25060 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 / Notices

proposed guide and how the

recommendations might best be applied.

II. Requests for Comments

Interested persons may submit written

comments on the meetings and on the

proposed guide to the Dockets

Management Branch (address above).

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. A copy of the proposed

guide and received comments are

available for public examination in the

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

Monday through Friday.

III. Transcripts

Transcripts of the meetings 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

each meeting at a cost of 10 cents per

page. The transcripts of the meetings

will be available for public examination

at the Dockets Management Branch

(address above).

Persons requiring a sign language

interpreter or other special

accommodations should notify the

contact person referenced above by

February 19, 1998.

IV. Electronic Access

Transcripts of the meetings will be

available on the Internet using the

WWW (http://www.fda.gov/ohrms/

dockets/default.htm). The proposed

guide is available at the same address.

Table 1.—Public Meetings

Meeting address Date and local time FDA contact person

WASHINGTON, DC: Department of Health

and Human Services, Hubert Humphrey

Bldg., rm. 800, 200 and Independence

Ave., Washington, DC 20201.

May 19, 1998, Tuesday, 10 a.m. to 5 p.m. Marilyn Veek, Food and Drug Administration,

Office of International Affairs (HFG–1),

5600 Fishers Lane, Rockville, MD 20857,

301–827–0906

MIAMI: Miami Dade County Cooperative Extension Service Agriculture Center,18710

SW. 288th St., Homestead, FL 33033.

May 21, 1998, Thursday, 10 a.m. to 5 p.m. Estela Niella-Brown, Food and Drug Administration, P.O. Box 59–2256, Miami, FL

33159–2256, 305–526–2800, ext. 930.

SAN DIEGO: Malcolm X Branch Library Multipurpose Room, 5148 Market St., San

Diego, CA 92114.

May 27, 1998, Wednesday, 10 a.m. to 5 p.m. Rosario Quintanilla Vior, Food and Drug Administration, 19900 MacArthur Blvd., suite

300, Irvine, CA 92612–2445, 714–798–

7607.

Dated: May 1, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12116 Filed 5–4–98; 1:10 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Surveillance Updates and Trends;

Notice of Workshops

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA), (Office of Regulatory Affairs,

Atlanta and Florida District Offices, and

the Center for Biologics Evaluation and

Research) is announcing two Workshops

entitled ‘‘Surveillance Updates and

Trends,’’ for persons involved in

licensed and unlicensed blood banks,

plasma centers, and transfusion services

served by FDA’s Southeast Regional

Office. The purpose of these workshops

is to provide industry with information

regarding regulations, surveillance

updates, and trends on error and

accident reporting, recalls, and

fatalities.

Date and Time: The workshops will

be held on Tuesday, June 23, 1998, 8

a.m. to 5:30 p.m., Doraville, GA (Atlanta

area), and on Thursday, June 25, 1998,

8 a.m. to 5:30 p.m., Altamonte Springs,

FL (Orlando area).

Location: On June 23, 1998, the

workshop will be held at the Ramada

Plaza Hotel, 4001 Presidential Pkwy.,

Doraville, GA, 770–216–9500. On June

25, 1998, the workshop will be held at

the Orlando North Hilton, 350 S. North

Lake Blvd., Altamonte Springs, FL, 407–

830–1985.

Contact: Barbara Ward-Groves, Food

and Drug Administration, 60 Eighth St.

NE., Atlanta GA 30309, 404–347–4001,

ext. 5256, FAX 404–347–4349, or

Sharon Schneider, Center for Biologics

Evaluation and Research, Food and

Drug Administration (HFM–43), 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–3840, FAX

301–827–3843.

Registration: For the June 23, 1998,

Atlanta area workshop, fax registration

information (including name, title, firm

name, address, telephone, and fax

number) to Vincent Williams,

Registration Coordinator at 404–347–

1913 or 404–347–4206 by May 15, 1998.

For the June 25, 1998, Orlando area

workshop, fax registration information

(including name, title, firm name,

address, telephone, and fax number) to

Ron Jackson, Registration Coordinator at

407–475–4768 by May 15, 1998. There

is no registration fee for these

workshops. Space is limited; therefore,

interested parties are encouraged to

register early.

SUPPLEMENTARY INFORMATION: These

workshops comply with the Small

Business Regulatory Enforcement

Fairness Act (Pub. L. 104–121) that

requires outreach activities by

Government agencies directed to small

businesses. These workshops are

intended to provide an exchange of

information between FDA and the

biologics industry on updates and trend

information regarding surveillance

functions. The topics to be discussed

include the following: (1) The current

regulation and proposed rule for error

and accident reporting; (2) recall

definitions, i.e., differences between

FDA and firm-initiated recalls, and (3)

the current regulation for reporting

fatalities, to include information

pertaining to the investigative followup.

Trend information will identify the

types of events occurring in the past few

years in each of the above three areas.

Dated: April 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–11983 Filed 5–5–98; 8:45 am]

BILLING CODE 4160–01–F