Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Rules and Regulations 37043

of Food and Drugs, 21 CFR part 880 is

amended as follows:

PART 880—GENERAL HOSPITAL AND

PERSONAL USE DEVICES

1. The authority citation for 21 CFR

part 880 continues to read as follows:

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

360j, 371.

2. Section 880.5965 is added to

subpart F to read as follows:

§ 880.5965 Subcutaneous, implanted,

intravascular infusion port and catheter.

(a) Identification. A subcutaneous,

implanted, intravascular infusion port

and catheter is a device that consists of

a subcutaneous, implanted reservoir

that connects to a long-term

intravascular catheter. The device

allows for repeated access to the

vascular system for the infusion of

fluids and medications and the

sampling of blood. The device consists

of a portal body with a resealable

septum and outlet made of metal,

plastic, or combination of these

materials and a long-term intravascular

catheter is either preattached to the port

or attached to the port at the time of

device placement. The device is

available in various profiles and sizes

and can be of a single or multiple lumen

design.

(b) Classification. Class II (special

controls) Guidance Document:

‘‘Guidance on 510(k) Submissions for

Implanted Infusion Ports,’’ FDA October

1990.

3. Section 880.5970 is added to

subpart F to read as follows:

§ 880.5970 Percutaneous, implanted, longterm intravascular catheter.

(a) Identification. A percutaneous,

implanted, long-term intravascular

catheter is a device that consists of a

slender tube and any necessary

connecting fittings, such as luer hubs,

and accessories that facilitate the

placement of the device. The device

allows for repeated access to the

vascular system for long-term use of 30

days or more, and it is intended for

administration of fluids, medications,

and nutrients; the sampling of blood;

and monitoring blood pressure and

temperature. The device may be

constructed of metal, rubber, plastic,

composite materials, or any

combination of these materials and may

be of single or multiple lumen design.

(b) Classification. Class II (special

controls) Guidance Document:

‘‘Guidance on Premarket Notification

[510(k)] Submission for Short-Term and

Long-Term Intravascular Catheters.’’

Dated: May 23, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–14698 Filed 6–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 206

RIN 1010–AC09

Approved Publications and Tables for

Use in Applying Revised Royalty

Valuation Regulations for Federal Oil

AGENCY: Minerals Management Service,

Interior.

ACTION: Notice of approved

publications.

SUMMARY: As required by revised

Federal oil valuation regulations, the

Minerals Management Service (MMS)

has approved three spot price

publications that royalty payors should

use to value oil produced from Federal

leases not sold at arm’s length.

EFFECTIVE DATE: June 1, 2000.

ADDRESSES: See FOR FURTHER

INFORMATION CONTACT section below.

FOR FURTHER INFORMATION CONTACT:

David Domagala, Royalty Valuation

Division, Royalty Management Program,

Minerals Management Service, P.O. Box

25165, Mail Stop 3151, Denver,

Colorado 80225, telephone number

(303) 275–7255 or fax number (303)

275–7227.

SUPPLEMENTARY INFORMATION: MMS

published its revised regulations

establishing oil value for royalty due on

Federal leases in the Federal Register

on March 15, 2000 (65 FR 14022),

effective June 1, 2000. The primary

changes in the revised regulations affect

Federal lessees who value oil not sold

at arm’s length. The rule provides that

the primary means of valuing crude oil

not sold at arm’s length is an adjusted

spot price, except in the Rocky

Mountain Region, where use of an

adjusted spot price for valuation

purposes is the third valuation

benchmark (30 CFR 206.103(b)(4))(65

FR 14091). The applicable spot price is

the one for the oil most closely

representing the lease production in

terms of physical proximity and quality

parameters. The lessee may select the

spot price from any MMS-approved

publication; however, once the lessee

selects a publication for a geographical

area (California/Alaska, the Rocky

Mountain Region, or the rest of the

country), it must continue to use that

same publication for 2 years in that area.

In § 206.104 of the final rule (65 FR

14092) for establishing oil value for

royalty due on Federal leases, MMS

explained that ‘‘approved publications’’

must be:

(1) Publications buyers and sellers

frequently use;

(2) Publications frequently mentioned

in purchase or sales contracts;

(3) Publications that use adequate

survey techniques, including

development of spot price estimates

based on daily surveys of buyers and

sellers of Alaska North Slope (ANS) and

other crude oil; and

(4) Publications independent from

MMS, other lessors, and lessees.

Additionally, MMS established that:

(1) Any publication may petition

MMS to be added to the published list

of acceptable publications.

(2) MMS will reference the tables a

lessee must use in the approved

publications to determine the associated

index prices.

(3) MMS may revoke its approval of

a particular publication if it determines

that the prices published in the

publication do not accurately represent

spot market values.

MMS has verified that the

publications listed below meet approval

criteria based on input from staff of the

publication itself, as well as information

from marketers, auditors and industry

consultants. MMS also examined and

compared historical published spot

prices from all three of the approved

publications to ensure comparability

and consistency. The approved

publications and applicable tables are as

follows:

• Platt’s Oilgram Price Report (The

same spot prices appear in Platt’s Global

Alert, Platt’s Crude Oil Marketwire, and

the soon-to-be-published Platt’s U.S.

Crudewire.) Use the spot prices found in

the ‘‘Crude Price Assessments’’ section.

• Petroleum Argus Americas Crude

(The same spot prices appear in Argus

Crude, Argus Americas Crude Datafile,

Argus Crude Datafile.) Use the spot

prices found in the ‘‘WTI Cushing,’’ ‘‘US

Gulf Coast,’’ ‘‘US Midcontinent,’’ and

‘‘US West Coast’’ sections.

• Bloomberg Oil Buyers Guide

Petroleum Price Supplement (The same

spot prices appear on the Bloomberg

Energy Web Site, and in Bloomberg

Professional.) Use the spot prices found

in the ‘‘Worldwide Crude Price

Snapshot’’ section.

If any of these entities use identical

spot price quotes in other of their

publications or distributions (such as

electronic bulletin boards, newsletters,

etc.), they are also approved. MMS will

37044 Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Rules and Regulations

monitor these three publications to

ensure that they continue to meet the

approval criteria.

Representatives of any other

publication who wish to obtain MMS

approval of their publication may

contact MMS at the address shown

above in the FOR FURTHER INFORMATION

CONTACT section.

Dated: June 6, 2000.

Lucy Querques Denett,

Associate Director for Royalty Management.

[FR Doc. 00–14778 Filed 6–12–00; 8:45 am]

BILLING CODE 4310–MR–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD05–00–016]

RIN 2115–AA97

Safety Zone; Chickahominy River, VA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone for

the Two Rivers Yacht Club fireworks

display to be held at Barret’s Point at the

mouth of the Chickahominy River,

Williamsburg, Virginia. This action will

restrict vessel traffic on the

Chickahominy River within a 500-foot

radius of the fireworks display, which

will be fired from shore. The safety zone

is necessary to protect mariners and

spectators from the hazards associated

with the fireworks display.

DATES: This rule is effective from 8 p.m.

until 11:30 p.m. on July 4, 2000.

ADDRESSES: You may mail comments

and related material to USCG Marine

Safety Office Hampton Roads, 200

Granby Street, Norfolk, VA, or deliver

them to the same address between 8

a.m. and 4 p.m., Monday through

Friday, except Federal Holidays. USCG

Marine Safety Office Hampton Roads

maintains the public docket for this

rulemaking. Comments and materials

received from the public, as well as

documents indicated in this preamble as

being available in the docket, will

become part of this docket and will be

available for inspection or copying at

the above address between 8 a.m. and 4

p.m., Monday through Friday, except

Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Chief Petty Officer Roddy Corr, project

officer, USCG Marine Safety Office

Hampton Roads, telephone number

(757) 441–3290.

SUPPLEMENTARY INFORMATION:

Request for Comments

Although this rule is being published

as a temporary final rule without prior

notice, an opportunity for public

comment is nevertheless desirable to

ensure the rule is both reasonable and

workable. Accordingly, we encourage

you to submit comments and related

material. If you do so, please include

your name and address, identify the

docket number (CGD05–00–016),

indicate the specific section of this

document to which each comment

applies, and give the reason for each

comment. Please submit all comments

and related material in an unbound

format, no larger than 8.5 by 11 inches,

suitable for copying. If you would like

to know if they reached us, please

enclose a stamped, self-addressed

postcard or envelope.

Regulatory Information

We did not publish a notice of

proposed rulemaking (NPRM) for this

regulation. Under 5 U.S.C. 553(b)(B), the

Coast Guard finds that good cause exists

for not publishing an NPRM. We were

not notified of the event with sufficient

time to publish an NPRM, allow for

comments, and publish a final rule in

sufficient time to allow notice to the

public for the fireworks display. In

previous years, this event and similar

ones have been held without incident

and without comment from the public

regarding the Coast Guard’s

establishment of limited safety zones

around fireworks displays.

Background and Purpose

The Coast Guard is establishing a

temporary safety zone for the Two

Rivers Yacht Club fireworks display to

be held at Barret’s Point, at the mouth

of the Chickahominy River,

Williamsburg, Virginia. The safety zone

will restrict vessel traffic on the

Chickahominy River within a 500-foot

radius of the fireworks display, which

will be fired from shore, in approximate

position 37° 14.51′ N, 076° 52.10′ W.

The safety zone is necessary to protect

mariners and spectators from the

hazards associated with the fireworks

display.

The safety zone is effective from 8

p.m. until 11:30 p.m. on July 4, 2000.

Additional public notifications will be

made prior to the event via marine

information broadcasts.

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

temporary final rule only affects a

limited area for three and a half hours,

alternative routes exist for maritime

traffic, and advance notification via

marine information broadcasts will

enable mariners to plan their transit to

avoid entering the restricted area. The

Coast Guard expects the economic

impact of this rule to be so minimal that

a full regulatory evaluation under

paragraph 10(e) of the regulatory

policies and procedures of the DOT is

unnecessary.

Small Entities

Under the Regulatory Flexibility Act

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

considered whether this rule would

have a significant economic impact on

a substantial number of small entities.

The term ‘‘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 of 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 rule will affect the following

entities, some of which might be small

entities: the owners or operators of

vessels intending to operate or anchor in

portions of the Chickahominy River

within 500 feet of a shoreside fireworks

display at Barret’s Point, located at the

mouth of the Chickahominy River in

approximate position 37° 14.51′ N, 076°

52.10′ W.

This safety zone will not have a

significant economic impact on a

substantial number of small entities for

the following reasons: This temporary

final rule only affects a limited area for

three and a half hours, alternative routes

exist for maritime traffic, and advance

notification via marine information

broadcasts will enable mariners to plan

their transit to avoid entering the

restricted area.

Collection of Information

This rule calls for no new collection

of information under the Paperwork

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

et seq.).

Federalism

We have analyzed this rule under

Executive Order 13132 and have