Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Rules and Regulations 23155

claims against the former stock form

depository institution.

Dated: May 2, 2001.

By the Office of Thrift Supervision.

Ellen Seidman,

Director.

[FR Doc. 01–11573 Filed 5–7–01; 8:45 am]

BILLING CODE 6720–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 2000–NE–12–AD; Amendment

39–12218; AD 2001–08–14]

RIN 2120–AA64

Airworthiness Directives: Turbomeca

S.A. Arrius Models 2B, 2B1, and 2F

Turboshaft Engines; Correction

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; correction.

SUMMARY: This document makes a

correction to Airworthiness Directive

(AD) 2001–08–14 applicable to

Turbomeca S.A. Arrius models 2B, 2B1,

and 2F turboshaft engines, that was

published in the Federal Register on

April 26, 2001 (66 FR 20910). The

amendment number of 39–12191 used

in this AD is incorrect. This document

corrects that amendment number. In all

other respects, the original document

remains the same.

EFFECTIVE DATE: May 31, 2001.

FOR FURTHER INFORMATION CONTACT:

James Rosa, Aerospace Engineer, Engine

Certification Office, FAA, Engine and

Propeller Directorate, 12 New England

Executive Park, Burlington, MA 01803;

telephone (781) 238–7152, fax (781)

238–7199.

SUPPLEMENTARY INFORMATION: A final

rule airworthiness directive (FR Doc.

01–10021) applicable to Turbomeca S.A.

Arrius models 2B, 2B1, and 2F

turboshaft engines was published in the

Federal Register on April 26, 2001 (66

FR 20912). The following correction is

needed:

1. On page 20910, in the first column,

in the Heading of the document, the

docket line is corrected to read ‘‘[Docket

No. 2000–NE–12–AD; Amendment 39–

12218; AD 2001–08–14]’’.

PART 39—[CORRECTED]

§ 39.13 [Corrected]

2. On page 20911, in the first column,

under amendatory instruction 2, the

heading of AD 2001–08–14 is corrected

to read as follows:

2001–08–14 Turbomeca S.A. Arrius Models

2B, 2B1, and 2F Turboshaft Engines:

Amendment 39–12218. Docket No.

2000–NE–12–AD.

* * * * *

Issued in Burlington, MA, on April 30,

2001.

Francis A. Favara,

Acting Manager, Engine and Propeller

Directorate, Aircraft Certification Service.

[FR Doc. 01–11456 Filed 5–7–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. 98N–0170]

Medical Devices; Medical Device

Reporting Regulations; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations governing Medical Device

Reporting (MDR) requirements. When

the final regulation was last amended,

the regulation published with some

errors and omissions that, if

uncorrected, may prove to be

misleading. This document corrects

those errors.

DATES: This rule is effective May 8,

2001.

FOR FURTHER INFORMATION CONTACT:

Susan E. Bounds, Center for Devices and

Radiological Health (HFZ–500), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–594–

2735.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 26,

2000 (65 FR 4112), FDA published a

final rule (the January 2000 rule) that

amended its MDR regulations governing

reporting by manufacturers, importers,

distributors, and user facilities of

adverse events related to medical

devices. These amendments were made

to implement revisions to the Federal

Food, Drug, and Cosmetic Act (the act)

under the Food and Drug

Administration Modernization Act of

1997 (FDAMA). These regulations

became effective March 27, 2000. Under

certain provisions of FDAMA, reporting

requirements for distributors were

eliminated, but reporting requirements

for importers, and requirements for

distributors to keep records concerning

adverse device events and make them

available to FDA upon request continue

to apply. To accommodate these

changes, part 804 (21 CFR part 804) was

removed and language was integrated

into part 803 (21 CFR part 803) that

reflected the retention of importer

reporting requirements and

recordkeeping requirements for

distributors. Another change made by

the January 2000 rule revised

procedures to require annual, rather

than semiannual, summary reporting by

user facilities, and eliminated reporting

certification requirements. As a result of

these substantive amendments, many

nonsubstantive changes were made to

the organization of provisions in part

803. During preparation of the final rule

for publication, however, a number of

typographical and editorial errors

occurred. In the subsequent months,

FDA discovered other errors. The

purpose of these amendments is to

correct the errors identified in part 803.

This document is published as a final

rule with the effective date shown

above. FDA has determined that this

final rule has no substantive impact on

the public. FDA, therefore, for good

cause, finds under 5 U.S.C.553(b)(3)(B)

and (d)(3) that notice and public

comment are unnecessary and that this

rule may take effect upon publication.

II. Need for Amendments

A. Incorporation of Importer Reporting

Requirements Into Part 803

Section 213 of FDAMA eliminated

reporting requirements for distributors

previously found at part 804. At the

same time, reporting requirements for

importers were retained and those

previously referenced in part 804 were

incorporated in part 803. Accordingly,

the word ‘‘distributor’’ was removed

from applicable paragraphs and the

word ‘‘importer’’ was integrated into the

text. During preparation of the final rule

amending the regulations to incorporate

importer requirements, however, the

word ‘‘importer’’ was not properly

integrated into §§ 803.10, 803.20,

803.50, and 803.52. FDA is amending

the regulations to correct this error.

B. Elimination of Reporting Certification

and Modification of Semi-Annual

Reporting

Section 213(a)(2) of FDAMA revoked

section 519(d) of the act (21 U.S.C.

360i(d)) resulting in the elimination of

certification requirements. Section

213(c)(1)(A) revised section 519(b)(1)(C)

of the act to require annual, rather than

23156 Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Rules and Regulations

semiannual, summary reporting by user

facilities. During preparation of the final

rule, however, an editorial error led to

the omission in certain paragraphs of

amended text that was written to

remove references to certification

requirements and change the word

‘‘semiannual’’ to ‘‘annual.’’ Sections

803.10, 803.17, and 803.58 contained

these errors. FDA is amending the

regulations to correct these errors.

C. Organization of Paragraphs

The integration of importer reporting

requirements and the removal of

certification references required

substantial reorganization of part 803.

This reorganization included the need

to redesignate certain paragraphs and

correct references to those paragraphs

throughout the text.

1. Definition of Device User Facility,

MDR Reportable Event (or reportable

event), and Work Day (§ 803.3(f),

(r)(2)(ii), and (ee))

Modifications to § 803.3 require that

paragraphs (m) through (ee) be

redesignated as paragraphs (n) through

(ff) to address the following:

• At paragraph (f), the definition of a

‘‘device user facility’’ states that a

‘‘physician’s office’’ is later defined in

paragraph ‘‘(w)’’ of this section. In fact,

the definition of ‘‘physician’s office’’ is

found later at paragraph ‘‘(x)’’ of this

section.

• A further error occurred when

redesignating the definition of an ‘‘MDR

reportable event (or reportable event)’’

as paragraph (r)(2)(ii). In this instance,

the words ‘‘or contribute’’ were

inadvertently omitted after the words

‘‘would be likely to cause,’’ in the

definition text.

• Finally, § 803.3 contains two

paragraphs ‘‘(ee)’’ because the definition

of ‘‘work day’’ was not redesignated as

paragraph ‘‘(ff).’’

FDA is amending the regulations to

correct these errors.

2. General Description of Reports

Required From User Facilities,

Importers, and Manufacturers

(§ 803.10(b))

Previously, § 803.10(b) was reserved.

As amended by the January 2000 rule,

§ 803.10(b) was revised to include

reporting requirements for importers.

During preparation of the January 2000

rule, the amended text incorporated in

this section was not organized in the

same manner as § 803.10(a) and (c). FDA

is amending the regulations to correct

this error.

3. Foreign Manufacturers (§ 803.58(b)(4),

(b)(5), and (b)(6))

The elimination of certification

requirements by manufacturers resulted

in the removal of § 803.58(b)(3);

therefore, paragraphs (b)(4), (b)(5), and

(b)(6) were to be redesignated

accordingly. FDA is amending the

regulations to correct this error.

4. Exemptions, Variances, and

Alternative Reporting Requirements

(§ 803.19)

Independent of the errors in part 803

that resulted from the January 2000 rule,

FDA discovered an obsolete reference in

§ 803.19(a)(2). In this instance, the text

of § 803.19(a)(2) references part 813,

which was removed by a final rule

published in the Federal Register on

January 29, 1997 (62 FR 4164). FDA is

amending the regulations to correct this

error.

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. 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) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

121)), and the Unfunded Mandates

Reform Act of 1995 (Public Law 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 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. The agency certifies that this

final rule will not have a significant

negative economic impact on a

substantial number of small entities.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4) requires that agencies

prepare a written statement of

anticipated costs and benefits before

proposing any rule that may result in an

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100 million in any 1

year (adjusted annually for inflation).

The Unfunded Mandates Reform Act of

1995 does not require FDA to prepare a

statement of costs and benefits for the

final rule, because the final rule is not

expected to result in any 1-year

expenditure that would exceed $100

million.

V. Paperwork Reduction Act of 1995

FDA has determined that this final

rule contains no additional collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 803

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 part 803 is

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 803.3 is amended by

revising paragraphs (f) and (r)(2)(ii) and

by redesignating the second paragraph

(ee) as paragraph (ff) to read as follows:

§ 803.3 Definitions.

* * * * *

(f) Device user facility means a

hospital, ambulatory surgical facility,

nursing home, outpatient diagnostic

facility, or outpatient treatment facility

as defined in paragraphs (b), (l), (t), (u),

and (v), respectively, of this section,

which is not a ‘‘physician’s office,’’ as

defined in paragraph (x) of this section.

School nurse offices and employee

health units are not device user

facilities.

* * * * *

(r) * * *

(2) * * *

(ii) Has malfunctioned and that the

device or a similar device marketed by

the manufacturer or importer would be

likely to cause or contribute to a death

or serious injury if the malfunction were

to recur.

* * * * *

Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Rules and Regulations 23157

3. Section 803.10 is amended by

revising paragraph (b) and by removing

paragraph (c)(5) to read as follows:

§ 803.10 General description of reports

required from user facilities, importers, and

manufacturers.

* * * * *

(b) Device importers. Importers must

submit the following reports, which are

described more fully in subpart D of this

part.

(1) Importers must submit MDR

reports of individual adverse events

within 30 days after the importer

becomes aware of an MDR reportable

event as described in §§ 803.40 and

803.42.

(i) Importers must submit reports of

device-related deaths or serious injuries

to FDA and to the manufacturer.

(ii) Importers must submit reports of

malfunctions to the manufacturer.

(2) [Reserved]

* * * * *

4. Section 803.17 is amended by

revising paragraph (b)(3) to read as

follows:

§ 803.17 Written MDR procedures.

* * * * *

(b) * * *

(3) Any information that was

evaluated for the purpose of preparing

the submission of annual reports; and

* * * * *

5. Section 803.19 is amended by

revising paragraph (a)(2) to read as

follows:

§ 803.19 Exemptions, variances, and

alternative reporting requirements.

(a) * * *

(2) An individual who manufactures

devices intended for use in humans

solely for such person’s use in research

or teaching and not for sale, including

any person who is subject to alternative

reporting requirements under the

investigational device exemption

regulations, part 812 of this chapter,

which require reporting of all adverse

device effects.

* * * * *

6. Section 803.20 is amended by

revising the introductory text of

paragraph (a), and paragraphs (a)(2) and

(c)(1) to read as follows:

§ 803.20 How to report.

(a) Description of form. There are two

versions of the MEDWATCH form for

individual reports of adverse events.

FDA Form 3500 is available for use by

health professionals and consumers for

the submission of voluntary reports

regarding FDA-regulated products. FDA

Form 3500A is the mandatory reporting

form to be used for submitting reports

by user facilities, importers, and

manufacturers of FDA-regulated

products. The form has some sections

that must be completed by all reporters

and other sections that must be

completed only by the user facility,

importer, or manufacturer.

* * * * *

(2) The back part of the form contains

sections to be completed by user

facilities, importers, and manufacturers.

User facilities and importers must

complete section F; device

manufacturers must complete sections G

and H. Manufacturers are not required

to recopy information submitted to them

on a Form 3500A unless the information

is being copied onto an electronic

medium. If the manufacturer corrects or

supplies information missing from the

other reporter’s 3500A form, it should

attach a copy of that form to the

manufacturer’s report form. If the

information from the other reporter’s

3500A form is complete and correct, the

manufacturer can fill in the remaining

information on the same form.

* * * * *

(c) Information that reasonably

suggests a reportable event occurred. (1)

Information that reasonably suggests

that a device has or may have caused or

contributed to an MDR reportable event

(i.e., death, serious injury, and, for

manufacturers and importers, a

malfunction that would be likely to

cause or contribute to a death or serious

injury if the malfunction were to recur)

includes any information, such as

professional, scientific or medical facts

and observations or opinions, that

would reasonably suggest that a device

has caused or may have caused or

contributed to a reportable event.

* * * * *

7. Section 803.50 is amended by

revising paragraphs (b)(1)(i) and (b)(2) to

read as follows:

§ 803.50 Individual adverse event reports;

manufacturers.

* * * * *

(b) * * *

(1) * * *

(i) Any information that can be

obtained by contacting a user facility,

importer, or other initial reporter;

* * * * *

(2) Manufacturers are responsible for

obtaining and providing FDA with

information that is incomplete or

missing from reports submitted by user

facilities, importers, and other initial

reporters. Manufacturers are also

responsible for conducting an

investigation of each event and

evaluating the cause of the event. If a

manufacturer cannot provide complete

information on an MDR report, it must

provide a statement explaining why

such information was incomplete and

the steps taken to obtain the

information. Any required information

not available at the time of the report,

which is obtained after the initial filing,

must be provided by the manufacturer

in a supplemental report under §

803.56.

8. Section 803.52 is amended by

revising paragraphs (d)(1), (f)(11)(i), and

(f)(11)(ii) to read as follows:

§ 803.52 Individual adverse event report

data elements.

* * * * *

(d) * * *

(1) Name, address, and phone number

of the reporter who initially provided

information to the user facility,

manufacturer, or importer;

* * * * *

(f) * * *

(11) * * *

(i) Any information missing on the

user facility report or importer report,

including missing event codes, or

information corrected on such forms

after manufacturer verification;

(ii) For each event code provided by

the user facility under § 803.32(e)(10) or

the importer under § 803.42(e)(10), a

statement of whether the type of event

represented by the code is addressed in

the device labeling; and

* * * * *

§ 803.58 [Amended]

9. Section 803.58 Foreign

manufacturers is amended by removing

paragraph (b)(3) and by redesignating

paragraphs (b)(4), (b)(5), and (b)(6) as

paragraphs (b)(3), (b)(4), and (b)(5),

respectively.

Dated: April 18, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–11449 Filed 5–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD01–01–054]

RIN 2115–AE47

Drawbridge Operation Regulations:

Harlem River, Newtown Creek, NY

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary final rule