Published 30-day FRN

44820

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 [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-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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ddrumheller on DSK120RN23PROD with NOTICES1

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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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices

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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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices
• 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]
BILLING CODE 4333–15–P

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44823

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: [email protected].
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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