[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