Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Rules and Regulations 5887 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2007–C–0456] (formerly 

Docket No. 2007C–0245) 

Listing of Color Additives Exempt 

From Certification; Paracoccus 

Pigment; 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 December 17, 2009, for 

the final rule that appeared in the 

Federal Register of November 16, 2009. 

The final rule amended the color 

additive regulations to provide for the 

safe use of paracoccus pigment as a 

color additive in the feed of salmonid 

fish to enhance the color of their flesh. 

DATES: The effective date for the final 

rule that published in the Federal 

Register on November 16, 2009 (74 FR 

58843) is confirmed as December 17, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Mical E. Honigfort, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1278. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 16, 2009 

(74 FR 58843), FDA amended the color 

additive regulations to add 21 CFR 

73.352 to provide for the safe use of 

paracoccus pigment as a color additive 

in the feed of salmonid fish to enhance 

the color of their flesh. 

FDA gave interested persons until 

December 16, 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 November 16, 2009, should 

be confirmed. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321, 

341, 342, 343, 348, 351, 352, 355, 361, 

362, 371, 379e) and under authority 

delegated to the Commissioner of Food 

and Drugs, and redelegated to the 

Director, Office of Food Additive Safety, 

notice is given that no objections or 

requests for a hearing were filed in 

response to the November 16, 2009, 

final rule. Accordingly, the amendments 

issued thereby became effective 

December 17, 2009. 

Dated: January 22, 2010. 

Mitchell A. Cheeseman, 

Acting Director, Office of Food Additive 

Safety, Center for Food Safety and Applied 

Nutrition. 

[FR Doc. 2010–2521 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2007–C–0044] (formerly 

Docket No. 2007C–0474) 

Listing of Color Additives Exempt 

From Certification; Astaxanthin 

Dimethyldisuccinate; 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 December 8, 2009, for 

the final rule that appeared in the 

Federal Register of November 5, 2009. 

The final rule amended the color 

additive regulations to provide for the 

safe use of astaxanthin 

dimethyldisuccinate as a color additive 

in the feed of salmonid fish to enhance 

the color of their flesh. 

DATES: The effective date for the final 

rule published in the Federal Register 

of November 5, 2009 (74 FR 57248) is 

confirmed as December 8, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Felicia M. Ellison, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1264. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 5, 2009 

(74 FR 57248), FDA amended the color 

additive regulations to add § 73.37 (21 

CFR 73.37) to provide for the safe use 

of astaxanthin dimethyldisuccinate as a 

color additive in the feed of salmonid 

fish to enhance the color of their flesh. 

FDA gave interested persons until 

December 7, 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 November 5, 2009, should be 

confirmed. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321, 

341, 342, 343, 348, 351, 352, 355, 361, 

362, 371, 379e) and under authority 

delegated to the Commissioner of Food 

and Drugs, and redelegated to the 

Director, Office of Food Additive Safety, 

notice is given that no objections or 

requests for a hearing were filed in 

response to the November 5, 2009, final 

rule. Accordingly, the amendments 

issued thereby became effective 

December 8, 2009. 

Dated: January 22, 2010. 

Mitchell A. Cheeseman, 

Acting Director, Office of Food Additive 

Safety, Center for Food Safety and Applied 

Nutrition. 

[FR Doc. 2010–2522 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

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; Ractopamine; 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 original new animal drug 

application (NADA) filed by Elanco 

Animal Health, A Division of Eli Lilly 

& Co. The NADA provides for use of 

single-ingredient Type A medicated 

articles containing ractopamine 

hydrochloride and monensin to 

formulate two-way combination Type C 

medicated feeds for finishing hen and 

tom turkeys. 

DATES: This rule is effective February 5, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Linda M. Wilmot, Center for Veterinary 

Medicine (HFV–120), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8101, email: linda.wilmot@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

WReier-Aviles on DSKGBLS3C1PROD with RULES

5888 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Rules and Regulations 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed NADA 

141–301 for use of TOPMAX 

(ractopamine hydrochloride) and 

COBAN (monensin, USP) singleingredient Type A medicated articles to 

formulate two-way combination Type C 

medicated feeds for finishing hen and 

tom turkeys. The NADA is approved as 

of December 11, 2009, and the 

regulations in 21 CFR 558.500 are 

amended 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. 

The agency has determined under 21 

CFR 25.33 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 the 

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. 

■ 2. In § 558.500, add paragraphs 

(e)(3)(iii) and (e)(3)(iv) to read as 

follows: 

§ 558.500 Ractopamine. 

* * * * * 

(e) * * * 

(3) * * * 

Ractopamine in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

* * * * * * * 

(iii) 4.6 to 11.8 (5 to 13 

ppm) 

Monensin 54 to 90 Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and 

for the prevention of coccidiosis in 

growing turkeys caused by Eimeria 

adenoeides, E. meleagrimitis and 

E. gallopavonis. 

Feed continuously as sole ration during the last 7 to 14 days prior to 

slaughter. See § 558.355(d). 

000986 

(iv) 4.6 to 11.8 (5 to 13 

ppm) 

Monensin 54 to 90 Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and 

for the prevention of coccidiosis in 

growing turkeys caused by Eimeria 

adenoeides, E. meleagrimitis and 

E. gallopavonis. 

Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom 

turkeys during periods of excessive 

heat can result in increased mortality. See § 558.355(d). 

000986 

Dated: February 1, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–2427 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 3280 and 3282 

[Docket No. FR–5343–IN–01] 

RIN 2502–AI77 

Federal Manufactured Home 

Construction and Safety Standards 

and Other Orders: HUD Statements 

That Are Subject to Consensus 

Committee Processes 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Interpretive rule. 

SUMMARY: The National Manufactured 

Housing Construction and Safety 

Standards Act of 1974 provides that 

certain classes of statements by HUD 

relating to manufactured housing 

requirements are subject to proposal, 

review, and comment processes 

involving a consensus committee. The 

consensus committee includes 

representatives of manufactured 

housing producers and users, as well as 

general interest and public officials. 

This rule interprets the statutory 

requirement to clarify the types of 

statements that are subject to the 

proposal, review, and comment 

processes. 

DATES: Effective Date: February 5, 2010. 

FOR FURTHER INFORMATION CONTACT: 

William W. Matchneer III, Associate 

Deputy Assistant Secretary for 

Regulatory Affairs and Manufactured 

Housing, Office of Manufactured 

Housing Programs, Department of 

Housing and Urban Development, 451 

Seventh Street, SW., Room 9164, 

Washington, DC 20410; telephone 

number 202–708–6401 (this is not a tollfree number). Persons with hearing or 

speech impairments may access this 

number via TTY by calling the toll-free 

Federal Information Relay Service at 

1–800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The National Manufactured Housing 

Construction and Safety Standards Act 

of 1974 (42 U.S.C. 5401–5426) (‘‘the 

Act’’), as amended by the Manufactured 

Housing Improvement Act of 2000 (Title 

VI, Pub. L. 106–659), provides for the 

establishment and revision of Federal 

construction and safety standards for 

manufactured housing, as well as for 

procedural and enforcement regulations 

and interpretive bulletins related to 

implementation of these standards. 

Section 604(a) of the Act provides, 

among other things, the process for the 

development, proposal, and issuance of 

revisions of Federal construction and 

safety standards, which govern the 

construction, design, and performance 

of a manufactured home. Section 604(a) 

establishes a consensus committee, 

which is comprised of representatives of 

manufactured housing producers and 

WReier-Aviles on DSKGBLS3C1PROD with RULES