40126 Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Notices

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: July 6, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–19894 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0568]

FMC Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that FMC Corp., has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of sodium stearoyl lactylate

as an emulsifier, stabilizer, and

texturizer in salad dressings and soups.

FOR FURTHER INFORMATION CONTACT:

Mary E. LaVecchia, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

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

202–418–3072.

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 8A4605) has been filed by

FMC Corp., c/o Keller and Heckman,

1001 G St. NW., suite 500 West,

Washington, DC 20001. The petition

proposes to amend the food additive

regulations in § 172.846 (21 CFR

172.846) to provide for the expanded

safe use of sodium stearoyl lactylate as

an emulsifier, stabilizer, and texturizer

in salad dressings and soups.The agency

has determined under 21 CFR 25.32(k)

that this action is of a type that does not

individually or cumulatively have a

significant effect on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

Dated: July 6, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–19893 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Granulocytes for Transfusion:

Research and Clinical Experience;

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Granulocytes for

Transfusion: Research and Clinical

Experience. This workshop, which is

cosponsored by FDA and the National

Institutes of Health (NIH), will include

a discussion of the effects of cytokine

administration on normal donors, the

functional properties of the transfusion

product, the effects of storage conditions

on the product, and the safety and

effectiveness of the product.

Date and Time: The public workshop

will be held on Friday, September 11,

1998, 8 a.m. to 5 p.m.

Location: The public workshop will

be held at the Jack Masur Auditorium,

Bldg. 10, National Institutes of Health,

9000 Rockville Pike, Bethesda, MD

20892.

Contact: Joseph Wilczek, Center for

Biologics Evaluation and Research

(HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6129, FAX 301–827–2843.

Registration and Requests for Oral

Presentations: Send or fax registration

information (including name, title, firm

name, address, telephone, and fax

number) and written material and

requests to make oral presentations to

the contact person by Wednesday,

August 12, 1998. Registration at the site

will be done on a space available basis

on the day of the workshop beginning

at 7:30 a.m. There is no registration fee

for the workshop.

If you need special accommodations

due to a disability, please contact Joseph

Wilczek at least 7 days in advance.

Agenda: The findings that

administration of Granulocyte–Colony

Stimulating Factor or Granulocyte–

Macrophage Colony Stimulating Factor

to normal volunteers results in the

peripheral mobilization of high

concentrations of granulocytes has

renewed an interest in the collection of

granulocytes for transfusion. The goals

of the workshop are to discuss: (1) The

current scientific and clinical

experience with cytokine mobilized

granulocyte transfusion products; (2) the

effects of cytokine administration on

normal donors; (3) the functional

properties of transfusion product; and

(4) studies needed to establish the safety

and effectiveness of the transfusion

product. The information obtained from

these presentations will assist FDA in

assessing the safety and effectiveness of

the product and will assist NIH in

identifying areas in need of further

research.

Transcripts: Transcripts of the

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

workshop at a cost of 10 cents per page.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19955 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Evaluation of In Vivo Efficacy of

Platelet Transfusion Products and

Platelet Substitutes; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Evaluation of In Vivo

Efficacy of Platelets and Platelet

Substitutes. This workshop is

cosponsored by FDA, the United States

Army, and the National Institutes of

Health. The topics to be discussed

include: Current methodology for

efficacy assessment of transfused

platelets; definition of efficacy for

platelet substitutes; animal models of

platelet efficacy; discussion of the

therapeutic ‘‘cost versus benefit’’ of

using platelets treated with novel

decontamination treatments or stored

with novel media/methods, or of using

platelet substitutes.

Date and Time: The public workshop

will be held on Monday, September 28,

1998, 8 a.m. to 5 p.m.

Location: The public workshop will

be held at Wilson Hall, Bldg. 1, National