Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Rules and Regulations 3079

amended in connection with the

rulemaking to fully implement

mandated electronic filing on the

EDGAR system for registrants whose

filings are processed by the Divisions of

Corporation Finance and Investment

Management and for those making

filings with respect to such registrants.

Development and implementation of the

EDGAR system was effected pursuant to

Section 35A of the Securities Exchange

Act of 1934 (15 U.S.C. 78ll).

Need for Corrections

This action is necessary to correct an

internal cross reference within Form 8–

A, for registration of certain classes of

securities pursuant to Section 12(b) or

(g) of the Securities Exchange Act of

1934. 15 U.S.C. 78l(b) or (g).

Correction of Publication

Accordingly, the publication on

December 30, 1994 of the final EDGAR

rules, which were the subject of FR Doc.

94–31579, is corrected as follows:

1. On page 67765, second column, the

amendatory language for amendment

No. 35 is corrected to read as follows:

‘‘35. By amending Form 8–A

(referenced in § 249.208a), Instruction

II.2 of Instructions as to Exhibits, by

revising the phrase ‘pursuant to

Instruction 3 above’ to read ‘pursuant to

Instruction II.1, above,’.’’

Dated: January 9, 1995.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 95–912 Filed 1–12–95; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Neomycin Sulfate Oral Solution

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 abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for use of a generic neomycin

sulfate oral solution in the drinking

water and milk for cattle (excluding veal

calves), swine, sheep, and goats for the

treatment and control of colibacillosis.

EFFECTIVE DATE: January 13, 1995.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th St.

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–118,

which provides for the use of neomycin

oral solution (neomycin sulfate) in the

drinking water and milk for cattle

(excluding veal calves), swine, sheep,

and goats for the treatment and control

of colibacillosis (bacterial enteritis)

caused by Escherichia coli susceptible

to neomycin sulfate. Approval of

ANADA 200–118 is as a generic copy of

the Upjohn Co.’s approved NADA 11–

315. The ANADA is approved as of

November 29, 1994, and 21 CFR

520.1485(b) is amended to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

In addition, the heading of the section

is editorially revised to reflect the name

of the product.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (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 Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

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

through Friday.

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.

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.1485 is amended by

revising the section heading and

paragraph (b) to read as follows:

§ 520.1485 Neomycin sulfate oral solution.

* * * * *

(b) Sponsors. See Nos. 000009 and

059130 in § 510.600(c) of this chapter.

* * * * *

Dated: January 3, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–899 Filed 1–12–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Salinomycin In Combination

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

approval of three abbreviated new

animal drug applications (ANADA’s)

filed by Hoechst-Roussel Agri-Vet Co.

The ANADA’s provide for using

approved Type A medicated articles to

make Type C medicated broiler feeds

containing salinomycin with

chlortetracycline and roxarsone, or

salinomycin with chlortetracycline, or

salinomycin with oxytetracycline.

EFFECTIVE DATE: January 13, 1995.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: HoechstRoussel Agri-Vet Co., P.O. Box 2500,

Somerville, NJ 08876–1258, filed the

following ANADA’s:

ANADA 200–091, salinomycin with

chlortetracycline and roxarsone, which

provides for using approved single

ingredient Type A medicated articles to

make Type C medicated broiler feeds

containing 40 to 60 grams per ton (g/t)

salinomycin sodium activity,

chlortetracycline calcium complex

equivalent to 500 g/t chlortetracycline

hydrochloride, and 45.4 g/t roxarsone

for prevention of coccidiosis and as an

aid in reduction of mortality due to

certain Escherichia coli infections.

ANADA 200–095, salinomycin with

chlortetracycline, which provides for

using approved single ingredient Type

A medicated articles to make Type C

medicated broiler feeds containing 40 to

60 g/t salinomycin sodium activity with
3080 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Rules and Regulations

chlortetracycline calcium complex

equivalent to 500 g/t chlortetracycline

hydrochloride for prevention of

coccidiosis and as an aid in the

reduction of mortality due to certain E.

coli infections.

ANADA 200–096, salinomycin with

oxytetracycline, which provides for

using approved single ingredient Type

A medicated articles to make Type C

medicated broiler feeds containing 40 to

60 g/t salinomycin sodium activity with

500 g/t oxytetracycline for prevention of

coccidiosis and as an aid in the

reduction of mortality due to

airsacculitis caused by certain strains of

E. coli.

ANADA’s 200–091 and 200–095 are

approved as generic copies of American

Cyanamid’s NADA’s 140–867 and 140–

859. ANADA 200–096 is approved as a

generic copy of Pfizer’s NADA 140–448.

ANADA 200–091 is approved as of

January 13, 1995. ANADA’s 200–095

and 200–096 are approved as of

November 25, 1994. The regulations are

amended in §§ 558.450 and 558.550 (21

CFR 558.450 and 558.550) to reflect the

approvals.

These approvals are for use of Type A

medicated articles to make Type C

medicated feeds. Roxarsone is a

Category II drug which, as in 21 CFR

558.4, requires an approved Form FDA

1900 for making a Type C medicated

feed. Use of salinomycin,

chlortetracycline, and roxarsone to

make Type C medicated feeds as in

ANADA 200–091 requires an approved

Form FDA 1900.

FDA has published several documents

amending § 558.550(a) to create

paragraphs (a)(1) and (a)(2) and add a

series of amendments to paragraph

(a)(2). At this time, FDA is editorially

amending the regulation following

addition of these approvals to simplify

the text.

In addition, FDA provided for the use

of 45 and 45.4 g/t of roxarsone in this

regulation. Those used at 45 g/t are

amended to read 45.4 g/t.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of these applications may be

seen in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

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

through Friday.

The agency has determined under 21

CFR 25.24(d)(1)(ii) 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.

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).

§ 558.450 [Amended]

2. Section 558.450 Oxytetracycline is

amended in paragraph (d)(1), in table 1,

under the heading ‘‘Sponsor,’’ in entry

(v) for ‘‘Salinomycin 40 to 60,’’ by

removing ‘‘000069’’ and adding in its

place ‘‘000069, 012799’’.

3. Section 558.550 is amended by

revising paragraph (a)(2) and by

amending paragraph (b)(1)(ii)(a) and

(b)(1)(xv)(a) by removing ‘‘45’’ and

adding in its place ‘‘45.4’’ to read as

follows:

§ 558.550 Salinomycin.

(a) * * *

(2) To 012799 for use as in paragraphs

(b)(1)(i), (b)(1)(iii) through (b)(1)(xvi),

and (b)(3)(i) through (b)(3)(iii) of this

section.

* * * * *

Dated: January 4, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–898 Filed 1–12–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

28 CFR Part 36

Nondiscrimination on the Basis of

Disability by Public Aaccomodations

and in Commercial Facilities

CFR Correction

In Title 28 of the Code of Federal

Regulations, parts 0 to 42, revised as of

July 1, 1994, appendix A to part 36 is

corrected as follows:

1. On page 544, section 4.30.4, the

first sentence is amended by adding the

words ‘‘(0.8 mm) minimum’’ after ‘‘1/32

in’’.

2. On page 554, section 7.3, paragraph

(1), the third entry in the first column

of the table is revised to read ‘‘9—15’’.

BILLING CODE 1505–01–D

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Parts 2610 and 2622

Late Premium Payments and Employer

Liability Underpayments and

Overpayments; Interest Rate for

Determining Variable Rate Premium;

Amendments to Interest Rates

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: This document notifies the

public of the interest rate applicable to

late premium payments and employer

liability underpayments and

overpayments for the calendar quarter

beginning January 1, 1995. This interest

rate is established quarterly by the

Internal Revenue Service. This

document also sets forth the interest

rates for valuing unfunded vested

benefits for premium purposes for plan

years beginning in November 1994

through January 1995. These interest

rates are established pursuant to section

4006 of the Employee Retirement

Income Security Act of 1974, as

amended. The effect of these

amendments is to advise plan sponsors

and pension practitioners of these new

interest rates.

EFFECTIVE DATE: January 1, 1995.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General

Counsel, Office of the General Counsel,

Pension Benefit Guaranty Corporation,

1200 K Street, NW., Washington, DC

20005–4026; telephone 202–326–4024

(202–326–4179 for TTY and TTD).

These are not toll-free numbers.

SUPPLEMENTARY INFORMATION: As part of

title IV of the Employee Retirement

Income Security Act of 1974, as

amended (‘‘ERISA’’), the Pension

Benefit Guaranty Corporation (‘‘PBGC’’)

collects premiums from ongoing plans

to support the single-employer and

multiemployer insurance programs.

Under the single-employer program, the

PBGC also collects employer liability

from those persons described in ERISA

section 4062(a). Under ERISA section

4007 and 27 CFR 2610.7, the interest

rate to be charged on unpaid premiums

is the rate established under section

6601 of the Internal Revenue Code

(‘‘Code’’). Similarly, under 29 CFR

2622.7, the interest rate to be credited or