New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; Zilpaterol, 31722-31724 [2012-13010]
Download as PDF
<![CDATA[
31722
Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Rules and Regulations
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75–15 issued under Sec. 204,
Title II, Pub. L. 106–113, 113 Stat. 1501
A–293; sections 301.75–15 and 301.75–16
issued under Sec. 203, Title II, Pub. L. 106–
224, 114 Stat. 400 (7 U.S.C. 1421 note).
2. In § 301.51–3, paragraph (c) is
amended as follows:
■ a. Under the heading
‘‘Massachusetts,’’ by revising the entry
for Worcester County;
■ b. Under the entry for ‘‘New York,’’ by
removing the second paragraph under
the entry for Nassau and Suffolk
Counties.
■ c. By adding, in alphabetical order, an
entry for ‘‘Ohio.’’
The revision and addition read as
follows:
■
§ 301.51–3
*
Quarantined areas.
*
*
(c) * * *
*
*
Massachusetts
erowe on DSK2VPTVN1PROD with RULES
*
*
*
*
*
Worcester County. The portion of
Worcester County, including portions or
all of the municipalities of Worcester,
Holden, West Boylston, Boylston,
Auburn, and Shrewsbury that is
bounded by a line starting at the
intersection of Route 9 (Belmont Street)
and the eastern boundary of the town of
Shrewsbury; then follow the
Shrewsbury town boundary northerly
until the Boylston town boundary; then
follow the entirety of the Boylston town
boundary until it comes to the West
Boylston town boundary on the
Massachusetts Department of
Conservation and Recreation Watershed
property; then along the West Boylston
town boundary until it intersects
Manning Street; then southwest on
Manning Street in Holden to Wachusett
Street (Route 31); then south on
Wachusett Street to Highland Street
(still Route 31); then southwest on
Highland Street to Main Street; then
southeast on Main Street to Bailey Road;
then south on Bailey Road to Chapin
Road; then south on Chapin Road to its
end; then continuing in a southeasterly
direction to Fisher Road; then southwest
on Fisher Road to Stonehouse Hill Road;
then south on Stonehouse Hill Road to
Reservoir Street; then southeast on
Reservoir Street until it intersects the
Worcester city boundary; turn south on
Oxford Street to Auburn Street; then
southeast on Auburn Street crossing
VerDate Mar<15>2010
12:23 May 29, 2012
Jkt 226001
under the Massachusetts Turnpike
(I–90) and continuing southeast on
Millbury Street; at the intersection of
Washington Street, turn northeast and
continue along Washington Street to the
northern boundary of the Massachusetts
Turnpike (I–90); then east along the
northern boundary of the Massachusetts
Turnpike (I–90) to the Auburn town
boundary; then follow the Auburn town
boundary northerly to the Worcester
city boundary; continue along the
Worcester city boundary until the
Shrewsbury town boundary; then follow
the entirety of the Shrewsbury town
boundary until the point of beginning.
*
*
*
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Ohio
Clermont County. The portion of
Clermont County, including all of the
municipalities of Tate and East Fork
State Park, and the portions of the
Township of Monroe that include the
following land parcels: 232609C094,
232609C113, 232609C215, 232609C085,
232609C128, 232609B224, 232609B188,
232609E223, 232609B215, 32609B193,
232609E075, 232609B161, 232609E156,
232609E245, 232609E037, 232609E074,
232609E230, 232609E031, 232609E220,
232609E232, 232609E240, 232609E239,
232609E241, 232609E175, 232609E228,
232609E250, 232609E235, 232609E238,
232609E227, 232609E242, 32609E226,
232609E249, 232609E236, 232609E234,
232609C217, 232609C040, 234715.008,
232609C227, 232609C222, 232609C092,
232609C093, 232609C129, 232609C098,
232609C195, 232609C100, 232609C169,
232609C136, 232609C097, 232609C139,
232609C148, 232609C042, 232609C150,
232609C182, 234715.009, 234715.005,
234715.006, 234715.001, 232609E246,
232609E247, 234715.004, 234715.003,
232609E222, 232609C228, 234425.001,
232609E233, 232609C170, 232609C216,
232609C196, 232609C105, 232609E237,
232609C225, 232609C091, 232609C197,
232609C218, 232609C198, 232609C041,
232609C212, 232609C194, 232609C214,
232609E224, 232609E231, 232609E248,
234715.007, 234715.002, 232609C120,
232609C226, 232609C229, and
232609C043.
AGENCY:
Done in Washington, DC, this 23rd day of
May 2012.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
Food and Drug Administration
21 CFR Parts 510, 522, and 558
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Change of
Sponsor; Estradiol; Estradiol Benzoate
and Testosterone Propionate;
Progesterone and Estradiol Benzoate;
Trenbolone Acetate; Trenbolone
Acetate and Estradiol; Melengestrol;
Ractopamine; Zilpaterol
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 17 new animal
drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) for various
steroid ear implants for cattle and for
melengestrol acetate liquid Type A
medicated article and use in
combination medicated feeds for heifers
fed in confinement for slaughter from
Ivy Laboratories, Division of Ivy Animal
Health, Inc., to Elanco Animal Health,
Division of Eli Lilly & Co.
SUMMARY:
DATES:
This rule is effective May 30,
2012.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300,
email: steven.vaughn@fda.hhs.gov.
Ivy
Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland
Park, KS 66214, has informed FDA that
it has transferred ownership of, and all
rights and interest in, the NADAs and
ANADAs in this table to Elanco Animal
Health, Division of Eli Lilly & Co., Lilly
Corporate Center, Indianapolis, IN
46285.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–13111 Filed 5–29–12; 8:45 am]
BILLING CODE 3410–34–P
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
E:\FR\FM\30MYR1.SGM
30MYR1
Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Rules and Regulations
NADA/ANADA
Proprietary name (established name)
110–315 ............
COMPONENT E–C (progesterone and estradiol benzoate) with TYLAN (tylosin tartrate) .........................
COMPONENT E–S (progesterone and estradiol benzoate) with TYLAN (tylosin tartrate).
COMPONENT 200 (estradiol benzoate).
ENCORE (COMPUDOSE 400) (estradiol benzoate).
COMPONENT E–H (estradiol benzoate and testosterone propionate) with TYLAN (tylosin tartrate) ........
COMPONENT TE–IS (trenbolone acetate and estradiol) ............................................................................
COMPONENT TE–S (trenbolone acetate and estradiol).
COMPONENT TE–G (trenbolone acetate and estradiol).
COMPONENT TE–IS (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
COMPONENT TE–S (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
COMPONENT TE–G (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
COMPONENT TE–ID (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
COMPONENT T–H (trenbolone acetate) with TYLAN (tylosin tartrate) ......................................................
COMPONENT T–S (trenbolone acetate) with TYLAN (tylosin tartrate).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix .............................................................................
COMPONENT TE–H (trenbolone acetate and estradiol) ............................................................................
COMPONENT TE–H (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
COMPONENT TE–IH (trenbolone acetate and estradiol).
COMPONENT TE–200 (trenbolone acetate and estradiol).
COMPONENT TE–200 (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix/RUMENSIN (monensin)/TYLAN (tylosin phosphate).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus RUMENSIN (monensin) ..............................
HEIFERMAX 500 (melengestrol acetate) Liquid Premix/OPTAFLEXX (ractopamine HCI)/RUMENSIN
(monensin)/TYLAN (tylosin phosphate).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus TYLAN (tylosin phosphate) .........................
HEIFERMAX 500 (melengestrol acetate) Liquid Premix/BOVATEC (lasalocid)/TYLAN (tylosin phosphate).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix/OPTAFLEXX (ractopamine HCl)/RUMENSIN
(monensin).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus BOVATEC (lasalocid) .................................
HEIFERMAX 500 (melengestrol acetate) Liquid Premix/ZILMAX (zilpaterol)/RUMENSIN (monensin) ......
HEIFERMAX 500 (melengestrol acetate) Liquid Premix/ZILMAX (zilpaterol)/RUMENSIN (monensin)/
TYLAN (tylosin phosphate).
HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus ZILMAX (zilpaterol) .....................................
118–123 ............
135–906 ............
200–221 ............
200–224 ............
200–343 ............
200–346 ............
200–375 ............
200–422 ............
200–424 ............
200–427 ............
200–430 ............
200–448 ............
200–451 ............
200–479 ............
200–480 ............
200–483 ............
Accordingly, the Agency is amending
the regulations in parts 522 and 558 (21
CFR parts 522, and 558) to reflect the
transfer of ownership.
Following these changes of
sponsorship, Ivy Laboratories, Division
of Ivy Animal Health, Inc., is no longer
the sponsor of an approved application.
Accordingly, § 510.600 (21 CFR
510.600) is being amended to remove
the entries for this firm.
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.
erowe on DSK2VPTVN1PROD with RULES
21 CFR Part 522
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510, 522, and 558 are
amended as follows:
522.2476
558.342
522.2477
558.342
558.342
558.500
558.342
558.342
558.500
558.342
558.665
558.665
558.665
[Amended]
5. In paragraph (a)(2) of § 522.842,
remove ‘‘021641’’ and in its place add
‘‘000986’’.
■
[Amended]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 522.2476
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(l), remove the entry for
‘‘Ivy Laboratories, Div. of Ivy Animal
Health, Inc.’’; and in the table in
paragraph (c)(2), remove the entry for
‘‘021641’’.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.840
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
■
Jkt 226001
522.840
522.842
522.2477
6. In paragraph (a)(2) of § 522.1940,
remove ‘‘021641’’ and in its place add
‘‘000986’’.
1. The authority citation for 21 CFR
part 510 continues to read as follows:
21 CFR Part 558
12:23 May 29, 2012
§ 522.842
522.1940
■
Animal drugs.
VerDate Mar<15>2010
21 CFR section
§ 522.1940
PART 510—NEW ANIMAL DRUGS
31723
Frm 00005
Fmt 4700
[Amended]
7. In paragraph (b)(l) of § 522.2476,
remove ‘‘021641’’ and in its place add
‘‘000986’’.
■
§ 522.2477
[Amended]
8. In paragraph (b)(l) of § 522.2477,
remove ‘‘021641’’ and in its place add
‘‘000986’’.
■
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.
§ 558.342
[Amended]
[Amended]
10. In § 558.342, in paragraph (b)(2)
and in the ‘‘Sponsor’’ column of the
table, in paragraphs (e)(l)(i), (e)(1)(ii),
(e)(l)(iii), and (e)(l)(ix) remove ‘‘021641’’
■
4. In paragraph (b) of § 522.840,
remove ‘‘021641’’ and in its place add
‘‘000986’’.
PO 00000
■
Sfmt 4700
E:\FR\FM\30MYR1.SGM
30MYR1
31724
Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Rules and Regulations
and in its place add ‘‘000986’’; in
paragraphs (e)(1)(iv) and (e)(1)(x) add
‘‘000986’’; and in paragraph (e)(1)(xi),
remove ‘‘02164’’ and in its place add
‘‘000986’’.
62.32(h)(16) that will go into effect
November 1, 2012. The Department will
accept written comments from the
public up to 60 days from May 11,
2012.’’
§ 558.500
2. On page 27594, in the first column,
the FOR FURTHER INFORMATION CONTACT
section is revised to read as follows:
‘‘FOR FURTHER INFORMATION CONTACT:
Robin J. Lerner, Deputy Assistant
Secretary for Private Sector Exchange,
U.S. Department of State, SA–5, Floor 5,
2200 C Street NW., Washington, DC
20522–0505; phone (202) 632–2805; fax
(202) 632–2701.’’
[Amended]
11. In § 558.500, in the ‘‘Sponsor’’
column of the table, in paragraphs
(e)(2)(viii) and (e)(2)(x), remove
‘‘021641’’.
■
§ 558.665
[Amended]
12. In § 558.665, in the ‘‘Sponsor’’
column of the table, in paragraphs (e)(2),
(e)(4), and (e)(6), remove ‘‘021641’’ and
in its place add ‘‘000986’’.
■
Dated: May 23, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2012–13010 Filed 5–29–12; 8:45 am]
1. The authority citation for part 250
is revised to read as follows:
[FR Doc. 2012–13098 Filed 5–29–12; 8:45 am]
BILLING CODE 4310–VH–P
22 CFR Part 62
Bureau of Safety and Environmental
Enforcement
RIN 1400–AD14
Authority: 30 U.S.C. 1751, 31 U.S.C. 9701,
43 U.S.C. 1334.
[FR Doc. 2012–13086 Filed 5–29–12; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Public Notice 7902]
30 CFR Part 250
Exchange Visitor Program—Summer
Work Travel; Correction
[Docket ID: BSEE–2012–0003]
Department of State.
Interim final rule; correction
Drawbridge Operation Regulation; St.
Croix River, Stillwater, MN
Production Measurement Documents
Incorporated by Reference; Correction
This document contains
minor corrections to the Exchange
Visitor Program—Summer Work Travel
interim final rule published in the
Federal Register on May 11, 2012. In
the interim final rule the facsimile
number (under the contact section), a
citation to an exception to the category
of prohibited jobs, and the date by
which the public must submit
comments were all incorrect.
DATES: Effective on May 30, 2012.
FOR FURTHER INFORMATION CONTACT:
Robin J. Lerner, Deputy Assistant
Secretary for Private Sector Exchange,
U.S. Department of State, SA–5, Floor 5,
2200 C Street NW., Washington, DC
20522–0505; phone (202) 632–2805; fax
(202) 632–2701.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Correction
In the interim final rule published
May 11, 2012, at 77 FR 27593, make the
following corrections:
1. On page 27594, in the first column,
the DATES section is revised to read as
follows:
‘‘DATES: This rule is effective May 11,
2012, with the exception of 22 CFR
Jkt 226001
[Docket No. USCG–2012–0443]
RIN 1014–AA01
AGENCY:
erowe on DSK2VPTVN1PROD with RULES
PART 250—OIL AND GAS AND
SULPHUR OPERATIONS IN THE
OUTER CONTINENTAL SHELF
■
DEPARTMENT OF THE INTERIOR
12:23 May 29, 2012
Accordingly, the Bureau of Safety and
Environmental Enforcement is making
the correcting amendment to 30 CFR
part 250 as follows:
Dated: May 24, 2012.
Robin J. Lerner,
Deputy Assistant Secretary for Private Sector
Exchange, Bureau of Educational and
Cultural Affairs, Department of State.
DEPARTMENT OF STATE
VerDate Mar<15>2010
Dated: May 17, 2012.
Ned Farquhar,
Deputy Assistant Secretary—Land and
Minerals Management.
BILLING CODE 4710–05–P
BILLING CODE 4160–01–P
ACTION:
resources, Reporting and recordkeeping
requirements.
Bureau of Safety and
Environmental Enforcement (BSEE),
Interior.
ACTION: Correcting amendment.
AGENCY:
This document corrects an
amendment contained in a final rule
published in the Federal Register on
March 29, 2012, and involves only that
portion of the rule relating to the
authority citation.
DATES: This correction is effective on
May 30, 2012.
FOR FURTHER INFORMATION CONTACT:
Wilbon Rhome, Regulations and
Standards Branch, at
Wilbon.Rhome@BSEE.gov, 703–787–
1587.
SUMMARY:
BSEE is
correcting a portion of its final rule
published March 29, 2012 (77 FR
18916), that omitted part of the
authority citation for 30 CFR part 250.
The correction involves adding, 30
U.S.C. 1751, to the existing authorities
cited.
SUPPLEMENTARY INFORMATION:
List of Subjects in 30 CFR Part 250
Continental shelf, Incorporation by
reference, Public lands—mineral
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operation
schedule that governs the Stillwater
Highway Drawbridge across the St.
Croix River, mile 23.4, at Stillwater,
Minnesota. The deviation is necessary
due to increased vehicular traffic after a
local 4th of July fireworks display. The
deviation allows the bridge to be in the
closed-to-navigation position to clear
increased vehicular traffic.
DATES: This deviation is effective from
10 p.m., July 4, 2012 through
11:30 p.m., July 4, 2012.
ADDRESSES: Documents mentioned in
this preamble as being available in the
docket are part of docket USCG–2012–
0443 and are available online by going
to https://www.regulations.gov, inserting
USCG–2012–0443 in the ‘‘Keyword’’
box and then clicking ‘‘Search’’. They
are also available for inspection or
copying at the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
SUMMARY:
E:\FR\FM\30MYR1.SGM
30MYR1
]]>Agencies
[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Rules and Regulations]
[Pages 31722-31724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13010]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Change of Sponsor; Estradiol; Estradiol
Benzoate and Testosterone Propionate; Progesterone and Estradiol
Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol;
Melengestrol; Ractopamine; Zilpaterol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 17 new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) for various steroid ear implants for cattle and for
melengestrol acetate liquid Type A medicated article and use in
combination medicated feeds for heifers fed in confinement for
slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc.,
to Elanco Animal Health, Division of Eli Lilly & Co.
DATES: This rule is effective May 30, 2012.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8300, email:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, has informed FDA
that it has transferred ownership of, and all rights and interest in,
the NADAs and ANADAs in this table to Elanco Animal Health, Division of
Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285.
[[Page 31723]]
------------------------------------------------------------------------
Proprietary name
NADA/ANADA (established name) 21 CFR section
------------------------------------------------------------------------
110-315..................... COMPONENT E-C 522.1940
(progesterone and
estradiol benzoate)
with TYLAN (tylosin
tartrate).
COMPONENT E-S
(progesterone and
estradiol benzoate)
with TYLAN (tylosin
tartrate).
118-123..................... COMPONENT 200
(estradiol benzoate).
ENCORE (COMPUDOSE 400) 522.840
(estradiol benzoate).
135-906..................... COMPONENT E-H 522.842
(estradiol benzoate
and testosterone
propionate) with
TYLAN (tylosin
tartrate).
200-221..................... COMPONENT TE-IS 522.2477
(trenbolone acetate
and estradiol).
COMPONENT TE-S
(trenbolone acetate
and estradiol).
COMPONENT TE-G
(trenbolone acetate
and estradiol).
COMPONENT TE-IS
(trenbolone acetate
and estradiol) with
TYLAN (tylosin
tartrate).
COMPONENT TE-S
(trenbolone acetate
and estradiol) with
TYLAN (tylosin
tartrate).
COMPONENT TE-G
(trenbolone acetate
and estradiol) with
TYLAN (tylosin
tartrate).
COMPONENT TE-ID
(trenbolone acetate
and estradiol) with
TYLAN (tylosin
tartrate).
200-224..................... COMPONENT T-H 522.2476
(trenbolone acetate)
with TYLAN (tylosin
tartrate).
COMPONENT T-S
(trenbolone acetate)
with TYLAN (tylosin
tartrate).
200-343..................... HEIFERMAX 500 558.342
(melengestrol
acetate) Liquid
Premix.
200-346..................... COMPONENT TE-H 522.2477
(trenbolone acetate
and estradiol).
COMPONENT TE-H
(trenbolone acetate
and estradiol) with
TYLAN (tylosin
tartrate).
COMPONENT TE-IH
(trenbolone acetate
and estradiol).
COMPONENT TE-200
(trenbolone acetate
and estradiol).
COMPONENT TE-200
(trenbolone acetate
and estradiol) with
TYLAN (tylosin
tartrate).
200-375..................... HEIFERMAX 500 558.342
(melengestrol
acetate) Liquid
Premix/RUMENSIN
(monensin)/TYLAN
(tylosin phosphate).
200-422..................... HEIFERMAX 500 558.342
(melengestrol
acetate) Liquid
Premix plus RUMENSIN
(monensin).
200-424..................... HEIFERMAX 500 558.500
(melengestrol
acetate) Liquid
Premix/OPTAFLEXX
(ractopamine HCI)/
RUMENSIN (monensin)/
TYLAN (tylosin
phosphate).
200-427..................... HEIFERMAX 500 558.342
(melengestrol
acetate) Liquid
Premix plus TYLAN
(tylosin phosphate).
200-430..................... HEIFERMAX 500 558.342
(melengestrol
acetate) Liquid
Premix/BOVATEC
(lasalocid)/TYLAN
(tylosin phosphate).
200-448..................... HEIFERMAX 500 558.500
(melengestrol
acetate) Liquid
Premix/OPTAFLEXX
(ractopamine HCl)/
RUMENSIN (monensin).
200-451..................... HEIFERMAX 500 558.342
(melengestrol
acetate) Liquid
Premix plus BOVATEC
(lasalocid).
200-479..................... HEIFERMAX 500 558.665
(melengestrol
acetate) Liquid
Premix/ZILMAX
(zilpaterol)/RUMENSIN
(monensin).
200-480..................... HEIFERMAX 500 558.665
(melengestrol
acetate) Liquid
Premix/ZILMAX
(zilpaterol)/RUMENSIN
(monensin)/TYLAN
(tylosin phosphate).
200-483..................... HEIFERMAX 500 558.665
(melengestrol
acetate) Liquid
Premix plus ZILMAX
(zilpaterol).
------------------------------------------------------------------------
Accordingly, the Agency is amending the regulations in parts 522
and 558 (21 CFR parts 522, and 558) to reflect the transfer of
ownership.
Following these changes of sponsorship, Ivy Laboratories, Division
of Ivy Animal Health, Inc., is no longer the sponsor of an approved
application. Accordingly, Sec. 510.600 (21 CFR 510.600) is being
amended to remove the entries for this firm.
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 Part 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,
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.
Sec. 510.600 [Amended]
2. In Sec. 510.600, in the table in paragraph (c)(l), remove the
entry for ``Ivy Laboratories, Div. of Ivy Animal Health, Inc.''; and in
the table in paragraph (c)(2), remove the entry for ``021641''.
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.
Sec. 522.840 [Amended]
0
4. In paragraph (b) of Sec. 522.840, remove ``021641'' and in its
place add ``000986''.
Sec. 522.842 [Amended]
0
5. In paragraph (a)(2) of Sec. 522.842, remove ``021641'' and in its
place add ``000986''.
Sec. 522.1940 [Amended]
0
6. In paragraph (a)(2) of Sec. 522.1940, remove ``021641'' and in its
place add ``000986''.
Sec. 522.2476 [Amended]
0
7. In paragraph (b)(l) of Sec. 522.2476, remove ``021641'' and in its
place add ``000986''.
Sec. 522.2477 [Amended]
0
8. In paragraph (b)(l) of Sec. 522.2477, remove ``021641'' and in its
place add ``000986''.
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.
Sec. 558.342 [Amended]
0
10. In Sec. 558.342, in paragraph (b)(2) and in the ``Sponsor'' column
of the table, in paragraphs (e)(l)(i), (e)(1)(ii), (e)(l)(iii), and
(e)(l)(ix) remove ``021641''
[[Page 31724]]
and in its place add ``000986''; in paragraphs (e)(1)(iv) and (e)(1)(x)
add ``000986''; and in paragraph (e)(1)(xi), remove ``02164'' and in
its place add ``000986''.
Sec. 558.500 [Amended]
0
11. In Sec. 558.500, in the ``Sponsor'' column of the table, in
paragraphs (e)(2)(viii) and (e)(2)(x), remove ``021641''.
Sec. 558.665 [Amended]
0
12. In Sec. 558.665, in the ``Sponsor'' column of the table, in
paragraphs (e)(2), (e)(4), and (e)(6), remove ``021641'' and in its
place add ``000986''.
Dated: May 23, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2012-13010 Filed 5-29-12; 8:45 am]
BILLING CODE 4160-01-P
