Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31931

Special Priorities Assistance; and

Appendix IV to part 700: Memorandum

of Understanding on Priorities and

Allocations Support Between the

Department of Commerce and the

Canadian Department of Supply and

Services, are removed.

Issued: June 5, 1998.

Iain S. Baird,

Deputy Assistant Secretary for Export

Administration.

[FR Doc. 98–15410 Filed 6–10–98; 8:45 am]

BILLING CODE 3510–JT–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Gentamicin

Sulfate, Betamethasone Valerate, and

Clotrimazole Ointment

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

Med-Pharmex, Inc. The ANADA

provides for the use of gentamicin

sulfate, betamethasone valerate, and

clotrimazole (Tri-Otic ointment) for the

treatment of canine acute and chronic

otitis externa associated with yeast and/

or bacteria susceptible to gentamicin.

EFFECTIVE DATE: June 11, 1998.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767, filed ANADA

200–229 that provides for the use of

gentamicin sulfate, betamethasone

valerate, and clotrimazole (Tri-Otic

ointment) for the treatment of canine

acute and chronic otitis externa

associated with yeast and/or bacteria

susceptible to gentamicin.

The ANADA is approved as a generic

copy of Schering Plough Animal Health

Corp.’s NADA 140–896 for OTOMAX

(gentamicin sulfate, betamethasone

valerate, and clotrimazole). ANADA

200–229 is approved as of April 8, 1998,

and the regulations are amended in 21

CFR 524.1044g to reflect the approval.

The basis for approval is discussed in

the freedom of information summary. In

addition, the agency is amending 21

CFR 510.600(c)( 1) and (c)(2) to reflect

a change of sponsor’s name and address.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33(d)(1) 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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 524

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 parts 510 and 524 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.

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) in the entry

for ‘‘Med-Pharmex, Inc., Biomed

Laboratories’’ and in the table in

paragraph (c)(2) in the entry for

‘‘051259’’ by revising the sponsor name

and address to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–

1861

051259

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

051259 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–

1861

* * * * * * *
31932 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 524.1044g [Amended]

4. Section 524.1044g Gentamicin

sulfate, betamethasone valerate,

clotrimazole ointment is amended in

paragraph (b) by removing ‘‘000061’’

and adding in its place ‘‘000061 and

051259’’.

Dated: May 27, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–15554 Filed 6–10–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 141

[FRL–6109–7]

Removal of the Prohibition on the Use

of Point of Use Devices for Compliance

with National Primary Drinking Water

Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: Today’s action removes the

prohibition on point of use (POU)

devices as compliance technologies for

National Primary Drinking Water

Regulations that is set forth in the Code

of Federal Regulations in section

141.101. EPA is removing the

prohibition on the POU devices because

it conflicts with section 1412(b)(4)(E)(ii)

of the Safe Drinking Water Act (SDWA)

as amended on August 6, 1996. No other

part of section 141.101 is affected by

today’s action.

DATES: This action is effective June 11,

1998.

FOR FURTHER INFORMATION CONTACT: The

Safe Drinking Water Hotline, toll free

(800) 426–4791, or Tara Chhay

Cameron; Targeting and Analysis

Branch; Office of Ground Water and

Drinking Water; EPA (4607), 401 M

Street, S.W., Washington, DC 20460;

telephone (202) 260–3702.

SUPPLEMENTARY INFORMATION:

Table of Contents

A. Regulated Entities

B. Explanation of Today’s Action

C. Administrative Requirements

1. Executive Order 12866

2. Regulatory Flexibility Act

3. Paperwork Reduction Act

4. Unfunded Mandates Reform Act and

Executive Order 12875

5. Executive Order 13045—Protection of

Children From Environmental Health

Risks and Safety Risks

6. Submission to Congress and the General

Accounting Office

7. National Technology Transfer and

Advancement Act

8. Administrative Procedure Act

A. Regulated Entities

Entities potentially regulated by this

action are those which meet the criteria

of the Public Water Systems (PWS)

definition. Regulated categories and

entities include:

Category Example of Regulated Entities

Industry ...................................................................................................................... Public Water Systems

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. This table lists

the type of entities that EPA is now

aware of that could potentially be

regulated by this action. Other types of

entities not listed in the table could also

be regulated. To determine whether

your entity is regulated by this action,

you should carefully examine the

applicability criteria in §§ 141.2, 142.2,

142.3, and 142.10 of title 40 of the Code

of Federal Regulations. If you have

questions regarding the applicability of

this action to a particular entity, consult

the person listed in the preceding FOR

FURTHER INFORMATION CONTACT section.

B. Explanation of Today’s Action

On July 8, 1987 (52 FR 25716) EPA

promulgated a requirement in section 40

CFR 141.101 that public water systems

shall not use POU devices to achieve

compliance with a maximum

contaminant level (MCL) of a National

Primary Drinking Water Regulations.

On August 6, 1996, amendments to

the SDWA were enacted into law.

Section 1412(b)(4)(E)(ii) of the SDWA,

as amended, authorizes the use of POU

devices by public water systems to

comply with an MCL under certain

circumstances. In order to make the

regulatory provisions consistent with

the new statutory language, with today’s

action, EPA removes the prohibition on

the use of POU devices by public water

systems to comply with an MCL. No

other provision of section 141.101 is

affected by this action.

C. Administrative Requirements

1. Executive Order 12866

Under Executive Order 12866 (58 FR

51,735 (October 4, 1993)), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to OMB review and the

requirements of the Executive Order.

The Order defines ‘‘significant

regulatory action’’ as one that is likely

to result in a rule that may:

(a) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities;

(b) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(c) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

(d) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

It has been determined that this rule

is not a ‘‘significant regulatory action’’

under the terms of Executive Order

12866 and is therefore not subject to

OMB review.

2. Regulatory Flexibility Act

The Agency has determined that the

rule being issued today is not subject to

the Regulatory Flexibility Act (RFA),

which generally requires an Agency to

conduct a regulatory flexibility analysis

of any significant impact the rule will

have on a substantial number of small

entities. By its terms, the RFA applies

only to rules subject to notice and

comment rulemaking requirements