61336 Federal Register / Vol. 62, No. 221 / Monday, November 17, 1997 / Notices

respondent burden. The total annual

burden hours are 500.

Project No. of

respondents

No. of

responses/

respondent

Avg. burden/

response

(in hrs.)

QDRL Laboratory Interviews:

(1) NHIS modules ................................................................................................................. 150 1 1.0

(2) Behavioral Risk Factors Survey ...................................................................................... 100 1 1.0

(3) Other Questionnaire Testing: ..........................................................................................

1998 ............................................................................................................................... 200 1 1.0

1999 ............................................................................................................................... 200 1 1.0

2000 ............................................................................................................................... 200 1 1.0

(4) Perceptions of Quality of Life Project .............................................................................. 100 1 1.0

(5) Perceptions of Confidentiality Project ............................................................................. 50 1 1.0

(6) Perception of Statistical Maps Project ............................................................................ 100 1 1.0

(7) General Methodological Research .................................................................................. 200 1 0.5

Pilot Household Interviews:

1999 NHIS Modules .............................................................................................................. 100 1 1.0

2000 NHIS Modules .............................................................................................................. 100 1 1.0

2001 NHIS Modules .............................................................................................................. 100 1 1.0

Dated: November 10, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–30099 Filed 11–14–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Advisory Committee for Injury

Prevention and Control Meeting:

Change of Time and Location

Federal Register Citation of Previous

Announcement: 62 FR 54639—dated

October 21, 1997.

SUMMARY: Notice is given that the

meeting time and location of the

Advisory Committee for Injury

Prevention and Control (ACIPC) has

changed. The meeting date, status,

purpose, and matters to be discussed

announced in the original notice remain

unchanged. There will be no change in

the meeting location of the Science and

Program Review Work Group, which

will be meeting prior to the full

Committee from 1–1:45 p.m. at the

Sheraton Washington Hotel.

Original Time and Location: 1–4:30

p.m., Sheraton Washington Hotel, 2660

Woodley Road at Connecticut Avenue,

NW, Washington, DC 20008.

New Time and Location: 2–4:30 p.m.,

Omni Shoreham Hotel, 2500 Calvert

Street, NW, Washington, DC 20008.

CONTACT PERSON FOR MORE INFORMATION:

Thomas E. Blakeney, Executive

Secretary, ACIPC, National Center for

Injury Prevention and Control, CDC,

4770 Buford Highway, NE, M/S K61,

Atlanta, Georgia 30341–3724, telephone

770/488–1481.

Dated: November 10, 1997.

John C. Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–30098 Filed 11–14–97; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Fees for Sanitation Inspections of

Cruise Ships and Consultation

Services for Ship Construction and

Renovation

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services (DHHS).

ACTION: Notice and request for public

comment.

SUMMARY: This notice announces fees

for vessel sanitation inspections

effective January 1, 1998. The Public

Health Service (PHS) proposes an

additional vessel size category for ships

>90,000 gross register tonnage. The

purpose of the new ‘‘Mega’’ size

category is to more accurately recover

costs of the Vessel Sanitation Program

(VSP) for conducting sanitary

inspections of these super-large ships.

The PHS also proposes to begin

charging fees for consultation services

for ship construction and renovation.

The purpose of these charges would be

to recover costs of conducting the

consultation services for ship

construction and renovation.

Public comment is requested on the

proposed administrative policies to add

the new size category for inspections,

and to charge for consultation services

for ship construction and renovation.

DATES: To ensure consideration,

respondents must have their written

comments regarding the new size

category and charges for services for

ship construction and renovation to the

VSP by January 2, 1998. Fees for vessel

sanitation inspections are effective

January 1, 1998.

ADDRESSES: Written comments should

be sent by mail or facsimile to the

Vessel Sanitation Program, Special

Programs Group, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., (F16),

Atlanta, Georgia 30341–3724, facsimile

(770) 488–4127.

FOR FURTHER INFORMATION CONTACT:

Daniel M. Harper, Program Manager,

Vessel Sanitation Program, National

Center for Environmental Health,

telephone (770) 488–7093 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

The Centers for Disease Control and

Prevention (CDC) operates a vessel

sanitation inspection program for cruise

ships with international itineraries and

calling at United States ports under

sections 361–369 (42 U.S.C. 264–272) of

the Public Health Service Act, as

amended. Regulations for the inspection

program appear at 42 CFR part 71.
Federal Register / Vol. 62, No. 221 / Monday, November 17, 1997 / Notices 61337

The Vessel Sanitation Program is a

cooperative activity between the cruise

ship industry and CDC. The purpose

and goals of the VSP are to achieve and

maintain a level of sanitation that will

lower the risk for gastrointestinal

disease outbreaks and assist the

passenger line industry in its effort to

provide a healthful environment for

passengers and crew.

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 purpose of this notice is

to announce the revised fee schedule for

the period January 1, 1998, through

September 31, 1998. Public comment is

also being requested on the proposal to

create a new ‘‘Mega’’ category and on

the proposal to charge fees for

consultation services for ship

construction and renovation.

Revised Inspection Fee Schedule

This notice announces fees effective

January 1, 1998. The proposed revised

size/cost factor is presented in

Appendix A. The formula used to

determine the fees is as follows:

Average cost

per inspection

Total Cost of VSP

Weighted No. of =

Annual Inspections

The average cost per inspection is

multiplied by a size/cost factor to

determine the fee for vessels in each

size category. The fee schedule for

sanitation inspections is presented in

Appendix A and will be effective

January 1, 1998, through September 30,

1998. Beginning October 1, 1999, all

VSP fiscal activities will be on a Federal

fiscal year basis (October 1–September

30). Should a substantial increase occur

in the cost of air transportation, it may

be necessary to readjust the fees before

September 30, 1998, since travel

constitutes a sizable portion of the costs

of this program. If such a readjustment

in the fee schedule is necessary, a notice

will be published in the Federal

Register 30 days before the effective

date.

Calender year 1997 opened with the

delivery of the first cruise ship

exceeding 100,000 gross tonnage.

Records for new ship construction

document that additional ships of equal

or greater tonnage are coming into the

U.S. market in 1998 and beyond. As set

out in Appendix A, the PHS proposes

an additional vessel size category for

ships >90,000 gross register tonnage.

The purpose of the new ‘‘Mega’’ size

category is to more accurately recover

the VSP’s costs for conducting sanitary

inspections of these super-large ships.

Construction and Renovation

Consultation Fees

As part of the program designed to

assist cruise ship operators in achieving

and maintaining a healthy level of

sanitation, the VSP offers consultative

services upon the request of a ship’s

owner or operator. The VSP staff review

ship construction or renovation plans

before construction begins and conduct

on-site inspections of the cruise ship

during construction as needed. After

each review or inspection, VSP staff

members issue a written advisory report

summarizing any recommended

changes to conform to CDC inspection

guidelines.

The proposed fees for consultation

services by VSP for ship construction

and renovation will be three times the

cost of a routine sanitation inspection of

a passenger cruise ship (based on

tonnage) inspected under the VSP, plus

travel and per diem costs. The fee

schedule for sanitation inspections of

passenger cruise ships is published

annually in the Federal Register and is

determined by dividing the full cost of

the VSP by the estimated number of

inspections and multiplying by a size/

cost factor based on the size of the

vessel and the number of vessels in each

category.

The proposed fee structure for

consultation services is based on the

following time commitment from two

VSP inspectors:

Gross tonnage

Number of

days for

plan reviews

Number of

days for office consultations

Number of

days for

shipyard

visit (including travel)

Initial U.S.

inspection

Total number of days

consultation

provided

<3,000 ....................................................................................................... 1 3 3 1 8

3,000–15,000 ............................................................................................ 2 3 3 1 9

15,000–30,000 .......................................................................................... 2 3 4 1 10

30,001–60,000 .......................................................................................... 2 4 4 1 11

60,001–90,000 .......................................................................................... 2 5 5 1 13

>90,000 ..................................................................................................... 2 5 6 1 14

Procedure for Requesting Consultation

Services

Requests for consultation services for

ship construction and renovation must

be in writing and received at least 45

days prior to the requested travel dates.

(See Appendix B for a sample request.)

Applicability

The inspection fees will be applicable

to all passenger cruise vessels for which

sanitation inspections are conducted as

part of CDC’s VSP. The construction and

renovation fees will be applicable to all

passenger cruise vessels for which CDC

provides consultation on ship

construction and renovations.

Dated: November 7, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

Appendix A

SIZE/COST FACTOR

Vessel size (GRT1) Average

cost X

Extra Small (< 3,001) ............... 0.25

Small (3,001–15,000) ............... 0.50

Medium (15,001–30,000) .......... 1.00

Large (30,001–60,000) ............. 1.50

Extra Large (60,001—90,000) .. 2.00

Mega (>90,000) ........................ 2.50
61338 Federal Register / Vol. 62, No. 221 / Monday, November 17, 1997 / Notices

FEE SCHEDULE JANUARY 1, 1998—SEPTEMBER 30, 1998

Vessel size (GRT1) Inspection 2 Consultation

Extra Small (< 3,001) ............................................................................................................................................... $ 1,075 $ 3,225

Small (3,001–15,000) ............................................................................................................................................... $ 2,150 $ 6,450

Medium (15,001–30,000) ......................................................................................................................................... $ 4,300 $12,900

Large (30,001–60,000) ............................................................................................................................................. $ 6,450 $19,350

Extra Large (60,001–90,000 .................................................................................................................................... $ 8,600 $25,800

Mega (>90,000) ........................................................................................................................................................ $10,750 $32,250

1GRT-Gross Register Tonnage in cubic feet, as shown in Lloyd’s Register of Shipping.

2 Inspections and reinspections involve the same procedure, require the same amount of time, and will, therefore, be charged at the same rate.

Appendix B

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., (F28), Atlanta, GA 30341–3724

Facsimile (770) 488–4127

Fax copy to: Program Manager, Vessel

Sanitation Program, Special Programs

Group, National Center for Environmental

Health, Centers for Disease Control and

Prevention (CDC), 4770 Buford Highway,

NE., (F16), Atlanta, GA 30341–3724,

Facsimile (770) 488–4127

We request the presence of a DHHS

representative for consultation on cruise liner

(NAME). We tentatively expect to take

delivery of the cruise liner on (DATE). We

would like to schedule the consultation for

(DATE). We expect the consultation to take

approximately (NUMBER OF DAYS).

We will pay CDC in accordance with the

consultation 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. 97–30056 Filed 11–14–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 97N–0263 and 87N–0262]

European Research Associates, Ltd. et

al.; Withdrawal of Approval of Three

New Drug Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of three new drug applications

(NDA’s). The basis for the withdrawals

is that the holders of the applications

have repeatedly failed to file required

annual reports on these NDA’s.

EFFECTIVE DATE: November 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Pritzlaff, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: The

holders of approved applications to

market new drugs or antibiotics for

human use are required to submit

annual reports to FDA concerning each

of their approved applications in

accordance with § 314.81 (21 CFR

314.81).

In the Federal Register of July 10,

1997 (62 FR 37063), FDA offered an

opportunity for a hearing on a proposal

to withdraw approval of four NDA’s

because the firms had failed to submit

the required annual reports for these

NDA’s.

The agency received one request for a

hearing from Global Pharmaceutical

Corp., Castor and Kensington Aves.,

Philadelphia, PA 19124–5694. Global

has filed an annual report for NDA 9–

273, Rauwolfia Serpentina Tablets, 50

and 100 milligram (mg). Therefore,

approval of this NDA is not being

withdrawn.

The holders of the other three

applications did not respond to the

notice of opportunity for hearing.

Failure to file a written notice of

participation and request for a hearing

as required by 21 CFR 314.200

constitutes an election by the applicant

not to make use of the opportunity for

a hearing concerning the proposal to

withdraw approval of the applications

and a waiver of any contentions

concerning the legal status of the drug

products. Therefore, the Director, Center

for Drug Evaluation and Research, is

withdrawing approval of the NDA’s

listed in the table in this document.

Application No. Drug Applicant

NDA 11–623 Mucilose Super Powder European Research Associates, Ltd., Pailinakis Bldg.,

Elisabeth Ave., P.O. Box N3334, Nassau, N.P., Bahamas.

NDA 12–748 Duotrate (pentaerythritol tetranitrate) Capsules, 45 mg Jones Medical Industries, Inc., 1945 Craig Rd., St. Louis, MO

63146.

NDA 16–470 Duotrate (pentaerythritol tetranitrate) Capsules, 30 mg Do.

The last two products listed, NDA’s

12–748 and 16–470, were named in a

notice of opportunity for hearing

published in the Federal Register of

October 14, 1984 (49 FR 40213),

proposing to withdraw the applications,

along with other applicants’ products,

because they lack substantial evidence

of effectiveness. In response to that

notice, hearings were requested and a

hearing was granted (52 FR 32170;

August 26, 1987); Jones Medical, the