Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26129

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.

List of Subjects

21 CFR Part 430

Administrative practice and

procedure, Antibiotics.

21 CFR Part 431

Administrative practice and

procedure, Antibiotics, Confidential

business information, Reporting and

recordkeeping requirements.

21 CFR Part 432

Antibiotics, Labeling, Packaging and

containers.

21 CFR Part 433

Antibiotics, Labeling, Reporting and

recordkeeping requirements.

21 CFR Parts 436, 440, 441, 442, 443,

444, 446, 448, 449, 450, 452, 453, 455,

and 460

Antibiotics.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Food and

Drug Administration Modernization

Act, and under authority delegated to

the Commissioner of Food and Drugs, it

is proposed that 21 CFR chapter I be

amended as follows:

PART 430—ANTIBIOTIC DRUGS;

GENERAL

1. Part 430 is removed.

PART 431—CERTIFICATION OF

ANTIBIOTIC DRUGS

2. Part 431 is removed.

PART 432—PACKAGING AND

LABELING OF ANTIBIOTIC DRUGS

3. Part 432 is removed.

PART 433—EXEMPTIONS FROM

ANTIBIOTIC CERTIFICATION AND

LABELING REQUIREMENTS

4. Part 433 is removed.

PART 436—TESTS AND METHODS OF

ASSAY OF ANTIBIOTIC AND

ANTIBIOTIC-CONTAINING DRUGS

5. Part 436 is removed.

PART 440—PENICILLIN ANTIBIOTIC

DRUGS

6. Part 440 is removed.

PART 441—PENEM ANTIBIOTIC

DRUGS

7. Part 441 is removed.

PART 442—CEPHA ANTIBIOTIC

DRUGS

8. Part 442 is removed.

PART 443—CARBACEPHEM

ANTIBIOTIC DRUGS

9. Part 443 is removed.

PART 444—OLIGOSACCHARIDE

ANTIBIOTIC DRUGS

10. Part 444 is removed.

PART 446—TETRACYCLINE

ANTIBIOTIC DRUGS

11. Part 446 is removed.

PART 448—PEPTIDE ANTIBIOTIC

DRUGS

12. Part 448 is removed.

PART 449—ANTIFUNGAL ANTIBIOTIC

DRUGS

13. Part 449 is removed.

PART 450—ANTITUMOR ANTIBIOTIC

DRUGS

14. Part 450 is removed.

PART 452—MACROLIDE ANTIBIOTIC

DRUGS

15. Part 452 is removed.

PART 453—LINCOMYCIN ANTIBIOTIC

DRUGS

16. Part 453 is removed.

PART 455—CERTAIN OTHER

ANTIBIOTIC DRUGS

17. Part 455 is removed.

PART 460—ANTIBIOTIC DRUGS

INTENDED FOR USE IN LABORATORY

DIAGNOSIS OF DISEASE

18. Part 460 is removed.

Dated: May 1, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12542 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N–0170]

Medical Device Reporting:

Manufacturer Reporting, Importer

Reporting, User Facility Reporting, and

Distributor Reporting; Companion

Document to Direct Final Rule

AGENCY: Food and Drug

Administration, HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend certain regulations governing

reporting by manufacturers, importers,

distributors, and health care (user)

facilities of adverse events related to

medical devices. This proposed rule is

a companion document to the direct

final rule, published elsewhere in this

issue of the Federal Register. The

amendments are intended to implement

provisions of the Federal Food, Drug,

and Cosmetic Act (the act) as amended

by the Food and Drug Administration

Modernization Act of 1997 (FDAMA).

FDA is publishing this companion

proposed rule under FDA’s usual

procedures for notice and comment to

provide a procedural framework to

finalize the rule in the event the agency

receives a significant adverse comment

and withdraws the direct final rule.

DATES: Submit written comments on or

before July 27, 1998. Submit written

comments on the information collection

requirements on or before July 13, 1998.

ADDRESSES: Submit written comments

on the proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Patricia A. Spitzig, Center for Devices

and Radiological Health (HFZ–500),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

594–2812.

SUPPLEMENTARY INFORMATION: This

proposed rule is a companion to the

direct final rule published in the final

rules section of this issue of the Federal

Register. This companion proposed rule

is substantively identical to the direct

final rule. This proposed rule will

provide a procedural framework to

finalize the rule in the event the agency

receives a significant adverse comment

and the direct final rule is withdrawn.

FDA is publishing the direct final rule
26130 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules

because the rule contains

noncontroversial changes, and FDA

anticipates that it will receive no

significant adverse comments. A

detailed discussion of this rule is set

forth in the preamble of the direct final

rule. If no significant comment is

received in response to the direct final

rule, no further action will be taken

related to this proposed rule. Instead,

FDA will publish a confirmation notice

within 30 days after the comment

period ends confirming that the direct

final rule will go into effect on

September 24, 1998. Additional

information about FDA’s direct final

rulemaking procedures is set forth in a

guidance published in the Federal

Register of November 21, 1997 (62 FR

62466).

If FDA receives a significant adverse

comment regarding this rule, the agency

will publish a document withdrawing

the direct final rule within 30 days after

the comment period ends and will

proceed to respond to the comments

under this rule using usual notice-andcomment procedures. The comment

period for this companion proposed rule

runs concurrently with the direct final

rule’s comment period. Any comments

received under this companion

proposed rule will also be considered as

comments regarding the direct final

rule. A significant adverse comment is

defined as a comment that explains why

the rule would be inappropriate,

including challenges to the rule’s

underlying premise or approach, or

would be ineffective or unacceptable

without a change. In determining

whether a significant adverse comment

is sufficient to terminate a direct final

rulemaking, FDA will consider whether

the comment raises an issue serious

enough to warrant a substantive

response in a notice-and-comment

process. Comments that are frivolous,

insubstantial, or outside the scope of the

rule will not be considered adverse

under this procedure. For example, a

comment recommending a rule change

in addition to the rule will not be

considered a significant adverse

comment, unless the comment states

why the rule would be ineffective

without the additional change. In

addition, if a significant adverse

comment applies to part of a rule and

that part can be severed from the

remainder of the rule, FDA may adopt

as final those parts of the rule that are

not the subject of a significant adverse

comment.

This action is part of FDA’s

continuing effort to achieve the

objectives of the President’s

‘‘Reinventing Government’’ initiative,

and is intended to reduce the burden of

unnecessary regulations on medical

devices without diminishing the

protection of public health.

I. Background

Under the act and the Medical Device

Amendments of 1976 (Pub. L. 94–295)

(the 1976 amendments), FDA issued

medical device reporting regulations for

manufacturers on September 14, 1984

(49 FR 36326). To correct weaknesses

noted in the 1976 amendments, and to

better protect the public health by

increasing reports of device-related

adverse events, Congress enacted the

Safe Medical Devices Act of 1990 (Pub.

L. 101–629) that required medical

device user facilities and distributors to

report certain device-related adverse

events.

Distributor reporting requirements

became effective on May 28, 1992,

following the November 26, 1991,

publication of those provisions in a

tentative final rule (56 FR 60024). In the

Federal Register of September 1, 1993

(58 FR 46514), FDA published a notice

announcing that the proposed

distributor reporting regulations had

become final by operation of law and

were now codified in part 804 (21 CFR

part 804).

On June 16, 1992, the President

signed into law the Medical Device

Amendments of 1992 (the 1992

amendments) (Pub. L. 102–112)

amending certain provisions of section

519 of the act (21 U.S.C. 360i) relating

to reporting of adverse device events.

Prior to the 1992 amendments,

distributors and manufacturers reported

adverse events by using a ‘‘reasonable

probability’’ standard. Importers may be

manufacturers or distributors,

depending on their activities. Among

other things, the 1992 amendments

amended section 519 to change the

reporting standard for manufacturers

and importers, however, the reporting

standard for distributors who are not

importers remained the same.

On November 21, 1997, the President

signed FDAMA into law. FDAMA made

several changes regarding the reporting

of adverse events related to devices,

including the elimination of reporting

requirements for certain distributors,

which became effective on February 19,

1998, that are reflected in this proposed

rule. However, section 422 of FDAMA

states that FDA’s regulatory authority

under the act, relating to tobacco

products, tobacco ingredients, and

tobacco additives shall be exercised

under the act as in effect on the day

before the date of enactment of FDAMA.

Because the authority relating to tobacco

products remains the same, the

reporting requirements for

manufacturers and distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco remain unchanged.

Under part 897, the regulations

pertaining to tobacco products, and

parts 803 and 804, the regulations

pertaining to device adverse event

reporting, importers may be either

manufacturers or distributors,

depending on their activities. Under

parts 897, 803, and 804, importers who

repackage or relabel are manufacturers.

Similarly, under those sections,

importers whose sole activity is

distribution of devices are defined as

distributors.

As previously stated, the 1992

amendments created a bifurcated

reporting standard for distributors,

depending on whether they are

domestic distributors or importers.

When the agency asserted jurisdiction

over tobacco products and issued

regulations under part 897, tobacco

distributors also became subject to this

bifurcated reporting standard.

Accordingly, the reporting standard

applicable to tobacco products

distributors has depended on whether

the distributor is domestic or an

importer. Consistent with section 422 of

FDAMA, the proposed rule states that

tobacco distributors will continue to use

the appropriate reporting standard as

described in § 804.25.

Changes made by FDAMA relating to

reporting requirements for all medical

devices other than tobacco products are

as follows:

1. Section 213(a) of FDAMA revised

section 519(a) of the act to eliminate

distributors as an entity required to

report adverse device events. Importers

are still required to report under section

519(a) of the act.

2. Section 213(a) also amended

section 519(a) of the act to clarify that

existing requirements continue to apply

for distributors to keep records

concerning adverse device events and to

make them available to FDA upon

request.

3. Section 213(a)(2) revoked section

519(d) of the act, which required

manufacturers, importers, and

distributors to submit to FDA an annual

certification concerning the number of

reports filed under section 519(a) in the

preceding year. As a result, certification

requirements are eliminated.

4. Section 213(c)(1)(A) of FDAMA

revised section 519(b)(1)(C) of the act to

require that device user facilities submit

an annual rather than a semiannual

summary of their reports to FDA.

5. Section 213(c)(1)(B) of FDAMA

eliminated section 519(b)(2)(C) of the

act. This section had required FDA to
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26131

disclose, upon request, the identity of a

user facility making a report under

section 519(b), if the identity of the user

facility was included in a report

submitted by a manufacturer,

distributor, or importer. As a result of

this change by FDAMA, FDA may now

disclose the identity of a user facility

only in connection with an action

concerning a failure to report or false or

fraudulent reporting, in a

communication to the manufacturer of

the device, or to the employees of the

Department of Health and Human

Services, the Department of Justice, and

duly authorized committees and

subcommittees of Congress.

To implement these provisions, FDA

is issuing this proposed rule. A

summary of the rule is contained in the

preamble to the direct final rule

published elsewhere in this issue of the

Federal Register.

II. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

III. Analysis of Impacts

FDA has examined the impact of the

proposed rule under Executive Order

12866, the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Pub. L. 104–121)),

and the Unfunded Mandates Reform Act

of 1995 (Pub. L. 104–4). Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, this

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The proposed rule would

eliminate reporting by distributors,

other than distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco,

continue reporting by importers

(including distributors who are

importers), increase protections from

disclosure of the identity of device user

facilities that have submitted reports,

reduce summary reporting by device

user facilities from semiannual to

annual, eliminate annual certification

for manufacturers and distributors

(including importers) of medical devices

other than cigarettes or smokeless

tobacco, and make other nonsubstantive

changes. The agency certifies that this

proposed rule will not have a significant

economic impact on a substantial

number of small entities. This proposed

rule also does not trigger the

requirement for a written statement

under section 202(a) of the Unfunded

Mandates Reform Act because it does

not impose a mandate that results in an

expenditure of $100 million or more by

State, local, or tribal governments in the

aggregate, or by the private sector, in

any 1 year.

IV. Paperwork Reduction Act of 1995

This proposed rule contains

information collection provisions that

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3520). The title,

description, and respondent description

of the information collection provisions

are shown as follows with an estimate

of the annual reporting and

recordkeeping burden. Included in the

estimate is the time for reviewing the

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing each collection of

information. FDA invites comments on:

(1) Whether the proposed collection of

information is necessary for the proper

performance of FDA’s functions,

including whether the information will

have practical utility; (2) the accuracy of

FDA’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Reporting and recordkeeping

requirements for manufacturers,

importers, user facilities, and

distributors of medical devices under

FDAMA.

Description: FDAMA contained

provisions that affect medical device

reporting in a variety of ways. Section

213 of FDAMA modified the summary

reporting requirements for user facilities

to require annual, rather than

semiannual, reporting, and increased

confidentiality of user facility identities.

This section of FDAMA also eliminated

the reporting requirements for medical

device distributors (but not for

importers), as well as the certification

requirements for medical device

manufacturers and distributors.

However, section 422 of FDAMA states

that FDA’s regulatory authority under

the act relating to tobacco products,

tobacco ingredients, and tobacco

additives shall be exercised under the

act as in effect on the day before the date

of enactment of FDAMA. Under this

rule of construction, the reporting and

certification requirements for

manufacturers and distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco remain unchanged.

This proposed rule would amend

FDA’s regulations in 21 CFR Parts 803

and 804 to reflect the changes to

medical device reporting made by

FDAMA.

This proposed rule would eliminate

reporting by distributors other than

distributors of cigarettes or smokeless

tobacco, continue reporting by

importers, increase the protection from

disclosure of the identity of device user

facilities that have submitted reports,

reduce summary reporting by device

user facilities from semiannual to

annual, eliminate annual certification

for manufacturers and distributors

(including importers) of medical devices

other than cigarettes or smokeless

tobacco, and make other nonsubstantive

changes.

Description of Respondents:

Businesses or other for profit

organizations.

FDA estimates the burden for this

collection of information as follows:
26132 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents No. of Responses per

Respondent

Total Annual Responses Hours per Response Total Hours

803.19 150 1 150 3 450

803.33 1,800 1 1,800 1 1,800

803.40 195 1 195 3 585

803.56 750 20 15,000 1 15,000

803.57 31 1 31 1 31

804.25 10 1 10 1.5 15

804.30 1,365 1 1,365 1 1,365

804.32 5 1 5 1 5

804.33 0 0 0 1 0

Total 19,251

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of Recordkeepers Annual Frequency

per Recordkeeping

Total Annual

Records Hours per Recordkeeper Total Hours

803.17 2,000 1 2,000 2 4,000

803.18 39,764 1 39,764 1.5 59,646

804.34 1,365 1 1,365 1 1,365

804.35 1,365 1 1,365 1.5 2,047

Total 67,058

Note: There are no operating and maintainance cost or capital costs associated with this collection of information.

The burdens under this proposed rule

are explained as follows:

A. Reporting Requirements

Prior to the program change proposed

in this rule, § 803.19 allowed

manufacturers or user facilities to

request an exemption or variance from

the reporting requirements. The agency

had estimated that it would receive

approximately 100 such requests

annually. Distributors (including

importers) were able to request an

exemption or variance from the

reporting requirements under § 804.33.

Under this proposed rule, § 803.19

would be modified to transfer the

exemption provisions for importers of

medical devices other than cigarettes or

smokeless tobacco from § 804.33 to

§ 803.19. Furthermore, distributors (who

are not importers) of medical devices

other than cigarettes or smokeless

tobacco would no longer be required to

submit MDR reports under this

proposed rule. The estimated burden for

§ 803.19 is further adjusted to reflect the

agency’s actual experience with this

type of submission.

Prior to the program change proposed

in this rule, § 803.33 required medical

device user facilities to submit summary

reports semiannually. Under this

proposed rule, user facilities would be

required to submit summary reports

annually, thereby significantly

decreasing the reporting burden on user

facilities. The estimated burden for this

section is also adjusted to reflect the

agency’s actual experience with this

type of submission.

Under this proposed rule the

reporting requirement for importers of

medical devices other than cigarettes or

smokeless tobacco previously codified

under § 804.25 would be transferred to

new proposed § 803.40. The estimated

burden for importer reporting is based

upon the agency’s actual experience

with this type of submission. The

reporting requirements for distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco would be retained in part 804.

Prior to the program change proposed

in this rule, § 803.56 required

manufacturers to submit supplemental

reports containing information not

known or not available at the time the

initial report was submitted. The agency

had estimated that it would receive

approximately 500 such requests

annually. Distributors (including

distributors who are importers) were

required to submit supplemental

information under § 804.32. Under this

proposed rule, § 803.56 would be

modified to transfer the supplemental

reporting requirements for importers of

medical devices other than cigarettes or

smokeless tobacco from § 804.32.

Furthermore, distributors (who are not

importers) of medical devices other than

cigarettes or smokeless tobacco would

no longer be required to submit MDR

reports (and thus supplemental reports

as well) under this proposed rule. The

estimated burden for § 803.56 is further

adjusted to reflect the agency’s actual

experience with this type of submission.

The agency also notes that any

additional information requested by the

agency in accordance with § 803.15 is

considered to be supplemental

information for the purpose of this

information collection and is included

in the burden estimate for § 803.56.

Prior to the program change proposed

in this rule, § 803.57 required medical

device manufacturers to annually certify

as to the number of reports submitted

during the previous year, or that no

such reports had been submitted.

Distributors (including importers) were

required to certify under § 804.30.

Under this proposed rule, § 803.57

would be modified to require annual

certification only for manufacturers of

cigarettes or smokeless tobacco. The

certification requirements for

distributors (including distributors who

are importers) of cigarettes or smokeless

tobacco would be retained in § 804.30.

Prior to the program change proposed

in this rule, § 804.25 required medical

device distributors (including

importers) to report adverse device

events. Under this proposed rule,

distributors of medical devices other

than cigarettes or smokeless tobacco are

no longer required to submit MDR

reports, and the reporting requirements

for importers of medical devices other

than cigarettes or smokeless tobacco

would be transferred to part 803.

Section 804.25 would require

distributors (including distributors who

are importers) of cigarettes or smokeless

tobacco to submit MDR reports for

adverse events related to contamination

of their products. The agency believes

that there will be a very small number

of MDR reports related to contamination
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26133

of cigarettes or smokeless tobacco

submitted in any given year.

Prior to the program change proposed

in this rule, § 804.30 required medical

device distributors (including

importers) to certify as to the number of

MDR reports submitted during the

previous year, or that no such reports

were submitted. Under this rule, the

certification requirement has been

removed for distributors (including

distributors who are importers) of

medical devices other than cigarettes or

smokeless tobacco. Section 804.30 now

would require distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco to

submit certifications of the number of

MDR reports submitted for adverse

events related to contamination of their

products. The agency has identified

1,365 distributors of cigarettes or

smokeless tobacco, each of which would

submit one certification annually.

Prior to the program change proposed

in this rule, § 804.32 required medical

device distributors (including

importers) to submit supplemental

information related to a previously

submitted MDR report. Under this

proposed rule, distributors of medical

devices other than cigarettes or

smokeless tobacco are no longer

required to submit any MDR reports,

and the reporting requirements for

importers of medical devices other than

cigarettes or smokeless tobacco would

be transferred to part 803. Section

804.32 would require distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco to submit supplemental

information related to a previously

submitted MDR report. Because the

agency believes that there will be a very

small number of MDR reports related to

contamination of cigarettes or smokeless

tobacco submitted in any given year,

even fewer supplemental submissions

are anticipated. The agency also notes

that any additional information

requested by the agency in accordance

with section 804.31 is considered to be

supplemental information for the

purpose of this information collection

and is included in the burden estimate

for § 804.32.

Prior to the program change proposed

in this rule, § 804.33 allowed medical

device distributors (including

importers) to request an exemption or

variance from the reporting

requirements. Under this rule, the

exemption provisions for importers of

medical devices other than cigarettes or

smokeless tobacco would be transferred

to § 803.19, and distributors (who are

not importers) of medical devices other

than cigarettes or smokeless tobacco are

no longer required to submit any MDR

reports under this rule. Section 804.33

would allow distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco to

request an exemption or variance from

the reporting requirements. However,

because distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco are

required only to submit reports of

adverse events related to contamination

of their products, the agency does not

anticipate any requests for exemptions

or variances from the reporting

requirements.

B. Recordkeeping Requirements

Prior to the program change proposed

in this rule, § 803.17 required

manufacturers and user facilities to

establish written procedures for

employee education, complaint

processing, and documentation of

information related to MDR’s. Under

this proposed rule, the requirement for

establishing written MDR procedures for

importers of medical devices other than

cigarettes or smokeless tobacco would

be transferred to § 803.17, and the

requirements for distributors (including

importers) of medical devices other than

cigarettes of smokeless tobacco would

be retained in § 804.34. The agency

believes that the majority of

manufacturers, user facilities, and

importers have already established

written procedures to document

complaints and information related to

MDR reporting as part of their internal

quality control system. The agency has

estimated that no more than 2,000 such

entities would be required to establish

new procedures, or revise existing

procedures, in order to comply with this

provision. For those entities, a one-time

burden of 10 hours, annualized over a

period of 5 years, is estimated for

establishing written MDR procedures.

The remainder of manufacturers, user

facilities and importers not required to

revise their written procedures to

comply with this provision are excluded

from the burden because the

recordkeeping activities needed to

comply with this provision are

considered ‘‘usual and customary’’

under 5 CFR 1320.3(b)(2).

Prior to the program change proposed

in this rule, § 803.18 required

manufacturers and user facilities to

establish and maintain MDR event files.

Distributors (including importers) were

required to establish and maintain MDR

event files under § 804.35. Under this

proposed rule, § 803.18 would be

modified to transfer the recordkeeping

requirements for importers and other

distributors of medical devices other

than cigarettes or smokeless tobacco

from § 804.35. Recordkeeping

requirements for distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco would

be retained in § 804.35.

Prior to the program change proposed

in this rule, § 804.34 required

distributors (including importers) of all

medical devices to establish written

procedures for employee education,

complaint processing and

documentation of information related to

MDR reports. Under this proposed rule,

distributors of medical devices other

than cigarettes or smokeless tobacco

would no longer be required to submit

MDR reports although distributors are

required to establish device complaint

files in accordance with 21 CFR

820.198. Accordingly, they would no

longer be subject to the requirement to

establish and maintain written MDR

procedures. Under the proposed rule,

the requirement for establishing written

MDR procedures for importers of

medical devices other than cigarettes or

smokeless tobacco would be transferred

to § 803.17, and the requirements for

distributors (including distributors who

are importers) of cigarettes or smokeless

tobacco would be retained in § 804.34.

The agency has estimated a one-time

burden of 10 hours, annualized over a

period of 5 years, for distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco to establish written MDR

procedures under § 804.34.

Prior to the program change proposed

in this rule, § 804.35 required

distributors (including importers) to

establish and maintain MDR event files.

Under this proposed rule, the

recordkeeping burdens for distributors

(including importers) of medical devices

other than cigarettes or smokeless

tobacco would be transferred to

§ 803.18. Recordkeeping requirements

for distributors (including distributors

who are importers) of cigarettes or

smokeless tobacco would be retained in

§ 804.35.

For consistency with the direct final

rule to which this proposed rule is a

companion, FDA is following the

Paperwork Reduction Act comment

procedures for direct final rules in this

proposed rule. As provided in 5 CFR

1320.5(c)(1), collections of information

in a direct final rule are subject to the

procedures set forth in 5 CFR 1320.10.

Interested persons and organizations

may submit comments on the

information collection provisions of this

proposed rule July 13, 1998 to the

Dockets Management Branch (address

above).
26134 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules

At the close of the 60 day comment

period, FDA will review the comments

received, revise the information

collection provisions as necessary, and

submit these provisions to OMB for

review. FDA will publish a notice in the

Federal Register when the information

collection provisions are submitted to

OMB, and an opportunity for public

comment to OMB will be provided at

that time. Prior to the effective date of

the direct final rule, FDA will publish

a notice in the Federal Register of

OMB’s decision to approve, modify, or

disapprove the information collection

provisions. An agency may not conduct

or sponsor, and a person is not required

to respond to, a collection of

information unless it displays a

currently valid OMB control number.

V. Request for Comments

Interested persons may, on or before

July 27, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

companion proposed rule. The

comment period runs concurrently with

the comment period for the direct final

rule. 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 the brackets in the heading of

this document. Comments will be

considered to determine whether to

amend or revoke this proposed rule.

Received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday. All comments

received will be considered as

comments regarding the direct final rule

and this proposed rule. In the event the

direct final rule is withdrawn, all

comments received regarding the direct

final rule and this companion proposed

rule will be considered comments on

this proposed rule.

List of Subjects in 21 CFR Parts 803 and

804

Imports, Medical devices, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 803 and 804 be amended

as follows:

PART 803—MEDICAL DEVICE

REPORTING

1. The authority citation for 21 CFR

part 803 continues to read as follows:

Authority: 21 U.S.C. 352, 360, 360i, 360j,

371, 374.

2. Section 803.1 is amended by

revising paragraph (a) to read as follows:

§ 803.1 Scope.

(a) This part establishes requirements

for medical device reporting. Under this

part, device user facilities, importers,

and manufacturers, as defined in

§ 803.3, must report deaths and serious

injuries to which a device has or may

have caused or contributed, must

establish and maintain adverse event

files, and must submit to FDA specified

followup and summary reports. Medical

device distributors, as defined in

§ 803.3, are also required to maintain

incident files. Furthermore,

manufacturers and importers are also

required to report certain device

malfunctions. These reports will assist

FDA in protecting the public health by

helping to ensure that devices are not

adulterated or misbranded and are safe

and effective for their intended use.

* * * * *

3. Section 803.3 is amended by

redesignating paragraphs (m) through

(ee) as paragraphs (n) through (ff),

respectively; by revising the last

sentence of the introductory text of

paragraph (c), paragraph (c)(1), and

redesignated paragraphs (p), (p)(1), and

(r)(2); and by adding paragraphs (g) and

(m) to read as follows:

§ 803.3 Definitions.

* * * * *

(c) * * * Manufacturers and

importers are considered to have

become aware of an event when:

(1) Any employee becomes aware of a

reportable event that is required to be

reported by an importer within 10 days,

or by a manufacturer within 30 days or

within 5 days under a written request

from FDA under § 803.53(b); and

* * * * *

(g) Distributor means, for the purposes

of this part, any person (other than the

manufacturer or importer) who furthers

the marketing of a device from the

original place of manufacture to the

person who makes final delivery or sale

to the ultimate user, but who does not

repackage or otherwise change the

container, wrapper or labeling of the

device or device package. One who

repackages or otherwise changes the

container, wrapper, or labeling, is a

manufacturer under § 803.3(o). For the

purposes of this part, distributors do not

include distributors of cigarettes or

smokeless tobacco.

* * * * *

(m) Importer means, for the purposes

of this part, any person who imports a

device into the United States and who

furthers the marketing of a device from

the original place of manufacture to the

person who makes final delivery or sale

to the ultimate user, but who does not

repackage or otherwise change the

container, wrapper, or labeling of the

device or device package. One who

repackages or otherwise changes the

container, wrapper, or labeling, is a

manufacturer under § 803.3(o). For the

purposes of this part, importers do not

include importers of cigarettes or

smokeless tobacco.

* * * * *

(p) Manufacturer or importer report

number means the number that

uniquely identifies each individual

adverse event report submitted by a

manufacturer or importer. This number

consists of three parts as follows:

(1) The FDA registration number for

the manufacturing site of the reported

device, or for the importer. (If the

manufacturing site or the importer does

not have a registration number, FDA

will assign a temporary number until

the site is officially registered. The

manufacturer or importer will be

informed of the temporary number.);

* * * * *

(r) * * *

(2) An event about which

manufacturers or importers have

received or become aware of

information that reasonably suggests

that one of their marketed devices:

(i) May have caused or contributed to

a death or serious injury; or

(ii) Has malfunctioned and that the

device or a similar device marketed by

the manufacturer or importer would be

likely to cause a death or serious injury

if the malfunction were to recur.

* * * * *

§ 803.9 [Amended]

4. Section 803.9 Public availability of

reports is amended by adding ‘‘or’’ after

the semicolon at the end of paragraph

(c)(2), by removing paragraph (c)(3), and

by redesignating paragraph (c)(4) as

paragraph (c)(3).

5. Section 803.10 is amended by

revising the heading and paragraphs

(a)(2) and (c)(5), and by adding

paragraph (b) to read as follows:

§ 803.10 General description of reports

required from user facilities, importers, and

manufacturers.

(a) * * *

(2) User facilities must submit annual

reports as described in § 803.33.

(b) Importers must submit MDR

reports of individual adverse events

within 10 working days after the

importer becomes aware of an MDR

reportable event as described in § 803.3.

Importers must submit reports of

device-related deaths or serious injuries

to FDA and the manufacturer and

reports of malfunctions to the

manufacturer.
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26135

(c) * * *

(5) For manufacturers of cigarettes or

smokeless tobacco, annual certification

to FDA of the number of MDR reports

filed during the preceding year as

described in § 803.57.

§ 803.11 [Amended]

6. Section 803.11 Obtaining the forms

is amended in the first sentence by

adding the word

‘‘, importers,’’ after the phrase ‘‘User

facilities’’.

7. Section 803.12 is amended by

revising paragraph (b) to read as follows:

§ 803.12 Where to submit reports.

* * * * *

(b) Each report and its envelope shall

be specifically identified, e.g., ‘‘User

Facility Report,’’ ‘‘Annual Report,’’

‘‘Importer Report,’’ ‘‘Manufacturer

Report,’’ ‘‘5–Day Report,’’ ‘‘Baseline

Report,’’ etc.

§ 803.17 [Amended]

8. Section 803.17 Written MDR

procedures is amended in the

introductory paragraph by adding the

word ‘‘, importers,’’ after the phrase

‘‘User facilities’’.

9. Section 803.18 is amended by

revising the heading, the first sentence

of paragraphs (a) and (b)(1) introductory

text, paragraphs (b)(1)(ii) and (b)(2), and

the second sentence of paragraph (c),

and by adding paragraph (d) to read as

follows:

§ 803.18 Files and distributor records.

(a) User facilities, importers, and

manufacturers shall establish and

maintain MDR event files. * * *

(b)(1) For purposes of this part, ‘‘MDR

event files’’ are written or electronic

files maintained by user facilities,

importers, and manufacturers. * * *

(ii) Copies of all MDR forms, as

required by this part, and other

information related to the event that was

submitted to FDA and other entities

(e.g., an importer, distributor, or

manufacturer).

(2) User facilities, importers, and

manufacturers shall permit any

authorized FDA employee during all

reasonable times to access, to copy, and

to verify the records required by this

part.

(c) * * * Manufacturers and

importers shall retain an MDR event file

relating to an adverse event for a period

of 2 years from the date of the event or

a period of time equivalent to the

expected life of the device, whichever is

greater. * * *

(d)(1) A device distributor shall

establish device complaint files in

accordance with § 820.198 of this

chapter and maintain an incident record

containing any information, including

any written or oral communication, that

alleges deficiencies related to the

identity, quality, durability, reliability,

safety, effectiveness, or performance of

a device. Device incident records shall

be prominently identified as such and

shall be filed by device.

(2) A device distributor shall retain

copies of the records required to be

maintained under this section for a

period of 2 years from the date of

inclusion of the record in the file or for

a period of time equivalent to the design

and expected life of the device,

whichever is greater, even if the

distributor has ceased to distribute the

device that is the subject of the record.

(3) A device distributor shall maintain

the device complaint files established

under this section at the distributor’s

principal business establishment. A

distributor that is also a manufacturer

may maintain the file at the same

location as the manufacturer maintains

its complaint file under §§ 820.180 and

820.198 of this chapter. A device

distributor shall permit any authorized

FDA employee, during all reasonable

times, to have access to, and to copy and

verify, the records required by this part.

§ 803.19 [Amended]

10. Section 803.19 Exemptions,

variances, and alternative reporting

requirements is amended by adding in

paragraphs (b) and (c) the word ‘‘,

importers,’’ before the phrase ‘‘or user

facility,’’ and by adding in paragraph (c)

a comma after the word ‘‘variance’’.

11. Section 803.20 is amended by

revising the last sentence of

introductory text of paragraph (a),

paragraph (a)(1), and the first sentence

of paragraph (a)(2), and by adding

paragraph (b)(2) to read as follows:

§ 803.20 How to report.

(a) * * * The form has sections that

must be completed by all reporters and

other sections that must be completed

only by the user facility, importer, or

manufacturer.

(1) The front of FDA Form 3500A is

to be filled out by all reporters. The

front of the form requests information

regarding the patient, the event, the

device, and the ‘‘initial reporter’’ (i.e.,

the first person or entity that submitted

the information to the user facility,

manufacturer, or importer).

(2) The back part of the form contains

sections to be completed by user

facilities, importers, and manufacturers.

* * *

(b) * * *

(2) Importers are required to submit

MDR reports to FDA and the device

manufacturer, except for malfunctions

which are reported to the manufacturer

only:

(i) Within 10 working days of

becoming aware of information that

reasonably suggests that a device has or

may have caused or contributed to a

death or serious injury.

(ii) Within 10 working days of

receiving information that a device

marketed by the importer has

malfunctioned and that such a device or

a similar device marketed by the

importer would be likely to cause or

contribute to a death or serious injury if

the malfunction were to recur.

* * * * *

§ 803.22 [Amended]

12. Section 803.22 When not to file is

amended by adding in paragraphs (a)

and (b)(1) the word ‘‘, importer,’’ after

the word ‘‘facility’’.

§ 803.33 [Amended]

13. Section 803.33 Semiannual

reports is amended by revising the

heading to read ‘‘Annual reports’’; in

introductory text of paragraph (a) by

removing the phrase ‘‘(for reports made

July through December) and by July 1

(for reports made January through

June)’’; in introductory text of paragraph

(a) and paragraphs (a)(5), (a)(7)

introductory text, and (c) by removing

the word ‘‘semiannual’’ wherever it

appears and adding in its place the

word ‘‘annual’’; in paragraph (a)(2) by

removing the phrase ‘‘and period, e.g.,

January through June or July through

December’’; and by adding in paragraph

(a)(7)(vi) the word ‘‘importer,’’ after the

word ‘‘distributor,’’.

14. Subpart D, consisting of §§ 803.40

and 803.43, is added to read as follows:

Subpart D—Importer Reporting

Requirements

Sec.

803.40 Individual adverse event reporting

requirements; importers.

803.43 Individual adverse event report data

elements.

Subpart D—Importer Reporting

Requirements

§ 803.40 Individual adverse event

reporting requirements; importers.

(a) An importer shall submit to FDA

a report, and a copy of such report to the

manufacturer, containing the

information required by § 803.43 on

FDA form 3500A as soon as practicable,

but not later than 10 working days after

the importer receives or otherwise

becomes aware of information from any

source, including user facilities,

individuals, or medical or scientific
26136 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules

literature, whether published or

unpublished, that reasonably suggests

that one of its marketed devices may

have caused or contributed to a death or

serious injury.

(b) An importer shall submit to the

manufacturer a report containing

information required by § 803.43 on

FDA form 3500A, as soon as practicable,

but not later than 10 working days after

the importer receives or otherwise

becomes aware of information from any

source, including user facilities,

individuals, or through the importer’s

own research, testing, evaluation,

servicing, or maintenance of one of its

devices, that one of the devices

marketed by the importer has

malfunctioned and that such device or

a similar device marketed by the

importer would be likely to cause or

contribute to a death or serious injury if

the malfunction were to recur.

§ 803.43 Individual adverse event report

data elements.

(a) Each importer that submits a

report on an MDR reportable event shall

complete and submit the applicable

portions of FDA form 3500A in so far as

the information is known or should be

known to the importer, and submit it to

FDA, and to the manufacturer as

required by § 803.40.

(b) Each importer shall submit the

information requested on FDA form

3500A, including:

(1) Identification of the source of the

report.

(i) Type of source that reported the

event to the importer (e.g., lay user

owner, lay user lessee, hospital, nursing

home, outpatient diagnostic facility,

outpatient treatment facility, ambulatory

surgical facility);

(ii) Importer report number;

(iii) Name, address, and telephone

number of the source that reported the

event to the importer (e.g., distributor,

user facility, practitioner, etc.); and

(iv) Name of the manufacturer of the

device.

(2) Date information.

(i) The date of the occurrence of the

event;

(ii) The date the source that reported

the event to the importer became aware

of the event;

(iii) The date the event was reported

to the manufacturer and/or FDA; and

(iv) The date of this report.

(3) The type of MDR reportable event

(e.g., death, serious illness, serious

injury, or malfunction), and whether an

imminent hazard was involved;

(4) Patient information including age,

sex, diagnosis, and medical status

immediately prior to the event and after

the event;

(5) Device information including

brand and labeled name, generic name,

model number or catalog number or

other identifying numbers, serial

number or lot number, purchase date,

expected shelf life/expiration date (if

applicable), whether the device was

labeled for single use, and date of

implant (if applicable);

(6) Maintenance/service information

data including the last date of service

performed on the device, where service

was performed, whether service

documentation is available, and

whether service was in accordance with

the service schedule;

(7) Whether the device is available for

evaluation and, if not, the disposition of

the device;

(8) Description of the event,

including:

(i) Who was operating or using the

device when the event occurred;

(ii) Whether the device was being

used as labeled or as otherwise

intended;

(iii) The location of the event;

(iv) Whether there was multi-patient

involvement, and if so, how many

patients were involved;

(v) A list of any other devices whose

performance may have contributed to

the event and their manufacturers, and

the results of any analysis or evaluation

with respect to such device (or a

statement of why no analysis or

evaluation was performed); and

(vi) A complete description of the

event including, but not limited to, what

happened, how the device was

involved, the nature of the problem,

patient followup/treatment required,

and any environmental conditions that

may have influenced the event.

(9) The results of any analysis of the

device and the event, including:

(i) The method of the evaluation or an

explanation of why no evaluation was

necessary or possible;

(ii) The results and conclusions of the

evaluation;

(iii) The corrective actions taken; and

(iv) The degree of certainty

concerning whether the device caused

or contributed to the reported event;

(10) The name, title, address,

telephone number, and signature of the

person who prepared the report.

§ 803.56 [Amended]

15. Section 803.56 Supplemental

reports is amended in the introductory

paragraph and in paragraphs (a) and (b)

by adding the words ‘‘or importer’’ after

the word ‘‘manufacturer’’.

§ 803.57 [Amended]

16. Section 803.57 Annual

certification is amended in paragraphs

(a) and (d) by removing the word

‘‘manufacturers’’ wherever it appears

and by adding in its place the phrase

‘‘manufacturers of cigarettes or

smokeless tobacco’’, and in paragraphs

(b), (c)(1), and (d) by removing the word

‘‘manufacturer’’ wherever it appears and

adding in its place the phrase

‘‘manufacturer of cigarettes or smokeless

tobacco’’.

PART 804—MEDICAL DEVICE

REPORTING FOR DISTRIBUTORS OF

CIGARETTES OR SMOKELESS

TOBACCO

17. The authority citation for 21 CFR

part 804 continues to read as follows:

Authority: 21 U.S.C. 352, 360, 360i, 360j,

371, 374.

18. Part 804 is amended by revising

the heading to read as set forth above.

19. Section 804.1 is amended by

revising paragraph (a) to read as follows:

§ 804.1 Scope.

(a) FDA is requiring distributors of

cigarettes or smokeless tobacco to report

deaths, serious illnesses, and serious

injuries that are attributed to

contamination of a cigarette or

smokeless tobacco product. Distributors

of cigarettes or smokeless tobacco are

also required to submit a report to FDA

annually certifying the number of

medical device reports filed during the

preceding year, or that no reports were

filed. These reports enable FDA to

protect the public health by helping to

ensure that these products are not

adulterated or misbranded and are

otherwise safe and effective for their

intended use. In addition, distributors of

cigarettes or smokeless tobacco are

required to establish and maintain

complaint files or incident files as

described in § 804.35, and to permit any

authorized FDA employee at all

reasonable times to have access to, and

to copy and verify, the records

contained in this file. This part

supplements, and does not supersede,

other provisions of this subchapter,

including the provisions of part 820 of

this chapter.

* * * * *

20. Section 804.3 is amended by

revising paragraph (d), and in

paragraphs (m)(1) and (m)(2) by adding

the phrase ‘‘related to the contamination

of cigarettes or smokeless tobacco’’ after

the word ‘‘event’’ to read as follows:

§ 804.3 Definitions.

* * * * *

(d) Distributor means, for the purpose

of this part, any person who furthers the

distribution of cigarettes or smokeless

tobacco, whether domestic or imported,
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26137

at any point from the original place of

manufacture to the person who sells or

distributes the product to individuals

for personal consumption, but who does

not repackage or otherwise change the

container, wrapper, or labeling of the

product package. Common carriers are

not considered distributors for the

purposes of this part.

* * * * *

§ 804.25 [Amended]

21. Section 804.25 Reports by

distributors is amended in paragraph

(a)(1) by removing the words ‘‘a device’’

and adding in their place the phrase

‘‘contamination of a cigarette or

smokeless tobacco product’’; in

paragraph (a)(2) by removing the phrase

‘‘one of its marketed devices’’ and

adding in its place the phrase

‘‘contamination of one of its cigarette or

smokeless tobacco products’’; and by

removing paragraph (c).

Dated: May 1, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12610 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 141

[FRL–6012–1]

Announcement of a Stakeholder

Meeting on the Draft Unregulated

Contaminant Monitoring Regulation

and List

AGENCY: U.S. Environmental Protection

Agency.

ACTION: Notice of a stakeholder meeting.

SUMMARY: The U.S. Environmental

Protection Agency (EPA) has scheduled

a two-day public meeting on EPA’s draft

of the Unregulated Contaminant

Monitoring Regulation (UCMR) and List.

The focus of this meeting will be to

identify and discuss issues raised by the

draft Unregulated Contaminant

Monitoring Regulation and List of

unregulated contaminants to be

monitored by public water systems as

required by the Safe Drinking Water Act

(SDWA) as amended in 1996. The

UCMR is expected to be published as a

proposed rule in the Fall of 1998. EPA

has developed the draft regulation and

list based on the input of the

stakeholders meeting on the options for

the Unregulated Contaminant

Monitoring Regulation and List held by

EPA in Washington, DC on December 2–

3, 1997. The meeting will be open to

any interested parties. EPA encourages

the full participation of stakeholders

throughout this process.

DATES: The stakeholder meeting on the

Unregulated Contaminant Monitoring

Program will be held on June 3–4, 1998,

from 9 a.m. to 5 p.m. EST.

ADDRESSES: Resolve, Inc. (an EPA

contractor) will provide logistical

support for the stakeholders meeting.

The meeting will be held at Resolve,

Inc., 1255 23rd Street, NW., Suite 275,

Washington, DC 20037.

FOR FURTHER INFORMATION CONTACT: For

general information about the meeting,

please contact Mr. Jeff Citrin at Resolve,

Inc., 1255 23rd Street, NW., Suite 275,

Washington, DC 20037; phone: (202)

965–6388; fax: (202) 338–1264, or e-mail

at jcitrin@resolv.org. For other

information on the Unregulated

Contaminant Monitoring Regulation and

List, please contact Charles Job, at the

U.S. Environmental Protection Agency,

Phone: 202–260–7084, Fax: 202–260–

3762. Members of the public wishing to

attend the meeting may register by

phone by contacting Mr. Jeff Citrin by

May 20, 1998. Those registered by May

20, 1998 will receive background

materials prior to the meeting.

SUPPLEMENTARY INFORMATION:

A. Background on the Unregulated

Contaminant Monitoring Regulation

The EPA must issue regulations

establishing the monitoring program of

unregulated contaminants under the

SDWA. Within 3 years after enactment,

and every 5 years thereafter, EPA shall

issue a list of not more than 30

unregulated contaminants to be

monitored by public water systems. The

results of this monitoring will be

included in the National Contaminant

Occurrence Database.

Monitoring of unregulated

contaminants shall vary based on

system size, source water, and

contaminants likely to be found. For

those systems serving 10,000 persons or

fewer, only a representative sample

must be monitored. Each state may

develop an unregulated contaminant

monitoring plan for small and medium

systems (serving fewer than 10,000

persons). If a state plan is implemented,

the EPA is required to cover the

reasonable costs of testing and

laboratory analysis using funds

authorized by Congress for unregulated

contaminant monitoring. EPA shall

waive the requirement for monitoring of

specific unregulated contaminants in a

state if the state demonstrates that the

criteria for listing are not applicable in

the state. Water systems must provide

the results of unregulated contaminant

monitoring to the primacy agency (state/

EPA) and must notify persons served by

the system of the availability of results

(§ 1445(a)(2)).

B. Request for Stakeholder Involvement

The upcoming meeting deals

specifically with EPA’s efforts to

develop a proposed Unregulated

Contaminant Monitoring Regulation and

List based, in part, on information

obtained from Stakeholders’ discussion

of a draft regulation and list to be

presented at the meeting and in the

background materials. These items are

available prior to the stakeholder

meeting from Jeff Citrin, Resolve, Inc.,

1255 23rd St. NW., Suite 275,

Washington, DC 20037; phone: (202)

965–6388; fax: (202) 338–1264, or after

the meeting from the EPA by contacting

Chuck Job, at the U.S. EPA, 401 M

Street, SW (4607), Washington, DC

20460 or job.chuck@epa.gov. EPA

believes that the initial list of

unregulated contaminants for which

monitoring will be required will largely

come from the Contaminant Candidate

List (CCL) published in February 1998.

EPA will use the CCL to establish

priorities for additional occurrence data

gathering, health effects research, and

regulation development. One of EPA’s

goals is to obtain monitoring data on

certain unregulated contaminants to

determine whether any of the

contaminants should be regulated in the

future, thus protecting drinking water

used by consumers from public water

systems. The unregulated contaminant

data will also be used to support the

development of a future CCL and to

guide research. These data will be

reported to the National Contaminant

Occurrence Data Base and to the users

of the selected water systems, as

required by law.

The EPA Office of Ground Water and

Drinking Water (OGWDW) sees the

involvement of interested parties,

representing a variety of perspectives

and expertise, as critical to the

development of a credible, effective and

implementable regulation and list. This

stakeholder meeting will provide an

important opportunity for such

involvement. Some anticipated issues

for discussion include the following

questions:

1. What should be the criteria for

determining which of the unregulated

contaminants on the CCL should be a

candidate for required monitoring?

2. What should be the monitoring

frequency, location and timing for

unregulated contaminants?

3. How will the Governors’ petition

process place contaminants on the

monitoring list?