10304 Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Notices

Intermediary licenses have been

reissued by the Federal Maritime

Commission pursuant to section 19 of

the Shipping Act of 1984, as amended

by the Ocean Shipping Reform Act of

1998 (46 U.S.C. app. 1718) and the

regulations of the Commission

pertaining to the licensing of Ocean

Transportation Intermediaries, 46 CFR

515.

License No. Name/address Date reissued

4055N ......................... International Cargo Services, Inc., 139 Mitchell Avenue, Suite #106, South San Francisco, CA

94080.

December 31, 2000.

18F ............................. International Transportation Corp., 17 Battery Place, Suite 928, New York, NY 10004 ............... June 10, 1999.

4577F ......................... Transtar Shipping, Inc., 405 Victory Avenue, Suite D, South San Francisco, CA 94080 ............. January 1, 2001.

Sandra L. Kusumoto,

Director, Bureau of Consumer Complaints

and Licensing.

[FR Doc. 01–3766 Filed 2–13–01; 8:45 am]

BILLING CODE 6730–01–P

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

Agency Holding the Meeting: Board of

Governors of the Federal Reserve

System.

Time and Date: 11:00 a.m., Tuesday,

February 20, 2001.

Place: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, NW., Washington, DC 20551.

Status: Closed.

Matters to be Considered:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

Contact Person for More Information:

Lynn S. Fox, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.federalreserve.gov for an electronic

announcement that not only lists

applications, but also indicates

procedural and other information about

the meeting.

Dated: February 9, 2001.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 01–3814 Filed 2–9–01; 4:49 pm]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

The Department of Health and Human

Services, Office of the Secretary

publishes a list of information

collections it has submitted to the Office

of Mnagement and Budget (OMB) for

clearance in compliance with the

Paperwork Reduction Act of 1995 (44

U.S.C. Chapter 35) and 5 CFR 1320.5.

The following are those information

collections recently submitted to OMB.

1. Office of Research Integrity

Educational Program: A Needs

Assessment—NEW—The Office of

Research Integrity (ORI) is proposing a

survey of officials of research

institutions to collect information on

training needs in the areas of the

promotion of research integrity and the

prevention of scientific misconduct. The

results of this survey will be used to

develop a strategic plan for the ORI

educational program which will be

consistent with the recent

organizational change requiring ORI to

place greater emphasis on education

and prevention. Respondents: Research

Institutions; Number of Respondents:

500; Burden per Response: 10 minutes;

Total Burden: 84 hours.

OMB Desk Officer: Allison Eydt.

Copies of the information collection

packages listed above can be obtained

by calling the OS Reports Clearance

Officer on (202) 690–6207. Written

comments and recommendations for the

proposed information collection should

be sent directly to the OMB desk officer

designated above at the following

address: Human Resources and Housing

Branch, Office of Mnagement and

Budget, New Executive Office Building,

Room 10235, 725 17th Street NW.,

Washington, DC 20503.

Comments may also be sent to

Cynthia Agens Bauer, OS Reports

Clearance Officer, Room 503H,

Humphrey Building, 200 Independence

Avenue SW., Washington DC, 20201.

Written comments should be received

within 30 days of this notice.

Dated: January 29, 2001.

Kerry Weems

Acting Deputy Assistant Secretary, Budget.

[FR Doc. 01–3737 Filed 2–13–01; 8:45 am]

BILLING CODE 4150–31–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Peripheral and Central Nervous

System Drugs Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Peripheral and

Central Nervous System Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on March 13, 14, and 15, 2001, 8

a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact: Sandra L. Titus or Lauren W.

Parcover, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane (for

express delivery, 5630 Fishers Lane, rm.

1093), Rockville, MD 20857, 301–827–

7001, or e-mail: Tituss@cder.fda.gov, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area) code 12543.

Please call the Information Line for upto-date information on this meeting.

Agenda: On March 13, 2001, the

committee will discuss drug

development for individuals with mild

cognitive impairment (MCI). In the

Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Notices 10305

recent literature there has been a

discussion of an entity referred to as

MCI. While MCI is considered by some

to be a distinct clinical entity, others

consider that the majority of patients

diagnosed with MCI have an early form

of Alzheimer’s Disease. It is critical for

regulatory purposes that the issues

surrounding this diagnosis are fully

explored. Toward that end the

committee will listen to speakers and

discuss the following and other related

questions:

1. Can MCI be clearly defined in a

clinical setting?

2. Are there valid criteria for the

diagnosis of MCI?

3. Can MCI be distinguished from

Alzheimer’s Disease and other

causes of dementia?

4. What outcome measures are

appropriate to use in clinical drug

trials conducted in MCI?

5. Should clinical drug trials in MCI

incorporate any special features in

their design?

On March 14, 2001, the committee

will discuss drug development for

individuals with vascular dementia.

While vascular dementia is considered

by some to be a distinct entity others do

not agree that it can be easily

distinguished from Alzheimer’s Disease

and/or other dementias. It is critical for

regulatory purposes that the issues

surrounding this diagnosis are fully

explored. Toward that end the

committee will listen to presentations

and then discuss the following and

other related questions:

1. Can vascular dementia be clearly

defined in a clinical setting?

2. Are there valid criteria for the

diagnosis of vascular dementia?

3. Can vascular dementia be

distinguished from Alzheimer’s

Disease and other causes of

dementia?

4. What outcome measures are

appropriate to use in clinical drug

trials conducted in vascular

dementia?

5. Should clinical drug trials in

vascular dementia incorporate any

special features in their design?

FDA will provide a background

position paper on MCI and on vascular

dementia prior to each meeting. When

the background material becomes

available, it will be posted under the

Peripheral and Central Nervous Systems

Drugs Advisory Committee Docket site

at http://www.fda.gov/ohrms/dockets/

ac/acmenu.htm. (Click on the year 2001

and scroll down to the Peripheral and

Central Nervous Systems Drugs

meetings.)

On March 15, 2001, the committee

will consider the safety and efficacy of

new drug application (NDA) 21–196,

Xyrem (sodium oxybate, Orphan

Medical, Inc.), proposed to reduce the

incidence of cataplexy and to improve

the symptom of daytime sleepiness for

persons with narcolepsy. A main focus

of the deliberations will be on risk

management issues.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by March 1, 2001. On March 13

and 14, 2001, oral presentations from

the public will be scheduled between

approximately 10:30 a.m. and 12:30

p.m. Time allotted for each presentation

may be limited. On March 15, 2001, oral

presentations from the public will be

scheduled between approximately 1

p.m. and 1:30 p.m. Those desiring to

make formal oral presentations should

notify the contact person before March

1, 2001, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: February 6, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–3665 Filed 2–13–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: January 2001

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of January 2001, the

HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, and all Federal

Health Care programs. In addition, no

program payment is made to any

business or facility, e.g., a hospital, that

submits bills for payment for items or

services provided by an excluded party.

Program beneficiaries remain free to

decide for themselves whether they will

continue to use the services of an

excluded party even though no program

payments will be made for items and

services provided by that excluded

party. The exclusions have national

effect and also apply to all Executive

Branch procurement and nonprocurement programs and activities.

Subject city, state Effective

date

PROGRAM-RELATED CONVICTIONS

AHMED, ASHFAQ .................... 02/20/2001

BROWNSTOWN TWP, MI

BIAGGI, BART .......................... 02/20/2001

SAN JOSE, CA

BINDER, MARK ALBERT ........ 02/20/2001

UTICA, NY

BISLAMIAN, ARTHUR

SAMVEL ................................ 02/20/2001

LOS ANGELES, CA

BODISON, LARRY L 02/20/2001

WALTERBORO, SC

CENTRAL AMBULANCE

SERVICE, INC ...................... 02/20/2001

CORAOPOLIS, PA

CHIN, JENNY ........................... 02/20/2001

LONG BEACH, CA

CRAWFORD, CAROLYN ......... 02/20/2001

PICKENS, MS

D’AMATO, JAMES ................... 02/20/2001

W BABYLON, NY

DONNELLY, BARBARA J ........ 02/20/2001

CINCINNATI, OH

ELLENWOOD, JANET L .......... 02/20/2001

NAVARRE, OH

FELEKIAN, HRACH ................. 02/20/2001

LONG BEACH, CA

GALIANO, JORGE ................... 02/20/2001

MIAMI, FL

GOLDSTEIN, JOSEPH ............ 02/20/2001

SCARSDALE, NY

GOROSH, RICHARD P ............ 02/20/2001

LANSING, MI

GREATHOUSE, BETTY ........... 02/20/2001

LARVED, KS

GUIDOTTI-ALEXANDER,

ELAINE ................................. 02/20/2001

SAN JOSE, CA

IMPERIAL, NORMAN ............... 02/20/2001

ANAHEIM, CA

JOHNSON, DEROTT ............... 02/20/2001

STURTEVANT, WI

JOYNER, MELBA J .................. 02/20/2001

WINTERVILLE, NC

KURINETS, VLADIMIR ............ 02/20/2001

BROOKLYN, NY

LORENZO, LORENZO ............. 02/20/2001

HIALEAH, FL

MACDONALD, DANESSA

MAICHELE ............................ 02/20/2001

PUNXSUTAWNEY, PA

MATHIS, NELSON D ............... 02/20/2001

HENDERSONVILLE, NC

MATO, AMPARO ...................... 02/20/2001

HIALEAH, FL

MATO, ADOLFO ...................... 02/20/2001

HIALEAH, FL

NICKOLAOU, MARK LOUIS .... 02/20/2001

SAINT JOHN, IN

NIKOGOSYAN, VARDAN ........ 02/20/2001

LOS ANGELES, CA

PATEL, NIRANJAN .................. 02/20/2001