This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

65383

Vol. 62, No. 239

Friday, December 12, 1997

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 97–AAL–10]

Proposed Realignment of Colored

Federal Airway A–1; AK

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice proposes to

modify a Colored Federal Airway,

Amber-1 (A–1), between Campbell Lake

Nondirectional Radar Beacon (NDB) and

Takotna River NDB, AK, due to the

decommissioning of the Puntilla Lake

and Farewell Lake NDB’s and their

subsequent removal from the National

Airspace System (NAS).

DATES: Comments must be received on

or before January 30, 1998.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager, Air

Traffic Division, AAL–500, Docket No.

97–AAL–10, Federal Aviation

Administration, 222 West 7th Avenue,

#14, Anchorage, AK 99533.

The official docket may be examined

in the Rules Docket, Office of the Chief

Counsel, Room 916G, 800 Independence

Avenue, SW., Washington, DC,

weekdays, except Federal holidays,

between 8:30 a.m. and 5:00 p.m.

An informal docket may also be

examined during normal business hours

at the office of the Regional Air Traffic

Division.

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) 267–8783.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views,

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket number and be

submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 97–

AAL–10.’’ The postcard will be date/

time stamped and returned to the

commenter. All communications

received on or before the specified

closing date for comments will be

considered before taking action on the

proposed rule. The proposal contained

in this notice may be changed in light

of comments received. All comments

submitted will be available for

examination in the Rules Docket both

before and after the closing date for

comments. A report summarizing each

substantive public contact with FAA

personnel concerned with this

rulemaking will be filed in the docket.

Availability of NPRM’s

Any person may obtain a copy of this

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the Federal

Aviation Administration, Office of Air

Traffic Airspace Management,

Attention: Airspace and Rules Division,

ATA–400, 800 Independence Avenue,

SW., Washington, DC 20591, or by

calling (202) 267–8783.

Communications must identify the

notice number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRM’s should also

request a copy of Advisory Circular No.

11–2A, which describes the application

procedure.

The Proposal

The FAA is proposing an amendment

to 14 CFR part 71 to realign A–1 by

providing a direct route between

Campbell Lake, AK, NDB and Takotna

River, AK, NDB due to the

decommissioning of the Puntilla Lake

and Farewell Lake NDBs and their

subsequent removal from the NAS.

Colored Federal airways are published

in paragraph 6009 of FAA Order

7400.9E, dated September 10, 1997, and

effective September 16, 1997, which is

incorporated by reference in 14 CFR

71.1. The Colored Federal airway listed

in this document would be published

subsequently in the Order.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current.

Therefore, this regulation: (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)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule, when

promulgated, will not have a significant

economic impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for 14 CFR

part 71 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.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:
65384 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Proposed Rules

Paragraph 6009(c)—Amber Federal Airways

A–1 [Revised]

From Sandspit, BC, Canada, NDB 96 miles 12

AGL, 102 miles 35 MSL, 57 miles 12

AGL, via Sitka, AK, NDB; 31 miles 12

AGL, 50 miles 47 MSL, 88 miles 20 MSL,

40 miles 12 AGL, Ocean Cape, AK, NDB;

INT Ocean Cape NDB 283° and

Hinchinbrook, AK, NDB 106° bearings;

Hinchinbrook NDB; INT Hinchinbrook

NDB 286° and Campbell Lake, AK, NDB

123° bearings; Campbell Lake NDB;

Takotna River, AK, NDB; 24 miles 12

AGL, 53 miles 55 MSL; 51 miles 40 MSL,

25 miles 12 AGL, North River, AK, NDB;

17 miles 12 AGL, 89 miles 25 MSL, 17

miles 12 AGL, to Fort Davis, AK, NDB.

That airspace within Canada is excluded.

* * * * *

Issued in Washington, DC, on December 2,

1997.

Reginald C. Matthews,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 97–32569 Filed 12–11–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

15 CFR Part 960

[Docket No. 951031259–7103–02]

Licensing of Private Land RemoteSensing Space Systems

AGENCY: National Oceanic and

Atmospheric Administration,

Department of Commerce.

ACTION: Notice; extension of public

comment period.

SUMMARY: Pursuant to public request,

the National Oceanic and Atmospheric

Administration (NOAA) is extending by

90 days its public comment period for

the Notice of Proposed Rulemaking

concerning the licensing of private land

remote-sensing space systems,

published on November 3, 1997, 62 FR

59317.

DATES: Comments must be received by

April 2, 1998.

ADDRESSES: Comments should be sent

to, Charles Wooldridge, NOAA,

National Environmental Satellite, Data,

and Information Service, 1315 East-West

Highway Room 3620 Silver Spring, MD

20910–3282.

FOR FURTHER INFORMATION CONTACT:

Charles Wooldridge at (301) 713–2024

ext. 107 or Kira Alvarez, NOAA, Office

of General Counsel at (301) 713–1217.

SUPPLEMENTARY INFORMATION: On

November 3, 1997, NOAA published a

Notice of Proposed Rulemaking (62 FR

59317) proposing regulations revising

its regime for the licensing of private

Earth remote-sensing space systems

under Title II of the Land Remote

Sensing Policy Act of 1992, 15 U.S.C.

5601 et seq. (1992 Act). These proposed

regulations implement the licensing

provisions of the 1992 Act and the

Presidential Policy announced March

10, 1994. In response to numerous

written comments, NOAA is extending

the original 60 day public comment

period by 90 days. As a result,

comments on the notice of proposed

rulemaking must now be received by

April 2, 1998.

Dated: December 5, 1997.

Gregory W. Withee,

Deputy Assistant Administrator for Satellite

and Information Services.

[FR Doc. 97–32472 Filed 12–11–97; 8:45 am]

BILLING CODE 3510–12–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 97N–0222]

Medical Devices; Preemption of State

Product Liability Claims

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations regarding

preemption of State and local

requirements applicable to medical

devices. This action is being taken to

clarify and codify the agency’s

longstanding position that available

legal remedies, including State common

law tort claims, generally are not

preempted under the Federal Food,

Drug, and Cosmetic Act (the act).

DATES: Written comments by February

10, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ–215),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Introduction

Section 521 of the act (21 U.S.C. 360k)

contains an express preemption

provision applicable to medical devices

regulated by FDA. The Supreme Court

recently addressed whether section 521

of the act preempts State common law

tort claims arising from allegedly

defective medical devices. (See

Medtronic, Inc. v. Lohr (Lohr), 116 S. Ct.

2240 (1996).) The Court concluded that

section 521 of the act did not supplant

the State law duties at issue in that case.

In reaching that conclusion, the Court

noted that FDA has provided

interpretive guidance with respect to

section 521 of the act’s preemptive

effect. (See id. at 2255–2256 (citing 21

CFR 808.1(d)(2) and 808.5(b)(1)(i)

(1995)).) The Court gave ‘‘substantial

weight to the agency’s view of the

statute’’ (Id. at 2256). (See also id. at

2257; id. at 2260–2261 (Breyer, J.,

concurring in part and concurring in the

judgment).)

The Court’s decision in Lohr

construed section 521 of the act in the

context of a medical device that FDA

had cleared for distribution under

section 510(k) of the act (21 U.S.C.

360k), which requires premarket

notification for certain types of medical

devices. The Court did not definitively

decide whether section 521 of the act

may preempt State law claims in other

circumstances. Since Lohr was decided,

the lower courts have interpreted

section 521 of the act inconsistently and

have reached conflicting conclusions

with respect to whether section 521 of

the act preempts State law claims for

injuries allegedly resulting from medical

devices that have received premarket

approval under section 515 of the act

(21 U.S.C. 360e), or have received an

investigational device exemption (IDE)

under section 520(g) of the act (21

U.S.C. 360j(g)).

In light of the confusion among the

lower courts in interpreting section 521

of the act since Lohr, and in accordance

with the Supreme Court’s recognition

that FDA’s interpretation of the

preemptive effect of section 521 is

entitled to substantial weight, the

agency is issuing this proposed

interpretive rule, which addresses the

circumstances in which section 521 of

the act preempts State common tort

claims based on injury from allegedly

defective medical devices.

II. Background

Congress enacted the Medical Device

Amendments of 1976 (the amendments)

(21 U.S.C. 360c et seq.), ‘‘to provide for

the safety and effectiveness of medical

devices intended for human use.’’ It