31624 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Animal Health,

Inc., 2621 North Belt Hwy., St. Joseph,

MO 65406, has informed FDA of a

change of sponsor name to Boehringer

Ingelheim Vetmedica, Inc. Accordingly,

the agency is amending 21 CFR

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

change of sponsor name.

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.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Boehringer

Ingelheim Animal Health, Inc.’’ and by

alphabetically adding a new entry for

‘‘Boehringer Ingelheim Vetmedica,

Inc.’’; and in the table in paragraph

(c)(2) in the entry for ‘‘000010’’ by

removing the sponsor name ‘‘Boehringer

Ingelheim Animal Health, Inc.’’ and

adding in its place ‘‘Boehringer

Ingelheim Vetmedica, Inc.’’

Dated: May 22, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–15481 Filed 6–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Fenbendazole Paste

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

Hoechst Roussel Vet. The supplemental

NADA provides for expanding the

indications to include treatment of

encysted mucosal cyathostome (small

strongyle) larvae including early third

stage (hypobiotic), late third stage, and

fourth stage larvae.

EFFECTIVE DATE: June 10, 1998.

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: Hoechst

Roussel Vet, 30 Independence Blvd.,

P.O. Box 4915, Warren, NJ 07059, filed

supplemental NADA 120–648 that

provides for oral administration of

Panacur and Safe-Guard

(fenbendazole l0 percent) paste to

horses. The product is currently

approved for use concomitantly with an

approved form of trichlorfon.

Trichlorfon is approved for the

treatment of stomach bots

(Gasterophilus spp.) in horses. The

supplemental NADA provides for

expanding the indications to include

treatment of encysted mucosal

cyathostome (small strongyle) larvae

including early third stage (hypobiotic),

late third stage, and fourth stage larvae

when administered at 10 milligrams per

kilogram per day for 5 consecutive days.

The supplemental NADA is approved as

of April 20, 1998, and the regulations

are amended in 21 CFR

520.905c(d)(1)(iii) to reflect the

approval. The basis for 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 nonfood-producing

animals qualifies for 3 years of

marketing exclusivity beginning April

20, 1998, because the supplemental

application contains substantial

evidence of the effectiveness of the drug

involved, or any studies of animal

safety, required for approval of the

application and conducted or sponsored

by the applicant.

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 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: 21 U.S.C. 360b.

2. Section 520.905c is amended by

adding paragraph (d)(1)(iii) to read as

follows:

§ 520.905c Fenbendazole paste.

* * * * *

(d) * * *

(1) * * *

(iii)(a) Amount. 4.6 milligrams per

pound of body weight (10 milligrams

per kilogram) daily for 5 consecutive

days.

(b) Indications for use. For treatment

of encysted mucosal cyathostome (small

strongyle) larvae including early third

stage (hypobiotic), late third stage, and

fourth stage larvae in horses.

(c) Limitations. (Consult your

veterinarian for assistance in the

diagnosis, treatment, and control of

encysted mucosal cyathostomes). Do not

use in horses intended for food.

* * * * *

Dated: May 27, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–15480 Filed 6–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Part 982

[Docket No. FR–4054–C–03]

RIN 2577–AB63

Section 8 Certificate and Voucher

Programs Conforming Rule;

Correction

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31625

ACTION: Final rule; correction.

SUMMARY: This document contains

corrections to the final rule that was

published Thursday, April 30, 1998 (63

FR 23826). That final rule combined and

conformed the provisions of the Section

8 certificate and the voucher programs

and made some regulatory streamlining

changes.

EFFECTIVE DATE: June 10, 1998.

FOR FURTHER INFORMATION CONTACT:

Gloria Cousar, Deputy Assistant

Secretary for Public and Assisted

Housing Delivery, Office of Public and

Indian Housing, Department of Housing

and Urban Development, Room 4204,

451 7th Street, SW, Washington, DC

20410. Her telephone numbers are (202)

708–2841 (voice) and (202) 708–0850

(TTY). (These are not toll-free numbers.)

SUPPLEMENTARY INFORMATION:

Need for Correction

As published, the final rule contains

three errors that may prove to be

misleading and is in need of

clarification. The first error is the

omission of the definition of ‘‘Housing

quality standards’’ from § 982.4. The

definition as found in the rule before the

revision is restored in this document.

The second error is the failure to

include the term ‘‘near-elderly’’ in a

discussion in § 982.316 concerning the

family composition of a family eligible

to seek approval of a live-in aide. Such

a family, as described in 24 CFR 5.403,

may include near-elderly persons

without either elderly persons or

disabled persons. The omission of that

term in this rule would create

confusion, so it is added to § 982.316 in

this document. The third error is that

the statement of how to calculate the

amount of the monthly housing

assistance payment for a manufactured

home space in § 982.623 contains a

typographical error that cites an

incorrect paragraph reference. This

document corrects the reference.

Correction of Publication

Accordingly, FR Doc. 98–10374, a

final rule published on April 30, 1998

(63 FR 23826), which amended 24 CFR

part 982, is corrected as follows:

1. On page 23858, in the third

column, § 982.4 is corrected by

inserting, after the definition of

‘‘Housing assistance payment’’, the

following definition of ‘‘Housing quality

standards’’:

§ 982.4 Definitions.

* * * * *

Housing quality standards (HQS). The

HUD minimum quality standards for

housing assisted under the tenant-based

programs. See § 982.401.

* * * * *

§ 982.316 [Corrected]

2. On page 23860, in the third

column, in the first sentence of

§ 982.316, the word ‘‘elderly’’ is

corrected to read ‘‘elderly, nearelderly’’.

§ 982.623 [Corrected]

3. On page 23869, in the second

column, in § 982.623(b)(2)(i), the

reference to ‘‘the lesser of paragraphs

(b)(2)(i)(A) or (b)(2)(ii)(B)’’ is corrected

to read ‘‘the lesser of paragraphs

(b)(2)(i)(A) or (b)(2)(i)(B)’’.

Dated: June 3, 1998.

Camille E. Acevedo,

Assistant General Counsel for Regulations.

[FR Doc. 98–15479 Filed 6–9–98; 8:45 am]

BILLING CODE 4210–33–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD 08–98–022]

Drawbridge Operating Regulation;

Atchafalaya River, LA

AGENCY: Coast Guard, DOT.

ACTION: Notice of temporary deviation

from regulations.

SUMMARY: The Commander, Eighth

Coast Guard District has issued a

temporary deviation from the regulation

in 33 CFR 117.5 governing the operation

of the Union Pacific Railroad swing

span bridge across the Atchafalaya

River, mile 95.7 at Krotz Springs,

Louisiana. This deviation allows the

Union Pacific Railroad to close the

bridge to navigation from 7 a.m. on

Monday, July 27, 1998 through 6 p.m.

on Monday, August 3, 1998. This

temporary deviation is issued to allow

for the replacement of the electric

motors, gears and associated machinery

of the swing span operating mechanism

DATES: This deviation is effective 7 a.m.

on Monday, July 27, 1998 through 6

p.m. on Monday, August 3, 1998.

FOR FURTHER INFORMATION CONTACT:

Mr. Phil Johnson, Bridge Administration

Branch, Commander (ob), Eighth Coast

Guard District, 501 Magazine Street,

New Orleans, Louisiana, 70130–3396,

telephone number 504–589–2965.

SUPPLEMENTARY INFORMATION: The Union

Pacific Railroad swing span bridge

across the Atchafalaya River, mile 95.7

at Krotz Springs, Louisiana has a

vertical clearance of 6 feet above mean

high water, elevation 38.5 feet Mean Sea

Level, in the closed-to-navigation

position and unlimited clearance in the

open-to-navigation position. Navigation

on the waterway consists primarily of

tugs with tows and occasional

recreational craft. Presently, the draw

opens on signal.

The Union Pacific Railroad requested

a temporary deviation from the normal

operation of the bridge in order to

accomplish the maintenance work. The

work consists of replacing the electric

motors, gears and other components of

the operating machinery. This work is

essential for the continued operation of

the swing span. Alternate navigation

routes are available. Mariners may

transit the Atchafalaya River to the site

of the bridge from both upstream via the

Red River and Mississippi River and

from downstream via Atchafalaya Bay.

The District Commander has,

therefore, issued a deviation from the

regulations in 33 CFR 117.5 authorizing

the Union Pacific Railroad swing span

bridge across the Atchafalaya River,

mile 95.7 at Krotz Springs, Louisiana to

remain in the closed-to-navigation

position from 7 a.m. on July 27, 1998

through 6 p.m. on August 3, 1998.

Dated: June 1, 1998.

A.L. Gerfin, Jr.,

Captain, U.S. Coast Guard, Commander, 8th

Coast Guard Dist., Acting.

[FR Doc. 98–15422 Filed 6–9–98; 8:45 am]

BILLING CODE 4910–15–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[COTP Los Angeles-Long Beach, CA; 98–

004]

RIN 2115–AA97

Safety Zone; San Pedro Bay, CA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule; request for

comments.

SUMMARY: The Coast Guard is

establishing a temporary safety zone in

the navigable waters of San Pedro Bay,

California. This safety zone is

established as a result of the

construction of an artificial habitat and

is necessary to protect vessels from the

hazards associated with the

construction.

All vessels with a draft of 50 feet or

more are prohibited from entering this

area, unless specifically authorized by

the Captain of the Port, for the entire