Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66005

substantial number of small entities.

This final rule also does not trigger the

requirement for a written statement

under section 202(a) of the Unfunded

Mandates Reform Act because it does

not impose a mandate that results in an

expenditure of $100 million of more by

State, local, or tribal governments in the

aggregate, or by the private sector, in

any 1 year.

IV. References

The following references have been placed

on display in the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr., rm. 1–

23, Rockville, MD 20857, and may be seen by

interested persons between 9 a.m. and 4 p.m.,

Monday through Friday.

1. FDA letter (order) to Centocor, Inc.,

dated September 19, 1996.

2. Guidance Document for the Submission

of Tumor Associated Antigen Premarket

Notifications (510(k)) to FDA, September 19,

1996.

3. The National Committee for Clinical

Laboratory Standards: Document EP5–T2,

Evaluation of Precision Performance of

Clinical Chemistry Devices; Document EP9–

A, Method Comparison and Bias Estimation

Using Patient Samples; Document EP7–P,

Interference Testing in Clinical Chemistry.

List of Subjects in 21 CFR Part 866

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:

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

360j, 371.

2. Section 866.6010 is revised to read

as follows:

§ 866.6010 Tumor-associated antigen

immunological test system.

(a) Identification. A tumor-associated

antigen immunological test system is a

device that consists of reagents used to

qualitatively or quantitatively measure,

by immunochemical techniques, tumorassociated antigens in serum, plasma,

urine, or other body fluids. This device

is intended as an aid in monitoring

patients for disease progress or response

to therapy or for the detection of

recurrent or residual disease.

(b) Classification. Class II (special

controls). Tumor markers must comply

with the following special controls: (1)

A guidance document entitled

‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications

(510(k)s) to FDA,’’ and (2) voluntary

assay performance standards issued by

the National Committee on Clinical

Laboratory Standards.

Dated: November 6, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–32876 Filed 12–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD05–97–009]

RIN 2115–AE47

Drawbirdge Operation Regulations;

Pasquotank River, Elizabeth City,

North Carolina

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is changing

the regulations that govern the operation

of the Highway 158 drawbridge across

the Pasquotank River, mile 50.7, at

Elizabeth City, North Carolina, by

eliminating bridge openings for pleasure

vessels from Monday through Friday

between 7 a.m. and 9 a.m., and 4 p.m.

and 6 p.m., except that, openings will be

scheduled at 7:30 and 8:30 a.m., and

4:30 and 5:30 p.m. for any waiting

pleasure vessels. This rule is intended

to help relieve automobile traffic

congestion during the morning and

afternoon rush hours, while still

providing for the reasonable needs of

navigation.

DATES: This final rule is effective

January 16, 1998.

ADDRESSES: Documents as indicated in

this preamble are available for

inspection or copying at the office of the

Commander (Aowb), Fifth Coast Guard

District, Federal Building, 4th Floor, 431

Crawford Street, Portsmouth, Virginia

23704–5004, between 8 a.m. and 4:30

p.m., Monday through Friday, except

Federal holidays. The telephone number

is (757) 398–6222.

FOR FURTHER INFORMATION CONTACT:

Ann B. Deaton, Bridge Administrator,

Fifth Coast Guard District, at (757) 398–

6222.

SUPPLEMENTARY INFORMATION:

Regulatory History

On July 1, 1997, the Coast Guard

published a Notice of Proposed

Rulemaking (NPRM) entitled

‘‘Drawbridge Operation Regulations;

Pasquotank River, Elizabeth City, North

Carolina’’ in the Federal Register (62 FR

35453). The Coast Guard did not receive

any comments on the proposed

rulemaking. No public hearing was

requested and none was held.

Background and Purpose

The Highway 158 drawbridge across

the Pasquotank River, mile 50.7, at

Elizabeth City, North Carolina is

currently required to open on signal

year round. The City of Elizabeth City,

through the North Carolina Department

of Transportation (NCDOT), requested

permission to restrict drawbridge

openings for pleasure vessels only to

reduce highway traffic congestion

during the morning and evening rush

hours. In support of its request, the

NCDOT contends that 10 years of

records during the period from 1985

through 1995 show that highway traffic

increases have caused excessive

highway congestion.

Prior to publishing the Notice of

Proposed Rulemaking the Coast Guard

reviewed the NCDOT highway traffic

data during the 10 year period from

1985 through 1995, and the drawbridge

opening logs from January 1995 to

December 1995, copies of which are

included in the docket for this

rulemaking. This data supports

NCDOT’s request. According to the 1995

drawbridge logs, 234 openings occurred

between 7 a.m. and 9 a.m. and 235

openings occurred between 4 p.m. and

6 p.m. Thus, the daily average for the

year was 0.6 openings for each of the

proposed restricted periods. Only

during the month of May 1995 were

there more than 2.0 openings during the

time periods in question. During May

1995, an average of 2.6 openings

occurred between 7 a.m. and 9 a.m.

Even though 2.6 openings is not

excessive, NCDOT states that the

random timing of the openings caused

highway traffic to backup four to six

blocks. In support of this contention, the

NCDOT provided highway traffic data

which shows that highway traffic

volumes increased by an average of

between 200 and 300 vehicles during

the morning and evening restricted

periods as compared to other daylight

hours. Based upon this data, the Coast

Guard believes that 2.0 scheduled

openings for pleasures vessels for each

time period is adequate for marine

traffic and should help to reduce

highway traffic congestion.

Discussion of Comment and Changes

The Coast Guard received no

comments on the proposed rulemaking.
66006 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

Therefore, the proposed rule is being

implemented without change.

Regulatory Evaluation

This 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. It has been exempted from review

by the Office of Management and

Budget 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

final rule to be so minimal that a full

Regulatory Evaluation under paragraph

10e of the regulatory policies and

procedures of DOT is unnecessary.

Small Entities

Under the Regulatory Flexibility Act

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

must consider whether this final rule

will have significant economic impact

on a substantial number of small

entities. ‘‘Small entities’’ include

independently owned and operated

small businesses that are not dominant

in their field and that otherwise qualify

as ‘‘small business concerns’’ under

section 3 of the Small Business Act (15

U.S.C. 632). Because it expects the

impact of this rule to be minimal, the

Coast Guard certifies under 5 U.S.C.

605(b) that this final rule will not have

a significant encomic impact on a

substantial number of small entities.

Collection of Information

This final rule contains no collection

of information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism

The Cost Guard has analyzed this

final rule under the principles and

criteria contained in Executive Order

12612, and has determined that this

final rule does not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this final rule

and concluded that under section

2.B.2.e.(32)(e) of Commandant

Instruction M16475.1B (as amended, 59

FR 38654, 29 July 1994), this final rule

is categorically excluded from further

environmental documentation. A

Categorical Exclusion Determination

statement has been prepared and placed

in the rulemaking docket.

List of Subjects in 33 CFR Part 117

Bridges.

Regulations

For the reasons discussed in the

preamble, the Coast Guard amends 33

CFR part 117 as follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. The text of § 117.833 is

redesignated as paragraph (a) and a new

paragraph (b) is added to read as

follows:

§ 117.833 Pasquotank River.

(a) * * *

(b) The draw of the US 158 Highway

Bridge, mile 50.7, at Elizabeth City,

shall open on signal; except that

between 7 a.m. and 9 a.m., and 4 p.m.

and 6 p.m., Monday through Friday, the

draw need open only at 7:30 a.m., 8:30

a.m., 4:30 p.m., and 5:30 p.m. for any

pleasure vessels waiting to pass.

Dated: December 8, 1997.

Roger Rufe, Jr.,

Vice Admiral, U.S. Coast Guard, Commander,

Fifth Coast Guard District.

[FR Doc. 97–32885 Filed 12–16–97; 8:45 am]

BILLING CODE 4910–14–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD05–97–086]

RIN 2115–AE47

Drawbridge Operation Regulations;

Elizabeth River, Eastern Branch

AGENCY: Coast Guard, DOT.

ACTION: Notice of temporary deviation

from regulations.

SUMMARY: The Commander, Fifth Coast

Guard District has issued a temporary

deviation from the regulations

governing the operation of the US 460

(Berkley Bridge) drawbridge across the

Eastern Branch of the Elizabeth River,

mile 0.4, at Norfolk, Virginia. Beginning

December 15, 1997 through January 9,

1998, this deviation restricts bridge

openings between the hours of 9 a.m. to

3:30 p.m., seven days a week. During

these times, vessels requiring bridge lifts

will be required to provide the Berkley

Bridge bridge tender with a two-hour

advance notice. This closure is

necessary to allow the Virginia

Department of Transportation to

conduct an oil change on the major lift

equipment while still providing for the

reasonable needs of navigation.

DATES: This deviation is effective from

December 15, 1997 through January 9,

1998.

FOR FURTHER INFORMATION CONTACT:

Ann B. Deaton, Bridge Administrator,

Fifth Coast Guard District, at (757) 398–

6222.

SUPPLEMENTARY INFORMATION: The

Berkley Bridge is owned and operated

by the Virginia Department of

Transportation (VDOT) and maintained

by the Elizabeth River Tunnels

Department of Maintenance. On

December 1, 1997, VDOT sent a letter to

the Coast Guard requesting a temporary

deviation from the normal operation of

the bridge in order to accommodate the

maintenance work. Presently, the draw

is required to open on signal at any time

except from 5:30 a.m. to 9 a.m. and from

3:30 p.m. to 6:30 p.m., Monday through

Friday, except Federal holidays.

Between the hours of 5:30 a.m. and 9

a.m. and 3:30 p.m. and 6:30 p.m.,

vessels with a draft of 22 feet or more

may request a bridge lift provided at

least 12 hours advance notice is given.

The maintenance work involves

draining and subsequent refilling of oil

in the gear boxes in the major lift

equipment of the US 460 (Berkley

Bridge) drawbridge. Vessels presently

transiting through the Berkley Bridge

during the hours of deviation will not be

negatively impacted since bridge lifts

will be provided with a two-hour

advance notice.

From December 15, 1997 to January 9,

1998, this deviation restricts bridge lifts

of the Berkley Bridge between the hours

of 9 a.m. and 3:30 p.m. seven days a

week. Vessels requiring a bridge lift

during these times will be required to

provide a two-hour advance notice to

the Berkley Bridge bridge tender. All

other provisions of § 117.1007 remain in

effect during the period of the deviation.

Dated: December 8, 1997.

Roger Rufe, Jr.,

Vice Admiral, U.S. Coast Guard, Commander,

Fifth Coast Guard District.

[FR Doc. 97–32884 Filed 12–16–97; 8:45 am]

BILLING CODE 4910–14–M