Judith A Davis - Comment

I applaud FDA's initiative to revise 21 CFR part 58; it is overdue. The revised version should include elements reflective of the concepts and expectations of today's public sector regarding the use of animals in biomedical research. FDA is often criticized for animal testing requirements in lieu of alternative methodologies. FDA should encourage Centers to adopt reputable alternative methodologies to the use of animals but must also realize that animals are a key component for distributing "reasonable safety" prior to moving forward to clinical trials. Specifically, I believe the revised version should 1) recognize in the scope (58 subpart A, 58.1) the expectation that all preclinical studies comply with the USDA regulations governing the Animal Welfare Act and adhere to the U.S. Government Principles, and PHS Policies (e.g. Guide for the Care and Use of Laboratory Animals). Second, a subparagraph specifically denoting expectations of preclinical studies to follow the "3 Rs" for animal welfare. Third, include an expectation of "adequate veterinary care" as defined by the USDA/APHIS and ACLAM. Fourth, specifically recognize the veterinarian as "key personnel" (Subpart B, 58.29) with the expectation of full involvement by the veterinarian and a "scientist report" attached to the Study Director Report that summarizes, individually, the overall health and all clinical issues of each animal enrolled in a study. Fifth, emphasize that education, skills, and training of ALL personnel involved in a preclinical study must be for the species studied, relevant, and current. (58.29) Sixth, Raw Data (58.3(k)) includes all individual medical records of animals and results of all monitoring (EKG), testing (CBC, Serum Chem), etc. Seven, if a multi-site study, the StudyDirector ensures that the same protocol, procedures, end points, and acceptability criteria are used at each study site. Eight, the availabilit of the IACUC-approved (signed and dated) pr