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

67011

Vol. 62, No. 246

Tuesday, December 23, 1997

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 801, 803, 804, 806, 807,

810, 820, 821, 1002, and 1020

[Docket No. 97N–0477]

RIN 0910–ZA09

Medical Devices; Refurbishers,

Rebuilders, Reconditioners, Servicers,

and ‘‘As Is’’ Remarketers of Medical

Devices; Review and Revision of

Compliance Policy Guides and

Regulatory Requirements; Request for

Comments and Information

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

intention to review and, as necessary, to

revise or to amend its compliance policy

guides and regulatory requirements

relating to the remarketing of used

medical devices and the persons who

refurbish, recondition, rebuild, service,

or remarket such devices. The agency is

considering these actions because it

believes evolving industry practices

warrant reevaluation of current policy

and the application of certain regulatory

requirements in order to ensure that

particular remarketed devices meet

suitable performance requirements for

their intended uses, and are as safe as

the originally marketed finished device.

FDA is soliciting comments, proposals

for alternative regulatory approaches,

and information on these issues. In a

future issue of the Federal Register,

FDA will announce an open meeting of

the Good Manufacturing Practices

(GMP) Advisory Committee concerning

these matters.

DATES: Written comments by March 23,

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:

Casper E. Uldriks, Center for Devices

and Radiological Health (HFZ–300),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–4692.

SUPPLEMENTARY INFORMATION:

I. Background

Medical device marketing has always

involved a certain amount of

remarketing of used medical devices

that were refurbished, rebuilt, serviced,

reconditioned, cosmetically enhanced

or marketed ‘‘as is’’ for further use.

Under regulations issued by FDA for

medical devices, including radiation

emitting electronic products, at parts

801, 803, 804, 806, 807, 810, 820, 821,

1002, and 1020 (21 CFR parts 801, 803,

804, 806, 807, 810, 820, 821, 1002, and

1020), most such processing of used

devices falls within the definition of

manufacturing or is identified among

activities performed by manufacturers,

thereby subjecting remarketers to the

same regulatory requirements as other

manufacturers. These requirements

include: labeling (part 801); medical

device reporting (parts 803 and 804);

corrections and removals (part 806);

registration, listing and premarket

notification (part 807); physician,

patient notification and recall remedies

(part 810); current good manufacturing

practices (part 820); device tracking

(part 821); and for electronic devices,

electronic product reports (part 1002);

and electronic product performance

standards (part 1020).

Remarketing used devices may consist

of activities that significantly change the

finished device’s performance or safety

specifications, or intended use. These

types of activities constitute

‘‘remanufacturing’’ as defined in the

Quality System regulation (QS) (also

known as the current good

manufacturing practice (CGMP)

regulation) (§ 820.3(w)). Remarketing

used devices can also consist of

activities that do not significantly

change the finished device’s

performance or safety specifications, or

intended use. These activities may

consist of refurbishing, reconditioning,

rebuilding, servicing the device, or

merely selling the device ‘‘as is.’’

Current guidance, discussed further in

section II of this document, describes

whom FDA considers a reconditioner or

rebuilder of a device. FDA has not

issued regulations or guidance defining

what activities are considered

‘‘servicing’’ or ‘‘refurbishing.’’

II. Current Compliance Policy Guides

Relating to Remarketers Who Are

Considered Reconditioners, Rebuilders,

and X-Ray Tube Reloaders

FDA has issued two compliance

policy guides (CPG’s) that relate to

persons who remarket devices, but do

not change the finished device’s

intended use. On November 1, 1981,

FDA issued CPG 7133.20, which set

forth the agency’s position that

‘‘adequate enforcement can be

effectively accomplished’’ by

considering reloaders of x-ray tube

housing assemblies to be assemblers of

x-ray components if a reloaded x-ray

tube housing assembly is the only

finished device produced by the firms.

This CPG further stated reloaders must

retain complaint files, injury reports,

and failure analysis records that must be

available for inspection by the agency.

FDA has exercised its enforcement

discretion with respect to establishment

registration and device listing

requirements under section 510 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360) for such firms.

On December 29, 1987, FDA issued

CPG 7124.28 to address the application

of certain requirements of the act and its

implementing regulations to firms that

acquire and process used devices for

remarketing purposes. The agency

identified the reconditioner/rebuilder of

a medical device as ‘‘a person or firm

that acquires ownership of used medical

devices and restores and/or refurbishes

these (devices) to the device

manufacturer’s original or current

specifications, or new specifications, for

purposes of resale or commercial

distribution.’’

In CPG 7124.28, the agency stated that

reconditioners/rebuilders of medical

devices must comply with: The

registration, and premarket notification

requirements of the act (section 510)

and implementing regulatory

requirements (part 807); the labeling

requirements of the act (section 502)

and applicable regulatory requirements

(part 801); the CGMP requirements of

the act (section 520) and implementing

regulatory requirements (part 820); and,

the medical device reporting
67012 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Proposed Rules

requirements of the act (section 519)

and implementing regulatory

requirements (part 803). FDA intends to

revise this CPG based on FDA’s

experience in this area and the

comments received to this advance

notice of proposed rulemaking (ANPR).

III. Reasons for Review

In the Federal Register of October 7,

1996 (61 FR 52602), FDA issued a

revised QS regulation which set forth

CGMP requirements for medical devices

(part 820). The preamble of the October

7, 1996, QS regulation acknowledged

that:

[CPG] 7124.28 contains the agency’s policy

regarding the provisions of the act and

regulations with which persons who

recondition or rebuild used devices are

expected to comply. This CPG is in the

process of being revised in light of FDA’s

experience in this area. FDA is not including

the terms ‘‘servicer’’ or ‘‘refurbisher,’’ as they

relate to entities outside the control of the

original equipment manufacturer, in this

[QS] final regulation, even though it believes

that persons who perform such functions

meet the definition of manufacturer.

(61 FR 52602 at 52610)

FDA further advised that, ‘‘[b]ecause of

a number of competitive and other

issues, including sharply divided views

among members the GMP Advisory

Committee at the September 1995

meeting, FDA has elected to address

application of the GMP requirements to

persons who perform servicing and

refurbishing functions outside the

control of the original manufacturer in

a separate rulemaking later this year’’ Id.

In addition to the concerns raised in

the QS/CGMP rulemaking process

relating to the applicability of CGMP’s

to remarketers, issues have been raised

relating to the applicability of other

regulatory requirements to remarketers.

In response to these concerns, FDA has

attempted to learn more about the

concerns relating to remarketers. In

1994, FDA began discussing issues

related to remarketers with the

International Association of Medical

Equipment Remarketers (IAMER).

Beginning in 1994 and continuing

through IAMER’s April 10 to 12, 1997,

meeting, representatives of the FDA’s

Center for Devices and Radiological

Health have attended, and on occasion

made presentations at, various meetings

and conferences of IAMER membership

firms.

Through exchanges at these meetings

and correspondence with IAMER’s

Regulatory Affairs Committee, FDA has

preliminarily noted that rising costs and

health care expenses have apparently

contributed to expanded sales of a

growing variety of remarketed devices.

Much of this activity is occurring

outside the control of the original

equipment manufacturer. FDA also

tentatively concluded that a significant

number of firms that have been

refurbishing or otherwise remarketing

electronic radiation emitting medical

devices are unaware of FDA’s

compliance policy, and the applicable

regulations and statutory requirements,

such as the filing of initial and other

reports under parts 1002 and 1020, with

respect to their activities.

IV. Proposed Definitions of

Remarketing Activities That Constitute

Refurbishing, ‘‘As Is’’ Remarketing, and

Servicing

As stated in section II of this

document, FDA has issued guidance,

which is being considered for revision,

that describes who FDA considers to be

‘‘reconditioners’’ and ‘‘rebuilders.’’ FDA

has not issued regulations or guidance

defining what persons are considered to

be ‘‘refurbishers,’’ ‘‘as is’’ remarketers,

or ‘‘servicers.’’ These terms have been

difficult to define and at times have

been used interchangeably. Compliance

Policy Guide 7124.28 states only that

FDA considers rebuilders or

reconditioners to be persons who have

acquired ownership of the devices and

conduct refurbishing activities.

FDA is soliciting comments on

whether to propose definitions, as

described in the following three

paragraphs, of types of remarketers,

either in guidance or in a regulation,

that may or may not relate to the

ownership of the devices. Accordingly,

FDA is soliciting comments on whether

it should propose by regulation, or issue

by guidance, the following definitions

or a variation of these definitions to

describe remarketing activities that do

not significantly change a finished

device’s performance or safety

specifications or intended use.

Refurbishers: persons who, for the

purpose of resale or redistribution,

visually inspect, functionally test and

service devices, as may be required, to

demonstrate that the device is in good

repair and performing all the functions

for which it is designed. The device may

or may not be cosmetically enhanced.

Preventive maintenance procedures may

or may not be performed. Refurbishers

do not significantly change a finished

device’s performance or safety

specifications, or intended use.

‘‘As Is’’ Remarketers: for the purpose

of resale or redistribution, the

operational condition of the device is

unknown. The extent to which the

device meets the operational

requirements must be determined by the

user prior to patient exposure. The

device may or may not be cosmetically

enhanced. ‘‘As Is’’ remarketers do not

change a finished device’s performance

or safety specifications, or intended use.

Servicers: persons who repair a device

to return it to the manufacturer’s fitness

for use specifications, and perform the

manufacturer’s recommended

scheduled preventive maintenance.

Servicers do not significantly change a

finished device’s performance or safety

specifications, or intended use.

FDA believes that these definitions

encompass activities that do not

significantly change the finished

device’s performance or safety

specifications or intended use.

V. Revisions Under Consideration

In light of evolving industry practices,

and the concerns raised by the GMP

Advisory Committee, industry, and

others described previously, FDA is

reevaluating the application of various

regulatory controls to remarketers who

do not significantly change a finished

device’s performance or safety

specifications, or intended use, and is

reassessing the degree of regulatory

control necessary to ensure the

protection of the public health. FDA

intends to evaluate the current

regulatory approach with respect to

remarketers who are refurbishers, ‘‘as

is’’ remarketers, and servicers, as

defined in this document, and is

soliciting comments on whether FDA

should retain the current regulatory

approach, or whether the agency should

use alternative approaches to regulate

these types of remarketers.

The agency believes that any

regulatory approach for these types of

remarketers should, at a minimum,

include compliance with requirements

concerning: Representations of quality

under section 501(c) of the act (21

U.S.C. 351(c)); false or misleading

labeling under section 502 of the act (21

U.S.C. 352), and part 801; notification

and recall provisions under section 518

of the act (21 U.S.C. 360h), and part 810;

corrections and removal reporting

requirements under section 519(f) of the

act (21 U.S.C. 360i(f)), and part 806;

medical device reporting under section

519(a) of the act, and parts 803 and 804;

tracking requirements under section

519(e) of the act, and part 821; and

radiological health requirements under

sections 532 through 542 of the act (21

U.S.C. 360ii through 360ss), including

records and initial reporting

requirements under part 1002, and

standard requirements under part 1020.

Accordingly, FDA requests

information on the following issues

relating to remarketing activities that do

not significantly change the finished
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