Merck Sharp & Dohme LLC, et al.; Withdrawal of Approval of 35 New Drug Applications, 60690-60691 [2023-19013]
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
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Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19059 Filed 9–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3549]
Merck Sharp & Dohme LLC, et al.;
Withdrawal of Approval of 35 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 35 new drug
SUMMARY:
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
Approval is withdrawn as of
October 5, 2023.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 001546 ......
Guanidine (guanidine hydrochloride (HCl)) Tablets, 125 milligrams (mg).
Peganone (ethotoin) Tablets, 250 mg and 500 mg .................
Merck Sharp & Dohme LLC, 126 East Lincoln Ave., P.O. Box
2000, Rahway, NJ 07065.
Recordati Rare Diseases Inc., 100 Corporate Dr., Lebanon,
NJ 08833.
Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL
60047.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
NDA 010841 ......
NDA 016801 ......
NDA 016822 ......
NDA 017407 ......
NDA 017425 ......
NDA 017534 ......
ddrumheller on DSK120RN23PROD with NOTICES1
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
industry/fda-user-fee-programs/
prescription-drug-user-fee-amendments.
NDA 018582 ......
NDA 018676 ......
NDA 018878 ......
VerDate Sep<11>2014
Xylocaine Preservative Free (lidocaine HCl) Injection, 1%,
2%, 4%, 10%, and 20%.
FreAmine 8.5% (amino acids) Injection, 8.5 grams (g)/100
milliliters (mL).
FreAmine HBC 6.9% (amino acids) Injection, 6.9 g/100 mL.
FreAmine II 8.5% (amino acids) Injection, 8.5 g/100 mL.
FreAmine III 10% (amino acids) Injection, 10 g/100 mL.
FreAmine III 8.5% (amino acids) Injection, 8.5 g/100 mL.
FreAmine III 8.5% with electrolytes (amino acids, magnesium
acetate, phosphoric acid, potassium acetate, potassium
chloride, sodium acetate) Injection, 8.5%; 110mg/100mL;
230mg/100mL; 10mg/100mL; 440mg/100mL; 690mg/
100mL.
FreAmine III 3% with electrolytes (amino acids, magnesium
acetate, phosphoric acid, potassium chloride, sodium acetate, sodium chloride) Injection, 3%; 54mg/100mL; 40mg/
100mL; 150mg/100mL; 200mg/100mL; 120mg/100mL.
Catapres (clonidine HCl) Tablets, 0.1 mg, 0.2 mg, and 0.3
mg.
Proglycem (diazoxide) Capsules, 50 mg and 100 mg ............
Fiorinal (aspirin, butalbital, caffeine) Capsules, 325 mg/50
mg/40 mg.
Fiorinal (aspirin, butalbital, caffeine) Tablets, 325 mg/50 mg/
40 mg.
Procalamine (amino acids, calcium acetate, glycerin, magnesium acetate, phosphoric acid, potassium chloride, sodium
acetate, sodium chloride) Injection, 3%; 26mg/100mL; 3g/
100mL; 54mg/100mL; 41mg/100mL; 150mg/100mL;
200mg/100mL; 120mg/100mL.
HepatAmine 8% (amino acids) Injection, 8g/100mL ...............
Indocin (indomethacin sodium) Injection, equivalent to (EQ) 1
mg base/vial.
18:02 Sep 01, 2023
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Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury
Rd., P.O. Box 368, Ridgefield, CT 06877.
Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Pkwy., West Chester, PA 19380.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
B. Braun Medical Inc.
Do.
Recordati Rare Diseases Inc.
E:\FR\FM\05SEN1.SGM
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
Application No.
Drug
NDA 019099 ......
Dopamine HCl and Dextrose 5% Injection, 80 mg/100 mL
and 320 mg/100 mL.
Dopamine HCl and Dextrose 5% in plastic container Injection, 40 mg/100 mL and 160 mg/100 mL.
Tussionex Pennkinetic (chlorpheniramine polistirex,
hydrocodone polistirex) Extended-Release Suspension, EQ
8 mg maleate/5 mL; EQ 10 mg bitartrate/5 mL.
Fiorinal with Codeine (aspirin, butalbital, caffeine, codeine
phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg.
Pravachol (pravastatin sodium) Tablets, 10 mg, 20 mg, 40
mg, and 80 mg.
Ultram (tramadol HCl) Tablets, 50 mg and 100 mg ................
NDA 019111 ......
NDA 019429 ......
NDA 019898 ......
NDA 020281 ......
NDA 020381 ......
NDA 021790 ......
NDA 021830 ......
NDA 021844 ......
Asacol HD (mesalamine) Delayed-Release Tablets, 800 mg
Desonate (desonide) Gel, 0.05% .............................................
NDA 022292 ......
NDA 022439 ......
Aptivus (tipranavir) Oral Solution, 100 mg/mL .........................
Zutripro (chlorpheniramine maleate, hydrocodone bitartrate,
pseudoephedrine HCl) Oral Solution, 4 mg/5 mL; 5 mg/5
mL; 60 mg/5 mL.
Rezira (hydrocodone bitartrate, pseudoephedrine HCl) Oral
Solution, 5 mg/5 mL; 60 mg/5 mL.
Vituz (chlorpheniramine maleate, hydrocodone bitartrate)
Oral Solution, 4 mg/5 mL; 5 mg/5 mL.
Tivorbex (indomethacin) Capsules, 20 mg and 40 mg ...........
NDA 020616 ......
NDA 020636 ......
NDA 021065 ......
NDA 021066 ......
NDA 021123 ......
NDA 021513 ......
NDA 021615 ......
NDA 022442 ......
NDA 204307 ......
NDA 204768 ......
NDA 206619 ......
NDA 208374 ......
NDA 210583 ......
ddrumheller on DSK120RN23PROD with NOTICES1
Applicant
Niaspan (niacin) Extended-Release Tablets, 375 mg, 500
mg, 750 mg, and 1 g.
Niaspan Titration Starter Pack (niacin) Extended-Release
Tablets, 375 mg, 500 mg, and 750 mg.
Jadelle (levonorgestrel) Implants for Subdermal Use, 75 mg/
implant.
Kadian (morphine sulfate) Extended-Release Capsules, 10
mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg,
100 mg, 130 mg, 150 mg, and 200 mg.
Viramune (nevirapine) Tablets, 200 mg ..................................
Femhrt (ethinyl estradiol, norethindrone acetate) Tablets,
0.0025 mg/0.5 mg and 0.005 mg/1 mg.
Zaditor (ketotifen fumarate) Ophthalmic Solution, EQ 0.025%
base.
Ultracet (acetaminophen, tramadol HCl) Tablets, 325 mg/
37.5 mg.
Enablex (darifenacin hydrobromide) Extended-Release Tablets, EQ 7.5 mg base and EQ 15 mg base.
Razadyne ER (galantamine hydrobromide) Extended-Release Capsules, EQ 8 mg base, EQ 16 mg base, and EQ
24 mg base.
Dacogen (decitabine) Injection, 50 mg/vial ..............................
NDA 020544 ......
Viekira Pak (dasabuvir sodium; ombitasvir, paritaprevir,
ritonavir) Tablets, EQ 250 mg base; 12.5 mg/75 mg/50 mg.
Bivalirudin in 0.9% Sodium Chloride Intravenous Solution,
250 mg/50 mL and 500 mg/100 mL.
Anjeso (meloxicam) Intravenous Solution, 30 mg/mL .............
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of October 5,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms included in
the application but inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
commerce of products listed in the table
without approved new drug
applications violates sections 505(a) and
301(d) of the Federal Food, Drug, and
VerDate Sep<11>2014
18:02 Sep 01, 2023
Jkt 259001
B. Braun Medical Inc.
UCB Inc., 1950 Lake Park Dr., Building 2100, Smyrna, GA
30080.
AbbVie Inc.
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543.
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton
Rd., Titusville, NJ 08560.
AbbVie Inc.
Population Council, 1230 York Ave., New York, NY 10065.
AbbVie Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.
Allergan Pharmaceuticals International Limited c/o AbbVie
Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth,
TX 76134.
Janssen Pharmaceuticals, Inc.
AbbVie Inc.
Janssen Research and Development, LLC, 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Otsuka Pharmaceutical Co., Ltd., c/o Otsuka Pharmaceutical
Development and Commercialization, Inc., 2440 Research
Blvd., Rockville, MD 20850.
AbbVie Inc.
LEO Pharma A/S, c/o LEO Pharma Inc., 7 Giralda Farms,
Madison, NJ 07940.
Boehringer Ingelheim Pharmaceuticals, Inc.
Persion Pharmaceuticals LLC, 10 North Park Place, Suite
201, Morristown, NJ 07960.
Do.
Do.
Genus Lifesciences Inc., 514 North 12th St., Allentown, PA
18102.
AbbVie Inc.
Baxter Healthcare Corp., 1 Baxter Pkwy., Deerfield, IL
60015.
Baudax Bio, Inc., 490 Lapp Rd., Malvern, PA 19355.
Cosmetic Act (21 U.S.C. 355(a) and
331(d)). Drug products that are listed in
the table that are in inventory on
October 5, 2023 may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
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60691
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Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19013 Filed 9–1–23; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\05SEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60690-60691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19013]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3549]
Merck Sharp & Dohme LLC, et al.; Withdrawal of Approval of 35 New
Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 35 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of October 5, 2023.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 001546............. Guanidine (guanidine Merck Sharp & Dohme
hydrochloride (HCl)) LLC, 126 East Lincoln
Tablets, 125 Ave., P.O. Box 2000,
milligrams (mg). Rahway, NJ 07065.
NDA 010841............. Peganone (ethotoin) Recordati Rare
Tablets, 250 mg and Diseases Inc., 100
500 mg. Corporate Dr.,
Lebanon, NJ 08833.
NDA 016801............. Xylocaine Preservative Fresenius Kabi USA,
Free (lidocaine HCl) LLC, 3 Corporate Dr.,
Injection, 1%, 2%, 4%, Lake Zurich, IL
10%, and 20%. 60047.
NDA 016822............. FreAmine 8.5% (amino B. Braun Medical Inc.,
acids) Injection, 8.5 901 Marcon Blvd.,
grams (g)/100 Allentown, PA 18109.
milliliters (mL).
FreAmine HBC 6.9%
(amino acids)
Injection, 6.9 g/100
mL.
FreAmine II 8.5% (amino
acids) Injection, 8.5
g/100 mL.
FreAmine III 10% (amino
acids) Injection, 10 g/
100 mL.
FreAmine III 8.5%
(amino acids)
Injection, 8.5 g/100
mL.
FreAmine III 8.5% with
electrolytes (amino
acids, magnesium
acetate, phosphoric
acid, potassium
acetate, potassium
chloride, sodium
acetate) Injection,
8.5%; 110mg/100mL;
230mg/100mL; 10mg/
100mL; 440mg/100mL;
690mg/100mL.
FreAmine III 3% with
electrolytes (amino
acids, magnesium
acetate, phosphoric
acid, potassium
chloride, sodium
acetate, sodium
chloride) Injection,
3%; 54mg/100mL; 40mg/
100mL; 150mg/100mL;
200mg/100mL; 120mg/
100mL.
NDA 017407............. Catapres (clonidine Boehringer Ingelheim
HCl) Tablets, 0.1 mg, Pharmaceuticals,
0.2 mg, and 0.3 mg. Inc., 900 Ridgebury
Rd., P.O. Box 368,
Ridgefield, CT 06877.
NDA 017425............. Proglycem (diazoxide) Teva Branded
Capsules, 50 mg and Pharmaceutical
100 mg. Products R&D, Inc.,
145 Brandywine Pkwy.,
West Chester, PA
19380.
NDA 017534............. Fiorinal (aspirin, AbbVie Inc., 1 North
butalbital, caffeine) Waukegan Rd., North
Capsules, 325 mg/50 mg/ Chicago, IL 60064.
40 mg.
Fiorinal (aspirin,
butalbital, caffeine)
Tablets, 325 mg/50 mg/
40 mg.
NDA 018582............. Procalamine (amino B. Braun Medical Inc.
acids, calcium
acetate, glycerin,
magnesium acetate,
phosphoric acid,
potassium chloride,
sodium acetate, sodium
chloride) Injection,
3%; 26mg/100mL; 3g/
100mL; 54mg/100mL;
41mg/100mL; 150mg/
100mL; 200mg/100mL;
120mg/100mL.
NDA 018676............. HepatAmine 8% (amino Do.
acids) Injection, 8g/
100mL.
NDA 018878............. Indocin (indomethacin Recordati Rare
sodium) Injection, Diseases Inc.
equivalent to (EQ) 1
mg base/vial.
[[Page 60691]]
NDA 019099............. Dopamine HCl and B. Braun Medical Inc.
Dextrose 5% Injection,
80 mg/100 mL and 320
mg/100 mL.
Dopamine HCl and
Dextrose 5% in plastic
container Injection,
40 mg/100 mL and 160
mg/100 mL.
NDA 019111............. Tussionex Pennkinetic UCB Inc., 1950 Lake
(chlorpheniramine Park Dr., Building
polistirex, 2100, Smyrna, GA
hydrocodone 30080.
polistirex) Extended-
Release Suspension, EQ
8 mg maleate/5 mL; EQ
10 mg bitartrate/5 mL.
NDA 019429............. Fiorinal with Codeine AbbVie Inc.
(aspirin, butalbital,
caffeine, codeine
phosphate) Capsules,
325 mg/50 mg/40 mg/30
mg.
NDA 019898............. Pravachol (pravastatin Bristol-Myers Squibb
sodium) Tablets, 10 Co., P.O. Box 4000,
mg, 20 mg, 40 mg, and Princeton, NJ 08543.
80 mg.
NDA 020281............. Ultram (tramadol HCl) Janssen
Tablets, 50 mg and 100 Pharmaceuticals,
mg. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ 08560.
NDA 020381............. Niaspan (niacin) AbbVie Inc.
Extended-Release
Tablets, 375 mg, 500
mg, 750 mg, and 1 g.
Niaspan Titration
Starter Pack (niacin)
Extended-Release
Tablets, 375 mg, 500
mg, and 750 mg.
NDA 020544............. Jadelle Population Council,
(levonorgestrel) 1230 York Ave., New
Implants for Subdermal York, NY 10065.
Use, 75 mg/implant.
NDA 020616............. Kadian (morphine AbbVie Inc.
sulfate) Extended-
Release Capsules, 10
mg, 20 mg, 30 mg, 40
mg, 50 mg, 60 mg, 70
mg, 80 mg, 100 mg, 130
mg, 150 mg, and 200 mg.
NDA 020636............. Viramune (nevirapine) Boehringer Ingelheim
Tablets, 200 mg. Pharmaceuticals, Inc.
NDA 021065............. Femhrt (ethinyl Allergan
estradiol, Pharmaceuticals
norethindrone acetate) International Limited
Tablets, 0.0025 mg/0.5 c/o AbbVie Inc., 1
mg and 0.005 mg/1 mg. North Waukegan Rd.,
North Chicago, IL
60064.
NDA 021066............. Zaditor (ketotifen Alcon Laboratories,
fumarate) Ophthalmic Inc., 6201 South
Solution, EQ 0.025% Freeway, Fort Worth,
base. TX 76134.
NDA 021123............. Ultracet Janssen
(acetaminophen, Pharmaceuticals, Inc.
tramadol HCl) Tablets,
325 mg/37.5 mg.
NDA 021513............. Enablex (darifenacin AbbVie Inc.
hydrobromide) Extended-
Release Tablets, EQ
7.5 mg base and EQ 15
mg base.
NDA 021615............. Razadyne ER Janssen Research and
(galantamine Development, LLC,
hydrobromide) Extended- 1125 Trenton-
Release Capsules, EQ 8 Harbourton Rd.,
mg base, EQ 16 mg Titusville, NJ 08560.
base, and EQ 24 mg
base.
NDA 021790............. Dacogen (decitabine) Otsuka Pharmaceutical
Injection, 50 mg/vial. Co., Ltd., c/o Otsuka
Pharmaceutical
Development and
Commercialization,
Inc., 2440 Research
Blvd., Rockville, MD
20850.
NDA 021830............. Asacol HD (mesalamine) AbbVie Inc.
Delayed-Release
Tablets, 800 mg.
NDA 021844............. Desonate (desonide) LEO Pharma A/S, c/o
Gel, 0.05%. LEO Pharma Inc., 7
Giralda Farms,
Madison, NJ 07940.
NDA 022292............. Aptivus (tipranavir) Boehringer Ingelheim
Oral Solution, 100 mg/ Pharmaceuticals, Inc.
mL.
NDA 022439............. Zutripro Persion
(chlorpheniramine Pharmaceuticals LLC,
maleate, hydrocodone 10 North Park Place,
bitartrate, Suite 201,
pseudoephedrine HCl) Morristown, NJ 07960.
Oral Solution, 4 mg/5
mL; 5 mg/5 mL; 60 mg/5
mL.
NDA 022442............. Rezira (hydrocodone Do.
bitartrate,
pseudoephedrine HCl)
Oral Solution, 5 mg/5
mL; 60 mg/5 mL.
NDA 204307............. Vituz (chlorpheniramine Do.
maleate, hydrocodone
bitartrate) Oral
Solution, 4 mg/5 mL; 5
mg/5 mL.
NDA 204768............. Tivorbex (indomethacin) Genus Lifesciences
Capsules, 20 mg and 40 Inc., 514 North 12th
mg. St., Allentown, PA
18102.
NDA 206619............. Viekira Pak (dasabuvir AbbVie Inc.
sodium; ombitasvir,
paritaprevir,
ritonavir) Tablets, EQ
250 mg base; 12.5 mg/
75 mg/50 mg.
NDA 208374............. Bivalirudin in 0.9% Baxter Healthcare
Sodium Chloride Corp., 1 Baxter
Intravenous Solution, Pkwy., Deerfield, IL
250 mg/50 mL and 500 60015.
mg/100 mL.
NDA 210583............. Anjeso (meloxicam) Baudax Bio, Inc., 490
Intravenous Solution, Lapp Rd., Malvern, PA
30 mg/mL. 19355.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 5, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms included in the application
but inadvertently missing from the table. Introduction or delivery for
introduction into interstate commerce of products listed in the table
without approved new drug applications violates sections 505(a) and
301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)
and 331(d)). Drug products that are listed in the table that are in
inventory on October 5, 2023 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19013 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P
