Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Proposed Rules 67013

device’s performance or safety

specifications or intended uses. (1) Has FDA appropriately defined the

terms, ‘‘refurbisher,’’ ‘‘as is’’

remarketers, and ‘‘servicers’’? If not,

what changes to these definitions

should be made?

(2) What evidence exists regarding

actual problems with the safety and/or

performance of remarketed devices that

are the result of the remarketing?

Specific examples should be submitted. (3) What is the appropriate level of

regulatory controls that should be

applied to persons who remarket

devices?

(4) Should refurbishers, ‘‘as is’’

remarketers, and servicers be subject to

the same or different regulatory

requirements? In addition, FDA is specifically

considering whether to propose

rulemaking regarding modified

registration, listing, and CGMP

requirements for these types of

remarketers, or whether to make some

or all of the these three controls

voluntary. For example, the agency

could propose that refurbishers and/or

servicers be required to register and list

with FDA (part 807), and comply with

certain CGMP requirements, such as

quality system requirements (part 820,

subpart B), production and process

controls (part 820, subpart G),

acceptance activities (part 820, subpart

H), corrective and preventive action

(part 820, subpart J), labeling and

packaging control ( part 820, subpart K),

and records (part 820, subpart M).

Alternatively, the agency could propose

that refurbishers and/or servicers be

required to register and list, but comply

only with CGMP requirements for

maintaining complaint files

(§ 820.198(a)) and conducting failure

analyses (§ 820.198(b) and (c)). In

making comments relating to the

regulatory approaches, comments

should indicate whether their comments

relate to refurbishers, ‘‘as is’’

remarketers, and/or servicers, as

described in section IV of this

document. Other regulatory approaches

may be proposed by the agency or by

the comments which, if implemented,

would require the issuance of new

guidance documents, or consist of

changes to current regulations or

changes to existing guidances CPG

7124.28 and CPG 7133.20.

VI. Comments

The agency will consider any

comments submitted in response to this

ANPR, or comments relating to the

reevaluation of agency guidances,

including CPG’s 7124.28 and 7133.20.

FDA will consider the record of any

public meetings or any advisory

committee meetings, along with

comments, proposals and other

information received, when deciding

whether to issue or revise agency

guidance or modify any existing

regulations. Interested persons may, on or before

March 23, 1998 submit to Dockets

Management Branch (address above)

written comments regarding this ANPR.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

FDA does not anticipate granting

requests for extension to this 90-day

comment period.

Dated: December 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33372 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 52

[PS–158–86]

RIN 1545–AJ23

Petroleum Tax Imposed on Natural

Gasoline

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Withdrawal of notice of

proposed rulemaking.

SUMMARY: This document withdraws a

proposed regulation relating to the

petroleum tax imposed on natural

gasoline. The withdrawal affects

persons that produce natural gasoline at

fractionation facilities or receive natural

gasoline produced at those facilities.

FOR FURTHER INFORMATION CONTACT:

Ruth Hoffman, (202) 622–3130 (not a

toll-free number).

SUPPLEMENTARY INFORMATION:

Background

Section 4611 imposed a tax on crude

oil (including natural gasoline) received

at a United States refinery. On April 26,

1993, a notice of proposed rulemaking

(PS–158–86) relating to this tax was

published in the Federal Register (58

FR 21963). The proposed regulation

treats any facility that produces natural

gasoline by fractionation or similar

operation as a United States refinery.

Under this rule, tax would be imposed

on natural gasoline when it is produced

from natural gas liquids at a

fractionation facility.

Since the publication of the proposed

regulation, the tax imposed by section

4611 has expired. Because tax is not

currently imposed under section 4611,

the proposed regulation is being

withdrawn. For purposes of section

4611 prior to its expiration, the IRS will

follow the result in Enron Gas

Processing Co. v. United States, 96–1

USTC ¶ 70,058 (S.D. Tex. 1996), in all

cases involving substantially similar

facts. In Enron, the U.S. District Court

for the Southern District of Texas held

that fractionation facilities are not

United States refineries.

List of Subjects in 26 CFR Part 52

Chemicals, Excise taxes, Reporting

and recordkeeping requirements.

Withdrawal of Notice of Proposed

Rulemaking

Accordingly, under the authority of

26 U.S.C. 7805, the notice of proposed

rulemaking that was published in the

Federal Register on April 26, 1993 (58

FR 21963) is withdrawn.

Michael P. Dolan,

Deputy Commissioner of Internal Revenue.

[FR Doc. 97–33250 Filed 12–22–97; 8:45 am]

BILLING CODE 4830–01–U

DEPARTMENT OF LABOR

Mine Safety and Health Administration

30 CFR Parts 56, 57, 62, 70, and 71

RIN AA53

Health Standards for Occupational

Noise Exposure in Coal, Metal and

Nonmetal Mines

AGENCY: Mine Safety and Health

Administration (MSHA), Labor.

ACTION: Proposed rule; availability;

request for comments.

SUMMARY: On December 16, 1997,

MSHA published a notice in the Federal

Register (62 FR 65777) announcing the

availability of a report from the National

Institute for Occupational Safety and

Health (NIOSH) entitled ‘‘Prevalence of

Hearing Loss For Noise-Exposed Metal/

Nonmetal Miners.’’ The Agency further

stated its intent to supplement the

rulemaking record with this report and

to make it available to interested parties

upon request.

MSHA received several requests from

the mining community that they be

provided an opportunity to comment on