[Federal Register Volume 63, Number 211 (Monday, November 2, 1998)]
[Notices]
[Pages 58743-58744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29185]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Center for Biologics Evaluation and Research Medical Device 
Action Plan; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA) is announcing the following 
meeting: Center for Biologics Evaluation and Research Medical Device 
Action Plan. FDA is inviting interested parties, including industry, 
health professionals, patients and their advocacy groups to present 
their suggestions for improvements to the Center for Biologics 
Evaluation and Research's (CBER's) regulation of medical devices, or 
reasons to maintain the current systems to protect public health.

    Date and Time: The meeting will be held on Tuesday, December 1, 
1998, 9 a.m. to 5 p.m.
    Location: The meeting will be held at Natcher Auditorium, Balcony 
B, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD.
    Contact: Kathy A. Eberhart, Center for Biologics Evaluation and 
Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-1317, FAX 301-827-3079, e-mail 
``[email protected]''.

[[Page 58744]]

    Registration and Requests for Oral Presentations: Send or fax 
written material and requests to make oral presentations to the contact 
person by Monday, November 16, 1998, and registration information 
(including name, title, firm name, address, telephone, and fax number), 
by Monday, November 23, 1998. Registration at the site will be done on 
a space available basis on the day of the meeting beginning at 8:30 
a.m. There is no registration fee for the meeting. 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: Under section 406(b) of the Food and Drug 
Administration Modernization Act of 1997, CBER held two meetings with 
our external stakeholders. The first meeting was held on August 14, 
1998, in Washington, DC (63 FR 39877, July 24, 1998), and the second 
one on August 28, 1998, in Oakland, CA (63 FR 39877, July 24, 1998). In 
addition, the FDA Pacific Regional Office sponsored a grassroots 
meeting on September 15, 1998 (63 FR 42052, August 6, 1998), in Irvine, 
CA, with the biotechnology industry.
    A recurring theme during these meetings was a dissatisfaction with 
the handling of the medical devices regulated by CBER. Some important 
concerns were related to CBER procedures and standards for products 
similar to products regulated by the Center for Devices and 
Radiological Health. To address these concerns, CBER is developing a 
``Device Action Plan'' to evaluate various options to change CBER's 
regulatory approaches for medical devices without creating a risk to 
the public health.
    Transcripts: Transcripts of the meeting 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 meeting at a cost of 10 cents 
per page. The meeting transcript will also be available on CBER's 
website at ``http://www.fda.gov/cber/minutes/workshop-min.htm''.

    Dated: October 26, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-29185 Filed 10-30-98; 8:45 am]
BILLING CODE 4160-01-F