18740 Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations

D. Monosodium Phosphate

Monosodium phosphate functions as

a buffer in the subject sanitizing

solution. Monosodium phosphate is

listed as GRAS for use in human food

under 21 CFR 182.1778. FDA

regulations permit the addition to a

sanitizing solution of any substance that

is GRAS for use in food. On the basis

of the data submitted in support of the

already-regulated uses of monosodium

phosphate and the data contained in the

food additive petition submitted in

support of this sanitizing solution, FDA

finds that the use of monosodium

phosphate in the subject sanitizing

solution is safe (Ref. 1).

E. Conclusion on Safety

As discussed above, FDA has

evaluated the data in the petition and

other relevant materials. On the basis of

this evaluation, the agency concludes

that these data and materials establish

the use of the additive as a sanitizing

solution on food-processing equipment

and utensils and on dairy-processing

equipment is safe and that it will have

its intended technical effect. Therefore,

FDA is amending its regulations in

§ 178.1010 as set forth below.

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 are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in 21 CFR

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.

II. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

III. Reference

The following reference has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Memorandum entitled ‘‘Toxicological

Evaluation of Citric Acid, Disodium EDTA,

Sodium Lauryl Sulfate, and Monosodium

Phosphate as Sanitizer Components,’’ dated

March 24, 1994.

IV. Filing of Objections

Any person who will be adversely

affected by this regulation may at any

time on or before May 15, 1995, file

with the Dockets Management Branch

(address above) written objections

thereto. 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. Three copies of all documents

shall be submitted and shall be

identified 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 Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

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 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.1010 is amended by

adding new paragraphs (b)(44) and

(c)(38) to read as follows:

§ 178.1010 Sanitizing solutions.

* * * * *

(b) * * *

(44) An aqueous solution of citric

acid, disodium

ethylenediaminetetraacetate, sodium

lauryl sulfate, and monosodium

phosphate. In addition to use on foodprocessing equipment and utensils, this

solution may be used on dairyprocessing equipment.

* * * * *

(c) * * *

(38) The solution identified in

paragraph (b)(44) of this section shall

provide, when ready for use, at least

16,450 parts per million and not more

than 32,900 parts per million of citric

acid; at least 700 parts per million and

not more than 1,400 parts per million of

disodium ethylenediaminetetraacetate;

at least 175 parts per million and not

more than 350 parts per million of

sodium lauryl sulfate; and at least 175

parts per million and not more than 350

parts per million of monosodium

phosphate.

* * * * *

Dated: April 3, 1995.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 95–9089 Filed 4–12–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs; Technical

Amendments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendments.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

correct drug labeler code for Rhone

Poulenc, Inc. The agency codified an

incorrect drug labeler code. This

document corrects that error.

EFFECTIVE DATE: April 13, 1995.

FOR FURTHER INFORMATION CONTACT:

Judith M. O’Haro, Center for Veterinary

Medicine (HFV–238), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1737.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 28, 1994 (59 FR

33196), FDA published a document to

correct the drug labeler code for Hess &

Clark, Inc., from 011801 to 050749.

Several regulations were amended

including those for roxarsone used in

combinations in 21 CFR 558.95,

558.311, 558.355, and 558.550. This

amendment inadvertently created an

error in the regulations. However, in the
Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations 18741

Federal Register of February 13, 1981

(46 FR 10462), the agency amended the

regulations to reflect a change of

sponsor for several new animal drugs

(NADA’s) from Hess & Clerk, Inc.,

Division of Rhone-Poulenc, Inc., to Hess

& Clark, Inc. The roxarsone

combinations mentioned above were

improperly assigned to Hess & Clark,

Inc. This document corrects that error

by replacing the drug labeler code

‘‘050749’’ with the correct drug labeler

code, ‘‘011526.’’ Accordingly, 21 CFR

588.95, 558.311, 558.355, and 558.550

are amended to reflect the correct drug

labeler code for Rhone-Poulenc, Inc.

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: Secs. 512, 701 of the Federal

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

360b, 371).

§ 558.95 [Amended]

2. Section 558.95 Bambermycins is

amended in paragraphs (b)(1)(x)(b) and

(b)(1)(xi)(b) by removing ‘‘050749’’ and

adding in its place ‘‘011526’’.

§ 558.311 [Amended]

3. Section 558.311 Lasalocid is

amended in the table in paragraph

(e)(1), in entry (ii), in the ‘‘Limitations’’

column for the combinations with

‘‘Roxarsone 45.4’’, ‘‘Roxarsone 45.4 plus

bambermycins 1’’, ‘‘Roxarsone 45.4 plus

lincomycin 2.0’’, ‘‘Roxarsone 45.4 plus

bacitracin 10 to 25’’, and ‘‘Roxarsone

45.4 plus bacitracin 10 or 30’’, by

removing ‘‘050749’’ and adding in its

place ‘‘011526’’.

§ 558.355 [Amended]

4. Section 558.355 Monensin is

amended in paragraphs (f)(1)(xii)(b) and

(f)(1)(xx)(b) by removing ‘‘050749’’ and

adding in its place ‘‘011526’’.

§ 558.550 [Amended]

5. Section 558.550 Salinomycin is

amended in paragraph (b)(1)(ii)(c) by

removing ‘‘050749’’ and adding in its

place ‘‘011526’’.

Dated: March 13, 1995.

George A. Mitchell,

Director, Office of Surveillance and

Compliance, Center for Veterinary Medicine.

[FR Doc. 95–9177 Filed 4–12–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8592]

RIN 1545–AT17

Subchapter K Anti-Abuse Rule

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulation.

SUMMARY: This final regulation amends

the subchapter K anti-abuse rule to

provide that the rule applies solely with

respect to taxes under subtitle A of the

Internal Revenue Code. This document

provides guidance to partnerships and

the partners of those partnerships.

DATES: This regulation is effective May

12, 1994, except the amendment to

§ 1.701–2(f) is effective December 29,

1994.

For a discussion of dates of

applicability of this regulation, see

Explanation of Provisions under

SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: D.

Lindsay Russell on (202) 622–3050 (not

a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

On May 17, 1994, a notice of

proposed rulemaking was published in

the Federal Register (59 FR 25581)

containing a proposed anti-abuse rule

under subchapter K. On January 3, 1995,

§ 1.701–2 (TD 8588) was published in

the Federal Register (60 FR 23)

containing the final anti-abuse rule

under subchapter K.

Explanation of Provisions

Section 1.701–2 is amended to

provide that it applies solely with

respect to taxes under subtitle A of the

Internal Revenue Code. No inference is

intended as to the treatment under

current law of transactions not covered

by the regulation.

This amendment is effective as of the

effective dates of § 1.701–2(g) (May 12,

1994, except that paragraphs (e) and (f)

are effective December 29, 1994).

Special Analyses

It has been determined that this

Treasury decision is not a significant

regulatory action as defined in EO

12866. Therefore, a regulatory

assessment is not required. It also has

been determined that section 553(b) of

the Administrative Procedure Act (5

U.S.C. chapter 5) and the Regulatory

Flexibility Act (5 U.S.C. chapter 6) do

not apply to this amendment, and,

therefore, a Regulatory Flexibility

Analysis is not required. Pursuant to

section 7805(f) of the Internal Revenue

Code, this amendment was submitted to

the Small Business Administration for

comment on its impact on small

business.

List of Subjects in 26 CFR Part 1

Income taxes, Reporting and

recordkeeping requirements.

Adoption of Amendments to the

Regulations

Accordingly, 26 CFR part 1 is

amended as follows:

PART 1—INCOME TAXES

Paragraph 1. The authority citation

for part 1 continues to read, in part, as

follows:

Authority: 26 U.S.C. 7805 * * *

Par. 2. Section 1.701–2 is amended

by:

1. Amending the fourth sentence of

paragraph (a)(3) by:

a. Removing the language ‘‘Example

8’’ and adding ‘‘Example 6’’ in its place.

b. Removing the language ‘‘Example

11’’ and adding ‘‘Example 9’’ in its

place.

c. Removing the language ‘‘Examples

12 and 13’’ and adding ‘‘Examples 10

and 11’’ in its place.

2. Removing Examples 5 and 6 of

paragraph (d) and redesignating

Examples 7 through 13 of paragraph (d)

as Examples 5 through 11, respectively.

3. Removing the last sentence of

paragraph (f) introductory text.

4. Redesignating paragraph (h) as

paragraph (i).

5. Adding a new paragraph (h).

The addition reads as follows:

§ 1.701–2 Anti-abuse rule.

* * * * *

(h) Scope and application. This

section applies solely with respect to

taxes under subtitle A of the Internal

Revenue Code, and for purposes of this

section, any reference to a federal tax is

limited to any tax imposed under

subtitle A of the Internal Revenue Code.

* * * * *