Federal Register / Vol. 72, No. 45 / Thursday, March 8, 2007 / Rules and Regulations 10357 

21 CFR Part 170 

Administrative practice and 

procedure, Food additives, Reporting 

and recordkeeping requirements. 

21 CFR Part 171 

Administrative practice and 

procedure, Food additives. 

21 CFR Part 172 

Food additives, Reporting and 

recordkeeping requirements. 

21 CFR Part 180 

Food additives. 

21 CFR Part 184 

Food additives. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 71, 73, 

74, 170, 171, 172, 180, and 184 are 

amended as follows: 

PART 71—COLOR ADDITIVE 

PETITIONS 

■ 1. The authority citation for 21 CFR 

part 71 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 351, 

355, 360, 360b–360f, 360h–360j, 361, 371, 

379e, 381; 42 U.S.C. 216, 262. 

§ 71.1 [Amended] 

■ 2. Section 71.1 is amended in 

paragraph (c) by removing ‘‘Office of 

Premarket Approval (HFS–200),’’ and by 

adding in its place ‘‘Office of Food 

Additive Safety (HFS–200),’’. 

PART 73—LISTING OF COLOR 

ADDITIVES EXEMPT FROM 

CERTIFICATION 

■ 3. The authority citation for 21 CFR 

part 73 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 343, 

348, 351, 352, 355, 361, 362, 371, 379e. 

§ 73.1128 [Redesignated] 

■ 4. Section 73.1128 is redesignated as 

§ 73.1350. 

§ 73.2396 [Amended] 

■ 5. Section 73.2396 is amended in 

paragraph (d)(1) by removing ‘‘170.25’’

and by adding in its place ‘‘§ 70.25’’. 

PART 74—LISTING OF COLOR 

ADDITIVES SUBJECT TO 

CERTIFICATION 

■ 6. The authority citation for 21 CFR 

part 74 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 343, 

348, 351, 352, 355, 361, 362, 371, 379e. 

§ 74.2052 [Amended] 

■ 7. Section 74.2052 is amended in 

paragraph (b)(9) by removing 

‘‘Benzo[e]pyrene’’ and by adding in its 

place ‘‘Benzo[a]pyrene’’. 

PART 170—FOOD ADDITIVES 

■ 8. The authority citation for 21 CFR 

part 170 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 346a, 

348, 371. 

§ 170.45 [Amended] 

■ 9. Section 170.45 is amended by 

removing the phrase ‘‘as stated in 

§ 250.203 of this chapter’’ and by 

removing ‘‘§ 103.35(d)’’ and adding in 

its place ‘‘§ 165.110(d)’’. 

PART 171—FOOD ADDITIVE 

PETITIONS 

■ 10. The authority citation for 21 CFR 

part 171 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 371. 

§ 171.1 [Amended] 

■ 11. Section 171.1 is amended in 

paragraph (c) by removing 

‘‘Petitions Control Branch 

Food and Drug Administration 

Department of Health and Human 

Services, Washington, DC 20204.’’

and by adding in its place 

‘‘Office of Food Additive Safety 

(HFS–200), Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740.’’

PART 172—FOOD ADDITIVES 

PERMITTED FOR DIRECT ADDITION 

TO FOOD FOR HUMAN 

CONSUMPTION 

■ 12. The authority citation for 21 CFR 

part 172 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 348, 

371, 379e. 

§ 172.510 [Amended] 

■ 13. Section 172.510 is amended in 

paragraph (b) by removing ‘‘concretes’’

and adding in its place ‘‘concentrates’’. 

PART 180—FOOD ADDITIVES 

PERMITTED IN FOOD OR IN CONTACT 

WITH FOOD ON AN INTERIM BASIS 

PENDING ADDITIONAL STUDY 

■ 14. The authority citation for 21 CFR 

part 180 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 343, 348, 

371; 42 U.S.C. 241. 

§ 180.37 [Amended] 

■ 15. Section 180.37 is amended in 

paragraph (f)(2)(iii) by removing ‘‘or 

§ 100.130’’. 

PART 184—DIRECT FOOD 

SUBSTANCES AFFIRMED AS 

GENERALLY RECOGNIZED AS SAFE 

■ 16. The authority citation for 21 CFR 

part 184 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 371. 

§ 184.1769a [Amended] 

■ 17. Section 184.1769a is amended in 

paragraph (c)(2) by removing ‘‘§ 103.35’’

and adding in its place ‘‘§ 165.110’’. 

Dated: February 28, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4104 Filed 3–7–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs for Use in Animal 

Feeds; Melengestrol, Ractopamine, 

and Monensin 

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 an abbreviated new animal 

drug application (ANADA) filed by Ivy 

Laboratories, Division of Ivy Animal 

Health, Inc. The ANADA provides for 

use of single-ingredient Type A 

medicated articles containing 

melengestrol, ractopamine, and 

monensin to make three-way 

combination drug Type C medicated 

feeds for heifers fed in confinement for 

slaughter. 

DATES: This rule is effective March 8, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Ivy 

Laboratories, Division of Ivy Animal 

Health, Inc., 8857 Bond St., Overland 

Park, KS 66214, filed ANADA 200–448 

for use of HEIFERMAX 500 

(melengestrol acetate) Liquid Premix, 

OPTAFLEXX (ractopamine 

hydrochloride), and RUMENSIN 

(monensin sodium) single-ingredient 

Type A medicated article to make dry 

and liquid, three-way combination drug 

Type C medicated feeds for heifers fed 


pwalker on PROD1PC71 with RULES
10358 Federal Register / Vol. 72, No. 45 / Thursday, March 8, 2007 / Rules and Regulations 

in confinement for slaughter. Ivy 

Laboratories’ ANADA 200–448 is 

approved as a generic copy of Elanco 

Animal Health’s NADA 141–234 for 

combination feed use of MGA 500, 

OPTAFLEXX, and RUMENSIN. The 

application is approved as of January 

29, 2007, and the regulations are 

amended in 21 CFR 558.500 to reflect 

the approval. The basis of approval is 

discussed in the freedom of information 

summary. 

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)(2) 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 the table in paragraph (e)(2)(viii) 

of § 558.500, in the ‘‘Limitations’’

column remove ‘‘No. 000009’’ and add 

in its place ‘‘Nos. 000009 or 021641’’, 

and in the ‘‘Sponsor’’ column add in 

numerical sequence ‘‘021641’’. 

Dated: February 20, 2007. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. E7–4100 Filed 3–7–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD01–07–014] 

Drawbridge Operation Regulations; 

Connecticut River, East Haddam, CT 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Route 82 Bridge 

across the Connecticut River, mile 16.8, 

at East Haddam, Connecticut. Under 

this temporary deviation, the bridge 

may remain in the closed position for 

two nights from 8:30 p.m. to 4:30 a.m. 

between March 19, 2007 and March 23, 

2007. The exact two closure dates will 

be determined based upon favorable 

weather necessary to perform the 

scheduled repairs. This deviation is 

necessary to facilitate scheduled bridge 

maintenance. 

DATES: This deviation is effective from 

March 19, 2007 through March 23, 2007. 

ADDRESSES: Materials referred to in this 

document are available for inspection or 

copying at the First Coast Guard 

District, Bridge Branch Office, One 

South Street, New York, New York 

10004, between 7 a.m. and 3 p.m., 

Monday through Friday, except Federal 

holidays. The telephone number is (212) 

668–7165. The First Coast Guard 

District Bridge Branch Office maintains 

the public docket for this temporary 

deviation. 

FOR FURTHER INFORMATION CONTACT: Judy 

Leung-Yee, Project Officer, First Coast 

Guard District, at (212) 668–7195. 

SUPPLEMENTARY INFORMATION: The Route 

82 Bridge, across the Connecticut River, 

mile 16.8, at East Haddam, Connecticut, 

has a vertical clearance in the closed 

position of 22 feet at mean high water 

and 25 feet at mean low water. The 

existing drawbridge operation 

regulations are listed at 33 CFR 

117.205(c). 

The owner of the bridge, Connecticut 

Department of Transportation, requested 

a temporary deviation to facilitate 

scheduled bridge maintenance, drive 

gear repairs. The bridge will not be able 

to open while the bridge maintenance is 

underway. 

Under this temporary deviation the 

Route 82 Bridge may remain in the 

closed position between 8:30 p.m. and 

4:30 a.m., for two nights, between 

March 19, 2007 and March 23, 2007. 

The exact two closure dates will be 

selected depending upon favorable 

weather necessary to perform the 

required repairs. 

In accordance with 33 CFR 117.35(c), 

this work will be performed with all due 

speed in order to return the bridge to 

normal operation as soon as possible. 

This deviation from the operating 

regulations is authorized under 33 CFR 

117.35. 

Dated: February 26, 2007. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. E7–4112 Filed 3–7–07; 8:45 am] 

BILLING CODE 4910–15–U 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[CGD09–07–002] 

RIN 1625–AA00 

Safety Zones; Annual Fireworks 

Events in the Captain of the Port 

Milwaukee Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the Manitowoc St. Patrick’s Day 

Fireworks safety zone on the Manitowoc 

River on March 17, 2007 from 5:30 p.m. 

through 7 p.m. This action is necessary 

to protect the public from the hazards 

associated with fireworks displays. 

During the enforcement period no 

person or vessel may enter the safety 

zone without the permission of the 

Captain of the Port or his designated 

representative. 

DATES: Effective from 5:30 p.m. (local) 

through 7 p.m. (local) on March 17, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

CWO Brad Hinken, Prevention 

Department, Coast Guard Sector Lake 

Michigan, 2420 South Lincoln Memorial 

Drive, Milwaukee, WI at (414) 747–

7154. 

SUPPLEMENTARY INFORMATION: We are 

publishing this document to provide 

notice that under the provisions of 33 

CFR 165.909(a)(11), the St. Patrick’s Day 

Fireworks safety zone on the Manitowoc 

River will be enforced on March 17, 

2007 from 5:30 p.m. through 7 p.m. The 

safety zone consists of all waters and 

adjacent shoreline across from the 


pwalker on PROD1PC71 with RULES