Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Rules and Regulations 70305

The Rule

This action amends part 71 by

establishing VOR Federal Airway V–457

in Alaska. Presently, there is an

uncharted nonregulatory route using the

same routings as the V–457 which

becomes effective January 25, 2001. The

FAA is establishing V–457 for the

following reasons: (1) The conversion of

this uncharted nonregulatory route to a

VOR Federal airway adds to the IFR

airway and route infrastructure in

Alaska; (2) pilots will be provided with

minimum en route altitudes and

minimum obstruction clearance

altitudes information; (3) this

amendment establishes controlled

airspace, thus eliminating some of the

commercial IFR operations in

uncontrolled airspace; and (4) the

addition of this route improves the

management of air traffic operations and

thereby enhance safety.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this regulation: (1) Is

not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule, when

promulgated, will not have a significant

economic impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

Alaskan VOR Federal airways are

published in paragraph 6010(b) of FAA

Order 7400.9H dated September 1, 2000,

and effective September 16, 2000, which

is incorporated by reference in 14 CFR

71.1. The Alaskan VOR Federal airway

listed in this document will be

published subsequently in the order.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Rule

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

Paragraph 6010(b) Alaskan VOR Federal

Airways

* * * * *

V–457 [New]

From Iliamna, AK, NDB; to Kenai, AK.

* * * * *

Issued in Washington, DC, on November

15, 2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–29906 Filed 11–21–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 00N–1565]

Immunology and Microbiology

Devices; Classification of AntiSaccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Test

Systems

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

Anti-Saccharomyces cerevisiae (S.

cerevisiae) antibody (ASCA) test system

into class II (special controls). The

special control that will apply to this

device is a guidance document entitled

‘‘Guidance for Industry and FDA

Reviewers: Class II Special Control

Guidance Document for AntiSaccharomyces cerevisiae (S. cerevisiae)

Antibody (ASCA) Premarket

Notifications.’’ Elsewhere in this issue

of the Federal Register, FDA is

announcing the availability of this

guidance document. The agency is

taking this action in response to a

petition submitted under the Federal

Food, Drug, and Cosmetic Act (the act)

as amended by the Medical Device

Amendments of 1976, the Safe Medical

Devices Act of 1990, and the Food and

Drug Administration Modernization Act

of 1997. The agency is classifying these

devices into class II (special controls) in

order to provide a reasonable assurance

of the safety and effectiveness of the

devices.

DATES: This rule is effective December

22, 2000.

FOR FURTHER INFORMATION CONTACT:

Deborah M. Moore, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–1293.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976, generally referred

to as postamendments devices, are

classified automatically by statute into

class III without any FDA rulemaking

process. These devices remain in class

III and require premarket approval,

unless and until the device is classified

or reclassified into class I or II or 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

marketed devices by means of

premarket notification procedures in

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

360(k)) and 21 CFR part 807 of the FDA

regulations.

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1) of the act, request FDA

to classify the device under the criteria

set forth in section 513(a)(1) of the act.

FDA shall, within 60 days of receiving

such a request, classify the device by

written order. This classification shall

be the initial classification of the device.

Within 30 days after the issuance of an

order classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.

70306 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Rules and Regulations

In accordance with section 513(f)(1) of

the act, FDA issued an order on July 11,

2000, classifying the QUANTA LiteTM

ASCA (S. cerevisiae) IgG ELISA in class

III, because it was not substantially

equivalent to a device that was

introduced or delivered for introduction

into interstate commerce for commercial

distribution before May 28, 1976, or a

device which was subsequently

reclassified into class I or class II. On

July 18, 2000, FDA filed a petition

submitted by INOVA Diagnostics, Inc.,

requesting classification of the

QUANTA LiteTM ASCA (S. cerevisiae)

IgG ELISA into class II under section

513(f)(2) of the act.

After review of the information

submitted in the petition, FDA

determined that the INOVA Diagnostics

QUANTA LiteTM ASCA (S. cerevisiae)

IgG ELISA can be classified in class II

with the establishment of special

controls. This device is intended for use

in the semi-quantitative in vitro

determination of anti-Saccharomyces

cerevisiae (S. cerevisiae) antibodies

(ASCA) in human serum as an aid in the

diagnosis of Crohn’s disease. FDA

believes that class II special controls, in

addition to the general controls, will

provide reasonable assurance of the

safety and effectiveness of the device.

In addition to the general controls of

the act, the INOVA Diagnostics

QUANTA LiteTM ASCA (S. cerevisiae)

IgG ELISA is subject to a special control

guidance document entitled ‘‘Guidance

for Industry and FDA Reviewers: Class

II Special Control Guidance for AntiSaccharomyces cerevisiae (S. cerevisiae)

Antibody (ASCA) Premarket

Notifications.’’

Section 510(m) of the act provides

that FDA may exempt a class II device

from the premarket notification

requirements under section 510(k) of the

act, if FDA determines that premarket

notification is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. FDA has

determined that premarket notification

is necessary to provide reasonable

assurance of the safety and effectiveness

of this type of device and, therefore, the

device is not exempt from the premarket

notification requirements. The test is

used in the diagnosis of Crohn’s disease

and FDA review of data sets and

labeling ensure that minimum levels of

performance are obtained before

marketing and are subject to impartial

external quality control before labeling

is put into place. Thus, persons who

intend to market this device must

submit to FDA a premarket notification

submission containing information on

the anti-Saccharomyces cerevisiae (S.

cerevisiae) antibody (ASCA) test system

before marketing the device.

On August 16, 2000, FDA issued an

order to the petitioner classifying the

INOVA Diagnostics QUANTA LiteTM

ASCA (S. cerevisiae) IgG ELISA, and

substantially equivalent devices of this

generic type, into class II under the

generic name, anti-Saccharomyces

cerevisiae (S. cerevisiae) antibody

(ASCA) test system. FDA identifies this

generic type of device as an antiSaccharomyces cerevisiae (S. cerevisiae)

antibody (ASCA) test system, which is

intended to measure Saccharomyces

cerevisiae (S. cerevisiae) antibodies

(ASCA) in human serum or plasma as

an aid in the diagnosis of Crohn’s

disease. FDA is codifying this device by

adding § 866.5785. This order also

identified a special control applicable to

this device entitled ‘‘Guidance for

Industry and FDA Reviewers: Class II

Special Control Guidance for AntiSaccharomyces cerevisiae (S. cerevisiae)

Antibody (ASCA) Premarket

Notifications.’’

II. 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.

III. Analysis 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 it 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. FDA knows of only one

manufacturer of this type of device.

Classification of these devices in class II

will relieve this manufacturer of the

device of the cost of complying with the

premarket approval requirements of

section 515 of the act (21 U.S.C. 360e)

and may permit small potential

competitors to enter the market place by

lowering their costs. The agency,

therefore, certifies that this final rule

will not have a significant economic

impact on a substantial number of small

entities.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requires

that agencies prepare a written

statement of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation). The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the final rule, because the

final rule is not expected to result in any

1-year expenditure that would exceed

$100 million.

IV. 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, or 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.

V. Paperwork Reduction Act of 1995

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 866

Biologics, Laboratories, 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 866 is

amended as follows:

PART 866—IMMUNOLOGY AND

MICROBIOLOGY DEVICES

1. The authority citation for 21 CFR

part 866 continues to read as follows:

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Rules and Regulations 70307

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

360j, 371.

2. Section 866.5785 is added to

subpart F to read as follows:

§ 866.5785 Anti-Saccharomyces cerevisiae

(S. cerevisiae) antibody (ASCA) test

systems.

(a) Identification. The AntiSaccharomyces cerevisiae (S. cerevisiae)

antibody (ASCA) test system is an in

vitro diagnostic device that consists of

the reagents used to measure, by

immunochemical techniques, antibodies

to S. cerevisiae (baker’s or brewer’s

yeast) in human serum or plasma.

Detection of S. cerevisiae antibodies

may aid in the diagnosis of Crohn’s

disease.

(b) Classification. Class II (special

controls). The special control is FDA’s

‘‘Guidance for Industry and FDA

Reviewers: Class II Special Control

Guidance Document for AntiSaccharomyces cerevisiae (S. cerevisiae)

Antibody (ASCA) Premarket

Notifications.’’

Dated: November 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29841 Filed 11–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Part 645

[FHWA Docket No. FHWA–99–6232]

RIN 2125–AE68

Utilities

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Final rule.

SUMMARY: The FHWA is issuing a final

rule amending its regulation prescribing

policies, procedures, and

reimbursement provisions for the

relocation and adjustment of existing

utility facilities, and for the

accommodation of new utility facilities

and private lines on the right-of-way of

Federal-aid and direct Federal highway

projects. These amendments will bring

the FHWA’s utilities regulation into

conformance with recent laws,

regulations, or guidance, and will

provide State transportation

departments (STDs) clarification and

more flexibility in implementing it.

DATES: This final rule is effective

January 22, 2001.

FOR FURTHER INFORMATION CONTACT: Mr.

Paul Scott, Office of Program

Administration, HIPA–20, (202) 366–

4104; or Mr. Reid Alsop, Office of the

Chief Counsel, HCC–31, (202) 366–0791,

Federal Highway Administration, 400

Seventh Street, SW., Washington, D.C.

20590–0001. Office hours are from 7:45

a.m. to 4:15 p.m., e.t., Monday through

Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

Internet users may access all

comments received by the U.S. DOT

Dockets, Room PL–401, by using the

universal resource locator (URL):

http://dms.dot.gov. It is available 24

hours each day, 365 days each year.

Please follow the instructions online for

more information and help.

An electronic copy of this document

may be downloaded by using a modem

and suitable communications software

from the Government Printing Office’s

Electronic Bulletin Board Service at

(202) 512–1661. Internet users may

reach the Office of the Federal Register’s

home page at: http://www.nara.gov/

fedreg and the Government Printing

Office’s database at: http://

www.access.gpo.gov/nara.

Background

The amendments in this final rule are

based primarily on the notice of

proposed rulemaking (NPRM) published

at 65 FR 6344 on February 9, 2000

(FHWA Docket No. FHWA–99–6232).

All comments received in response to

this NPRM have been considered in

adopting these amendments.

Present FHWA regulations regarding

utility relocation and accommodation

matters have evolved from basic

principles established decades ago, with

many of the policies remaining

unchanged. The present regulations are

found at 23 CFR part 645. Subpart A of

this part pertains to utility relocations,

adjustments, and reimbursement.

Subpart B pertains to the

accommodation of utilities.

The utility regulations were revised

on May 15, 1985, when a final rule was

published at 50 FR 20344. Three

significant changes have occurred since

then, on February 2 and July 1, 1988,

when amendments to the regulation

were published at 53 FR 2829 and 53 FR

24932; and on July 5, 1995, when a final

rule was published at 60 FR 34846.

The February 2, 1988, amendment

provided that each State must decide, as

part of its utility accommodation plan,

whether to allow longitudinal utility

installations within the access control

limits of freeways and if allowed under

what circumstances.

The July 1, 1988, amendment clarified

that costs incurred by highway agencies

in implementing projects solely for

safety corrective measures to reduce the

hazards of utilities to highway users are

eligible for Federal-aid participation.

The July 5, 1995, amendment

eliminated the requirement for FHWA

pre-award review and/or approval of

consultant contracts for preliminary

engineering; increased the ceiling for

lump sum agreements from $25,000 to

$100,000; clarified the meaning of the

term ‘‘approved program’’ and the

methodology to be used to compute

indirect or overhead rates; required

utilities to submit final billings within

one year following completion of the

utility relocation work; eliminated the

certification of completed utility work

and the requirement for evidence of

payment prior to reimbursement;

brought the definition of ‘‘clear zone’’

into conformance with the American

Association of State Highway and

Transportation Officials (AASHTO)

‘‘Roadside Design Guide’’; and

conformed the utilities regulations to

the Intermodal Surface Transportation

Efficiency Act of 1991 (ISTEA), Public

Law 102–240, 105 Stat. 1914.

This final rule amends the regulation

as follows:

• Incorporates an amendment

conforming the utilities regulations to

the Transportation Equity Act for the

21st Century (TEA–21), Public Law

105–178, 112 Stat. 107.

• Eliminates the $100,000 upper limit

for lump-sum agreements.

• Allows reimbursement for utility

relocations to be based upon unit costs.

• Clarifies the intent of the regulation

requiring utilities to submit final

billings within one year following

completion of work.

• Deletes the provision encouraging

STDs to adopt the alternate procedure

for utilities.

• States that the most important

consideration in determining whether a

proposed facility is a utility or not, is

how the STD views it under its own

State laws and/or regulations.

• Eliminates a confusing provision to

clarify the intent that the utility

regulations are not applicable to

longitudinal installations of private

lines.

Discussion of Comments

Interested persons were invited to

participate in the development of this

final rule by submitting written

comments in response to the NPRM in

Docket No. FHWA–99–6232 on or

before April 10, 2000. Comments were

received from 6 STDs and 1 utility

company. A summary of the comments