Federal Register / Vol. 63, No. 151 /Thursday, August 6, 1998 / Notices 42065

licensing reveals that the granting or

denial of a manufacturer’s registration is

a licensing action, not a rulemaking.

Courts have frequently distinguished

between agency licensing actions and

rulemaking proceedings. See, e.g.

Gateway Transp. Co. v. United States,

173 F. Supp. 822, 828 (D.C. Wis. 1959);

Underwater Exotics, Ltd. v. Secretary of

the Interior, 1994 U.S. Dist. LEXIS 2262

(1994). Courts have interpreted agency

action relating to licensing as not falling

within the APA’s rulemaking

provisions.

The objector argues that Nycomed

cannot prove its registration as a bulk

manufacturer of methylphenidate is in

the public interest, that Nycomed’s

registration is not required to produce

an adequate and uninterrupted supply

of methylphenidate, that there is

sufficient competition with the present

bulk manufacturers and that by there

would be a public interest impact on

reported trends of over-prescribing,

abuse and diversion of

methylphenidate.

The arguments of the objector were

considered, however, DEA has reviewed

the firm’s safeguards to prevent the theft

and diversion of methylphenidate and

found that the firm has met the

regulatory requirements and public

interest factors of the Controlled

Substances Act.

Nycomed has been and is currently

registered with DEA as a manufacturer

of other Schedule II controlled

substances. Nycomed’s application is

based on the firm’s request to add

methylphenidate to its existing

registration as a bulk manufacturer. The

firm has been investigated by DEA on a

regular basis to determine if the firm

maintains effective controls against

diversion and if its continued

registration is consistent with the public

interest. These investigations have

included, in part, inspection and testing

of the firm’s physical security, audits of

the firm’s records, verification of

compliance with state and local law and

a review of the firm’s background and

history. These investigations have found

Nycomed to be in compliance with the

Controlled Substances Act (C.S.A.) and

its implementing regulations in recent

years.

Under Title 21, Code of Federal

Regulations, Section 1301.43(b), DEA is

not required to limit the number of

manufacturers solely because a smaller

number is capable of producing an

adequate supply provided effective

controls against diversion are

maintained. DEA has determined that

effective controls against diversion will

be maintained by Nycomed.

Additionally, Nycomed has applied

for registration as a bulk manufacturer

in order to perform a chemical isolation

process on methylphenidate which had

been manufactured by another

manufacturer currently registered to

bulk manufacture methylphenidate.

After reviewing all the evidence, DEA

has determined, pursuant to 21 U.S.C.,

Section 823(a) that it is consistent with

the public interest to grant Nycomed’s

application to manufacture

methylphenidate at this time. Therefore,

pursuant to 21 U.S.C. Section 823 and

28 CFR Section 0.100 and 0.104, the

Deputy Assistant Administrator, Office

of Diversion Control, hereby orders that

the application submitted by the above

firm for registration as a bulk

manufacturer of the basic class of

controlled substance listed above is

granted.

Dated: July 29, 1998.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 98–20977 Filed 8–5–98; 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 7, 1998, and

published in the Federal Register on

May 19, 1998 (63 FR 27590), Roche

Diagnostic Systems, Inc., 1080 U.S.

Highway 202, Somerville, New Jersey

08876–3771), made application by

renewal to the Drug Enforcement

Administration (DEA) to be registered as

an importer of tetrahydrocannabinols

(7370), a basic class of controlled

substance listed in Schedule I.

The tetrahydrocannabinols will be

utilized exclusively for non-human

consumption in drug of abuse detection

kits.

No comments or objections have been

received. DEA has considered the

factors in Title 21, United States Code,

Section 823(a) and determined that the

registration of Roche Diagnostic Systems

to import tetrahydrocannabinols is

consistent with the public interest and

with United Sates obligations under

international treaties, conventions, or

protocols in effect on May 1, 1971, at

this time. Therefore, pursuant to Section

1008(a) of the Controlled Substances

Import and Export Act and in

accordance with Title 21, Code of

Federal Regulations, Section 1301.34,

the above firm is granted registration as

an importer of the basic class of

controlled substance listed above.

Dated: July 17, 1998.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 98–20974 Filed 8–5–98; 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 4, 1998, and

published in the Federal Register on

May 19, 1998, (63 FR 27591), Sigma

Chemical Company, Subsidiary of

Sigma-Aldrich Company, 3500 Dekalb

Street, St. Louis, Missouri 63118, made

application to the Drug Enforcement

Administration (DEA) to be registered as

an importer of the basic classes of

controlled substances listed below:

Drug Schedule

Cathinone (1235) .......................... I

Methcathinone (1237) ................... I

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

Ibogaine (7260) ............................ I

Lysergic acid diethylamide (7315) I

Tetrahydrocannabinols (7370) ...... I

4-Bromo-2,5-

dimethoxyamphetamine (7391).

I

3,4-Methylenedioxyamphetamine

(7400).

I

3,4-Methlenedioxy-Nethylamphetamine (7404).I

3,4-Methlenedioxy- methamphetamine (7405).I

4-Methoxyamphetamine (7411) .... I

Psilocyn (7438) ............................. I

Normorphine (9313) ..................... I

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

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

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

Amobarbital (2125) ....................... II

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

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

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

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

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

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

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

Benzoylecgonine (9180) ............... II

Ethylmorphine (9190) ................... II

Hydrocodone (9193) ..................... II

Levorphanol (9220) ...................... II

Meperidine (9230) ........................ II

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

Dextropropoxyphene, bulk (nondosage forms) (9273).II

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

Thebaine (9333) ........................... II

Opium powdered (9639) ............... II

Oxymorphone (9652) .................... II

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