Oral Dosage Form New Animal Drugs; Altrenogest, 9455 [E8-3265]
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Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Rules and Regulations
radius of Williamsport-Lycoming County
Airport extending clockwise from a 025°
bearing to a 067° bearing from the airport and
within a 12.6-mile radius of WilliamsportLycoming County Airport extending
clockwise from a 067° bearing to a 099°
bearing from the airport and within a 6.7mile radius of Williamsport-Lycoming
County Airport extending clockwise from a
099° bearing to a 270° bearing from the
airport and within a 17.9-mile radius of
Williamsport-Lycoming County Airport
extending clockwise from a 270° bearing to
a 312° bearing from the airport and within a
19.6-mile radius of Williamsport-Lycoming
County Airport extending clockwise from a
312° bearing to a 350° bearing from the
airport and within a 6.7-mile radius of
Williamsport-Lycoming County Airport
extending clockwise from a 350° bearing to
a 025° bearing from the airport and within
4.4 miles each side of the WilliamsportLycoming County Airport ILS localizer east
course extending from the Picture Rocks NDB
to 11.3 miles east of the NDB; and that
airspace within a 6-mile radius of the point
in space (Lat. 41°14′43″ N., long. 77°00′04″
W.) serving the Williamsport Hospital.
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Issued in College Park, GA, on February 7,
2008.
Barry A. Knight,
Acting Manager, System Support Group,
Eastern Service Center.
[FR Doc. 08–728 Filed 2–20–08; 8:45 am]
Millsboro, DE 19966, filed a supplement
to NADA 131–310 for REGU-MATE
(altrenogest), an oral solution
administered to mares for suppression
of estrus. The supplemental application
provides for a revised warning
statement on product labeling. The
supplemental NADA is approved as of
January 18, 2008, and 21 CFR 520.48 is
amended to reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(1) 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.
List of Subjects in 21 CFR Part 520
Animal drugs.
BILLING CODE 4910–13–M
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 520 is amended as follows:
I
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Altrenogest
AGENCY:
Food and Drug Administration,
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
HHS.
ACTION:
Authority: 21 U.S.C. 360b.
Final rule.
ebenthall on PRODPC61 with RULES
VerDate Aug<31>2005
14:36 Feb 20, 2008
2. In § 520.48, revise the section
heading and paragraph (d)(1)(iii) to read
as follows:
I
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
Intervet, Inc. The supplemental NADA
provides for revised food safety labeling
for altrenogest oral solution used in
horses.
DATES: This rule is effective February
21, 2008.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
e-mail: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
SUMMARY:
Jkt 214001
§ 520.48
Altrenogest.
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(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
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Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–3265 Filed 2–20–08; 8:45 am]
BILLING CODE 4160–01–S
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9455
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Ivermectin Liquid
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by IVX Animal Health, Inc. The
supplemental ANADA provides revised
labeling for ivermectin oral liquid used
in horses.
DATES: This rule is effective February
21, 2008.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
a supplement to ANADA 200–202 for
PHOENECTIN (ivermectin) Liquid for
Horses. The supplemental application
provides for the addition of indications
for use and minor revisions to product
labeling that conform to the pioneer
product labeling. The supplemental
ANADA is approved as of January 24,
2008, and 21 CFR 520.1195 is amended
to reflect the approval.
In addition, the regulation is being
amended to add the drug labeler code
for another approved generic product
(69 FR 24958, May 5, 2004), which was
removed in error in the Federal Register
of September 24, 2004 (69 FR 57173).
This action is being taken to improve
the accuracy of the regulations.
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)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
E:\FR\FM\21FER1.SGM
21FER1
]]>Agencies
[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Rules and Regulations]
[Page 9455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Altrenogest
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 Intervet, Inc. The supplemental NADA
provides for revised food safety labeling for altrenogest oral solution
used in horses.
DATES: This rule is effective February 21, 2008.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed a supplement to NADA 131-310 for REGU-
MATE (altrenogest), an oral solution administered to mares for
suppression of estrus. The supplemental application provides for a
revised warning statement on product labeling. The supplemental NADA is
approved as of January 18, 2008, and 21 CFR 520.48 is amended to
reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33(a)(1) 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.
List of Subjects in 21 CFR Part 520
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 part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.48, revise the section heading and paragraph
(d)(1)(iii) to read as follows:
Sec. 520.48 Altrenogest.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-3265 Filed 2-20-08; 8:45 am]
BILLING CODE 4160-01-S
