[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Notices]
[Page 25060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11983]


-----------------------------------------------------------------------

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