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