Federal Register / Vol. 63, No. 129 /Tuesday, July 7, 1998 / Notices 36699

Place: CDC, Koger Center, Williams

Building, Conference Rooms 1802 and 1805,

2877 Brandywine Road, Atlanta, Georgia

30341.

Status: Open to the public, limited only by

the space available. The meeting rooms

accommodate approximately 85 people.

Purpose: This workgroup advises CLIAC

on issues related to Genetic Testing.

Matters to be Discussed: The workgroup

will discuss and revise recommendations for

general or specific Clinical Laboratory

Improvement Amendments (CLIA)

requirements for pre-analytic, analytic, and

post-analytic components of genetic testing.

Agenda items are subject to change as

priorities dictate.

Contact Person for Additional Information:

John C. Ridderhof, Dr. P.H., Division of

Laboratory Systems, Public Health Practice

Program Office, CDC, 4770 Buford Highway,

NW Mailstop G–25, Atlanta, Georgia 30341,

telephone 770/488–8076, FAX 770/488–

8282.

Dated: June 26, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17917 Filed 7–6–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Meeting

National Institute for Occupational

Safety and Health (NIOSH) of the

Centers for Disease Control and

Prevention (CDC) announces the

following meeting.

Name: Laboratory Evaluation of Novel

Personal Heat Strain Monitors in Young and

Older Wearers of Protective Clothing.

Time and Date: 1 p.m.–3:30 p.m., July 21,

1998.

Location: NIOSH, CDC, Room H–203, 1095

Willowdale Road, Morgantown, WV 26505.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 35 people.

Purpose: Participants will provide NIOSH

with their individual advice and comments

regarding the technical and scientific aspects

of the study protocol, A Laboratory

Evaluation of Novel Personal Heat Strain

Monitors in Young and Older Wearers of

Protective Clothing, being conducted at

NIOSH. Participants on the peer review panel

will review the study protocol and provide

individual advice on the conduct of this

study. Viewpoints and suggestions from

industry, labor, academia, other

governmental agencies, and the public are

invited.

Contact Person for Additional Information:

Nina L. Turner, NIOSH, CDC, M/S 35, 1095

Willowdale Road, Morgantown, West

Virginia, 26505–2888, telephone 304/285–

5976.

Dated: June 30, 1998.

Carolyn J. Russell.

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17916 Filed 7–6–98; 8:45 am]

BILLING CODE 4160–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0492]

ICI PLC; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that ICI PLC has filed a petition

proposing that the food additive

regulations be amended to provide for

the expanded safe use of N,N-bis (2-

hydroxyethyl) alkyl (C13-C15) amine as

an antistatic agent in polypropylene

homo- and copolymers intended for

contact with food.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

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

202–418–3089.

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 8B4602) has been filed by

ICI PLC, c/o ICI Surfactants, P.O. Box

8340, Wilmington, DE 19803–8340. The

petition proposes to amend the food

additive regulations in § 178.3130

Antistatic and/or antifogging agents in

food-packing materials (21 CFR

178.3130) to provide for the expanded

safe use of N,N-bis (2-hydroxyethyl)

alkyl (C13-C15) amine as an antistatic

agent in polypropylene homo- and

copolymers intended for contact with

food.

The agency has determined under 21

CFR 25.32(i) 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: June 17, 1998.

Linda M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17877 Filed 7–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Team Biologics; Workshop for

Manufacturers of Licensed In Vitro

Diagnostics

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA), Center for Biologics Evaluation

and Research (CBER) and the Office of

Regulatory Affairs (ORA) is announcing

the following workshop for the biologics

industry: Team Biologics: Workshop for

Manufacturers of Licensed In Vitro

Diagnostics. The topics to be discussed

include information for manufacturers

of licensed in vitro diagnostics on team

biologics, good manufacturing practices,

and compliance and enforcement issues.

Questions submitted by industry prior

to the workshop will be addressed by

FDA staff.

Date and Time: The workshop will be

held on Friday, August 7, 1998, 8 a.m.

to 5 p.m.

Location: The workshop will be held

at the Hyatt Regency Bethesda, One

Bethesda Metro, Bethesda, MD 20814,

301–657–6406.

Contact: Kathy A. Eberhart, Food and

Drug Administration, Center for

Biologics Evaluation and Research

(HFM–49), 1401 Rockville Pike, suite

200N, Rockville, MD 20852–1448, 301–

827–2000, FAX 301–827–3079, e-mail

‘‘eberhart@cber.fda.gov’’.

Registration: Fax registration

information (including name, title, firm

name, address, telephone, and fax

number) and questions to the contact

person by Friday, July 24, 1998. There

is no registration fee for the workshop.

Space is limited, therefore interested

parties are encouraged to register early.

If you need special accommodations

due to a disability, please contact Kathy

A. Eberhart at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA has

established a framework for a

partnership between ORA and CBER

called Team Biologics. This partnership

will use the diverse skills and

knowledge of both ORA and CBER staffs

to focus resources on inspectional and

compliance issues in the biologics area.