57622 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices

The remifentanil is being imported for

the production of Ultiva dosage forms

and for research and new product

development.

Any manufacturer holding, or

applying for, registration as a bulk

manufacturer of this basic class of

controlled substance may file written

comments on or objections to the

application described above and may, at

the same time, file a written request for

a hearing on such application in

accordance with 21 CFR 1301.43 in

such form as prescribed by 21 CFR

1316.47.

Any such comments, objections, or

requests for a hearing 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 (CCR), and must be filed

no later than October 25, 2000.

This procedure is to be conducted

simultaneously with and independent

of the procedures described in 21 CFR

1301.34(b), (c), (d), (e), and (f). As noted

in a previous notice at 40 FR 43745–46

(September 23, 1975), all applicants for

registration to import basic class of any

controlled substance in Schedule I or II

are and will continue to be required to

demonstrate to the Deputy Assistant

Administrator, Office of Diversion

Control, Drug Enforcement

Administration that the requirements

for such registration pursuant to 21

U.S.C. 958(a), 21 U.S.C. 823(a), and 21

CFR 1301.34(a), (b), (c), (d), (e), and (f)

are satisfied.

Dated: September 1, 2000.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 00–24557 Filed 9–22–00; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer of Controlled

Substances; Notice of Registration

By Notice dated April 21, 2000, and

published in the Federal Registeron

April 28, 2000, (65 FR 24986), Lonza

Riverside, 900 River Road,

Conshohocken, Pennsylvania 19428,

made application by letter to the Drug

Enforcement Administration (DEA) to

be registered ax a bulk manufacturer of

gamma hydroxybutyric acid (2010), a

basic class of controlled substance listed

in Schedule I.

The firm plans to bulk manufacture

gamma hydroxybutyric acid for

distribution to its customers.

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 Lonza Riverside to

manufacture the listed controlled

substances is consistent with the public

interest at this time. DEA has

investigated Lonza Riverside on a

regular basis to ensure that the

company’s continued registration is

consistent with the public interest.

These investigations have included

inspection and testing of the company’s

physical security systems, audits of the

company’s records, 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 28 CFR 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: September 1, 2000.

John H. King,

Deputy, Assistant Administrator, Office of

Diversion Control Drug Enforcement

Administration.

[FR Doc. 00–24561 Filed 9–22–00; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Importation of Controlled Substances;

Notice of Application

Pursuant to Section 1008 of the

Controlled Substances Import and

Export Act (21 U.S.C. 958(i)), the

Attorney General shall, prior to issuing

a registration under this Section to a

bulk manufacturer of a controlled

substance in Schedule I or II and prior

to issuing a regulation under Section

1002(a) authorizing the importation of

such a substance, provide

manufacturers holding registrations for

the bulk manufacture of the substance

an opportunity for a hearing.

Therefore, in accordance with Section

1301.34 of Title 21, Code of Federal

Regulations (CFR), notice is hereby

given that on March 17, 2000, Noramco

Inc., 1440 Olympic Drive, Athens,

Georgia 30601, made application to the

Drug Enforcement Administration to be

registered as an importer of the basic

classes of controlled substances listed

below:

Drug Schedule

Phenylacetone (8501) ................ II

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

The firm plans to import

phenylacetone for the production of

amphetamine and fentanyl for seed

material for the manufacture of fentanyl

base.

Any manufacturer holding, or

applying for, registration as a bulk

manufacturer of these basic classes of

controlled substances may file written

comments on or objections to the

application described above and may, at

the same time, file a written request for

a hearing on such application in

accordance with 21 CFR 1301.43 in

such form as prescribed by 21 CFR

1316.47.

Any such comments, objections, or

requests for a hearing 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 (CCR), and must be filed

no later than October 25, 2000.

This procedure is to be conducted

simultaneously with and independent

of the procedures described in 21 CFR

1301.34 (b), (c), (d), (e), and (f). As noted

in a previous notice at 40 FR 43745–46

(September 23, 1975), all applicants for

registration to import basic class of any

controlled substance in Schedule I or II

are and will continue to be required to

demonstrate to the Deputy Assistant

Administrator, Office of Diversion

Control, Drug Enforcement

Administration that the requirements

for such registration pursuant to 21

U.S.C. 958(a), 21 U.S.C. 823(a), and 21

CFR 1311.42 (a), (b), (c), (d), (e), and (f)

are satisfied.

Dated: September 5, 2000.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 00–24555 Filed 9–22–00; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer of Controlled

Substances; Notice of Application

Pursuant to Section 1301.33(a) of Title

21 of the Code of Federal Regulations

(CFR), this is notice that on July 28,