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April 28, 2003

Division of Drug Information (HFD-240)

Center for Drug Evaluation and Research

Food and Drug Administration

5630 Fishers Lane

Rockville, MD 20857

Re: Docket Nos. 03D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542, and
00D-1539

Draft Guidance for Industry on "Part 11, Electronic Records, Electronic
Signatures Scope and Application"

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The American Association of Blood Banks (AABB) appreciates this
opportunity to comment on the Draft Guidance for Industry on "Part 11,
Electronic Records, Electronic Signatures Scope and Application." The
American Association of Blood Banks (AABB) is the professional society
for over 8,000 individuals involved in blood banking and transfusion
medicine and represents approximately 2,000 institutional members,
including blood collection centers, hospital based blood banks, and
transfusion services as they collect, process, distribute, and transfuse
blood and blood components and hematopoietic stem cells. Our members are
responsible for virtually all of the blood collected and more than 80
percent of the blood transfused in this country. For over 50 years, the
AABB\'s highest priority has been to maintain and enhance the safety and
availability of the nation\'s blood supply.

The AABB applauds the FDA for embarking on a reexamination of Part 11 as
it applies to all FDA-regulated products. We support the FDA's decision
to narrowly interpret the scope of Part 11 and to exercise enforcement
discretion with respect to enforcing compliance with validation, audit
trail, record retention, and record copying requirements of Part 11
while this re-examination is underway. The described narrow
interpretation is logical and reasonable, and the definitions of Part 11
Records seem appropriate and easy to understand. The discussion of the
planned approach to enforcement actions in these areas is clear.
Further, the plan to exercise enforcement discretion during the
re-examination period by not normally taking regulatory action to
enforce Part 11 for existing/legacy systems that were operational before
August 20, 1997, the date Part 11 became effective, is also welcomed.

As part of the agency's re-examination process, the AABB encourages the
agency to carefully consider the public comments it has received on the
Part 11 draft guidances that have been withdrawn, and to reissue these
guidances as draft guidance to permit additional public input. This is
particularly important as the AABB anticipates this re-examination
process to result in new approaches to Part 11.

The AABB recommends that CBER consider the recommendations and
regulations applied to computer systems in use in blood banks and
transfusion services as the agency reconsiders Part 11. In particular,
the Draft Guideline for the Validation of Blood Establishment Computer
Systems is not referenced in this current Part 11 draft guidance.
Although this guideline, issued in 1993, has never been made final, it
is currently being used by the blood bank community. The AABB requests
that this guideline be withdrawn and the issues discussed in it be
included in updated guidance that correlates with Part 11 requirements.
The AABB believes it would be useful for the agency to meet with
constituents on matters relating to Part 11, and is available to meet
with the agency to discuss such issues, particularly as they relate to
blood bank computer systems.

If you have questions, please contact Kay Gregory at (910) 842-2790, or
by email at *<kayg@aabb.org>.*

Sincerely,

Karen Shoos Lipton, JD

Chief Executive Officer