Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices 27579

5.87 percent, of the voting shares of

Cardinal Bancorp II, Inc., St. Louis,

Missouri, and thereby indirectly acquire

United Bank of Union, Union, Missouri.

Board of Governors of the Federal Reserve

System, May 14, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–13316 Filed 5–18–98; 8:45 am]

BILLING CODE 6210–01–F

FEDERAL RESERVE SYSTEM

Notice of Proposals to Engage in

Permissible Nonbanking Activities or

to Acquire Companies that are

Engaged in Permissible Nonbanking

Activities

The companies listed in this notice

have given notice under section 4 of the

Bank Holding Company Act (12 U.S.C.

1843) (BHC Act) and Regulation Y, (12

CFR Part 225) to engage de novo, or to

acquire or control voting securities or

assets of a company, including the

companies listed below, that engages

either directly or through a subsidiary or

other company, in a nonbanking activity

that is listed in § 225.28 of Regulation

Y (12 CFR 225.28) or that the Board has

determined by Order to be closely

related to banking and permissible for

bank holding companies. Unless

otherwise noted, these activities will be

conducted throughout the United States.

Each notice is available for inspection

at the Federal Reserve Bank indicated.

The notice also will be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether the proposal complies

with the standards of section 4 of the

BHC Act.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than June 3, 1998.

A. Federal Reserve Bank of Cleveland

(Paul Kaboth, Banking Supervisor) 1455

East Sixth Street, Cleveland, Ohio

44101-2566:

1. FirstMerit Corporation, Akron,

Ohio; to acquire Security First Corp.,

Mayfield Heights, Ohio, and thereby

indirectly acquire Security Federal

Savings & Loan Association of

Cleveland, Cleveland, Ohio, and First

Federal Security Bank of Kent, Kent,

Ohio, and thereby engage in permissible

savings and loan activities, pursuant to

§ 225.28(b)(4)(ii) of the Board’s

Regulation Y.

Board of Governors of the Federal Reserve

System, May 14, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–13318 Filed 5–18–98; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Fees for Consultation Services for

Ship Construction and Renovation

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services (HHS).

ACTION: Notice.

SUMMARY: This notice announces fees

for conducting voluntary inspections of

newly constructed or renovated cruise

ships. This notice also announces a

change in the proposal to charge a fee

for consultation on construction and

renovation, and to add a new ‘‘mega’’

size category to the sanitation

inspection fee schedule.

DATES: Fees for construction and

renovation inspections are effective June

18, 1998.

FOR FURTHER INFORMATION CONTACT:

Daniel M. Harper, Program Manager,

Vessel Sanitation Program, National

Center for Environmental Health,

telephone (770) 488–3524 or e-mail

DMH2@CDC.GOV, or Dave Forney,

Public Health Advisor, Division of

Environmental Hazards and Health

Effects, National Center for

Environmental Health, telephone (770)

488–7333 or e-mail DLF1@CDC.GOV.

SUPPLEMENTARY INFORMATION:

Purpose and Background

A notice of request for public

comment on a proposal to charge fees

for consultation services for ship

construction and renovation, and to

create a new ‘‘Mega’’ category for the

routine sanitary inspection of ships was

published in the Federal Register on

November 17, 1997, [Volume 62, Pages

61336–61338]. A subsequent

amendment to extend the comment

period an additional 30 days was

published in the Federal Register on

January 13, 1998, [Volume 63, Number

8, Page 1973].

Discussion of Comments

The public notice of the intent to

collect fees for consultation services for

ship construction and renovation and to

create a new ‘‘Mega’’ category for

routine inspections provided a 45 day

comment period which was extended an

additional 28 days at the request of the

members of the cruise ship industry.

During the comment period, comments

were received from two sources, one of

which was the International Council of

Cruise Lines (ICCL) representing the 17

largest passenger cruise lines that call

on major ports in the U.S. and abroad.

Discussion of the comments received

and CDC’s responses follows:

Comment: One commentor stated that

the use of Gross Register Tons alone

does not correctly indicate a ship’s

capacity to carry passengers and crew,

while the Total Safe Number does, and

better reflects the type of ship that is

being inspected.

Response: The fees set forth in the

public notice were based on Gross

Register Tonnage (GRT) of the passenger

vessels as reported by Lloyds of London.

CDC believes that the use of GRT is a

reasonable and equitable method for

determining fees since the number and

size of the food service areas and the

size of the onboard water systems are

generally functions of the vessel’s GRT.

CDC, after considering the commentor’s

alternative proposal, sees no advantage

in the commentor’s proposal over

CDC’s. CDC will continue to

periodically review the fee schedule. If

actual experience in fee collection

indicates that CDC’s proposed system

does result in substantial inequity, CDC

will act promptly to correct the

situation.

Comment: One commentor stated that

the proposed ‘‘Mega’’ category placed an

increased financial burden on these

large craft by increasing the basic

inspection fee by approximately 31%

over what these ships were charged in

1997. In addition, the galley size and

complexity on these ships is not

significantly different than that found

on ships in the Extra Large category.

Response: It has been CDC’s

experience that the size and complexity

of the galleys and water systems aboard

ships >90,000 GRT are often greater

than those found on smaller ships. It is

also our belief that performing

sanitation inspections of these ships

requires additional staff time and

resources. However, we have not

quantified the increase in resources.

Therefore, CDC agrees to postpone any

modifications to the existing category

structure until there can be a more

thorough evaluation of the time, effort

and other factors involved with the

inspection of these ships.

Comment: One commentor stated that

the fee increase in the FY 98 budget

should adequately cover the costs of

providing construction consultation

services without the creation of a new
27580 Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices

fee category and that this is supported

by the vessel fee calculation utilized in

the CDC’s Federal Register notice which

stipulates that current inspection fees

fully fund the VSP Program. The

commentor states that the proposed

consultation fees are duplicative of the

fees already being paid by vessel

operators to CDC through the sanitation

inspection fees.

Response: Generally, the CDC recoups

the costs of the VSP through the

collection of fees. The fee schedule for

sanitation inspections of passenger

cruise ships currently inspected under

the VSP was first published in the

Federal Register on November 24, 1987

(52 FR 45019), and revised in a schedule

published in the Federal Register on

November 28, 1989 (54 FR 48942). Since

then, CDC has published the fee

schedule annually. The formula

historically used to determine the fees

has been calculated by dividing the cost

of the VSP by the weighted number of

annual inspections. With the

tremendous expansion of the cruise line

industry, and concurrent expansion in

the number of ships being constructed

and renovated, an increasing percentage

of VSP staff time and expense is being

spent on providing consultation directly

to the individual cruise lines building

and renovating ships. In the past,

consultations for new construction and

renovation have included an extensive

review of the ships’ blueprints, an onsite shipyard inspection as the ship

neared completion, and a final

construction inspection. This has

contributed to an overall increase in the

VSP budget and reduces the inspector

time available to conduct routine

sanitation inspections. Because these

construction consultations and

inspections are voluntary and are

directed to individual ship owners,

builders and operators, CDC feels that

the cost of these services should be

borne by the individual recipients, and

not by the collective cruise lines

participating in the vessel sanitation

program. CDC did not include the cost

of construction consultations or

inspections in calculating the average

cost per inspection for FY 1998. If CDC

added the cost of these voluntary

services into the existing formula, the

sanitation inspection for ALL vessels

would have been substantially higher

even though none of the existing ships

in the program would have received

direct benefit from the consultation.

In order to more equitably distribute

the cost of the program among the

participants, CDC will charge for all

inspections conducted by VSP staff.

CDC agrees to postpone charging a fee

for plan reviews and consultation

during construction and renovation

until there can be a more thorough

evaluation of the time, effort and other

factors involved with this activity.

Future program budgets will be

determined by dividing the cost of the

VSP by the weighted number of all

inspections.

Comment: One commentor stated that

the proposed fee for consultation is all

inclusive of plan review, shipyard

inspection and final construction

inspection and does not allow an

interested cruise line to request a

consultation or inspection during a

specific individual phase of

construction or renovation.

Response: CDC agrees that a

consultation or inspection should be

available for any or all phases of

construction and renovation. Therefore,

consultation or inspection services for

new construction or renovation will be

provided in three phases:

In Phase 1, CDC will:

• Conduct a Plan Review with ship

officials in either the Miami or Atlanta

VSP offices and provide a written

report, with recommendations, to the

ship officials following the review.

• Provide written consultations to the

appropriate ship officials (owners,

builders, sub-contractors, etc.) during

the construction phase of the ship.

• Provide these plan reviews and

consultations at no cost.

In Phase 2, CDC will:

• Require that requests for shipyard

inspections be submitted to VSP Atlanta

45 days prior to travel dates (see

Appendix A).

• Require that the shipyard pay CDC

for all expenses in connection with the

shipyard inspection and make all

necessary arrangements for lodging and

transportation, which includes airfare

and ground transportation.

• Charge a standard inspection fee for

the shipyard inspection based on the

published fee announced annually in

the Federal Register. Provide the

shipyard with an invoice at the

completion of the inspection.

• Provide a written report of the

shipyard inspection.

In Phase 3, CDC will:

• Conduct the final construction

inspection at a U.S. port prior to the

ship entering operational service. The

time and place of this inspection will be

mutually agreed upon by the builder,

owner and VSP staff. This inspection

will NOT be scored.

• Provide a written report of the final

construction inspection.

• Charge a standard inspection fee for

the inspection based on the published

fee announced annually in the Federal

Register. Provide the shipyard with an

invoice at the completion of the

inspection.

This is a voluntary program for the

cruise ship builders/owners and a

formal written request must be made for

a consultation and/or construction

inspection. CDC’s ability to honor these

requests will be based on the

availability of VSP staff. A builder/

owner may request any one, two, or all

of the consultation and inspection

phases.

CDC will assign one inspector as the

‘‘project manager’’ for each request for

consultation or renovation of a ship.

The project manager will be the single

point of contact at VSP for any

discussion regarding the ship from the

initial plan review through the final

construction inspection. CDC will also

provide a second inspector to

participate in all plan reviews,

consultations, and inspections.

Fees

CDC will not charge a fee for plan

reviews and consultation but will

charge the published standard fee for all

inspections conducted by the program

(e.g., shipyard, final construction,

sanitation, etc.). The inspection fee is

based on the existing fee schedule for

sanitation inspections of passenger

cruise ships, published annually in the

Federal Register.

FEE SCHEDULE JANUARY 1, 1998–

SEPTEMBER 30, 1998

Vessel size and GRT 1 Inspection

fee

Extra Small (<3,001) ................. $1,075

Small (3,001–15,000) ............... 2,150

Medium (15,001–30,000) .......... 4,300

Large (30,001–60,000) ............. 6,450

Extra Large (>60,000) .............. 8,600

1GRT—Gross Register Tonnage in cubic

feet, as shown in Lloyd’s Register of Shipping.

Applicability

The inspection fees will be applicable

to all passenger cruise vessels

requesting and receiving services as

described in this notice.
Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices 27581

Dated: May 13, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

Appendix A

Sample

Fax to: Henry Falk, M.D., Director, Division

of Environmental Hazards and Health

Effects, National Center for

Environmental Health Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

28, Atlanta, GA 30341–3724, Facsimile

(770) 488–4127

Fax copy to: Chief, Vessel Sanitation

Program, National Center for

Environmental Health Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

16, Atlanta, GA 30341–3724, Facsimile

(770) 488–4127

We request the presence of a PHS

representative for shipyard consultation on

cruise liner (NAME). We tentatively expect to

take delivery of the cruise liner on (DATE).

We would like to schedule the shipyard

consultation for (DATE). We expect the

consultation to take approximately

(NUMBER OF DAYS).

We will pay CDC in accordance with the

inspection fee published in the Federal

Register, and for all expenses in connection

with the shipyard inspection. We will make

all necessary arrangements for lodging and

transportation, which includes airfare and

ground transportation in (CITY, STATE,

COUNTRY). We will provide in-kind for

lodging and transportation expenses. All

remaining expenses, such as en route per

diem and meals and miscellaneous expenses,

including ground transportation to and from

the airport nearest the representatives work

site or residence, should be sent to the

following address:

Company

Attention:

Street Address

City, State, Country

Zip Code

Office Telephone Number

Facsimile Number

If you have questions regarding this

confirmation, please contact:

Signed:

[FR Doc. 98–13212 Filed 5–18–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0194]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the information collection provisions of

FDA’s regulations governing batch

certification of color additives

manufactured for use in foods, drugs,

cosmetics or medical devices in the

United States.

DATES: Submit written comments on the

collection of information by July 20,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Color Additive Certification Requests

and Recordkeeping—21 CFR Part 80

(OMB Control Number 0910–0216—

Extension)

Section 721(a) of the Federal Food,

and Drug and Cosmetic Act (the act) (21

U.S.C. 379e(a)) provides that a color

additive shall be deemed unsafe unless

the additive and its use are in

conformity with a regulation that

describes the conditions under which

the additive may be safely used, or

unless the additive and its use conform

to the terms of an exemption for

investigational use. If a regulation

prescribing safe conditions of use has

been issued, the additive must be from

a batch certified by FDA to conform to

the requirements of that regulation and

other applicable regulations, unless the

additive has been exempted from the

certification requirement. Section 721 of

the act instructs the Secretary of Health

and Human Services (through FDA) to

issue regulations providing for batch

certification of color additives for which

she finds such requirement to be

necessary in the interest of protecting

the public health. FDA’s implementing

regulations in part 80 (21 CFR part 80)

specify the information that must

accompany a request for certification of

a batch of color additive and require

certain records to be kept pending and

after certification. FDA requires batch

certification for all color additives listed

in 21 CFR part 74 and for all color

additives provisionally listed in 21 CFR

part 82. Color additives listed in 21 CFR

part 73 are exempt from certification.

Under § 80.21, a request for

certification must include: Name of

color additive, batch number and weight

in pounds, name/address of

manufacturer, storage conditions,

statement of use(s), fee, and signature of

requester. The request for certification

must also include a sample of the batch

of color additive that is the subject of

the request. Under § 80.22, the sample

must be labeled to show: Name of color

additive, batch number and quantity,

and name and address of person