable
exemptions, such as the critical use
exemption and the quarantine and
preshipment (QPS) exemption.
Consumption is defined under the CAA
as production plus imports minus
exports. With this action, EPA is
authorizing the uses that qualify for the
2012 critical use exemption as well as
specific amounts of methyl bromide that
may be produced and imported, or sold
from pre-phaseout inventory (also
referred to as ‘‘stocks’’) for critical uses
in 2012.
Section 553(d) of the Administrative
Procedure Act (APA), 5 U.S.C. Chapter
5, generally provides that rules may not
take effect earlier than 30 days after they
are published in the Federal Register.
EPA is issuing this final rule under
section 307(d)(1) of the Clean Air Act,
which states: ‘‘The provisions of section
553 through 557 * * * of Title 5 shall
not, except as expressly provided in this
section, apply to actions to which this
subsection applies.’’ Thus, section
553(d) of the APA does not apply to this
rule. EPA is nevertheless acting
consistently with the policies
underlying APA section 553(d) in
making this rule effective on May 17,
2012. APA section 553(d) allows an
effective date less than 30 days after
publication ‘‘as otherwise provided by
the agency for good cause found and
published with the rule.’’ Section 5
U.S.C. 553(d)(1) allows an effective date
less than 30 days after publication for a
rule that ‘‘that grants or recognizes an
exemption or relieves a restriction.’’ 5
U.S.C. 553(d)(1). Since today’s action
can be considered to either grant an
exemption for limited critical uses
during 2012 from the general
E:\FR\FM\17MYR1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Rules and Regulations]
[Pages 29216-29218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11937]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin;
Tylosin
AGENCY: Food and Drug Administration, HHS.
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 March 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 17, 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: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 NADAs and abbreviated 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 March
2012, as listed in table 1 of this document. FDA is also informing the
public of the availability of environmental review documents required
under the National Environmental Policy Act (NEPA), where applicable.
For actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA) 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.
[[Page 29217]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2012
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR FOIA
NADA/ANADA Sponsor product name Action Section summary NEPA review
----------------------------------------------------------------------------------------------------------------
118-980....... Elanco Animal MONTEBAN Supplement 558.363 Yes........ Environmental
Health, A (narasin) Type increasing the assessment (EA)/
Division of Eli A medicated upper dose Finding of no
Lilly & Co., article. limit for significant
Lilly Corporate narasin in impact (FONSI).
Center, broiler feed.
Indianapolis,
IN 46285.
111-636....... Pharmacia & LINCOMIX Supplement 520.1263c Yes........ Categorically
Upjohn Co., a (lincomycin adding an excluded
Division of hydrochloride) indication for (CE).\1\
Pfizer, Inc., Soluble Powder. control of
235 East 42d American
St., New York, foulbrood in
NY 10017. honey bees.
200-421....... Hospira, Inc., Ceftiofur for Original 522.313c Yes........ CE.
275 N. Field Injection approval of
Dr., Lake (ceftiofur generic copy of
Forest, IL sodium) Sterile NADA 140-338.
60045. Powder.
200-455....... Cross Vetpharm TYLOMED-WS Supplement 520.2640 Yes........ CE.\1\
Group, Ltd., (tylosin adding an
Broomhill Rd., tartrate) indication for
Tallaght, Soluble Powder. control of
Dublin 24, porcine
Ireland. proliferative
enteropathies.
200-473....... Huvepharma AD, TYLOVET Soluble Supplement 520.2640 Yes........ CE.\1\
33 James (tylosin adding an
Boucher Blvd., tartrate). indication for
Sophia 1407, control of
Bulgaria. porcine
proliferative
enteropathies.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is 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.
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.
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,
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 ``Hospira, Inc.''; and in the table in paragraph
(c)(2), numerically add an entry for ``000409'' 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
------------------------------------------------------------------------
* * * * *
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 000409
60045.................................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000409.............................. Hospira Inc., 275 North Field Dr.,
Lake Forest, IL 60045.
* * * * *
------------------------------------------------------------------------
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.
0
4. In Sec. 520.1263c, revise paragraph (b) and add paragraph (d)(3) to
read as follows:
Sec. 520.1263c Lincomycin powder.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (d) of this section.
(1) No. 000009 for use as in paragraph (d) of this section.
(2) Nos. 046573, 054925, 061623, and 076475 for use as in
paragraphs (d)(1) and (d)(2) of this section.
* * * * *
(d) * * *
(3) Honey bees--(i) Amount. Mix 100 milligrams lincomycin with 20
grams confectioners'/powdered sugar and dust over the top bars of the
brood chamber once weekly for 3 weeks.
(ii) Indications for use. For the control of American foulbrood
(Paenibacillus larvae).
(iii) Limitations. The drug should be fed early in the spring or
late in the fall and consumed by the bees before the main honey flow
begins to avoid contamination of production honey. Complete treatments
at least 4 weeks before main honey flow.
0
5. In Sec. 520.2640, revise paragraph (b) introductory text to read as
follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) Sponsors. See Nos. 000986, 016592, and 061623 in Sec.
510.600(c) of this chapter.
* * * * *
[[Page 29218]]
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 522.313c, revise paragraphs (b), (e)(2)(ii), (e)(3)(ii),
(e)(4)(ii), and (e)(8)(i) to read as follows:
Sec. 522.313c Ceftiofur sodium.
* * * * *
(b) Sponsors. See Nos. 000009, 000409, and 068330 in Sec.
510.600(c) of this chapter.
* * * * *
(e) * * *
(2) * * *
(ii) Indications for use. For treatment of bovine respiratory
disease (shipping fever, pneumonia) associated with Mannheimia
haemolytica, Pasteurella multocida, and Histophilus somni. Also, for
the treatment of acute bovine interdigital necrobacillosis (foot rot,
pododermatitis) associated with Fusobacterium necrophorum and
Bacteroides melaninogenicus.
* * * * *
(3) * * *
(ii) Indications for use. For treatment of sheep respiratory
disease (sheep pneumonia) associated with Mannheimia haemolytica and
Pasteurella multocida.
* * * * *
(4) * * *
(ii) Indications for use. For treatment of caprine respiratory
disease (goat pneumonia) associated with Mannheimia haemolytica and
Pasteurella multocida.
* * * * *
(8) * * *
(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous
injection. Treatment should be repeated at 24-hour intervals for 5 to
14 days.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
8. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
9. In Sec. 558.363, revise paragraph (d)(1)(i) introductory text to
read as follows:
Sec. 558.363 Narasin.
* * * * *
(d) * * *
(1) * * *
(i) Amount per ton. Narasin, 54 to 90 grams.
* * * * *
Dated: May 7, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-11937 Filed 5-16-12; 8:45 am]
BILLING CODE 4160-01-P
