Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 58539

hereby is, revoked. The Deputy 

Administrator further orders that any 

pending applications for renewal or 

modification of such registration be, and 

they hereby are, denied. This order is 

effective November 1, 2004.

Dated: September 8, 2004. 

Michele M. Leonhart, 

Deputy Administrator.

[FR Doc. 04–21959 Filed 9–29–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Registration 

By Notice dated May 5, 2004, and 

published in the Federal Register on 

May 26, 2004, (69 FR 29979), 

Boehringer Ingelheim Chemicals Inc., 

2820 N. Normandy Drive, Petersburg, 

Virginia 23805, made application by 

renewal to the Drug Enforcement 

Administration (DEA) to be registered as 

a bulk manufacturer of the basic classes 

of controlled substances:

Drug Schedule 

Amphetamine (1100) .................... II 

Methylphenidate (1724) ................ II 

Methadone (9250) ........................ II 

Methadone Intermediate (9254) ... II 

Dextropropoxyphene (9273) ......... II 

Levo-alphacetylmethadol (9648) .. II 

Fentanyl (9801) ............................ II 

The company plans to manufacture 

the listed controlled substances for 

formulation into finished 

pharmaceuticals. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 

determined that the registration of 

Boehringer Ingelheim Chemicals Inc. to 

manufacture the basic classes of 

controlled substances listed is 

consistent with the public interest at 

this time. DEA has investigated 

Boehringer Ingelheim Chemicals Inc. to 

ensure that the company’s registration is 

consistent with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 823, 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic classes of controlled 

substances listed.

Dated: September 16, 2004, 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–21957 Filed 9–29–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration 

By Notice dated May 5, 2004 and 

published in the Federal Register on 

May 26, 2004, (69 FR 29978–29979), 

Boehringer Ingelheim Chemicals, Inc., 

2820 N. Normandy Driver, Petersburg, 

Virginia 23805, made application by 

renewal to the Drug Enforcement 

Administration (DEA) to be registered as 

an importer of Phenylacetone (8501), a 

basic class of controlled substance listed 

in Schedule II. 

The company plans to import 

Phenylacetone for the bulk manufacture 

of amphetamine. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 952(a) 

and determined that the registration of 

Boehringer Ingelheim Chemicals, Inc. to 

import the basic classes of controlled 

substances is consistent with the public 

interest and with United States 

obligations under international treaties, 

conventions, or protocols in effect on 

May 1, 1971, at this time. DEA has 

investigated Boehringer Ingelheim 

Chemicals, Inc. to ensure that the 

company’s registration is consistent 

with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 952(a) 

and 958(a), and in accordance with 21 

CFR 1301.34, the above named company 

is granted registration as an importer of 

the basic class of controlled substance 

listed.

Dated: September 16, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–21958 Filed 9–29–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Registration 

By Notice dated May 21, 2004, and 

published in the Federal Register on 

June 3, 2004, (69 FR 31412), Cambrex 

North Brunswick, Inc., Technology 

Centre of New Jersey, 661 Highway One, 

North Brunswick, New Jersey 08902, 

made application by letter to the Drug 

Enforcement Administration (DEA) for 

registration as a bulk manufacturer of 

Methadone (9250) and Methadone 

Intermediate (9254), basic classes of 

controlled substances listed in Schedule 

II. 

The company plans to manufacture 

the controlled substances for research 

and development purposes. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 

determined that the registration of 

Cambrex North Brunswick, Inc. to 

manufacture the listed basic classes of 

controlled substances is consistent with 

the public interest at this time. DEA has 

investigated Cambrex North Brunswick, 

Inc. to ensure that the company’s 

registration is consistent with the public 

interest. The investigation has included 

inspection and testing of the company’s 

physical security systems, verification 

of the company’s compliance with state 

and local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 823, 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic classes of controlled 

substances listed.

Dated: September 8, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–21949 Filed 9–29–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Application 

Pursuant to 21 CFR 1301.33(a), this is 

notice that on July 7, 2004, Cambridge 

Isotope Laboratory, 50 Frontage Road, 

Andover, Massachusetts 01810, made 

application by renewal to the Drug 

Enforcement Administration (DEA) for 

registration as a bulk manufacturer of 

58540 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 

the basic classes of controlled 

substances listed:

Drug Schedule 

Methaqualone (2565) ................... I 

Dimethyltryptamine (7435) ........... I 

Amphetamine (1100) .................... II 

Methamphetamine (1105) ............ II 

Pentobarbital (2270) ..................... II 

Secobarbital (2315) ...................... II 

Phencyclidine (7471) .................... II 

Cocaine (9041) ............................. II 

Codeine (9050) ............................. II 

Oxycodone (9143) ........................ II 

Hydromorphone (9150) ................ II 

Benzzoylecgonine (9180) ............. II 

Methadone (9250) ........................ II 

Dextropropoxyphene (9273) ......... II 

Morphine (9300) ........................... II 

Fentanyl (9801) ............................ II 

The company plans to manufacture 

small quantities of the listed controlled 

substances to produce isotope labeled 

standards for drug analysis. 

Any other such applicant and any 

person who is presently registered with 

DEA to manufacture such a substance 

may file comments or objections to the 

issuance of the proposed registration 

pursuant to 21 CFR 1301.33(a). 

Any such comments or objections 

may be addressed, in quintuplicate, to 

the Deputy Assistant Administrator, 

Office of Diversion Control, Drug 

Enforcement Administration, United 

States Department of Justice, 

Washington, DC 20537, Attention: DEA 

Federal Register Representative (CCD) 

and must be filed no later than 

November 29, 2004.

Dated: September 16, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–21947 Filed 9–29–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

[Docket No. 03–27] 

Paramabaloth Edwin, M.D.; Revocation 

of Registration 

On April 24, 2003, the Deputy 

Administrator of the Drug Enforcement 

Administration (DEA), issued an Order 

to Show Cause/Immediate Suspension 

of Registration to Paramabaloth Edwin, 

M.D. (Dr. Edwin), notifying him of an 

opportunity to show cause as to why 

DEA should not revoke his DEA 

Certificate of Registration, AE7528295, 

as a practitioner, and deny any pending 

applications for renewal of registration 

pursuant to 21 U.S.C. 824(a)(4), for 

reason that Dr. Edwin’s continued 

registration would be inconsistent with 

the public interest. The Order to Show 

Cause/Immediate Suspension of 

Registration further advised Dr. Edwin 

that his DEA Certification of 

Registration had been suspended, 

pursuant to 21 U.S.C. 824(d), as an 

imminent danger to public health and 

safety. 

The Order to Show Cause/Immediate 

Suspension of Registration alleged, in 

part, that in August 2001, DEA had 

received information from a cooperating 

source that Dr. Edwin was selling and 

prescribing controlled substances for 

non-therapeutic uses. This information 

was corroborated by interviews of 

former patients, pharmacists and 

acquaintances of Dr. Edwin, as well as 

through a cooperating individual who 

purchased controlled substances from 

Dr. Edwin. It further alleged Dr. Edwin 

had purchased excessive quantities of 

controlled substances, stored controlled 

substances at an unregistered location 

and that his prescribing practices had 

hastened the addiction and/or death of 

patients. 

Finally, it was alleged that on April 

17, 2003, the Illinois Department of 

Professional Regulations (IDPR) 

summarily suspended Dr. Edwin’s state 

medical and controlled substance 

licenses, thus rendering him without 

state authority to handle controlled 

substances. 

By letter dated May 21, 2003, Dr. 

Edwin, through counsel, requested a 

hearing and on May 29, 2003, Presiding 

Administrative Law Judge Mary Ellen 

Bittner (Judge Bittner) ordered the 

parties to file prehearing statements. On 

June 13, 2003, in lieu of filing a 

prehearing statement, the Government 

filed a Motion for Summary Disposition, 

asserting Dr. Edwin was without 

authorization to handle controlled 

substances in the State of Illinois and as 

a result, further proceedings in the 

matter were not required. Attached to 

the Government’s motion was a copy of 

the IDPR’s Order dated April 17, 2003, 

directing Dr. Edwin to ‘‘immediately 

surrender all indicia of licensure to the 

Department.’’

On June 16, 2003, Judge Bittner issued 

a Memorandum to the Parties affording 

Dr. Edwin an opportunity to respond to 

the Government’s motion. In his 

response, Dr. Edwin argued it would 

violate due process to summarily 

dispose of the case premised on the 

IDPR’s Order, which, according to Dr. 

Edwin, was ‘‘based on mere allegations, 

which have not yet been tested.’’ Dr. 

Edwin further argued there had been no 

hearings before the IDPR in which he 

had been afforded a chance to present 

evidence or rebut the allegations against 

him. However, Dr. Edwin did not deny 

that his state professional licenses had 

been surrendered.

On July 18, 2003, Judge Bittner issued 

the Opinion and Recommended 

Decision of the Administrative Law 

Judge (Opinion and Recommended 

Decision). As part of her recommended 

ruling, Judge Bittner granted the 

Government’s Motion for Summary 

Disposition, finding Dr. Edwin lacked 

authorization to handle controlled 

substances in Illinois, the jurisdiction in 

which he is registered with DEA. 

In granting the Government’s motion, 

Judge Bittner further recommended that 

Dr. Edwin’s DEA registration be revoked 

and any pending applications for 

modification or renewal be denied. No 

exceptions to the Opinion and 

Recommended Decision were filed. 

The Deputy Administrator has 

considered the record in its entirety and 

pursuant to 21 CFR 1316.67, hereby 

issues her final order based upon 

findings of fact and conclusions of law 

as hereinafter set forth. The Deputy 

Administrator adopts, in full, the 

Opinion and Recommended Decision of 

the Administrative Law Judge. 

The Deputy Administrator finds that 

Dr. Edwin currently possesses DEA 

Certificate of Registration AE7528295, 

and is registered to handle controlled 

substances in the State of Illinois. The 

Deputy Administrator further finds that 

in response to allegations of 

professional misconduct, on April 17, 

2003, the IDPR issued an order directing 

Dr. Edwin to surrender all professional 

licenses. There is no evidence before the 

Deputy Administrator that IDPR’s Order 

has been lifted, stayed or modified. 

Therefore, the Deputy Administrator 

finds that Dr. Edwin is currently not 

licensed to practice medicine in Illinois 

and as a result, it is reasonable to infer 

he is also without authorization to 

handle controlled substances in that 

state. 

DEA does not have statutory authority 

under the Controlled Substances Act to 

issue or maintain a registration if the 

applicant or registrant is without state 

authority to handle controlled 

substances in the state in which he 

conducts business. See 21 U.S.C. 

802(21), 823(f) and 824(a)(3). This 

prerequisite has been consistently 

upheld. See Stephen J. Graham, M.D., 

69 FR 11661 (2004); Dominick A. Ricci, 

M.D., 58 FR 51104 (1993); Bobby Watts, 

M.D., 53 FR 11919 (1988). Revocation is 

also appropriate when a state license 

has been suspended, but with the 

possibility of future reinstatement. See

Alton E. Ingram, Jr., M.D., 69 FR 22562