3078 Federal Register / Vol. 60, No. 9 / Friday, January 13, 1995 / Rules and Regulations

treatment prescribed for pests of that

plant by the plant protection service of

the exporting country and then grown

for at least 9 months in the exporting

country prior to importation of the

descendent plants into the United

States;

(v) Watered only with rainwater that

has been boiled or pasteurized, with

clean well water, or with potable water;

(vi) Rooted and grown in approved

growing media listed in § 319.37–8(e)(1)

on benches supported by legs and raised

at least 46 cm above the floor;

(vii) Stored and packaged only in

areas free of sand, soil, earth, and plant

pests; and,

(viii) Inspected in the greenhouse and

found free from evidence of plant pests

and diseases by an APHIS inspector or

an inspector of the plant protection

service of the exporting country, no

more than 30 days prior to the date of

export to the United States.

* * * * *

(g) Pest risk evaluation standards for

plants established in growing media.

When evaluating a request to allow

importation of additional taxa of plants

established in growing media, the

Animal and Plant Health Inspection

Service will conduct the following

analysis in determining the pest risks

associated with each requested plant

article and in determining whether or

not to propose allowing importation

into the United States of the requested

plant article.

(1) Collect commodity information.

(i) Determine the kind of growing

medium, origin and taxon of the

regulated article.

(ii) Collect information on the method

of preparing the regulated article for

importation.

(iii) Evaluate history of past plant pest

interceptions or introductions

(including data from plant protection

services of foreign countries) associated

with each regulated article.

(2) Catalog quarantine pests. For the

regulated article specified in an

application, determine what plant pests

or potential plant pests are associated

with the type of plant from which the

regulated article was derived, in the

country and locality of origin. A plant

pest that meets one of the following

criteria is a quarantine pest and will be

further evaluated in accordance with

paragraph (g)(3) of this section:

(i) Non-indigenous plant pest not

present in the United States;

(ii) Non-indigenous plant pest,

present in the United States and capable

of further dissemination in the United

States;

(iii) Non-indigenous plant pest that is

present in the United States and has

reached probable limits of its ecological

range, but differs genetically from the

plant pest in the United States in a way

that demonstrates a potential for greater

damage potential in the United States;

(iv) Native species of the United

States that has reached probable limits

of its ecological range, but differs

genetically from the plant pest in the

United States in a way that

demonstrates a potential for greater

damage potential in the United States;

or

(v) Non-indigenous or native plant

pest that may be able to vector another

plant pest that meets one of the criteria

in (g)(2)(i) through (iv) of this section.

(3) Conduct individual pest risk

assessments. Each of the quarantine

pests identified by application of the

criteria in paragraph (g)(2) of this

section will be evaluated based on the

following estimates:

(i) Estimate the probability the

quarantine pest will be on, with, or in

the regulated article at the time of

importation;

(ii) Estimate the probability the

quarantine pest will survive in transit

on the regulated article and enter the

United States undetected;

(iii) Estimate the probability of the

quarantine pest colonizing once entered

into the United States;

(iv) Estimate the probability of the

quarantine pest spreading beyond the

colonized area; and

(v) Estimate the actual and perceived

economic, environmental and social

damage that would occur if the

quarantine pest is introduced, colonizes,

and spreads.

(4) Determine overall estimation of

risk based on compilation of component

estimates. This step will evaluate

whether the pest risk of importing a

regulated article established in growing

media, as developed through the

estimates of paragraph (g)(3) of this

section, is greater than the pest risk of

importing the regulated article with bare

roots as allowed by § 319.37–8(a).

(i) If the pest risk is determined to be

the same or less, the regulated article

established in growing media will be

allowed importation under the same

conditions as the same regulated article

with bare roots.

(ii) If the pest risk is determined to be

greater for the regulated article

established in growing media, APHIS

will evaluate available mitigation

measures to determine whether they

would allow safe importation of the

regulated article. Mitigation measures

currently in use as requirements of this

subsection, and any other mitigation

methods relevant to the regulated article

and plant pests involved, will be

compared with the individual pest risk

assessments in order to determine

whether requiring particular mitigation

measures in connection with

importation of the regulated article

would reduce the pest risk to a level

equal to or less than the risk associated

with importing the regulated article

with bare roots as allowed by § 319.37–

8(a). If APHIS determines that use of

particular mitigation measures could

reduce the pest risk to this level, and

determines that sufficient APHIS

resources are available to implement or

ensure implementation of the

appropriate mitigation measures, APHIS

will propose to allow importation into

the United States of the requested

regulated article if the appropriate

mitigation measures are employed.

§ 319.37–9 [Amended]

5. In § 319.37–9, the phrase ‘‘is not

intermixed with other approved packing

material;’’ is removed.

Done in Washington, DC, this 9th day of

January 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–935 Filed 1–12–95; 8:45 am]

BILLING CODE 3410–34–P

SECURITIES AND EXCHANGE

COMMISSION

17 CFR Part 249

[Release Nos. 34–35204]

RIN 3235–AG10

Rulemaking for EDGAR System;

Correction

AGENCY: Securities and Exchange

Commission.

ACTION: Correction to final rules.

SUMMARY: This document contains a

correction to the final rules that were

published Friday, December 30, 1994

(59 FR 67752). Those rules relate to the

implementation of the Electronic Data

Gathering, Analysis and Retrieval

(‘‘EDGAR’’) system.

EFFECTIVE DATE: The EDGAR rules and

amendments are effective January 30,

1995.

FOR FURTHER INFORMATION CONTACT:

James R. Budge, Office of Disclosure

Policy, Division of Corporation Finance

at (202) 942–2910.

SUPPLEMENTARY INFORMATION:

Background

The disclosure form that is the subject

of this correction was intended to be
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