11328 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

6 5 U.S.C. 553(b). 

7For similar reasons, the amendments do not 

require analysis under the Regulatory Flexibility 

Act (‘‘RFA’’) or analysis of major rule status under 

the Small Business Regulatory Enforcement 

Fairness Act. See 5 U.S.C. 601(2) (for purposes of 

RFA analysis, the term ‘‘rule’’ means any rule for 

which the agency publishes a general notice of 

proposed rulemaking); and 5 U.S.C. 804(3)(C) (for 

purposes of Congressional review of agency 

rulemaking, the term ‘‘rule’’ does not include any 

rule of agency organization, procedure or practice 

that does not substantially affect the rights or 

obligations of non-agency parties). 

8See 5 U.S.C. 553(d)(3). 

9 15 U.S.C. 78c(f). 

10 15 U.S.C. 78w(a)(2). 

11 15 U.S.C. 78c, 78j, 78o, 78q, and 78w. 

replaced with references to ‘‘Chapter X 

of title 31.’’ 

II. Certain Findings 

Under the Administrative Procedure 

Act (‘‘APA’’), notice of proposed 

rulemaking is not required when an 

agency, for good cause, finds ‘‘that 

notice and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest.’’ 6 The 

Commission is making technical 

amendments to Rule 17a–8 to update 

the reference to the BSA implementing 

regulations. The Commission finds that 

because the amendment is technical in 

nature and is being made solely to 

reflect the changes in applicable 

references to the BSA’s implementing 

regulations, publishing the amendment 

for comment is unnecessary.7

The APA also requires publication of 

a rule at least 30 days before its effective 

date unless the agency finds otherwise 

for good cause.8 Due to the need to 

coordinate the effectiveness of the 

amendment to Rule 17a–8 with the 

effective date of FinCEN’s rule 

reorganization scheduled to take effect 

on March 1, 2011, and for the same 

reasons described above with respect to 

notice and opportunity for comment, 

the Commission finds that there is good 

cause for these technical amendments to 

take effect on March 1, 2011. 

III. Consideration of Competitive Effects 

of Amendment 

Section 3(f) of the Exchange Act,9

provides that whenever the Commission 

is engaged in rulemaking and is 

required to consider or determine 

whether an action is necessary or 

appropriate in the public interest, the 

Commission shall consider, in addition 

to the protection of investors, whether 

the action will promote efficiency, 

competition, and capital formation. 

Section 23(a)(2) of the Exchange Act 

requires the Commission, in adopting 

rules under the Exchange Act, to 

consider the competitive effects of such 

rules, if any, and to refrain from 

adopting a rule that would impose a 

burden on competition not necessary or 

appropriate in the furtherance of the 

purposes of the Exchange Act.10

Because the amendments to Exchange 

Act Rule 17a–8 are technical in nature, 

and do not impose any additional 

requirements beyond those already 

required, we do not anticipate that the 

amendments would have a significant 

effect on efficiency, competition, or 

capital formation, and we do not 

anticipate that any competitive 

advantages or disadvantages would be 

created. 

IV. Statutory Authority 

We are adopting this technical 

amendment to Rule 17a–8 under the 

authority set forth in the Exchange Act, 

in particular, Sections 3, 10, 15, 17 and 

23 thereof.11

List of Subjects in 17 CFR Part 240 

Broker-dealers, Reporting and 

recordkeeping requirements, Securities. 

Text of Amendments 

For the reasons set out in the 

preamble, Title 17, Chapter II of the 

Code of Federal Regulations is amended 

as follows: 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 1. The authority citation for Part 240 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p, 

78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a– 

20, 80a–23, 80a–29, 80a–37, 80b–3, 80b–4, 

80b–11, and 7201 et seq., and 18 U.S.C. 1350, 

unless otherwise noted. 

* * * * * 

■ 2. Amend § 240.17a–8 by removing 

the phrase ‘‘part 103’’ in the two places 

it appears and adding in its place 

‘‘Chapter X.’’ 

Dated: February 23, 2011. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2011–4694 Filed 3–1–11; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 173 

[Docket No. FDA–2010–F–0200] 

Secondary Direct Food Additives 

Permitted in Food for Human 

Consumption 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

food additive regulations to permit the 

use of hydrogen peroxide as an 

antimicrobial agent in the manufacture 

of modified whey by ultrafiltration 

methods. This action is in response to 

a petition filed by Fonterra (USA), Inc. 

DATES: This rule is effective March 2, 

2011. Submit either electronic or 

written objections and requests for a 

hearing by April 1, 2011. See section VI 

of this document for information on the 

filing of objections. The incorporation 

by reference of certain publications 

listed in the rule is approved by the 

Director of the Federal Register as of 

March 2, 2011. 

ADDRESSES: You may submit either 

electronic or written objections and 

requests for a hearing, identified by 

Docket No. FDA–2010–F–0200, by any 

of the following methods: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written objections in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (For 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2010–F–0200 for this 

rulemaking. All objections received will 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11329 

Docket: For access to the docket to 

read background documents or 

objections received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Celeste Johnston, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 301–436–1282. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a notice published in the Federal 

Register of April 28, 2010 (75 FR 

22411), FDA announced that Fonterra 

(USA), Inc., c/o Burdock Group, 801 N. 

Orange Ave., suite 710, Orlando, FL 

32801 filed a food additive petition 

(FAP 0A4781). The petition proposed to 

amend the food additive regulations in 

part 173—Secondary Direct Food 

Additives Permitted in Food for Human 

Consumption (21 CFR part 173) to 

provide for the safe use of hydrogen 

peroxide as an antimicrobial agent in 

the manufacture of modified whey by 

ultrafiltration methods. In 

ultrafiltration, the whey stream is 

directed under pressure against 

membranes that permit undesirable 

substances to pass through the 

membranes while retaining the whey 

protein. 

Hydrogen peroxide is currently 

affirmed as generally recognized as safe 

(GRAS) for use as an antimicrobial agent 

in the preparation of modified whey by 

electrodialysis methods at a maximum 

treatment level of 0.04 percent in the 

whey (§ 184.1366 (21 CFR 184.1366)). 

As a condition of use, the regulation 

requires that residual hydrogen 

peroxide be removed from the whey 

during processing by appropriate 

chemical and physical means. 

Under 21 CFR 184.1(b)(2), a substance 

affirmed as GRAS with specific 

limitations may be used in food only 

within such limitations, including the 

category of food, functional use, and 

level of use. Therefore, any additional 

uses of hydrogen peroxide in processing 

food beyond those limitations set out in 

§ 184.1366 requires either a food 

additive regulation or an amendment of 

§ 184.1366. The current petition 

proposes to amend the food additive 

regulations to provide for the use of 

hydrogen peroxide in the preparation of 

modified whey by ultrafiltration 

methods, as an alternative to 

electrodialysis methods, at a maximum 

use level of 0.001 percent by weight of 

the whey, providing that residual 

hydrogen peroxide is removed from the 

whey during processing by appropriate 

chemical and physical means. 

II. Conclusion 

FDA reviewed data in the petition and 

other available relevant material to 

evaluate the safety of the use of 

hydrogen peroxide as an antimicrobial 

agent in the production of modified 

whey prepared by ultrafiltration 

methods. Based on this information, the 

Agency concludes that the proposed use 

of the additive will accomplish the 

intended technical effect, and that, since 

the proposed use of hydrogen peroxide 

in the preparation of modified whey by 

ultrafiltration would be substitutional 

for its already-regulated use in the 

preparation of modified whey by 

electrodialysis under § 184.1366, the 

exposure to hydrogen peroxide will not 

increase and may potentially decrease 

due to a lower maximum use level than 

what is currently permitted in the 

manufacture of modified whey by 

electrodialysis. Based on this 

information, FDA concludes that the 

proposed use of the additive is safe and 

the additive will achieve its intended 

technical effect as an antimicrobial 

agent under the proposed conditions of 

use. Therefore, the regulations in 21 

CFR part 173 should be amended as set 

forth in this document. 

III. Public Disclosure 

In accordance with § 171.1(h) (21 CFR 

171.1(h)), the petition and the 

documents that FDA considered and 

relied upon in reaching its decision to 

approve the petition will be made 

available for inspection at the Center for 

Food Safety and Applied Nutrition by 

appointment with the information 

contact person (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 171.1(h), the Agency will delete from 

the documents any materials that are 

not available for public disclosure 

before making the documents available 

for inspection. 

IV. Environmental Impact 

The Agency has previously 

considered the environmental effects of 

this rule as announced in the notice of 

filing for FAP 0A4781 (75 FR 22411). No 

new information or comments have 

been received that would affect the 

Agency’s previous determination that 

there is no significant impact on the 

human environment and that an 

environmental impact statement is not 

required. 

V. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VI. Objections 

Any person who will be adversely 

affected by this regulation may file with 

the Division of Dockets Management 

(see ADDRESSES) either electronic or 

written objections by (see DATES). Each 

objection shall be separately numbered, 

and each numbered objection shall 

specify with particularity the provisions 

of the regulation to which objection is 

made and the grounds for the objection. 

Each numbered objection on which a 

hearing is requested shall specifically so 

state. Failure to request a hearing for 

any particular objection shall constitute 

a waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. It is only necessary to send 

one set of documents. It is no longer 

necessary to send three copies of all 

documents. Identify documents with the 

docket number found in brackets in the 

heading of this document. Any 

objections received in response to the 

regulation may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VII. Section 301(ll) of the Federal Food, 

Drug, and Cosmetic Act 

FDA’s review of this petition was 

limited to section 409 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act). This final rule is not a 

statement regarding compliance with 

other sections of the FD&C Act. For 

example, the Food and Drug 

Administration Amendments Act of 

2007, which was signed into law on 

September 27, 2007, amended the FD&C 

Act to, among other things, add section 

301(ll) (21 U.S.C. 331(ll)). Section 

301(ll) of the FD&C Act prohibits the 

introduction or delivery for introduction 

into interstate commerce of any food 

that contains a drug approved under 

section 505 of the FD&C Act (21 U.S.C. 

355), a biological product licensed 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262), or a drug or 

biological product for which substantial 

clinical investigations have been 

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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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