26050 Federal Register / Vol. 60, No. 94 / Tuesday, May 16, 1995 / Notices

advise the Commissioner of the Immigration

and Naturalization Service on issues related

to the performance of airport and seaport

immigration inspectional services. This

advice should include, but need not be

limited to, the time period during which

such services should be performed, the

proper number and deployment of inspection

officers, the level of fees, and the

appropriateness of any proposed fee. These

responsibilities are related to the assessment

of an immigration user fee pursuant to

section 286(d) of the Immigration and

Nationality Act, as amended, 8 U.S.C.

1356(d). The Committee focuses attention on

those areas of most concern and benefit to the

travel industry, the traveling public, and the

Federal government.

Agenda

1. Introduction of the Committee members.

2. Discussion of administrative issues.

3. Discussion of activities since last meeting.

4. Discussion of specific concerns and

questions of Committee members.

5. Discussion of future traffic trends.

6. Discussion of relevant written statements

submitted in advance by members of the

public.

7. Scheduling of next meeting.

Public Participation

The meeting is open to the public, but

advance notice of attendance is requested to

ensure adequate seating. Persons planning to

attend should notify the contact person at

least two (2) days prior to the meeting.

Members of the public may submit written

statements at any time before or after the

meeting to the contact person for

consideration by this Advisory Committee.

Only written statements received at least five

(5) days prior to the meeting by the contact

person will be considered for discussion at

the meeting.

Contact Person

Elaine Schaming, Office of the Assistant

Commissioner, Inspections, Immigration and

Naturalization Service, room 7223, 425 I

Street, NW., Washington, DC 20536,

telephone number (202) 514–9587 or fax

number 202–514–8345.

Dated: May 10, 1995.

Doris Meissner,

Commissioner, Immigration and

Naturalization Service.

[FR Doc. 95–11969 Filed 5–15–95; 8:45 am]

BILLING CODE 4410–10–M

Drug Enforcement Administration

[Docket No. 93–18]

Johnson Matthey, Inc.; Approval of

Registration

On September 14, 1992, Johnson

Matthey, Inc. of West Deptford, New

Jersey (Johnson Matthey) applied for

registration under 21 U.S.C. 823(a) with

the Drug Enforcement Administration

(DEA) as a bulk manufacturer of

methylphenidate, a Schedule II

controlled substance. Notice of Johnson

Matthey’s application was published in

the Federal Register on November 13,

1992 (57 FR 53935). On December 11,

1992, MD Pharmaceutical, Inc. of Santa

Ana, California (MD), a registered bulk

manufacturer of methylphenidate,

objected to the proposed registration

and filed a request for a hearing on

Johnson Matthey’s application pursuant

to 21 CFR 1301.43(a).

The matter was docketed before

Administrative Law Judge Mary Ellen

Bittner. On July 27, 1993, Judge Bittner

issued a memorandum, ruling and

protective order designating as

‘‘confidential and protected’’ certain

exhibits, as well as the identification of

certain witnesses. Following extensive

prehearing proceedings, a hearing was

held in Arlington, Virginia on August

10, 11, 12, and 20 and September 28,

1993. Johnson Matthey, MD, the

Government and a third party research

partner of Johnson Matthey introduced

testimony and documentary evidence.

During opening statements, the

Government stated the DEA, at that

time, had no information upon which to

base a decision that the application of

Johnson Matthey for registration as a

bulk manufacturer of methylphnidate

should not be approved.

On September 29, 1994 the

administrative law judge issued her

opinion and recommended ruling,

findings of fact, conclusions of law and

decision, as well as an order allowing

all parties to submit motions to redact

confidential and protected information

from the opinion pursuant to the terms

of the July 27, 1993 protective order. A

redacted opinion was issued on

November 1, 1994. Exceptions to the

opinion were filed by MD, Johnson

Matthey and the Government.

The administrative law judge

transmitted the record of the

proceedings to the Deputy

Administrator on November 30, 1994.

Portions of the transcript and certain

exhibits were designated confidential

and protected pursuant to the protective

order. Additionally, the Deputy

Administrator received redacted

versions of the opinion and such

motions, briefs, exceptions and other

pleadings subject to the protective

order. On January 10, 1995, MD filled

with the Deputy Administrator a

response to the Government’s

exceptions to the opinion of the

administrative law judge.

The Deputy Administrator has

carefully considered the record in this

matter in its entirety, as well as all

exceptions thereto. Pursuant to 21 CFR

1301.57, the Deputy Administrator

hereby issues his final order in this

matter based upon findings of fact and

conclusions of law as set forth herein.

The administrative law judge made

the following findings of fact as

background for her opinion.

Methylphenidate, a central nervous

system stimulant, is a Schedule II

controlled substance. There currently

are two DEA registered bulk

manufacturers of methylphenidate:

CIBA Pharmaceutical Company (CIBA),

which manufactures methylphenidate

under its brand name ‘‘Ritalin’’; and

MD, which manufactures a generic form

of methylphenidate. Johnson Matthey

produces some bulk pharmaceuticals

and is a major manufacturer of

platinum-based anti-cancer drugs. The

principal controlled substance

manufactured by Johnson Matthey is

fentanyl, a Schedule II controlled

substance.

The administrative law judge found

that Johnson Matthey applied for

registration as a researcher and bulk

manufacturer of methylphenidate in

1989. The researcher registration was

issued by DEA on January 26, 1990.

Johnson Matthey withdrew its

application for registration as a bulk

manufacturer of methylphenidate

following the filing of an objection by

CIBA.

The administrative law judge referred

to testimony that, in the fall of 1990,

Johnson Matthey began initial studies

on methylphenidate. In November of

1990, Johnson Matthey applied for a

researcher registration for

methylphenidate, but did not apply for

a registration to manufacture it. Judge

Bitter noted testimony by Johnson

Matthey’s compliance and regulatory

manager that he was advised by DEA

that Johnson Matthey’s application for

registration as a researcher had been

processed and that drug codes did not

have to be reported on the application

unless Johnson Matthey intended to

import or manufacture Schedule II

controlled substances as a coincident

activity of its researcher registration.

The administrative law judge noted

evidence that Johnson Matthey

responded, by letter dated January 30,

1991, advising DEA that Johnson

Matthey does manufacture on a research

basis and therefore must be registered.

She further noted that the letter did not

indicate how much methylphenidate

Johnson Matthey had manufactured or

intended to manufacture in the future.

The administrative law judge noted

testimony that, in 1991, Johnson

Matthey discussed with a third party

research partner the possibility of

Johnson Matthey manufacturing bulk

methylphenidate for the third party to

market and, if Johnson Matthey
Federal Register / Vol. 60, No. 94 / Tuesday, May 16, 1995 / Notices 26051

obtained the requisite approvals to

manufacture methylphenidate, the third

party would purchase Johnson

Matthey’s output. She further noted

that, in August 1991, DEA, in response

to Johnson Matthey’s request to

manufacture methylphenidate

coincidental to its researcher

registration, authorized Johnson

Matthey to produce 0.1 kg of

methylphenidate for use by the third

party in its product development. At

this time, DEA also authorized the third

party to procure methylphenidate from

Johnson Matthey, although DEA did not

know at the time if Johnson Matthey

had, in fact, produced and

methylphenidate yet.

Judge Bittner found that, in November

1991, Johnson Matthey applied for both

re-registration as a researcher and

additionally applied for registration as a

bulk manufacturer of methylphenidate.

She further noted testimony by Johnson

Matthey that DEA, again, notified

Johnson Matthey that there was no need

to report drug codes unless

manufacturing would be a coincident

activity to its research activities.

The administrative law judge found

that, in April 1992, Johnson Matthey

made its first scale-up lot of

methylphenidate. Judge Bittner also

noted that Johnson Matthey shipped

methylphenidate to the third party

pursuant to DEA order forms. In May

1992, when Johnson Matthey received

the first order form from the third party,

Johnson Matthey realized that the third

party had put Johnson Matthey’s

fentanyl manufacturer registration

number on the form. Judge Bittner

found that it was uncontroverted that

the third party listing of that number

was improper both because the supplier,

rather than the purchaser, is required to

fill in the supplier’s registration number

and because, in any event, the form

should have shown Johnson Matthey’s

researcher registration number instead

of its fentanyl manufacturer number.

Johnson Matthey’s compliance and

regulatory affairs manager testified that

Johnson Matthey assumed that its 1992

application for registration as a

manufacturer for methylphenidate had

been approved because they had not

heard anything to the contrary.

Consequently, the compliance and

regulatory affairs manager wrote to DEA

requesting 1993 manufacturing quotas

for Johnson Matthey’s production of

fentanyl and methylphenidate. In

August 1992, Johnson Matthey received

a 1993 quota for fentanyl, but did not

receive any DEA quota for

methylphenidate. Following inquiries

by Johnson Matthey, DEA advised

Johnson Matthey that there was no

record of Johnson Matthey being

registered to manufacture

methylphenidate.

Judge Bittner noted testimony by DEA

maintaining that it had not been

advised, either orally or in writing, that

Johnson Matthey had manufactured 3.5

kg of methylphenidate under its

researcher registration in April 1992,

nor was it aware that Johnson Matthey

had been producing the quantity of

methylphenidate that it had actually

manufactured.

The administrative law judge also

noted that, on December 12, 1992, the

third party ordered another 500 grams of

methylphenidate from Johnson Matthey

who subsequently shipped 325 grams

on December 16, 1992. On December 30,

1992, Johnson Matthey shipped

approximately 7.8 kilograms to the third

party pursuant to its December 23, 1992

order for 8.0 kilograms. The

administrative law judge found that

there was no dispute that the third party

compensated Johnson Matthey for costs

incurred in the manufacturing of these

amounts of methylphenidate.

The administrative law judge referred

to 21 CFR 1301.22(b)(5) which allows a

researcher to manufacture controlled

substances for which it is registered to

conduct research ‘‘if and to the extent

that such manufacture is set forth in a

statement filed with the application for

registration . . .’’ Judge Bittner held that

it is undisputed that Johnson Matthey

did not file such a statement with DEA

for any of the applications for

registration as a researcher for

methylphenidate discussed throughout

the course of this proceeding.

As a threshold matter, the

administrative law judge first addressed

the complicated issue of allocation of

the burden of proof. Title 21 U.S.C.

823(a) provides that the Deputy

Administrator shall register an applicant

to manufacture controlled substances in

Schedules I and II upon a determination

that such registration is consistent with

the public interest. Before taking action

to deny any such application for

registration, the Deputy Administrator,

in accordance with 21 U.S.C. 824(c),

shall provide the applicant the

opportunity to be heard pursuant to an

order to show cause. Pursuant to 21 CFR

1301.43(a), a hearing on a proposed

application for registration as a

manufacturer also may be requested by

bulk manufacturers who are registered,

or have applied for registration, to

manufacture Schedule I or II controlled

substances. Title 21 CFR 1301.55(a)

specifically provides:

At any hearing on an application to

manufacture any controlled substance listed

in Schedule I or II, the applicant shall have

the burden of proving that the requirements

for such registration pursuant to * * * [21

U.S.C. 823(a)] are satisfied. Any other person

participating in the hearing pursuant to

1301.43 shall have the burden of proving any

propositions of fact or law asserted by him

in the hearing.

In keeping with the plain language of

21 CFR 1301.55(a), the administrative

law judge assigned the initial burden of

proof to Johnson Matthey, as the

applicant, to demonstrate by a

preponderance of credible evidence,

that its application for registration as a

bulk manufacturer of methylphenidate

met the statutory criteria. She also

found that MD and the Government had

the burden to show that the registration

of Johnson Matthey as a bulk

manufacturer nonetheless is not in the

public interest.

The administrative law judge further

asked the Deputy Administrator to

overrule the standard for allocating

burdens of proof elicited by

Administrative Law Judge Young in a

series of decisions starting with

McNeilab, Inc., 46 FR 22089 (1981).

Although not explicitly decided by the

then-Administrator, Judge Young’s

opinion in McNeilab was adopted by

the then-Administrator. In McNeilab

and its progeny, Judge Young construed

21 CFR 1301.55(a) as assigning the

burden of proof to the applicant seeking

registration as a Schedule II bulk

manufacturer only if an order to show

cause had been issued. In all other

situations, the applicant had the initial

burden to make a preliminary showing

to the agency that registration met the

public interest criteria, but had no

obligation at the hearing except to rebut

adverse evidence presented by third

parties.

In the present case, Judge Bittner’s

opinion noted that Judge Young’s

interpretation did not comport with the

plain language of 21 CFR 1301.55(a)

which specifically assigns the burden of

proof to the applicant at any hearing

concerning registration of a

manufacturer of Schedule I and

Schedule II controlled substances. Judge

Bittner also expressed concern that

McNeilab did not address the potential

problem where the Government does

not initially oppose the application but

nonetheless participates in the hearing.

In such a situation, if the Government

later concludes that the application

should be denied, a literal reading of 21

U.S.C. 824(c) would require the

subsequent issuance of a show cause

order and a second hearing pursuant to

that order. Beyond the hardship this

would impose on the applicant, an

issuance is raised as to whether the
26052 Federal Register / Vol. 60, No. 94 / Tuesday, May 16, 1995 / Notices

Government should be estopped from

introducing evidence at the second

hearing that it knew or should have

known existed at the time of the first

hearing.

In assigning the burden of proof in

this matter, Judge Bittner noted that

such assignment would promote

judicial economy by avoiding multiple

hearings. She stated that, although the

regulations provide that a hearing may

be requested either by an applicant in

response to an order to show cause, or

by a third party pursuant to 21 CFR

1301.43(a), the issue of the applicant’s

compliance with the statutory criteria

for registration as a manufacturer, as

well as any third party objections,

should be raised in a single hearing with

the applicant bearing the burden of

proof as to his or her compliance with

the statutory requirements. She

concluded that the language contained

in 21 U.S.C. 824(c) should be

interpreted as a notice provision rather

than a condition precedent to the denial

or revocation of a registration.

Judge Bittner concluded that the

burden is on Johnson Matthey to prove,

by a preponderance of the credible

evidence, that its application for

registration as a bulk manufacturer of

methylphenidate meets the public

interest criteria of 21 U.S.C. 823(a), and,

if so, whether any other party has

demonstrated, by a preponderance of

the credible evidence, that Johnson

Matthey’s registration, nonetheless,

would not be in the public interest.

In accordance with the provisions of

21 U.S.C. 823)a) the Deputy

Administrator shall register an applicant

to manufacture controlled substances in

Schedules I and II upon a determination

that such registration is consistent with

the public interest. The following

factors are to be considered in

determining whether registration is

consistent with the public interest:

(1) Maintenance of effective controls

against diversion of particular

controlled substances and any

controlled substance in schedule I or II

compounded therefrom into other than

legitimate medical, scientific, research,

or industrial channels, by limiting the

importation and bulk manufacture of

such controlled substances to a number

of establishments which can produce an

adequate and uninterrupted supply to

these substances under adequately

competitive conditions for legitimate

medical, scientific, research and

industrial purpose;

(2) Compliance with applicable State

and local law;

(3) Promotion of technical advances

in the art of manufacturing these

substances and the development of new

substances;

(4) Prior conviction record of

applicant under Federal and State laws

relating to the manufacture,

distribution, or dispensing of such

substances;

(5) Past experience in the manufacture

of controlled substances, and the

existence in the establishment of

effective control against diversion; and

(6) Such other factors as may be

relevant to and consistent with the

public health and safety. 21 U.S.C.

823(a).

It is well established that the Deputy

Administrator is not required to make

findings with respect to each of the

above-listed factors, but has discretion

to give each factor the weight he deems

appropriate, depending upon the facts

and circumstances in each case. See

Michael J. Schnitzer, M.D., 56 FR 67331

(1991).

The administrative law judge stated in

her opinion that Johnson Matthey and

MD had agreed that competition in the

methylphenidate market is not an issue

in this proceeding. Further, Judge

Bittner found that there is no dispute

concerning Johnson Matthey’s physical

security, nor whether Johnson Matthey

has complied with applicable state and

local law, that registration of Johnson

Matthey as a bulk manufacturer of

methylphenidate would promote

technical advances in manufacturing

controlled substances, nor whether

Johnson Matthey has any prior

convictions relating to the manufacture,

distribution or dispensing of controlled

substances. Therefore, the only public

interest factors which remain to be

considered in this matter are 21 U.S.C.

823(a) (1) and (5).

The administrative law judge found

that there is insufficient evidence in the

record to make any findings as to 21

U.S.C. 823(a)(1). Judge Bittner, referring

to the legislative history of the

Controlled Substances Act, concluded

that 21 U.S.C. 823(a)(1) contemplates

that the concern for diversion of

controlled substances would determine

the maximum number of manufacturers

to be registered and, similarly, that

concern for insuring an adequate and

uninterrupted supply of the same

substances would determine the

minimum number. However, in the

instant case, the administrative law

judge found that there is no evidence

that registering an additional bulk

manufacturer would increase the risk of

diversion, nor is there evidence that the

two bulk manufacturers currently

registered to manufacture

methylphenidate are incapable of

assuring an adequate supply of the drug.

With respect to 21 U.S.C. 823(a)(5),

the administrative law judge found that

there is no evidence of diversion of any

of the controlled substances, such as

fentanyl, that Johnson Matthey has

manufactured pursuant to its existing

manufacturer registration. Judge Bittner

specifically found that Johnson

Matthey’s successful past experience in

manufacturing fentanyl weighed in

favor of granting its application to

manufacture methylphenidate.

With respect to Johnson Matthey’s

experience producing methylphenidate,

the administrative law judge found that

Johnson Matthey’s history with regard

to compliance with DEA regulations is

much less satisfactory. On a number of

occasions, Johnson Matthey failed to file

a statement with DEA specifying how

much methylphenidate the company

intended to manufacture coincident to

its researcher registration, as required by

21 CFR 1301.32(e). Additionally, order

forms used to transfer methylphenidate

from Johnson Matthey to the third party

were altered to reflect Johnson

Matthey’s researcher registration

number instead of a manufacturer

registration number.

Judge Bittner further found that

Johnson Matthey’s principal witness

with respect to the company’s handling

of methylphenidate, its compliance and

regulatory affairs manager, was

unfamiliar with DEA regulations and

procedures and concluded that he was

not a particularly credible witness. She

additionally found that the record does

not establish that Johnson Matthey

advised any DEA official how much

methylphenidate it had manufactured or

that it intended to manufacture

coincidental to its researcher

registration.

The administrative law judge found

that the record did not provide support

for Johnson Matthey’s argument that

these incidents were merely technical

violations of DEA regulations and,

therefore, do not indicate that Johnson

Matthey’s registration as a bulk

manufacturer would be inconsistent

with the public interest. Johnson

Matthey further argued that DEA

officials were aware of its handling of

methylphenidate at all times and

approved of it.

Judge Bittner found that Johnson

Matthey’s refusal to acknowledge that it

had engaged in substantial misconduct

indicates that the responsible officials of

the company lacked not only

understanding of DEA’s regulatory

scheme, but respect for it. Further, by

not filing the requisite statement with

DEA and not otherwise advising DEA of

its intentions, Johnson Matthey was able

to manufacture significant quantities of
Federal Register / Vol. 60, No. 94 / Tuesday, May 16, 1995 / Notices 26053

methylphenidate while avoiding, not

only the regulatory restrictions on bulk

manufacturers, but also the scrutiny of

potential competitors. The

administrative law judge concluded that

sufficient grounds exist to deny Johnson

Matthey’s application.

Notwithstanding this finding, Judge

Bittner recommended that the Deputy

Administrator grant Johnson Matthey’s

application, subject to certain

requirements, because Johnson Matthey

has demonstrated that it had no relevant

prior convictions or history of

noncompliance with state and local law,

that its security systems are adequate to

handle methylphenidate, and that it has

a satisfactory history of handling other

controlled substances. Judge Bittner

additionally relied on her finding that

DEA’s own actions served to complicate

the issue by granting Johnson Matthey’s

application for a researcher registration

even though Johnson Matthey’s yearly

applications for researcher registration

clearly expressed the company’s intent

to manufacture methylphenidate but

were not accompanied by statements of

the quantity of methylphenidate the

company intended to manufacture.

Further, DEA had not published any

clarification of the permissible scope of

manufacturing under a researcher

registration, and that Johnson Matthey’s

conduct may already have resulted in

adverse consequences to that company

in view of the lengthy hearing and

consequent delay in achieving the

registration. Finally, Johnson Matthey’s

most recent application for renewal of

registration as a researcher, lists the

quantity of methylphenidate that the

company intends to manufacture,

indicating that Johnson Matthey may

have learned from the experience.

The administrative law judge

recommended that Johnson Matthey’s

application be granted subject to the

requirements that: (1) within 120 days

following issuance of its registration to

manufacture bulk methylphenidate,

Johnson Matthey provide, at its own

expense, training for its regulatory and

compliance affairs staff about DEA

regulations (the curriculum and number

of hours of such training to be approved

by the Deputy Assistant Administrator

of the Office of Diversion Control or his

designee); (2) until such time as Johnson

Matthey receives an individual

manufacturing quota to manufacture

methylphenidate pursuant to 21 CFR

1303.21, Johnson Matthey receive

permission from DEA’s office of Drug

and Chemical Evaluation in advance of

undertaking any manufacture of

methylphenidate; and (3) Johnson

Matthey limit such manufacture to a

quantity authorized in writing by the

Office of Drug and Chemical Evaluation

of DEA.

Johnson Matthey took exception to

the administrative law judge’s

conclusion that there is no evidence that

the two currently registered bulk

manufacturers of methylphenidate were

incapable of assuring an adequate

supply of methylphenidate. Johnson

Matthey argued that these two

producers cannot produce an adequate

and uninterrupted supply of

methylphenidate and, therefore, that the

market situation is not competitive.

Johnson Matthey also took exception to

Judge Bittner’s statements that the

record does not support Johnson

Matthey’s contention that DEA knew

that it was manufacturing

methylphenidate, arguing that the

record provides ample evidence of

DEA’s knowledge. Additionally,

Johnson Matthey took exception to the

administrative law judge’s conclusions

that Johnson Matthey’s record with

regard to methylphenidate presented a

‘‘history of evasion and/or outright

violations of DEA regulations,’’ arguing

that Johnson Matthey never deliberately

misled DEA and DEA has no written

public policy defining research and

quantities permitted to be manufactured

under a researcher registration. Johnson

Matthey also noted that it had hired a

new DEA coordinator who had already

attended training, that Johnson

Matthey’s training plan is broader in

scope than that recommended by the

administrative law judge, and that

Johnson Matthey already had presented

its curriculum to DEA for approval.

MD, while concurring with the

majority of the administrative law

judge’s findings of fact and conclusions

of law, took exception to Judge Bittner’s

recommendation to grant Johnson

Matthey’s registration subject to certain

restrictions. MD argued that Johnson

Matthey’s conduct and its part

experience in manufacturing controlled

substances, particularly

methylphenidate, are bases to deny

Johnson Matthey’s application. MD

argued that the administrative law

judge’s proposed restrictions are

inadequate and improperly reward

Johnson Matthey’s illegal activities.

Additionally, MD argued that the

instant proceeding is similar in many

respects to that of Alra Laboratories,

Inc., 59 FR 50620 (1994) wherein the

application for registration as a

manufacturer was denied by the Deputy

Administrator after the administrative

law judge recommended approval. MD

submitted that DEA registration of

Johnson Matthey would not be in the

public interest.

The Government took exception to the

administrative law judge’s finding that

‘‘once [a] hearing is requested [on an

application to manufacture controlled

substances under Schedule I or II], the

issue of the applicant’s compliance with

the statutory requirements and any

other issued raised by a third party

should be litigated in a single hearing.’’

The Government further objected to the

administrative law judge’s conclusion

that 21 U.S.C. 824(c), requiring that a

show cause proceeding be initiated

prior to the denial of such application,

is simply a ‘‘notice provision’’, stating

that the Government was not ware of

any situation in which the DEA did not

require the issuance of a show cause

order prior to denying an application for

registration. The Government concurred

with Judge Young’s conclusion in

McNeilab, that separate hearings could

be required for a third party request

under 21 CFR 1301.43, or under a show

cause order pursuant to 21 U.S.C. 824(c)

and 21 CFR 1301.44.

With regard to the allocation of

burdens of proof, the Deputy

Administrator concurs with, and hereby

adopts, Judge Bittner’s reliance on the

plain language of 21 CFR 1301.55(a)

which clearly assigns to the applicant

the burden to the applicant to prove the

statutory requirements for registration as

a manufacturers

The Deputy Administrator gave

favorable consideration to the

exceptions filed by Johnson Matthey,

but concurs with the administrative law

judge’s recommended restrictions

concerning the granting of Johnson

Matthey’s registration to manufacture

bulk methylphenidate.

The Deputy Administrator finds that

the exceptions filed by MD were fully

considered by the administrative law

judge. The Deputy administrator rejects

MD’s argument that the decision

rendered in Alra is applicable to the

present case because the facts at issue in

Alra are markedly different from those

in the present case. In Alra, the denial

of its application as a manufacturer of

controlled substances followed findings

of numerous recordkeeping violations, a

failure to ensure proper security, failure

to ensure proper DEA registration as a

manufacturer, illegal possession and

distribution of controlled substances

and a lengthy history of Food, Drug &

Cosmetic Act violations with respect to

the manufacture and distribution of

prescription drugs. Further, Alra twice

had been the subject of seizure of its

product, and its president consistently

demonstrated that he had not taken his

responsibilities concerning controlled

substances seriously. Contrary to Alra,

Johnson Matthey has an history of
26054 Federal Register / Vol. 60, No. 94 / Tuesday, May 16, 1995 / Notices

responsible manufacture of controlled

substances in accordance with its

previous manufacturing registration.

Additionally, Johnson Matthey has

addressed and corrected prior regulatory

discrepancies in a timely manner,

demonstrating the commitment required

of a DEA registrant.

Finally, concerning the administrative

law judge’s recommendation with

respect to duplicative mandated hearing

provisions, the Deputy Administrator

disagrees with Judge Bittner’s

conclusion in this proceeding that the

requirement of an order to show cause,

pursuant to 21 U.S.C. 824(c), comprises

simply a ‘‘notice provision.’’ Rather, the

Deputy Administrator finds that, as

currently written, the statute mandates

that the Government issue an order to

show cause whenever it seeks to deny

or revoke a DEA Certificate of

Registration. The Deputy Administrator

acknowledges that, in some cases, this

may subject an applicant to multiple

hearings. however, whether the

Government would be estopped from

raising issues at a show cause hearing

subsequent to a ‘‘third-party hearing’’

would depend on whether the issues

were actually litigated and determined.

In any event, this decision could only be

determined on a case-by-case basis. The

Deputy Administrator also notes, as

provided in the regulations, that

hearings conducted pursuant to an order

to show cause may be consolidated with

a hearing requested by a third-party. 21

CFR 1301.43(a). The Deputy

Administrator encourages that parties to

these type of proceedings consolidate

these hearings whenever possible.

The Deputy Administrator hereby

adopts the administrative law judge’s

findings of fact and conclusions of law,

except as previously noted.

Accordingly, the Deputy Administrator

of the Drugs Enforcement

Administration, pursuant to the

authority vested in him by 21 U.S.C. 823

and 824 and 28 CFR 0.100(b) and 0.104,

hereby orders that the application of

Johnson Matthey, Inc. for registration as

a bulk manufacturer of

methylphenidate, be, and it hereby is,

approved subject to the requirements

enumerated by the administrative law

judge.

Dated: May 8, 1995.

Stephen H. Greene,

Deputy Administrator.

[FR Doc. 95–11934 Filed 5–15–95; 8:45 am]

BILLING CODE 4410–09–M

MARTIN LUTHER KING, JR. FEDERAL

HOLIDAY COMMISSION

Meeting

AGENCY: Martin Luther King, Jr. Federal

Holiday Commission.

ACTION: Notice of meeting.

SUMMARY: In accordance with the

Federal Advisory Act, Public Law 92–

463, as amended, the Martin Luther

King, Jr. Federal Holiday Commission

announces a forthcoming meeting of the

Commission.

DATE: May 23, 1995.

TIME: 12:30 p.m.–3:30 p.m.

LOCATION: U.S. House of

Representatives, O’Neill Building,

House Annex 1, Room 116, Washington,

D.C. The public is invited.

FOR FURTHER INFORMATION CONTACT:

Valerie Pinkney, Executive Officer,

Washington Office (202) 708–1005.

Dated: May 10, 1995.

Valerie Pinkney,

Executive Officer.

[FR Doc. 94–12021 Filed 5–15–94; 8:45 am]

BILLING CODE 4210–01–M

NATIONAL FOUNDATION ON THE

ARTS AND THE HUMANITIES

Institute of Museum Services

Information Collection Submitted to

OMB for Review

AGENCY: Institute of Museum Services.

ACTION: Notice of information submitted

to OMB for review.

SUMMARY: The Institute of Museum

Services (IMS) is submitting an

information collection for review by the

Office of Management and Budget under

the Paperwork Reduction Act. The

collection is entitled ‘‘US. Museums on

the Internet 1995—A Survey for the

Institute of Museum Services.’’ IMS has

requested that review be completed by

May 19, 1995.

IMS recently established a connection

to the Internet. We would like to

enhance our service to the museum

community by providing IMS

information through the Internet.

Currently, no body of data exists to

determine how many museums have

Internet connections or, if they do, what

level of service museums have.

Therefore, we propose to survey the

museum community on a voluntaryresponse basis with a brief

questionnaire to ask museums to give us

the information we need to know to be

able to provide information most

efficiently. IMS distribution plan for the

survey will assure a broad collection of

data. A statistical analysis is not

warranted due to the cost of such

analysis and the limited usefulness of

this data collect which, due to the

rapidly changing use of the Internet,

will become obsolete.

For this collection, the estimated

average burden hours is .05 and the

frequency of response is once. The

number of respondents is 1000.

ADDRESSES: Submit comments to Mr.

Dan Chenok, Office of Information and

Regulatory Affairs, Office of

Management and Budget, Room 3002

NEOB, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Submit requests for more information,

including copies of the proposed

collection of information and

supporting documentation, to IMS

Internet Policy Committee, Institute of

Museum Services, Room 609, 1100

Pennsylvania Ave., NW., Washington,

DC 20506.

Diane Frankel,

Director, Institute of Museum Services.

[FR Doc. 95–11953 Filed 5–15–95; 8:45 am]

BILLING CODE 7036–01–M

NUCLEAR REGULATORY

COMMISSION

[Docket No. 999–90004 Texas License No.

L04153 EA 95–007]

IHS Geotech & CMT, Inc., San Antonio,

Texas; Order Imposing Civil Monetary

Penalty

I

IHS Geotech & CMT, Inc., (Licensee)

is the holder of Texas Radioactive

Material License L04153 issued by the

Texas Bureau of Radiation Control. The

license authorizes the Licensee to

possess and use sealed sources of

various radioisotopes in moisture/

density gauges at temporary job sites

throughout Texas, except in areas under

exclusive federal jurisdiction. In areas of

exclusive federal jurisdiction, these

activities can only be conducted

pursuant to an NRC specific or general

license.

II

An inspection of the Licensee’s

activities in areas under exclusive

federal jurisdiction, i.e., certain military

installations located in Texas, was

conducted December 16, 1994 to

January 12, 1995. The results of this

inspection indicated that the Licensee

had not conducted its activities in full

compliance with NRC requirements. A

written Notice of Violation and