Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Proposed Rules 27893

dibasic sodium phosphate/monobasic

sodium phosphate oral solution) as a

single daily dose. ‘‘Do not take more

than 45 mL (9 teaspoonfuls or 3

tablespoonfuls) in a 24-hour period.’’

Children 10 and 11 years of age: Oral

dosage is dibasic sodium phosphate

1.71 to 3.78 grams and monobasic

sodium phosphate 4.5 to 10.1 grams (10

to 20 mL dibasic sodium phosphate/

monobasic sodium phosphate oral

solution) as a single daily dose. ‘‘Do not

take more than 20 mL (4 teaspoonfuls)

in a 24-hour period.’’ Children 6 to 9

years of age: Oral dosage is dibasic

sodium phosphate 0.86 to 1.89 gram and

monobasic sodium phosphate 2.2 to

5.05 grams (5 to 10 mL dibasic sodium

phosphate/monobasic sodium

phosphate oral solution) as a single

daily dose. ‘‘Do not take more than 10

mL (2 teaspoonfuls) in a 24-hour

period.’’ Children under 6 years of age:

ask a doctor.

(ii) Rectal enema dosage. (A) Adults

and children 12 years of age and over:

Enema dosage is dibasic sodium

phosphate 6.84 to 7.56 grams and

monobasic sodium phosphate 18.24 to

20.16 grams in a single daily dose.

Children 2 to 11 years of age: Enema

dosage is dibasic sodium phosphate

3.42 to 3.78 grams and monobasic

sodium phosphate 9.12 to 10.08 grams

in a single daily dose. ‘‘Do not use in

children under 2 years of age.’’

(Manufacturers should convert these

dosages to the amount of solution to be

used.)

(B) ‘‘If no urge is felt after 5 minutes

of using, try to empty bowel. Call a

doctor promptly if no liquid comes out

of the rectum after 30 minutes because

dehydration could occur.’’

(C) ‘‘Stop using if tip is hard to insert.

Forcing the tip into the rectum can

cause injury (especially if you have

hemorrhoids). If enema tip causes rectal

bleeding or pain, get immediate medical

care.’’

(6) For products containing dibasic

sodium phosphate identified in

§ 334.16(e). Adults and children 12

years of age and over: Oral dosage is

3.42 to 7.56 grams in a single daily dose.

Children 10 to 11 years of age: Oral

dosage is 1.71 to 3.78 grams in a single

daily dose. Children 6 to 9 years of age:

Oral dosage is 0.86 to 1.89 gram in a

single daily dose. Children under 6

years of age: ask a doctor.

(7) For products containing

monobasic sodium phosphate identified

in § 334.16(f). Adults and children 12

years of age and over: Oral dosage is 4.5

to 20.2 grams in a single daily dose.

Children 10 to 11 years of ages: Oral

dosage is 2.25 to 10.1 grams in a single

daily dose. Children 6 to 9 years of age:

Oral dosage is 1.12 to 5.05 grams in a

single daily dose. Children under 6

years of age: ask a doctor.

4. Section 334.80 is amended by

redesignating paragraph (b)(2) as

paragraph (b)(2)(i) and revising it, and

by adding paragraph (b)(2)(ii), to read as

follows.

§ 334.80 Professional labeling.

* * * * *

(b) * * *

(2) For products containing dibasic

sodium phosphate or monobasic

sodium phosphate identified in

§ 334.16(d), (e), or (f)—(i) Oral and

rectal dosage forms—(A) ‘‘Do not use’’

(these three words in bold print) ‘‘in

patients with congestive heart failure.’’

(B) ‘‘Use with caution’’ (these three

words in bold print) ‘‘in patients with

impaired renal function, heart disease,

acute myocardial infarction, unstable

angina, preexisting electrolyte

disturbances (such as dehydration or

those secondary to the use of diuretics),

the elderly, or people taking drugs that

may affect electrolyte levels.’’

(C) ‘‘Monitor electrolytes.’’ (these two

words in bold print) ‘‘Give sufficient

fluid replacement with all oral and

rectal sodium phosphates products to

prevent dehydration.’’

(D) ‘‘What can occur:’’ (these three

words in bold print) ‘‘Hypocalcemia,

hyperphosphatemia, hypernatremia,

hypokalemia, and acidosis. These

conditions are more likely to occur

when more than one dose of sodium

phosphates is given in a 24-hour

period.’’

(E) ‘‘What you should do:’’ (these four

words in bold print) ‘‘Advise people to

follow recommended dose. Treatment of

electrolyte imbalance may require

immediate medical intervention with

appropriate electrolyte and fluid

replacement. (Some examples of

references for treatment of this

condition are Fonkalsrud, E., and J.

Keen, ‘Hypernatremic Dehydration

Hypertonic Enemas in Congenital

Megacolon,’ The Journal of the

American Medical Association,

199:584–586, 1967, and Edmondson, S.,

and T. D. Almquist, ‘Iatrogenic

Hypocalcemic Tetany,’ Annals of

Emergency Medicine, 19:938–940,

1990.)’’

(ii) Rectal dosage forms. (A) ‘‘Do not

use’’ (these three words in bold print)

‘‘sodium phosphates enema in children

under 2 years of age or in patients with

congenital megacolon or imperforate

anus because of the risk of hyperosmotic

dehydration and hyperphosphatemia.’’

(B) ‘‘Stop using’’ (these two words in

bold print) ‘‘if there is resistance to the

enema tip. Forcing the tip into the

rectum can result in a serious injury that

requires immediate medical attention.’’

(C) ‘‘Use sodium phosphates enema

with extreme caution’’ (these seven

words in bold print) ‘‘in patients with

a colostomy or atonic colon (because of

the risk of hyperosmotic dehydration

and hyperphosphatemia) or with a

rectal abnormality, such as hemorrhoids

(because sodium phosphates can cause

serious damage to the rectal mucosa if

an enema tip injury occurs). Using more

than one sodium phosphates enema in

a 24-hour period can cause serious

electrolyte problems.’’

* * * * *

Dated: April 27, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12054 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGDO1–98–002]

RIN 2121–AA97

Safety Zone; New York Super Boat

Race, New York

AGENCY: Coast Guard, DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Coast Guard proposes to

establish a temporary safety zone in the

lower Hudson River, for the New York

Super Boat Race. The temporary safety

zone would be in effect on Sunday,

September 13, 1998, from 11:30 a.m.

until 4:00 p.m. unless extended or

terminated sooner by the Captain of the

Port, New York. The proposed safety

zone would restrict vessel traffic in the

Lower Hudson River between Battery

Park and Pier 76 in Manhattan. The

proposed safety zone is needed to

protect racing participants and spectator

craft from the hazards associated with

high speed powerboat racing.

DATES: Comments must be received on

or before August 19, 1998.

ADDRESSES: Comments should be

mailed to Lieutenant Junior Grade Alma

Kenneally, Waterways Oversight

Branch, Coast Guard Activities New

York, 212 Coast Guard Drive, Staten

Island, New York 10305.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Junior Grade Alma

Kenneally, Waterways Oversight

Branch, Coast Guard Activities New

York (718) 354–4195.
27894 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Proposed Rules

SUPPLEMENTARY INFORMATION:

Request for Comments

The Coast Guard encourages

interested persons to participate in this

rulemaking by submitting written data,

views, or arguments.

Persons submitting comments should

include their names and addresses,

identify this notice (CGD01–98–002)

and the specific section of the proposal

to which their comments apply, and

give reasons for each comment. Persons

wanting acknowledgment of receipt of

comments should enclose a stamped,

self-addressed postcard or envelope.

The Coast Guard will consider all

comments received during the comment

period. It may change this proposal in

view of the comments. The Coast Guard

plans no public hearing; however,

persons may request a public hearing by

writing to the Waterways Oversight

Branch at the address under ADDRESSES.

If it is determined that the opportunity

for oral presentations will aid this

rulemaking, the Coast Guard will hold

a public hearing at a time and place

announced by a later notice in the

Federal Register.

Background and Purpose

Super Boat International Productions,

Inc. has submitted an Application for

Approval of Marine Event for a Super

Boat Race in the waters of the Lower

Hudson River. This regulation would

establish a temporary safety zone in the

waters of the Lower Hudson River south

of a line drawn from the northwest

corner of Pier 76 in Manhattan and a

point in Weehawken, New Jersey at

approximate position 40°45′52′′N

074°01′01′′W, and north of a line

connecting the following points:

Latitude Longitude

40°42′16.0′′N 074°01′09.0′′W, then

south to

40°41′55.0′′N 074°01′16.0′′W, then

southwest to

40°41′47.0′′N 074°01′36.0′′W, then

northwest to

40°41′55.0′′N 074°01′59.0′′W, then

to shore at

40°42′20.5′′N 074°02′06.0′′W.

The safety zone would be effective on

Sunday, September 13, 1998, from 11:30

a.m. until 4:00 p.m., unless extended or

terminated sooner by the Captain of the

Port of New York. This safety zone

would restrict vessel traffic in the Lower

Hudson River south of a line drawn

from Pier 76 in Manhattan to a point

located directly opposite on the New

Jersey shoreline and north of a line

drawn between Battery Park in

Manhattan and the southern most point

of Ellis Island in the Upper New York

Bay. This safety zone is needed to

protect mariners from the hazards

associated with a boat race in which the

participants transit at excessive speeds.

This event will include up to 40

powerboats, 24 to 50 feet in length,

racing on an 8 mile oval course at

speeds in excess of 100 mph. No more

than 100 spectator craft are expected for

the event.

Regulatory Evaluation

This proposal 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

proposal to be so minimal that a full

Regulatory Evaluation under paragraph

10(e) of the regulatory policies and

procedures of DOT is unnecessary. This

safety zone would restrict vessel traffic

in the Lower Hudson River south of a

line drawn from Pier 76 in Manhattan

to a point located directly opposite on

the New Jersey shoreline and north of a

line drawn between Battery Park in

Manhattan and the southern most point

of Ellis Island in the Upper New York

Bay on Sunday, September 13, 1998,

from 11:30 a.m. until 4:00 p.m., unless

extended or terminated sooner by the

Captain of the Port of New York.

Although this regulation would prevent

traffic from transiting this area, the

effect of this regulation would not be

significant for several reasons: the

volume of commercial vessel traffic

transiting the Lower Hudson River on a

Sunday is less than half of the normal

daily traffic volume; pleasure craft

desiring to view the event will be

directed to designated spectator viewing

areas outside the safety zone; pleasure

craft can take an alternate route through

the East River and the Harlem River; the

duration of the event is limited to four

and one half hours; the extensive

advisories which will be made to the

affected maritime community by Local

Notice to Mariners, Safety Voice

Broadcast, and facsimile notification.

Small Entities

Under the Regulatory Flexibility Act

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

must consider whether this proposal

will have a 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 (21

U.S.C. 632).

For reasons set forth in the above

Regulatory Evaluation, the Coast Guard

expects the impact of this proposal to be

minimal. The Coast Guard certifies

under 5 U.S.C. 605(b) that this proposal

will not have a significant economic

impact on a substantial number of small

entities. If, however, you think that your

business or organization qualifies as a

small entity and that this rule, is

adopted, will have significant economic

impact on your business or

organization, please submit a comment

explaining why you think it qualifies

and in what way and to what degree this

rule will economically affect it.

Collection of Information

This proposal contains no collection

of information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501).

Federalism

The Coast Guard has analyzed this

action in accordance with the principles

and criteria contained in Executive

Order 12612 and has determined that

this proposal does not raise sufficient

federal implications to warrant the

preparation of a Federalism Assessment.

Environment

The Coast Guard has considered the

environmental impact of this proposal

and concluded that under Figure 2–1,

paragraph 34(g), of Commandant

Instruction M16475.1C, it is

categorically excluded from further

environmental documentation.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

Proposed Regulations

For reasons set out in the preamble,

the Coast Guard proposes to amend 33

CFR Part 165 as follows:

PART 165—[AMENDED]

1. The authority citation for Part 165

continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;

33 CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5;

49 CFR 1.46.

2. A temporary section 165.T01–002,

is added to read as follows:
Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Proposed Rules 27895

§ 165.T01–002 Safety Zone; New York

Super Boat Race, Hudson River, New York

and New Jersey.

(a) Location. The following area is a

safety zone: All waters of the Lower

Hudson River between Pier 76 in

Manhattan and a point on the New

Jersey shore in Weehawken, New Jersey

at 40°45′52′′N 074°01′01′′W, and north

of a line connecting the following

points:

Latitude Logitude

40°42′16.0′′N 074°01′09.0′′W, then

south to

40°41′55.0′′N 074°01′16.0′′W, then

west to

40°41′47.0′′N 074°01′36.0′′W, then

northwest to

40°41′55.0′′N 074°01′59.0′′W, then

to shore at

40°42′20.5′′N 074°02′06.0′′W.

(b) Effective period. This safety zone

is in effect on Sunday, September 13,

1998, from 11:30 a.m. until 4 p.m.,

unless terminated sooner by the Captain

of the Port New York.

(c) Regulations. (1) The general

regulations contained in 33 CFR 165.23

apply.

(2) All persons and vessels shall

comply with the instructions of the

Coast Guard Captain of the Port or the

designated on scene patrol personnel.

U.S. Coast Guard patrol personnel

include commissioned, warrant, and

petty officers of the Coast Guard. Upon

being hailed by a U.S. Coast Guard

vessel via siren, radio, flashing light, or

other means, the operator of a vessel

shall proceed as directed.

Dated: May 8, 1998.

L.M. Brooks,

Captain, U.S. Coast Guard, Acting Captain

of the Port, New York.

[FR Doc. 98–13581 Filed 5–20–98; 8:45 am]

BILLING CODE 4910–15–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[OH115–1; FRL–6100–7]

Approval and Promulgation of

Maintenance Plan Revisions; Ohio

AGENCY: Environmental Protection

Agency, (USEPA).

ACTION: Proposed rule.

SUMMARY: The United States

Environmental Protection Agency

(USEPA) is proposing to approve an

April 27, 1998, request from Ohio, for

State Implementation Plan (SIP)

maintenance plan revisions for the

following maintenance areas in Ohio:

Canton (Stark County), Cleveland

(Lorain, Cuyahoga, Lake, Ashtabula,

Geauga, Medina, Summit and Portage

Counties), Columbus (Franklin,

Delaware and Licking Counties),

Steubenville (Jefferson County), Toledo

(Lucas and Wood Counties),

Youngstown (Mahoning and Trumbull

Counties) as well as Clinton County,

Columbiana County and Preble County.

The revisions would remove the air

quality triggers from each area’s

contingency plan. The contingency

plans were included in these areas’

maintenance plans to correct violations

of the one hour ozone National Ambient

Air Quality Standard (NAAQS).

DATES: Written comments on this

proposal must be received on or before

June 22, 1998.

ADDRESSES: Copies of the documents

relevant to this action are available for

inspection during normal business

hours at the following location:

Regulation Development Section, Air

Programs Branch, (AR–18J), U.S.

Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois 60604.

Please contact Scott Hamilton at (312)

353–4775 before visiting the Region 5

office.

Written comments should be sent to:

J. Elmer Bortzer, Chief, Regulation

Development Section, Air Programs

Branch, (AR–18J), U.S. Environmental

Protection Agency, Region 5, 77 West

Jackson Boulevard, Chicago, Illinois

60604.

FOR FURTHER INFORMATION CONTACT:

Scott Hamilton, Environmental

Scientist, Regulation Development

Section, Air Programs Branch (AR–18J),

U.S. Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois 60604, (312) 353–4775.

SUPPLEMENTARY INFORMATION:

I. Attainment Areas in Ohio

Since the Clean Air Act (CAA)

attainment status designations were

made, all of the Ohio areas listed in the

summary section of this Federal

Register Notice have attained the one

hour ozone standard and have been

redesignated to attainment for ozone. As

a requirement to being redesignated to

attainment, these areas developed

maintenance plans. The purpose of the

maintenance plans is to assure

maintenance of the one hour ozone

NAAQS for at least ten years. Included

in the maintenance plans were

contingency provisions. The purpose of

the contingency provisions are to

identify and correct any violation of the

one hour ozone NAAQS in a timely

fashion. Triggers are included in the

contingency provisions to identify the

need to implement measures and correct

air quality problems until such time as

a revised maintenance or attainment

plan could be developed to address the

level of the air quality problem.

Triggering events in the contingency

plans could be linked to ozone air

quality and/or an emission level of

ozone precursors.

The maintenance plan approvals were

finalized by USEPA and published in

the Federal Register for these Ohio

areas as follows: Canton and

Youngstown (61 FR 3319; January 31,

1996), Cleveland (61 FR 20458; May 7,

1996), Columbus (61 FR 3591; February

1, 1996), Steubenville, Columbiana

County and Preble County (60 FR 7453;

February 8, 1995), Toledo (60 FR 39115;

August 1, 1995) and Clinton County (61

FR 11560; March 21, 1996).

II. One Hour Ozone Standard

Revocation

On July 18, 1998, USEPA finalized a

revision to the NAAQS for ozone which

changed the standard from 0.12 parts

per million (ppm) averaged over one

hour, to 0.08 ppm, averaged over eight

hours. USEPA is revoking the one hour

standard in separate rulemakings based

on an area’s attainment of the one hour

ozone standard. The first round of

revocations will be for areas attaining

the one hour standard based on quality

assured air monitoring data for the years

1994–1996. The second round of one

hour ozone standard revocations will be

for areas attaining the one hour standard

based on quality assured air monitoring

data for the years 1995–1997. After

these two rulemakings are finalized, the

USEPA intends to publish rulemakings

on an annual basis revoking the one

hour ozone standard for additional areas

that come into attainment of the one

hour standard.

On January 16, 1998, USEPA

published a proposed rule (63 FR 2726)

in the Federal Register proposing to

revoke the one hour ozone standard in

areas attaining the standard based on

quality assured air monitoring data for

the years 1994–1996 (first round of

revocations). In that proposal, USEPA

proposed to revoke the one hour ozone

standard in the Ohio areas subject to

this proposed action [Canton (Stark

County), Cleveland (Lorain, Cuyahoga,

Lake, Ashtabula, Geauga, Medina,

Summit and Portage Counties),

Columbus (Franklin, Delaware and

Licking Counties), Steubenville

(Jefferson County), Toledo (Lucas and

Wood Counties), Youngstown

(Mahoning and Trumbull Counties)] as