Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26069

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. 98–12543 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

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations governing reporting by

manufacturers, importers, distributors,

and health care (user) facilities of

adverse events related to medical

devices. Amendments are being made to

implement revisions to 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 these

amendments in accordance with its

direct final rule procedures. Elsewhere

in this issue of the Federal Register,

FDA is publishing a 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 this direct final rule.

DATES: This rule is effective September

24, 1998. 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

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:

I. Background

Under the act and the Medical Device

Amendments of 1976 (the 1976

amendments) (Pub. L. 94–295), 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 (the SMDA) (Pub. L. 101–629) that

required medical device user facilities

and distributors to report certain devicerelated adverse events.

Distributor reporting requirements

became effective on May 28, 1992,

following the November 26, 1991 (56 FR

60024), publication of those provisions

in a tentative final rule. 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 of the act 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 direct

final 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 (21 CFR part 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 direct final 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

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
26070 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

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

disclose, upon request, the identity of a

device user facility making a report

under section 519(b) of the act if the

identity of the device user facility was

included in a report required to be

submitted by a manufacturer,

distributor, or importer. As a result of

this change by FDAMA, FDA may now

disclose the identity of a device user

facility only in connection with an

action concerning a failure to report or

false or fraudulent reporting, 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.

II. Final Rule

A. General Approach

1. To implement these provisions,

FDA is amending part 804, Distributor

Reporting, to reflect that the distributor

reporting requirements under that part

remain in effect only for distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco, as defined in part 897. FDA is

revoking the reporting requirements

under parts 803 and 804 as they apply

to distributors who are not importers of

all medical devices other than cigarettes

or smokeless tobacco. FDA is

transferring the reporting requirements

for importers of all devices other than

cigarettes or smokeless tobacco from

part 804 to part 803, Medical Device

Reporting. Importers of medical devices

will continue to be subject to the same

reporting and recordkeeping

requirements as they have been under

parts 803 and 804, with the exception

that, in accordance with FDAMA,

importers of devices other than

cigarettes or smokeless tobacco products

are no longer required to submit annual

certifications. They will continue to

submit reports on Form 3500A. FDA

will review and revise this form as

necessary in the near future.

2. Distributor recordkeeping

requirements, which also remain in

effect, are being transferred from part

804 to part 803, except for those

requirements that apply to distributors

of cigarettes or smokeless tobacco. The

recordkeeping requirements for

distributors of cigarettes or smokeless

tobacco remain in part 804. No

additional requirements for distributor

recordkeeping are being added by these

changes.

3. In accordance with FDAMA, FDA

is also amending part 803 to reflect the

change from semiannual to annual

reporting for device user facilities, to

eliminate certification requirements for

manufacturers of medical devices other

than cigarettes or smokeless tobacco,

and to limit the disclosability of device

user facility identities.

4. FDA is not changing or adding any

requirements with respect to

manufacturers or distributors of

cigarettes or smokeless tobacco, as

defined in part 897.

B. Specific Changes to Parts 803 and

804

Reporting and recordkeeping

requirements for distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco, as

defined in part 897, remain in part 804.

Reporting and recordkeeping

requirements for manufacturers of all

medical devices, including

manufacturers of cigarettes or smokeless

tobacco, and importers of devices other

than cigarettes or smokeless tobacco are

contained in part 803. Recordkeeping

requirements for distributors of

products other than cigarettes or

smokeless tobacco are also contained in

part 803. These parts are amended as

follows:

Changes to Part 803

1. Section 803.1 is amended to reflect

that the scope of the regulation now

includes reporting requirements for

importers, as well as manufacturers and

device user facilities, and to clarify that

distributors continue to be responsible

for maintaining incident files.

2. Section 803.3 is amended to reflect

that importers continue to be

responsible for reporting, by modifying

definitions related to reporting so that

importers are included.

3. Section 803.9 is amended by

removing paragraph (c)(3), which had

required FDA to disclose the name of a

device user facility making a report if

the adverse event was required to be

reported by a manufacturer or

distributor. The removal of this

paragraph corresponds to the

elimination by FDAMA of section

519(b)(2)(C) of the act.

4. Section 803.10 is amended to

reflect that importers of medical devices

remain responsible for reporting adverse

device events, by transferring to this

section the requirements that were

previously codified under part 804.

Furthermore, § 803.10(a)(2) is amended

to reflect that device user facilities are

now responsible for submitting annual,

not semiannual reports. Section

803.10(c)(5) is amended to correspond

with the revocation of section 519(d) of

the act, which had required annual

certification of the number of medical

devices report (MDR) reports filed

during the preceding year. Revised

§ 803.10(c)(5) reflects that

manufacturers of cigarettes or smokeless

tobacco continue to be responsible for

complying with the annual certification

requirements described in § 803.57.

5. Sections 803.11, 803.17, 803.19,

803.20, 803.22, and 803.56 are amended

to reflect that importers continue to be

subject to the MDR reporting

requirements. Section 803.18 is

amended to add ‘‘importers’’ to reflect

that importers continue to be

responsible for maintaining MDR event

files, and to clarify that distributors of

medical devices also continue to be

responsible for establishing device

complaint files and maintaining device

incident records.

6. Section 803.12 is amended to

reflect the change from ‘‘semiannual’’ to

‘‘annual’’ reports, and the continued

inclusion of importers as reporting

entities. Section 803.33 is amended to

reflect that device user facilities are

required to submit annual, not

semiannual reports.

7. A new subpart D, consisting of

§§ 803.40 and 803.43, has been added to

reflect that importers of medical devices

continue to be subject to the MDR

reporting requirements. These sections

represent the transfer of relevant

provisions of part 804 (which now

applies only to distributors, including

those who are importers, of cigarettes or

smokeless tobacco) into part 803.

Importer reporting and recordkeeping

requirements are not being changed by

this transfer.

8. Section 803.57 is amended to

clarify that the section applies only to

manufacturers of cigarettes or smokeless

tobacco. This amendment reflects the

revocation of section 519(d) of the act,

which had required annual certification

of the number of MDR reports filed

during the preceding year, as it applied

to manufacturers of all devices other

than cigarettes or smokeless tobacco.

This change also reflects the rule of

construction in section 422 of FDAMA

under which FDA’s regulatory authority

under the act relating to tobacco

products shall be exercised under the

act as in effect on the day before the date

of enactment of FDAMA.
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26071

Changes to Part 804

1. Section 804.1, the scope of part

804, Medical Device Distributor

Reporting, is amended to reflect that

this part now applies only to distributor

reports of adverse events relating to

contamination of cigarettes or smokeless

tobacco products.

2. Section 804.3 is amended to limit

the definition of distributors, for the

purposes of part 804, to distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco products, and to clarify that

adverse events that are reportable by

distributors are only those related to

contamination of cigarettes or smokeless

tobacco.

3. Section 804.25 is amended to

clarify that adverse events that are

reportable under this part are only those

related to contamination of cigarettes or

smokeless tobacco.

III. Rulemaking Action

In the Federal Register of November

21, 1997, FDA described its procedures

on when and how FDA will employ

direct final rulemaking. FDA believes

that this rule is appropriate for direct

final rulemaking because FDA views

this rule as a noncontroversial

amendment and anticipates no

significant adverse comments.

Consistent with FDA’s procedures on

direct final rulemaking, FDA is

publishing elsewhere in this issue of the

Federal Register a companion proposed

rule to amend existing parts 803 and

804. The companion proposed rule and

the direct final rule are substantively

identical. The companion proposed rule

provides a procedural framework within

which the rule may be finalized in the

event the direct final rule is withdrawn

because of a significant adverse

comment. The comment period for the

direct final rule runs concurrently with

the companion proposed rule. Any

comments to the companion proposed

rule will be considered as comments

regarding the direct final rule.

FDA has provided a comment period

on the direct final rule of July 27, 1998.

If the agency receives a significant

adverse comment, FDA intends to

withdraw this final rule by publication

in the Federal Register within 30 days

after the comment period ends. 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

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 significant

or adverse under this procedure. For

example, a comment recommending an

additional change to the rule may be

considered a significant adverse

comment if the comment demonstrates

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.

If FDA withdraws the direct final rule,

all comments received will be

considered under the proposed rule in

developing a final rule in accordance

with usual Administrative Procedure

Act notice-and-comment procedures.

If FDA receives no significant adverse

comment during the specified comment

period, FDA intends to 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.

IV. 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.

V. Analysis of Impacts

FDA has examined the impact of this

direct final rule under Executive Order

12866 and 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 direct final rule

is consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, this

direct final 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 rule codifies the

elimination of reporting by distributors,

other than distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco,

continues reporting by importers

(including distributors who are

importers), increases protection from

disclosure of the identity of device user

facilities that have submitted reports,

reduces summary reporting by device

user facilities from semiannual to

annual, eliminates annual certification

for manufacturers and distributors

(including importers) of medical devices

other than cigarettes or smokeless

tobacco, and makes other

nonsubstantive changes. The agency

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities.

This direct final 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.

VI. Paperwork Reduction Act of 1995

This direct final 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

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

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
26072 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

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 eliminated the reporting

requirements for medical device

distributors (but not for importers), as

well as the certification requirements for

medical device manufacturers and

distributors. This section of FDAMA

also modified the summary reporting

requirements for user facilities to

require annual, rather than semiannual,

reporting, and increased confidentiality

of user facility identities. 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 rule amends FDA’s regulations

in parts 803 and 804 to reflect the

changes to medical device reporting

made by FDAMA.

This direct final rule eliminates

reporting by distributors other than

distributors of cigarettes or smokeless

tobacco, continues reporting by

importers, increases the protection from

disclosure of the identity of device user

facilities that have submitted reports,

reduces summary reporting by device

user facilities from semiannual to

annual, eliminates annual certification

for manufacturers and distributors

(including importers) of medical devices

other than cigarettes or smokeless

tobacco, and makes other

nonsubstantive changes.

Description of Respondents:

Businesses or other for profit

organizations.

FDA estimates the burden for this

collection of information as follows:

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 2 1,365

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

TOTAL .......................... .......................... .......................... .......................... 67,058

There are no capital costs or operating and maintenance costs associated with this collection of information.

The burdens under this direct final

rule are explained as follows:

Reporting Requirements

Prior to the program change reflected

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 rule, § 803.19 is 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 are no longer

required to submit MDR reports under

this 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 reflected

in this rule, § 803.33 required medical

device user facilities to submit summary

reports semiannually. Under this rule,

user facilities are 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 rule the reporting

requirement for importers of medical

devices other than cigarettes or

smokeless tobacco previously codified

under § 804.25 is being transferred to

§ 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 have

been retained in part 804.

Prior to the program change reflected

in this rule, § 803.56 required
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26073

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

importers) were required to submit

supplemental information under

§ 804.32. Under this rule, § 803.56 is

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 are no

longer required to submit MDR reports

(and thus supplemental reports as well)

under this 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 reflected

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 rule, § 803.57 is 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 have been retained in

§ 804.30.

Prior to the program change reflected

in this rule, § 804.25 required medical

device distributors (including

importers) to report adverse device

events. Under this 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 have been transferred

to part 803. Section 804.25 now requires

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

of cigarettes or smokeless tobacco

submitted in any given year.

Prior to the program change reflected

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

importers) of medical devices other than

cigarettes or smokeless tobacco. Section

804.30 now requires 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

shall submit one certification annually.

Prior to the program change reflected

in this rule, § 804.32 required medical

device distributors (including

importers) to submit supplemental

information related to a previously

submitted MDR report. Under this 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

have been transferred to part 803.

Section 804.32 now requires 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 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 § 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 reflected

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 are 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

now allows 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.

Recordkeeping Requirements

Prior to the program change reflected

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 rule, the requirements for

establishing written MDR procedures for

importers of medical devices other than

cigarettes or smokeless tobacco have

been transferred to § 803.17, and the

requirements for distributors (including

importers) of cigarettes or smokeless

tobacco are 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 reflected

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

rule, § 803.18 is 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 have been retained in § 804.35.

Prior to the program change reflected

in this rule, § 804.34 required

distributors (including importers) of all

medical devices to establish written
26074 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

procedures for employee education,

complaint processing, and

documentation of information related to

MDR reports. Under this rule,

distributors of medical devices other

than cigarettes or smokeless tobacco are

no longer required to submit MDR

reports. Accordingly, they are no longer

subject to the requirement to establish

and maintain written MDR procedures

although distributors are required to

establish device complaint files in

accordance with 21 CFR 820.198. Under

this rule, the requirement for

establishing written MDR procedures for

importers of medical devices other than

cigarettes or smokeless tobacco is

transferred to § 803.17, and the

requirements for distributors (including

distributors who are importers) of

cigarettes or smokeless tobacco are

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 reflected

in this rule, § 804.35 required

distributors (including importers) to

establish and maintain MDR event files.

Under this rule, the recordkeeping

burdens for distributors (including

importers) of medical devices other than

cigarettes or smokeless tobacco have

been transferred to § 803.18.

Recordkeeping requirements for

distributors (including distributors who

are importers) of cigarettes or smokeless

tobacco are retained in § 804.35.

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 direct final rule by

July 13, 1998, to the Dockets

Management Branch (address above).

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 current

valid OMB control number.

VII. Request for Comments

Interested persons may, on or before

July 27, 1998, submit to the Docket

Management Branch (address above)

written comments regarding this rule.

The comment period runs concurrently

with the comment period for the

companion proposed 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

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. All

comments received will be considered

as comments regarding the companion

proposed rule and this direct final rule.

In the event the direct final rule is

withdrawn, all comments received

regarding the companion proposed rule

and this direct final rule will be

considered comments on the 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, 21 CFR parts 803

and 804 are 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
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26075

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.

(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.

* * * * *
26076 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

§ 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

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.
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26077

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,

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. 98–12614 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1240

[Docket No. 97P–0418]

Revocation of Lather Brushes

Regulation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking its

regulation pertaining to the treatment,

sterilization, handling, storage, marking,

and inspection of lather brushes. FDA is

revoking this regulation because the

regulation is no longer necessary to

protect the public health.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Policy Development and

Coordination Staff (HF–23), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3380.

DATES: This final rule is effective June

11, 1998.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 20,

1997 (62 FR 54398), FDA proposed to

revoke a regulation pertaining to the

treatment, sterilization, handling,

storage, marking, and inspection of

lather brushes. The preamble to the

proposal explained that the lather brush

regulation was originally published in

1949 by the Federal Security Agency

and was intended to prevent cases of

cutaneous anthrax through lather

brushes made from animal hair or

bristles. A Government reorganization

transferred the Federal Security

Agency’s functions to the thenDepartment of Health, Education, and

Welfare (now known as the Department

of Health and Human Services), and

responsibility for the rule was later

assigned, in 1975, to FDA. The rule was

codified at § 1240.70 (21 CFR 1240.70).

FDA proposed to revoke the

regulation because it was unaware of

any reliance on the lather brush

requirements or of any current concerns

associated with lather brushes and

because the regulation was no longer

necessary to protect the public health.

The proposal also noted that the thenCenter for Disease Control (now the

Centers for Disease Control and

Prevention) revoked a similar lather

brush regulation in 1985 on the grounds

that no case of cutaneous anthrax in the

United States had been associated with

lather brushes since 1930.

FDA received no comments on the

proposal. Consequently, this final rule

revokes § 1240.70.

II. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). 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 final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final 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. Because the final rule

eliminates certain manufacturing

requirements for lather brushes, the

agency certifies that the final rule will

not have a significant economic impact

on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

III. 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.

IV. Paperwork Reduction Act of 1995

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.