New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
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Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
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<title>Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026)</title>
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[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Rules and Regulations]
[Pages 5299-5303]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02331]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 516, 520, 522, 529, 556, and 558
[Docket No. FDA-2025-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Application; Change of
Sponsor; Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (CNADAs) during July, August, and September 2025. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective February 6, 2026.
FOR FURTHER INFORMATION CONTACT: Cathie Marshall, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, <a href="/cdn-cgi/l/email-protection#a2c1c3d6cacbc78ccfc3d0d1cac3cecee2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="325153465a5b571c5f5340415a535e5e725456531c5a5a411c555d44">[email protected]</span></a>, 240-402-5693.
SUPPLEMENTARY INFORMATION:
I. Approval of Applications
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and CNADAs during July, August, and
September 2025, as listed in table 1. Documentation of environmental
review required under the National Environmental Policy Act, summaries
of the basis of approval under the Freedom of Information Act (FOIA
summaries), and marketing exclusivity and patent information are
available at Animal Drugs @FDA: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
Table 1--Original, Conditional, and Supplemental Applications Approved During July, August, and September 2025
----------------------------------------------------------------------------------------------------------------
Application Sponsor (drug Effect of the 21 CFR
Date of approval No. labeler code \1\) Product name action sections
----------------------------------------------------------------------------------------------------------------
July 8, 2025............... 200-807 Huvepharma EOOD MGA (melengestrol Original approval 558.330
(016592). acetate Type A as a generic copy
medicated of NADA 141-590.
article) and
EXPERIOR
(lubabegron Type
A medicated
article) and
MONOVET (monensin
Type A medicated
article).
July 8, 2025............... 200-808 Huvepharma EOOD MGA (melengestrol Original approval 558.625
(016592). acetate Type A as a generic copy
medicated of NADA 141-591.
article) and
EXPERIOR
(lubabegron Type
A medicated
article) and
MONOVET (monensin
Type A medicated
article) and
TYLOVET (tylosin
phosphate Type A
medicated
article).
July 8, 2025............... 200-815 Felix Cefpodoxime Original approval 520.370
Pharmaceuticals Proxetil Tablets as a generic copy
Pvt. Ltd. (cefpodoxime of NADA 141-232.
(086101). proxetil tablets).
July 10, 2025.............. 141-599 Intervet, Inc. BRAVECTO QUANTUM Original approval. 522.998
(000061). (fluralaner for
extended-release
injectable
suspension).
July 11, 2025.............. 200-816 Cronus Pharma Meloxisol Original approval 520.1367
Specialities (meloxicam oral as a generic copy
India Private suspension 1.5 mg/ of NADA 141-213.
Ltd. (069043). mL).
July 17, 2025.............. 141-607 Intervet, Inc. EXZOLT (fluralaner Original approval. 520.999
(000061). oral solution). 556.290
July 18, 2025.............. 200-759 ZyVet Animal Furosemide Tablets Original approval 520.1010
Health, Inc. (furosemide as a generic copy
(086117). tablets). of NADA 034-621.
July 21, 2025.............. 200-817 Felix Meloxicam Oral Original approval 520.1367
Pharmaceuticals Suspension as a generic copy
Pvt. Ltd. (meloxicam oral of NADA 141-213.
(086101). suspension 1.5mg/
mL).
August 5, 2025............. 200-818 Bimeda Animal MOXICLOPRID for Original approval 524-1146
Health Ltd. dogs as a generic copy
(061133). (imidacloprid and of NADA (141-251).
moxidectin).
August 14, 2025............ 200-794 Cronus Pharma MELOXISOL Original approval 520.1367
Specialities (meloxicam oral as a generic copy
India Private suspension 0.5mg/ of NADA 141-213.
Ltd. (069043). mL).
August 28, 2025............ 200-821 Parnell Isoflurane Original approval 529.1186
Technologies Pty. (isoflurane as a generic copy
Ltd. (068504). liquid). of NADA 135-773.
August 28, 2025............ 200-819 Bimeda Animal GAMROZYNE Original approval 522.1014
Health Ltd. (gamithromycin). as a generic copy
(061133). of NADA 141-328.
September 19, 2025......... 200-824 Felix Dexmedetomidine Original approval 522.558
Pharmaceuticals (dexmedetomidine as a generic copy
Pvt. Ltd. hydrochloride of NADA 141-267.
(086101). sterile
injectable
solution).
September 30, 2025......... 141-616 Zoetis Inc., DECTOMAX-CA1 Conditional 516.570
(054771). (doramectin approval.
injectable
solution).
----------------------------------------------------------------------------------------------------------------
\1\ See 21 CFR 510.600(c) for sponsor addresses.
II. Withdrawal of Approval of Applications
Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46211 (drug
labeler code 058198) requested that FDA withdraw approval of the NADA
listed in table 2 because the product information has been combined
with NADA 010-918. No change to the regulatory text is required.
[[Page 5300]]
Table 2--Applications for Which Approval Was Voluntarily Withdrawn
During July, August, and September 2025
------------------------------------------------------------------------
Date of withdrawal of Application 21 CFR
approval No. Product name section
------------------------------------------------------------------------
August 02, 2023\1\......... 011-948 HYGROMIX 2.5 558.274
(hygromycin B
Type A medicated
article).
------------------------------------------------------------------------
\1\ This withdrawal was not previously published.
III. Changes of Sponsor
The sponsor of the approved applications listed in table 3 has
informed FDA that they have transferred ownership of, and all rights
and interest in, these applications to another sponsor. The regulations
cited in table 3 are amended to reflect these actions.
Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During July, August, and September
2025
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug 21 CFR
Application No. Product name (drug labeler code) labeler code) section
----------------------------------------------------------------------------------------------------------------
141-136................. BIO-COX (salinomycin sodium Zoetis Inc. (054771).. Phibro Animal Health 558.550
Type A medicated article) Corp. (066104).
and BMD (bacitracin
methylenedisalicylate Type
A medicated article).
091-749................. TYLAN 10 SULFA-G and TYLAN Do.................... Do.................... 558.630
40 SULFA-G (tylosin
phosphate Type A medicated
article and sulfamethazine
Type A medicated article).
----------------------------------------------------------------------------------------------------------------
IV. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed
a rule under the FD&C Act, this document does not meet the definition
of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of particular
applicability'' and is not subject to the congressional review
requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject
to Executive Order 12866.
List of Subjects
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods, Meat and meat products.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
516, 520, 522, 529, 556, and 558 are amended as follows:
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
1. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
2. Add Sec. 516.570 to read as follows:
Sec. 516.570 Doramectin.
(a) Specifications. Each milliliter of solution contains 10
milligrams of doramectin.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Amount. 200 micrograms per
kilogram (10 milligrams per 110 pounds).
(2) Indications for use. For prevention and treatment of
infestations caused by larvae of Cochliomyia hominivorax (myiasis), and
prevention of reinfestation for 21 days in cattle.
(3) Limitations. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism. Administer as a single
subcutaneous or intramuscular injection. Do not slaughter cattle for
human consumption within 35 days of treatment. Not for use in female
dairy cattle 20 months of age or older. A withdrawal period has not
been established for this product in preruminating calves. Do not use
in calves to be processed for veal.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.370 [Amended]
0
4. In Sec. 520.370, in paragraph (b)(1), remove the text ``No.
017033'' and in its place add the text ``Nos. 017033 and 086101''.
0
5. Revise the heading of Sec. 520.998 to read as follows:
Sec. 520.998 Fluralaner chewable tablets.
* * * * *
0
6. Add Sec. 520.999 to read as follows:
Sec. 520.999 Fluralaner oral solution.
(a) Specifications. Each milliliter (mL) of solution contains 10
milligrams (mg) fluralaner.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in laying hens and replacement chickens--(1)
Amount. Administer orally to chickens via the drinking water as 2
single doses, spaced 7 days apart, with each dose consumed over a
period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kilogram (kg)
(0.227 mg/pound (mg/lb)) body weight, equivalent to 0.05 mL fluralaner
oral solution/kg body weight (0.023 mL/lb).
(2) Indications for use. For the treatment and control of northern
fowl mites (Ornithonyssus sylviarum).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Chickens must not be slaughtered
for human consumption for 11 days after the last treatment. No egg
discard is required when used according to the labeling.
Sec. 520.1010 [Amended]
0
7. In Sec. 520.1010, in paragraph (b)(1), remove the text ``No.
000010'' and in its place add the text ``Nos. 000010 and 086117''.
[[Page 5301]]
0
8. In Sec. 520.1367, revise paragraphs (b)(1) and (2) and the last
sentence in paragraph (c)(1) to read as follows:
Sec. 520.1367 Meloxicam.
* * * * *
(b) * * *
(1) Nos. 000010 and 069043 for use of the products described in
paragraph (a) of this section; and
(2) Nos. 013744, 055529, and 086101 for use of the product
described in paragraph (a)(2) of this section.
(c) * * *
(1) * * * For all treatments after day 1, administer 0.045 mg/lb
(0.1 mg/kg) body weight once daily.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.558 [Amended]
0
10. In Sec. 522.558, in paragraph (b)(1), remove the text ``and
086117'' and in its place add the text ``086101, and 086117''.
0
11. Add Sec. 522.998 to read as follows:
Sec. 522.998 Fluralaner.
(a) Specifications. The product is supplied in two vials, one vial
containing 2.51 grams of sterile fluralaner and one vial containing the
required 15 milliliters (mL) of sterile vehicle for constitution. Each
mL of constituted suspension contains 150 milligrams (mg) fluralaner.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer as a single
subcutaneous dose every 12 months or every 8 months in the case of
potential exposure to Amblyomma americanum ticks. The subcutaneous dose
volume is 0.1 mL of the constituted suspension/kilogram (kg) body
weight (0.045 mL per pound (mL/lb)). This volume provides a dose of 15
mg fluralaner per kilogram body weight (6.8 mg/lb).
(2) Indications for use. Kills adult fleas and for the treatment
and prevention of flea infestations (Ctenocephalides felis); for the
treatment and control of tick infestations Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and
Rhipicephalus sanguineus (brown dog tick) for 12 months in dogs and
puppies 6 months of age and older; and for the treatment and control of
Amblyomma americanum (lone star tick) infestations for 8 months in dogs
and puppies 6 months of age and older.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1014 [Amended]
0
12. In Sec. 522.1014, in paragraph (b), remove the text ``No. 000010''
and in its place add the text ``Nos. 000010 and 061133''.
0
13. In Sec. 522.2680 revise paragraphs (d)(1)(ii)(A) and (B) as
follows:
Sec. 522.2680 Zeranol.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) For increased rate of weight gain and improved feed efficiency
in growing beef steers and heifers fed in confinement for slaughter.
(B) For increased rate of weight gain in beef calves 2 months of
age or older, in growing beef steers and heifers on pasture (stocker,
feeder, and slaughter), and in growing beef steers and heifers in a dry
lot.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
14. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1186 [Amended]
0
15. In Sec. 529.1186, in paragraph (b), remove the text ``See Nos.
017033, 054771, and 065085'' and in its place add the text ``See Nos.
017033, 054771, 065085, and 068504''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
16. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
17. Add Sec. 556.290 to read as follows:
Sec. 556.290 Fluralaner.
(a) Acceptable daily intake (ADI). The ADI for total residue of
fluralaner is 10 [micro]g/kg of body weight per day.
(b) Tolerances. The tolerances for parent fluralaner (marker
residue) are:
(1) Chickens. (i) Liver (target tissue): 320 ppb.
(ii) Muscle: 110 ppb.
(iii) Eggs: 2500 ppb.
(2) [Reserved]
(c) Related conditions of use. See Sec. 520.999 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
18. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
19. In Sec. 558.330, revise paragraph (e)(1)(v) to read as follows:
Sec. 558.330 Lubabegron.
* * * * *
(e) * * *
(1) * * *
[[Page 5302]]
----------------------------------------------------------------------------------------------------------------
Lubabegron (as lubabegron Combination in
fumarate) in grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) 1.25 to 4.54.................. Monensin, 10 to 40 Growing beef Melengestrol acetate 058198
and melengestrol heifers fed in Type C top-dress 016592
acetate, 0.25 to 2. confinement for medicated feed (0.5 to
slaughter: For 2 lb(s) per head per
increased rate of day) must be top
weight gain, dressed onto or mixed
improved feed at feeding with a Type
efficiency, C medicated feed
suppression of containing 1.25 to
estrus (heat), for 4.54 g/ton lubabegron
reduction of and 10 to 40 g/ton
ammonia gas monensin, to provide
emissions per 0.25 to 0.5 mg
pound of live melengestrol acetate
weight and hot and 13 to 90 mg
carcass weight, lubabegron per head
and for the per day, and 0.14 to
prevention and 0.42 mg monensin per
control of pound of body weight
coccidiosis caused per day, depending
by Eimeria bovis upon severity of
and Eimeria challenge, up to a
zuernii during the maximum of 480 mg
last 14 to 91 days monensin per head per
on feed. day. Feed as the sole
ration during the last
14 to 91 days on feed.
See special labeling
considerations in
paragraph (d) of this
section, and in Sec.
Sec. 558.342(d) and
558.355(d). Lubabegron
fumarate as provided
by No. 058198;
monensin as provided
by No. 058198 or
016592; melengestrol
acetate as provided by
No. 054771 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
20. In Sec. 558.550, revise paragraphs (e)(1)(ii) through (iv) to read
as follows:
Sec. 558.550 Salinomycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Salinomycin sodium activity in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 40 to 60..................... Bacitracin (as feed Broiler chickens Feed continuously as 016592
grade bacitracin and replacement sole ration. 066104
methylenedisalicyl chickens. Not for Discontinue use prior
ate) 4 to 50. use in laying to sexual maturity.
hens: For the The dosage of
prevention of salinomycin sodium
coccidiosis caused should be adjusted to
by Eimeria meet the severity of
tenella, E. the coccidial
necatrix, E. challenge, which
acervulina, E. varies with
maxima, E. environmental and
brunetti, and E. management conditions.
mivati, and for May be fatal if fed to
increased rate of adult turkeys or
weight gain and horses. Salinomycin as
improved feed provided by No.
efficiency. 016592; bacitracin
methylenedisalicylate
as provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(iii) 40 to 60.................... Bacitracin (as feed Broiler chickens Feed continuously as 066104
grade bacitracin and replacement sole ration.
methylenedisalicyl chickens. Not for Discontinue use prior
ate) 50. use in laying to sexual maturity.
hens: For the The dosage of
prevention of salinomycin sodium
coccidiosis caused should be adjusted to
by Eimeria meet the severity of
tenella, E. the coccidial
necatrix, E. challenge, which
acervulina, E. varies with
maxima, E. environmental and
brunetti, and E. management conditions.
mivati, and as an May be fatal if fed to
aid in the adult turkeys or
prevention of horses. Salinomycin as
necrotic enteritis provided by No.
caused or 016592; bacitracin
complicated by methylenedisalicylate
Clostridium spp. as provided by No.
or other organisms 066104 in Sec.
susceptible to 510.600(c) of this
bacitracin chapter.
methylenedisalicyl
ate.
(iv) 40 to 60..................... Bacitracin (as feed Broiler chickens Feed continuously as 066104
grade bacitracin and replacement the sole ration.
methylenedisalicyl chickens. Not for Discontinue use prior
ate) 100 to 200. use in laying to sexual maturity.
hens: For the The dosage of
prevention of salinomycin sodium
coccidiosis caused should be adjusted to
by Eimeria meet the severity of
tenella, E. the coccidial
necatrix, E. challenge, which
acervulina, E. varies with
maxima, E. environmental and
brunetti, and E. management conditions.
mivati, and as an To control a necrotic
aid in the control enteritis outbreak,
of necrotic start medication at
enteritis caused the first clinical
or complicated by signs of disease. The
Clostridium spp. bacitracin
or other organisms methylenedisalicylate
susceptible to dosage range permitted
bacitracin provides for different
methylenedisalicyl levels based on
ate. severity of the
infection. Consult a
poultry diagnostic
laboratory or
pathologist to
determine the
diagnosis and advice
regarding the optimal
level of bacitracin
methylenedisalicylate.
Administer
continuously for 5-7
days or as long as
clinical signs
persist, and then
reduce bacitracin
methylenedisalicylate
dosage to prevention
level (50 g/ton). May
be fatal if fed to
adult turkeys or to
horses. Salinomycin as
provided by No.
016592; bacitracin
methylenedisalicylate
as provided by No.
066104 in Sec.
510.600(c) in this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[[Page 5303]]
0
21. In Sec. 558.625, revise paragraph (e)(2)(ix) to read as follows:
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Tylosin in grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ix) 8 to 10...................... Monensin, 10 to 40 Growing beef Feed as the sole ration 058198
plus lubabegron heifers fed in during the last 14 to 016592
(as lubabegron confinement for 91 days on feed.
fumarate), 1.25 to slaughter: For Melengestrol acetate
4.54, plus increased rate of Type C top-dress
melengestrol weight gain, medicated feed (0.5 to
acetate, 0.25 to improved feed 2.0 lb per head per
2.0. efficiency, day) must be top
suppression of dressed onto or mixed
estrus (heat), for at feeding with a Type
reduction of C medicated feed
ammonia gas containing 8 to 10 g/
emissions per ton tylosin, 1.25 to
pound of live 4.54 g/ton lubabegron,
weight and hot and 10 to 40 g/ton
carcass weight, monensin, to provide
for the prevention 0.25 to 0.5 mg
and control of melengestrol acetate,
coccidiosis caused 60 to 90 mg tylosin
by Eimeria bovis per head per day, 13
and Eimeria to 90 mg lubabegron
zuernii, and for per head per day, and
reduction of 0.14 to 0.42 mg
incidence of liver monensin per pound of
abscesses body weight per day,
associated with depending on severity
Fusobacterium of challenge, up to
necrophorum and 480 mg monensin per
Arcanobacterium head per day. See
pyogenes during special labeling
the last 14 to 91 considerations in Sec.
days on feed. Sec. 558.330(d),
558.342(d), and
558.355(d). Tylosin
and monensin as
provided by No. 058198
or 016592; lubabegron
fumarate as provided
by No. 058198;
melengestrol acetate
as provided in No.
054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Sec. 558.630 [Amended]
0
22. In Sec. 558.630:
0
a. In paragraph (b)(2), remove the text ``054771'' and in its place add
the text ``066104''; and
0
b. In the table in paragraph (e)(2), in the ``Sponsor'' column, remove
the text ``054771'' and in its place add the text ``066104''.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02331 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.