Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66741

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

2001–26–10 Airbus Industrie: Amendment

39–12574. Docket 2001–NM–354–AD.

Applicability: Model A319, A320, and

A321 series airplanes, certificated in any

category, having manufacturer serial numbers

1035 and 1384 inclusive.

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 (c) 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 failure of the oxygen containers

to deliver oxygen to the passengers in the

event of a rapid decompression or cabin

depressurization; accomplish the following:

Inspection, Installation, and Other Actions

(a) Within 600 flight hours after the

effective date of this AD, do an in-situ onetime detailed visual inspection of Dra ̈eger

Type I (three/four mask) oxygen containers,

located in the passenger service units, and

Dra ̈ eger Type II (two-mask) oxygen

containers, located in the utility areas, for the

presence of foam pads, per Airbus Service

Bulletin A320–35–1022, dated June 27, 2001.

Note 2: For the purposes of this AD, a

detailed visual inspection is defined as: ‘‘An

intensive visual examination of a specific

structural area, system, installation, or

assembly to detect damage, failure, or

irregularity. Available lighting is normally

supplemented with a direct source of good

lighting at intensity deemed appropriate by

the inspector. Inspection aids such as mirror,

magnifying lenses, etc., may be used. Surface

cleaning and elaborate access procedures

may be required.’’

(1) If all foam pads are installed, before

further flight, complete the other actions

(including repacking the masks in the correct

position; checking the masks, tubes, and

lanyards for correct stowage; and doing a

manual release test and an operational test)

specified in the Accomplishment

Instructions of the service bulletin to ensure

proper operation of the masks.

(2) If any foam pad is missing, before

further flight, install a foam pad in the

applicable oxygen container, and complete

the other actions (including repacking the

masks in the correct position; checking the

masks, tubes, and lanyards for correct

stowage; and doing a manual release test and

an operational test) specified in the

Accomplishment Instructions of the service

bulletin to ensure proper operation of the

masks.

Spares

(b) As of the effective date of this AD, no

person shall install on any airplane a Dra ̈eger

Type I or Dra ̈eger Type II oxygen container

unless it has been inspected and other

actions done per Airbus Service Bulletin

A320–35–1022, dated June 27, 2001.

Alternative Methods of Compliance

(c) 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,

International Branch, ANM–116, Transport

Airplane Directorate, FAA. Operators shall

submit their requests through an appropriate

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, International Branch, ANM–116

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

Special Flight Permits

(d) 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.

Incorporation by Reference

(e) The actions shall be done in accordance

with Airbus Service Bulletin A320–35–1022,

dated June 27, 2001. 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 Airbus Industrie 1 Rond Point,

Maurice Bellonte, 31707 Blagnac Cedex,

France. 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.

Note 4: The subject of this AD is addressed

in French airworthiness directive 2001–

363(B), dated August 8, 2001.

Effective Date

(f) This amendment becomes effective on

January 11, 2002

Issued in Renton, Washington, on

December 17, 2001.

Kalene C. Yanamura,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 01–31549 Filed 12–26–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 01–ACE–7]

Amendment to Class E Airspace;

Ankeny, IA

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Direct final rule; confirmation of

effective date.

SUMMARY: This document confirms the

effective date of a direct final rule which

revises Class E airspace at Ankeny, IA.

EFFECTIVE DATE: 0901 UTC, December

27, 2001.

FOR FURTHER INFORMATION CONTACT:

Kathy Randolph, Air Traffic Division,

Airspace Branch, ACE–52OC, DOT

Regional Headquarters Building, Federal

Aviation Administration, 901 Locust,

Kansas City, MO 64106; telephone:

(816) 329–2525.

SUPPLEMENTARY INFORMATION: The FAA

published this direct final rule with a

request for comments in Federal

Register on September 24, 2001 (66 FR

48794). The FAA uses the direct final

rulemaking procedure for a noncontroversial rule where the FAA

believes that there will be no adverse

public comment. This direct final rule

advised the public that no adverse

comments were anticipated, and that

unless a written adverse comment, or a

written notice of intent to submit such

an adverse comment, were received

within the comment period, the

regulation would become effective on

December 27, 2001. Adverse comments

were received, and thus this document

confirms that this direct final rule will

become effective on that date.

Issued in Kansas City, MO on December

18, 2001.

Herman J. Lyons, Jr.,

Manager, Air Traffic Division, Central Region.

[FR Doc. 01–31727 Filed 12–26–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

Change of Address; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

66742 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to remove references to

certain room numbers that no longer are

valid because the address of the Center

for Food Safety and Applied Nutrition

(CFSAN) changed to 5100 Paint Branch

Pkwy., College Park, MD, on December

14, 2001. FDA also is amending its

regulations to remove a reference to an

alternate site for submissions of

documents to the Docket Management

Branch. This alternate site is no longer

available effective December 14, 2001.

This action is editorial in nature and is

intended to improve the accuracy and

clarity of the agency’s regulations.

EFFECTIVE DATE: December 14, 2001.

FOR FURTHER INFORMATION CONTACT:

Louis B. Brock, Office of Regulations

and Policy, Center for Food Safety and

Applied Nutrition (HFS–24), 5100 Paint

Branch Pkwy., College Park, MD,

20740–3835, 301–436–2378.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 6, 2001

(66 FR 56034), FDA amended its

regulations to reflect that on December

14, 2001, CFSAN’s address was changed

to 5100 Paint Branch Pkwy., College

Park, MD 20740. This change of address

will make room numbers cited in

certain regulations invalid. Therefore,

FDA is amending its regulations in 21

CFR parts 73, 101, 172, 173, 177, 178,

and 184 to remove the phrase ‘‘rm.

3321’’ wherever it appears. FDA also is

amending 21 CFR 10.20(f) to add a

period after ‘‘20857’’ and to remove the

following phrase: ‘‘, except that a

submission which is required to be

received by the Branch by a specified

date may be delivered in person to the

FDA building in Washington (Room

6819, 200 C Street, SW., Washington,

DC 20204) and will be considered as

received by the Branch on the date on

which it is delivered.’’ This alternate

site, originally provided for the

convenience of the public, is no longer

available because CFSAN’s address has

changed to College Park.

Publication of this document

constitutes final action on these changes

under the Administrative Procedure Act

(5 U.S.C. 553). Notice and public

procedure are unnecessary because FDA

is merely correcting nonsubstantive

errors.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR chapter I is

amended as follows:

1. Section 10.20(f) is amended by

adding a period after ‘‘20857’’ and by

removing the rest of the sentence.

2. Parts 73, 101, 172, 173, 177, 178,

and 184 are amended by removing the

words ‘‘rm. 3321’’ wherever they

appear.

Dated: December 19, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31714 Filed 12–26–01; 8:45 am]

BILLING CODE 4160–01–S

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 Phibro

Animal Health.

DATES: This rule is effective December

27, 2001.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Phibro

Animal Health, One Parker Plaza, Fort

Lee, NJ 07024, has informed FDA of a

change of sponsor’s address to 710 Rt.

46 East, suite 401, Fairfield, NJ 07004.

Accordingly, the agency is amending

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

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

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 ‘‘Phibro Animal Health’’ and in

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

the entry for ‘‘066104’’ 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

*******

Phibro Animal Health, 710 Rt. 46 East, suite 401, Fairfield, NJ 07004 .. 066104

*******

(2) * * *

Drug labeler code Firm name and address

*******

066104 Phibro Animal Health, 710 Rt. 46 East, suite 401, Fairfield, NJ 07004