Letters from CVM responding to AADAP submissions ...

AQUI-S^®

Status of effectiveness technical section (coolwater species) - 28 November 06

Status of effectiveness technical section (salmonids) - 28 November 06

Status of effectiveness technical section (warmwater species) - 28 November 06

Acceptance of rainbow trout target animal safety study - 8 December 06

Acceptance of blue catfish life-stage preliminary safety study - 16 February 07

Acceptance of largemouth bass pilot safety study - 27 April 07

Review of Freedom of Information Summary content - 10 July 07

Acceptance of cutthroat trout target animal safety study -10 January 08

Chloramine-T

Concurrence with pivotal efficacy protocol for BGD/external columnaris - 26 July 07

EFF technical section complete for external columnaris & walleye - 3 March 08

Acceptance of external columnaris and largemouth bass pivotal efficacy study -
14 April 07

Rejection of pivotal efficacy Final Study Report suporting claim for the control of mortality in largemouth bass caused by external columnaris - 23 May 08

Rejection of white paper argument supporting a "Request to Consider the
Chloramine-T Effectiveness Technical Section Complete for the Control of Mortality in All Freshwater-Reared Coolwater and Warmwater Finflsh due to External Columnaris Disease Associated with Flavobacterium columnare - 2 October 2009

EFF technical section complete for external columnaris disease in all freshwater-reared warmwater finfish - 5 October 2009

Aquaflor^® (florfenicol)

Rejection as pivotal, but acceptance as supportive efficacy study on cutthroats & coldwater disease - 8 February 02

Rejection as pivotal, but acceptance as supportive efficacy study on cutthroats & coldwater disease - 4 October 02

Acceptance of cutthroat EFF data for coldwater disease in FW salmonids - 4 March 03

Acceptance of rainbow EFF data for coldwater disease in FW salmonids - 10 June 03

EFF technical section complete for coldwater disease & FW salmonids - 7 August 03

EFF technical section complete for furunculosis in FW salmonids - 19 April 07

EFF technical section complete for Streptococcus iniae in hybrid striped bass -
4 April 08

Concurrence with target animal safety study strategy to achieve a 15 mg florfenicol per kg of fish per day for 10 days claim for all freshwater finfish - 16 September 08

Concurrence with sunshine bass target animal safety protocol to establish dose of 15 mg florfenicol per kg of fish per day for 10 days - 23 February 2009

Rejection as pivotal, but acceptance as supportive efficacy study on Oncorhynchus mykiss & columnaris disease - 29 May 2009

Rejection of EFF technical section complete request for 10 mg/kg for 10 consecutive days to control mortality in all freshwater-reared salmonids caused by columnaris disease associated with Flavobactium columnare - 29 May 2009

17-α methyltestosterone (MT)

Acceptance of one EFF pivotal study for MT in tilapia - 27 July 07

EFF technical section incomplete for MT in tilapia - 1 May 08

EFF technical section complete for MT in tilapia - 10 December 08

Acceptance of TAS pivotal study for MT in tilapia - 21 August 2009

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

Acceptance of proposal - 25 July 07

35% Perox-Aid^® (hydrogen peroxide)

Rejection of INAD efficacy protocol - 13 November 07

Acceptance of INAD efficacy protocol - 6 February 08

Acceptance of a pivotal EFF study for external columaris in largemouth bass - 5 May 09

Acceptance of a pivotal EFF study for external columaris in bluegill - 26 August 09

EFF technical section complete for external columnaris on warmwater finfish - 26 August 09

Oxytetracycline medicated feed

Acceptance of EFF data for coldwater disease in all FW salmonids and systemic columnaris in FW steelhead trout - 31 December 03

SLICE^® (emamectin benzoate)

Rejection of pivotal ectoparasite efficacy protocol and supplemental information submissions - 5 October 2009