66002 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 97–SW–54–AD.’’ The

postcard will be date stamped and

returned to the commenter.

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979). If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, 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 a new airworthiness directive to

read as follows:

97–26–09 Agusta S.p.A.: Amendment 39–

10252. Docket No. 97–SW–54–AD.

Applicability: Model A109K2 helicopters

with main transmission assembly, part

number (P/N) 109–0400–03, serial number

(S/N) 005, 006, 007, 008, 010, 011, 012, 013,

014, 015, 016, 017, 018, 020, 022, 024, 027,

030, 031, 032, 033, 034, 035, 038, 039, 042,

047, 048, A2/1053, A2/1073, 2/1397, or

B54895 e C347, installed, certificated in any

category.

Note 1: This AD applies to each helicopter

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

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (c) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To prevent failure of the main transmission

Gleason crown (Gleason crown), failure of

the main transmission and subsequent loss of

control of the helicopter, accomplish the

following:

(a) Within 50 hours time-in-service (TIS)

after the effective date of this AD, and

thereafter at intervals not to exceed 300 hours

TIS, perform a magnetic particle inspection

of the Gleason Crown, P/N 109–0403–07, for

cracks in accordance with steps 1 through 3

of Part II of the Compliance Instructions of

Agusta Bollettino Tecnico (Technical

Bulletin) No. 109K–16, dated April 24, 1997.

(b) If any crack is found, remove the

Gleason crown and replace it with an

airworthy Gleason crown, P/N 109–0403–07–

103, S/N B58264 through S/N B58270, or S/

N B58272 and subsequent (S/N B58271 is not

an acceptable replacement part), and vibroetch the main transmission tag with ‘‘S.M.

109–25094’’. Replacement of the Gleason

crown with an airworthy Gleason crown, P/

N 109–0403–07–103, S/N B58264 through S/

N B58270 or S/N B58272 and subsequent,

constitutes a terminating action for the

requirements of this AD.

(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, Rotorcraft

Standards Staff, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Rotorcraft Standards Staff.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Rotorcraft Standards Staff.

(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 helicopter

to a location where the requirements of this

AD can be accomplished.

(e) The inspections and replacement shall

be done in accordance with Agusta Bollettino

Tecnico (Technical Bulletin) No. 109K–16,

dated April 24, 1997. 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 Agusta S.p.A., 21017 Cascina

Costa di Samarate (VA), Via Giovanni Agusta

520, telephone (0331) 229111, fax (0331)

229605–222595. Copies may be inspected at

the FAA, Office of Regional Counsel,

Southwest Region, 2601 Meacham Blvd.,

Room 663, Fort Worth, Texas 76137; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(f) This amendment becomes effective on

January 2, 1998.

Note 3: The subject of this AD is addressed

in Registro Aeronautico Italiano (Italy) AD

97–122, dated April 29, 1997.

Issued in Fort Worth, Texas, on December

9, 1997.

Larry M. Kelly,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–32992 Filed 12–16–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Airspace Docket No. 97–ANM–10]

RIN 2120–AA66

Change Controlling Agency for

Restricted Areas R–6412A and R–

6412B; Camp Williams, UT

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action changes the

published controlling agencies for

Restricted Areas R–6412A and R–6412B,

Camp Williams, UT. This is an

administrative change initiated by the

Northwest Mountain Region. There are

no changes to the boundaries, altitudes,

times of designation, or activities

conducted within the restricted areas.

EFFECTIVE DATE: 0901 UTC, February 26,

1998.

FOR FURTHER INFORMATION CONTACT: Ken

McElroy, Airspace and Rules Division,

ATA–400, Office of Air Traffic Airspace

Management, Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, DC 20591;

telephone (202) 267–7686.

SUPPLEMENTARY INFORMATION:

The Rule

This action amends 14 CFR part 73 by

changing the published controlling
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66003

agencies for Restricted Areas R–6412A

and R–6412B, Camp Williams, UT. This

is an administrative change initiated by

the Northwest Mountain Region. There

are no changes to the boundaries,

altitudes, times of designation, or

activities conducted within the

restricted areas.

Since this action simply changes the

published controlling agency of the

affected restricted areas, and does not

involve a change in the dimensions or

operating requirements of the restricted

areas, the FAA finds that notice and

public procedure under 5 U.S.C. 553(b)

are unnecessary. Section 73.64 of part

73 of the Federal Aviation Regulations

was republished in FAA Order 7400.8E,

dated November 7, 1997.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, it (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, 1997); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal.

Environmental Review

In accordance with FAA Order

1050.1D, ‘‘Polices and Procedures for

Considering Environmental Impacts,’’

this action is not subject to

environmental assessments and

procedures.

List of Subjects in 14 CFR Part 73

Airspace, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 73, as follows:

PART 73—SPECIAL USE AIRSPACE

1. The authority citation for part 73

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389

§ 73.64 [Amended]

2. § 73.64 is amended as follows:

* * * * *

R–6412A Camp Williams UT [Amended]

By removing ‘‘Controlling agency. FAA,

Salt Lake City Tower’’ and substituting the

following:

‘‘Controlling agency. FAA, Salt Lake City

TRACON.’’

R–6412B Camp Williams UT [Amended]

By removing ‘‘Controlling agency.

FAA, Salt Lake City Tower’’ and

substituting the following:

‘‘Controlling agency. FAA, Salt Lake City

TRACON.’’

* * * * *

Issued in Washington, DC, on December 2,

1997.

Reginald C. Matthews,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 97–32571 Filed 12–16–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

15 CFR Part 922

[Docket No. 960712192–6192–01]

RIN 0648–AD85

Florida Keys National Marine

Sanctuary Final Regulations

AGENCY: Sanctuaries and Reserves

Division (SRD), Office of Ocean and

Coastal Resource Management (OCRM),

National Ocean Service (NOS), National

Oceanic and Atmospheric

Administration (NOAA), Department of

Commerce (DOC).

ACTION: Correction to final regulations.

SUMMARY: This document contains a

correction to the final regulations which

were published Thursday, January 30,

1997 (62 FR 4578). The regulations

pertain to the Florida Keys National

Marine Sanctuary and made revisions to

the national marine sanctuary program

regulations at 15 CFR Part 922.

EFFECTIVE DATE: December 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Michael Weiss (301) 713–2969, ext. 216.

SUPPLEMENTARY INFORMATION: Final

regulations for the Florida Keys

National Marine Sanctuary were

published on Thursday, January 30,

1997 (62 FR 4578). These regulations

were subsequently amended on June 12,

1997 (62 FR 32154). The January 30,

1997 Federal Register document made

revisions to the national marine

sanctuary program regulations at 15 CFR

Part 922. The January 30, 1997 Federal

Register document that is the subject of

this correction contains amendatory

language for § 922.48(b) of the national

marine sanctuary program regulations,

which pertains to national marine

sanctuary permits. The amendatory

instruction for paragraph (b) of section

922.48 was incorrect by failing to state

that only the introductory language to

paragraph (b) was amended, thus

leaving the remaining subparagraphs to

paragraph (b) unchanged. Left

uncorrected, the amendatory language

would erroneously result in

subparagraphs (1) through (5) of

paragraph 922.48(b) being deleted from

the Code of Federal Regulations.

Correction of Publication

Accordingly, the Federal Register

document published on January 30,

1997 (62 FR 4578) is corrected by

revising amendatory instruction 14 on

page 4607, third column, to read as

follows:

‘‘14. Section 922.48 is amended by

revising paragraph (a) and the

introductory text of paragraph (b) as

follows:’’

Nancy Foster,

Assistant Administrator for Ocean Services

and Coastal Zone Management.

[FR Doc. 97–32857 Filed 12–16–97; 8:45 am]

BILLING CODE 3510–12–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 95P–0136]

Medical Devices; Reclassification of

Tumor-Associated Antigen

Immunological Test Systems

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is codifying the reclassification of

tumor-associated antigen

immunological test systems intended as

an aid in monitoring patients for disease

progression or response to therapy or for

the detection of recurrent or residual

disease from class III (premarket

approval) to class II (special controls).

FDA is also announcing that it has

issued an order in the form of a letter

to Centocor, Inc., reclassifying serum

tumor markers into class II. This action

is being taken under the Federal Food,

Drug, and Cosmetic Act (the act), as

amended by the Medical Device

Amendments of 1976 and the Safe

Medical Devices Act of 1990.

EFFECTIVE DATES: The reclassification

was effective September 19, 1996. The

codification becomes effective

December 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices