Public Master Files submitted by AADAP ...

Note: some of the below-linked files are very big, so you may only want to attempt a download if you have a high-speed connection, and even then, please be patient.

Chloramine-T - "...for use to control mortality caused by bacterial gill disease in freshwater-reared salmonids. Treat fish one time per day at 12 – 20 mg per L for 60 min in a static or flow-through bath on three alternate or consecutive days."

AADAP's original submission to CVM (24 May 2007)

Cover letter

Efficacy Protocol

Dose confirmation Protocol

Abstracts from Efficacy Final Study Reports

Apache trout

fall chum salmon

fingerling rainbow trout

dose confirmation

CVM Correspondence related to Technical Section completion

July 11, 2000; INAD 4000 H-0071

June 10, 2002; INAD 4000 H-0091

Target Animal Safety Protocol

Executive Summaries for Final Study Reports

Target Animal Safety experiments 1 -8, and 10 (Acute Toxicity)

Target Animal Safety experiment 9 (Pathologies)

CVM Correspondence related to Technical Section completion

September 13, 2002; INAD 4000 P-0093

Freedom of Information Summary (4 February 2003)

CVM's letter assigning a PMF Number (30 May 2007)

AADAP's amendment to PMF submission (23 January 2008)

Cover Letter

Target Animal Safety Study Report Abstract

CVM's acceptance letter of PMF (28 July 2008)

CVM-generated "Summary of Safety and Effectiveness Data in PMF 005893"

Federal Register notice of availability of data within the PMF (21 August 2008)

Florfenicol: "...for use to control mortality caused by furunculosis associated with Aeromonas salmonicida in freshwater-reared salmonids; for use to control mortality caused by coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonids; and for use to control mortality caused by streptococcal septicemia associated with Streptococcus iniae in hybrid striped bass. Treat fish one time per day at 10 mg/kg of fish for 10 consecutive days."

AADAP's original submission to CVM (1 October 2008)

Cover letter

Efficacy Protocols

Original

First revision

Second revision

Third revision

Abstracts from Efficacy Final Study Reports

Fingerling cutthroat trout/cold water disease (#FLOR-01-EFF-03)

Fingerling cutthroat trout/cold water disease (#FLOR-01-FF-04)

Fingerling steelhead trout/cold water disease (#FLOR-01-EFF-06)

Fry cutthroat trout/cold water disease (#FLOR-01-EFF-12)

Fingerling coho salmon /furunculosis disease (#FLOR-01-EFF-01)

Fall chinook salmon/furunculosis disease (#FLOR-01-EFF.3-22)

Coho salmon /furunculosis disease (#FLOR-01-EFF.3-27)

Fingerling hybrid striped bass/streptococcal septicemia (#Flor-01-EFF-02.b)

Hybrid striped bass/streptococcal septicemia (#Flor-01-EFF.3-19)

CVM Correspondence related to Technical Section completion

CVM's "Efficacy Technical Section Complete" letter for cold water disease in freshwater-reared salmonids (7 August 2003)

CVM's "Efficacy Technical Section Complete" letter for furunculosis disease in freshwater-reared salmonids (19 April 2007)

CVM's "Efficacy Technical Section Complete" letter for streptococcal septicemia in hybrid striped bass (4 April 2008)

CVM-generated Freedom of Information Summaries

Coldwater disease/freshwater-reared salmonids (19 March 2007)

Furunculosis disease/freshwater-reared salmonids (26 October 2007)

Streptococcal septicemia/hybrid striped bass (4 April 2008)

CVM's letter assigning a PMF Number (3 October 2008)

CVM acceptance letter of PMF (21 April 2009)

Oxytetracycline: "...for use to control mortality caused by coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonids and columnaris disease associated with Flavobacterium columnare in freshwater-reared Oncorhynchus mykiss. Treat fish one time per day at 3.75g per 100 lbs of fish for 10 consecutive days.”

AADAP's original submission to CVM (13 August 2008)

Cover letter

Efficacy

Protocol

Abstracts from Efficacy Final Study Reports

Juvenile steelhead trout/columnaris disease (#BOZ-98-OTF Study #1)

Juvenile steelhead trout/columnaris disease (#BOZ-98-OTF-02)

Fingerling coho salmon/cold water disease (#BOZ-99-OTF-03)

Juvenile steelhead trout/columnaris disease (#BOZ-98-OTF-04)

Supplemental Efficacy Report

Report Title:" 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." (9 February 2007)

CVM Correspondence related to Technical Section completion

CVM's "Efficacy Technical Section Complete" letter for cold water disease in freshwater-reared salmonids (23 November 2001)

CVM's "Efficacy Technical Section Complete" letter for columaris disease in freshwater-reared Oncorhynchus mykiss (25 July 2007)

Human Food Safety

Document addressing Section IV of Guidance Document #152 entitled: “Safety Assessment of the Microbiological Effects on Bacteria of Human Concern for Oxytetracycline Type A Medicated Feed (INAD 9332)” (18 July 2006)

CVM Correspondence related to acceptance of microbial food safety assessment (15 March 2007)

CVM-generated Freedom of Information Summary (6 July 2008)

CVM's letter assigning a PMF Number (3 October 2008)

CVM's acceptance letter of PMF (14 April 2009)

 

 

 

 

 

 

 

 
 
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LAST UPDATED: 16-Jan-2013