Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Notices 40125

provides advice on the appropriate balance

and mix of intramural and extramural

research, including laboratory research, and

provides guidance on intramural and

extramural scientific program matters, both

present and future, particularly from a longrange viewpoint. The Committee provides

second-level scientific and programmatic

review for applications for research grants,

cooperative agreements, and training grants

related to injury control and violence

prevention, and recommends approval of

projects that merit further consideration for

funding support. The Committee

recommends areas of research to be

supported by contracts and provides concept

review of program proposals and

announcements.

Matters to be Discussed: The meeting will

convene in closed session from 1 p.m. to 3

p.m. on August 11, 1998. The purpose of this

closed session is for the Science and Program

Review Work Group (SPRWG) to consider

Injury Control Research Center grant

applications recommended for further

consideration by the CDC Injury Research

Grant Review Committee. On August 12,

1998, from 8:30 a.m. to 9 a.m., the meeting

will convene in closed session in order for

the full Committee to vote on a funding

recommendation. These portions of the

meeting will be closed to the public in

accordance with provisions set forth in

section 552(c) (4) and (6) title 5 U.S.C., and

the Determination of the Associate Director

for Management and Operations, CDC,

pursuant to Pub. L. 92–463. Following the

SPRWG closed session, there will be a

program oversight session which will include

(1) discussion of the extramural research

budget, (2) intramural/extramural program

oversight, (3) upcoming program

announcements, (4) upcoming Injury

Research Grant Review Committee and

ACIPC meeting dates, (5) State and Territorial

Injury Control Research Center funding/

program balance, (6) progress on standing

Work Group issues, and (7) extramural

research review process. The full Committee

will discuss (1) an update from the Director,

National Center for Injury Prevention and

Control (NCIPC); (2) updates on Safe

America/Partnership Council; (3) translation/

communicating research findings; and (4) a

report from the Science and Program Review

Work Group, including a programmatic

review of biomechanics.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information: Mr.

Thomas E. Blakeney, Executive Secretary,

ACIPC, NCIPC, CDC, 4770 Buford Highway,

NE, M/S K61, Atlanta, Georgia 30341–3724,

telephone 770/488–1481.

Dated: July 20, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–19927 Filed 7–24–98; 8:45 am]

BILLING CODE 4161–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Citizens Advisory Committee on Public

Health Service Activities and Research

at Department of Energy (DOE) Sites:

Fernald Health Effects Subcommittee

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Agency for Toxic

Substances and Disease Registry

(ATSDR) and the Centers for Disease

Control and Prevention (CDC) announce

the following meeting.

Name: Citizens Advisory Committee on

Public Health Service Activities and

Research at DOE Sites: Fernald Health Effects

Subcommittee.

Times and Dates: 1 p.m.–9 p.m., August

26, 1998; 8:30 a.m.–5 p.m., August 27, 1998.

Place: The Plantation, 9660 Dry Fork Road,

Harrison, Ohio 45020, telephone 513/367–

5610.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Background: Under a Memorandum of

Understanding (MOU) signed in December

1990 with DOE and replaced by an MOU

signed in 1996, the Department of Health and

Human Services (HHS) was given the

responsibility and resources for conducting

analytic epidemiologic investigations of

residents of communities in the vicinity of

DOE facilities, workers at DOE facilities, and

other persons potentially exposed to

radiation or to potential hazards from nonnuclear energy production use. HHS

delegated program responsibility to CDC.

In addition, a memo was signed in October

1990 and renewed in November 1992

between ATSDR and DOE. The MOU

delineates the responsibilities and

procedures for ATSDR’s public health

activities at DOE sites required under

sections 104, 105, 107, and 120 of the

Comprehensive Environmental Response,

Compensation, and Liability Act (CERCLA or

‘‘Superfund’’). These activities include health

consultations and public health assessments

at DOE sites listed on, or proposed for, the

Superfund National Priorities List and at

sites that are the subject of petitions from the

public; and other health-related activities

such as epidemiologic studies, health

surveillance, exposure and disease registries,

health education, substance-specific applied

research, emergency response, and

preparation of toxicological profiles.

Purpose: This subcommittee is charged

with providing advice and recommendations

to the Director, CDC, and the Administrator,

ATSDR, regarding community, American

Indian Tribes, and labor concerns pertaining

to CDC’s and ATSDR’s public health

activities and research at this DOE site. The

purpose of this meeting is to provide a forum

for community, American Indian Tribal, and

labor interaction and serve as a vehicle for

communities, American Indian Tribes, and

labor to express concerns and provide advice

and recommendations to CDC and ATSDR.

Matters to be Discussed: Agenda items

include presentations from the National

Center for Environmental Health (NCEH), the

National Institute for Occupational Safety

and Health, and ATSDR on updates regarding

the progress of current studies.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Steven A. Adams, Radiation Studies Branch,

Division of Environmental Hazards and

Health, NCEH, CDC, 4770 Buford Highway,

NE, M/S F–35, Atlanta, Georgia 30341–3724,

telephone 770/488–7040, FAX 770/488–

7044.

Dated: July 20, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–19928 Filed 7–24–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0571]

BASF Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that BASF Corp., has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of nickel antimony titanium

yellow rutile (C.I. Pigment Yellow 53) as

a colorant for polymers intended for use

in contact with food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

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 8B4611) has been filed by

BASF Corp., 3000 Continental Dr.

North, Mt. Olive, NJ 07828–1234. The

petition proposes to amend the food

additive regulations to provide for the

safe use of nickel antimony titanium

yellow rutile (C.I. Pigment Yellow 53) as

a colorant for polymers intended for use

in contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on
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