30230 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Notices

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 01–3]

Penick Corp., Newark, New Jersey;

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

Penick Corporation (Penick) for

registration as an importer of the

Schedule II controlled substances coca

leaves, raw opium, poppy straw, and

poppy straw concentrate is published

pursuant to 21 CFR 1301.34(a). On

August 18, 200, notice was published in

the Federal Register, 65 FR 50568 (DEA

2000), stating that Penick has applied to

be registered as an importer of coca

leaves, raw opium, poppy straw, and

poppy straw concentrate.

Both Noramco of Delaware, Inc.

(Noramco), and Mallinckrodt, Inc.

(Mallinckrodt), timely filed comments

and objections to and requested a

hearing on Penick’s application.

Organichem Corporation (Organichem)

filed comments on Penick’s application.

Notice is hereby given that a hearing

with respect to Penick’s application to

be registered as an importer of raw

opium and of poppy straw concentrate

will be conducted pursuant to the

provisions of 21 U.S.C. 952(a) and 958

and 21 CFR 1301.34.

Hearing Date

The hearing will begin at 9:30 a.m. on

July 9, 2001, and will be held at the

Drug Enforcement Administration

Headquarters, 600 Army Navy Drive,

Hearing Room, Room E–2103,

Arlington, Virginia. The hearing will be

closed to any person not involved in the

preparation or presentation of the case.

Notice of Appearance

Any person entitled to participate in

this hearing pursuant to 21 CFR

1301.34, and desiring to do so, may

participate by filing a notice of intention

to participate, in triplicate, and in

accordance with 21 CFR 1301.34, with

the Hearing Clerk, Office of

Administrative Law Judges, Drug

Enforcement Administration,

Washington, DC 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. Penick,

Noramco, Mallinckrodt, and DEA Office

of Chief Counsel need not file a notice

of intention to participate.

FOR FURTHER INFORMATION CONTACT:

Helen Farmer, Hearing Clerk, Drug

Enforcement Administration, Office of

Administrative Law Judges,

Washington, DC 20537; Telephone (202)

307–8188.

Summary of Comments and Objections

Mallinckrodt’s Comments

Mallinckrodt states that Penick has

not manufactured controlled substances

for the last ten years and is now owned

by a company with no experience in

controlled substance manufacturing or

importation, that consequently Penick

would likely be wasteful in

manufacturing opiate based products,

and that the ability of current registrants

to provide and maintain an adequate

and uninterrupted supply of controlled

substances would be undermined.

Mallinckrodt contends that it, unlike

Penick, has taken significant efforts to

maintain adequate and uninterrupted

supplies of active pharmaceutical

ingredients.

Mallinckrodt further asserts that the

United States is obligated to limit the

international shipment of narcotics to

the minimum to meet medical and

scientific needs, and that inasmuch as

the current registrants can adequately

supply those needs, it is inconsistent

with the United States’ treaty

obligations under the Single Convention

on Narcotic Drugs to register Penick to

import raw opium and poppy straw

concentrate.

Mallinckrodt also states that Penick

has a history of ‘‘marginal compliance’’

with DEA regulations, and that if it

resumes manufacturing controlled

substances it will be unable to comply

with Environmental Protection Agency

and Food and Drug Administration

requirements. Mallinckrodt contends

that competition among domestic

manufacturers is adequate, that

registering Penick will not enhance

competition, and that any difference

between domestic and foreign prices of

relevant substances reflects the

regulations and policies faced by

domestic producers. Finally,

Mallinckrodt states that Penick’s lack of

adequate manufacturing facilities

indicates that it is not capable of

maintaining effective controls against

diversion.

Noramco’s Comments

Noramco asserts that because Penick

has not produced significant quantities

of bulk narcotic substances since 1991,

it will be difficult for Penick to produce

these materials as efficiently as existing

registrants, thereby aggravating the longterm shortage of narcotics raw materials.

Noramco also states that existing

manufacturers of bulk narcotic

substances are producing an adequate

and uninterrupted supply under

adequately competitive conditions, that

Penick’s troubled financial history

raises concerns regarding its ability to

manufacture narcotic substances in a

manner consistent with the public

interest, and that Penick will have to

demonstrate that it can effectively

control diversion. Additionally,

Noramco asserts that Penick’s

management intends to fund the

business with a sum that is inadequate

to the task of starting and maintaining

a viable narcotic raw material import

and bulk manufacturing business.

Organichem’s Comments

Organichem states that Penick’s

financial difficulties have prevented it

from heretofore operating successfully,

that it should be required to comply

with current DEA security requirements,

and that it should also be required to

demonstrate that it can meet current

Food and Drug Administration,

environmental, and international

standards.

Organichem further asserts that

Penick should be required to

demonstrate that it has the financial

resources necessary to finance

production and a business plan

adequate to establish and maintain a

profitable business.

Dated: May 29, 2001.

Donnie R. Marshall,

Administrator, Drug Enforcement

Administration.

[FR Doc. 01–14114 Filed 6–4–01; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF LABOR

Employment and Training

Administration

ETA–9016 Report on Alien Claimant

Activity; Comment Request

ACTION: Notice; request for comments

SUMMARY: The Department of Labor, as

part of its continuing effort to reduce

paperwork and respondent burden,

conducts a preclearance consultation

program to provide the general public

and Federal agencies with an

opportunity to comment on proposed

and/or continuing collections of

information in accordance with a

provision of the Paperwork Reduction

Act of 1995 at 44 U.S.C. 3506(c)(2)(A).

This program helps to ensure that

requested data can be provided in the

desired format, reporting burdens (time

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Notices 30231

and financial resources) are minimized,

collection instruments are clearly

understood, and the impact of collection

requirements on respondents can be

properly assessed. Currently, the

Employment and Training

Administration is soliciting comments

concerning the proposed revision/

extention for collection of the ETA–

9016 Report on Alien Claimant Activity.

A copy of the proposed information

collection request can be obtained by

contacting the office listed below in the

addressee section of this notice.

DATES: Written comments must be

submitted to the office listed in the

addressee’s section below on or before

August 6, 2001.

ADDRESSES: Office of Workforce

Security, Employment and Training

Administration, U.S. Department of

Labor, Attn: Bob Whiting, Room S–

4522, 200 Constitution Avenue NW,

Washington, DC 20210. Telephone

number: (202) 693–3215 (this is not a

toll-free number). Fax: (202) 693–3229.

E-mail: rwhiting@doleta.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The ETA–9016 Report is used by the

Department of Labor to assess whether

(and the extent to which) the

requirements of the Immigration and

Naturalization Service (INS), Systematic

Alien Verification for Entitlement

(SAVE) system are cost-effective and

otherwise appropriate for the

Unemployment Insurance (UI) program.

In addition, data from the Alien Claims

Activity report is being used to assist

the Secretary of Labor in determining

whether a State Employment Security

Agency’s administrative costs associated

with the verification program are

reasonable and reimbursable. There is

no other report or system available for

collecting this required information.

The report allows the Department of

Labor to determine the number of aliens

filing for UI, the number of benefit

issues detected, the denials of benefits

to aliens, the extent to which State

Agencies use the system, and the overall

effectiveness and cost efficiency of the

verification system. If SESAs are not

required to submit the information on

the Alien Claims Activity Report, the

Department of Labor would not be able

to fulfill its responsibilities to assess the

SAVE system.

II. Review Focus

The Department of Labor is

particularly interested in comments

which:

• Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility;

• Evaluate the accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used;

• Enhance the quality, utility, and

clarity of the information to be

collected; and

• Minimize the burden of the

collection of information on those who

are to respond, including through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology,

e.g., permitting electronic submissions

of responses.

III. Current Actions

In the year 2000, over 1.172 million

UI claimants were identified by the

SESAs as aliens, constituting almost

eight percent of UI claims taken in the

nation. Continued collection of the

ETA–9016 data will provide for a

comprehensive evaluation of alien

claims activity. The data is collected

quarterly, and an analysis of the data is

made for each one-year period. The

most recent analysis identified concerns

with the consistency of the

interpretation of the reporting

instructions among the SESAs, each of

whom must apply the instructions to

claimstaking procedures that vary

significantly. In order to encourage more

consistency in the reporting by the

SESAs, changes are being proposed that

will simplify the reporting and decrease

the burden.

Currently, seven items are reported on

the ETA–9016 Report:

1. Initial claims where claimant is not

a citizen.

2. Number of claimants verified

through the INS designated automated

system.

3. Number of secondary (mail)

verifications through the INS.

4. Nonmonetary determinations

resulting from the verification in items

number 2 and/or 3.

5. Denials resulting from issues in

item number 4.

6. Nonmonetary determinations on

the alien issue not a result of

verification through the INS designated

automated system or secondary INS

verification.

7. Denials resulting from issues in

item number 6. ETA proposes to

consolidate items 4–7 into two items as

follows:

• Nonmonetary determinations on the

alien issue.

• Denials resulting from the

nonmonetary determinations on the

alien issue.

The effectiveness of the SAVE

verification process is well established.

For the year 2000, it is estimated that

over $24 million was realized by

identifying and denying benefits to

ineligible aliens through the SAVE

process. The total savings for the past 10

years is estimated at over $100 million.

Thus, it is no longer deemed necessary

to justify use of the SAVE process on a

national basis.

Consolidation of the reporting items

on nonmonetary determinations will

eliminate the distinction between issues

detected through the SAVE process and

issues detected through other means, as

will consolidation of the reporting items

on denials. The Department of Labor

believes that this will simplify the

reporting process by reducing the

burden, with no corresponding loss of

the Department of Labor’s ability to

evaluate the effectiveness and cost

efficiency of the SAVE process in the

individual SESAs.

Type of Review: Revision.

Agency: Employment and Training

Administration.

Title: Alien Claims Activity Report.

OMB Number: 1205–0268.

Agency Number: ETA–9016.

Affected Public: State Governments.

Total Respondents: 53 State Agencies.

Frequency: Quarterly.

Total Responses: 212.

Average Time per Response: 1 hour.

Estimated Total Burden Hours: 212

hours.

Total Burden Cost (capital/startup):

$10,200 which is a one time cost of

reprogramming the State systems.

Total Burden Cost (operating/

maintaining): $5300 which is allowable

cost under the administrative grants

awarded to States by the Federal

government.

Comments submitted in response to

this comment request will be

summarized and/or included in the

request for Office of Management and

Budget approval of the information

collection request; they will also

become a matter of public record.

Dated: May 29, 2001.

Cheryl Atkinson,

Director, Office of Income Support.

[FR Doc. 01–14096 Filed 6–4–01; 8:45 am]

BILLING CODE 4510–30–P