New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine, 20917 [2010-9304]

Download as PDF Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Rules and Regulations be available upon request from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993–0002. * * * * * PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS Dated: April 12, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–8863 Filed 4–21–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 33. The authority citation for 21 CFR part 1040 continues to read as follows: ■ Authority: 21 U.S.C. 351, 352, 360, 360e– 360j, 371, 381; 42 U.S.C. 263B–263n. 34. Section 1040.10 is amended by revising paragraph (a)(3)(i) to read as follows: ■ § 1040.10 AGENCY: ACTION: Laser products. § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products. emcdonald on DSK2BSOYB1PROD with RULES * * * * * (d) * * * (3) * * * (iii) If the size, configuration, design, or function of the sunlamp product or ultraviolet lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, or would render the required label unnecessary, the Director, Office of Communication, Education, and Radiation Programs 10903 New Hampshire Ave., Bldg. 66, rm. 4312, Silver Spring, MD 20993– 0002, Center for Devices and Radiological Health, on the center’s own initiative or upon written application by the manufacturer, may approve alternate means of providing such label(s), alternate wording for such label(s), or deletion, as applicable. * * * * * 15:00 Apr 21, 2010 New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine Jkt 220001 Food and Drug Administration, HHS. (a) * * * (3) * * * (i) Registers, and provides a listing by type of such laser products manufactured that includes the product name, model number and laser medium or emitted wavelength(s), and the name and address of the manufacturer. The manufacturer must submit the registration and listing to the Food and Drug Administration, Center for Devices and Radiological Health, Director, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993–0002. * * * * * ■ 35. Section 1040.20 is amended by revising paragraph (d)(3)(iii) to read as follows: VerDate Nov<24>2008 [Docket No. FDA–2010–N–0002] Final rule. 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 Ivy Laboratories, Div. of Ivy Animal Health, Inc. The supplemental NADA provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter. DATES: This rule is effective April 22, 2010. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to ANADA 200–448 that provides for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix, OPTAFLEXX (ractopamine hydrochloride), and RUMENSIN (monensin, USP) singleingredient Type A medicated articles to make dry and liquid, three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. The supplemental ANADA provides for an increased level of monensin. The supplemental ANADA is approved as of February 16, 2010, and the regulations are amended in 21 CFR 558.500 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 9990 20917 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 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 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. § 558.500 [Amended] 2. In § 558.500, in paragraph (e)(2)(viii), in the ‘‘Limitations’’ column, remove ‘‘000009’’and add in its place ‘‘000009 or 021641’’, and in the ‘‘Sponsor’’ column, remove ‘‘No. 000986’’and add in its place ‘‘000986, 021641’’; and remove paragraph (e)(2)(xii). ■ Dated: April 19, 2010. Elizabeth Rettie, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 2010–9304 Filed 4–21–10; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\22APR1.SGM 22APR1

Agencies

[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Rules and Regulations]
[Page 20917]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]


New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, 
and Ractopamine

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 abbreviated new 
animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy 
Animal Health, Inc. The supplemental NADA provides for an increased 
level of monensin in three-way combination Type C medicated feeds 
containing ractopamine, melengestrol, and monensin for heifers fed in 
confinement for slaughter.

DATES: This rule is effective April 22, 2010.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to 
ANADA 200-448 that provides for use of HEIFERMAX 500 (melengestrol 
acetate) Liquid Premix, OPTAFLEXX (ractopamine hydrochloride), and 
RUMENSIN (monensin, USP) single-ingredient Type A medicated articles to 
make dry and liquid, three-way combination drug Type C medicated feeds 
for heifers fed in confinement for slaughter. The supplemental ANADA 
provides for an increased level of monensin. The supplemental ANADA is 
approved as of February 16, 2010, and the regulations are amended in 21 
CFR 558.500 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 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 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.  558.500  [Amended]

0
2. In Sec.  558.500, in paragraph (e)(2)(viii), in the ``Limitations'' 
column, remove ``000009''and add in its place ``000009 or 021641'', and 
in the ``Sponsor'' column, remove ``No. 000986''and add in its place 
``000986, 021641''; and remove paragraph (e)(2)(xii).

    Dated: April 19, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-9304 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S

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