New Animal Drugs for Use in Animal Feeds; Zilpaterol, 11451-11452 [2010-5224]

Download as PDF jlentini on DSKJ8SOYB1PROD with RULES Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Rules and Regulations restrictions in paragraph (c) of this section. (b) A vessel that has a representative provide notification to NMFS as described in paragraph (a) of this section may only embark on a Loligo trip without an observer if a vessel representative has been notified that the vessel has received a waiver of the observer requirement for that trip. NMFS shall notify a vessel representative whether the vessel must carry an observer, or if a waiver has been granted, for the specified Loligo trip, within 24 hr of the vessel representative’s notification of the prospective Loligo trip, as specified by paragraph (a) of this section. Any request to carry an observer may be waived by NMFS. A vessel that fishes with an observer waiver confirmation number that does not match the Loligo trip plan that was called in to NMFS is prohibited from fishing for, possessing, harvesting, or landing Loligo except as specified in paragraph (c) of this section. Confirmation numbers for trip notification calls are only valid for 48 hr from the intended sail date. (c) A vessel issued a Loligo and butterfish moratorium permit, as specified at § 648.4(a)(5)(i), that does not have a representative provide the trip notification required in paragraph (a) of this section is prohibited from fishing for, possessing, harvesting, or landing 2,500 lb (1.13 mt) or more of Loligo per trip at any time, and may only land Loligo once on any calendar day, which is defined as the 24-hr period beginning at 0001 hours and ending at 2400 hours. (d) If a vessel issued a Loligo and butterfish moratorium permit, as specified at § 648.4(a)(5)(i), intends to possess, harvest, or land 2,500 lb (1.13 mt) or more of Loligo per trip or per calendar day, has a representative notify NMFS of an upcoming trip, is selected by NMFS to carry an observer, and then cancels that trip, the representative is required to provide notice to NMFS of the vessel name, vessel permit number, contact name for coordination of observer deployment, and telephone number for contact, and the intended date, time, and port of departure for the cancelled trip within 72 hr of the initial notification. In addition, if a trip selected for observer coverage is canceled, then that vessel is required to carry an observer, provided an observer is available, on its next trip. [FR Doc. 2010–5184 Filed 3–10–10; 8:45 am] BILLING CODE 3510–22–P VerDate Nov<24>2008 16:21 Mar 10, 2010 Jkt 220001 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; Zilpaterol 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 three abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADAs provides for use of single-ingredient Type A medicated articles containing zilpaterol, melengestrol, monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter. DATES: This rule is effective March 11, 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 ANADA 200–483 for use of ZILMAX (zilpaterol hydrochloride) and HEIFERMAX 500 (melengestrol acetate) Liquid Premix single-ingredient Type A medicated articles to make dry and liquid, two way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200–483 is approved as a generic copy of Intervet, Inc.’s combination medicated feed use of ZILMAX and MGA 500 (melengestrol acetate), approved under NADA 141– 284. Ivy Laboratories also filed ANADA 200–479 for use of ZILMAX, HEIFERMAX 500 Liquid Premix, and RUMENSIN (monensin USP) singleingredient Type A medicated articles to make dry and liquid, three-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200–479 is approved as a generic copy of Intervet, Inc.’s combination medicated feed use of ZILMAX, MGA 500, and RUMENSIN, approved under NADA 141–282. PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 11451 Ivy Laboratories also filed ANADA 200–480 for use of ZILMAX, HEIFERMAX 500 Liquid Premix, RUMENSIN, and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make dry and liquid, four-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200–480 is approved as a generic copy of Intervet, Inc.’s combination medicated feed use of ZILMAX, MGA 500, RUMENSIN, and TYLAN, approved under NADA 141– 280. The abbreviated applications are approved as of December 30, 2009, and the regulations are amended in 21 CFR 558.665 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 each 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 these actions are of a type that do 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 Subject 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. § 558.665 [Amended] 2. In § 558.665, in the table in paragraphs (e)(2), (e)(4), and (e)(6), in the ‘‘Limitations’’ column remove ‘‘No. 000009’’ and add in its place ‘‘Nos. 000009 or 021641’’ and in the ‘‘Sponsor’’ ■ E:\FR\FM\11MRR1.SGM 11MRR1 11452 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Rules and Regulations column add in numerical sequence ‘‘021641’’. Dated: March 8, 2010. William T. Flynn, Acting Director, Center for Veterinary Medicine. [FR Doc. 2010–5224 Filed 3–10–10; 8:45 am] BILLING CODE 4160–01–S POSTAL REGULATORY COMMISSION 39 CFR Part 3020 Docket No. MC2009–19; Order No. 391 New Postal Product Postal Regulatory Commission. Final rule. AGENCY: ACTION: SUMMARY: The Commission is adding special postal services to the product lists. This action is consistent with changes in a postal reform law. Republication of the product lists is also consistent with a statutory provision. The Commission also has prepared a supporting library reference. DATES: Effective March 11, 2010 and is applicable beginning January 13, 2010. FOR FURTHER INFORMATION CONTACT: Stephen L. Sharfman, General Counsel, 202–789–6824 or stephen.sharfman@prc.gov. Regulatory History, 74 FR 15784 (April 7, 2009). SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction and Summary II. Procedural History III. Commission Analysis IV. Ordering Paragraphs I. Introduction and Summary jlentini on DSKJ8SOYB1PROD with RULES In Docket No. MC2008–1, the Commission found that six previously stated unclassified services were postal services.1 It directed the Postal Service to make an appropriate filing to add those services to the Mail Classification Schedule (MCS) product lists. In this proceeding, the Postal Service seeks to add seven postal services to the product lists. Based upon a review of the record, the Commission approves the addition of two products to the Market Dominant Product List and five products to the Competitive Product List as follows: 1 Docket No. MC2008–1, Review of Nonpostal Services Under the Postal Accountability and Enhancement Act, December 19, 2008, at 27–38, 63–64 and Appendix 1 (Order No. 154). Order No. 154 was issued in proceedings instituted to fulfill the Commission’s responsibilities under 39 U.S.C. 404(e)(3) to determine which services offered by the Postal Service were nonpostal services and which, if any, of those nonpostal services should be continued. VerDate Nov<24>2008 16:21 Mar 10, 2010 Jkt 220001 Market Dominant Product List: Address Management Services (to replace Address List Services) and Customized Postage and [to the] Competitive Product List: Address Enhancement Service; Greeting Cards and Stationery; Shipping and Mailing Supplies; and International Money Transfer ServiceOutbound and International Money Transfer Service-Inbound (to replace International Money Transfer Service). The Commission also confirms its finding in Order No. 154 that Stamp Fulfillment Services is a postal product and directs the Postal Service to make an appropriate filing within 60 days to add Stamp Fulfillment Services to the MCS. In addition, the Commission revises the draft MCS product descriptions for Greeting Cards and Stationery and for Shipping and Mailing Supplies. Product descriptions for these and other services covered by the Postal Service’s request in this proceeding are set forth in a PRC Library Reference being filed in this docket. PRC-MC2009–19–LR1. Subject to further possible modifications, these product descriptions are to be incorporated into the draft MCS at the time of its future publication. Finally, the Commission directs that the Postal Service file draft product descriptions for eight existing items that are to be included in Address Management Services. II. Procedural History Background. In Order No. 154, the Commission ruled that six previously unclassified services were postal services. Those six services were Address Management Services; Customized Postage; Stamp Fulfillment Services; Greeting Cards; ReadyPost; and International Money Transfer Service. Because the Postal Service had not complied with the requirements of 39 U.S.C. 3642(d) and 39 CFR 3020.30 et seq. the Commission did not address whether these six services should be added to the MCS product lists. Instead, the Commission classified each of these services as either a market dominant or competitive product pending the outcome of classification proceedings that the Commission directed the Postal Service to institute within 60 days. Id. at 27–29, 89. Postal Service Requests. On March 10, 2009, the Postal Service filed a request to add seven products to the MCS product lists: Address Management Services; Customized Postage; Address Enhancement Service; Greeting Cards, Stationery, and Related Items; Shipping and Mailing Supplies; International Money Transfer Service-Inbound; and PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 International Money Transfer ServiceOutbound.2 One of the six products classified as a postal service by Order No. 154, Stamp Fulfillment Services, was intentionally omitted from the March 10, 2009 filing. That omission was based upon the Postal Service’s view that Stamp Fulfillment Services was no longer a postal service because of planned modifications to the service. Of the remaining five services classified as postal services by Order No. 154, two, Address Management Services (AMS) and International Money Transfer Service, were split into narrower services. Address Management Services was subdivided into a market dominant product called ‘‘Address Management Services’’ and a competitive product, ‘‘Address Enhancement Service.’’ International Money Transfer Service was separated into an inbound service, ‘‘International Money Transfer Service-Inbound’’ and an outbound service, ‘‘International Money Transfer Service-Outbound.’’3 As a result of the foregoing changes, the March 10, 2009 filing proposed the addition of seven products to the MCS product lists in place of the six products discussed in Order No. 154. Commission Order No. 198 provided formal notice of the Request, established the captioned docket to consider the Request, appointed an officer of the Commission to represent the interests of the general public, and set April 30, 2009 as the deadline for comments.4 Thereafter, on May 8, 2009, the Postal Service filed a notice of an amendment to its March 10, 2009 filing.5 The amendment was made to reflect the manner in which one of the components of Address Management Services would be offered.6 Commission Order No. 215 2 Request of the United States Postal Service to Add Postal Products to the Mail Classification Schedule in Response to Order No. 154, March 10, 2009 (Request). 3 Supplemental information regarding International Money Transfer Service-Inbound and International Money Transfer Service-Outbound was subsequently provided by the Postal Service. See Supplemental Response of the United States Postal Service to Order No. 154, July 15, 2009. 4 PRC Order No. 198, Notice and Order Concerning Request to Add Seven Postal Services to the Mail Classification Schedule Product Lists, March 30, 2009 (Order No. 198). 5 Notice of the United States Postal Service of Amendment to Its Request to Add Postal Products to the Mail Classification Schedule in Response to Order No. 154, May 8, 2009 (Amended Request). 6 More specifically, two services previously offered as stand-alone components of Address Management Services (i.e., FASTforward MLOCR service and FASTforward Move Update Notification) were being combined under the name FASTforward MLOCR service. The charge for FASTforward MLOCR service remained unchanged and there was no longer to be a separate charge for FASTforward Move Update Notification service. E:\FR\FM\11MRR1.SGM 11MRR1

Agencies

[Federal Register Volume 75, Number 47 (Thursday, March 11, 2010)]
[Rules and Regulations]
[Pages 11451-11452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5224]


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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; Zilpaterol

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 three abbreviated new animal 
drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy 
Animal Health, Inc. The ANADAs provides for use of single-ingredient 
Type A medicated articles containing zilpaterol, melengestrol, 
monensin, and tylosin to make two-way, three-way, and four-way 
combination drug Type B and Type C medicated feeds for heifers fed in 
confinement for slaughter.

DATES:  This rule is effective March 11, 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 ANADA 200-483 for 
use of ZILMAX (zilpaterol hydrochloride) and HEIFERMAX 500 
(melengestrol acetate) Liquid Premix single-ingredient Type A medicated 
articles to make dry and liquid, two way combination drug Type B and 
Type C medicated feeds for heifers fed in confinement for slaughter. 
Ivy Laboratories' ANADA 200-483 is approved as a generic copy of 
Intervet, Inc.'s combination medicated feed use of ZILMAX and MGA 500 
(melengestrol acetate), approved under NADA 141-284.
    Ivy Laboratories also filed ANADA 200-479 for use of ZILMAX, 
HEIFERMAX 500 Liquid Premix, and RUMENSIN (monensin USP) single-
ingredient Type A medicated articles to make dry and liquid, three-way 
combination drug Type B and Type C medicated feeds for heifers fed in 
confinement for slaughter. Ivy Laboratories' ANADA 200-479 is approved 
as a generic copy of Intervet, Inc.'s combination medicated feed use of 
ZILMAX, MGA 500, and RUMENSIN, approved under NADA 141-282.
    Ivy Laboratories also filed ANADA 200-480 for use of ZILMAX, 
HEIFERMAX 500 Liquid Premix, RUMENSIN, and TYLAN (tylosin phosphate) 
single-ingredient Type A medicated articles to make dry and liquid, 
four-way combination drug Type C medicated feeds for heifers fed in 
confinement for slaughter. Ivy Laboratories' ANADA 200-480 is approved 
as a generic copy of Intervet, Inc.'s combination medicated feed use of 
ZILMAX, MGA 500, RUMENSIN, and TYLAN, approved under NADA 141-280.
    The abbreviated applications are approved as of December 30, 2009, 
and the regulations are amended in 21 CFR 558.665 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 
each 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 these actions are 
of a type that do 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 Subject 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.  558.665   [Amended]

0
2. In Sec.  558.665, in the table in paragraphs (e)(2), (e)(4), and 
(e)(6), in the ``Limitations'' column remove ``No. 000009'' and add in 
its place ``Nos. 000009 or 021641'' and in the ``Sponsor''

[[Page 11452]]

column add in numerical sequence ``021641''.

    Dated: March 8, 2010.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-5224 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S

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