Federal Register / Vol. 60, No. 49 / Tuesday, March 14, 1995 / Notices 13735

1 59 FR 14426.

2 59 FR 25126.

Importer of Controlled Substances;

Notice of Registration

By Notice dated January 17, 1995, and

published in the Federal Register on

January 25, 1995, (60 FR 4925), Knight

Seed Company, Inc., 151 W. 126th

Street, Burnsville, Minnesota 55337,

made application to the Drug

Enforcement Administration (DEA) to

be registered as an importer of

Marihuana (7360), a basic class of

controlled substance listed in Schedule

I.

No comments or objections have been

received. 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 1311.42,

the above firm is granted registration as

an importer of the basic class of

controlled substance listed above.

Dated: March 8, 1995.

Gene R. Haislip,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 95–6219 Filed 3–13–95; 8:45 am]

BILLING CODE 4410–09–M

[Docket No. 94–52]

Mallinckrodt Chemical, Inc.; St. Louis,

Missouri; Notice of Administrative

Hearing, Summary of Comments and

Objections; Notice of Hearing

This Notice of Administrative

Hearing, Summary of Comments and

Objections, regarding the application of

Mallinckrodt Chemical, Inc.

(Mallinckrodt) for registration as a bulk

manufacturer of methylphenidate, a

Schedule II controlled substance, is

published pursuant to 21 CFR

1301.43(a). Notice was published in the

Federal Register on March 28, 1994,1

and May 13, 1994,2 respectively,

naming the applicant and stating that

the applicant has applied to be

registered as a bulk manufacturer of

methylphenidate.

On June 14, 1994, MD Pharmaceutical

Inc. (MD Pharmaceutical) filed an

objection and requested a hearing on the

application, in accordance with 21 CFR

1301.43(a). Notice is hereby given that

a hearing with respect to the

Mallinckrodt’s application to be

registered as a bulk manufacturer of

methylphenidate will be conducted

pursuant to the provisions of 5 U.S.C.

552 et seq. and 21 CFR 1301.43 et seq.

and 1316.41 et seq.

Hearing Date: The hearing is

scheduled for May 2 through 5 1994,

commencing at 9:30 a.m. on May 2,

1995, at the Drug Enforcement

Administration Headquarters, 600 Army

Navy Drive, Hearing Room, Room E–

2103, Arlington, Virginia.

Notice of Appearance: Any person

entitled to participate in this hearing

pursuant to 21 CFR 1301.43(a), and

interested in doing so, may participate

by filing a notice of intention to

participate in accordance with 21 CFR

1301.54, in duplicate, with the Hearing

Clerk, Office of the Administrative Law

Judge, Drug Enforcement

Administration, Washington, D.C.

20537, within 30 days of the date of

publication of this notice in the Federal

Register. Each notice of appearance

must be in the form prescribed in 21

CFR 1316.48. The entities whose

comment and/or objections are

referenced below need not file a notice

of intention to participate.

For Further Information Contact: Ms.

Helen Farmer, Hearing Clerk, Drug

Enforcement Administration,

Washington, D.C. 20537; Telephone

(202) 307–8188.

Summary of Comments and Objections

Drug Enforcement Adminstration Comments

The Government does not know of

any reason to deny Mallinckrodt’s

application.

MD Pharmaceutical’s Comments and

Objections

MD Pharmaceutical intends to show

that the registration of Mallinckrodt to

manufacture methylphenidate in its

generic form is not consistent with the

public interest as that term is used in 21

U.S.C. 823(a). MD Pharmaceutical seeks

to establish that Mallinckrodt does not

satisfy the public interest standard by

showing that: (1) Mallinckrodt does not

meet the Controlled Substances Act

requirements for registration as a bulk

manufacturer of methylphenidate; and

(2) the Food and Drug Administration

has cited Mallinckrodt frequently in the

twelve months preceding MD

Pharmaceutical’s hearing request for

serious violations directly related to the

manufacture and distribution of

adulterated drug products.

Mallinckrodt’s Comments

Mallinckrodt intends to establish that

it meets the requirements of 21 USC

823(a) and, therefore, qualifies for

registration as a manufacturer of

methylphenidate. Mallinckrodt seeks to

demonstrate that it satisfies the

requirements of § 823(a) by showing

that: (1) Mallinckrodt is registered as a

bulk manufacturer of numerous

Schedule II controlled substances; (2)

Mallinckrodt has been a bulk

manufacturer of narcotics for more than

ninety-five years; (3) Mallinckrodt has a

long history of successful controls

against diversion and is prepared to

apply that experience to its

Mallinckrodt production; (4)

Mallinckrodt has proven its

commitment to insuring that there is an

adequate and uninterrupted supply of

bulk narcotics; (5) Mallinckrodt has a

proven track record of promoting

technical advances in the field of bulk

narcotics manufacture; and (6)

Mallinckrodt has used its special status

as a registered manufacturer of narcotics

to promote public health and safety.

Dated: March 8, 1995.

Stephen H. Greene,

Deputy Administrator, Drug Enforcement

Administration.

[FR Doc. 95–6159 Filed 3–13–95; 8:45 am]

BILLING CODE 4410–09–M

Manufacturer of Controlled

Substances; Notice of Registration

By Notice dated January 17, 1995, and

published in the Federal Register on

January 25, 1995, (60 FR 4926), MD

Pharmaceutical, Inc., 3501 West Garry

Avenue, Santa Ana, California 92704,

made application to the Drug

Enforcement Administration (DEA) to

be registered as a bulk manufacturer of

the basic classes of controlled

substances listed below:

Drug Schedule

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

Diphenoxylate (9170) ................... II

No comments or objections have been

received. Therefore, pursuant to Section

303 of the Comprehensive Drug Abuse

Prevention and Control Act of 1970 and

Title 21, Code of Federal Regulations,

Section 1301.54(e), 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 classes of controlled

substances listed above is granted.

Dated: March 8, 1995.

Gene R. Haislip,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 95–6220 Filed 3–13–95; 8:45 am]

BILLING CODE 4410–09–M