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