Guide for the Care and Use of Laboratory Animals (8th ed.)

1. 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

2. 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 decision-making by PHS grantees, contractors, IRGs

3. A Few Specific Issues • 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).

4. 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

5. 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)

6. Federal Register link http://grants.nih.gov/grants/olaw/2011guidecomments/add.htm Note: Names of commenters will not be made public.