Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Rules and Regulations 37041

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 175 is

amended as follows:

PART 175—INDIRECT FOOD

ADDITIVES: ADHESIVES AND

COMPONENTS OF COATINGS

1. The authority citation for 21 CFR

part 175 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

§ 175.300 [Amended]

2. Section 175.300 Resinous and

polymeric coatings is amended in

paragraph (b)(3)(xxxiii), under the entry

‘‘5-Chloro-2-methyl * * *’’, by

removing ‘‘(CAS Reg. No. 2628–20–4)’’

and adding in its place ‘‘(CAS Reg. No.

2682–20–4)’’.

3. Section 175.320 is amended in the

table in paragraph (b)(3) by revising the

entry under item (iii) for ‘‘5–Chloro-2-

methyl-4-isothiazolin-3-one’’ under the

headings ‘‘List of substances’’ and

‘‘Limitations’’ to read as follows:

§ 175.320 Resinous and polymeric

coatings for polyolefin films.

* * * * *

(b) * * *

(3) * * *

List of substances Limitations

*******

(iii) Adjuvants (release agents, waxes, and dispersants):

*******

5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4)

and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture, at a ratio of 3 parts to 1 part, respectively, manufactured from

methyl-3-mercaptopropionate (CAS Reg. No. 2935–90–2) and optionally containing magnesium nitrate (CAS Reg. No. 10377–60–3) at a

concentration equivalent to the isothiazolone active ingredients

(weight/weight).

For use only as an antimicrobial agent in emulsion-based silicone

coatings at a level not to exceed 50 milligrams per kilogram (based

on isothiazolone active ingredient) in the coating formulation.

*******

* * * * *

Dated: June 7, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–14905 Filed 6–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 99N–2099]

General Hospital and Personal Use

Devices; Classification of the

Subcutaneous, Implanted,

Intravascular Infusion Port and

Catheter and the Percutaneous,

Implanted, Long-term Intravascular

Catheter

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

subcutaneous, implanted, intravascular

(IV) infusion port and catheter, and the

percutaneous, implanted, long-term IV

catheter intended for repeated vascular

access into class II (special controls).

This action is being taken to establish

sufficient regulatory controls that will

provide reasonable assurance of the

safety and effectiveness of these devices.

DATES: This rule is effective July 13,

2000.

FOR FURTHER INFORMATION CONTACT: M.

Patricia Cricenti, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1287.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et. seq.), as

amended by the Medical Device

Amendments of 1976 (the 1976

amendments) (Public Law 94–295), the

Safe Medical Devices Act of 1990 (the

SMDA) (Public Law 101–629), and the

Food and Drug Administration

Modernization Act of 1997 (FDAMA)

(Public Law 105-115), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until: (1) The device is

reclassified into class I or II; (2) FDA

issues an order classifying the device

into class I or II in accordance with

section 513(f)(2) of the act, as amended

by FDAMA; or (3) FDA issues an order

finding the device to be substantially

equivalent, in accordance with section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

37042 Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Rules and Regulations

(21 U.S.C. 360(k)) and 21 CFR part 807

of the regulations.

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

the act (21 U.S.C. 360e(b)) requiring

premarket approval.

Consistent with the act and the

regulations, FDA consulted with the

General Hospital and Personal Use

Devices Panel (the Panel), an FDA

advisory committee, regarding the

classification of these devices.

II. Regulatory History of the Devices

In the Federal Register of October 1,

1999 (64 FR 53294), FDA issued a

proposed rule to classify the

subcutaneous, implanted, IV infusion

port and catheter, and the percutaneous,

implanted, long-term IV catheter

intended for repeated vascular access

into class II. Interested persons were

given until December 30, 1999, to

comment on the proposed regulation.

In 1980, when other general hospital

and personal use devices were classified

(45 FR 69678, October 21, 1980), FDA

was not aware that these two vascular

access devices (the subcutaneous,

implanted, IV infusion port and catheter

and the percutaneous, implanted, longterm IV catheter) intended for repeated

vascular access were preamendments

devices, and inadvertently omitted

classifying them.

FDA received one comment from a

manufacturer who concurred with the

proposed rule to classify the devices

into class II. FDA agrees with the

comment.

III. Summary of Final Rule

Based on the Panel’s recommendation

(Ref. 1), FDA is classifying the

subcutaneous, implanted, IV infusion

port and catheter and the percutaneous,

implanted, long-term IV catheter

intended for repeated vascular access

into class II. FDA has determined that

existing premarket notification FDA

guidance documents, ‘‘Guidance on

510(k) Submissions for Implanted

Infusion Ports’’ (Ref. 2) and ‘‘Guidance

on Premarket Notification [510(k)]

Submission for Short-Term and LongTerm Intravascular Catheters’’ (Ref. 3)

are adequate special controls capable of

providing reasonable assurance of safety

and effectiveness with regard to the

identified risks to health of these

devices. The Panel also recommended

including the prescription statement

(§ 801.109 (21 CFR 801.109)) as a special

control. Because this prescription

statement is already required by

§ 801.109, FDA believes it is

unnecessary to list prescription labeling

as a special control for these devices.

IV. Summary of the Reasons for the

Recommendations

Therefore, under section 513 of the

act, FDA is adopting the summary of

reasons for the Panel’s recommendation

and the summary of data upon which

the Panel’s recommendation is based

(Ref. 1), and it is also adopting the

assessment of the risks to public health

stated in the proposed rule published on

October 1, 1999. Furthermore, FDA is

issuing this final rule which classifies

the generic types of devices, the

subcutaneous, implanted, IV infusion

port and catheter, and the percutaneous,

implanted, long-term IV catheter

intended for repeated vascular access

into class II.

V. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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.

VI. 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. As unclassified devices, these

devices are already subject to premarket

notification and the general labeling

provisions of the act. FDA, therefore,

believes that classification in class II

with premarket notification guidances

as special controls will impose no

significant economic impact on any

small entities. The agency therefore

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities. In

addition, this final rule will not impose

costs of $100 million or more on either

the private sector or State, local, and

tribal governments in the aggregate, and

therefore a summary statement or

analysis under section 202(a) of the

Unfunded Mandates Reform 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.

VIII. 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.

IX. References

The following references have been

placed on display in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

These references may be seen by

interested persons between 9 a.m. and 4

p.m., Monday through Friday.

1. General Hospital and Personal Use

Devices Panel, thirtieth meeting,

transcript, March 11, 1996.

2. ‘‘Guidance on 510(k) Submissions

for Implanted Infusion Ports,’’ FDA,

October 1990.

3. ‘‘Guidance on Premarket

Notification [510(k)] Submission for

Short-Term and Long-Term

Intravascular Catheters,’’ FDA, March

1995.

List of Subjects in 21 CFR Part 880

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

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