Published 60-day FRN

Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices
Dated: July 15, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–15366 Filed 7–19–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–HQ–FAC–2021–N167;
FXFR13110900000 201 FF09F11000; OMB
Control Number 1018–New]

Agency Information Collection
Activities; Administration of U.S. Fish
and Wildlife Service Investigational
New Animal Drug (INAD) Program
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 in use without
Office of Management and Budget
(OMB) approval.
DATES: Interested persons are invited to
submit comments on or before
September 20, 2021.
ADDRESSES: Send your comments on the
information collection request (ICR) by
mail to the Service Information
Collection Clearance Officer, U.S. Fish
and Wildlife Service, MS: PRB (JAO/
3W), 5275 Leesburg Pike, Falls Church,
VA 22041–3803 (mail); or by email to
[email protected]. Please reference
OMB Control Number ‘‘1018–INAD’’ in
the subject line of your comments.
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact Madonna L. Baucum,
Service Information Collection
Clearance Officer, by email at Info_
[email protected], or by telephone at (703)
358–2503. Individuals who are hearing
or speech impaired may call the Federal
Relay Service at 1–800–877–8339 for
TTY assistance.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995 (PRA, 44 U.S.C.
3501 et seq.) and 5 CFR 1320.8(d)(1), we
provide the general public and other
Federal agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information

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SUMMARY:

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collection requirements and provide the
requested data in the desired format.
As part of our continuing effort to
reduce paperwork and respondent
burdens, we invite the public and other
Federal agencies to comment on new,
proposed, revised, and continuing
collections of information. This helps us
assess the impact of our information
collection requirements and minimize
the public’s reporting burden. It also
helps the public understand our
information collection requirements and
provide the requested data in the
desired format.
We are especially interested in public
comment addressing the following:
(1) Whether or not the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether or not the
information will have practical utility;
(2) The accuracy of our estimate of the
burden for this collection of
information, including the validity of
the methodology and assumptions used;
(3) Ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) How might the agency minimize
the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of response.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Abstract: The Aquatic Animal Drug
Approval Partnership (AADAP) Program
is part of the Fish and Aquatic
Conservation fish health network. It is
the only program in the United States
singularly dedicated to obtaining U.S.
Food and Drug Administration (FDA)
approval of new medications needed for
use in fish culture and fisheries
management. Ultimately, the AADAP
program allows fisheries professionals
to more effectively and efficiently rear
and manage a variety of fish species to
meet production goals, stock healthy

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fish, and maintain a healthy
environment. In order for participants
(U.S. aquaculture facilities or
researchers) to be able to use an
unapproved drug under AADAP’s
National Investigational New Animal
Drug (INAD) Program, they need to
follow the FDA-approved study
protocol(s) and submit the required data
forms, including the INAD treatment
data, to AADAP’s INAD Program.
There are 18 approved INADs
approved for use within the Service’s
INAD Program (see fws.gov/fisheries/
aadap/inads.html) described as follows:
Medicated Feeds
Florfenicol (Aquaflor®) 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.
Oxytetracylcine dihydrate
(Terramycin® 200 for Fish) INAD
#9332—Terramycin 200® for fish is an
aquaculture premix containing
oxytetracycline dehydrate (OTC) and is
available through Syndel USA. Feed
medicated with OTC can be purchased
from aquaculture feed mills and used to
treat bacterial diseases or to apply a
skeletal mark on the fish. The primary
goal of field studies conducted under
INAD #9332 is to generate additional
OTC-medicated feed efficacy data which
can be used to expand the existing OTC
label claims. Five treatment options are
allowed, and disposition of
investigational animals (including
withdrawal times) vary with treatment
regimen.
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

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administered in feed to larval tilapia to
produce populations comprised of
>90% male fish.
17a-methyltestosterone INAD #8557—
17a-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.
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 and is available through
Pharmgate. OTIMM is available for
purchase through many local farm and
ranch stores or veterinarian supply
outlets. The primary goal of field studies
conducted under INAD #9033 is to
evaluate the efficacy of OTIMM for

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controlling mortality in a variety of
freshwater and marine finfish species
for bacterial diseases. Immersion
therapy is often the only option when
treating young fish not yet accustomed
to feeding on man-made fish diets.
Diquat® INAD #10–969—Reward®
(DQT) is a liquid concentrate containing
diquat dibromide that is applied as an
immersion bath treatment. DQT is
available for purchase through many
local farm and ranch stores or through
Syngenta Crop Protection, LLC. The
primary goal of field studies conducted
under INAD #10–969 is to evaluate the
efficacy of DQT for controlling mortality
in all freshwater-reared finfish
diagnosed with BGD or external
flavobacteriosis.
Sedatives
AQUI–S®20E INAD #11–741—AquiS®20E is a liquid containing 10%
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.
Spawning Aids
Lutenizing Hormone—Releasing
Hormone (LHRHa) INAD #8061—
Luteinizing Hormone—Releasing
Hormone analogue (LHRHa) is a
solution that is applied as either an
intraperitoneal (IP) or intramuscular
(IM) injection. LHRHa is only available
for purchase through Syndel USA. The
use of hormones to induce spawning in
fish is critical to the success of many
aquatic programs that need hormone
treatment to complete final gamete
maturation to ensure spawning. The
primary goal of field studies conducted
under INAD #8061 is to generate data to
help determine appropriate LHRHa
treatment regimens for inducing gamete
maturation in a variety of cultured and
wildstock finfish species.
GnRH IIa Chicken Gonadotropin—
Releasing Hormone II analog INAD #13–
345—GnRH IIa is a synthetic peptide
analogue of chicken 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
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

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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 Gonadotropin—
Releasing Hormone analoque (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 Gonadotropin—
Releasing Hormone analoque (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.
Marking
Calcein (Se-Mark®) INAD #10–987—
Calcein (Se-Mark®) is a liquid that
contains 1% calcein for bath marking
treatments on finfish and select
freshwater mussels. Calcein is only
available for purchase through Syndel

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Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices
USA. Calcein is a fluorochrome
compound that chemically binds with
alkaline earth metals such as calcium,
and upon binding, shows a marked
increase in fluorescence when excited
with blue light of about 500 nm
wavelength. The primary goal of field
studies conducted under INAD #10–987
is to establish the effectiveness of
calcein to mark fin rays, scales, otoliths,
and other calcified fish, oysters, or
selected mussel tissues via immersion
baths. This is a non-lethal marking
evaluation method.
Injectable

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Erythromycin 200 Injectable INAD
#12–781—Erymicin 200 Injection
(Erymicin 200) is a solution that
contains erythromycin for injection on
juvenile and adult Salmonids. Erymicin
200 is only available for purchase
through Syndel USA. The primary goal
of field studies conducted under INAD
#12–781 is to evaluate the efficacy of
erythromycin for (1) controlling
mortality caused by BKD (causative
agent: Renibacterium salmoninarum) in
salmonid species; and (2) control the
vertical transmission of R.
salmoninarum from BKD positive
female broodstock to eggs/progeny.
Approved INAD study protocols
require submission of the following
forms associated with the data
collection:
• Form–W: Worksheet (all INADs);
• Form–1: Report on Receipt of Drug
(all INADs);
• Form–2A or 2B: Chemical Use Log
(all INADs);
• Form–3: Diagnosis, Treatment, and
Mortality/Spawning/Anesthetic Record
(all INADs);
• Form–4: Necropsy Report Form
(specific INADs);
• Form–4a: Report on Efficacy
Determination Sample (specific INADs);
and,
• Form–5: Transfer of Treated
Fingerling (specific INADs).
The INAD forms listed above collect
the following information from program
participants (specific information may
vary depending on INAD protocol used):
• Study identification number and
title;

• Sponsor name and contact
information;
• Facility name;
• Study director and contact
information;
• Principal clinical field trial
coordinator name;
• Study monitor’s name and
addresses;
• Investigator’s name and addresses;
• Proposed study starting and
completion dates;
• Background, purpose, and
objectives of study;
• Study materials;
• Experimental units;
• Entrance criteria;
• Identification of treatment groups;
• Treatment schedules;
• Treatment response parameters;
• Recordkeeping procedures;
• Disposition of investigational
animals;
• Disposition of investigational drug;
• Data handling, quality control,
monitoring, and administrative
responsibilities;
• Plans for data analysis;
• Protocol and protocol amendments;
and,
• Protocol deviations.
The Service’s AADAP Program will
use the information that is collected on
the study forms to ensure the studies are
following the guidelines set by the FDA.
The study data will be downloaded to
a spreadsheet where it will be analyzed
for compliance. Summary reports will
be created from the data collected from
the forms and will be submitted to the
FDA, as required. Submission of the
data forms is required by the FDA for
the facility to participate in the INAD
Program.
A cooperative agreement is also
needed between the participating
companies/agencies and the Service’s
AADAP Program. This agreement
establishes obligations to be met and
procedures to be followed by the
Service and participant to establish and
maintain cooperative INADs to enable
the use of certain drugs and chemicals
under the INAD process as set forth by
the FDA. The goal of this agreement is
to consolidate the INAD process;
eliminate duplication of effort; reduce
workloads and costs; and ensure needed
Average
number of
annual
respondents

Requirement

Average
number of
responses
each

drugs are made available to aquaculture
and fisheries management facilities in
the U.S. in compliance with FDA
regulations.
Additional information for the INAD
Program and how to participate can be
found at the following link: https://
www.fws.gov/fisheries/aadap/inaduniversity.html. This web page
describes frequently asked questions
regarding how to participate in the
INAD Program and what is expected of
the participants. The site also includes
the investigator and monitor guides
created to explain the INAD Program
process to study participants. We are
currently developing additional study
templates for the INADs for use as a
guide for filling out the forms. These
templates will provide study
participants with helpful information to
correctly complete each form. We also
created a user manual for the online
INAD database used to enter the data
that also describes each step of the
database for the INAD participants.
Title of Collection: Administration of
U.S. Fish and Wildlife Service
Investigational New Animal Drug
(INAD) Program.
OMB Control Number: 1018–New.
Form Number(s): Form–W, Form–1,
Form–2A or 2B, Form–3, Form–4,
Form–4a, and Form–5.
Type of Review: Existing collection in
use without an OMB control number.
Respondents/Affected Public:
Respondents will be the private
aquaculture facilities; universities; and
State, local, and Tribal governments that
have a need to use INADs.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: One time for
the initial registration and submission of
cooperative agreement, and on occasion
for submission of study data.
Total Estimated Annual Nonhour
Burden Cost: There is an enrollment fee
that is currently $700 per INAD per
facility each year as of 2021. The facility
is also responsible for purchasing the
INAD from the appropriate drug
supplier. All equipment that would be
used for the INAD studies is typically
standard equipment already used by the
facilities.
Average
number of
annual
responses *

Average
completion
time per
response
(hours)

Estimated
annual burden
hours *

Cooperative Agreement
Private Sector ......................................................................
Government .........................................................................

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Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices
Average
number of
annual
respondents

Requirement

Average
number of
responses
each

Average
completion
time per
response
(hours)

Average
number of
annual
responses *

Estimated
annual burden
hours *

Medicated Feed—Florfenicol (Aquaflor®) INAD #10–697
Private Sector ......................................................................
Government .........................................................................

4
4

1
1

4
4

0.25
0.25

1
1

5
4

0.25
0.25

1
1

5
16

0.25
0.25

1
4

4
5

0.25
0.25

1
1

5
1

0.25
0.25

1
0

1
1

0.25
0.25

0
0

1
8

0.25
0.25

0
2

5
4

0.25
0.25

1
1

1
2

1
4

0.25
0.25

0
1

1
2

1
14

0.25
0.25

0
4

11
73

0.25
0.25

3
18

0.25
0.25

5
4

0.25
0.25

2
0

Medicated Feed—Slice® (Emamectin Benzoate) INAD #11–370
Private Sector ......................................................................
Government .........................................................................

5
4

1
1

Medicated Feed—Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332
Private Sector ......................................................................
Government .........................................................................

5
16

1
1

Medicated Feed—17α-methyltestosterone INAD #11–236
Private Sector ......................................................................
Government .........................................................................

4
5

1
1

Medicated Feed—17α-methyltestosterone INAD #8557
Private Sector ......................................................................
Government .........................................................................

5
1

1
1

Medicated Feed—17β-Estradiol INAD #12–671
Private Sector ......................................................................
Government .........................................................................

1
1

1
1

Immersion—Chloramine-T INAD #9321
Private Sector ......................................................................
Government .........................................................................

1
8

1
1

Immersion—Hydrogen peroxide (35% Perox Aid®) INAD #11–669
Private Sector ......................................................................
Government .........................................................................

1
2

5
2

Immersion—Oxytetracycline hydrochloride INAD #9033
Private Sector ......................................................................
Government .........................................................................

1
2

Immersion—Diquat® INAD #10–969
Private Sector ......................................................................
Government .........................................................................

1
7

Sedative—AQUI-S®20E INAD #11–741
Private Sector ......................................................................
Government .........................................................................

11
73

1
1

Spawning Aid—Lutenizing Hormone—Releasing Hormone (LHRHa) INAD #8061
Private Sector ......................................................................
Government .........................................................................

19
7

1
2

19
14

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Spawning Aid—GnRH IIa Chicken Gonadotropin—Releasing Hormone II analog INAD #13–345
Private Sector ......................................................................
Government .........................................................................

9
1

1
1

9
1

Spawning Aid—Ovaplant® Salmon Gonadotropin—Releasing Hormone analoque (sGnRHa) INAD #11–375
Private Sector ......................................................................
Government .........................................................................

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0.25

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Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices
Average
number of
annual
respondents

Requirement

Average
number of
responses
each

Average
completion
time per
response
(hours)

Average
number of
annual
responses *

Estimated
annual burden
hours *

Spawning Aid—Ovaplant®-L Salmon Gonadotropin—Releasing Hormone analoque (sGnRHa) INAD #13–298
Private Sector ......................................................................
Government .........................................................................

1
4

1
1

1
4

0.25
0.25

0
1

5
14

0.25
0.25

1
4

1
2

0.25
0.25

0
1

2
14

0.25
0.25

1
4

3
3

189
444

1
1

189
444

2
2

90
176

0.5
0.5

45
88

189
444

0.25
0.25

47
111

3
3

189
444

1.5
1.5

284
666

1
1

27
24

0.5
0.5

14
12

6
6

0.75
0.75

5
5

Spawning Aid—Common Carp Pituitary (CCP) INAD #8391
Private Sector ......................................................................
Government .........................................................................

5
7

1
2

Marking—Calcein (Se-Mark®) INAD #10–987
Private Sector ......................................................................
Government .........................................................................

1
2

1
1

Injectable—Erythromycin 200 Injectable INAD #12–781
Private Sector ......................................................................
≤Government .......................................................................

2
14

1
1

Form-W: ‘‘Worksheet for Designing Individual Field Trials’’
Private Sector ......................................................................
Government .........................................................................

63
148

Form-1: Report on Receipt of Drug
Private Sector ......................................................................
Government .........................................................................

45
88

Form FFC–2A or 2B: Chemical Use Log
Private Sector ......................................................................
Government .........................................................................

63
148

3
3

Form-3: Diagnosis, Treatment, and Mortality Record
Private Sector ......................................................................
Government .........................................................................

63
148

Form-4: Necropsy Report Form
Private Sector ......................................................................
Government .........................................................................

27
24

Form-4a: Report on Efficacy Determination Sample
Private Sector ......................................................................
Government .........................................................................

3
3

2
2

Form-5: Transfer of Treated Fingerling
Private Sector ......................................................................
Government .........................................................................

2
1

8
1

16
1

0.5
0.5

8
1

Totals ............................................................................

1,097

........................

2,545

........................

2,027

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* Rounded.

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38354

Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices

An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Madonna Baucum,
Information Collection Clearance Officer, U.S.
Fish and Wildlife Service.
[FR Doc. 2021–15418 Filed 7–19–21; 8:45 am]
BILLING CODE 4333–15–P

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[Docket No. FWS–HQ–MB–2018–0090;
FF09M22000–212–FXMB1231099BPP0]
RIN 1018–BD76

Economic Analysis for Proposed
Regulations Governing the Take of
Migratory Birds
Fish and Wildlife Service,
Interior.
ACTION: Proposed rule; document
availability.
AGENCY:

We announce the opportunity
to review and comment on two
economic analysis documents prepared
during development of the proposed
rule to revoke the January 7, 2021, rule
governing the prohibitions on incidental
take under the Migratory Bird Treaty
Act. This document announces the
availability of an initial regulatory
flexibility analysis and a regulatory
impact analysis for public review.
DATES: Submit comments by August 19,
2021.
ADDRESSES: You may submit comments
by one of the following methods:
(1) Electronically: Go to the Federal
eRulemaking Portal: https://
www.regulations.gov/docket/FWS-HQMB-2018-0090/document. You may
submit a comment by clicking on
‘‘Comment.’’ Please ensure you have
located the correct document before
submitting your comments.
(2) By hard copy: Submit by U.S. mail
to: Public Comments Processing, Attn:
FWS–HQ–MB–2018–0090, U.S. Fish
and Wildlife Service, MS: JAO/3W,
5275 Leesburg Pike, Falls Church, VA
22041–3803.
We request that you send comments
only by the methods described above.
We will post all comments on https://
www.regulations.gov. This generally
means that we will post any personal
information you provide us (see Public
Comments, below, for more
information).

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SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

Jerome Ford, Assistant Director,
Migratory Birds, at 202–208–1050.
SUPPLEMENTARY INFORMATION:
Background
On January 7, 2021, the Service
published a final rule defining the scope
of the Migratory Bird Treaty Act
(MBTA; 16 U.S.C. 703 et seq.) as it
applies to conduct resulting in the
injury or death of migratory birds
protected by the MBTA (86 FR 1134)
(hereafter referred to as the ‘‘January 7
rule’’). The January 7 rule codified an
interpretation of the MBTA set forth in
a 2017 legal opinion of the Solicitor of
the Department of the Interior,
Solicitor’s Opinion M–37050, which
concluded that the MBTA does not
prohibit incidental take.
Following Council on Environmental
Quality regulations that implement the
National Environmental Policy Act (42
U.S.C. 4321 et seq.), the Service
prepared a final environmental impact
statement (EIS) for the January 7 rule:
‘‘Final Environmental Impact Statement;
Regulations Governing Take of
Migratory Birds,’’ available on http://
www.regulations.gov in Docket No.
FWS–HQ–MB–2018–0090 (https://
www.regulations.gov/document/FWSHQ-MB-2018-0090-14242). The
alternatives analyzed in that EIS cover
the effects of interpreting the MBTA
both to include and exclude incidental
take. We issued a record of decision
based on the final EIS. The Service also
prepared a regulatory impact analysis
(RIA) to support the January 7 rule,
available on http://www.regulations.gov
in Docket No. FWS–HQ–MB–2018–0090
(https://www.regulations.gov/document/
FWS-HQ-MB-2018-0090-14241). That
RIA analyzed the economic impacts of
three alternatives: A No Action
Alternative—Retain the existing legal
interpretation under M–37050 that the
MBTA excludes incidental take;
Alternative A—Promulgate regulations
that define the scope of the MBTA to
exclude incidental take; and Alternative
B—Promulgate regulations that define
the scope of the MBTA to include
incidental take.
On May 7, 2021, the Service
published in the Federal Register (86
FR 24573) a proposed rule seeking
public comment on whether the Service
should revoke the January 7 rule, which
defined the scope of the MBTA as it
applies to conduct resulting in the
injury or death of migratory birds
protected by the MBTA. This proposed
rule is available on http://
www.regulations.gov in Docket No.
FWS–HQ–MB–2018–0090 (https://
www.regulations.gov/document/FWS-

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HQ-MB-2018-0090-18943). For the May
7, 2021, proposed rule, we modified the
analysis in the RIA for the January 7
rule, given that the January 7 rule went
into effect on March 8, 2021. The
regulatory impact analysis presented for
the proposed rule revises the
alternatives to reflect the current
baseline with the January 7 rule in
effect. While the proposed rule does not
itself propose codification of a new
regulation that interprets the MBTA to
prohibit incidental take, the effects of
the removal of the January 7 rule are
substantially similar to those described
in Alternative B of the RIA for the
January 7 rule. Revoking the January 7
rule would have the effect of reverting
the government’s interpretation of the
MBTA to prohibit incidental take
consistent with longstanding agency
practice prior to publication of M–
37050, subject to the exercise of
enforcement discretion and the
applicable judicial precedent in a given
jurisdiction. Consistent with Alternative
B, the Service will consider further
steps to implement the MBTA
consistent with an interpretation that it
prohibits incidental take if it finalizes
the proposed revocation rule.
The Regulatory Flexibility Act of 1980
(RFA; 5 U.S.C. 601 et seq.) requires
agencies to evaluate the potential effects
of their proposed and final rules on
small businesses, small organizations,
and small governmental jurisdictions.
Section 603 of the RFA requires
agencies to prepare and make available
for public comment an initial regulatory
flexibility analysis (IRFA) describing the
impact of proposed rules on small
entities unless the agency can certify
under section 605(b) that the proposed
rule, if promulgated, will not have a
significant economic impact on a
substantial number of small entities.
Section 603(b) of the Act specifies that
each IRFA must contain:
D A description of the reasons why
action by the agency is being
considered;
D A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
D A description—and, where feasible,
an estimate of the number—of small
entities to which the proposed rule will
apply;
D A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule including an estimate of
the classes of small entities that will be
subject to the requirement and the type
of professional skills necessary for
preparation of the report or record; and
D An identification, to the extent
practicable, of all relevant Federal rules

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