[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Pages 55037-55040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19391]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1070]


Bulk Manufacturer of Controlled Substances Application: Cayman 
Chemical Company

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Cayman Chemical Company, has applied to be registered as a 
bulk manufacturer 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 
November 7, 2022. Such persons may also file a written request for a 
hearing on the application on or before November 7, 2022.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on July 26, 2022, Cayman Chemical Company, 1180 East 
Ellsworth Road, Ann Arbor, Michigan 48108-2419, applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
           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            1238  I
 N flephedrone; 1-(4-fluorophenyl)-2-
 (methylamino)propan-1-one) (Positional
 isomer: 2-FMC).
Para-Methoxymethamphetamine (PMMA), 1-(4-            1245  I
 1245 I N 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-4-1595 I N 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
JWH-250 (1-Pentyl-3-(2-                              6250  I
 methoxyphenylacetyl) 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-                  7012  I
 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide).
FUB-144 (1-(4-fluorobenzyl)-1H-indol-3-              7014  I
 yl)(2,2,3,3-
 tetramethylcyclopropyl)methanone).
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)..            7019  I
MDMB-FUBINACA (Methyl 2-(1-(4-                       7020  I
 fluorobenzyl)-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-1-oxobutan-           7023  I
 2-yl)-1-pentyl-1H-indazole-3-
 carboxamide).
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-            7024  I
 3-yl](naphthalen-1-yl)methanone).
5F-AB-PINACA (N-(1-amino-3-methyl-1-                 7025  I
 oxobutan-2-yl)-1-(5-fluropentyl)-1H-
 indazole-3-carboximide).
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).
5F-EDMB-PINACA (ethyl 2-(1-(5-                       7036  I
 fluoropentyl)-1H-indazole-3-carboxamido)-
 3,3-dimethylbutanoate).
5F-MDMB-PICA (methyl 2-(1-(5-                        7041  I
 fluoropentyl)-1H-indole-3-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).
FUB-AKB48, FUB-APINACA, AKB48 N-(4-                  7047  I
 FLUOROBENZYL) (N-(adamantan-1-yl)-1-(4-
 fluorobenzyl)-1H-indazole-3-carboximide).
APINACA and AKB48 (N-(1-Adamantyl)-1-                7048  I
 pentyl-1H-indazole-3-carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-            7049  I
 1-(5-fluoropentyl)-1H-indazole-3-
 carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-                           7081  I
 methoxynaphthoyl) indole).

[[Page 55038]]

 
5F-CUMYL-PINACA, 5GT-25 (1-(5-                       7083  I
 fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-
 indazole-3-carboxamide).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2-            7085  I
 phenylpropan-2-yl)-1H-pyrrolo[2,3-
 b]pyridine-3-carboxamide).
4-CN-CUML-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-
 carboxamide).
SR-19 (Also known as RCS-4) (1-Pentyl-3-             7104  I
 [(4-methoxy)-benzoyl] indole).
JWH-018 (also known as AM678) (1-Pentyl-3-           7118  I
 (1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-                     7122  I
 naphthoyl) 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-                     7201  I
 naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2-                              7203  I
 chlorophenylacetyl) 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-                        7225  I
 fluoropentyl)-1H-indole-3-carboxylate).
4-methyl-alpha-ethylaminopentiophenone (4-           7245  I
 MEAP) 7245 I N 4-MEAP.
N-ethylhexedrone 7246 I N................            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
2C-T-7 (2,5-Dimethoxy-4-(n)-                         7348  I
 propylthiophenethylamine.
Marihuana................................            7360  I
Tetrahydrocannabinols....................            7370  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-                     7398  I
 naphthoyl) 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              7443  I
 (4-chloro-aPV.
4[acute]-methyl-alpha-                               7446  I
 pyrrolidinohexiophenone (MPHP.
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-Benzylpiperazine.......................            7493  I
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)-                        7524  I
 propylphenyl) 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-                           7536  I
 dimethoxyphenyl)-N-(2-methoxybenzyl)
 ethanamine).
25C-NBOMe (2-(4-chloro-2,5-                          7537  I
 dimethoxyphenyl)-N-(2-methoxybenzyl)
 ethanamine).
25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-           7538  I
 N-(2-methoxybenzyl) ethanamine).
Methylone (3,4-Methylenedioxy-N-                     7540  I
 methylcathinone).
Butylone.................................            7541  I
Pentylone................................            7542  I
alpha-pyrrolidinohexanophenone (a-PHP)...            7544  I
alpha-pyrrolidinopentiophenone ([alpha]-             7545  I
 PVP).
alpha-pyrrolidinobutiophenone ([alpha]-              7546  I
 PBP).

[[Page 55039]]

 
Ethylone.................................            7547  I
alpha-pyrrolidinoheptaphenone (PV8)......            7548  I
AM-694 (1-(5-Fluoropentyl)-3-(2-                     7694  I
 iodobenzoyl) indole).
Acetyldihydrocodeine.....................            9051  I
Benzylmorphine...........................            9052  I
Codeine-N-oxide..........................            9053  I
Desomorphine.............................            9055  I
Etorphine (except HCl)...................            9056  I
Codeine methylbromide....................            9070  I
Brorphine (1-(1-(1-(4-                               9098  I
 bromophenyl)ethyl)piperidin-4-4l)1,3-
 dihydro-2H-benzo[d]imidazol-2-one).
Dihydromorphine..........................            9145  I
Difenoxin................................            9168  I
Heroin...................................            9200  I
Hydromorphinol...........................            9301  I
Morphine-N-oxide.........................            9307  I
Normorphine..............................            9313  I
Thebacon.................................            9315  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)).
Clonitazene..............................            9612  I
Isotonotazene (N,N-diethyl-2-(2-(4                   9614  I
 isopropoxybenzyl)-5-nitro-1H-
 benzimidazol-1-yl)ethan-1-amine).
Etonitazene..............................            9624  I
Ketobemidone.............................            9628  I
Trimeperidine............................            9646  I
Tilidine.................................            9750  I
lunitazene (N,N-diethyl-2-(2-(4-                     9756  I
 fluorobenzyl)-5-nitro1H-benzimidazol-1-
 yl)ethan-1-amine).
Metonitazene (N,N-diethyl-2-(2-(4-                   9757  I
 methoxybenzyl)-5-nitro-1Hbenzimidazol-1-
 yl)ethan-1-amine.
N-pyrrolidino etonitazene; etonitazepyne             9758  I
 (2-(4-ethoxybenzyl)-5-nitro-1-(2-
 (pyrrolidin-1-yl)ethyl)-1Hbenzimidazole).
Protonitazene (N,N-diethyl-2-(5-nitro-2-             9759  I
 (4-propoxybenzyl)-1H-benzimidazol-1-
 yl)ethan-1-amine).
Metodesnitazene (N,N-diethyl-2-(2-(4-                9764  I
 methoxybenzyl)-1H-benzimidazol-1-
 yl)ethan-1-amine).
Etodesnitazene; etazene (2-(2-(4-                    9765  I
 ethoxybenzyl)-1Hbenzimidazol-1-yl)-N,N-
 diethylethan-1-amine).
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-                             9816  I
 phenethylpiperidin-4-yl)propionamide.
Para-Methylfentanyl (N-(4-methylphenyl)-N-           9817  I
 (1-phenethylpiperidin-4-yl)propionamide;
 also known as 4-methylfentanyl).
4'-Methyl acetyl fentanyl (N-(1-(4-                  9819  I
 methylphenethyl)piperidin-4-yl)-N-
 phenylacetamide).
ortho-Methyl methoxyacetyl fentanyl (2-              9820  I
 methoxy-N-(2-methylphenyl)-N-(1-
 phenethylpiperidin-4-yl)acetamide).
Acetyl Fentanyl (N-(1-phenethylpiperidin-            9821  I
 4-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-           9834  I
 4-yl)-N-phenylfuran-2-carboxamide).
Thiofentanyl.............................            9835  I
Beta-hydroxythiofentanyl.................            9836  I
Para-methoxybutyryl fentanyl.............            9837  !
Ocfentanil...............................            9838  I
Thiofuranyl fentanyl (N-(1-                          9839  I
 phenethylpiperidin-4-yl)-
 Nphenylthiophene-2-carboxamide; also
 known as 2-thiofuranyl fentanyl;
 thiophene fentanyl).
Valeryl fentanyl.........................            9840  I
Phenyl fentanyl (N-(1-phenethylpiperidin-            9841  I
 4-yl)-Nphenylbenzamide; also known as
 benzoyl fentanyl).
beta'-Phenyl fentanyl (N-(1-                         9842  I
 phenethylpiperidin-4-yl)-N,3-
 diphenylpropanamide; also known as
 [beta]'-phenyl fentanyl; 3-
 phenylpropanoyl fentanyl).
N-(1-phenethylpiperidin-4-yl)-N-                     9843  I
 phenyltetrahydrofuran-2-carboxamide.
Crotonyl fentanyl ((E-N-(1-                          9844  I
 phenethylpiperidin-4-yl)-N-phenylbut-2-
 enamide).
Cyclopropyl Fentanyl.....................            9845  I
ortho-Fluorobutyryl fentanyl (N-(2-                  9846  I
 fluorophenyl)-N-(1-phenethylpiperidin-4-
 yl)butyramide; also known as 2-
 fluorobutyryl fentanyl).
Cyclopentyl fentanyl.....................            9847  I
ortho-Methyl acetylfentanyl (N-(2-                   9848  I
 methylphenyl)-N-(1-phenethylpiperidin-4-
 yl)acetamide; also known as 2-methyl
 acetylfentanyl).
Fentanyl related-compounds as defined in             9850  I
 21 CFR 1308.11(h).
Fentanyl carbamate (ethyl (1-                        9851  I
 phenethylpiperidin-4-
 yl)(phenyl)carbamate).

[[Page 55040]]

 
ortho-Fluoroacryl fentanyl (N-(2-                    9852  I
 fluorophenyl)-N-(1-phenethylpiperidin-4-
 yl)acrylamide).
ortho-Fluoroisobutyryl fentanyl (N-(2-               9853  I
 fluorophenyl)-N-(1-phenethylpiperidin-4-
 yl)isobutyramide).
Para-Fluoro furanyl fentanyl (N-(4-                  9854  I
 fluorophenyl)-N-(1-phenethylpiperidin-4-
 yl)furan-2-carboxamide).
2'-Fluoro ortho-fluorofentanyl (N-(1-(2-             9855  I
 fluorophenethyl)piperidin-4-yl)-N-(2-
 fluorophenyl)propionamide; also known as
 2'-fluoro 2-fluorofentanyl).
beta-Methyl fentanyl (N-phenyl-N-(1-(2-              9856  I
 phenylpropyl)piperidin-4-
 yl)propionamide; also known as [beta]-
 methyl fentanyl).
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
1-Phenylcyclohexylamine..................            7460  II
Phencyclidine............................            7471  II
ANPP (4-Anilino-N-phenethyl-4-piperidine)            8333  II
Norfentanyl (N-phenyl-N-(piperidin-4-yl)             8366  II
 propionamide).
Phenylacetone............................            8501  II
1-Piperidinocyclohexanecarbonitrile......            8603  II
Cocaine..................................            9041  II
Codeine..................................            9050  II
Etorphine HCl............................            9059  II
Dihydrocodeine...........................            9120  II
Oxycodone................................            9143  II
Hydromorphone............................            9150  II
Ecgonine.................................            9180  II
Ethylmorphine............................            9190  II
Hydrocodone..............................            9193  II
Levomethorphan...........................            9210  II
Levorphanol..............................            9220  II
Isomethadone.............................            9226  II
Meperidine...............................            9230  II
Meperidine intermediate-B................            9233  II
Oliceridine (N-[(3-methoxythiophen-                  9245  II
 2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-
 oxaspiro[4.5] decan-9-yl] ethyl
 {time{time} )amine fumarate).
Methadone................................            9250  II
Dextropropoxyphene, bulk (non-dosage                 9273  II
 forms).
Morphine.................................            9300  II
Thebaine.................................            9333  II
Oxymorphone..............................            9652  II
Noroxymorphone...........................            9668  II
Thiafentanil.............................            9729  II
Alfentanil...............................            9737  II
Remifentanil.............................            9739  II
Sufentanil...............................            9740  II
Carfentanil..............................            9743  II
Tapentadol...............................            9780  II
Fentanyl.................................            9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for internal use or for sale to its customers. In reference 
to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the 
company plans to bulk manufacture these drugs as synthetic. No other 
activities for these drug codes are authorized for this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-19391 Filed 9-7-22; 8:45 am]
BILLING CODE P