Notice2023-14834
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 13, 2023
Issuing agencies
Interior DepartmentFish and Wildlife Service
Abstract
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing a new information collection.
Full Text
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<title>Federal Register, Volume 88 Issue 133 (Thursday, July 13, 2023)</title>
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[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Notices]
[Pages 44820-44823]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#0f46616960504c6063634f69787c21686079"><span class="__cf_email__" data-cfemail="6b22050d0434280407072b0d1c18450c041d">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#31785f575e6e725e5d5d715746421f565e47"><span class="__cf_email__" data-cfemail="bef7d0d8d1e1fdd1d2d2fed8c9cd90d9d1c8">[email protected]</span></a>, 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:
<bullet> 21 CFR part 511 (New Animal Drugs for Investigational Use)
and
<bullet> 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 <a href="https://www.fws.gov/find-inad">https://www.fws.gov/find-inad</a>), 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:
<bullet> Form-W: Worksheet (all INADs);
<bullet> Form-1: Report on Receipt of Drug (all INADs);
<bullet> Form-2A or 2B: Chemical Use Log (all INADs);
<bullet> Form-3: Diagnosis, Treatment, and Mortality/Spawning/
Anesthetic Record (all INADs);
<bullet> Form-4: Necropsy Report Form (specific INADs);
<bullet> Form-4a: Report on Efficacy Determination Sample (specific
INADs); and
<bullet> 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):
<bullet> Study identification number and title;
<bullet> Sponsor name and contact information;
<bullet> Facility name;
[[Page 44823]]
<bullet> Study director and contact information;
<bullet> Principal clinical field trial coordinator name;
<bullet> Study monitor's name and addresses;
<bullet> Investigator's name and addresses;
<bullet> Proposed study start and completion dates;
<bullet> Background, purpose, and objectives of study;
<bullet> Study materials;
<bullet> Experimental units;
<bullet> Entrance criteria;
<bullet> Identification of treatment groups;
<bullet> Treatment schedules;
<bullet> Treatment response parameters;
<bullet> Recordkeeping procedures;
<bullet> Disposition of investigational animals;
<bullet> Disposition of investigational drug;
<bullet> Data handling, quality control, monitoring, and
administrative responsibilities;
<bullet> Plans for data analysis;
<bullet> Protocol and protocol amendments; and
<bullet> 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: <a href="https://www.fws.gov/service/investigational-new-animal-drugs">https://www.fws.gov/service/investigational-new-animal-drugs</a>. 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
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