Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations 62285

* * * * *

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26248 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 00P–1280]

Medical Devices; Exemption From

Premarket Notification; Class II

Devices; Triiodothyronine Test System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is publishing an

order granting a petition requesting

exemption from the premarket

notification requirements for the

triiodothyronine test system with

certain limitations. This rule will

exempt from premarket notification the

triiodothyronine test system intended

for measuring the hormone

triiodothyronine in serum and plasma.

FDA is publishing this order in

accordance with procedures established

by the Food and Drug Administration

Modernization Action of 1997

(FDAMA).

DATES: This rule is effective October 18,

2000.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for

Devices, and Radiological Health (HFZ–

404), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal

Food, and Drug, and Cosmetic Act (the

act) (21 U.S.C. 360c), FDA must classify

devices into one of three regulatory

classes: Class I, class II, or class III. The

FDA classification of a device is

determined by the amount of regulation

necessary to provide a reasonable

assurance of safety and effectiveness.

Under the Medical Device Amendments

of 1976 (the 1976 amendments (Public

Law 94–295)), as amended by the Safe

Medical Devices Act of 1990 (the SMDA

(Public Law 101–629)), devices are to be

classified into class I (general controls)

if there is information showing that the

general controls of the act are sufficient

to ensure safety and effectiveness; into

class II (special controls), if general

controls, by themselves, are insufficient

to provide reasonable assurance of

safety and effectiveness, but there is

sufficient information to establish

special controls to provide such

assurance; and into class III (premarket

approval), if there is insufficient

information to support classifying a

device into class I or class II and the

device is a life-sustaining or lifesupporting device or is for a use that is

of substantial importance in preventing

impairment of human health, or

presents a potential unreasonable risk of

illness or injury.

Most generic types of devices that

were on the market before the date of

the 1976 amendments (May 28, 1976)

(generally referred to as preamendments

devices) have been classified by FDA

under the procedures set forth in section

513(c) and (d) of the act through the

issuance of classification regulations

into one of these three regulatory

classes. Devices introduced into

interstate commerce for the first time on

or after May 28, 1976, (generally

referred to as postamendments devices)

are classified through the premarket

notification process under section

510(k) of the act (21 U.S.C. 360(k)).

Section 510(k) of the act and the

implementing regulations, 21 CFR part

807, require persons who intend to

market a new device to submit a

premarket notification report (510(k))

containing information that allows FDA

to determine whether the new device is

substantially equivalent within the

meaning of section 513(i) of the act to

a legally marketed device that does not

require premarket approval.

On November 21, 1997, the President

signed into law FDAMA (Public Law

105–115). Section 206 of FDAMA, in

part, added a new section 510(m) to the

act. Section 510(m)(1) of the act requires

FDA, within 60 days after enactment of

FDAMA, to publish in the Federal

Register a list of each type of class II

device that does not require a report

under section 510(k) of the act to

provide reasonable assurance of safety

and effectiveness. Section 510(m) of the

act further provides that a 510(k) will no

longer be required for these devices

upon the date of publication of the list

in the Federal Register. FDA published

that list in the Federal Register of

January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the act provides

that 1 day after date of publication of

the list under section 510(m)(1), FDA

may exempt a device on its own

initiative or upon petition of an

interested person, if FDA determines

that a 510(k) is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. This section

requires FDA to publish in the Federal

Register a notice of intent to exempt a

device, or of the petition, and to provide

a 30-day comment period. Within 120

days of publication of this document,

FDA must publish in the Federal

Register its final determination

regarding the exemption of the device

that was the subject of the notice. If FDA

fails to respond to a petition under this

section within 180 days of receiving it,

the petition shall be deemed granted.

II. Criteria for Exemption

There are a number of factors FDA

may consider to determine whether a

510(k) is necessary to provide

reasonable assurance of the safety and

effectiveness of a class II device. These

factors are discussed in the guidance the

agency issued on February 19, 1998,

entitled ‘‘Procedures for Class II Device

Exemptions from Premarket

Notification, Guidance for Industry and

CDRH Staff.’’ That guidance can be

obtained through the Internet on the

CDRH home page at http://

www.fda.gov/cdrh or by facsimile

through CDRH Facts-on-Demand at 1–

800–899–0381 or 301–827–0111.

Specify ‘‘159’’ when prompted for the

document shelf number.

III. Petition

On April 26, 2000, FDA received a

petition requesting an exemption from

premarket notification for the

triiodothyronine test system. The

triiodothyronine test system is currently

classified under 21 CFR 862.1710. In the

Federal Register of July 11, 2000 (65 FR

42706), FDA published a notice

announcing that this petition had been

received and provided an opportunity

for interested persons to submit

comments on the petition by August 10,

2000. FDA received no comments. FDA

has reviewed the petition and has

determined that the triiodothyronine

test system intended for measuring the

hormone triiodothyronine in serum and

plasma does meet the criteria for

exemption from the notification

requirements. This is the only type of

triiodothyronine test system of which

FDA presently has any knowledge. The

exemption is limited to triiodothyronine

test systems of the type described and

is also subject to the general limitations

on exemptions from premarket

notification for clinical chemistry and

clinical toxicology devices as described

in 21 CFR 870.9. For example, the

exemption will not apply to devices of

this type that present new indications,

novel designs, or alternative materials.

The exemption also will not apply if the

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