[Federal Register Volume 90, Number 80 (Monday, April 28, 2025)]
[Notices]
[Pages 17615-17620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07283]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1533]
Importer of Controlled Substances Application: Lipomed
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Lipomed has applied to be registered as an importer of basic
class(es) of controlled substance(s). Refer to Supplementary
Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants, therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
May 28, 2025. Such persons may also file a written request for a
hearing on the application on or before May 28, 2025.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal,
[[Page 17616]]
which provides the ability to type short comments directly into the
comment field on the web page or attach a file for lengthier comments.
Please go to https://www.regulations.gov and follow the online
instructions at that site for submitting comments. Upon submission of
your comment, you will receive a Comment Tracking Number. Please be
aware that submitted comments are not instantaneously available for
public view on https://www.regulations.gov. If you have received a
Comment Tracking Number, your comment has been successfully submitted
and there is no need to resubmit the same comment. All requests for a
hearing must be sent to: (1) Drug Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a hearing should also be sent to: Drug
Enforcement Administration, Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on March 21, 2025, Lipomed, 150 Cambridgepark Drive,
Suite 705, Cambridge, Massachusetts 02140-2300, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
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Controlled substance Drug code Schedule
------------------------------------------------------------------------
3-Fluoro-N-methylcathinone (3-FMC)......... 1233 I
Cathinone.................................. 1235 I
Methcathinone.............................. 1237 I
4-Fluoro-N-methylcathinone (4-FMC)......... 1238 I
Para-Methoxymethamphetamine (PMMA), 1-(4- 1245 I
methoxyphenyl)-N-methylpropan-2-amine.
Pentedrone ([alpha]- 1246 I
methylaminovalerophenone).
Mephedrone (4-Methyl-N-methylcathinone).... 1248 I
4-Methyl-N-ethylcathinone (4-MEC).......... 1249 I
Naphyrone.................................. 1258 I
N-Ethylamphetamine......................... 1475 I
N,N-Dimethylamphetamine.................... 1480 I
Fenethylline............................... 1503 I
Aminorex................................... 1585 I
4-Methylaminorex (cis isomer).............. 1590 I
4,4'-Dimethylaminorex (4,4'-DMAR; 4,5- 1595 I
dihydro-4- methyl-5-(4-methylphenyl)-2-
oxazolamine; 4-methyl-5- (4-methylphenyl)-
4,5-dihydro-1,3-oxazol-2-amine).
Gamma Hydroxybutyric Acid.................. 2010 I
Methaqualone............................... 2565 I
Mecloqualone............................... 2572 I
Etizolam (4-(2-chlorophenyl)-2-ethyl-9- 2780 I
methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-
a][1,4]diazepine.
Flualprazolam (8-chloro-6-(2-fluorophenyl)- 2785 I
1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-
a][1,4]diazepine).
Clonazolam (6-(2-chlorophenyl)-1-methyl-8- 2786 I
nitro-4H-benzo[f][1,2,4]triazolo[4,3-
a][1,4]diazepine.
Flubromazolam (8-bromo-6-(2-fluorophenyl)-1- 2788 I
methyl-4H-benzo[f][1,2,4]triazolo[4,3-
a][1,4]diazepine.
Diclazepam (7-chloro-5-(2-chloro-5-(2- 2789 I
chlorophenyl)-1- methyl-1,3-dihydro-2H-
benzo[e][1,4]diazepin-2-one.
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) 6250 I
indole).
SR-18 (Also known as RCS-8) (1- 7008 I
Cyclohexylethyl-3-(2-methoxyphenylacetyl)
indole).
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1- 7010 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide).
5-Fluoro-UR-144 and XLR11 ([1-(5-Fluoro- 7011 I
pentyl)1H-indol-3-yl] (2,2,3,3-
tetramethylcyclopropyl)methanone).
AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan- 7012 I
2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide).
(1-(4-Fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- 7014 I
tetramethylcyclopropyl)methanone.
JWH-019 (1-Hexyl-3-(1-naphthoyl) indole)... 7019 I
MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)- 7020 I
1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate).
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (2-(1- 7021 I
(4-fluorobenzyl)-1Hindazole-3-carboxamido)-
3-methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-............ 7023 I
1-oxobutan-2-yl)-1-pentyl-1H-indazole-)3-
carboxamide.
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- 7024 I
yl](naphthalen-1-yl)methanone).............
5F-AB-PINACA (N-(1-amino-3methyl-1-oxobutan- 7025 I
2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1-........ 7031 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-.......
1H-indazole-3-carboxamide).................
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1- 7032 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H- 7033 I
indazole-3-carboxamido)-3-methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5- 7034 I
fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-1- 7035 I
oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide).
Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 7036 I
carboxamido) 3,3-dimethylbutanoate).
Methyl 2-(1-(5-fluoropentyl)-1H-indole-3- 7041 I
carboxamido)- 3,3-dimethylbutanoate.
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1- 7042 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2-(1- 7044 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate).
N-(Adamantan-1-yl)-1-(4-fluorobenzyl)-1H- 7047 I
indazole-3-carboximide).
APINACA and AKB48 (N-(1-Adamantyl)-1-pentyl- 7048 I
1H- indazole-3-carboxamide)indazole-3-
carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1- 7049 I
(5-fluoropentyl)-1H-indazole-3-
carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) 7081 I
indole).
1-(5-Fluoropentyl)-1H-indazole-3- 7083 I
carboxamide.
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2- 7085 I
phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide).
4-CN-CUMYL-BUTINACA, 4-cyano-CUMYL- 7089 I
BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-
BINACA, SGT-78 (1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-
carboximide).
SR-19 (Also known as RCS-4) (1-Pentyl-3-[(4- 7104 I
methoxy)-benzoyl] indole).
[[Page 17617]]
JWH-018 (also known as AM678) (1-Pentyl-3- 7118 I
(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) 7122 I
indole).
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3- 7144 I
tetramethylcyclopropyl)methanone).
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).... 7173 I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 7200 I
naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) 7201 I
indole).
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) 7203 I
indole).
NM2201, CBL2201 (Naphthalen-1-yl 1-(5- 7221 I
fluoropentyl)-1H-indole-3-carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3- 7222 I
carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)- 7225 I
1H-indole-3-carboxylate).
4-methyl-alpha-ethylaminopentiophenone (4- 7245 I
MEAP).
N-ethylhexedrone........................... 7246 I
Alpha-ethyltryptamine...................... 7249 I
Ibogaine................................... 7260 I
2-(ethylamino)-2-(3- 7286 I
methoxyphenyl)cyclohexan-1-one
(methoxetamine).
CP-47,497 (5-(1,1-Dimethylheptyl)-2- 7297 I
[(1R,3S)-3-hydroxycyclohexyl-phenol).
CP-47,497 C8 Homologue (5-(1,1- 7298 I
Dimethyloctyl)-2- [(1R,3S)3-
hydroxycyclohexyl]-phenol).
Lysergic acid diethylamide................. 7315 I
2,5-Dimethoxy-4-(n)- 7348 I
propylthiophenethylamine (2C-T-7).
Marihuana extract.......................... 7350 I
Marihuana.................................. 7360 I
Tetrahydrocannabinols...................... 7370 I
Parahexyl.................................. 7374 I
Mescaline.................................. 7381 I
2C-T-2, (2-(4-Ethylthio-2,5- 7385 I
dimethoxyphenyl) ethanamine).
3,4,5-Trimethoxyamphetamine................ 7390 I
4-Bromo-2,5-dimethoxyamphetamine........... 7391 I
4-Bromo-2,5-dimethoxyphenethylamine........ 7392 I
4-Methyl-2,5-dimethoxyamphetamine.......... 7395 I
2,5-Dimethoxyamphetamine................... 7396 I
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl) 7398 I
indole).
2,5-Dimethoxy-4-ethylamphetamine........... 7399 I
3,4-Methylenedioxyamphetamine.............. 7400 I
5-Methoxy-3,4-methylenedioxyamphetamine.... 7401 I
N-Hydroxy-3,4-methylenedioxyamphetamine.... 7402 I
3,4-Methylenedioxy-N-ethylamphetamine...... 7404 I
3,4-Methylenedioxymethamphetamine.......... 7405 I
4-Methoxyamphetamine....................... 7411 I
5-Methoxy-N-N-dimethyltryptamine........... 7431 I
Alpha-methyltryptamine..................... 7432 I
Bufotenine................................. 7433 I
Diethyltryptamine.......................... 7434 I
Dimethyltryptamine......................... 7435 I
Psilocybin................................. 7437 I
Psilocyn................................... 7438 I
5-Methoxy-N,N-diisopropyltryptamine........ 7439 I
4-chloro-alpha-pyrrolidinovalerophenone (4- 7443 I
chloro-a-PVP).
N-Ethyl-1-phenylcyclohexylamine............ 7455 I
1-(1-Phenylcyclohexyl)pyrrolidine.......... 7458 I
1-[1-(2-Thienyl)cyclohexyl]piperidine...... 7470 I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine..... 7473 I
N-Ethyl-3-piperidyl benzilate.............. 7482 I
N-Methyl-3-piperidyl benzilate............. 7484 I
N-Benzylpiperazine......................... 7493 I
4-MePPP (4-Methyl- 7498 I
alphapyrrolidinopropiophenone).
2C-D (2-(2,5-Dimethoxy-4-methylphenyl) 7508 I
ethanamine).
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I
ethanamine).
2C-H (2-(2,5-Dimethoxyphenyl) ethanamine).. 7517 I
2C-I (2-(4-iodo-2,5-dimethoxyphenyl) 7518 I
ethanamine).
2C-C (2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I
ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I
ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl) 7524 I
ethanamine).
2C-T-4 (2-(4-Isopropylthio)-2,5- 7532 I
dimethoxyphenyl) ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone)...... 7535 I
25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)- 7536 I
N-(2-methoxybenzyl) ethanamine).
25C-NBOMe (2-(4-chloro-2,5-dimethoxyphenyl)- 7537 I
N-(2-methoxybenzyl) ethanamine).
25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N- 7538 I
(2-methoxybenzyl) ethanamine).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone................................... 7541 I
Pentylone.................................. 7542 I
N-Ethylpentylone, ephylone (1-(1,3- 7543 I
benzodioxol-5-yl)-2-(ethylamino)-pentan-1-
one).
[alpha]-PHP, alpha-Pyrrolidinohexanophenone 7544 I
[alpha]-PVP (alpha- 7545 I
pyrrolidinopentiophenone).
[alpha]-PBP (alpha-pyrrolidinobutiophenone) 7546 I
[[Page 17618]]
Ethylone................................... 7547 I
PV8, alpha-Pyrrolidinoheptaphenone......... 7548 I
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I
iodobenzoyl) indole).
Acetyldihydrocodeine....................... 9051 I
Benzylmorphine............................. 9052 I
Codeine-N-oxide............................ 9053 I
Cyprenorphine.............................. 9054 I
Desomorphine............................... 9055 I
Etorphine (except HCl)..................... 9056 I
Codeine methylbromide...................... 9070 I
Brorphine (1-(1-(1-(4- 9098 I
bromophenyl)ethyl)piperidin-4-yl)- 1,3-
dihydro-2H-benzo[d]imidazol-2-one).
Dihydromorphine............................ 9145 I
Difenoxin.................................. 9168 I
Heroin..................................... 9200 I
Hydromorphinol............................. 9301 I
Methyldesorphine........................... 9302 I
Methyldihydromorphine...................... 9304 I
Morphine methylbromide..................... 9305 I
Morphine methylsulfonate................... 9306 I
Morphine-N-oxide........................... 9307 I
Myrophine.................................. 9308 I
Nicocodeine................................ 9309 I
Nicomorphine............................... 9312 I
Normorphine................................ 9313 I
Pholcodine................................. 9314 I
Thebacon................................... 9315 I
Acetorphine................................ 9319 I
Drotebanol................................. 9335 I
U-47700 (3,4-dichloro-N-[2- 9547 I
(dimethylamino)cyclohexyl]-N-
methylbenzamide).
AH-7921 (3,4-dichloro-N-[(1- 9551 I
dimethylamino)cyclohexylmethyl]benzamide)).
MT-45 (1-cyclohexyl-4-(1,2- 9560 I
diphenylethyl)piperazine)).
Acetylmethadol............................. 9601 I
Allylprodine............................... 9602 I
Alphacetylmethadol except levo- 9603 I
alphacetylmethadol.
Alphameprodine............................. 9604 I
Alphamethadol.............................. 9605 I
Benzethidine............................... 9606 I
Betacetylmethadol.......................... 9607 I
Betameprodine.............................. 9608 I
Betamethadol............................... 9609 I
Betaprodine................................ 9611 I
Clonitazene................................ 9612 I
Dextromoramide............................. 9613 I
Diampromide................................ 9615 I
Diethylthiambutene......................... 9616 I
Dimenoxadol................................ 9617 I
Dimepheptanol.............................. 9618 I
Dimethylthiambutene........................ 9619 I
Dioxaphetyl butyrate....................... 9621 I
Dipipanone................................. 9622 I
Ethylmethylthiambutene..................... 9623 I
Etonitazene................................ 9624 I
Etoxeridine................................ 9625 I
Furethidine................................ 9626 I
Hydroxypethidine........................... 9627 I
Ketobemidone............................... 9628 I
Levomoramide............................... 9629 I
Levophenacylmorphan........................ 9631 I
Morpheridine............................... 9632 I
Noracymethadol............................. 9633 I
Norlevorphanol............................. 9634 I
Normethadone............................... 9635 I
Norpipanone................................ 9636 I
Phenadoxone................................ 9637 I
Phenampromide.............................. 9638 I
Phenoperidine.............................. 9641 I
Piritramide................................ 9642 I
Proheptazine............................... 9643 I
Properidine................................ 9644 I
Racemoramide............................... 9645 I
Trimeperidine.............................. 9646 I
Phenomorphan............................... 9647 I
Propiram................................... 9649 I
1-Methyl-4-phenyl-4-propionoxypiperidine... 9661 I
[[Page 17619]]
1-(2-Phenylethyl)-4-phenyl-4- 9663 I
acetoxypiperidine.
Tilidine................................... 9750 I
Acryl fentanyl (N-(1-phenethylpiperidin-4- 9811 I
yl)-N-phenylacrylamide).
Para-Fluorofentanyl........................ 9812 I
3-Methylfentanyl........................... 9813 I
Alpha-Methylfentanyl....................... 9814 I
Acetyl-alpha-methylfentanyl................ 9815 I
N-(2-fluorophenyl)-N-(1-phenethylpiperidin- 9816 I
4-yl)propionamide.
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- 9821 I
yl)-N-phenylacetamide).
Butyryl Fentanyl........................... 9822 I
Para-fluorobutyryl fentanyl................ 9823 I
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N- 9825 I
phenylacetamide.
Para-chloroisobutyryl fentanyl............. 9826 I
Isobutyryl fentanyl........................ 9827 I
Beta-hydroxyfentanyl....................... 9830 I
Beta-hydroxy-3-methylfentanyl.............. 9831 I
Alpha-methylthiofentanyl................... 9832 I
3-Methylthiofentanyl....................... 9833 I
Furanyl fentanyl (N-(1-phenethylpiperidin-4- 9834 I
yl)-N-phenylfuran-2-carboxamide).
Thiofentanyl............................... 9835 I
Beta-hydroxythiofentanyl................... 9836 I
Para-methoxybutyryl fentanyl............... 9837 I
Ocfentanil................................. 9838 I
Valeryl fentanyl........................... 9840 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-carboxamide).
Cyclopropyl Fentanyl....................... 9845 I
Cyclopentyl fentanyl....................... 9847 I
Fentanyl related compounds as defined in 21 9850 I
CFR 1308.11(h).
Amphetamine................................ 1100 II
Methamphetamine............................ 1105 II
Lisdexamfetamine........................... 1205 II
Phenmetrazine.............................. 1631 II
Methylphenidate............................ 1724 II
Amobarbital................................ 2125 II
Pentobarbital.............................. 2270 II
Secobarbital............................... 2315 II
Glutethimide............................... 2550 II
Dronabinol in an oral solution in a drug 7365 II
product approved for marketing by the U.S.
Food and Drug Administration (FDA).
Nabilone................................... 7379 II
1-Phenylcyclohexylamine.................... 7460 II
Phencyclidine.............................. 7471 II
ANPP (4-Anilino-N-phenethyl-4-piperidine).. 8333 II
Norfentanyl (N-phenyl-N-(piperidin-4- 8366 II
yl)propionamide).
Phenylacetone.............................. 8501 II
1-Piperidinocyclohexanecarbonitrile........ 8603 II
Alphaprodine............................... 9010 II
Anileridine................................ 9020 II
Cocaine.................................... 9041 II
Codeine.................................... 9050 II
Etorphine HCl.............................. 9059 II
Dihydrocodeine............................. 9120 II
Oxycodone.................................. 9143 II
Hydromorphone.............................. 9150 II
Diphenoxylate.............................. 9170 II
Ecgonine................................... 9180 II
Ethylmorphine.............................. 9190 II
Hydrocodone................................ 9193 II
Levomethorphan............................. 9210 II
Levorphanol................................ 9220 II
Isomethadone............................... 9226 II
Meperidine................................. 9230 II
Meperidine-intermediate-A.................. 9232 II
Meperidine intermediate-B.................. 9233 II
Meperidine intermediate-C.................. 9234 II
Metazocine................................. 9240 II
Methadone.................................. 9250 II
Methadone intermediate..................... 9254 II
Metopon.................................... 9260 II
Dextropropoxyphene, bulk (non-dosage forms) 9273 II
Morphine................................... 9300 II
Oripavine.................................. 9330 II
Thebaine................................... 9333 II
[[Page 17620]]
Dihydroetorphine........................... 9334 II
Levo-alphacetylmethadol.................... 9648 II
Oxymorphone................................ 9652 II
Noroxymorphone............................. 9668 II
Phenazocine................................ 9715 II
Thiafentanil............................... 9729 II
Piminodine................................. 9730 II
Racemethorphan............................. 9732 II
Racemorphan................................ 9733 II
Alfentanil................................. 9737 II
Remifentanil............................... 9739 II
Sufentanil................................. 9740 II
Carfentanil................................ 9743 II
Tapentadol................................. 9780 II
Bezitramide................................ 9800 II
Fentanyl................................... 9801 II
Moramide-intermediate...................... 9802 II
------------------------------------------------------------------------
The company plans to import analytical reference standards for
distribution to its customers for research and analytics purposes.
Placement of these drug codes onto the company's registration does not
translate into automatic approval of subsequent permit applications to
import controlled substances. No other activities for these drug codes
are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-07283 Filed 4-25-25; 8:45 am]
BILLING CODE P