[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Notices]
[Pages 55808-55809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27678]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0345]
Issues Related to Pharmaceutical Laboratory Practices Procedures;
Notice of Public Meetings
Agency: Food and Drug Administration, HHS.
Action: Notice of public meetings; request for submission of topics.
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Summary: The Food and Drug Administration's (FDA's) Office of
Regulatory Affairs (ORA) is announcing a series of meetings to be held
with the pharmaceutical industry. These meetings will follow a
prescribed format and will involve representatives from ORA's Division
of Field Science, Field Drug laboratories, Center for Drug Evaluation
and Research's (CDER's) Office of Pharmaceutical Science and other
representatives from the field and headquarters. The purpose of these
meetings is to continue a dialogue with trade associations, technical
and professional organizations, and FDA to discuss issues of mutual
concern to the agency and industry associated with pharmaceutical
laboratory practices and procedures. The intent of the dialogue is to
explore issues of mutual concern that affect the agency and industry
laboratories.
Dates: The first meeting will be held on Wednesday, November 20, 1996,
from 8:30 a.m. to 4:30 p.m. Submit topics and written comments by
Friday, November 8, 1996. Interested persons may contact the
information contact person (address below) for registration forms.
There is no registration fee for this meeting. However, advance
registration is required because space is limited.
Addresses: The first meeting will be held at the Parklawn Bldg., 5600
Fishers Lane, conference room M, Rockville, MD. Submit written comments
to the
[[Page 55809]]
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. Persons who are unable to
attend, or who cannot be accommodated due to space limitations, are
invited to provide written comments. A transcript of the meeting may be
seen at the Dockets Management Branch (address above) between 9 a.m.
and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Elise A. Murphy or Richard A. Baldwin,
Division of Field Science (HFC-141), 5600 Fishers Lane, rm. 12-41,
Rockville, MD 20857, 301-443-3320, FAX 301-443-6388.
SUPPLEMENTARY INFORMATION: This dialogue will be accomplished by the
submission of topics by participants. Topics should be submitted with a
justification for their relevance and significance within the
pharmaceutical industry. All topics will be considered for their
inclusion into the meetings. After each meeting, a report will be
prepared and made available to the public.
I. Background
On March 28, 1996, members of the pharmaceutical industry and FDA
came together to informally discuss practical problems associated with
laboratory aspects of the development and monitoring of pharmaceutical
products. Prior to this, a series of meetings was held in the Mid-
Atlantic region on December 15, 1994, February 24, May 1, and July 20,
1995. Following are the topics of meetings that were held in the Mid-
Atlantic Region. Topics previously discussed locally can be revisited
in the future if there is an interest.
A. Topics That Have Been Discussed Previously in the Mid-Atlantic
Region
Topics that have been discussed previously are laboratory computer
validation, laboratory automation and robotics, computer systems and
subsystem validations, validation of software updates, vendor support
of outdated software, integrity of data in electronic signatures,
regulatory requirements for electronic signatures, bar coding
technology, systems for sample tracking, installation qualification
(IQ), operation qualification (OQ), and performance qualification (PQ)
of laboratory instruments.
On March 28, 1996, the meeting was convened by FDA's facilitator
Richard A. Baldwin, Director, Division of Field Science. Gerald E.
Vince, Director, Office of Regional Operations, gave the opening
remarks and indicated that communication is beneficial to FDA and
industry. Several presentations were given: Jeanne White from the
Office of the Commissioner spoke about previous grassroots exercises
and how successful they have been and Marie Urban, ORA 21 Coordinator,
spoke on various initiatives by ORA in response to the Clinton
Administration's National Performance Review and the Government
Performance and Results Act of 1993. To conclude the presentations,
James Farley, Director of the Philadelphia District Laboratory, gave
background information as to how the discussion group came into
existence.
An open dialogue was initiated as to how the discussion group
should proceed and what the shared expectations should be for the
group. The guiding principles and the items that emerged from the
meeting are listed below.
B. Meeting Objectives (Guiding Principles)
One of the primary purposes of the discussion group is information
sharing, which is vital for future success. At the March 28, 1996
meeting, it was suggested that FDA work with the trade associations to
disseminate information, and utilize the associations as a vehicle for
eliciting a priority list of topics from industry. Discussions will be
open to all of the pharmaceutical industry and others so that everyone
who is interested can participate. Another vehicle which was suggested
was the use of the Internet and the FDA homepage for announcing the
meetings and sharing information. Other suggestions for sharing
information included focus groups, roundtable discussions, forums, and
working groups.
The overall purpose of these meetings is to facilitate discussion
and get a better understanding of expectations. The intent is a 360
degree understanding in context of flexibility--understanding the
breath and depth of an issue from the various perspectives. There was
an overall consensus that if there were a better understanding of each
others situations, the agency and industry could work together to
provide safer products to consumers.
II. Laboratory Issues: New Topics
Some laboratory issues and new topics that may be addressed at
future meetings include the following: Identifying the acceptable
``best practices,'' research/quality assurance (QA), acceptable uses of
technology, changes in technology, and pharmaceutical science-data
integrity. FDA is interested in hearing whether there is interest in
discussing these topics, as well as suggestions for other topics, by
November 8, 1996.
Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-27678 Filed 10-28-96; 8:45 am]
BILLING CODE 4160-01-F
