Federal Register / Vol. 65, No. 112 / Friday, June 9, 2000 / Rules and Regulations 36615

Name: File No. (beginning with 84– or 85–):

[FR Doc. 00–14594 Filed 6–8–00; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs; Change of

Sponsor’s Address

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor’s address for Medicis

Dermatologics, Inc.

DATES: This rule is effective June 9,

2000.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Medicis

Dermatologics, Inc., 4343 East

Camelback Rd., suite 250, Phoenix, AZ

85018–2700, has informed FDA of a

change of sponsor’s address to 8125

North Hayden Rd., Scottsdale, AZ

85258. Accordingly, the agency is

amending the regulations in 21 CFR

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

change of sponsor’s address.

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 in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is 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 is amended in the

table in paragraph (c)(1) by revising the

entry for ‘‘Medicis Dermatologics, Inc.’’

and in the table in paragraph (c)(2) by

revising the entry for ‘‘099207’’ to read

as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

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: