Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Rules and Regulations 48939

factor only analysis performed online at

an applicant’s facility.

Final Action

Effective October 1, 1997, the Agency

will apply a 12.5-percent increase to

Administrative Fees in 7 CFR 800.71,

Table 1 (3), and will delete fees for

Additional Service (assessed in addition

to all other fees) in Table 1 (3)(ii).

Good cause exists for not postponing

the effective date of this rule until 30

days after publication in the Federal

Register (5 U.S.C. 553) because an

October 1, 1997, effective date

corresponds to the beginning of the

1998 fiscal year and the start of a new

accounting cycle.

List of Subjects in 7 CFR Part 800:

Administrative practice and

procedure; Grain.

For the reasons set out in the

preamble, 7 CFR Part 800 is amended as

follows:

PART 800—GENERAL REGULATIONS

1. The authority citation for Part 800

continues to read as follows:

Authority: Pub. L. 94–582, 90 Stat. 2867,

as amended (7 U.S.C. 71 et seq.)

2. Section 800.71 is amended by

revising Table 1(3) in Schedule A of

paragraph (a) to read as follows:

§ 800.71 Fees assessed by the Service.

(a)

* * * * *

Schedule A—Fees for Official

Inspection and Weighing Services

Performed in the United States

TABLE 1.—FEES FOR OFFICIAL SERVICES PERFORMED AT AN APPLICANT’S FACILITY IN AN ONSITE FGIS

LABORATORY 1

* * * * *

(3) Administrative Fee (assessed in addition to

all other applicable fees, only one administrative fee will be assessed when inspection

and weighing services are performed on the

same carrier).

(i) All outbound carriers (per-metric-ton) 4

(a) 1–1,000,000 ........................ $0.1013

(b) 1,000,001–1,500,000 .......... .0923

(c) 1,500,001–2,000,000 .......... .0473

(d) 2,000,001–5,000,000 .......... .0360

(e) 5,000,001–7,000,000 .......... .0192

(f) 7,000,001 + .......................... .0023

1 Fees for original inspection and weighing,

reinspection, and appeal inspection service include, but are not limited to, sampling, grading, weighing, prior to loading stowage examinations, and certifying results performed within

25 miles of an employee’s assigned duty station. Travel and related expenses will be

charged for service outside 25 miles as found

in § 800.72 (a).

* * * * *

4 The administrative fee is assessed on an

accumulated basis beginning at the start of

the Service’s fiscal year (October 1 each

year).

* * * * *

Dated: September 12, 1997.

James R. Baker,

Administrator.

[FR Doc. 97–24814 Filed 9–17–97; 8:45 am]

BILLING CODE 3410–EN–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs; Change of Sponsor

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 address for K. C.

Pharmacal, Inc.

EFFECTIVE DATE: September 18, 1997.

FOR FURTHER INFORMATION CONTACT:

Judith O’Haro, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–3664.

SUPPLEMENTARY INFORMATION: K. C.

Pharmacal, Inc., 1310 Atlantic, P.O. Box

7496, North Kansas City, MO 64116, has

informed FDA of a change of sponsor

address to K. C. Pharmacal, Inc., 8345

Melrose Dr., Lenexa, KS 66214.

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) to reflect the change of

sponsor address.

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: Secs. 201, 301, 501, 502, 503,

512, 701, 721 of the Federal Food, Drug, and

Cosmetic Act (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

sponsor address for ‘‘K. C. Pharmacal,

Inc.’’ and in the table in paragraph (c)(2)

in the entry for ‘‘038782’’ by revising the

sponsor 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

* * * * * * *

K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214 ........... 038782

* * * * * * *

(2) * * *
48940 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Rules and Regulations

Drug labeler code Firm name and address

* * * * * * *

038782 ...................................................................................................... K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214

* * * * * * *

Dated: September 4, 1997.

George A. Mitchell,

Acting Director, Center for Veterinary

Medicine.

[FR Doc. 97–24736 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Cyclosporine

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

Schering-Plough Animal Health. The

supplemental NADA provides for use of

cyclosporine ophthalmic ointment on

dogs for management of chronic

superficial keratitis (CSK) and changing

the approved label claim to management

of chronic keratoconjunctivitis sicca

(KCS).

EFFECTIVE DATE: September 18, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health, Schering-Plough

Corp., P.O. Box 529, Kenilworth, NJ

07033, has filed supplemental NADA

141–052 Optimmune (cyclosporine)

ophthalmic ointment that provides for

use on dogs for the management of

chronic superficial keratitis (CSK) and

changing the approved label claim from

treatment to management of chronic

keratoconjunctivitis sicca (KCS) in dogs.

The term management reflects the

complexity of the therapy for the

diseases. The drug is limited to use by

or on the order of a licensed

veterinarian. The supplement is

approved as of August 26, 1997, and the

regulations are revised in 21 CFR

524.575(c)(2) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

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.

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

Federal Food, Drug, and Cosmetic Act,

this approval for use in nonfoodproducing animals qualifies for 3 years

of marketing exclusivity beginning

August 26, 1997, because the

supplemental application contains

substantial evidence of the effectiveness

of the drug involved, 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 3 years of

marketing exclusivity applies only to

the new indication for management of

CSK in dogs.

FDA has carefully considered the

potential environmental effects of this

action and has concluded that the action

will not have a significant impact on the

human environment, and that an

environmental impact statement is not

required. FDA’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).

List of Subjects in 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 part 524 is amended as follows:

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: Sec. 512 of the Federal Food,

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

2. Section 524.575 is amended by

revising paragraph (c)(2) to read as

follows:

§ 524.575 Cyclosporine ophthalmic

ointment.

* * * * *

(c) * * *

(2) Indications for use. For

management of chronic

keratoconjunctivitis sicca (KCS) and

chronic superficial keratitis (CSK) in

dogs.

* * * * *

Dated: September 10, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–24850 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812

[Docket No. 96N–0299]

Investigational Device Exemptions;

Treatment Use

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is establishing

procedures to allow for the treatment

use of investigational devices. These

procedures are intended to facilitate the

availability of promising new

therapeutic and diagnostic devices to

desperately ill patients as early in the

device development process as possible,

i.e., before general marketing begins,

and to obtain additional data on the

device’s safety and effectiveness. These

procedures apply to patients with

serious or immediately life-threatening

diseases or conditions for which no

comparable or satisfactory alternative

device, drug, or other therapy exists.

DATES: The regulation is effective

January 16, 1998.