Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Rules and Regulations 11451 

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 

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. 

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’’ 


jlentini on DSKJ8SOYB1PROD with RULES
11452 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Rules and Regulations 

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. 

2Request 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). 

3Supplemental 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. 

4PRC 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). 

5Notice 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). 

6More 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. 

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 

AGENCY: Postal Regulatory Commission. 

ACTION: Final rule. 

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. 

SUPPLEMENTARY INFORMATION: Regulatory 

History, 74 FR 15784 (April 7, 2009). 

Table of Contents 

I. Introduction and Summary 

II. Procedural History 

III. Commission Analysis 

IV. Ordering Paragraphs 

I. Introduction and Summary 

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: 

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 

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 


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