[Federal Register Volume 86, Number 136 (Tuesday, July 20, 2021)]
[Notices]
[Pages 38349-38354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15418]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS-HQ-FAC-2021-N167; FXFR13110900000 201 FF09F11000; OMB Control
Number 1018-New]
Agency Information Collection Activities; Administration of U.S.
Fish and Wildlife Service Investigational New Animal Drug (INAD)
Program
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of information collection; request for comment.
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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, we,
the U.S. Fish and Wildlife Service (Service), are proposing a new
information collection in use without Office of Management and Budget
(OMB) approval.
DATES: Interested persons are invited to submit comments on or before
September 20, 2021.
ADDRESSES: Send your comments on the information collection request
(ICR) by mail to the Service Information Collection Clearance Officer,
U.S. Fish and Wildlife Service, MS: PRB (JAO/3W), 5275 Leesburg Pike,
Falls Church, VA 22041-3803 (mail); or by email to Info_Coll@fws.gov.
Please reference OMB Control Number ``1018-INAD'' in the subject line
of your comments.
FOR FURTHER INFORMATION CONTACT: To request additional information
about this ICR, contact Madonna L. Baucum, Service Information
Collection Clearance Officer, by email at Info_Coll@fws.gov, or by
telephone at (703) 358-2503. Individuals who are hearing or speech
impaired may call the Federal Relay Service at 1-800-877-8339 for TTY
assistance.
SUPPLEMENTARY INFORMATION: In accordance with the Paperwork Reduction
Act of 1995 (PRA, 44 U.S.C. 3501 et seq.) and 5 CFR 1320.8(d)(1), we
provide the general public and other Federal agencies with an
opportunity to comment on new, proposed, revised, and continuing
collections of information. This helps us assess the impact of our
information collection requirements and minimize the public's reporting
burden. It also helps the public understand our information collection
requirements and provide the requested data in the desired format.
As part of our continuing effort to reduce paperwork and respondent
burdens, we invite the public and other Federal agencies to comment on
new, proposed, revised, and continuing collections of information. This
helps us assess the impact of our information collection requirements
and minimize the public's reporting burden. It also helps the public
understand our information collection requirements and provide the
requested data in the desired format.
We are especially interested in public comment addressing the
following:
(1) Whether or not the collection of information is necessary for
the proper performance of the functions of the agency, including
whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection
of information, including the validity of the methodology and
assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
(4) How might the agency minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of response.
Comments that you submit in response to this notice are a matter of
public record. We will include or summarize each comment in our request
to OMB to approve this ICR. Before including your address, phone
number, email address, or other personal identifying information in
your comment, you should be aware that your entire comment--including
your personal identifying information--may be made publicly available
at any time. While you can ask us in your comment to withhold your
personal identifying information from public review, we cannot
guarantee that we will be able to do so.
Abstract: The Aquatic Animal Drug Approval Partnership (AADAP)
Program is part of the Fish and Aquatic Conservation fish health
network. It is the only program in the United States singularly
dedicated to obtaining U.S. Food and Drug Administration (FDA) approval
of new medications needed for use in fish culture and fisheries
management. Ultimately, the AADAP program allows fisheries
professionals to more effectively and efficiently rear and manage a
variety of fish species to meet production goals, stock healthy fish,
and maintain a healthy environment. In order for participants (U.S.
aquaculture facilities or researchers) to be able to use an unapproved
drug under AADAP's National Investigational New Animal Drug (INAD)
Program, they need to follow the FDA-approved study protocol(s) and
submit the required data forms, including the INAD treatment data, to
AADAP's INAD Program.
There are 18 approved INADs approved for use within the Service's
INAD Program (see fws.gov/fisheries/aadap/inads.html) described as
follows:
Medicated Feeds
Florfenicol (Aquaflor[supreg]) INAD #10-697--Aquaflor[supreg] is an
aquaculture premix containing florfenicol and is only available through
Merck Animal Health. The primary goal of field studies conducted under
INAD #10-697 is to evaluate the efficacy of florfenicol-medicated feed
for controlling mortality in a variety of fish species diagnosed with a
variety of diseases that are caused by pathogens susceptible to
florfenicol.
Slice[supreg] (Emamectin Benzoate) INAD #11-370--SLICE[supreg] is
an aquaculture premix containing emamectin benzoate and is only
available through Merck Animal Health. SLICE[supreg] premix can be
purchased through Merck Animal Health and sent to an aquaculture feed
mill for top coating. The primary goal of field studies conducted under
INAD #11-370 is to evaluate the efficacy of SLICE[supreg]-medicated
feed and safety of SLICE[supreg] to control mortality caused by
external parasites in a variety of freshwater and marine fish species.
Oxytetracylcine dihydrate (Terramycin[supreg] 200 for Fish) INAD
#9332--Terramycin 200[supreg] for fish is an aquaculture premix
containing oxytetracycline dehydrate (OTC) and is available through
Syndel USA. Feed medicated with OTC can be purchased from aquaculture
feed mills and used to treat bacterial diseases or to apply a skeletal
mark on the fish. The primary goal of field studies conducted under
INAD #9332 is to generate additional OTC-medicated feed efficacy data
which can be used to expand the existing OTC label claims. Five
treatment options are allowed, and disposition of investigational
animals (including withdrawal times) vary with treatment regimen.
17[alpha]-methyltestosterone INAD #11-236--17[alpha]-
methyltestosterone (MET) is an aquaculture premix and is only available
through Rangen Inc. The primary goal of studies conducted under INAD
#11-236 is to generate data evaluating the efficacy of MET
[[Page 38350]]
administered in feed to larval tilapia to produce populations comprised
of >90% male fish.
17[alpha]-methyltestosterone INAD #8557--17[alpha]-
methyltestosterone (MET) is an aquaculture premix and is only available
through Rangen Inc. The primary goal of studies conducted under INAD
#8557 is to generate data evaluating the efficacy of MET administered
in feed to larval rainbow trout and Atlantic salmon to produce
masculinized female fish that produce sperm.
17[beta]-Estradiol INAD #12-671--17[beta]-estradiol (E2) will be
administered as a medicated feed and is only available to FDA-approved
facilities. The primary goal of studies conducted under INAD #12-671 is
to generate data evaluating the efficacy of E2 administered in feed to
larval brook trout to produce feminized male fish that produce eggs.
Immersion
Chloramine-T INAD #9321--Chloramine-T (CLT) is a powder that is
applied as an immersion bath treatment. CLT is only available for
purchase through Syndel USA or B.L. Mitchell, Inc. The primary goal of
field studies conducted under INAD #9321 is to evaluate the efficacy of
CLT for controlling mortality in a variety of freshwater fish species
for bacterial diseases not currently listed on the approved label.
Approval of INAD #9321 is for non-labeled use only and its use must
comply with the approved label directions.
Hydrogen peroxide (35% Perox Aid[supreg]) INAD #11-669--35% Perox-
Aid[supreg] (H2O2) is a liquid solution containing hydrogen peroxide
that is applied as an immersion bath treatment. H2O2 is only available
for purchase through Syndel USA. The primary goal of field studies
conducted under INAD #11-669 is to evaluate the efficacy of H2O2 for
controlling mortality caused by specific ectoparasites in freshwater or
marine finfish species. It is also expected that the additional data
will be used to expand the current H2O2 label claim. Approval of INAD
#11-669 is for non-labeled use only and its use must comply with the
approved label directions.
Oxytetracycline hydrochloride INAD #9033--Oxytetracycline
hydrochloride (OTIMM) is an aquaculture premix containing
oxytetracycline hydrochloride and is available through Pharmgate. OTIMM
is available for purchase through many local farm and ranch stores or
veterinarian supply outlets. The primary goal of field studies
conducted under INAD #9033 is to evaluate the efficacy of OTIMM for
controlling mortality in a variety of freshwater and marine finfish
species for bacterial diseases. Immersion therapy is often the only
option when treating young fish not yet accustomed to feeding on man-
made fish diets.
Diquat[supreg] INAD #10-969--Reward[supreg] (DQT) is a liquid
concentrate containing diquat dibromide that is applied as an immersion
bath treatment. DQT is available for purchase through many local farm
and ranch stores or through Syngenta Crop Protection, LLC. The primary
goal of field studies conducted under INAD #10-969 is to evaluate the
efficacy of DQT for controlling mortality in all freshwater-reared
finfish diagnosed with BGD or external flavobacteriosis.
Sedatives
AQUI-S[supreg]20E INAD #11-741--Aqui-S[supreg]20E is a liquid
containing 10% eugenol that is applied as an immersion bath treatment.
Aqui-S[supreg]20E is only available for purchase through AquaTactics
Fish Health. The primary goal of field studies conducted under INAD
#11-741 is to evaluate the efficacy of Aqui-S[supreg]20E for use as an
anesthetic/sedative in all freshwater-reared finfish, freshwater prawn,
all saltwater-reared finfish, and sharks.
Spawning Aids
Lutenizing Hormone--Releasing Hormone (LHRHa) INAD #8061--
Luteinizing Hormone--Releasing Hormone analogue (LHRHa) is a solution
that is applied as either an intraperitoneal (IP) or intramuscular (IM)
injection. LHRHa is only available for purchase through Syndel USA. The
use of hormones to induce spawning in fish is critical to the success
of many aquatic programs that need hormone treatment to complete final
gamete maturation to ensure spawning. The primary goal of field studies
conducted under INAD #8061 is to generate data to help determine
appropriate LHRHa treatment regimens for inducing gamete maturation in
a variety of cultured and wildstock finfish species.
GnRH IIa Chicken Gonadotropin--Releasing Hormone II analog INAD
#13-345--GnRH IIa is a synthetic peptide analogue of chicken
gonadotropin-releasing hormone (cGnRH IIa). It is presented as a dry
powder to be resuspended in saline solution for IP injection and is
only available for purchase through AquaTactics Fish Health. The use of
hormones to induce spawning in fish is critical to the success of many
aquatic programs that need hormone treatment to complete final gamete
maturation to ensure spawning. The primary goal of field studies
conducted under INAD #13-345 is to generate data to help determine
appropriate GnRH IIa treatment regimens for use as a spawning aid for
female ictalurids.
Ovaplant[supreg] Salmon Gonadotropin--Releasing Hormone analoque
(sGnRHa) INAD #11-375--Ovaplant[supreg] is a synthetic peptide analogue
of salmon gonadotropin-releasing hormone (sGnRHa). It is presented in a
biodegradable cholesterol-based matrix as an IM pellet implant and is
only available for purchase through Syndel USA. The use of hormones to
induce spawning in fish is critical to the success of many aquatic
programs that need hormone treatment to complete final gamete
maturation to ensure spawning. The primary goal of field studies
conducted under INAD #11-375 is to generate data to help determine
appropriate Ovaplant[supreg] treatment regimens.
Ovaplant[supreg]-L Salmon Gonadotropin--Releasing Hormone analoque
(sGnRHa) INAD #13-298--Ovaplant[supreg]-L is a synthetic peptide
analogue of salmon gonadotropin-releasing hormone (sGnRHa). It is
presented in a sustained release gel for injection and is only
available for purchase through Syndel USA. The use of hormones to
induce spawning in fish is critical to the success of many aquatic
programs that need hormone treatment to complete final gamete
maturation to ensure spawning. The primary goal of field studies
conducted under INAD #13-298 is to generate data to help determine
appropriate Ovaplant-L treatment regimens for inducing gamete
maturation in a variety of cultured finfish species.
Common Carp Pituitary (CCP) INAD #8391--Common carp pituitary (CCP)
is a powder (for suspension) that is applied as either an IP or IM
injection. CCP is only available for purchase through Argent
Aquaculture. The use of hormones to induce spawning in fish is critical
to the success of many aquatic programs that need hormone treatment to
complete final gamete maturation to ensure spawning. The primary goal
of field studies conducted under INAD #8391 is to generate data to help
determine appropriate CCP treatment regimens for inducing gamete
maturation in a variety of cultured and wildstock finfish species.
Marking
Calcein (Se-Mark[supreg]) INAD #10-987--Calcein (Se-Mark[supreg])
is a liquid that contains 1% calcein for bath marking treatments on
finfish and select freshwater mussels. Calcein is only available for
purchase through Syndel
[[Page 38351]]
USA. Calcein is a fluorochrome compound that chemically binds with
alkaline earth metals such as calcium, and upon binding, shows a marked
increase in fluorescence when excited with blue light of about 500 nm
wavelength. The primary goal of field studies conducted under INAD #10-
987 is to establish the effectiveness of calcein to mark fin rays,
scales, otoliths, and other calcified fish, oysters, or selected mussel
tissues via immersion baths. This is a non-lethal marking evaluation
method.
Injectable
Erythromycin 200 Injectable INAD #12-781--Erymicin 200 Injection
(Erymicin 200) is a solution that contains erythromycin for injection
on juvenile and adult Salmonids. Erymicin 200 is only available for
purchase through Syndel USA. The primary goal of field studies
conducted under INAD #12-781 is to evaluate the efficacy of
erythromycin for (1) controlling mortality caused by BKD (causative
agent: Renibacterium salmoninarum) in salmonid species; and (2) control
the vertical transmission of R. salmoninarum from BKD positive female
broodstock to eggs/progeny.
Approved INAD study protocols require submission of the following
forms associated with the data collection:
Form-W: Worksheet (all INADs);
Form-1: Report on Receipt of Drug (all INADs);
Form-2A or 2B: Chemical Use Log (all INADs);
Form-3: Diagnosis, Treatment, and Mortality/Spawning/
Anesthetic Record (all INADs);
Form-4: Necropsy Report Form (specific INADs);
Form-4a: Report on Efficacy Determination Sample (specific
INADs); and,
Form-5: Transfer of Treated Fingerling (specific INADs).
The INAD forms listed above collect the following information from
program participants (specific information may vary depending on INAD
protocol used):
Study identification number and title;
Sponsor name and contact information;
Facility name;
Study director and contact information;
Principal clinical field trial coordinator name;
Study monitor's name and addresses;
Investigator's name and addresses;
Proposed study starting and completion dates;
Background, purpose, and objectives of study;
Study materials;
Experimental units;
Entrance criteria;
Identification of treatment groups;
Treatment schedules;
Treatment response parameters;
Recordkeeping procedures;
Disposition of investigational animals;
Disposition of investigational drug;
Data handling, quality control, monitoring, and
administrative responsibilities;
Plans for data analysis;
Protocol and protocol amendments; and,
Protocol deviations.
The Service's AADAP Program will use the information that is
collected on the study forms to ensure the studies are following the
guidelines set by the FDA. The study data will be downloaded to a
spreadsheet where it will be analyzed for compliance. Summary reports
will be created from the data collected from the forms and will be
submitted to the FDA, as required. Submission of the data forms is
required by the FDA for the facility to participate in the INAD
Program.
A cooperative agreement is also needed between the participating
companies/agencies and the Service's AADAP Program. This agreement
establishes obligations to be met and procedures to be followed by the
Service and participant to establish and maintain cooperative INADs to
enable the use of certain drugs and chemicals under the INAD process as
set forth by the FDA. The goal of this agreement is to consolidate the
INAD process; eliminate duplication of effort; reduce workloads and
costs; and ensure needed drugs are made available to aquaculture and
fisheries management facilities in the U.S. in compliance with FDA
regulations.
Additional information for the INAD Program and how to participate
can be found at the following link: https://www.fws.gov/fisheries/aadap/inad-university.html. This web page describes frequently asked
questions regarding how to participate in the INAD Program and what is
expected of the participants. The site also includes the investigator
and monitor guides created to explain the INAD Program process to study
participants. We are currently developing additional study templates
for the INADs for use as a guide for filling out the forms. These
templates will provide study participants with helpful information to
correctly complete each form. We also created a user manual for the
online INAD database used to enter the data that also describes each
step of the database for the INAD participants.
Title of Collection: Administration of U.S. Fish and Wildlife
Service Investigational New Animal Drug (INAD) Program.
OMB Control Number: 1018-New.
Form Number(s): Form-W, Form-1, Form-2A or 2B, Form-3, Form-4,
Form-4a, and Form-5.
Type of Review: Existing collection in use without an OMB control
number.
Respondents/Affected Public: Respondents will be the private
aquaculture facilities; universities; and State, local, and Tribal
governments that have a need to use INADs.
Respondent's Obligation: Required to obtain or retain a benefit.
Frequency of Collection: One time for the initial registration and
submission of cooperative agreement, and on occasion for submission of
study data.
Total Estimated Annual Nonhour Burden Cost: There is an enrollment
fee that is currently $700 per INAD per facility each year as of 2021.
The facility is also responsible for purchasing the INAD from the
appropriate drug supplier. All equipment that would be used for the
INAD studies is typically standard equipment already used by the
facilities.
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Average
Average number Average number Average number completion Estimated
Requirement of annual of responses of annual time per annual burden
respondents each responses * response hours *
(hours)
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Cooperative Agreement
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Private Sector.................. 15 1 15 2 30
Government...................... 5 1 5 2 10
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[[Page 38352]]
Medicated Feed--Florfenicol (Aquaflor[supreg]) INAD #10-697
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Private Sector.................. 4 1 4 0.25 1
Government...................... 4 1 4 0.25 1
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Medicated Feed--Slice[supreg] (Emamectin Benzoate) INAD #11-370
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Private Sector.................. 5 1 5 0.25 1
Government...................... 4 1 4 0.25 1
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Medicated Feed--Oxytetracylcine dihydrate (Terramycin[supreg] 200 for Fish) INAD #9332
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Private Sector.................. 5 1 5 0.25 1
Government...................... 16 1 16 0.25 4
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Medicated Feed--17[alpha]-methyltestosterone INAD #11-236
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Private Sector.................. 4 1 4 0.25 1
Government...................... 5 1 5 0.25 1
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Medicated Feed--17[alpha]-methyltestosterone INAD #8557
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Private Sector.................. 5 1 5 0.25 1
Government...................... 1 1 1 0.25 0
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Medicated Feed--17[beta]-Estradiol INAD #12-671
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Private Sector.................. 1 1 1 0.25 0
Government...................... 1 1 1 0.25 0
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Immersion--Chloramine-T INAD #9321
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Private Sector.................. 1 1 1 0.25 0
Government...................... 8 1 8 0.25 2
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Immersion--Hydrogen peroxide (35% Perox Aid[supreg]) INAD #11-669
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Private Sector.................. 1 5 5 0.25 1
Government...................... 2 2 4 0.25 1
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Immersion--Oxytetracycline hydrochloride INAD #9033
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Private Sector.................. 1 1 1 0.25 0
Government...................... 2 2 4 0.25 1
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Immersion--Diquat[supreg] INAD #10-969
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Private Sector.................. 1 1 1 0.25 0
Government...................... 7 2 14 0.25 4
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Sedative--AQUI-S[supreg]20E INAD #11-741
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Private Sector.................. 11 1 11 0.25 3
Government...................... 73 1 73 0.25 18
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Spawning Aid--Lutenizing Hormone--Releasing Hormone (LHRHa) INAD #8061
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Private Sector.................. 19 1 19 0.25 5
Government...................... 7 2 14 0.25 4
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Spawning Aid--GnRH IIa Chicken Gonadotropin--Releasing Hormone II analog INAD #13-345
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Private Sector.................. 9 1 9 0.25 2
Government...................... 1 1 1 0.25 0
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Spawning Aid--Ovaplant[supreg] Salmon Gonadotropin--Releasing Hormone analoque (sGnRHa) INAD #11-375
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Private Sector.................. 5 1 5 0.25 1
Government...................... 12 1 12 0.25 3
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[[Page 38353]]
Spawning Aid--Ovaplant[supreg]-L Salmon Gonadotropin--Releasing Hormone analoque (sGnRHa) INAD #13-298
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Private Sector.................. 1 1 1 0.25 0
Government...................... 4 1 4 0.25 1
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Spawning Aid--Common Carp Pituitary (CCP) INAD #8391
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Private Sector.................. 5 1 5 0.25 1
Government...................... 7 2 14 0.25 4
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Marking--Calcein (Se-Mark[supreg]) INAD #10-987
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Private Sector.................. 1 1 1 0.25 0
Government...................... 2 1 2 0.25 1
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Injectable--Erythromycin 200 Injectable INAD #12-781
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Private Sector.................. 2 1 2 0.25 1
>Government..................... 14 1 14 0.25 4
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Form-W: ``Worksheet for Designing Individual Field Trials''
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Private Sector.................. 63 3 189 1 189
Government...................... 148 3 444 1 444
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Form-1: Report on Receipt of Drug
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Private Sector.................. 45 2 90 0.5 45
Government...................... 88 2 176 0.5 88
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Form FFC-2A or 2B: Chemical Use Log
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Private Sector.................. 63 3 189 0.25 47
Government...................... 148 3 444 0.25 111
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Form-3: Diagnosis, Treatment, and Mortality Record
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Private Sector.................. 63 3 189 1.5 284
Government...................... 148 3 444 1.5 666
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Form-4: Necropsy Report Form
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Private Sector.................. 27 1 27 0.5 14
Government...................... 24 1 24 0.5 12
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Form-4a: Report on Efficacy Determination Sample
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Private Sector.................. 3 2 6 0.75 5
Government...................... 3 2 6 0.75 5
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Form-5: Transfer of Treated Fingerling
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Private Sector.................. 2 8 16 0.5 8
Government...................... 1 1 1 0.5 1
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Totals...................... 1,097 .............. 2,545 .............. 2,027
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* Rounded.
[[Page 38354]]
An agency may not conduct or sponsor and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.).
Madonna Baucum,
Information Collection Clearance Officer, U.S. Fish and Wildlife
Service.
[FR Doc. 2021-15418 Filed 7-19-21; 8:45 am]
BILLING CODE 4333-15-P