New Animal Drugs; Change of Sponsor's Name; Iron Injection; Technical Amendment, 14384-14385 [E8-5452]
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14384
Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Rules and Regulations
REVISIONS TO IFR ALTITUDES & CHANGEOVER POINTS—Continued
[Amendment 473 effective date April 10, 2008 ]
From
To
§ 95.6489
MEA
VOR Federal Airway V489 Is Amended To Read in Part
Albany, NY VORTAC ....................................................................
*5000—GNSS MEA
Glens Falls, NY VORTAC .............................................................
*8000—MRA
*Fairb, NY FIX ...............................................................................
*8000—MRA
**6000—GNSS MEA
Glens Falls, NY VORTAC ...........................................................
*7000
*Fairb, NY FIX .............................................................................
6000
Leafy, NY FIX ..............................................................................
**8000
From
To
MEA
MAA
§ 95.7001 Jet Routes
§ 95.7029 Jet Route J29 Is Amended To Read in Part
Humble, TX VORTAC .......................................................
§ 95.7101
El Dorado, AR VORTAC ..................................................
18000
18300
Little Rock, AR VORTAC .................................................
Airway segment
Changeover points
From
To
§ 95.8003
Food and Drug Administration
21 CFR Parts 510 and 522
New Animal Drugs; Change of
Sponsor’s Name; Iron Injection;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
rwilkins on PROD1PC63 with PROPOSALS
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Animal
Health Pharmaceuticals, LLC, to
Pharmacosmos, Inc.
DATES: This rule is effective March 18,
2008.
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, email: david.newkirk@fda.hhs.gov.
VerDate Aug<31>2005
16:03 Mar 17, 2008
Jkt 214001
From
Pulaski, VA VORTAC .......................................................
46
Beckley
Parkersburg, WV VORTAC ..............................................
46
Beckley
Animal
Health Pharmaceuticals, LLC, 1805 Oak
Ridge Circle, suite 101, St. Joseph, MO
64506, has informed FDA that it has
transferred ownership of, and all rights
and interest in, NADA 106–772 for IronGARD Injection 100 milligrams per
milliliter (mg/mL) and NADA 134–708
for Iron-GARD Injection 200 mg/mL to
Pharmacosmos, Inc., 776 Mountain
Blvd., Watchung, NJ 07069.
Accordingly, the regulations are
amended in 21 CFR 522.1182 to reflect
these changes of sponsorship.
In addition, Pharmacosmos, Inc., is
not currently listed in the animal drug
regulations as a sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to add
entries for Pharmacosmos, Inc.
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.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Distance
VOR Federal Airway Changeover Points
Is Amended To Delete Changeover Point V59:
Beckley, WV VORTAC ..............................................
Is Amended To Add Changeover Point V59:
Beckley, WV VORTAC ..............................................
BILLING CODE 4910–13–P
45000
Jet Route J101 Is Amended To Read in Part
Lufkin, TX VORTAC ..........................................................
[FR Doc. E8–5372 Filed 3–17–08; 8:45 am]
45000
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Frm 00014
Fmt 4700
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 and 522 are amended as
follows:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add a
new entry for ‘‘Pharmacosmos, Inc.’’;
and in the table in paragraph (c)(2)
numerically add a new entry for
‘‘042552’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
List of Subjects
PO 00000
21 CFR Part 522
Sfmt 4700
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
Drug labeler
code
*
*
E:\FR\FM\18MRR1.SGM
*
18MRR1
*
*
14385
Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Rules and Regulations
Drug labeler
code
Firm name and address
Pharmacosmos, Inc., 776
Mountain
Blvd.,Watchung, NJ
07069.
*
*
*
042552
Food and Drug Administration
21 CFR Part 558
*
*
New Animal Drugs for Use in Animal
Feed; Zilpaterol
(2) * * *
AGENCY:
Firm name and address
*
*
ACTION:
*
*
*
Pharmacosmos, Inc., 776
Mountain
Blvd.,Watchung, NJ
07069
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 522.1182
[Amended]
4. In § 522.1182, in paragraphs (b)(1)
and (b)(7) remove ‘‘059130 and 068718’’
and add in its place ‘‘042552 and
059130’’.
I
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–5452 Filed 3–17–08; 8:45 am]
BILLING CODE 4160–01–S
Zilpaterol in
grams/ton
*
rwilkins on PROD1PC63 with PROPOSALS
VerDate Aug<31>2005
Indications for use
*
*
Jkt 214001
PO 00000
*
Frm 00015
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In § 558.665, add paragraph (e)(3) to
read as follows:
I
§ 558.665
*
Zilpaterol.
*
*
(e) * * *
*
Cattle fed in confinement for slaughter: As
in paragraph (e)(1) of this section; and
for prevention and control of coccidiosis
due to Eimeria bovis and E. zuernii.
*
regulations in 21 CFR 558.665 are
amended 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 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(2) 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 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
*
Monensin 10 to
40
16:03 Mar 17, 2008
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for use of
approved, single-ingredient zilpaterol
hydrochloride and monensin U.S.P.
Type A medicated articles to make twoway combination Type B and Type C
medicated feeds for cattle fed in
confinement for slaughter.
DATES: This rule is effective March 18,
2008.
FOR FURTHER INFORMATION CONTACT:
Gerald L. Rushin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8103, email: gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
278 that provides for use of ZILMAX
(zilpaterol hydrochloride) and
RUMENSIN (monensin U.S.P.) Type A
medicated articles to make dry and
liquid, two-way combination Type B
and Type C medicated feeds used for
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness; and for prevention and control
of coccidiosis due to Eimeria bovis and
E. zuernii in cattle fed in confinement
for slaughter during the last 20 to 40
days on feed. The NADA is approved as
of February 15, 2008, and the
Combination in
grams/ton
*
(3) 6.8 to provide
60 to 90 mg/
head/day
*
Food and Drug Administration,
HHS.
Drug labeler
code
*
042552
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fmt 4700
*
*
As in paragraph (e)(1) of this section; see
paragraph § 558.355(d) of this chapter.
Monensin as provided by No. 000986 in
§ 510.600(c) of this chapter.
*
Sfmt 4700
Sponsor
E:\FR\FM\18MRR1.SGM
*
18MRR1
057926
*
]]>Agencies
[Federal Register Volume 73, Number 53 (Tuesday, March 18, 2008)]
[Rules and Regulations]
[Pages 14384-14385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5452]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
New Animal Drugs; Change of Sponsor's Name; Iron Injection;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Animal
Health Pharmaceuticals, LLC, to Pharmacosmos, Inc.
DATES: This rule is effective March 18, 2008.
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: Animal Health Pharmaceuticals, LLC, 1805 Oak
Ridge Circle, suite 101, St. Joseph, MO 64506, has informed FDA that it
has transferred ownership of, and all rights and interest in, NADA 106-
772 for Iron-GARD Injection 100 milligrams per milliliter (mg/mL) and
NADA 134-708 for Iron-GARD Injection 200 mg/mL to Pharmacosmos, Inc.,
776 Mountain Blvd., Watchung, NJ 07069. Accordingly, the regulations
are amended in 21 CFR 522.1182 to reflect these changes of sponsorship.
In addition, Pharmacosmos, Inc., is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for
Pharmacosmos, Inc.
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.
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 parts 510 and
522 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 a new entry for ``Pharmacosmos, Inc.''; and in the table in
paragraph (c)(2) numerically add a new entry for ``042552'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
[[Page 14385]]
Pharmacosmos, Inc., 776 Mountain 042552
Blvd.,Watchung, NJ 07069.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
042552 Pharmacosmos, Inc., 776 Mountain
Blvd.,Watchung, NJ 07069
* * * * *
------------------------------------------------------------------------
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. 522.1182 [Amended]
0
4. In Sec. 522.1182, in paragraphs (b)(1) and (b)(7) remove ``059130
and 068718'' and add in its place ``042552 and 059130''.
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5452 Filed 3-17-08; 8:45 am]
BILLING CODE 4160-01-S
