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
Federal Register / Vol. 62, No. 221 / Monday, November 17, 1997 / Notices 61339

successor in interest to NDA’s 12–748

and 16–470, filed a Notice of

Participation; on May 10, 1989, the

Administrative Law Judge issued his

Initial Decision, ordering that NDA’s

12–748 and 16–470, and others, be

withdrawn; Jones Medical, as well as

two other parties, appealed that

decision to the Commissioner. On the

basis of the present withdrawal of

approval of NDA’s 12–748 and 16–470

for failing to file required annual

reports, the appeal by Jones Medical in

Docket No. 87N–0262 is regarded as

withdrawn.

The Director, Center for Drug

Evaluation and Research, under section

505(e) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355(e)), and

under authority of 21 CFR 5.82, finds

that the holders of the applications

listed above have repeatedly failed to

submit reports required by § 314.81.

Therefore, under this finding, approval

of the NDA’s listed above, and all

amendments and supplements thereto,

is hereby withdrawn, effective

November 17, 1997.

Dated: November 6, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–30148 Filed 11–14–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0459]

Osteonics Corp.; Premarket Approval

of the Osteonics Constrained

Acetabular Insert

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Osteonics Corp., Allendale, NJ, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the Osteonics Constrained Acetabular

Insert. After reviewing the

recommendation of the Orthopedic and

Rehabilitation Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of June 13, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by December 17, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT: Erin

I. Keith, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On

December 16, 1996, Osteonics Corp.,

Allendale, NJ 07401–1677, submitted to

CDRH an application for premarket

approval of the Osteonics Constrained

Acetabular Insert. The device is a

constrained hip and is indicated for use

as a component of a total hip prosthesis

in primary and revision patients at high

risk of hip dislocation due to a history

of prior dislocation, bone loss, joint or

soft tissue laxity, neuromuscular

disease, or intraoperative instability.

On June 10, 1997, the Orthopedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On June 13, 1997, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before December 17, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: October 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30149 Filed 11–14–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Eye Institute; Notice of

Meeting of Board of Scientific

Counselors

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Board of Scientific Counselors,

National Eye Institute, December 8 and

9, 1997 in Building 10, Room 10B16,

National Institutes of Health, Bethesda,

Maryland.

This meeting will be open to the

public on December 8 from 9 a.m. until

approximately 10 a.m. for general

remarks by the Director, Intramural

Research Program, National Eye

Institute (NEI), on matters concerning

the intramural program of the NEI.

Attendance by the public will be limited

to space available.

In accordance with provisions set

forth in section 552b(c)(6), Title 5,

U.S.C. and section 10(d) of Public Law

92–463, the meting will be closed to the

public on December 8 from

approximately 10 a.m. until recess and