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

23158 Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Rules and Regulations

governing the operation of the Third

Avenue Bridge, mile 1.9, across the

Harlem River between Manhattan and

the Bronx; the Madison Avenue Bridge,

mile 2.3, across the Harlem River

between Manhattan and the Bronx; and

the Pulaski Bridge, mile 0.6, across

Newtown Creek between Brooklyn and

Queens. This temporary final rule

authorizes the bridge owner to close the

above bridges on May 6, 2001, at

different times of short duration to

facilitate the running of the Five

Borough Bike Tour. Vessels that can

pass under the bridges without a bridge

opening may do so at any time.

DATES: This temporary final rule is

effective only on Sunday, May 6, 2001.

ADDRESSES: Comments and material

received from the public, as well as

documents indicated in this preamble as

being available in the docket, are part of

docket (CGD01–01–054) and are

available for inspection or copying at

the First Coast Guard District, Bridge

Branch Office, 408 Atlantic Avenue,

Boston, Massachusetts, 02110, 6:30 a.m.

to 3 p.m., Monday through Friday,

except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr.

Joseph Arca, Project Officer, First Coast

Guard District, (212) 668–7165.

SUPPLEMENTARY INFORMATION:

Regulatory Information

The Coast Guard has determined that

good cause exists under the

Administrative Procedure Act (5 U.S.C.

553) to forego notice and comment for

this rulemaking because notice and

comment are unnecessary. The Coast

Guard believes notice and comment are

unnecessary because the requested

closures are of such short duration on a

Sunday when there have been few

requests to open these bridges. The

Harlem River and Newtown Creek is

used mostly by commercial vessels and

those vessels normally pass under the

draws without openings. The

commercial vessels that do require

openings are work barges that do not

operate on Sundays. The Coast Guard,

for the reasons just stated, has also

determined that good cause exists for

this rule to be effective less than 30 days

after it is published in the Federal

Register.

Background

Third Avenue Bridge

The Third Avenue Bridge, mile 1.9,

across the Harlem River between

Manhattan and the Bronx, has a vertical

clearance of 25 feet at mean high water

and 30 feet at mean low water in the

closed position. The existing operating

regulations listed at § 117.789(c) require

the draw to open on signal from 10 a.m.

to 5 p.m., if at least a four-hour notice

is given. From 5 p.m. to 10 a.m., the

draw need not be opened for vessel

traffic.

Madison Avenue Bridge

The Madison Avenue Bridge, mile

2.3, across the Harlem River between

Manhattan and the Bronx, has a vertical

clearance of 25 feet at mean high water

and 29 feet at mean low water in the

closed position. The existing operating

regulations listed at § 117.789(c) require

the draw to open on signal from 10 a.m.

to 5 p.m., if at least a four-hour notice

is given. From 5 p.m. to 10 a.m., the

draw need not be opened for vessel

traffic.

Pulaski Bridge

The Pulaski Bridge, mile 0.6, across

the Newtown Creek between Brooklyn

and Queens, has a vertical clearance of

39 feet at mean high water and 43 feet

at mean low water in the closed

position. The existing operating

regulations listed at 117.801(g) require

the draw to open on signal, if at least a

two-hour advance notice is given. The

Coast Guard published a temporary final

rule on March 23, 2001, entitled

Drawbridge operation regulations, New

York, (66 FR 16128) which allows the

Pulaski Bridge, to need open only one

bascule span for the passage of vessel

traffic, from April 23, 2001 through

August 31, 2001.

The New York City Department of

Transportation (NYCDOT) requested a

change to the operating regulations for

the Third Avenue Bridge, the Madison

Avenue Bridge, and the Pulaski Bridge

on May 6, 2001, to allow the bridges to

remain in the closed position to

facilitate the running of the Five

Borough Bike Tour.

The Third Avenue Bridge, mile 1.9,

across the Harlem River between

Manhattan and the Bronx and the

Madison Avenue Bridge, mile 2.3,

across the Harlem River between

Manhattan and the Bronx, shall remain

in the closed position from 8 a.m. to 12

p.m. on May 6, 2001. The Pulaski

Bridge, mile 0.6, across the Newtown

Creek between Brooklyn and Queens,

shall remain in the closed position from

9:30 a.m. to 1:30 p.m. on May 6, 2001.

Vessels that can pass under the bridges

without bridge openings may do so at

all times.

Regulatory Evaluation

This rule is not a ‘‘significant

regulatory action’’ under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

Order. The Office of Management and

Budget has not reviewed it under that

Order. It is not ‘‘significant’’ under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979). This

conclusion is based on the fact that the

requested closures are of short duration

and on Sunday morning when there

have been few requests to open these

bridges.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612) we considered

whether this rule would have a

significant economic impact on a

substantial number of small entities.

‘‘Small entities’’ comprises small

businesses, not-for profit organizations

that are independently owned and

operated and are not dominant in their

fields, and governmental jurisdictions

with populations less than 50,000.

The Coast Guard certifies under 5

U.S.C. 605(b) that this rule will not have

a significant economic impact on a

substantial number of small entities.

This conclusion is based on the fact that

the requested closures are of short

duration and on Sunday when there

have been few requests to open these

bridges.

Assistance for Small Entities

Under section 213(a) of the Small

Business Regulatory Enforcement

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

we offered to assist small entities in

understanding the rule so that they

could better evaluate its effects on them

and participate in the rulemaking

process. Small businesses may send

comments on the actions of Federal

employees who enforce, or otherwise

determine compliance with, Federal

regulations to the Small Business and

Agriculture Regulatory Enforcement

Ombudsman and the Regional Small

Business Regulatory Fairness Boards.

The Ombudsman evaluates these

actions annually and rates each agency’s

responsiveness to small business. If you

wish to comment on actions by

employees of the Coast Guard, call 1–

888–REG–FAIR (1–888–734–3247).

Collection of Information

This rule calls for no new collection

of information under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520).

Federalism

We have analyzed this rule under

Executive Order 13132 and have

determined that this rule does not have

implications for federalism under that

Order.

Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Rules and Regulations 23159

Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act

of 1995 (2 U.S.C. 1531–1538) governs

the issuance of Federal regulations that

require unfunded mandates. An

unfunded mandate is a regulation that

requires a State, local, or tribal

government or the private sector to

incur direct costs without the Federal

Government’s having first provided the

funds to pay those unfunded mandate

costs. This rule will not impose an

unfunded mandate.

Taking of Private Property

This rule will not effect a taking of

private property or otherwise have

taking implications under Executive

Order 12630, Governmental Actions and

Interference with Constitutionally

Protected Property Rights.

Civil Justice Reform

This rule meets applicable standards

in sections 3(a) and 3(b)(2) of Executive

Order 12988, Civil Justice Reform, to

minimize litigation, eliminate

ambiguity, and reduce burden.

Protection of Children

We have analyzed this rule under

Executive Order 13045, Protection of

Children from Environmental Health

Risks and Safety Risks. This rule is not

an economically significant rule and

does not concern an environmental risk

to health or risk to safety that may

disproportionately affect children.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that under figure 2–1,

paragraph (32)(e) of Commandant

Instruction M16475.1C, this rule is

categorically excluded from further

environmental documentation because

promulgation of changes to drawbridge

regulations have been found to not have

a significant effect on the environment.

A written ‘‘Categorical Exclusion

Determination’’ is not required for the

temporary final rule.

Indian Tribal Governments

This final rule does not have tribal

implications under Executive Order

13175, Consultation and Coordination

with Indian Tribal Governments,

because it does not have substantial

direct effect on one or more Indian

tribes, on the relationship between the

Federal Government and Indian tribes,

or on the distribution of power and

responsibilities between the Federal

Government and Indian tribes.

List of Subjects in 33 CFR Part 117

Bridges.

Regulations

For the reasons set out in the

preamble, the Coast Guard amends 33

CFR part 117 as follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. In § 117.789, from 8 a.m. through

12 p.m. on May 6, 2001, paragraph (c)

is temporarily suspended and a new

paragraph (g) is added to read as

follows:

§ 117.789 Harlem River

* * * * *

(g) The draws of the Third Avenue

Bridge, mile 1.9, and the Madison

Avenue Bridge, mile 2.3, across the

Harlem River between Manhattan and

the Bronx, need not open for vessel

traffic on May 6, 2001, from 8 a.m. to

12 p.m.

3. In section 117.801, from 9:30 a.m.

through 1:30 p.m. on May 6, 2001,

paragraph (g) and (h) are suspended and

a new paragraph (i) is added to read as

follows:

§ 117.801 Newtown Creek, Dutch Kills,

English Kills, and their tributaries.

* * * * *

(i) The draw of the Pulaski Bridge,

mile 0.6, across the Newtown Creek

between Brooklyn and Queens, need not

open for vessel traffic, on May 6, 2001,

from 9:30 a.m. to 1:30 p.m.

Dated: April 19, 2001.

G.N. Naccara,

Rear Admiral, U.S. Coast Guard, Commander,

First Coast Guard District.

[FR Doc. 01–11493 Filed 5–7–01; 8:45 am]

BILLING CODE 4910–15–U

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR PART 117

[CGD08–01–007]

RIN 2115–AE47

Drawbridge Operating Regulation;

Ouachita River, LA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

temporarily changing the regulation

governing the operation of the Kansas

City Southern Railroad swing span

bridge across the Ouachita River, mile

167.1, at Monroe, Ouachita Parish,

Louisiana. This rule allows for the

passage of vessels from June 4, 2001,

through November 15, 2001 during the

morning hours with proper advance

notice. This rule is issued to facilitate

the repairs to the turn span of the

bridge. Normally, the draw opens on

signal at all times.

DATES: This rule is effective from June

4, 2001, through November 15, 2001.

ADDRESSES: Comments and materials

received from the public, as well as

documents indicated in this preamble as

being available in the docket, will be

available for inspection or copying at

the office of the Eighth Coast Guard

District, Bridge Administration Branch,

Hale Boggs Federal Building, Room

1313, 501 Magazine Street, New

Orleans, Louisiana 70130–3396 between

7 a.m. and 3 p.m., Monday through

Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr.

David Frank, Bridge Administration

Branch, Commander (ob), Eighth Coast

Guard District, telephone number 504–

589–2965.

SUPPLEMENTARY INFORMATION:

Regulatory Information

On March 30, 2001, we published a

notice of proposed rulemaking (NPRM)

entitled Drawbridge Operating

Regulation; Ouachita River, Louisiana,

in the Federal Register (66 FR 17376).

We received one letter commenting on

the proposed rule. No public hearing

was requested, and none was held.

Background and Purpose

The Kansas City Southern Railroad

has submitted plans to repair the turn

span of the swing span bridge across the

Ouachita River, mile 167.1, at Monroe.

To facilitate the continued movement of

trains across the bridge during the

repairs, the railroad plans to remove the

swing span and temporarily replace it

with a removable span bridge with 70

feet of horizontal clearance. The railroad

has requested limited openings during

the repair period of May 7, 2001 through

November 30, 2001. Frequent need to

remove and replace the span will

severely limit the railroad’s ability to

complete the repairs in a timely manner.

Discussions were held between the

railroad, its contractor, waterway users,

and facility operators to determine the

best method of allowing vessels to

transit the waterway during the repair

period. The discussions centered on the

mariner’s ability to transit the bridge

site on any day if proper notification

was given. The railroad only wanted to