Federal Register / Vol. 61, No. 130 / Friday, July 5, 1996 / Rules and Regulations 35129

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

96–14–02 Boeing: Amendment 39–9684.

Docket 95–NM–154–AD.

Applicability: Model 767 series airplanes

having line position 1 through 329, inclusive;

equipped with Pratt & Whitney Model JT9D–

7R4 engines; certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent chafing of the number 18 fuel

nozzle secondary transfer fuel tube of the

engine, and subsequent fuel leakage and

possible engine fire, accomplish the

following:

(a) Within 6 months after the effective date

of this AD, perform a visual inspection to

verify proper clearance (0.5 inch) between

the number 18 fuel nozzle secondary transfer

fuel tube and the pylon drain tube of the

engine.

(1) If the clearance is equal to or greater

than 0.5 inch: Prior to further flight, install

clamps and associated fasteners between the

environmental control system (ECS) and the

pylon drain tube, in accordance with Boeing

Alert Service Bulletin 767–71A0082, dated

July 6, 1995.

(2) If the clearance is less than 0.5 inch:

Prior to further flight, perform a visual

inspection to detect damage of the number 18

fuel nozzle secondary transfer fuel tube and

the pylon drain tube.

(i) If no damage is detected; or if any

damage to the number 18 fuel nozzle

secondary transfer tube is less than or equal

to 0.003 inch deep, as specified in Section

72–09–71 of Pratt & Whitney JT9D Engine

Manual, and if any damage to the drain tube

is less than or equal to 0.004 inch deep, as

specified in the Boeing 767 Maintenance

Manual 28–22–07: Prior to further flight,

relocate the pylon drain tube to meet the 0.5

inch specification. After accomplishing the

relocation, prior to further flight, install the

clamps and associated fasteners between the

ECS and the pylon drain tube, in accordance

with Boeing Alert Service Bulletin 767–

71A0082, dated July 6, 1995.

(ii) If any damage to the number 18 fuel

tube is greater than 0.003 inch deep, as

specified in Section 72–09–71 of the Pratt &

Whitney JT9D Engine Manual; or if any

damage to the drain tube is greater than 0.004

inch deep, as specified in the Boeing 767

Maintenance manual 28–22–07: Prior to

further flight, repair or replace the damaged

tube, in accordance with Section 28–00–10 of

the Boeing 767 Overhaul Manual. After

accomplishing the repair or replacement,

prior to further flight, install the clamps and

associated fasteners between the ECS and the

pylon drain tube, in accordance with Boeing

Alert Service Bulletin 767–71A0082, dated

July 6, 1995.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Seattle

Aircraft Certification Office (ACO), FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Seattle ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(d) The installation of the clamps and

associated fasteners shall be done in

accordance with Boeing Alert Service

Bulletin 767–71A0082, dated July 6, 1995.

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Boeing Commercial Airplane Group,

P.O. Box 3707, Seattle, Washington 98124–

2207. Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(e) This amendment becomes effective on

August 9, 1996.

Issued in Renton, Washington, on June 25,

1996.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 96–16652 Filed 7–3–96; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ceftiofur

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 The

Upjohn Co. The supplemental NADA

provides for a revised indication for use

of a reconstituted solution of ceftiofur

sterile powder for injection in day-old

chicks for control of mortality

associated with Escherichia coli

organisms susceptible to ceftiofur and

for use of the reconstituted injection in

day-old turkey poults for the same

indication.

EFFECTIVE DATE: July 5, 1996.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: The

Upjohn Co., Kalamazoo, MI 49001, is

sponsor of supplemental NADA 140–

338, which provides for use of Naxcel

Sterile Powder (ceftiofur sodium) as a

50 milligrams per milliliter

reconstituted injectable for use in cattle,

swine, day-old chicks, horses, and dogs.

The supplemental NADA provides for:

(1) A revised indication for use in
35130 Federal Register / Vol. 61, No. 130 / Friday, July 5, 1996 / Rules and Regulations

chicks for control of early mortality

associated with E. coli organisms

susceptible to ceftiofur, and (2) use in a

new species, day-old turkey poults, for

the revised indication. According to 21

CFR 556.113 a tolerance for ceftiofur

residues in edible tissues derived from

treated poultry is not needed. The

supplemental NADA is approved as of

May 21, 1996, and the regulations are

amended in 21 CFR 522.313(d) 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 part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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

(21 U.S.C. 360b(c)(2)(F)(iii)), approval

for use in turkeys qualifies for 3 years

of marketing exclusivity beginning May

21, 1996, because the application

contains reports of new clinical or field

investigations (other than

bioequivalence or residue studies) or

human food safety studies (other than

bioequivalence or residue studies)

essential to the approval 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.

List of Subjects in 21 CFR Part 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

2. Section 522.313 is amended by

revising paragraph (d)(3)(ii), by

redesignating paragraphs (d)(4) and

(d)(5) as paragraphs (d)(5) and (d)(6),

respectively, and by adding new

paragraph (d)(4) to read as follows:

§ 522.313 Ceftiofur sterile powder for

injection.

* * * * *

(d) * * *

(3) * * *

(ii) Indications for use. For control of

early mortality associated with

Escherichia coli organisms susceptible

to ceftiofur.

* * * * *

(4) Day-old turkey poults—(i)

Amount. 0.17 to 0.5 milligram per poult.

(ii) Indications for use. For control of

early mortality associated with E. coli

organisms susceptible to ceftiofur.

(iii) Limitations. For subcutaneous use

in the neck of day-old poults only. As

a single dose only. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian.

* * * * *

Dated: June 14, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–17103 Filed 7–3–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD01–96–041]

RIN 2115–AA97

Safety Zone: Macy’s 1996 Fourth of

July Fireworks, East River, New York

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone for

the annual Macy’s Fourth of July

Fireworks program in New York Harbor.

The event will take place on Thursday,

July 4, 1996, from 7:30 p.m. until 11

p.m. on the East River. This safety zone

temporarily closes a major portion of the

East River to vessel transits.

EFFECTIVE DATE: This rule is effective

from 7:30 p.m. until 11 p.m. on July 4,

1996, unless extended or terminated

sooner by the Captain of the Port New

York.

FOR FURTHER INFORMATION CONTACT:

Lieutenant J. W. Green, Chief,

Waterways Oversight Branch,

Waterways Management Division, Coast

Guard Activities New York (212) 668–

7906.

SUPPLEMENTARY INFORMATION:

Regulatory History

Pursuant to 5 U.S.C. 553, a notice of

proposed rulemaking (NPRM) was not

published for this regulation. Good

cause exists for not publishing an NPRM

and for making this regulation effective

less than 30 days after Federal Register

publication. Due to the date complete

information regarding this event was

received, there was insufficient time to

draft and publish an NPRM. Any delay

encountered in this regulation’s

effective date would be contrary to

public interest since immediate action is

needed protect the maritime public from

the hazards associated with large

amounts of fireworks exploding from

four separate barge locations in the

waters of the East River.

Background and Purpose

Macy’s has submitted an Application

for Approval of Marine Event to hold a

fireworks program on the waters of the

East River. This regulation establishes a

temporary safety zone in the waters of

the East River. The safety zone includes

all waters of the East River, shore to

shore, north of a line drawn from the

foot of East 10th Street, Manhattan, east

through the chartered position of Buoy

18 (LLNR 27335) to the foot of North 8th

Street, Brooklyn, New York, and south

of a line drawn from Lawrence Point

(40°47′27′′N latitude 073°54′35′′W

longitude) to Stony Point (40°47′48′′N

latitude 073°54′42′′W longitude), and

south of the Harlem River Foot Bridge,

New York. This safety zone area also

includes all waters of Newtown Creek

west of the 073°57′37′′W line of

longitude and all waters inward of the

pierheads and bulkheads between the

Queensboro Bridge, Roosevelt Island,

and the southern boundary of this safety

zone. No vessel may enter the safety

zone without permission of the Captain

of the Port New York. Certain

designated vessels will be allowed to

take position within the zone as follows:

(1) vessels less than 20 meters (65.6 feet)

in length, carrying persons for the sole

purpose of viewing the fireworks may

take position north of the southern tip

of Roosevelt Island; and (2) vessels

equal to or greater than 20 meters (65.6

feet) in length, carrying persons for the

sole purpose of viewing the fireworks

display, may take position in an area at

least 300 yards off the bulkhead on the

west bank and just off the pierhead faces

on the east bank of the East River