Transcript Powerpoint Slides

Guide for the Care and Use of
Laboratory Animals (8th ed.)
• To supplant 1996 Guide as PHS Policy
• Was originally supposed to be an
“update” of the 1996 Guide
• Final product is twice as long
• Contains a great deal of new “policy”
• “Codifies” the “non-pharmaceutical
grade drug policy that was mandated
via an OLAW FAQ
Reasons for Concern
• Expense to institutions (e.g., cage size)
• Expense to investigators (e.g., drugs)
• Large increase in paperwork burden all
around (“departures from the Guide”)
• No chance to diminish such issues where
institutions already have “overregulated.”
• Increased infringement on scientific decisionmaking by PHS grantees, contractors, IRGs
A Few Specific Issues
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Constraints on multiple procedures in animals
Constraints on multiple surgeries (per se)
New requirements for food- or fluid-restriction
Naïve and constraining section on choices of
“chemicals and other substances” to give
animals
• Specific guidance on “post-approval”
monitoring (e.g., observation of procedures).
Federal Register Comment Period
• Obtained by NABR
• •Deadline is midnight April 24
• Important for Scientific organizations
AND many individual scientists to
weigh in on “Adopt” vs. Not
• Numbers of comments on issues count
Possible Outcomes
• OLAW will adopt as PHS Policy “as is”
• OLAW will adopt but with published guidance
on “exceptions” to PHS Policy
• OLAW will retain 1996 Guide as PHS Policy
• If it adopts: Time Frame? This is the second
question in the Fed Register--currently
deadline would be March, 2012.
Recommend at least 4 years (e.g., 2015)
Federal Register link
http://grants.nih.gov/grants/olaw/20
11guidecomments/add.htm
Note: Names of commenters will
not be made public.