Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 10483 

Sections 12.104 through 12.104i also 

issued under 19 U.S.C. 2612; 

* * * * * 

■ 2. In § 12.104g, paragraph (a), the table 

is amended in the entry for Honduras by 

removing the reference to ‘‘CBP Dec. 

04–08’’ in the column headed ‘‘Dec. 

No.’’ and adding in its place the 

language ‘‘CBP Dec. 04–08 extended by 

CBP Dec. 09–05’’. 

W. Ralph Basham, 

Commissioner, U.S. Customs and Border 

Protection. 

Approved: March 5, 2009. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. E9–5001 Filed 3–10–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 73 and 101 

[Docket No. FDA–1998–P–0032] (formerly 

Docket No. 1998P–0724) 

Listing of Color Additives Exempt 

From Certification; Food, Drug, and 

Cosmetic Labeling: Cochineal Extract 

and Carmine Declaration; Confirmation 

of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of January 5, 2011, for the 

final rule that appeared in the Federal 

Register of January 5, 2009. The final 

rule amends the regulations for 

cochineal extract and carmine by 

requiring their declaration by name on 

the label of all food and cosmetic 

products that contain these color 

additives. This final rule responds to 

reports of severe allergic reactions, 

including anaphylaxis, to cochineal 

extract-containing food and carminecontaining food and cosmetics and will 

allow consumers who are allergic to 

these color additives to identify and 

thus avoid products that contain these 

color additives. This action also 

responds to a citizen petition submitted 

by the Center for Science in the Public 

Interest. 

DATES: The effective date of the final 

rule published on January 5, 2009 (74 

FR 207), amending 21 CFR 73.100, 

73.2087, and 101.22, is confirmed: 

January 5, 2011. 

FOR FURTHER INFORMATION CONTACT: 

James C. Wallwork, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1303. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 5, 2009 (74 

FR 207), FDA amended the color 

additive regulation in 21 CFR 73.100 

that permits the use of cochineal extract 

and carmine in foods by adding new 

paragraph (d)(2) to require that all foods 

(including butter, cheese, and ice cream) 

that contain cochineal extract or 

carmine specifically declare the 

presence of the color additive by its 

respective common or usual name, 

‘‘cochineal extract’’ or ‘‘carmine,’’ in the 

ingredient statement of the food label. 

Because § 101.22(k) (21 CFR 101.22(k)) 

allows any certification-exempt color 

additive to be declared with a general 

phrase, such as ‘‘Artificial Color’’ or 

‘‘Artificial Color Added,’’ rather than by 

its specific common or usual name, FDA 

amended § 101.22(k) to disallow generic 

declaration of color additives for which 

individual declaration is required by 

applicable regulations in part 73 (21 

CFR part 73). 

For cosmetic products, FDA amended 

the color additive regulation in 

§ 73.2087 (21 CFR 73.2087) permitting 

the use of carmine in cosmetics by 

revising paragraph (c) to require that 

cosmetics containing carmine that are 

not subject to the requirements of 

§ 701.3 (21 CFR 701.3) specifically 

declare the presence of carmine 

prominently and conspicuously at least 

once in the labeling. This amendment 

covers all cosmetic products, including 

those cosmetics that are manufactured 

and sold for use only by professionals 

(e.g., makeup used in photography 

studios and by makeup artists for 

television, movie, and theater actors/ 

actresses, products intended for use 

only by professionals in beauty salons, 

and camouflage makeup dispensed by 

physicians and aestheticians to clients 

with skin conditions such as scarring) 

and those cosmetics that are gifts or free 

samples. FDA also included in 

§ 73.2087, as an example, the following 

statement: ‘‘Contains carmine as a color 

additive.’’ 

FDA gave interested persons until 

February 4, 2009, to file objections or 

requests for a hearing. The agency 

received no objections or requests for a 

hearing on the final rule. Therefore, 

FDA finds that the effective date of the 

final rule that published in the Federal 

Register of January 5, 2009, should be 

confirmed. 

List of Subjects 

21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Medical devices. 

21 CFR Part 101 

Food labeling, Nutrition, Reporting 

and recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act (15 U.S.C. 1453, 

1454, 1455; 21 U.S.C. 321, 331, 341, 

342, 343, 348, 351, 352, 355, 361, 362, 

371, 379e; 42 U.S.C. 243, 264, 271) and 

under the authority delegated to the 

Commissioner of Food and Drugs 

(1410.10 of the FDA Staff Manual 

Guide) notice is given that no objections 

or requests for a hearing were filed in 

response to the January 5, 2009, final 

rule. Accordingly, the amendments 

issued thereby become effective 

January 5, 2011. 

Dated: March 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5286 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2009–N–0665] 

Oral Dosage Form New Animal Drugs; 

Amprolium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

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 IVX 

Animal Health, Inc. The ANADA 

provides for the use of generic 

amprolium concentrate solution to make 

medicated drinking water for chickens 

and turkeys for the treatment of 

coccidiosis. 

DATES: This rule is effective March 11, 

2009. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: IVX 

Animal Health, Inc., 3915 South 48th 


rwilkins on PROD1PC63 with RULES
10484 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 

Street Ter., St. Joseph, MO 64503, filed 

ANADA 200–463 that provides for the 

use of Amprolium 9.6% Oral Solution 

to make medicated drinking water for 

chickens and turkeys for the treatment 

of coccidiosis. IVX Animal Health, Inc.’s 

Amprolium 9.6% Oral Solution is 

approved as a generic copy of 

Huvepharma, AD’s AMPROVINE 9.6% 

Solution, approved under NADA 13– 

149. The ANADA is approved as of 

February 12, 2009, and the regulations 

are amended in 21 CFR 520.100 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. 

FDA has determined under 21 CFR 

25.33(a)(1) 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 520 

Animal drugs. 

■ 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 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. In § 520.100, revise paragraph (b)(3) 

to read as follows: 

§ 520.100 Amprolium. 

* * * * * 

(b) * * * 

(3) No. 059130 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (d) of this 

section. 

* * * * * 

Dated: February 27, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–5131 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

[Docket No. FDA–2009–N–0665] 

Other Dosage Form New Animal 

Drugs; Sevoflurane 

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 new animal 

drug application (NADA) filed by 

Abbott Laboratories, Inc. The 

supplemental NADA provides for a 

revised induction dose of sevoflurane 

inhalant anesthetic in dogs. 

DATES: This rule is effective March 11, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Abbott 

Laboratories, North Chicago, IL 60064, 

has filed a supplement to NADA 141– 

103 for SEVOFLO (sevoflurane) used for 

induction and maintenance of general 

anesthesia in dogs. The supplemental 

NADA provides for a revised induction 

dose of sevoflurane. The supplemental 

NADA is approved as of July 27, 2006, 

and the regulations are amended in 21 

CFR 529.2150 to reflect the approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33(d)(1) 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 529 

Animal drugs. 

■ 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 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

§ 529.2150 [Amended] 

■ 2. In § 529.2150, in the first sentence 

in paragraph (c)(1), remove ‘‘5 to 7 

percent sevoflurane’’ and in its place 

add ‘‘Up to 7 percent sevoflurane’’. 

Dated: March 3, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–4879 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 110 

[Docket No. USCG–2008–0155] 

RIN 1625–AA01 

Anchorage Regulations; Port of New 

York 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

size of Romer Shoal Anchorage Ground 

in Lower New York Bay. This action is 

necessary to facilitate safe navigation in 

the area and to provide safe and secure 

anchorages for vessels transiting this 

area. This change to the anchorage is 

intended to increase the safety of life 

and property within this area of the Port 

of New York by providing for greater 

safety of anchored vessels and to 

enhance the safe and efficient flow of 

commercial vessels and commerce. 

DATES: This rule is effective April 10, 

2009. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2008–0155 and are 

available online by going to http:// 

www.regulations.gov, selecting the 


rwilkins on PROD1PC63 with RULES