Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Proposed Rules 39789

50The Commission anticipates that a foreign

board of trade that currently is trading its products

through computer terminals in the U.S. would be

required to comply with any new rules eventually

adopted by the Commission, but would be provided

a transition period in which to come into

compliance.

case, each foreign board of trade whose

products would be made available

through U.S.-located computer

terminals would be required to comply

with any requirements adopted by the

Commission in its order. For example,

if two or more foreign boards of trade

share the same computer terminal

platform and each wished to place

computer terminals in the U.S. for the

use of its members (or members’

affiliates), each would be required to

receive an order from the Commission

and comply with the requirements in

that order under the approach described

above. The Division’s approach would

also arguably apply to a foreign board of

trade which trades through terminals

shared with a U.S. exchange that has

been designated as a U.S. contract

market.50 The Commission requests

comment as to whether different

requirements should apply to a foreign

board of trade’s products which are

traded on the computer terminals of a

U.S. contract market. If so, how should

such requirements differ and why?

III. Conclusion

The Commission believes that it is

appropriate to develop rules concerning

placement of foreign board of trade

terminals in the U.S. in light of the

growing interest among foreign boards

of trade to do so. The Commission

hopes to develop an approach to

address these issues that will provide

certainty to foreign exchanges that wish

to place their computer terminals in the

U.S. for trading purposes and will be

consistent with the Commission’s

obligations under the Act to maintain

the integrity and competitiveness of the

U.S. markets and to provide protection

to U.S. customers. To this end, the

Commission requests public comment

on the issues and the Division’s

approach, as discussed above.

Issued in Washington, D.C. on July 17,

1998 by the Commission.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 98–19723 Filed 7–23–98; 8:45 am]

BILLING CODE 6351–01–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: Withdrawal of proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is withdrawing a proposed rule

that published in the Federal Register of

December 12, 1997 (62 FR 65384),

relating to medical device preemption of

State product liability claims. FDA is

making this withdrawal because of

concerns that have been raised

regarding the interplay between the

FDA Modernization Act of 1997

(FDAMA) and the proposed rule.

DATES: The proposed rule is withdrawn

July 24, 1998.

ADDRESSES: Copies of the draft proposed

rule and its comments may be obtained

from the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

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: Section

521 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360k)

contains an express preemption

provision applicable to medical devices

regulated by FDA. The Supreme Court

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 for

devices marketed pursuant to a

premarket clearance issued under

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

360(k)). 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 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 of the

act is entitled to substantial weight, the

agency issued the proposed rule in the

Federal Register of December 12, 1997

(62 FR 65384), addressing the

circumstances under which section 521

of the act preempts State common law

tort claims based on injury from

allegedly defective medical devices. The

proposal is consistent with the position

that the agency has historically taken on

issues related to device preemption. The

comment period on this proposed rule

was open until February 10, 1998. The

agency received 41 comments from a

variety of associations, law firms, and

individuals representing industry and

consumer interests.

FDA has decided to withdraw the

rulemaking to amend its regulations

regarding preemption of State and local

requirements applicable to medical

devices. FDA is taking this action

because, even though the proposed rule

was issued after the enactment of

FDAMA, it was conceptualized and

written prior to enactment.

Concerns have been raised by

industry and congressional

representatives that the agency did not

share its thinking on its interpretation of

section 521 of the act during FDAMA

deliberations, even though an early draft

of the proposed rule was shared during

the spring of 1997 with attorneys for

Public Citizen Litigation Group, who

represented Lohr in the Lohr case. The

remedy under FDA’s regulations for

disclosure of a draft regulation is

ordinarily to issue a notice in the

Federal Register making the draft

publicly available. See 21 CFR

10.80(b)(2). Such a contemporaneous

notice was not, however, provided in

this case.

Because of the great policy

significance of these preemption issues,

the concern that Congress was not aware

of the agency’s thinking during FDAMA

deliberations, and the potential

interplay between the FDAMA device

provisions and device preemption, the

agency believes that it is imperative for

all interested parties to have confidence

that the agency is addressing their

concerns in an impartial manner.

Therefore, the agency is taking the

unusual step of withdrawing the

proposed rule.

The early draft of the proposed rule

that was disclosed, the comments on it,

and the correspondence raising
39790 Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Proposed Rules

concerns about the disclosure are being

placed in the Dockets Management

Branch (address above) and can be

identified with the docket number

found in brackets in the heading of the

document.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19916 Filed 7–21–98; 5:07 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 948

[WV–077–FOR]

West Virginia Permanent Regulatory

Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; reopening of

public comment period and opportunity

for a public hearing.

SUMMARY: OSM is reopening the public

comment period on certain parts of a

proposed amendment to the West

Virginia permanent regulatory program

(hereinafter referred to as the West

Virginia program) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). The amendment was

submitted on April 28, 1997 (with

revisions submitted on May 14, 1997)

and amends both the West Virginia

Surface Mining Reclamation

Regulations and the West Virginia

Surface Mining Code. The comment

period is being reopened specifically on

the amendments to the definition of

surface mining, special authorizations,

fish and wildlife as a postmining land

use for mountaintop removal

operations, removal of abandoned coal

refuse piles, remining, and no-cost

reclamation. The amendments are

intended to revise the State program to

be consistent with the counterpart

Federal provisions and to improve the

effectiveness of the West Virginia

program.

DATES: Written comments must be

received on or before 4:00 p.m. on

August 24, 1998. If requested, a public

hearing on the proposed amendments

will be held at 1:00 p.m. on August 18,

1998. Requests to present oral testimony

at the hearing must be received on or

before 4:00 p.m. on August 10, 1998.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to Mr.

Roger W. Calhoun, Director, Charleston

Field Office at the address listed below.

Copies of the West Virginia program,

the program amendments, and the

administrative record on the West

Virginia program are available for public

review and copying at the addresses

below, during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed changes

by contacting the OSM Charleston Field

Office.

Mr. Roger W. Calhoun, Director,

Charleston Field Office, Office of

Surface Mining Reclamation and

Enforcement, 1027 Virginia Street,

East, Charleston, West Virginia 25301

Telephone: (304) 347–7158.

West Virginia Division of

Environmental Protection, 10

McJunkin Road, Nitro, West Virginia

25143, Telephone: (304) 759–0515

In addition, copies of the amendments

that are the subject of this notice are

available for inspection during regular

business hours at the following

locations:

Office of Surface Mining Reclamation

and Enforcement, Morgantown Area

Office, 75 High Street, Room 229, P.O.

Box 886, Morgantown, West Virginia

26507, Telephone: (304) 291–4004

Office of Surface Mining Reclamation

and Enforcement, Beckley Area

Office, 323 Harper Park Drive, Suite 3,

Beckley, West Virginia 25801,

Telephone: (304) 255–5265

FOR FURTHER INFORMATION CONTACT: Mr.

Roger W. Calhoun, Director, Charleston

Field Office; Telephone: (304) 347–

7158.

SUPPLEMENTARY INFORMATION:

I. Background on the West Virginia

Program

On January 21, 1981, the Secretary of

the Interior conditionally approved the

West Virginia program. Background

information on the West Virginia

program, including the Secretary’s

findings, the disposition of comments,

and the conditions of the approval can

be found in the January 21, 1981,

Federal Register (46 FR 5915–5956).

Subsequent actions concerning the West

Virginia program and previous

amendments are codified at 30 CFR

948.10, 948.12, 948.13, 048.15, and

948.16.

II. Discussion of the Proposed

Amendment

By letter dated April 28, 1997

(Administrative Record Number WV–

1056), the West Virginia Division of

Environmental Protection (WVDEP)

submitted an amendment to its

approved permanent regulatory program

pursuant to 30 CFR 732.17. Some

revisions of the original amendments

were submitted by letter dated May 14,

1997 (Administrative Record Number

WV–1057). The amendment revises the

West Virginia Surface Mining

Reclamation Regulations (CSR Section

38–2 et seq.), and Sec. 22–3 of the West

Virginia Surface Mining Code. The

amendment concerns changes to

implement the standards of the Federal

Energy Policy Act of 1992, and other

changes desired by the State.

During OSM’s review of the proposed

amendments the State submitted a new

amendment to its Surface Mining

Reclamation Regulations at CSR 38–2 by

letter dated may 11, 1998

(Administrative Record Number WV

1086). The public comment period on

the new amendment is open until July

15, 1998 (63 FR 32632; June 15, 1998).

Certain of the proposed regulations in

the new amendment are intended to

implement some of the statutes which

OSM is reviewing under the current

amendment. Therefore, OSM is

reopening the public comment period

on the specific statutes identified below

for which the State has recently

submitted a new amendment containing

implementing regulations. In addition,

OSM received a request from a

commenter that the public comment

period be reopened on the proposed

amendments at Section 22–3–13(c)(3)

concerning the proposed addition of

fish and wildlife habitat and recreation

lands as an approvable postmining land

use for mountaintop removal

operations.

The Director is reopening the public

comment period on the following

Sections:

22–3–3(u) concerning the definition

of ‘‘surface mine,’’ ‘‘surface mining’’ or

‘‘surface mining operations;’’

22–3–3(y) concerning the definition of

‘‘lands eligible for remining;’’

22–3–13(b)(20) concerning the

revegetation responsibility period for

lands eligible for remining;

22–3–13(c) concerning the proposed

addition of fish and wildlife habitat and

recreation lands as an approvable

postmining land use for mountaintop

removal operations; and

22–3–28 concerning special

authorization for reclamation of existing

abandoned coal processing waste piles;

coal extraction pursuant to a

government financed reclamation

contract; coal extraction as an incidental

part of development of land for

commercial, residential, industrial, or

civic uses; and no cost reclamation

contracts.