[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