Misc. AADAP submissions to CVM...

Proposal to accept data from any strain/subspecies of Oncorhynchus mykiss as representing the species

Submission cover letter (dated 9 February 2007)

Proposal entitled: "Justification to consider studies that demonstrate drug efficacy on freshwater-reared steelhead trout or rainbow trout be sufficient to satisfy the effectiveness requirements for all freshwater-reared Oncorhynchus mykiss"

CVM's response letter (dated 25 July 07)

Proposal to address the a portion of the microbial food safety assessment component of the human food technical section for oxytetracycline medicated feed: a hazard characterization to comply with CVM's Guidance for Industry #152 (Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects of human health concern).

Submission cover letter (dated 18 July 2006)

Proposal entitled: "Safety Assessment of the microbiological effects on bacteria of human concern for oxytetracycline type A medicated feed"

CVM's response letter (dated 15 March 2007)

Proposed freshwater fish classification based on rearing temperature.

Submission cover letter (dated 24 October 2007)

A Proposed Classification System for Finfish Based on Rearing Temperature

Proposed label expansion of oxytetracycline medicated feed for marking. Current approved skeletal marking claim is only for Pacific salmon. The proposed claim expansion is for all salmonids.

Background and links to correspondence