Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11331 

TABLE 2—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF FIVE NADAS BY TRUOW NUTRITION, INC. 

Previous sponsor NADA No. product 

(established name of drug) 

21 CFR section affected 

(sponsor drug labeler code) 

NutriBasics Co., P.O. Box 1014, Wilmar, MN 56201 ...... NADA 100–352; Seeco T–10 Premix (tylosin phosphate).§ 558.625 (053740). 

Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 ............. NADA 107–002; Seeco TYLAN-Sulfa 10 Premix (tylosin 

phosphate and sulfamethazine).

Not codified. 

Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 ............. NADA 123–000; Super Swine Wormer B–9 

BANMINTH(pyrantel tartrate).

§ 558.485 (011749). 

Southern Micro-Blenders, Inc., 3801 N. Hawthorne St., 

Chattanooga, TN 37406.

NADA 133–833; TYLAN 10 Premix (tylosin phosphate) § 558.625 (049685). 

Southern Micro-Blenders, Inc., 3801 N. Hawthorne St., 

Chattanooga, TN 37406.

NADA 135–243; Swine Guard-BN BANMINTH Premix 

(pyrantel tartrate).

§ 558.485 (049685). 

In a notice published elsewhere in 

this issue of the Federal Register, FDA 

gave notice that approval of NADA 48– 

647, 96–161, 100–352, 107–002, 119– 

062, 123–000, 133–833, and 135–243, 

and all supplements and amendments 

thereto, is withdrawn, effective March 

14, 2011. As provided in the regulatory 

text of this document, the animal drug 

regulations are amended to reflect these 

withdrawals of approval. 

Following these changes of 

sponsorship, Yoder Feed, Division of 

Yoder, Inc., Triple ‘‘F’’, Inc., NutriBasics 

Co., Seeco, Inc., and Southern MicroBlenders, Inc., are no longer the sponsor 

of an approved application. 

Accordingly, 21 CFR 510.600(c) is being 

amended to remove the entries for these 

firms. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 520 

Animal drugs. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510, 520, and 558 are 

amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entries for 

‘‘Triple ‘‘F’’, Inc.’’ and ‘‘Yoder Feed, 

Division of Yoder, Inc.’’; and in the table 

in paragraph (c)(2), remove the entries 

for ‘‘011490’’, ‘‘011749’’, ‘‘035369’’, 

‘‘049685’’, and ‘‘053740’’. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. In § 520.1720a, revise paragraph 

(b)(6) to read as follows: 

§ 520.1720a Phenylbutazone tablets and 

boluses. 

* * * * * 

(b) * * * 

(6) No. 058829 for use of 100-mg or 

1-g tablets in dogs and horses. 

* * * * * 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 5. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 6. In § 558.485, revise the section 

heading and paragraph (b)(3) to read as 

follows: 

§ 558.485 Pyrantel. 

* * * * * 

(b) * * * 

(3) Nos. 010439, 012286, 016968, and 

017790: 9.6 and 19.2 grams per pound 

for use as in paragraphs (e)(1)(i) through 

(e)(1)(iii) of this section. 

* * * * * 

§ 558.625 [Amended] 

■ 7. In § 558.625, remove and reserve 

paragraphs (b)(8), (b)(38), and (b)(80). 

Dated: February 18, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–4546 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 516 

[Docket No. FDA–2010–N–0534] 

RIN 0910–AG58 

New Animal Drugs for Minor Use and 

Minor Species; Confirmation of 

Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of March 30, 2011, for the 

final rule that appeared in the Federal 

Register of November 15, 2010 (75 FR 

69586). The direct final rule amends the 

regulations regarding new animal drugs 

for minor use and minor species 

(MUMS) to update language and clarify 

the intent of the regulations consistent 

with the preambles to the proposed and 

final rules. This document confirms the 

effective date of the direct final rule. 

DATES: Effective date confirmed: March 

30, 2011. 

FOR FURTHER INFORMATION CONTACT: Meg 

Oeller, Center for Veterinary Medicine 

(HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9005, 

e-mail: margaret.oeller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 15, 2010 

(75 FR 69586), FDA solicited comments 

concerning the direct final rule for a 

75-day period ending January 31, 2011. 

FDA stated that the effective date of the 

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11332 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

direct final rule would be on March 30, 

2011, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA did 

not receive any significant adverse 

comments. 

Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. Accordingly, the amendments issued 

thereby are effective. 

Dated: February 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4593 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–1030] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Duluth Ship Canal, Duluth-Superior 

Harbor, MN 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is 

establishing a drawbridge opening 

schedule for the Duluth Aerial Lift 

Bridge for vessels under 300 gross tons. 

Scheduled drawbridge openings will 

improve traffic congestion in the area 

and enhance safety for all modes of 

transportation. 

DATES: This rule is effective April 1, 

2011. 

ADDRESSES: Comments and related 

materials received from the public, as 

well as documents mentioned in this 

preamble as being available in the 

docket, are part of docket USCG–2010– 

1030 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–1030 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ This 

material is also available for inspection 

or copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Lee Soule, Bridge 

Management Specialist, Ninth Coast 

Guard District; telephone (216) 902– 

6085, e-mail lee.d.soule@uscg.mil. If you 

have questions on viewing material in 

the docket, call Renee V. Wright, 

Program Manager, Docket Operations, 

telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

Commander, Ninth Coast Guard 

District, published a temporary 

deviation from these regulations, with 

request for comments, on April 22, 

2010, in the Federal Register (75 FR 

20918). The temporary deviation was 

used to test a new bridge schedule 

during the 2010 navigation and tourist 

season. On December 8, 2010, we 

published a notice of proposed 

rulemaking (NPRM) entitled Drawbridge 

Operation Regulation; Duluth Ship 

Canal, Duluth-Superior Harbor, MN. in 

the Federal Register (75 FR 76324). We 

received two comments in response to 

the proposed rule. No public meeting 

was requested, and none was held. 

Basis and Purpose 

The Duluth Aerial Bridge is located 

0.25 miles from Duluth Harbor North 

Pier Light at the lakeward end of the 

Duluth Ship Canal. It is a vertical lift 

type bridge that provides 15 feet of 

vertical clearance in the down position 

and up to 141 feet in the open position. 

The bridge currently opens on signal for 

all vessel traffic that requires a bridge 

opening. Marine traffic on the waterway 

consists of both large and smaller 

commercial vessels, as well as both 

power and sail recreational vessels. 

Pursuant to 33 CFR 117.8 various 

entities in Duluth requested scheduled 

openings instead of opening on signal. 

The requesting entities included the 

City of Duluth, the Duluth Fire 

Department-Emergency Management, 

the Duluth Police Department, the Park 

Point Community Association, and the 

Canal Park Business Association. The 

scheduled drawbridge openings were 

requested during the peak navigation 

and tourist season to improve the flow 

of vehicular traffic over the bridge, 

relieve vehicular traffic congestion near 

the bridge and on city streets on both 

sides of the bridge (Park Point and Canal 

Park), improve access and response 

times for emergency response entities, 

and enhance pedestrian safety in the 

vicinity of the bridge. The test schedule 

allowed for scheduled bridge openings 

on the hour and half-hour for all vessels 

under 300 gross tons between the hours 

of 6 a.m. and 9 p.m., seven days per 

week, and on signal between 9 p.m. and 

6 a.m., from May 3 to October 29, 2010. 

The bridge continued to open on signal 

at all times for all vessels over 300 gross 

tons and Federal, state, and local 

government vessels, vessels in distress, 

commercial vessels engaged in rescue or 

emergency salvage operations, vessels 

engaged in pilot duties, and vessels 

seeking shelter from severe weather. 

The City of Duluth collected data 

throughout the test period related to 

vehicular and vessel traffic counts, and 

the number of bridge openings. In 

addition to the data collected, each 

stakeholder had the opportunity to 

amplify their written comments and 

provide additional direct input to the 

Coast Guard during the October 20, 

2010 meeting. During the stakeholder 

meeting it was generally agreed by all 

parties that the scheduled bridge 

openings appeared to improve the 

general flow of vehicular traffic on both 

sides of the bridge and reduced 

vehicular traffic congestion. Regarding 

the time of year and hours each day that 

the scheduled openings would apply, it 

was generally agreed during the 

stakeholders meeting that the scheduled 

openings would be beneficial and 

effective between Memorial Day and 

Labor Day each year between the hours 

of 7 a.m. and 9 p.m. The data below 

collected by the City of Duluth 

illustrates support for the times and 

dates: 

May June July Aug Sep Oct 

TOTAL VESSELS UNDER 300 GROSS TONS 

2009 383 1287 2015 1974 1331 212 

2010 528 1066 2088 1430 1016 380 

TOTAL BRIDGE OPENINGS 

2009 320 841 1097 1184 800 350 

2010 300 576 860 630 752 429 

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