[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]


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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,

[[Page 44821]]

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;

[[Page 44823]]

     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