Letters from CVM responding to AADAP submissions (in alphabetical order)...

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 protocol for MT in tilapia - 21 August 2009

Acceptance of TAS pivotal study for MT in tilapia and CVM concurrence that the TAS Technical Section is complete - 4 May 2012

35% Perox-Aid^® (hydrogen peroxide)

Rejection of INAD efficacy protocol - 13 November 07

Acceptance of INAD efficacy protocol - 6 February 08

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

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

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

Rejection of pivotal EFF protocol for Gyrodactylus salmonis on rainbow trout - 18 June 2010

Concurrence with pivotal EFF protocol for Gyrodactylus salmonis on rainbow trout - 27 October 2010

Acceptance of pivotal EFF study for Gyrodactylus salmonis on rainbow trout - 26 July 2011

EFF technical section considered "...complete for the use of 35% PEROX-AID^® (hydrogen peroxide) for the treatment and control of Gyrodactylus spp. in freshwater-reared salmonids." - 6 August 2012

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 Flavobacterium columnare - 29 May 2009.

Concurrence with efficacy protocol to support the claim for the control of mortality in freshwater finfish caused by florfenicol-susceptible bacterial pathogens, when used at a dose of 10 mg florfenicol per kg of fish per day for 10 days when administered in the feed - 29 December 2009.

Concurrence with largemouth bass/columnaris EFF study conducted at 10 mg florfenicol per kg of fish per day for 10 consecutive days - 29 January 2010.

TAS technical section complete for Streptococcus iniae in hybrid striped bass -
8 July 2010.

Acceptance of pivotal EFF study on bluegill and systemic columnaris - 29 July 2010.

TAS technical section complete for susceptible pathogens in yellow perch when treated at 15 mg per kg of fish per day for 10 days - 10 February 2011.

Acceptance of pivotal EFF studies on Chinook salmon and Bacterial Kidney Disease, and denial of request for EFF technical section complete - 23 June 2011.

Acceptance of pivotal EFF study protocol entitled "The Safety of AQUAFLOR^® (50% florfenicol; Type A Medicated Article) Administered in Feed to Cobia Rachycentron canadum" - 9 August 2012

Equivocal acceptance of EFF study to demonstrate control of systemic columnaris in rainbow trout - 2 September 2011

Aquamycin^® 100 (22.045% erythromycin thiocyanate)

EFF technical section complete for the control of mortality due to bacterial kidney disease associated with Renibacterium salmoninarum in freshwater-reared Chinook salmon - 30 April 2012

AQUI-S^® (50% isoeugenol)

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

AQUI-S^®E (50% eugenol)

Non-concurrence of pivotal efficacy protocol for testing of Aqui-S^® E to sedate freshwater-reared finfish to a handleable stage- 23 October 2009

Concurrence of pivotal efficacy protocol for testing of Aqui-S^® E to sedate
freshwater-reared finfish to a handleable stage- 18 February 2010

AQUI-S^®20E (10% eugenol)

Concurrence of pivotal efficacy protocol for testing of Aqui-S^® 20E to sedate
a variety of freshwater-reared finfish to a handleable stage- 20 June 2011

Concurrence with request to reduce the number of tissues examined histologically for Aqui-S^®20E target animal safety studies - 22 July 2011

Concurrence of pivotal target animal safety protocol for testing of Aqui-S^®20E on a variety of freshwater fish - 9 December 2011

Concurrence of a UV-Vis spectrophotometric method for verifying concentrations of eugenol in efficacy and target animal safety studies testing Aqui-S^®20E - 17 January 2012

Acceptance of pivotal efficacy study on rainbow trout - 10 February 2012

Acceptance of high quality supportive efficacy study on Arctic char - 10 February 2012

Acceptance of high quality supportive efficacy study on walleye - 26 March 2012

Acceptance of high quality supportive study as evidence of efficacy in sedating cutthroat trout at 250 mg/L of AQUI-S^®20E - 4 April 2012

Acceptance of several pivotal and non-pivotal efficacy studies as substantial evidence of the effectiveness of AQUI-S ^®20E to sedate freshwater-reared hybrid striped bass, blue catfish, channel catfish and Nile tilapia to a handleable condition. However, the effectiveness technical section remains incomplete - 19 July 2012

Acceptance of EFF studies on common carp and fathead minnows as part of substantial evidence of effectiveness for the use of AQUI-S^®20E (10% eugenol) liquid to sedate freshwater-reared finfish to a handleable condition. However, the effectiveness technical section remains incomplete.- 17 September 2012

Acceptance as substantial evidence of the effectiveness of AQUI-S^®20E to sedate coolwater freshwater-reared finfish to a handleable condition as demonstrated via an EFF supportive study on walleye, an EFF supportive study on yellow per and an EFF high quality supportive studies on yellow perch. However, the EFF technical section remains incomplete - 25 September 2012

BENZOAK^® (benzocaine)

Non-concurrence of pivotal efficacy protocol for testing of benzocaine to sedate freshwater-reared finfish to a handleable stage - 6 November 2009

Concurrence of pivotal efficacy protocol for testing of benzocaine to sedate freshwater-reared finfish to a handleable stage - 22 March 2010

Acceptance of genotoxicity battery (and incomplete human food safety technical section) - 28 July 2010

Acceptance of pivotal efficacy study of rainbow trout (but technical section still incomplete) - 9 March 2012

Acceptance of high quality supportive efficacy study on walleye - 26 March 2012

Acceptance of high quality supportive efficacy study on cutthroat trout; Technical Section remains incomplete for claim of all freshwater-reared salmonids - 20 April 2012

Acceptance of several non-pivotal efficacy studies as substantial evidence of the effectiveness of BENZOAK^® (benzocaine) to sedate freshwater-reared hybrid striped bass and blue catfish to a handleable condition. However, the effectiveness technical section remains incomplete - 19 July 2012

Acceptance of two pivotal efficacy studies as substantial evidence of the effectiveness of BENZOAK^® (benzocaine) to sedate freshwater-reared Nile tilapia and blue catfish to a handleable condition. However, the results from the pivotal hybrid striped bass study were not accepted and hence, the effectiveness technical section remains incomplete - 20 August 2012

Acceptance of EFF studies on common carp and fathead minnows as part of substantial evidence of effectiveness for the use of BENZOAK^® (benzocaine) liquid to sedate freshwater-reared finfish to a handleable condition. However, the effectiveness technical section remains incomplete.- 20 September 2012

Acceptance as substantial evidence of the effectiveness of BENZOAK^® to sedate freshwater-reared finfish to a handleable condition as demonstrated via an EFF supportive study on walleye and two EFF supportive studies on yellow perch. However, the EFF technical section remains incomplete - 26 September 2012

Channel Catfish Pituitary

Concurrence with request for waiver of human food safety technical section - 2 August 2010

Non-concurrence with request to substitute a "white paper" for the formal submission of an Environmental Assessment - 29 November 2010

CVM's Memorandum of Conference for the 12 October 2011 Product Development Meeting - 23 November 2011

Non-acceptance of revised Environmental Assessment - 3 February 2012

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 supporting 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

Oxytetracycline medicated feed

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

EFF technical section complete for the "...use of Terramycin 200 for Fish (oxytetracycline dihydrate) type A medicated article for the skeletal marking of all freshwater-reared salmonids when administered orally in fed at 3.75 g OTC per 100 pounds of fish per day for 10 consecutive days." - 21 January 2010

Concurrence with pivotal efficacy protocol entitled: "The Efficacy of TERRAMYCIN 200 for Fish (oxytetracycline dihydrate) Type A Medicated Article Administered in Feed to Control Mortality caused by susceptible pathogens of Freshwater-Reared Finfish." - 30 April 2010.

PENNOX 343^® (oxytetracycline hydrochloride soluble powder)

Concurrence with pivotal study protocol entitled "The Efficacy of PENNOX 343^® (oxytetracycline hydrochloride) administered as a Static Bath to Control Mortality of Freshwater-Reared Finfish" - 26 September 2012

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

Acceptance of proposal - 25 July 07

SLICE^® (emamectin benzoate)

Rejection of pivotal ectoparasite efficacy protocol and review of supplemental information submissions - 27 November 2009

Concurrence with pivotal ectoparasite efficacy protocol - 17 March 2010

Concurrence with pivotal target animal safety protocol - 30 December 2010

Acceptance of three pivotal studies demonstrating the efficacy of SLICE^® for the control of Salmincola californiensis on rainbow trout - 2 September 2011

EFF technical section is complete for the use of emamectin medicated feed for the control of Salmincola californiensis in freshwater-reared Oncorhynchus mykiss - 13 April 2012