f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 469 [Entry Date] 04/24/2011 at 10:16:16 AM [Affiliation] Self [Comments] 
Comment 1: Areas of concern include: (1) the requirement to use pharmaceutical grade chemicals or justify lack of availability, when there is no clear definition of pharmaceutical grade and when most drugs used for research purposes are not available in clinical preparations (where pharmaceutical grade ratings are typically used) and, even if available, may be produced in preparations inappropriate for research use in laboratory animals; (2) major increases in research costs for inadequately justified increases in cage sizes as well as for the mandate for daily monitoring of both food and fluid of all animals receiving one or the other restriction; (3) restrictions against multiple survival surgeries that are necessary for certain types of empirical research questions (e.g., when conducting surgery to implant a replacement hormone pellet after gonadectomy, mandating the conduct of the 2 surgeries at the same time would result in inappropriate, unphysiologically high hormone levels during the initial post-surgical period). The changes provided in the Guide clearly provide additional constraints to the exercise of scientific and professional judgment of investigators and will add significantly to the paperwork burden of investigators and IACUCs. The new Guide also oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., DEA and OSHA). Comment 2: I concur with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document" as defined by the OMB which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more..." Therefore, a meaningful opportunity to comment is necessary before a decision on Guide adoption and implementation strategy can be made.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals