Agency Information Collection Activities; Submission to the Office of Management and Budget; Administration of U.S. Fish and Wildlife Service Investigational New Animal Drug (INAD) Program, 44820-44823 [2023-14834]
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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices
Total Estimated Annual Nonhour
Burden Cost: None.
Annual
number of
respondents
Requirement
Total annual
responses
Completion time per response
Total annual
burden hours
FWS Form 3–2273 (Title 50 Certifying Official Form)
Private Sector .................................................
Government ....................................................
9
7
9
7
1 hour .............................................................
1 hour .............................................................
9
7
FWS Form 3–2274 (U.S. Title 50 Health Certification Form)
Private Sector .................................................
Government ....................................................
10
15
20
30
30 minutes ......................................................
30 minutes ......................................................
10
15
FWS Form 3–2275 (Title 50 Importation Request Form)
Private Sector .................................................
Government ....................................................
10
15
20
30
15 minutes ......................................................
15 minutes ......................................................
5
8
Totals .......................................................
66
116
.........................................................................
54
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. 2023–14833 Filed 7–12–23; 8:45 am]
BILLING CODE 4333–15–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–HQ–FAC–2023–N049; FF09M21200–
234–FXMB1231099BPP0; OMB Control
Number 1018–New]
Agency Information Collection
Activities; Submission to the Office of
Management and Budget;
Administration of U.S. Fish and
Wildlife Service Investigational New
Animal Drug (INAD) Program
Fish and Wildlife Service,
Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, we,
the U.S. Fish and Wildlife Service
(Service), are proposing a new
information collection.
DATES: Interested persons are invited to
submit comments on or before August
14, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
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SUMMARY:
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notice to https://www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under Review—
Open for Public Comments’’ or by using
the search function. Please provide a
copy of your comments 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 ‘‘1018–New’’ in the subject
line of your comments.
FOR FURTHER INFORMATION CONTACT:
Madonna L. Baucum, Service
Information Collection Clearance
Officer, by email at Info_Coll@fws.gov,
or by telephone at (703) 358–2503.
Individuals in the United States who are
deaf, deafblind, hard of hearing, or have
a speech disability may dial 711 (TTY,
TDD, or TeleBraille) to access
telecommunications relay services.
Individuals outside the United States
should use the relay services offered
within their country to make
international calls to the point-ofcontact in the United States.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act (PRA; 44 U.S.C. 3501 et
seq.) and its implementing regulations
in the Code of Federal Regulations
(CFR) at 5 CFR 1320, all information
collections require approval under the
PRA. We may not conduct or sponsor
and you are not required to respond to
a collection of information unless it
displays a currently valid OMB control
number.
On July 20, 2021, we published in the
Federal Register (86 FR 38349) a notice
of our intent to request that OMB
approve this information collection. In
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that notice, we solicited comments for
60 days, ending on September 20, 2021.
We did not receive any comments in
response to that notice.
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,
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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices
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, operating under the authority
of the Federal Food, Drug, and Cosmetic
Act (FDCA; 21 U.S.C. 360b(j)), which
permits the use of an investigational
new animal drug to generate data to
support a new animal drug approval
(NADA), 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. Data
collection is required by the FDA under
the following regulations:
• 21 CFR part 511 (New Animal
Drugs for Investigational Use) and
• 21 CFR part 514, subpart A (New
Animal Drug Applications, General
Provisions).
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
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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 19 approved INADs
approved for use within the Service’s
INAD Program (see https://
www.fws.gov/find-inad), described as
follows:
Medicated Feeds
Florfenicol (Aquaflor®) INAD #10–
697—Aquaflor® 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 florfenicolmedicated 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® (Emamectin Benzoate) INAD
#11–370—SLICE® is an aquaculture
premix containing emamectin benzoate
and is only available through Merck
Animal Health. SLICE® 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®-medicated feed and safety of
SLICE® to control mortality caused by
external parasites in a variety of
freshwater and marine fish species.
Oxytetracycline dihydrate
(Terramycin® 200 for Fish) INAD
#9332—Terramycin 200® for fish is an
aquaculture premix containing
oxytetracycline dihydrate (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) varies with treatment
regimen.
17a-methyltestosterone INAD #11–
236—17a-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
administered in feed to larval tilapia to
produce populations comprised of over
90 percent male fish.
17a-methyltestosterone INAD #8557—
17a-methyltestosterone (MET) is an
aquaculture premix and is only
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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.
17b-Estradiol INAD #12–671—17bestradiol (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®)
INAD #11–669—35% Perox-Aid®
(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 nonlabeled 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, 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.
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Diquat® INAD #10–969—Reward®
(DQT) is a liquid concentrate containing
diquat dibromide, which 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 bacterial gill disease or
external flavobacteriosis.
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Sedatives
AQUI–S®20E INAD #11–741—AquiS®20E is a liquid containing 10 percent
eugenol, that is applied as an immersion
bath treatment. Aqui-S®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®20E for use as an anesthetic/
sedative in all freshwater-reared finfish,
freshwater prawn, all saltwater-reared
finfish, and sharks.
BENZOAK VET® #11–740—
BENZOAK VET® is a liquid containing
20 percent benzocaine, that is applied as
an immersion bath treatment.
BENZOAK VET® is only available for
purchase through Riverence Brood LLC.
The primary goal of field studies
conducted under INAD #11–740 is to
evaluate the efficacy of BENZOAK
VET® for use as an anesthetic/sedative
in all freshwater-reared finfish,
freshwater prawn, and all saltwaterreared finfish.
Spawning Aids
Luteinizing 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 GonadotropinReleasing Hormone II analog INAD #13–
345—GnRH IIa is a synthetic peptide
analogue of chicken gonadotropinreleasing hormone (cGnRH IIa). It is
presented as a dry powder to be
resuspended in saline solution for IP
injection, and is only available for
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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® Salmon GonadotropinReleasing Hormone analogue (sGnRHa)
INAD #11–375—Ovaplant® 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® treatment
regimens.
Ovaplant®-L Salmon GonadotropinReleasing Hormone analogue (sGnRHa)
INAD #13–298—Ovaplant®-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.
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Marking
Calcein (Se-Mark®) INAD #10–987—
Calcein (Se-Mark®) is a liquid that
contains 1 percent calcein for bath
marking treatments on finfish and
selected freshwater mussels. Calcein is
only available for purchase through
Syndel 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 nanometers
(nm) in 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 nonlethal
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 bacterial kidney
disease (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;
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• Study director and contact
information;
• Principal clinical field trial
coordinator name;
• Study monitor’s name and
addresses;
• Investigator’s name and addresses;
• Proposed study start 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/service/investigationalnew-animal-drugs. 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
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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.
The public may request copies of any
form or document contained in this
information collection by sending a
request to the Service Information
Collection Clearance Officer in
ADDRESSES, above.
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-2, Form-2A or 2B, Form-3, Form4, Form-4a, and Form-5.
Type of Review: Existing collection in
use without an OMB control number.
Respondents/Affected Public: Private
aquaculture facilities; universities; and
State, local, and Tribal governments that
have a need to use INADs.
Total Estimated Number of Annual
Respondents: 273.
Total Estimated Number of Annual
Responses: 302.
Estimated Completion Time per
Response: Varies from 2 hours to 5
hours, depending on activity.
Total Estimated Number of Annual
Burden Hours: 1,215.
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: $289,232 ($197,400 for
enrollment fees (282 INADS × $700 per
INAD per facility each year), along with
$91,832 associated with the costs of
purchasing the INAD from the
appropriate drug supplier).
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. 2023–14834 Filed 7–12–23; 8:45 am]
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DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[DOI–2023–0009; 2341A2100DD/
AAKC0010130/A0A501010.999900]
Privacy Act of 1974; System of
Records
Bureau of Indian Affairs,
Interior.
ACTION: Notice of a new system of
records.
AGENCY:
Pursuant to the Privacy Act of
1974, as amended, the Department of
the Interior (DOI) is issuing a public
notice of its intent to create the Bureau
of Indian Affairs (BIA) Privacy Act
system of records, INTERIOR/BIA–35,
Behavioral Health and Wellness
Program. This system helps the
Behavioral Health and Wellness
Program (BHWP) provide immediate
behavioral health crisis support, clinical
counseling services, crisis care
coordination, and communication with
the client and appropriate points of
contact for referrals and continued
service delivery or emergency care. This
newly established system will be
included in DOI’s inventory of systems
of records.
DATES: This new system will be effective
upon publication on July 13, 2023. New
routine uses will be effective August 14,
2023. Submit comments on or before
August 14, 2023.
ADDRESSES: You may send comments
identified by docket number [DOI–
2023–0009] by any of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for sending comments.
• Email: DOI_Privacy@ios.doi.gov.
Include docket number [DOI–2023–
0009] in the subject line of the message.
• U.S. mail or hand-delivery: Teri
Barnett, Departmental Privacy Officer,
U.S. Department of the Interior, 1849 C
Street NW, Room 7112, Washington, DC
20240.
Instructions: All submissions received
must include the agency name and
docket number [DOI–2023–0009]. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Richard Gibbs, Associate Privacy
Officer, Assistant Secretary—Indian
Affairs, 1011 Indian School Road NW,
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]]>Agencies
[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Notices]
[Pages 44820-44823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14834]
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS-HQ-FAC-2023-N049; FF09M21200-234-FXMB1231099BPP0; OMB Control
Number 1018-New]
Agency Information Collection Activities; Submission to the
Office of Management and Budget; 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.
DATES: Interested persons are invited to submit comments on or before
August 14, 2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function.
Please provide a copy of your comments 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 [email protected]. Please reference ``1018-New'' in the
subject line of your comments.
FOR FURTHER INFORMATION CONTACT: Madonna L. Baucum, Service Information
Collection Clearance Officer, by email at [email protected], or by
telephone at (703) 358-2503. Individuals in the United States who are
deaf, deafblind, hard of hearing, or have a speech disability may dial
711 (TTY, TDD, or TeleBraille) to access telecommunications relay
services. Individuals outside the United States should use the relay
services offered within their country to make international calls to
the point-of-contact in the United States.
SUPPLEMENTARY INFORMATION: In accordance with the Paperwork Reduction
Act (PRA; 44 U.S.C. 3501 et seq.) and its implementing regulations in
the Code of Federal Regulations (CFR) at 5 CFR 1320, all information
collections require approval under the PRA. We may not conduct or
sponsor and you are not required to respond to a collection of
information unless it displays a currently valid OMB control number.
On July 20, 2021, we published in the Federal Register (86 FR
38349) a notice of our intent to request that OMB approve this
information collection. In that notice, we solicited comments for 60
days, ending on September 20, 2021. We did not receive any comments in
response to that notice.
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,
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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, operating under the authority of the Federal Food, Drug, and
Cosmetic Act (FDCA; 21 U.S.C. 360b(j)), which permits the use of an
investigational new animal drug to generate data to support a new
animal drug approval (NADA), 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. Data collection is required by
the FDA under the following regulations:
21 CFR part 511 (New Animal Drugs for Investigational Use)
and
21 CFR part 514, subpart A (New Animal Drug Applications,
General Provisions).
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 19 approved INADs approved for use within the Service's
INAD Program (see https://www.fws.gov/find-inad), 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.
Oxytetracycline dihydrate (Terramycin[supreg] 200 for Fish) INAD
#9332--Terramycin 200[supreg] for fish is an aquaculture premix
containing oxytetracycline dihydrate (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) varies 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 administered
in feed to larval tilapia to produce populations comprised of over 90
percent 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, 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.
[[Page 44822]]
Diquat[supreg] INAD #10-969--Reward[supreg] (DQT) is a liquid
concentrate containing diquat dibromide, which 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 bacterial gill disease or
external flavobacteriosis.
Sedatives
AQUI-S[supreg]20E INAD #11-741--Aqui-S[supreg]20E is a liquid
containing 10 percent 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.
BENZOAK VET[supreg] #11-740--BENZOAK VET[supreg] is a liquid
containing 20 percent benzocaine, that is applied as an immersion bath
treatment. BENZOAK VET[supreg] is only available for purchase through
Riverence Brood LLC. The primary goal of field studies conducted under
INAD #11-740 is to evaluate the efficacy of BENZOAK VET[supreg] for use
as an anesthetic/sedative in all freshwater-reared finfish, freshwater
prawn, and all saltwater-reared finfish.
Spawning Aids
Luteinizing 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 analogue
(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 analogue
(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 percent calcein for bath marking treatments
on finfish and selected freshwater mussels. Calcein is only available
for purchase through Syndel 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 nanometers (nm) in 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 nonlethal 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 bacterial kidney
disease (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;
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Study director and contact information;
Principal clinical field trial coordinator name;
Study monitor's name and addresses;
Investigator's name and addresses;
Proposed study start 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/service/investigational-new-animal-drugs. 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.
The public may request copies of any form or document contained in
this information collection by sending a request to the Service
Information Collection Clearance Officer in ADDRESSES, above.
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-2, 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: Private aquaculture facilities;
universities; and State, local, and Tribal governments that have a need
to use INADs.
Total Estimated Number of Annual Respondents: 273.
Total Estimated Number of Annual Responses: 302.
Estimated Completion Time per Response: Varies from 2 hours to 5
hours, depending on activity.
Total Estimated Number of Annual Burden Hours: 1,215.
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: $289,232 ($197,400 for
enrollment fees (282 INADS x $700 per INAD per facility each year),
along with $91,832 associated with the costs of purchasing the INAD
from the appropriate drug supplier).
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. 2023-14834 Filed 7-12-23; 8:45 am]
BILLING CODE 4333-15-P
