11330 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

instituted and their existence has been 

made public, unless one of the 

exceptions in section 301(ll)(1) to (ll)(4) 

applies. In our review of this petition, 

FDA did not consider whether section 

301(ll) of the FD&C Act or any of its 

exemptions apply to food containing 

this additive. Accordingly, this final 

rule should not be construed to be a 

statement that a food containing this 

additive, if introduced or delivered for 

introduction into interstate commerce, 

would not violate section 301(ll) of the 

FD&C Act. Furthermore, this language is 

included in all food additive final rules 

and therefore should not be construed to 

be a statement of the likelihood that 

section 301(ll) of the FD&C Act applies. 

List of Subjects in 21 CFR Part 173 

Food additives, Incorporation by 

reference. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Director, Center for Food Safety and 

Applied Nutrition, 21 CFR part 173 is 

amended as follows: 

PART 173—SECONDARY DIRECT 

FOOD ADDITIVES PERMITTED IN 

FOOD FOR HUMAN CONSUMPTION 

■ 1. The authority citation for 21 CFR 

part 173 continues to read as follows: 

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

■ 2. Section 173.356 is added to subpart 

D to read as follows: 

§ 173.356 Hydrogen peroxide. 

Hydrogen peroxide (CAS Reg. No. 

7722–84–1) may be safely used to treat 

food in accordance with the following 

conditions: 

(a) The additive meets the 

specifications of the Food Chemicals 

Codex, 7th ed. (2010), pp. 496 and 497, 

which is incorporated by reference. The 

Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may obtain copies 

from the United States Pharmacopeial 

Convention, 12601 Twinbrook Pkwy., 

Rockville, MD 20852 (Internet address 

http://www.usp.org). Copies may be 

examined at the Center for Food Safety 

and Applied Nutrition’s Library, Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2163, or at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

call 202–741–6030, or go to: http:// 

www.archives.gov/federal_register/ 

code_of_federal regulations/ 

ibr_locations.html. 

(b) The additive is used as an 

antimicrobial agent in the production of 

modified whey (including, but not 

limited to, whey protein concentrates 

and whey protein isolates) by 

ultrafiltration methods, at a level not to 

exceed 0.001 percent by weight of the 

whey, providing that residual hydrogen 

peroxide is removed by appropriate 

chemical or physical means during the 

processing of the modified whey. 

Dated: February 16, 2011. 

Susan M. Bernard, 

Acting Director, Office of Regulations, Policy 

and Social Services, Center for Food Safety 

and Applied Nutrition. 

[FR Doc. 2011–4497 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, and 558 

[Docket No. FDA–2011–N–0003] 

Animal Drugs, Feeds, and Related 

Products; Withdrawal of Approval of a 

New Animal Drug Applications; 

Phenylbutazone; Pyrantel; Tylosin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations by removing 

those portions that reflect approval of 

eight new animal drug applications 

(NADAs). In a notice published 

elsewhere in this issue of the Federal 

Register, FDA is withdrawing approval 

of these NADAs. 

DATES: This rule is effective March 14, 

2011. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079, 

e-mail: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

sponsors have requested that FDA 

withdraw approval of the three NADAs 

listed in table 1 of this document 

because the products are no longer 

manufactured or marketed: 

TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF THREE NADAS

Sponsor NADA No. product 

(established name of drug) 

21 CFR section affected 

(sponsor drug labeler code) 

First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 NADA 48–647; Phenylbutazone Boluses 

(phenylbutazone).

§ 520.1720a (058829). 

Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247 ... NADA 96–161; Hy-Con TYLAN Premix (tylosin phosphate).§ 558.625 (035369). 

Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des Moines, IA 

50322.

NADA 119–062; Cadco-BN-10 BANMINTH Premix 

(pyrantel tartrate).

§ 558.485 (011490). 

Truow Nutrition, Inc., 1590 Todd 

Farm Dr., Elgin, IL 60123 (Truow) has 

informed FDA that it is the owner of 

five feed premix NADAs previously 

owned by milling companies which it 

has purchased. NADA 100–352 was 

owned by NutriBasics Co., last doing 

business at P.O. Box 1014, Wilmar, MN 

56201. NADA 107–002 and NADA 123– 

000 were owned by Seeco, Inc., also last 

doing business at P.O. Box 1014, 

Wilmar, MN 56201. NADA 133–833 and 

NADA 135–243 were owned by 

Southern Micro-Blenders, Inc., last 

doing business at 3801 N. Hawthorne 

St., Chattanooga, TN 37406. Truow has 

requested that FDA withdraw approval 

of the five NADAs in table 2 of this 

document because they are no longer 

manufactured or marketed: 

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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 

WReier-Aviles on DSKGBLS3C1PROD with RULES