[Federal Register Volume 61, Number 213 (Friday, November 1, 1996)]
[Notices]
[Page 56549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0394]


Notification of Plasma Product Withdrawals and Recalls; Notice of 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA), the National Heart, 
Lung, and Blood Institute of the National Institutes of Health (NHLBI), 
and the Centers for Disease Control and Prevention (CDC) are sponsoring 
a meeting to discuss public notification of withdrawals and recalls of 
plasma-derived products. The goals of the meeting include: Informing 
the public about available notification resources; describing the roles 
and responsibilities of public health service agencies, manufacturers, 
distributors, and private organizations in the notification process; 
stimulating discussion about improving the notification system; and 
soliciting public testimony regarding these issues.

DATES: The public meeting will be held on Tuesday, November 19, 1996, 
from 8 a.m. to 5 p.m. Registration for the public meeting is required 
by November 12, 1996. Written comments may be submitted at any time.

ADDRESSES: The public meeting will be held at the National Institutes 
of Health, Bldg. 10, Masur Auditorium, 9000 Rockville Pike, Bethesda, 
MD. Those persons interested in attending this meeting should fax their 
registration information, including name, title, firm name, address, 
telephone, and fax number, to the information contact person (below). 
Those persons interested in presenting information at the meeting 
should fax the above requested registration information and a copy or 
summary of their presentation to the information contact person 
(below). Submit written comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. 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.

FOR FURTHER INFORMATION CONTACT: Joseph Wilczek, Office of Blood 
Research and Review (HFM-350), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-3512, FAX 301-827-2843.

SUPPLEMENTARY INFORMATION: Notifying users and recipients of plasma 
derivatives that are classified as recalls or market withdrawals in a 
timely and meaningful manner has emerged as an issue for FDA and the 
public health community. Recently, questions have been raised regarding 
how FDA and manufacturers reach these objectives, the role of other 
government agencies in the notification process, who should be 
notified, and the role of private organizations in disseminating 
information. Therefore, FDA, NHLBI, and CDC will hold a public meeting 
to allow interested persons to present their comments on these issues. 
Representatives from FDA's Center for Biologics Evaluation and Research 
will chair the public meeting.
    The main goal of this public meeting is to exchange information 
regarding the topics identified above. To achieve this goal, interested 
members of the public including patient, industrial, medical, and 
regulatory communities are invited to attend the meeting. Public health 
service agencies will describe their roles and resources available for 
public notification of market withdrawals and recalls of plasma derived 
products. Manufacturers and distributors are requested to provide 
information regarding their procedures and roles regarding public 
notification. Private organizations, including volunteer groups and 
companies specializing in information dissemination, are requested to 
discuss their potential roles.
    Persons interested in participating in the public meeting are 
requested to present their positions, rationales, and/or experiences 
regarding the following areas: (1) The nature and scope of notification 
regarding real or potential adverse experiences; (2) the timing of 
information dissemination regarding adverse experiences; (3) the best 
means of disseminating information; and (4) the means and level of 
notification that are needed, once a significant problem is identified. 
Information presented at this meeting will assist the sponsoring public 
health agencies in assessing the current mechanisms and efficiency of 
recipient notification, and will help to determine what future action 
may be appropriate.
    Every effort will be made to accommodate each person who wants to 
present information at the public meeting. However, persons who want to 
ensure their participation at the meeting are encouraged, by the close 
of business on November 12, 1996, to fax to the contact person (address 
and fax number above) a written request for participation with the 
name, address, phone number, fax number, affiliation, topic of 
presentation, approximate amount of time requested for the 
presentation, and a copy or summary of their presentation. Public 
presentations will be limited to 5-10 minutes due to the time 
constraints of the meeting.
    A schedule listing the persons making presentations and all 
presentation information submitted will be filed with the Dockets 
Management Branch (address above). The meeting schedule will be mailed 
or faxed to each presenter before the meeting. Interested persons 
attending the meeting who do not request an opportunity to make a 
presentation will be given an opportunity to make oral presentations at 
the conclusion of the meeting if time permits.
    Transcripts of the public 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 transcript of the public meeting and submitted comments 
will be available for public examination at the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: October 28, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-28049 Filed 10-31-96; 8:45 am]
BILLING CODE 4160-01-F