New Animal Drugs for Use in Animal Feeds; Change of Sponsor, 61028-61029 [E9-28009]
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61028
Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Rules and Regulations
Issued in Washington, DC on November 13,
2009.
John M. Allen,
Director, Flight Standards Service.
Adoption of the Amendment
Accordingly, pursuant to the authority
delegated to me, Title 14, Code of
Federal regulations, Part 97, 14 CFR part
97, is amended by amending Standard
Instrument Approach Procedures,
effective at 0901 UTC on the dates
specified, as follows:
■
AIRAC
date
State
PART 97—STANDARD INSTRUMENT
APPROACH PROCEDURES
1. The authority citation for part 97
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40106,
40113, 40114, 40120, 44502, 44514, 44701,
44719, 44721–44722.
2. Part 97 is amended to read as
follows:
■
§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33,
and 97.35 [Amended]
By amending: § 97.23 VOR, VOR/
DME, VOR or TACAN, and VOR/DME
or TACAN; § 97.25 LOC, LOC/DME,
LDA, LDA/DME, SDF, SDF/DME;
§ 97.27 NDB, NDB/DME; § 97.29 ILS,
ILS/DME, MLS, MLS/DME, MLS/RNAV;
§ 97.31 RADAR SIAPs; § 97.33 RNAV
SIAPs; and § 97.35 COPTER SIAPs,
Identified as follows:
Effective Upon Publication
City
Airport
FDC No.
FDC date
Subject
17–Dec–09
17–Dec–09
CT
IL
Danielson ............................
Kewanee .............................
Danielson ............................
Kewanee Muni ....................
9/3449
9/5179
10/9/09
10/16/09
17–Dec–09
17–Dec–09
17–Dec–09
RI
VA
KY
North Kingstown .................
Clarksville ............................
Mount Sterling .....................
9/5393
9/6484
9/6872
10/21/09
10/23/09
10/23/09
17–Dec–09
ND
Devils Lake .........................
Quonset State .....................
Marks Muni .........................
Sterling-Montgomery County.
Devils Lake RgNL ...............
9/7299
10/28/09
17–Dec–09
ME
Auburn/Lewiston .................
Auburn/Lewiston Muni ........
9/7617
10/30/09
17–Dec–09
17–Dec–09
17–Dec–09
17–Dec–09
17–Dec–09
ME
ME
NC
NC
NC
Auburn/Lewiston .................
Auburn/Lewiston .................
Greenville ............................
Greenville ............................
Greenville ............................
Auburn/Lewiston Muni ........
Auburn/Lewiston Muni ........
Pitt-Greenville .....................
Pitt-Greenville .....................
Pitt-Greenville .....................
9/7618
9/7620
9/8037
9/8038
9/8040
10/30/09
10/30/09
10/30/09
10/30/09
10/30/09
[FR Doc. E9–27900 Filed 11–20–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 10 new animal
drug applications (NADAs) from Merial
Ltd. to Huvepharma AD.
DATES: This rule is effective November
23, 2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307,
e-mail: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
VerDate Nov<24>2008
15:09 Nov 20, 2009
Jkt 220001
Duluth, GA 30096–4640, has informed
FDA that it has transferred ownership
of, and all rights and interest in, the
following 10 approved NADAs to
Huvepharma AD, 33 James Boucher
Blvd., Sophia 1407, Bulgaria: NADA
036–304, 049–179, 049–180, 118–507,
040–264, 041–541, 044–016, 046–209,
049–934, and 099–150. Accordingly, the
agency is amending the regulations to
reflect the transfer of ownership.
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 in 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 part 558 is amended as follows:
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
§ 558.55
VOR–A, AMDT 6C.
Takeoff Minimums and Obstacle
DP, ORIG.
ILS OR LOC RWY 16, AMDT 10.
VOR/DME A, ORIG.
NDB OR GPS RWY 3, AMDT
1C.
Takeoff Minimums and Obstacle
DP, AMDT 1.
ILS OR LOC RWY 4, AMDT
10A.
RNAV (GPS) RWY 4, ORIG.
RNAV (GPS) RWY 22, ORIG.
RNAV (GPS) RWY 26, AMDT 2.
RNAV (GPS) RWY 20, AMDT 2.
RNAV (GPS) RWY 8, AMDT 2.
[Amended]
2. In § 558.55, in paragraph (d)(2)(iv),
in the table, in the entry for ‘‘Carbarsone
227 to 340.5’’, in the ‘‘Sponsor’’ column,
remove ‘‘000006’’ and in its place add
‘‘016592’’.
■
3. Amend § 558.58 as follows:
a. Remove paragraphs (a)(3), (b)(1),
and (b)(2);
b. In paragraph (e)(1)(i), in the table,
in the ‘‘Sponsor’’ column, remove
‘‘050604’’;
c. In paragraphs (e)(1)(ii) and
(e)(1)(iii), in the table, in the
‘‘Limitations’’ column, remove
‘‘050604’’ wherever it occurs and in its
place add ‘‘016592’’; and
d. Revise paragraph (b).
The revisions are to read as follows:
■
§ 558.58
Amprolium and ethopabate.
*
*
*
*
*
(b) Approvals. See No. 016592 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 558.175
[Amended]
4. In § 558.175, in paragraph (b) and
in the table in paragraph (d), in the
‘‘Sponsor’’ column, remove ‘‘050604’’
wherever it occurs and in its place add
‘‘016592’’.
■
E:\FR\FM\23NOR1.SGM
23NOR1
61029
Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Rules and Regulations
Dated: November 16, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–28009 Filed 11–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Melengestrol; Monensin;
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 of a supplemental new animal
drug application (NADA) filed by
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA
provides for use of the same dose levels
approved for single-ingredient Type C
medicated feeds containing
melengestrol acetate, monensin, or
tylosin phosphate for heifers fed in
confinement for slaughter in three-way,
combination drug Type C medicated
feeds containing melengestrol acetate,
monensin, and tylosin phosphate.
Melengestrol acetate in mg/head/
day
*
erowe on DSK5CLS3C1PROD with RULES
Combination in mg/head/day
*
(xi) 0.25 to 0.5 ......
DATES: This rule is effective November
23, 2009.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 138–870
for use of MGA (melengestrol acetate),
RUMENSIN (monensin, USP), and
TYLAN (tylosin phosphate) singleingredient Type A medicated articles to
make three-way, combination drug Type
C medicated feeds for heifers fed in
confinement for slaughter. The
supplemental NADA provides for use of
the same dose levels approved for single
ingredient Type C medicated feeds
containing melengestrol acetate,
monensin, or tylosin phosphate in the
three-way, combination drug Type C
medicated feeds. The supplemental
application is approved as of October
19, 2009, and the regulations are
amended in 21 CFR 558.342 to reflect
the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between
*
List of Subjects in 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 part 558 is amended as follows:
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
2. In § 558.342, add paragraph
(e)(1)(xi) to read as follows:
■
§ 558.342
*
Melengestrol.
*
*
(e) * * *
(1) * * *
Indications for use
*
Monensin 50 to 480, plus tylosin 60 to
90.
9 a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
*
*
Limitations
*
Heifers fed in confinement
for slaughter: As in paragraph (e)(1)(i) of this section; for the prevention
and control of coccidiosis
due to Eimeria bovis and
E. zuernii; and for reduction of incidence of liver
abscesses caused by
Fusobacterium
necrophorum and
Arcanobacterium
pyogenes.
*
Feed continuously as sole ration (liquid or dry) at a rate of 0.5 to 2.0
lb/head/day to provide 0.25 to 0.5
mg/head/day melengestrol acetate; 0.14 to 0.42 mg monensin/lb
body weight/day, depending on
the severity of the coccidiosis
challenge, up to 480 mg/head/day;
and 60 to 90 mg/head/day tylosin.
The melengestrol acetate portion
of this Type C medicated feed
must be mixed into a complete
feed containing 10 to 40 g/ton
monensin and 8 to 10 g/ton tylosin
in the amount of complete feed
consumed by an animal per day.
Monensin and tylosin phosphate provided by No. 000986 in
§ 510.600(c) of this chapter.
VerDate Nov<24>2008
15:09 Nov 20, 2009
Jkt 220001
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
E:\FR\FM\23NOR1.SGM
23NOR1
Sponsor
*
000009
]]>Agencies
[Federal Register Volume 74, Number 224 (Monday, November 23, 2009)]
[Rules and Regulations]
[Pages 61028-61029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28009]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Change of Sponsor
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 10 new animal drug
applications (NADAs) from Merial Ltd. to Huvepharma AD.
DATES: This rule is effective November 23, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, has informed FDA that it has transferred
ownership of, and all rights and interest in, the following 10 approved
NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria:
NADA 036-304, 049-179, 049-180, 118-507, 040-264, 041-541, 044-016,
046-209, 049-934, and 099-150. Accordingly, the agency is amending the
regulations to reflect the transfer of ownership.
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 in 21 CFR Part 558
Animal drugs, Animal feeds.
0
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 part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.55 [Amended]
0
2. In Sec. 558.55, in paragraph (d)(2)(iv), in the table, in the entry
for ``Carbarsone 227 to 340.5'', in the ``Sponsor'' column, remove
``000006'' and in its place add ``016592''.
0
3. Amend Sec. 558.58 as follows:
a. Remove paragraphs (a)(3), (b)(1), and (b)(2);
b. In paragraph (e)(1)(i), in the table, in the ``Sponsor'' column,
remove ``050604'';
c. In paragraphs (e)(1)(ii) and (e)(1)(iii), in the table, in the
``Limitations'' column, remove ``050604'' wherever it occurs and in its
place add ``016592''; and
d. Revise paragraph (b).
The revisions are to read as follows:
Sec. 558.58 Amprolium and ethopabate.
* * * * *
(b) Approvals. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 558.175 [Amended]
0
4. In Sec. 558.175, in paragraph (b) and in the table in paragraph
(d), in the ``Sponsor'' column, remove ``050604'' wherever it occurs
and in its place add ``016592''.
[[Page 61029]]
Dated: November 16, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-28009 Filed 11-20-09; 8:45 am]
BILLING CODE 4160-01-S
