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Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Rules and Regulations 9455
radius of Williamsport-Lycoming County Millsboro, DE 19966, filed a supplement DEPARTMENT OF HEALTH AND
Airport extending clockwise from a 025° to NADA 131–310 for REGU-MATE HUMAN SERVICES
bearing to a 067° bearing from the airport and (altrenogest), an oral solution
within a 12.6-mile radius of Williamsport- Food and Drug Administration
administered to mares for suppression
Lycoming County Airport extending
clockwise from a 067° bearing to a 099° of estrus. The supplemental application
bearing from the airport and within a 6.7- provides for a revised warning 21 CFR Part 520
mile radius of Williamsport-Lycoming statement on product labeling. The
County Airport extending clockwise from a supplemental NADA is approved as of Oral Dosage Form New Animal Drugs;
099° bearing to a 270° bearing from the January 18, 2008, and 21 CFR 520.48 is Ivermectin Liquid
airport and within a 17.9-mile radius of amended to reflect the approval. AGENCY: Food and Drug Administration,
Williamsport-Lycoming County Airport
extending clockwise from a 270° bearing to Approval of this supplemental NADA HHS.
a 312° bearing from the airport and within a did not require review of additional Final rule; technical
ACTION:
19.6-mile radius of Williamsport-Lycoming safety or effectiveness data or amendment.
County Airport extending clockwise from a information. Therefore, a freedom of
312° bearing to a 350° bearing from the information summary is not required. SUMMARY: The Food and Drug
airport and within a 6.7-mile radius of Administration (FDA) is amending the
Williamsport-Lycoming County Airport The agency has determined under 21 animal drug regulations to reflect
extending clockwise from a 350° bearing to CFR 25.33(a)(1) that this action is of a approval of a supplemental abbreviated
a 025° bearing from the airport and within type that does not individually or new animal drug application (ANADA)
4.4 miles each side of the Williamsport- cumulatively have a significant effect on filed by IVX Animal Health, Inc. The
Lycoming County Airport ILS localizer east the human environment. Therefore,
course extending from the Picture Rocks NDB supplemental ANADA provides revised
neither an environmental assessment labeling for ivermectin oral liquid used
to 11.3 miles east of the NDB; and that nor an environmental impact statement
airspace within a 6-mile radius of the point in horses.
in space (Lat. 41°14′43″ N., long. 77°00′04″
is required.
DATES: This rule is effective February
W.) serving the Williamsport Hospital. This rule does not meet the definition 21, 2008.
* * * * * of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because FOR FURTHER INFORMATION CONTACT: John
it is a rule of ‘‘particular applicability.’’ K. Harshman, Center for Veterinary
Issued in College Park, GA, on February 7,
2008.
Therefore, it is not subject to the Medicine (HFV–104), Food and Drug
congressional review requirements in 5 Administration, 7500 Standish Pl.,
Barry A. Knight,
U.S.C. 801–808. Rockville, MD 20855, 240–276–8197,
Acting Manager, System Support Group,
Eastern Service Center. List of Subjects in 21 CFR Part 520 e-mail: john.harshman@fda.hhs.gov.
[FR Doc. 08–728 Filed 2–20–08; 8:45 am] SUPPLEMENTARY INFORMATION: IVX
Animal drugs. Animal Health, Inc., 3915 South 48th
BILLING CODE 4910–13–M
■ Therefore, under the Federal Food, Street Ter., St. Joseph, MO 64503, filed
Drug, and Cosmetic Act and under a supplement to ANADA 200–202 for
DEPARTMENT OF HEALTH AND authority delegated to the Commissioner PHOENECTIN (ivermectin) Liquid for
HUMAN SERVICES of Food and Drugs and redelegated to Horses. The supplemental application
the Center for Veterinary Medicine, 21 provides for the addition of indications
Food and Drug Administration CFR part 520 is amended as follows: for use and minor revisions to product
labeling that conform to the pioneer
21 CFR Part 520 PART 520—ORAL DOSAGE FORM product labeling. The supplemental
NEW ANIMAL DRUGS ANADA is approved as of January 24,
Oral Dosage Form New Animal Drugs; 2008, and 21 CFR 520.1195 is amended
Altrenogest ■ 1. The authority citation for 21 CFR to reflect the approval.
part 520 continues to read as follows: In addition, the regulation is being
AGENCY: Food and Drug Administration,
amended to add the drug labeler code
HHS. Authority: 21 U.S.C. 360b.
for another approved generic product
ACTION: Final rule. ■ 2. In § 520.48, revise the section (69 FR 24958, May 5, 2004), which was
SUMMARY: The Food and Drug heading and paragraph (d)(1)(iii) to read removed in error in the Federal Register
Administration (FDA) is amending the as follows: of September 24, 2004 (69 FR 57173).
animal drug regulations to reflect This action is being taken to improve
§ 520.48 Altrenogest. the accuracy of the regulations.
approval of a supplemental new animal
drug application (NADA) filed by * * * * * In accordance with the freedom of
Intervet, Inc. The supplemental NADA (d) * * * information provisions of 21 CFR part
provides for revised food safety labeling 20 and 21 CFR 514.11(e)(2)(ii), a
(1) * * * summary of safety and effectiveness
for altrenogest oral solution used in
(iii) Limitations. Do not use in horses data and information submitted to
horses.
intended for human consumption. support approval of this application
DATES: This rule is effective February Federal law restricts this drug to use by may be seen in the Division of Dockets
21, 2008. or on the order of a licensed Management (HFA–305), Food and Drug
FOR FURTHER INFORMATION CONTACT: veterinarian. Administration, 5630 Fishers Lane, rm.
Melanie R. Berson, Center for Veterinary * * * * * 1061, Rockville, MD 20852, between 9
Medicine (HFV–110), Food and Drug a.m. and 4 p.m., Monday through
Dated: February 11, 2008.
ebenthall on PRODPC61 with RULES
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