Oral Dosage Form New Animal Drugs; Ivermectin Liquid, 9455-9456 [E8-3266]

Download as PDF 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. * * * * * 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. * * * * * (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 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 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 9456 Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Rules and Regulations 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. I 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 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. In § 520.1195, revise paragraphs (b)(1) and (b)(2) to read as follows: I § 520.1195 Ivermectin liquid. * * * * * (b) * * * (1) Nos. 050604, 054925, and 059130 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section. (2) Nos. 058005 and 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section. * * * * * Dated: February 11, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–3266 Filed 2–20–08; 8:45 am] BILLING CODE 4160–01–S Department of the Air Force 32 CFR Part 903 [Docket No. USAF–2007–0001] RIN 0701–AA72 Air Force Academy Preparatory School DoD, USAF. Final rule. AGENCY: ebenthall on PRODPC61 with RULES SUMMARY: This final rule tells how to apply for the Air Force Academy Preparatory School. It also explains the procedures for selection, disenrollment, and assignment. This rule has been VerDate Aug<31>2005 14:36 Feb 20, 2008 Jkt 214001 Executive Order 12866, ‘‘Regulatory Planning and Review’’ It has been determined that 32 CFR part 903 is not a significant regulatory action. This rule does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of the recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive Order. Unfunded Mandates Reform Act (Sec. 202, Pub. L. 104–4) It has been certified the 32 CFR part 903 does not contain a Federal Mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year. Public Law 96–354, ‘‘Regulatory Flexibility Act’’ (5 U.S.C. 601) It has been determined that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. DEPARTMENT OF DEFENSE ACTION: updated to identify USAFA’s revised mission statement, new selection criteria and updates of associated Air Force Instructions. DATES: Effective Date: This rule is effective March 24, 2008. FOR FURTHER INFORMATION CONTACT: Mr. Scotty Ashley at (703) 695–3594, scotty.Ashley@pentagon.af.mil. SUPPLEMENTARY INFORMATION: The proposed rule was published in the Federal Register on July 12, 2007 (72 FR 10436–10438). No comments were received. Public Law 95–511, ‘‘Paperwork Reduction Act’’ (44 U.S.C. Chapter 35) It has been certified that 32 CFR part 903 does not impose any reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Federalism (Executive Order 13132) It has been certified that 32 CFR part 903 does not have federalism PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on: (1) The States; (2) The relationship between the National Government and the States; or (3) The distribution of power and responsibilities among the various levels of government. List of Subjects in 32 CFR Part 903 Military academy; Military personnel. Therefore, for the reasons set forth in the preamble, 32 CFR part 903 is revised to read as follows: I PART 903—AIR FORCE ACADEMY PREPARATORY SCHOOL Sec. 903.1 Mission and responsibilities. 903.2 Eligibility requirements. 903.3 Selection criteria. 903.4 Application process and procedures. 903.5 Reserve enlistment procedures. 903.6 Reassignment of Air Force members to become cadet candidates at the preparatory school. 903.7 Reassignment of cadet candidates who graduate from the Preparatory School with an appointment to U.S. Air Force Academy (USAFA). 903.8 Cadet candidate disenrollment. 903.9 Cadet records and reassignment forms. 903.10 Information collections, records, and forms or information management tools. Authority: 5 U.S.C. 301, 10 U.S.C. 8013, and 10 U.S.C. 9331 unless otherwise noted). Note: This part is derived from AFI 36– 2021, September 12, 2006. Part 806 of this chapter states the basic policies and instructions governing the disclosure of records and tells members of the public what they must do to inspect or obtain copies of the material referenced herein. § 903.1 Mission and responsibilities. (a) Mission. To motivate, prepare, and evaluate selected candidates in an educational, military, moral, and physical environment, to perform successfully and enhance diversity at USAFA. (b) Responsibilities: (1) Superintendent, USAFA (HQ USAFA/CC). Ensures adequate oversight of HQ USAFA/PL activities, administration, and resources. Means of oversight include but are not limited to: (i) United States Air Force Academy Instruction (USAFAI) 36–3502, USAFA Assessment Board. (ii) The Preparatory School Advisory Committee, as established in USAFAI 36–2013, Superintendent’s Preparatory School Advisory Committee of the USAF Academy Preparatory School. (iii) Annual Assessment, as established in Department of Defense E:\FR\FM\21FER1.SGM 21FER1

Agencies

[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Rules and Regulations]
[Pages 9455-9456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3266]


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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.

ACTION: Final rule; technical amendment.

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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

[[Page 9456]]

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.  520.1195, revise paragraphs (b)(1) and (b)(2) to read as 
follows:


Sec.  520.1195  Ivermectin liquid.

* * * * *
    (b) * * *
    (1) Nos. 050604, 054925, and 059130 for use of product described in 
paragraph (a)(1) of this section as in paragraphs (e)(1)(i), 
(e)(1)(ii)(A), and (e)(1)(iii) of this section.
    (2) Nos. 058005 and 058829 for use of product described in 
paragraph (a)(1) of this section as in paragraphs (e)(1)(i), 
(e)(1)(ii)(B), and (e)(1)(iii) of this section.
* * * * *

    Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-3266 Filed 2-20-08; 8:45 am]
BILLING CODE 4160-01-S

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