Survey Unmet Private076 by 3w6aA7x

VIEWS: 4 PAGES: 17

									       2006 PRIVATE AQUACULTURE SECTOR SURVEY ON
              UNMET LABEL CLAIM DRUG NEEDS
INTRODUCTION

Through coordinated and collaborative efforts, we have been successful in getting NINE NEW DRUGS
approved for use in the aquaculture industry with SEVEN ADDITIONAL NEW DRUGS expected to be
approved in the immediate future. However, compared to other animal agriculture groups, even if all
anticipated approvals are gained, aquaculture will still have a relatively small number of drugs approved
to treat a limited number of diseases in a few species.

THIS SURVEY IS YOUR OPPORTUNITY TO RECOMMEND WHAT ADDITIONAL UNMET LABEL
CLAIMS SHOULD BE MOST ACTIVELY PURSUED WITH LIMITED RESOURCES. Your responses to
this survey will help collaborators focus on generating data to address the unmet label claims that are
most critical to commercial aquaculture production in the United States. The survey allows you to identify
what will be needed to meet your needs for a basic medicine chest for (1) the species you culture, (2) the
diseases you need to control, (3) the procedures for which you need a zero withdrawal anesthetic or
sedative so that you can release or slaughter the fish immediately after treatment, (4) artificial spawning
procedures, (5) gender manipulation, and (6) marking.

An FDA approval of a drug is for a specific disease to be controlled or condition to be managed in a
particular species or group of species by a specific drug produced by a specific drug sponsor. This
means that unless both the disease and the species to be treated are on the label, a particular drug
cannot be used unless a veterinarian prescribes its use under extra label provisions and it is not restricted
by a National Pollutant Discharge Elimination System (NPDES) permit. For example, oral oxytetracycline
approved for systemic columnaris disease in freshwater-reared salmonids must be prescribed by a
veterinarian to control the same disease in either coolwater or warmwater fish species. Since this use is
not on the approved label, you would also need to contact your NPDES permit writer to request
authorization to release oxytetracycline-medicated feed. Thus, veterinarian extra-label use could be
restricted by your NPDES permit office. In the case of florfenicol, the current regulatory policy would not
allow extra label use because florfenicol is classified as a Veterinary Feed Directive drug.

Most of the initial drug approvals are limited to freshwater-reared salmonids or channel catfish. However,
for several drugs,* all the data (except efficacy) are being generated to extend the label claims to all
freshwater-reared fish to include coolwater species (reared at 15.6 to 24 ºC and includes percids and
esocids) and warmwater fish (generally reared above 24 ºC and includes tropical, ornamental, and
aquarium species). After initial approvals, copper sulfate and potassium permanganate will be limited to
channel catfish in earthen ponds with no outflows and veterinarians will not be able to prescribe them for
fish reared in flow-through systems or ponds that have effluent discharges.

All information collected from this survey will be treated as confidential. Any specific comments from you
either by name or by facility will not be identified in any report; instead only your responses and
comments without identifying your name or your facility will be included in the summary report of the
survey to protect your identity.

Please complete the attached survey by marking each question with an “X” under either “Yes”, “No”, or
“NA” for not applicable. Please note that the questions start with “will” for initial label claims and “would”
for unmet label claims. Please return the survey by August 25, 2006 to Rosalie (Roz) Schnick via e-mail
(RozSchnick@centurytel.net) or regular mail (National Coordinator for Aquaculture New Animal Drug
Applications, Michigan State University, 3039 Edgewater Lane, La Crosse, WI 54603-1088).

*AQUI-S®, chloramine-T, florfenicol, formalin, hydrogen peroxide, oral oxytetracycline, and immersion
oxytetracycline
.



Page 1 of 17 – 2006 UNMET LABEL CLAIM SURVEY
                             CONFIDENTIAL INFORMATION FROM THE SURVEY RESPONDENT

          Name

          Position

          Species Produced

          Facility & State

          E-mail address

          Telephone number

          ************************************************************************************************************************


                                              A. EXTERNAL BACTERIAL DISEASES


           A1. Initial Label Claims for Control of Mortalities Due to Bacterial Gill Disease Associated with
           Flavobacterium branchophilum
                     Drug                          Species                Projected Dates for Final Submissions
          Chloramine-T                All freshwater-reared salmonids    2007
          Hydrogen peroxide           All freshwater-reared salmonids    2006

            A1. Survey for Label Claim Needs for Bacterial Gill Disease
                   Questions Related to Initial Label Claims After They are Approved                                      Yes    No   NA
A1.1. Will these initial label claims meet your medicinal drug needs regarding bacterial gill disease?
A1.2. Will you use chloramine-T for bacterial gill disease on any freshwater-reared salmonid species?
A1.3. Will you use hydrogen peroxide for bacterial gill disease on any freshwater-reared salmonid species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                                Yes    No   NA
A1.4. Would you use chloramine-T for bacterial gill disease on any coolwater fish species?
A1.5. Would you use copper sulfate for bacterial gill disease on any coolwater fish species?
A1.6. Would you use hydrogen peroxide for bacterial gill disease on any coolwater fish species?
A1.7. Would you use immersion oxytetracycline for bacterial gill disease on any coolwater fish species?
A1.8. Would you use potassium permanganate for bacterial gill disease on any coolwater fish species?

A1.9. Would you use chloramine-T for bacterial gill disease on any warmwater fish species?
A1.10. Would you use copper sulfate for bacterial gill disease on any warmwater fish species?
A1.11. Would you use hydrogen peroxide for bacterial gill disease on any warmwater fish species?
A1.12. Would you use immersion oxytetracycline for bacterial gill disease on any warmwater fish
species?
A1.13. Would you use potassium permanganate for bacterial gill disease on any warmwater fish
species?

A1.14. Would you use copper sulfate for bacterial gill disease on any freshwater-reared salmonid
species?
A1.15. Would you use immersion oxytetracycline for bacterial gill disease on any freshwater-reared
salmonid species?
A1.16. Would you use potassium permanganate for bacterial gill disease on any freshwater-reared
salmonid species?




          Page 2 of 17 – 2006 UNMET LABEL CLAIM SURVEY
         A2. Initial Label Claims for Control of Mortalities Due to External Columnaris Disease Associated
         with Flavobacterium columnare
               Drug                              Species                 Projected Dates for Final Submissions
     Chloramine-T                 Walleye                              2007
     Hydrogen peroxide            All coolwater fish & catfish         2006
     Immersion oxytetracycline    All coolwater & warmwater fish       2007-2008
     Potassium permanganate       Channel catfish                      2009+

            A2. Survey for Label Claim Needs for External Columnaris Disease
                  Questions Related to Initial Label Claims After They are Approved                    Yes   No   NA
A2.1. Will these initial label claims meet your medicinal drug needs regarding external columnaris
disease?
A2.2. Will you use chloramine-T for external columnaris disease on walleye?
A2.3. Will you use hydrogen peroxide for external columnaris disease on any coolwater fish species?
A2.4. Will you use hydrogen peroxide for external columnaris disease on catfish?
A2.5. Will you use immersion oxytetracycline for external columnaris disease on any coolwater fish
species?
A2.6. Will you use immersion oxytetracycline for external columnaris disease on any warmwater fish
species?
A2.7. Will you use potassium permanganate for external columnaris disease on channel catfish?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested             Yes   No   NA
A2.8. Would you use chloramine-T for external columnaris disease on any freshwater-reared salmonid
species?
A2.9. Would you use copper sulfate for external columnaris disease on any freshwater-reared salmonid
species?
A2.10. Would you use hydrogen peroxide for external columnaris disease on any freshwater-reared
salmonid species?
A2.11. Would you use immersion oxytetracycline for external columnaris disease on any freshwater-
reared salmonid species?
A2.12. Would you use potassium permanganate for external columnaris disease on any freshwater-
reared salmonid species

A2.13 Would you use chloramine-T for external columnaris disease on any coolwater fish species
other than walleye?
A2.14. Would you use copper sulfate for external columnaris disease on any coolwater fish species?
A2.15. Would you use potassium permanganate for external columnaris disease on any coolwater fish
species?

A2.16. Would you use chloramine-T for external columnaris disease on any warmwater fish species?
A2.17. Would you use copper sulfate for external columnaris disease on any warmwater fish species?
A2.18. Would you use hydrogen peroxide for external columnaris disease on any scaled warmwater
fish species?
A2.19. Would you use potassium permanganate for external columnaris disease on any warmwater fish
species other than channel catfish?




          Page 3 of 17 – 2006 UNMET LABEL CLAIM SURVEY
                                          B. SYSTEMIC BACTERIAL DISEASES


          B1. Initial Label Claims for Control of Mortalities Due to Hemorrhagic Septicemia or Motile
          Aeromonad Septicemia Associated with Aeromonas hydrophila (was A. liquifaciens)
                     Drug                           Species              Projected Dates for Final Submissions
       Florfenicol                      Tilapia                          NA
       Oral oxytetracycline             All salmonids & catfish          PREVIOUSLY APPROVED 09/23/70

            B1. Survey for Label Claim Needs for Motile Aeromonad Septicemia
                   Questions Related to Initial Label Claims After They are Approved                       Yes   No   NA
B1.1. Will these initial and previously approved label claim meet your medicinal drug needs regarding
motile aeromonad septicemia?
B1.2. Will you use florfenicol for motile aeromonad septicemia in tilapia?
B1.3. Will you use oral oxytetracycline for motile aeromonad septicemia in any salmonid species?
B1.4. Will you use oral oxytetracycline for motile aeromonad septicemia in any catfish species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                 Yes   No   NA
B1.5. Would you use florfenicol for motile aeromonad septicemia in any freshwater-reared salmonid
species?
B1.6. Would you use Romet-30® or Romet-TC® for motile aeromonad septicemia in any freshwater-
reared salmonid species?

B1.7. Would you use florfenicol for motile aeromonad septicemia in any coolwater fish species?
B1.8. Would you use oral oxytetracycline for motile aeromonad septicemia in any coolwater fish species?
B1.9. Would you use Romet-30® or Romet-TC® for motile aeromonad septicemia in any coolwater fish
species?

B1.10. Would you use florfenicol for motile aeromonad septicemia in any warmwater fish species other
than tilapia?
B1.11. Would you use oral oxytetracycline for motile aeromonad septicemia in any scaled warmwater fish
species?
B1.12. Would you use Romet-30® or Romet-TC® for motile aeromonad septicemia in any warmwater fish
species?


          B2. Initial Label Claims for Control of Mortalities Due to Enteric Septicemia Associated with
          Edwardsiella ictaluri
                     Drug                           Species                Projected Dates for Final Submissions
       Florfenicol                      Catfish                           RECENTLY APPROVED 10/24/05
       Romet-30®, Romet-TC®             Catfish                           PREVIOUSLY APPROVED 05/23/86

            B2. Survey for Label Claim Needs for Enteric Septicemia
                   Questions Related to Initial Label Claims After They are Approved                       Yes   No   NA
B2.1. Will these recently and previously approved label claims meet your medicinal drug needs regarding
enteric septicemia?
B2.2. Will you use florfenicol for enteric septicemia in any catfish species?
B2.3. Will you use Romet-30® or Romet-TC® for enteric septicemia in any catfish species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                 Yes   No   NA
B2.4. Would you use florfenicol for enteric septicemia in any warmwater fish species other than catfish?
B2.5. Would you use oral oxytetracycline for enteric septicemia in any catfish species?
B2.6. Would you use oral oxytetracycline for enteric septicemia in any warmwater fish species other
than catfish?
B2.7. Would you use Romet-30® or Romet-TC® for enteric septicemia in any warmwater fish species?
other than catfish?



          Page 4 of 17 – 2006 UNMET LABEL CLAIM SURVEY
           B3. Initial Label Claims for Control of Mortalities Due to Furunculosis Associated with Aeromonas
           salmonicida
                      Drug                            Species              Projected Dates for Final Submissions
        Florfenicol                      All freshwater-reared salmonids 2006-2007
        Florfenicol                      All saltwater-reared salmonids    NA
        Oral oxytetracycline             All salmonids                     PREVIOUSLY APPROVED 09/23/70
        Romet-30®, Romet-TC®             All salmonids                     PREVIOUSLY APPROVED 11/26/84
        Sulfamerazine                    Rainbow, brown, & brook trout     PREVIOUSLY APPROVED 11/30/67 but
                                                                           currently not available

            B3. Survey for Label Claim Needs for Furunculosis
                  Questions Related to Initial Label Claims After They are Approved                      Yes   No   NA
B3.1. Will these initial and previously approved label claims meet your medicinal drug needs regarding
furunculosis?
B3.2. Will you use florfenicol for furunculosis in any freshwater-reared salmonid species?
B3.3. Will you use florfenicol for furunculosis in any saltwater-reared salmonid species?
B3.4. Will you use oral oxytetracycline for furunculosis in any salmonid species?
B3.5. Will you use Romet-30® or Romet-TC® for furunculosis in any salmonid species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested               Yes   No   NA
B3.6. Would you use florfenicol for furunculosis in any coolwater fish species?
B3.7. Would you use oral oxytetracycline for furunculosis in any coolwater fish species?
B3.8. Would you use Romet-30® or Romet-TC® for furunculosis in any coolwater fish species?

B3.9. Would you use florfenicol for furunculosis in any warmwater fish species?
B3.10. Would you use oral oxytetracycline for furunculosis in any warmwater fish species?
B3.11. Would you use Romet-30® or Romet-TC® for furunculosis in any warmwater fish species?

           B4. Initial Label Claims for Control of Mortalities Due to Streptococcosis Associated with
           Streptococcus iniae
                      Drug                           Species                Projected Dates for Final Submissions
        Amoxicillin                      Tilapia & hybrid striped bass     2009+
        Florfenicol                      Tilapia & hybrid striped bass     2007-2008

            B4. Survey for Label Claim Needs for Streptococcosis
                   Questions Related to Initial Label Claims After They are Approved                     Yes   No   NA
B4.1. Will these initial label claims meet your medicinal drug needs regarding streptococcosis?
B4.2. Will you use amoxicillin for streptococcosis in tilapia?
B4.3. Will you use amoxicillin for streptococcosis in hybrid striped bass?
B4.4. Will you use florfenicol for streptococcosis in tilapia?
B4.5. Will you use florfenicol for streptococcosis in hybrid striped bass?
    Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested              Yes   No   NA
B4.6. Would you use amoxicillin for streptococcosis in any warmwater fish species other than tilapia &
hybrid striped bass?
B4.7. Would you use florfenicol for streptococcosis in any warmwater fish species other than tilapia &
hybrid striped bass?
B4.8. Would you use oral oxytetracycline for streptococcosis in tilapia?
B4.9. Would you use oral oxytetracycline for streptococcosis in hybrid striped bass?
B4.10. Would you use oral oxytetracycline for streptococcosis in any warmwater fish species other than
tilapia & hybrid striped bass?
B4.11. Would you use Romet-30® or Romet-TC® for streptococcosis in tilapia?
B4.12. Would you use Romet-30® or Romet-TC® for streptococcosis in hybrid striped bass?
B4.13. Would you use Romet-30® or Romet-TC® for streptococcosis in any warmwater fish species
other than tilapia or hybrid striped bass?



          Page 5 of 17 – 2006 UNMET LABEL CLAIM SURVEY
           B5. Initial Label Claims for Control of Mortalities Due to Systemic Coldwater Disease Associated
           with Flavobacterium psychrophilum
                      Drug                           Species               Projected Dates for Final Submissions
        Florfenicol                      All freshwater-reared salmonids 2006-2007
        Oral oxytetracycline             All freshwater-reared salmonids 2007

            B5. Survey for Label Claim Needs for Systemic Coldwater Disease
                    Questions Related to Initial Label Claims After They are Approved                        Yes   No   NA
B5.1. Will these initial label claims meet your medicinal drug needs regarding systemic coldwater disease?
B5.2. Will you use florfenicol for systemic coldwater disease in any freshwater-reared salmonid species?
B5.3. Will you use oral oxytetracycline for systemic coldwater disease in any freshwater-reared salmonid
species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                   Yes   No   NA
B5.4. Would you use Romet-30® or Romet-TC® for systemic coldwater disease in any freshwater-reared
salmonid species?


           B6. Initial Label Claims for Control of Mortalities Due to Systemic Columnaris Disease Associated
           with Flavobacterium columnare
                      Drug                           Species               Projected Dates for Final Submissions
        Florfenicol                      All freshwater-reared salmonids 2007
                                         & catfish
        Nifurpirinol                     Aquarium fish                     1975 (cancelled 2005)
        Oral oxytetracycline             Steelhead trout                   2007

            B6. Survey for Label Claim Needs for Systemic Columnaris Disease
                   Questions Related to Initial Label Claims After They are Approved                         Yes   No   NA
B6.1. Will these initial label claims meet your medicinal drug needs regarding systemic columnaris
disease?
B6.2. Will you use florfenicol for systemic columnaris disease in any freshwater-reared salmonid species?
B6.3. Will you use florfenicol for systemic columnaris disease in any catfish species?
B6.4. Will you use oral oxytetracycline for systemic columnaris disease in steelhead trout?
    Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                  Yes   No   NA
B6.5. Would you use florfenicol for systemic columnaris disease in any coolwater fish species?
B6.6. Would you use oral oxytetracycline for systemic columnaris disease in any coolwater fish species?
B6.7. Would you use immersion oxytetracycline for systemic columnaris disease in any coolwater fish
species?
B6.8. Would you use Romet-30® or Romet-TC® for systemic columnaris disease in any coolwater fish
species?

B6.9. Would you use florfenicol for systemic columnaris disease in any scaled warmwater fish species?
B6.10. Would you use oral oxytetracycline for systemic columnaris disease in any warmwater fish
species?
B6.11. Would you use immersion oxytetracycline for systemic columnaris disease in any warmwater fish
species?
B6.12. Would you use Romet-30® or Romet-TC® for systemic columnaris disease in any warmwater fish
species?

B6.13. Would you use oral oxytetracycline for systemic columnaris disease in any freshwater-reared
salmonid species other than steelhead trout?
B6.14. Would you use immersion oxytetracycline for systemic columnaris disease in any freshwater-
reared salmonid species?
B6.15. Would you use Romet-30® or Romet-TC® for systemic columnaris disease in any freshwater-
reared salmonid species?



          Page 6 of 17 – 2006 UNMET LABEL CLAIM SURVEY
           B7. Initial Label Claims for Control of Mortalities Due to Bacterial Kidney Disease Associated with
           Renibacterium salmoninarum
                      Drug                           Species               Projected Dates for Final Submissions
        Erythromycin                     All freshwater-reared salmonids 2009

            B7. Survey for Label Claim Needs for Bacterial Kidney Disease
                      Questions Related to Initial Label Claims After They are Approved                   Yes   No   NA
B7.1. Will this initial label claim meet your medicinal drug needs regarding bacterial kidney disease?
B7.2. Will you use erythromycin for bacterial kidney disease in any freshwater-reared salmonid species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                Yes   No   NA
B7.3. Would you use florfenicol for bacterial kidney disease in any freshwater-reared salmonid species?
B7.4. Would you use oral oxytetracycline for bacterial kidney disease in any freshwater-reared salmonid
species?
B7.5. Would you use Romet-30® or Romet-TC® for bacterial kidney disease in any freshwater-reared
salmonid species?

           B8. Initial Label Claims for Control of Mortalities Due to Coldwater Vibriosis Caused by Vibrio
           salmonicida
                      Drug                            Species              Projected Dates for Final Submissions
        Florfenicol                      All saltwater-reared salmonids   NA

            B8. Survey for Label Claim Needs for Coldwater Vibriosis
                    Questions Related to Initial Label Claims After They are Approved                     Yes   No   NA
B8.1. Will these initial label claims meet your medicinal drug needs regarding coldwater vibriosis?
B8.2. Will you use florfenicol for coldwater vibriosis in any saltwater-reared salmonid species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                Yes   No   NA
B8.3. Would you use florfenicol for coldwater vibriosis in any other saltwater-reared fish species?
B8.4. Would you use oral oxytetracycline for coldwater vibriosis in any saltwater-reared fish species?
B8.5. Would you use Romet-30® or Romet-TC® for coldwater vibriosis in any saltwater-reared fish
species?

B8.6. Would you use oral oxytetracycline for coldwater vibriosis in any saltwater-reared salmonid
species?
Would you use Romet-30® or Romet-TC® for coldwater vibriosis in any saltwater-reared salmonid
species?

           B9. Initial Label Claims for Control of Mortalities Due to Edwardsiellosis Caused by Edwardsiella
           tarda
                      Drug                           Species              Projected Dates for Final Submissions
        Florfenicol                      Tilapia                          NA

            B9. Survey for Label Claim Needs for Edwardsiellosis
                      Questions Related to Initial Label Claims After They are Approved                   Yes   No   NA
B9.1. Will this initial label claim meet your medicinal drug needs regarding edwardsiellosis?
B9.2. Will you use florfenicol for edwardsiellosis in tilapia?
    Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested               Yes   No   NA
B9.3. Would you use florfenicol for edwardsiellosis in any freshwater-reared fish species other than
tilapia?
B9.4. Would you use oral oxytetracycline for edwardsiellosis in tilapia?
B9.5. Would you use Romet-30® or Romet-TC® for edwardsiellosis in tilapia?

B9.6. Would you use oral oxytetracycline for edwardsiellosis in any freshwater-reared fish species?
B9.7. Would you use Romet-30® or Romet-TC® for edwardsiellosis in any freshwater-reared fish
species?



          Page 7 of 17 – 2006 UNMET LABEL CLAIM SURVEY
          B10. Initial Label Claims for Control of Mortalities Due to Enteric Redmouth Disease Caused by
          Yersinia ruckeri
                   Drug                           Species                 Projected Dates for Final Submissions
       Florfenicol                   All Freshwater-reared salmonids      NA

           B10. Survey for Label Claim Needs for Enteric Redmouth Disease
                     Questions Related to Initial Label Claims After They are Approved                    Yes   No   NA
B10.1. Will this initial label claim meet your medicinal drug needs regarding enteric redmouth disease?
B10.2. Will you use florfenicol for enteric redmouth disease in any freshwater-reared salmonid species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                Yes   No   NA
B10.3. Would you use oral oxytetracycline for enteric redmouth disease in any freshwater-reared
salmonid species?
B10.4. Would you use Romet-30® or Romet-TC® for enteric redmouth disease in any freshwater-reared
salmonid species?


         B11. Initial Label Claims for Control of Mortalities Due to Gaffkemia Caused by Aerococcus
         viridans
                    Drug                           Species               Projected Dates for Final Submissions
       Oral oxytetracycline             Lobsters                         PREVIOUSLY APPROVED 06/30/87

           B11. Survey for Label Claim Needs for Gaffkemia
                    Questions Related to Initial Label Claims After They are Approved                     Yes   No   NA
B11.1. Will this previously approved label claims meet your medicinal drug needs regarding gaffkemia?
B11.2. Will you use oral oxytetracycline for gaffkemia in lobsters?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                Yes   No   NA
B11.3. Would you use florfenicol for gaffkemia in lobsters?
B11.4. Would you use Romet-30® or Romet-TC® for gaffkemia in lobsters?


         B12. Initial Label Claims for Control of Mortalities Due to Necrotizing Hepatopancreatitus
                    Drug                           Species               Projected Dates for Final Submissions
       Oral oxytetracycline             Penaeid shrimp                  2009

           B12. Survey for Label Claim Needs for Necrotizing Hepatopancreatitus
                     Questions Related to Initial Label Claims After They are Approved                    Yes   No   NA
B12.1. Will this initial label claim meet your medicinal drug needs regarding necrotizing
hepatopancreatitus?
B12.2. Will you use oral oxytetracycline for necrotizing hepatopancreatitus in penaeid shrimp?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                Yes   No   NA
B12.3. Would you use florfenicol for necrotizing hepatopancreatitus in penaeid shrimp?
B12.4. Would you use Romet-30® or Romet-TC® for necrotizing hepatopancreatitus in penaeid shrimp?




          Page 8 of 17 – 2006 UNMET LABEL CLAIM SURVEY
                                                  C. FUNGAL DISEASES

          C1. Initial Label Claims for Control of Mortalities Due to Saprolegniasis on Fish
                     Drug                           Species               Projected Dates for Final Submissions
        Formalin                        All freshwater-reared fish        2007
        Hydrogen peroxide               Channel catfish                   2007

            C1. Survey for Label Claim Needs for Saprolegniasis on Fish
                   Questions Related to Initial Label Claims After They are Approved                     Yes   No   NA
C1.1. Will these initial label claims meet your medicinal drug needs regarding saprolegniasis on fish?
C1.2. Will you use formalin for saprolegniasis on any freshwater-reared fish species?
C1.3. Will you use hydrogen peroxide for saprolegniasis on channel catfish?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested               Yes   No   NA
C1.4. Would you use copper sulfate for saprolegniasis on any freshwater-reared salmonid species?
C1.5. Would you use hydrogen peroxide for saprolegniasis on any freshwater-reared salmonid species?

C1.6. Would you use copper sulfate for saprolegniasis on any coolwater fish species?
C1.7. Would you use hydrogen peroxide for saprolegniasis on any coolwater fish species?

C1.8. Would you use copper sulfate for saprolegniasis on any warmwater fish species?
C1.9. Would you use hydrogen peroxide for saprolegniasis on any warmwater fish species other than
channel catfish?


          C2. Initial Label Claims for Control of Mortalities Due to Saprolegniasis on Fish Eggs
                     Drug                           Species               Projected Dates for Final Submissions
        Copper sulfate                  Channel catfish eggs              2008-2009
        Formalin                        All freshwater-reared fish eggs   RECENTLY APPROVED 07/16/98 &
                                                                          11/25/02
        Hydrogen peroxide               All freshwater-reared fish eggs   2006

            C2. Survey for Label Claim Needs for Saprolegniasis on Fish Eggs
                   Questions Related to Initial Label Claims After They are Approved                     Yes   No   NA
C2.1. Will these recently approved and initial label claims meet your medicinal drug needs regarding
saprolegniasis on fish eggs?
C2.2. Will you use copper sulfate for saprolegniasis on eggs of channel catfish?
C2.3. Will you use formalin for saprolegniasis on eggs of any freshwater-reared fish species?
C2.4. Will you use hydrogen peroxide for saprolegniasis on eggs of any freshwater-reared fish species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested               Yes   No   NA
C2.5. Would you use copper sulfate for saprolegniasis on eggs of any freshwater-reared salmonid
species?

C2.6. Would you use copper sulfate for saprolegniasis on eggs of any coolwater fish species?

C2.7. Would you use copper sulfate for saprolegniasis on eggs of any warmwater fish species other
than channel catfish?




          Page 9 of 17 – 2006 UNMET LABEL CLAIM SURVEY
                                                 D. PARASITE DISEASES

         D1. Initial Label Claims for Control of Mortalities Due to Ichthyophthiriasis (Ichthyophthirius sp)
                    Drug                          Species                 Projected Dates for Final Submissions
       Copper sulfate                  Channel catfish                   2007
       Formalin                        All fish                          APPROVED 07/16/98 & 11/25/02

            D1. Survey for Label Claim Needs for Ichthyophthiriasis
                   Questions Related to Initial Label Claims After They are Approved                   Yes   No   NA
D1.1. Will these recently approved and initial label claims meet your medicinal drug needs regarding
ichthyophthiriasis?
D1.2. Will you use copper sulfate for ichthyophthiriasis on channel catfish?
D1.3. Will you use formalin for ichthyophthiriasis on any fish species?
    Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested            Yes   No   NA
D1.4. Would you use copper sulfate for ichthyophthiriasis on any freshwater-reared salmonid species?
D1.5. Would you use hydrogen peroxide for ichthyophthiriasis on any freshwater-reared salmonid
species?
D1.6. Would you use potassium permanganate for ichthyophthiriasis on any freshwater-reared salmonid
species?

D1.7. Would you use copper sulfate for ichthyophthiriasis on any coolwater fish species?
D1.8. Would you use hydrogen peroxide for ichthyophthiriasis on any coolwater fish species?
D1.9. Would you use potassium permanganate for ichthyophthiriasis on any coolwater fish species?

D1.10. Would you use copper sulfate for ichthyophthiriasis on any warmwater fish species other than
channel catfish?
D1.11. Would you use hydrogen peroxide for ichthyophthiriasis on any warmwater fish species?
D1.12. Would you use potassium permanganate for ichthyophthiriasis on any warmwater fish species?




          Page 10 of 17 – 2006 UNMET LABEL CLAIM SURVEY
          D2. Initial Label Claims for Control of Mortalities Due to External Protozoa Including
          Ichthyophthirius sp, Chilodonella sp, Ichthyobodo (Costia) sp, Ambiphrya (Scyphidia) sp,
          Epistylis sp, & Trichodina sp on Finfish & Bodo sp, Epistylis sp, and Zoothamnium sp on Penaeid
          Shrimp
                     Drug                           Species               Projected Dates for Final Submissions
        Formalin                        All fish                          APPROVED 07/16/98 & 11/25/02
        Formalin                        Penaeid shrimp                    APPROVED 09/30/93 & 11/25/02

            D2. Survey for Label Claim Needs for External Protozoa
                   Questions Related to Initial Label Claims After They are Approved                  Yes   No    NA
D2.1. Will these recently approved label claims meet your medicinal drug needs regarding the listed
external protozoa?
D2.2. Will you use formalin for the listed external protozoa on any fish species?
D2.3. Will you use formalin for the listed external protozoa on penaeid shrimp?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested            Yes   No    NA
D2.4. Would you use copper sulfate for any external protozoa on any freshwater-reared salmonid
species?
D2.5 Would you use hydrogen peroxide for any external protozoa on any freshwater-reared salmonid
species?
D2.6. Would you use potassium permanganate for any external protozoa on any freshwater-reared
salmonid species?

D2.7. Would you use copper sulfate for any external protozoa on any coolwater fish species?
D2.8. Would you use hydrogen peroxide for any external protozoa on any coolwater fish species?
D2.9. Would you use potassium permanganate for any external protozoa on any coolwater fish species?

D2.10. Would you use copper sulfate for any external protozoa on any warmwater fish species?
D2.11. Would you use hydrogen peroxide for any external protozoa on any warmwater fish species?
D2.12. Would you use potassium permanganate for any external protozoa on any warmwater fish
species?

D2.13. Would you use formalin for external protozoa other than those listed on any fish species?

D2.14. Would you use formalin for external protozoa other than those listed on penaeid shrimp?




          Page 11 of 17 – 2006 UNMET LABEL CLAIM SURVEY
         D3. Initial Label Claims for Control of Monogenetic Trematodes (Cleidodiscus sp, Gyrodactylus
         sp, and Dactylogyrus sp)
                    Drug                           Species            Projected Dates for Final Submissions
       Formalin                        All fish                      APPROVED 07/16/98 & 11/25/02

            D3. Survey for Label Claim Needs for All Monogenetic Trematodes
                   Questions Related to Initial Label Claims After They are Approved                   Yes   No   NA
D3.1. Will this recently approved label claim meet your medicinal drug needs regarding the listed
monogenetic trematodes?
D3.2. Will you use formalin for the listed monogenetic trematodes on any fish species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested             Yes   No   NA
D3.3. Would you use formalin for monogenetic trematodes other than those listed on any fish species?

D3.4. Would you use hydrogen peroxide for any monogenetic trematodes on any freshwater-reared
salmonid species?
D3.5. Would you use potassium permanganate for any monogenetic trematodes on any freshwater-
reared salmonid species?

D3.6. Would you use hydrogen peroxide for any monogenetic trematodes on any coolwater fish species?
D3.7. Would you use potassium permanganate for any monogenetic trematodes on any coolwater fish
species?

D3.8. Would you use hydrogen peroxide for any monogenetic trematodes on any warmwater fish
species?
D3.9. Would you use potassium permanganate for any monogenetic trematodes on any warmwater fish
species?


          D4. Initial Label Claims for Control of Crustacean Parasites (Copepods & Argulids)
                     Drug                           Species              Projected Dates for Final Submissions
       Slice®                           Sea lice on saltwater-reared     NA
                                        salmonids

            D4. Survey for Label Claim Needs for Crustacean Parasites (Copepods & Argulids)
                     Questions Related to Initial Label Claims After They are Approved                 Yes   No   NA
D4.1. Will this initial label claim meet your medicinal drug needs regarding sea lice?
D4.2. Will you use Slice® for sea lice on any saltwater-reared salmonid species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested             Yes   No   NA
D4.3. Would you use Slice® for any copepods or argulids on any freshwater-reared fish species?
D4.4. Would you use Slice® for any copepods or argulids on any freshwater-reared fish species?

D4.5. Would you use Slice® for any copepods or argulids on any freshwater-reared fish species?

D4.6. Would you use Slice® for sea lice on any saltwater-reared salmonid species?




          Page 12 of 17 – 2006 UNMET LABEL CLAIM SURVEY
                                                 E. SEDATION AND ANESTHESIA

          E1. Initial Label Claims for Zero Withdrawal Time Sedative to Handleable Condition for Tagging,
          Grading, Sorting, Spawning, Hormone induction, Vaccination, Harvesting, & Collecting Population
          Assessment Data
                    Drug                            Species            Projected Dates for Final Submissions
        AQUI-S®                         All freshwater fish           2009
        AQUI-S®                         Saltwater salmonids           2009+

            E1. Survey for Label Claim Needs for Zero Withdrawal Sedative to Handleable Condition
                   Questions Related to Initial Label Claims After They are Approved                           Yes     No   NA
E1.1. Will these initial label claims for AQUI-S® meet your zero withdrawal sedative needs to sedate fish to
handleable condition?
E1.2. Will you use AQUI-S® to sedate any freshwater salmonid species to handleable condition?
E1.3. Will you use AQUI-S® to sedate any saltwater salmonid species to handleable condition?
E1.4. Will you use AQUI-S® to sedate any coolwater fish species to handleable condition?
E1.5. Will you use AQUI-S® to sedate any warmwater fish species to handleable condition?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                     Yes     No   NA
E1.6. Would you use AQUI-S® to sedate any freshwater shellfish species to handleable condition?

E1.7. Would you use AQUI-S® to sedate any saltwater shellfish species to handleable condition?

E1.8. Would you use AQUI-S® to sedate any molluscan species to handleable condition?

          E2. Initial Label Claims for Label Claim for Zero Withdrawal Time Light Sedative for
          Transportation or Treatment Baths
                     Drug                             Species            Projected Dates for Final Submissions
        AQUI-S®                          All freshwater fish             2009+
        AQUI-S®                          All saltwater salmonids         2009+

            E2. Survey for Label Claim Needs for Zero Withdrawal Light Sedative for Transportation or
            Treatment Baths
                   Questions Related to Initial Label Claims After They are Approved                             Yes   No   NA
E2.1. Will these initial label claims meet your needs for a zero withdrawal light sedative for transportation or
treatment?
E2.2. Will you use AQUI-S® for light sedation for transportation or treatment baths on any freshwater
salmonid species?
E2.3. Will you use AQUI-S® for light sedation for transportation or treatment baths on any saltwater
salmonid species?
E2.4. Will you use AQUI-S® for light sedation for transportation or treatment baths on any coolwater fish
species?
E2.5. Will you use AQUI-S® for light sedation for transportation or treatment baths on any warmwater fish
species?
    Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                      Yes   No   NA
E2.6. Would you use AQUI-S® for light sedation for transportation or treatment baths on any freshwater
shellfish species?

E2.7. Would you use AQUI-S® for light sedation for transportation or treatment baths on saltwater
shellfish species?

E2.8. Would you use AQUI-S® for light sedation for transportation or treatment baths on saltwater
molluscan species?




           Page 13 of 17 – 2006 UNMET LABEL CLAIM SURVEY
          E3. Initial Label Claims for Label Claim for Sedative Needs with a 21-Day Withdrawal Time for
          Food Fish or for Use on Non-Food Finfish
           Drug                              Species                         Projected Dates for Final Submissions
       Aquacalm® Ornamental fish                                             2009+
       Tricaine®      Ictaluridae, Salmonidae, Esocidae, and Percidae,       PREVIOUSLY APPROVED 01/04/72 &
                      and water temperature should not exceed 10 ºC. In 11/27/97
                      non-food fish, this drug should be limited to hatchery
                      or lab use; 21-day withdrawal time

            E3. Survey for Label Claim Needs for Sedative with a 21-Day Withdrawal Time for Food Fish or for
            Use on Non-Food Finfish
                  Questions Related to Initial Label Claims After They are Approved                  Yes No          NA
E3.1. Will these approved and initial label claims meet your sedative needs?
E3.2. Will you use Aquacalm® for sedation in ornamental fish?
E3.3. Will you use Tricaine® for sedation in fish species listed above with 21-day withdrawal time?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested           Yes No          NA
E3.4. Would you use Aquacalm® for sedation in food fish species with 21-day withdrawal time?




         Page 14 of 17 – 2006 UNMET LABEL CLAIM SURVEY
                               F. SPAWNING, GENDER MANIPULATION, AND MARKING AIDS

          F1. Initial Label Claims for Spawning Aids
                     Drug                          Species                    Projected Dates for Final Submissions
        Chorulon®                        All fish                             APPROVED 09/07/99
        LHRHa                            Catfish                              2009+
        Ovaprim®                         Ornamental fish                      2009+
        Crude carp pituitary             All fish                             Low Regulatory Priority?

            F1. Survey for Label Claim Needs for Spawning Aids
                   Questions Related to Initial Label Claims After They are Approved                          Yes   No   NA
F1.1. Will these approved and initial label claims meet your spawning aid needs?
F1.2. Will you use Chorulon® for spawning of any fish species?
F1.3. Will you use LHRHa for spawning of any catfish species?
F1.4. Will you use Ovaprim® for spawning of any ornamental fish species?
F1.5. Will you use crude carp pituitary for spawning of any fish species as a Low Regulatory Priority drug?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                    Yes   No   NA
F1.6. Would you use LHRHa for spawning of any fish species other than catfish?

F1.7. Would you use Ovaprim® for spawning of any fish species other than ornamental fish species?

           F2. Initial Label Claims for Gender Manipulation Aids
                      Drug                          Species                   Projected Dates for Final Submissions
        17 α-methyltestosterone           Tilapia                             2009
        17 α-methyltestosterone           Ornamental fish                     2009+

            F2. Survey for Label Claim Needs for Gender Manipulation Aids
                   Questions Related to Initial Label Claims After They are Approved                          Yes   No   NA
F2.1. Will this approved label claim meet your gender manipulation aid needs?
F2.2. Will you use 17 α-methyltestosterone for gender manipulation in tilapia?
F2.3. Will you use 17 α-methyltestosterone for gender manipulation in ornamental fish?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested                    Yes   No   NA
F2.4. Would you use 17 α-methyltestosterone for gender manipulation in freshwater-reared salmonid
species?

F2.5. Would you use 17 α-methyltestosterone for gender manipulation in coolwater fish species?

F2.6. Would you use 17 α-methyltestosterone for gender manipulation in warmwater fish species other
than tilapia?




           Page 15 of 17 – 2006 UNMET LABEL CLAIM SURVEY
         F3. Initial Label Claims for Marking Aids
                    Drug                           Species               Projected Dates for Final Submissions
       Oral oxytetracycline            Pacific salmon                    APPROVED 09/23/70
       Immersion oxytetracycline       All fish                          APPROVED 12/24/03, 09/15/04, &
                                                                         06/13/05
       Calcein                          All fish                         2009+
       Strontium chloride               All fish                         2009+

            F3. Survey for Label Claim Needs for Marking Aids
                   Questions Related to Initial Label Claims After They are Approved                 Yes   No    NA
F3.1. Will these approved and initial label claims meet your marking aid needs?
F3.2. Will you use oral oxytetracycline for marking of any Pacific salmon species?
F3.3. Will you use immersion oxytetracycline for marking of any fish species?
F3.4. Will you use calcein for spawning for marking of any fish species?
F3.5. Will you use strontium chloride for marking of any fish species?
   Questions Related to UNMET Label Claims That Would be Pursued for Approval If Requested           Yes   No    NA
F3.6. Would you use oral oxytetracycline for marking of any fish species other than Pacific salmon
species?




          Page 16 of 17 – 2006 UNMET LABEL CLAIM SURVEY
  LIST THE TOP FOUR UNMET LABEL CLAIMS INCLUDED IN THIS SURVEY THAT YOU WOULD
                             LIKE TO SEE ADDRESSED

      Disease/Condition                     Species              Suggested Drug




  LIST ANY LABEL CLAIMS NOT INCLUDED IN THIS SURVEY THAT YOU WOULD LIKE TO SEE
                                  ADDRESSED

      Disease/Condition                     Species              Suggested Drug




PROVIDE ANY ADDITIONAL COMMENTS FOR CONSIDERATION RELATED TO DRUG APPROVAL
                                  NEEDS




Page 17 of 17 – 2006 UNMET LABEL CLAIM SURVEY

								
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