New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide, 17866-17868 [2013-06748]
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17866
Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations
(78 FR 11572, February 19, 2013).
Allowing the airworthiness limitation
section (ALS) required by AD 2008–07–
11 to remain valid could cause
confusion as to what is required and
this could introduce an unsafe
condition if certain areas were not
inspected. Therefore, we determined
that notice and opportunity for public
comment before issuing this AD are
impracticable and that good cause exists
for making this amendment effective in
fewer than 30 days.
srobinson on DSK4SPTVN1PROD with NOTICES
Comments Invited
This AD is a final rule that involves
requirements affecting flight safety, and
we did not precede it by notice and
opportunity for public comment. We
invite you to send any written relevant
data, views, or arguments about this AD.
Send your comments to an address
listed under the ADDRESSES section.
Include ‘‘Docket No. FAA–2008–0070;
Directorate Identifier 2007–CE–098–
AD’’ at the beginning of your comments.
We specifically invite comments on the
overall regulatory, economic,
environmental, and energy aspects of
this AD. We will consider all comments
received by the closing date and may
amend this AD because of those
comments.
We will post all comments we
receive, without change, to https://
www.regulations.gov, including any
personal information you provide. We
will also post a report summarizing each
substantive verbal contact we receive
about this AD.
Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs,’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in ‘‘Subtitle VII,
Part A, Subpart III, Section 44701:
General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Regulatory Findings
We determined that this AD will not
have federalism implications under
VerDate Mar<15>2010
16:01 Mar 22, 2013
Jkt 229001
Executive Order 13132. This AD will
not have a substantial direct effect on
the States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
(2) Is not a ‘‘significant rule’’ under
the DOT Regulatory Policies and
Procedures (44 FR 11034, February 26,
1979),
(3) Will not affect intrastate aviation
in Alaska, and
(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
Issued in Kansas City, Missouri on March
11, 2013.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft
Certification Service.
List of Subjects in 14 CFR Part 39
HHS.
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
removing AD 2008–07–11, Amendment
39–15452 (73 FR 18433, April 4, 2008),
and adding the following new AD:
■
2008–07–11 R1 PILATUS AIRCRAFT LTD.:
Amendment 39–17398; Docket No.
FAA–2008–0070; Directorate Identifier
2007–CE–098–AD.
(a) Effective Date
This airworthiness directive (AD) becomes
effective April 15, 2013.
(b) Affected ADs
This AD rescinds AD 2008–07–11,
Amendment 39–15452 (73 FR 18433, April 4,
2008).
(c) Applicability
This AD applies to PILATUS AIRCRAFT
LTD. Models PC–12, PC–12/45, and PC–12/
47 airplanes, all serial numbers, certificated
in any category.
(d) Subject
Air Transport Association of America
(ATA) Code 27: Flight Controls.
PO 00000
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[FR Doc. 2013–06169 Filed 3–22–13; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, 524, and 529
[Docket No. FDA–2013–N–0002]
New Animal Drug Approvals; Change
of Sponsor; Change of Sponsor’s Drug
Labeler Code; Gonadorelin Acetate;
Isoflurane; Praziquantel; Propofol;
Sevoflurane; Triamcinolone Acetonide
AGENCY:
ACTION:
Food and Drug Administration,
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 January 2013. FDA is
also informing the public of the
availability of summaries the basis of
approval and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to reflect changes of
sponsorship for an NADA and ANADA,
and a change of a sponsor’s drug labeler
code.
DATES: This rule is effective March 25,
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: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during January 2013, 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
SUMMARY:
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Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations
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 through the Center for
Veterinary Medicine’s (CVM’s) FOIA
Electronic Reading Room at https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
In addition, FDA is amending the
animal drug regulations to reflect
changes of sponsorship for an NADA
and ANADA, and a change of a
sponsor’s drug labeler code.
RMS Laboratories, Inc., 1903 East
First St., Vidalia, GA 30474, has
informed FDA that it has transferred
ownership of, and all rights and interest
in, NADA 141–210 for GENESIS
(triamcinolone acetonide) Topical Spray
to Virbac AH, Inc., 3200 Meacham
Blvd., Ft. Worth, TX 76137. Following
this change of sponsorship, RMS
Laboratories, Inc., will no longer be the
sponsor of an approved application.
Teva Animal Health, Inc., 3915 South
48th Street Ter., St. Joseph, MO 64503,
has informed FDA that it has transferred
ownership of, and all rights and interest
in, ANADA 200–176 for PRAZITECH
(praziquantel) Injectable Solution to
Cross Vetpharm Group Ltd., Broomhill
Rd., Tallaght, Dublin 24, Ireland.
Abbott Laboratories, North Chicago,
IL 60064, has informed FDA of a change
in drug labeler code. Accordingly, the
Agency is amending the regulations in
21 CFR 510.600 to reflect this change of
drug labeler code and to remove entries
for RMS Laboratories, Inc., and in 21
CFR parts 522 and 529 to make
conforming changes to Abbott
Laboratories’ product listings.
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 JANUARY 2013
NADA/
ANADA
Sponsor
200–541 .......
Parnell Technologies
Pty. Ltd., unit 4, 476
Gardeners Rd., Alexandria, New South
Wales 2015, Australia.
New animal drug product
name
GONABREED
(gonadorelin acetate)
Injectable Solution.
21 CFR
Section
Action
1. Original approval as a
generic copy of NADA
098–379; and.
2. Supplemental approval for use with
cloprostenol sodium to
synchronize estrous
cycles to allow for
fixed time artificial insemination in lactating
dairy cows and beef
cows.1
FOIA
Summary
522.1073
yes
NEPA Review
1. CE 2
2. EA/FONSI 3
1 Supplemental
approval under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act.
Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment (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.
3 Based on its review of an 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 EIS is not required. A finding of no significant impact (FONSI) has been prepared.
2 The
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 522, 524, and 529
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, 522, 524, and 529 are
amended as follows:
srobinson on DSK4SPTVN1PROD with NOTICES
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Laboratories’’ and remove the entry for
‘‘RMS Laboratories, Inc.’’; and
■ b. In the table in paragraph (c)(2),
remove the entries for ‘‘000074’’ and
‘‘067292’’ and add an entry for
‘‘000044’’ in numerical order.
The addition and revision read as
follows:
*
*
(c) * * *
(1) * * *
*
2. Amend § 510.600 as follows:
a. In the table in paragraph (c)(1),
revise the entry for ‘‘Abbott
16:01 Mar 22, 2013
Jkt 229001
*
*
*
Abbott Laboratories, North
Chicago, IL 60064.
*
*
*
Abbott Laboratories, North
Chicago, IL 60064 ...........
Drug labeler
code
*
*
*
Frm 00003
Fmt 4700
*
000044
*
(2) * * *
PO 00000
*
*
*
3. The authority citation for 21 CFR
part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
■
*
*
■
Firm name and address
■
■
VerDate Mar<15>2010
*
*
000044 .............
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
*
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Firm name and address
*
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
Drug labeler
code
Sfmt 4700
*
4. Add § 522.1073 to read as follows:
§ 522.1073
Gonadorelin acetate.
(a) Specifications. Each milliliter of
solution contains 100 micrograms (mg)
of gonadorelin as gonadorelin acetate.
(b) Sponsor. See No. 068504 in
§ 510.600(c) of this chapter.
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Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations
(c) Conditions of use in cattle—(1)
Indications for use and amounts.
(i) For the treatment of ovarian
follicular cysts in dairy cattle.
Administer 100 mg gonadorelin by
intramuscular or intravenous injection.
(ii) For use with cloprostenol sodium
to synchronize estrous cycles to allow
for fixed-time artificial insemination in
lactating dairy cows and beef cows.
Administer to each cow 100 mg
gonadorelin by intramuscular injection,
followed 6 to 8 days later by 500 mg
cloprostenol by intramuscular injection,
followed 30 to 72 hours later by 100 mg
gonadorelin by intramuscular injection.
(2) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 5. In § 522.1077, revise the section
heading to read as set forth below; and
in paragraph (c)(3), remove the first
sentence.
§ 522.1077
Gonadorelin hydrochloride.
*
*
*
§ 522.1078
*
*
Authority: 21 U.S.C. 360b.
12. In paragraph (b) of § 529.1186,
remove ‘‘000074’’ and in its place add
‘‘000044’’.
also modify the regulations under
section 704(b) regarding the
maintenance of the partners’ capital
accounts and the determination of the
partners’ distributive shares of
partnership items. The final regulations
also contain a characterization rule
providing that the holder of a
noncompensatory option is treated as a
partner under certain circumstances.
DATES: This correction is effective on
March 25, 2013 and is applicable on or
after February 5, 2013.
FOR FURTHER INFORMATION CONTACT:
Benjamin Weaver, at (202) 622–3050
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
§ 529.2150
Background
§ 524.2482
[Amended]
10. In paragraph (b) of § 524.2482,
remove ‘‘067292’’ and in its place add
‘‘051311’’.
■
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
11. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 529.1186
[Amended]
■
[Amended]
13. In paragraph (b) of § 529.2150,
remove ‘‘000074’’ and in its place add
‘‘000044’’.
■
The final regulations that are the
subject of this document are under
sections 171, 704, 721, 761, 1272, 1273,
and 1275 of the Internal Revenue Code.
Dated: March 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Need for Correction
BILLING CODE 4160–01–P
List of Subjects in 26 CFR Part 1
Internal Revenue Service
6. Redesignate § 522.1078 as
§ 522.1075.
■ 7. In § 522.1870, revise the section
heading and paragraphs (b), (c)(1)(iii),
and (c)(2)(iii) to read as follows:
As published, the final regulations
(TD 9612) contain errors that may prove
to be misleading and are in need of
clarification.
DEPARTMENT OF THE TREASURY
[Redesignated as § 522.1075]
Income taxes, Reporting and
recordkeeping requirements.
26 CFR Part 1
Correction of Publication
[TD 9612]
RIN 1545–BA53
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
Noncompensatory Partnership
Options; Correction
PART 1—INCOME TAXES
[FR Doc. 2013–06748 Filed 3–22–13; 8:45 am]
■
§ 522.1870
Praziquantel.
*
*
*
*
*
(b) Sponsors. See Nos. 000859 and
061623 in § 510.600(c) of this chapter.
(c) * * *
(1) * * *
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) * * *
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 522.2005
[Amended]
8. In paragraph (b)(2) of § 522.2005,
remove ‘‘000074’’ and in its place add
‘‘000044’’.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
9. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
This document contains
corrections to final regulations (TD
9612) that were published in the
Federal Register on Tuesday, February
5, 2013 (78 FR 7997) relating to the tax
treatment of noncompensatory options
and convertible instruments issued by a
partnership. The final regulations
generally provide that the exercise of a
noncompensatory option does not cause
the recognition of immediate income or
loss by either the issuing partnership or
the option holder. The final regulations
Authority: 26 U.S.C. 7805 * * *
SUMMARY:
K
srobinson on DSK4SPTVN1PROD with NOTICES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
■
Tax
Par. 2. Section 1.704–1 is amended by
revising the table in paragraph (b)(5)
Example 35 (ii), and the first sentence
of paragraph (b)(5) Example 35 (iii) to
read as follows:
■
§ 1.704–1
*
Partner’s distributive share.
*
*
*
*
(b) * * *
(5) * * *
Example 35. * * *
(ii) * * *
L
Book
Tax
M
Book
Tax
Book
Initial capital account ...............................
Year 1 net income ...................................
Year 2 net income ...................................
Year 3 net income ...................................
$10,000
1,000
1,000
1,000
$10,000
1,000
1,000
1,000
$10,000
1,000
1,000
1,000
$10,000
1,000
1,000
1,000
0
0
0
0
0
0
0
0
Year 4 initial capital account ....................
13,000
13,000
13,000
13,000
0
0
VerDate Mar<15>2010
16:01 Mar 22, 2013
Jkt 229001
PO 00000
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Fmt 4700
Sfmt 4700
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]]>Agencies
[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Rules and Regulations]
[Pages 17866-17868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06748]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, 524, and 529
[Docket No. FDA-2013-N-0002]
New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's
Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel;
Propofol; Sevoflurane; Triamcinolone Acetonide
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 January 2013. FDA is also informing the public of the
availability of summaries the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect changes of sponsorship for an NADA and
ANADA, and a change of a sponsor's drug labeler code.
DATES: This rule is effective March 25, 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:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during January 2013,
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
[[Page 17867]]
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 through the Center for Veterinary Medicine's (CVM's)
FOIA Electronic Reading Room at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, FDA is amending the animal drug regulations to reflect
changes of sponsorship for an NADA and ANADA, and a change of a
sponsor's drug labeler code.
RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 30474, has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-210 for GENESIS (triamcinolone acetonide) Topical
Spray to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.
Following this change of sponsorship, RMS Laboratories, Inc., will no
longer be the sponsor of an approved application.
Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph,
MO 64503, has informed FDA that it has transferred ownership of, and
all rights and interest in, ANADA 200-176 for PRAZITECH (praziquantel)
Injectable Solution to Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland.
Abbott Laboratories, North Chicago, IL 60064, has informed FDA of a
change in drug labeler code. Accordingly, the Agency is amending the
regulations in 21 CFR 510.600 to reflect this change of drug labeler
code and to remove entries for RMS Laboratories, Inc., and in 21 CFR
parts 522 and 529 to make conforming changes to Abbott Laboratories'
product listings.
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 January 2013
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR FOIA
NADA/ANADA Sponsor product name Action Section Summary NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-541................. Parnell Technologies GONABREED (gonadorelin 1. Original approval 522.1073 yes 1. CE \2\
Pty. Ltd., unit 4, 476 acetate) Injectable as a generic copy of 2. EA/FONSI \3\
Gardeners Rd., Solution. NADA 098-379; and.
Alexandria, New South 2. Supplemental
Wales 2015, Australia. approval for use with
cloprostenol sodium
to synchronize
estrous cycles to
allow for fixed time
artificial
insemination in
lactating dairy cows
and beef cows.\1\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Supplemental approval under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act.
\2\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
assessment (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.
\3\ Based on its review of an 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 EIS is not required. A finding of no significant impact (FONSI) has been prepared.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 522, 524, and 529
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,
522, 524, and 529 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. Amend Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1), revise the entry for ``Abbott
Laboratories'' and remove the entry for ``RMS Laboratories, Inc.''; and
0
b. In the table in paragraph (c)(2), remove the entries for ``000074''
and ``067292'' and add an entry for ``000044'' in numerical order.
The addition and revision 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
------------------------------------------------------------------------
* * * * *
Abbott Laboratories, North Chicago, IL 60064........... 000044
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000044................................ Abbott Laboratories, North
Chicago, IL 60064.
* * * * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Add Sec. 522.1073 to read as follows:
Sec. 522.1073 Gonadorelin acetate.
(a) Specifications. Each milliliter of solution contains 100
micrograms ([micro]g) of gonadorelin as gonadorelin acetate.
(b) Sponsor. See No. 068504 in Sec. 510.600(c) of this chapter.
[[Page 17868]]
(c) Conditions of use in cattle--(1) Indications for use and
amounts.
(i) For the treatment of ovarian follicular cysts in dairy cattle.
Administer 100 [micro]g gonadorelin by intramuscular or intravenous
injection.
(ii) For use with cloprostenol sodium to synchronize estrous cycles
to allow for fixed-time artificial insemination in lactating dairy cows
and beef cows. Administer to each cow 100 [micro]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [micro]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 100 [micro]g gonadorelin by intramuscular injection.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
5. In Sec. 522.1077, revise the section heading to read as set forth
below; and in paragraph (c)(3), remove the first sentence.
Sec. 522.1077 Gonadorelin hydrochloride.
* * * * *
Sec. 522.1078 [Redesignated as Sec. 522.1075]
0
6. Redesignate Sec. 522.1078 as Sec. 522.1075.
0
7. In Sec. 522.1870, revise the section heading and paragraphs (b),
(c)(1)(iii), and (c)(2)(iii) to read as follows:
Sec. 522.1870 Praziquantel.
* * * * *
(b) Sponsors. See Nos. 000859 and 061623 in Sec. 510.600(c) of
this chapter.
(c) * * *
(1) * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.2005 [Amended]
0
8. In paragraph (b)(2) of Sec. 522.2005, remove ``000074'' and in its
place add ``000044''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.2482 [Amended]
0
10. In paragraph (b) of Sec. 524.2482, remove ``067292'' and in its
place add ``051311''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1186 [Amended]
0
12. In paragraph (b) of Sec. 529.1186, remove ``000074'' and in its
place add ``000044''.
Sec. 529.2150 [Amended]
0
13. In paragraph (b) of Sec. 529.2150, remove ``000074'' and in its
place add ``000044''.
Dated: March 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-06748 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P
