36616 Federal Register / Vol. 65, No. 112 / Friday, June 9, 2000 / Rules and Regulations

Firm name and address Drug labeler code

*******

099207 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ

85258

*******

(2) * * *

Drug labeler code Firm name and address

*******

099207 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ

85258

*******

Dated: May 29, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–14464 Filed 6–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 524 and 556

Ophthalmic and Topical Dosage Form

New Animal Drugs; Moxidectin

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 a supplemental new animal

drug application (NADA) filed by Fort

Dodge Animal Health, Division of

American Home Products Corp. The

supplemental NADA provides for

topical use of a 0.5 percent moxidectin

solution on dairy cattle of breeding age

for treatment and control of infections

and infestations of certain internal and

external parasites. FDA is also

amending the regulations to establish a

tolerance for moxidectin residues in

milk.

DATES: This rule is effective June 9,

2000.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7584.

SUPPLEMENTARY INFORMATION: Fort

Dodge Animal Health, Division of

American Home Products Corp., 800

Fifth St. NW., Fort Dodge, IA 50501,

filed supplemental NADA 141–099 that

provides for use of Cydectin

(moxidectin) 0.5 percent pouron for

dairy cattle at 500 micrograms

moxidectin per kilogram of body weight

for treatment and control of infections

and infestations of certain

gastrointestinal roundworms,

lungworms, cattle grubs, mites, lice, and

horn flies. The supplemental NADA is

approved as of November 2, 1999, and

the regulations are amended in 21 CFR

524.1451 to reflect the approval. The

basis for approval is discussed in the

freedom of information summary.

In addition, the regulations are

amended in 21 CFR 556.426 to add a

tolerance for residues of moxidectin in

milk and, editorially, to reflect current

format.

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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(ii)), this

approval qualifies for 3 years of

marketing exclusivity beginning

November 2, 1999, because the

application contains substantial

evidence of the effectiveness of the drug

involved, any studies of animal safety

or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

application and conducted or sponsored

by the applicant.

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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects

21 CFR Part 524

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 524 and 556 are amended as

follows:

Federal Register / Vol. 65, No. 112 / Friday, June 9, 2000 / Rules and Regulations 36617

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

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

§ 524.1451 [Amended]

2. Section 524.1451 Moxidectin is

amended in the first sentence of

paragraph (d)(2) by removing the phrase

‘‘Beef and non-lactating dairy cattle’’

and by adding in its place the phrase

‘‘Beef and dairy cattle’’, and in

paragraph (d)(3) by removing the first

and second sentences.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

4. Section 556.426 is revised to read

as follows:

§ 556.426 Moxidectin.

(a) Acceptable daily intake (ADI). The

ADI for total residues of moxidectin is

4 micrograms per kilogram of body

weight per day.

(b) Tolerances. The tolerance for

parent moxidectin (the marker residue)

in edible tissues of cattle is 200 parts

per billion (ppb) in liver (the target

tissue) and 50 ppb in muscle. The

tolerance for parent moxidectin is 50

ppb in milk.

Dated: May 29, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–14463 Filed 6–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1952

State Plans: Coverage of the United

States Postal Service and Other

Coverage Issues—Changes to Level of

Federal Enforcement for Alaska,

Arizona, California, Hawaii, Indiana,

Iowa, Kentucky, Maryland, Michigan,

Minnesota, Nevada, New Mexico, North

Carolina, Oregon, Puerto Rico, South

Carolina, Tennessee, Utah, Vermont,

Virginia, the Virgin Islands,

Washington and Wyoming

AGENCY: Occupational Safety and Health

Administration (OSHA), U.S.

Department of Labor.

ACTION: Final rule.

SUMMARY: This document amends

OSHA’s regulations to reflect

declination of jurisdiction over the

United States Postal Service (U.S. Postal

Service or USPS) and its facilities by all

twenty-three (23) approved State Plans

which cover the private sector. The

Postal Employees’ Safety Enhancement

Act of 1998 (PESEA) amended the

Occupational Safety and Health Act of

1970 (the Act) to include the USPS

within its definition of ‘‘employer.’’

Accordingly, OSHA assumed

jurisdiction for the USPS on September

29, 1998. PESEA extends all provisions

of the Act to the USPS, including

section 18 of the Act, thus granting the

OSHA-approved State plans the

authority to regulate the USPS.

Subsequently, OSHA required the State

plan States to either elect to amend their

State plans to cover the USPS, or to

decline to exercise such coverage, in

which case coverage would remain a

Federal OSHA responsibility. All

affected State plans declined. OSHA is

hereby amending pertinent sections of

its regulations on approved State plans

to reflect the declination of State

jurisdiction and the continuation of

Federal OSHA enforcement authority

over the USPS, including contract

employees and contractor-operated

facilities engaged in USPS mail

operations, in all of the twenty-three

(23) States operating OSHA-approved

State plans covering the private sector,

and notifying affected employers and

employees of this action. As a result,

Federal OSHA is responsible for safety

and health enforcement with respect to

the USPS and its facilities in all States

nationwide. In addition, technical

corrections are being made pertaining to

maritime jurisdiction in several of the

States; military jurisdiction in the State

of Washington; coverage on Indian

Reservations in the State of Oregon; and

information on where the plan

documents for the various State plans

may be inspected.

EFFECTIVE DATE: June 9, 2000.

FOR FURTHER INFORMATION CONTACT:

Bonnie Friedman, Director, Office of

Information and Consumer Affairs,

Occupational Safety and Health

Administration, U.S. Department of

Labor, Room N3637, 200 Constitution

Avenue NW, Washington, D.C. 20210,

(202) 693–1999.

SUPPLEMENTARY INFORMATION:

Introduction

Section 18 of the Occupational Safety

and Health Act of 1970, 29 U.S.C. 667,

provides that States which wish to

assume responsibility for developing

and enforcing their own occupational

safety and health standards may do so

by submitting and obtaining Federal

approval of a State plan. State plan

approval occurs in stages which include

initial approval under section 18(c) of

the Act and ultimately, final approval

under section 18(e) of the Act. In the

interim, between initial approval and

final approval, there is a period of

concurrent Federal/State jurisdiction

within a State operating an approved

plan. In the following States which have

not received section 18(e) final

approval, concurrent Federal

enforcement authority remains in effect

but has been suspended voluntarily in

accordance with operational status

agreements between OSHA and the

individual States. See 29 CFR 1954.3 for

guidelines and procedures. These States

are: California, Michigan, New Mexico,

Oregon, Puerto Rico, Vermont and

Washington. In the following States

which have received final approval

pursuant to section 18(e) of the Act,

Federal OSHA standards and

enforcement authority have been

relinquished. These States are: Alaska,

Arizona, Hawaii, Indiana, Iowa,

Kentucky, Maryland, Minnesota,

Nevada, North Carolina, South Carolina,

Tennessee, Utah, Virginia, and

Wyoming. (Concurrent Federal

enforcement authority is currently being

exercised in the Virgin Islands.

Connecticut and New York operate State

plans limited in coverage to State and

local government employees and are not

affected by this rule.)

Background

United States Postal Service

States ordinarily cannot exercise

regulatory authority over Federal

agencies or other Federal institutions or