Federal Register / Vol. 62, No. 219 / Thursday, November 13, 1997 / Notices 60903

Australia

Telephone: 61 2 6232 8100

FAX: 61 2 6232 8140

I am confident the implementation of these

provisions will provide a sound basis on

which to develop further cooperative

arrangements between us on orphan drug

products and to work toward a reciprocal

arrangement in the future.

I look forward to your official confirmation

these arrangements can be agreed.

Yours sincerely

Terry Slater

National Manager

Therapeutic Goods Administration

12 August 1997

[FR Doc. 97–29906 Filed 11–12–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0450]

Nalco Chemical Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Nalco Chemical Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of an emulsifier blend

containing sorbitan monostearate,

polyoxyethylene (20) sorbitan

monostearate, and polyoxyethylene (20)

sorbitan monolaurate as an anticorrosive agent in boilers where steam

may contact food.

DATES: Written comments on the

petitioner’s environmental assessment

by December 15, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Martha D. Peiperl, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3077.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7A4540) has been filed by

Nalco Chemical Co., One Nalco Center,

Naperville, IL 60568–1198. The petition

proposes to amend the food additive

regulations in § 173.310 Boiler water

additives (21 CFR 173.310) to provide

for the safe use of an emulsifier blend

containing sorbitan monostearate,

polyoxyethylene (20) sorbitan

monostearate, and polyoxyethylene (20)

sorbitan monolaurate as an anticorrosive agent in boilers where steam

may contact food.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before December 15,

1997, submit to the Dockets

Management Branch (address above)

written comments. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: October 28, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–29771 Filed 11–12–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: October 1997

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of October 1997,

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, Maternal and

Child Health Services Block Grant and

Block Grants to States for Social

Services 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

ADEFIHAN, TITILAYO O, MILWAUKEE, WI .......................................................................................................................................... 11/20/97

ALEXANDER, EDNA DENISE, DEVINE, TX .......................................................................................................................................... 11/20/97

ALLEN, ANDREW JACKSON, WINSLOW, AZ ....................................................................................................................................... 11/20/97

AMICUCCI, DIANE CAROL, CARMEL, NY ............................................................................................................................................ 11/20/97

BANDY, BRIAN DWAYNE, ASHLAND, KY ............................................................................................................................................ 11/20/97

BARNES, DAVID L, HAMMOND, LA ...................................................................................................................................................... 11/20/97

BATRA, KRISHAN KUMAR, ODESSA, FL ............................................................................................................................................. 11/20/97

BEAUDOIN, GERARD MARCEL JR, EGLIN AFB, FL ........................................................................................................................... 11/20/97

BROWN, YVONNE, ROCKVILLE CENTRE, NY .................................................................................................................................... 11/20/97

BROYLES, STEPHEN R, TAMPA, FL .................................................................................................................................................... 11/20/97

BUDDE, MICHAEL J, COLUMBIA, IL ..................................................................................................................................................... 11/20/97