62286 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations

device is intended for over-the-counter

use.

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 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. Because this rule will relieve a

burden and simplify the marketing of

these devices, 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.

VI. Paperwork Reduction Act of 1995

FDA concludes that 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.

VII. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

List of Subjects in 21 CFR Part 862

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 862 is

amended as follows:

PART 862—CLINICAL CHEMISTRY

AND CLINICAL TOXICOLOGY

DEVICES

1. The authority citation for 21 CFR

part 862 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 862.1710 is amended by

revising paragraph (b) to read as follows:

§ 862.1710 Total triiodothyronine test

system.

* * * * *

(b) Classification. Class II. This device

is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter subject to the

limitations in § 862.9.

Dated: October 12, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–26740 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Parts 110 and 165

[CGD05–00–048]

RIN 2115–AA98

Safety Zone and Anchorage

Regulations; Delaware Bay and River

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Army Corps of Engineers

will begin dredging parts of the

Delaware River including the Marcus

Hook Range Ship Channel. Because of

the dredging operations, temporary

additional requirements will be

imposed in Marcus Hook Anchorage

(Anchorage 7), the Deepwater Point

Anchorage (Anchorage 6), and the

Mantua Creek Anchorage (Anchorage 9).

The Coast Guard is also establishing a

temporary moving safety zone around

the dredge vessel Essex that will be

working in the Marcus Hook Range Ship

Channel adjacent to Anchorage 7.

DATES: This rule is effective from

October 3, 2000 until November 30,

2000.

ADDRESSES: Documents indicated in this

preamble as being available are part of

docket CGD05–00–048 and are available

for inspection or copying at Coast Guard

Marine Safety Office/Group

Philadelphia, One Washington Avenue,

Philadelphia, Pennsylvania 19147

between 8 a.m. and 3 p.m., Monday

through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Junior Grade Wade

Kirschner or Senior Chief Robert Ward,

Coast Guard Marine Safety Office/Group

Philadelphia, (215) 271–4889 or (215)

271–4888.

SUPPLEMENTARY INFORMATION:

Regulatory Information

A Notice of Proposed Rule Making

(NPRM) was not published for this

regulation. In keeping with 5 U.S.C.

553(b)(B), the Coast Guard finds that

good cause exists for not publishing an

NPRM. In keeping with the

requirements of 5 U.S.C. 533(d)(3), the

Coast Guard also finds good cause exists

for making this regulation effective less

than 30 days after publication in the

Federal Register. U.S. Army Corps of

Engineers, Philadelphia District,

informed the Coast Guard on September

13, 2000 that dredging operations would

commence on October 1, 2000.

Publishing a NPRM and delaying its

effective date would be contrary to the

public interest, since immediate action

is needed to protect mariners against

potential hazards associated with the

dredging operations in the Marcus Hook

Range Ship Channel and to modify the

anchorage regulations to facilitate vessel

traffic.

Background and Purpose

The U.S. Army Corps of Engineers

(ACOE) notified the Coast Guard that it

needed to conduct dredging operations

on the Delaware River, in the vicinity of

the Marcus Hook Range Ship Channel.

The dredging is needed to maintain the

project depth of the channel. Similar

dredging is conducted each year. This

period of dredging begins October 1,

2000 and is anticipated to end on

November 30, 2000.

To reduce the hazards associated with

dredging the channel, vessel traffic that

would normally transit through the

Marcus Hook Range Ship Channel may

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations 62287

divert through a portion of anchorage 7

to maintain a 150 foot radius around

dredging operations. This necessitates

additional requirements/restrictions on

the use of Anchorage 7. For the

protection of mariners transiting in the

vicinity of dredging operations, the

Coast Guard is also establishing a safety

zone around the dredging vessel Essex.

The safety zone will ensure mariners

remain a safe distance from the

potentially dangerous dredging

equipment.

Discussion of the Regulation

33 CFR 110.157(b)(2) allows vessels to

anchor for up to 48 hours in the

anchorages listed in § 110.157(a), which

includes Anchorage 7. However,

because of the limited anchorage space

available in Anchorage 7 during

dredging operations, the Coast Guard is

adding a temporary paragraph in 33 CFR

110.157(b)(11) to provide additional

requirements and restrictions on vessels

utilizing Anchorage 6, 7 and 9.

Vessels desiring to use the Marcus

Hook Anchorage (Anchorage 7) must

seek permission from the Captain of the

Port at least 24 hours in advance. Only

one vessel will be allowed to anchor in

Anchorage 7 at one time, and the

Captain of the Port will grant

permission on a ‘‘first come, first serve

basis.’’ A vessel desiring to use

anchorage 7 will be directed to a

location within the anchorage, and no

vessel may remain in the anchorage

beyond twelve hours.

The Coast Guard expects that vessels

normally permitted to anchor in

Anchorage 7 will use Anchorage 6 off

Deepwater Point or Anchorage 9 near

the entrance to Mantua Creek, because

they are the closest anchorages to

Anchorage 7. To control access to

Anchorages 6 and 9, the Coast Guard is

requiring any vessel 700 feet or greater

in length to obtain advance permission

from the Captain of the Port before

anchoring. The Coast Guard is also

concerned that the holding ground in

Anchorages 6 and 9 is not as good as in

Anchorage 7. As larger vessels do not

typically use these anchorages, any

vessel 700 to 750 feet in length is

required to have one tug standing

alongside while at anchor, and any

vessel of over 750 feet in length must

have two tugs standing alongside. The

tug(s) must have sufficient horsepower

to prevent the vessel they’re attending

from swinging into the channel.

The Coast Guard is also establishing

a safety zone within a 150-yard radius

of the dredging operations being

conducted in the Marcus Hook Range

Ship Channel in the vicinity of

Anchorage 7 by the dredge vessel Essex.

The safety zone will protect mariners

transiting the area from the potential

hazards associated with dredging

operations. Vessels transiting the

Marcus Hook Range Ship Channel will

have to divert from the main ship

channel through Anchorage 7, and must

operate at the minimum safe speed

necessary to maintain steerage. No

vessel may enter the safety zone unless

it receives permission from the Captain

of the Port.

Regulatory Evaluation

This temporary final 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

exempted it from review 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). The

Coast Guard expects the economic

impact of this proposal to be so minimal

that a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

Although this regulation requires

certain vessels to have one or two tugs

alongside while at anchor, the

requirement only applies to vessels 700

feet or greater in length, that choose to

anchor in Anchorages 6 and 9. Alternate

anchorages, such as Anchorage A

(Breakwater) and Anchorage 1 (Big

Stone) in Delaware Bay, are also

reasonably close and generally

available. Vessels anchoring in

Anchorage A and 1 are not required to

have tugs alongside, except when

specifically directed to do so by the

Captain of the Port because of a specific

hazardous condition. Furthermore, few

vessels 700 feet or greater are expected

to enter the port during the effective

period. The majority of vessels expected

are less than 700 feet and thus will not

be required to have tugs alongside.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

considered whether this temporary final

rule will have a significant economic

impact on a substantial number of small

entities. ‘‘Small Entities’’ include small

businesses, not-for-profit organizations

that are independently owned and

operated and are not dominant in their

fields, and governmental jurisdictions

with populations of less than 50,000.

This regulation’s greatest impact is on

vessels greater than 700 feet in length

which choose to anchor in Anchorages

6 and 9 and will have virtually no

impact on any small entities. Therefore,

the Coast Guard certifies under section

605(b) of the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.) that this temporary

final rule will not have a significant

economic impact on a substantial

number of small entities.

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.

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 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

We considered the environmental

impact of this rule and concluded that,

under figure 2–1, paragraphs (34)(f) and

(g), of Commandant Instruction

M16475.1C, this rule is categorically

excluded from further environmental

documentation.

62288 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations

List of Subjects

33 CFR Part 110

Anchorage grounds.

33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

Regulation

For the reasons discussed in the

preamble, the Coast Guard amends 33

CFR part 110 and 33 CFR part 165 as

follows:

PART 110—[AMENDED]

1. The authority citation for part 110

continues to read as follows:

Authority: 33 U.S.C. 471, 1221 through

1236, 2030, 2035, and 2071; 49 CFR 1.46 and

33 CFR 1.05–1(g). Section 110.1a and each

section listed in 110.1a is also issued under

33 U.S.C. 1223 and 1231.

2. A new temporary § 110.157(b)(11)

is added to read as follows:

§ 110.157 Delaware Bay and River.

* * * * *

(b) * * *

(11) Additional requirements and

restrictions for the anchorages defined

in paragraphs (a)(7), (a)(8), and (a)(10)

of this section.

(i) Prior to anchoring in Anchorage 7

off Marcus Hook, as described in

paragraph (a)(8) of this section, a vessel

must first obtain permission from the

Captain of the Port, Philadelphia, at

least 24 hours in advance of arrival.

Permission to anchor will be granted on

a ‘‘first-come, first-serve’’ basis. The

Captain of the Port will allow only one

vessel at a time to be at anchor in

Anchorage 7, and no vessel may remain

within Anchorage 7 for more than 12

hours.

(ii) For Anchorage 6 as described in

paragraph (a)(7) of this section, and

Anchorage 9 as described in paragraph

(a)(10) of this section.

(A) Any vessel 700 feet or greater in

length requesting anchorage shall obtain

permission from the Captain of the Port,

Philadelphia, Pennsylvania, at least 24

hours in advance.

(B) Any vessel from 700 to 750 feet in

length shall have one tug alongside at

all times while the vessel is at anchor.

(C) Any vessel greater than 750 feet in

length shall have two tugs alongside at

all times while the vessel is at anchor.

(D) The master, owner or operator of

a vessel at anchor shall ensure that any

tug required by this section is of

sufficient horsepower to assist with

necessary maneuvers to keep the vessel

clear of the navigation channel.

(iii) Effective Dates. This paragraph

(b)(11) is effective from October 3, 2000

until November 30, 2000.

PART 165—[AMENDED]

1. The authority citation for part 165

continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;

33 CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5;

49 CFR 1.46. Section 165.100 is also issued

under authority of Sec. 311, Pub. L. 105–383.

4. Add temporary § 165.T05–048 to

read as follows:

§ 165.T05–048 Safety Zone; Delaware Bay

and River.

(a) Location. The following area is a

safety zone: All waters within the arc of

a circle with a 150 yard radius having

at its center dredging vessel Essex

operating in or near the Marcus Hook

Range Ship Channel in the vicinity of

Anchorage 7.

(b) Regulations. (1) All persons are

required to comply with the general

regulations governing safety zones in

§ 165.23 of this part.

(2) No person or vessel may enter or

navigate within this safety zone unless

authorized to do so by the Captain of the

Port. Any person or vessel authorized to

enter the safety zone must operate in

strict conformance with any directions

given by the Captain of the Port and

leave the safety zone immediately if the

Captain of the Port so orders.

(3) Vessels may navigate in and

through Anchorage 7 (Marcus Hook

Anchorage) to the minimum extent

necessary to stay clear of the safety

zone. Vessels navigating in Anchorage 7

for this purpose shall do so at minimum

speed to maintain steerage, unless

otherwise directed by the Captain of the

Port.

(4) The Coast Guard vessels enforcing

this section can be contacted on VHF

Marine Band Radio, channels 13 and 16.

The Captain of the Port can be contacted

at telephone number (215) 271–4940.

(5) The Captain of the Port will notify

the public of any changes in the status

of this safety zone by Marine Safety

Radio Broadcast on VHF-FM marine

band radio, channel 22 (157.1 MHz).

(c) Definitions. Captain of the Port

means the Commanding Officer of the

Coast Guard Marine Safety Office/Group

Philadelphia or any Coast Guard

commissioned, warrant, or petty officer

who has been authorized by the Captain

of the Port to act on his behalf.

(d) Effective dates: This section is

effective from October 3, 2000 to

November 30, 2000.

Dated: October 3, 2000.

T.C. Parr,

Captain, U.S. Coast Guard, Commander, Fifth

U.S. Coast Guard District, Acting.

[FR Doc. 00–26768 Filed 10–17–00; 8:45 am]

BILLING CODE 4910–15–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 154

[USCG–1999–5149]

RIN 2115–AF79

Response Plans for Marine

Transportation-Related Facilities

Handling Non-Petroleum Oils;

Clarification

AGENCY: Coast Guard, DOT.

ACTION: Clarification to final rule.

SUMMARY: This document clarifies a

preamble discussion to a final rule

published in the Federal Register of

June 30, 2000. The rule amended Coast

Guard regulations requiring response

plans for marine transportation-related

(MTR) facilities that handle, store, or

transport animal fats or vegetable oils.

Specifically, this document clarifies the

explanation for higher volume ports.

DATES: This document becomes effective

on October 18, 2000.

FOR FURTHER INFORMATION CONTACT: For

questions on this clarification or the

final rule, call Lieutenant Claudia

Gelzer, Project Manager, Coast Guard,

telephone 202–267–1983. For questions

on viewing or submitting material to the

docket, call Dorothy Beard, Chief,

Dockets, Department of Transportation,

telephone 202–366–9329.

SUPPLEMENTARY INFORMATION:

Clarification of Preamble to Final Rule

On June 30, 2000, we published in the

Federal Register the final rule titled

‘‘Response Plans for Marine

Transportation-Related Facilities

Handling Non-Petroleum Oils’’ (USCG–

1999–5149)[65 FR 40820]. In the

preamble to that rule, on page 40822, we

stated that higher volume port areas

were designated based on the

availability of response equipment on

hand in those ports. After that

publication, the Coast Guard received

comments from the affected public

requesting clarification of our high

volume ports discussion.