67962 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

10However, as noted earlier, for the limited 

purpose of interpreting the term ‘‘listed chemical’’

as it appears in section 971(c)(1) and the policy 

implications of the alternatives, the findings and 

conclusions contained in the above cited cases are 

considered relevant to DEA’s application of the 

agency’s current knowledge and expertise.

chemical products through the gray 

market and in particular, through 

independent convenience stores. In 

Mediplas, my predecessor discounted 

the probative weight of the 

Government’s ‘‘anecdotal’’ evidence 

‘‘without some form of further extrinsic 

evidence to support these arguments.’’

Mediplas, supra, 67 FR at 41,264. In 

sustaining the shipments in the initial 

final order here, my predecessor noted 

the evidence in PDK’s hearing was 

‘‘essentially identical’’ to the evidence 

in Mediplas. Accordingly, he applied 

the same rule and declined to find that 

the Government’s evidence of PDK’s 

gray market distribution chain 

supported the suspension orders. See, 

e.g., Indace/Malladi, supra, 67 FR at 

77808. 

In Branex, Incorporated, supra, 69 FR 

at 8696 while then-Acting Deputy 

Administrator, I approve use of the 

above Mediplas evidentiary standard:

In deference to my predecessor’s ruling in 

[Mediplas], a finding regarding convenience 

stores [as] conduits for the diversion of listed 

chemicals does not necessarily translate to a 

finding regarding the existence of the socalled ‘traditional’ versus ‘non-traditional’

markets for products containing ephedrine 

and pseudoephedrine. Rather, in Mediplas, 

the then-Deputy Administrator found there 

was little probative value to such evidence, 

and the probative weight of evidence 

regarding traditional and non-traditional 

markets is ‘minimal without some form of 

further extrinsic evidence to support these 

arguments [Citation].’ The Acting Deputy 

Administrator notes further, my 

predecessor’s conclusion that a registrant’s 

sale of large quantities of list I chemicals do 

not, in and of themselves, demonstrate that 

the chemicals may be diverted.

Branex, supra, 69 FR at 8693. 

However, at the Branex hearing the 

Government did introduce substantial 

extrinsic evidence satisfying the 

Mediplas standard. In that regard, I 

held:

The Acting Deputy Administrator concurs 

with Judge Bittner’s conclusion that the 

government met the Mediplas evidentiary 

requirement by showing that Respondent 

sold pseudoephedrine to customers that did 

not have a reasonable expectation of being 

able to resell the product to a legitimate 

customer base. Specifically, the Government 

presented a relevant comparison analysis 

involving the marketing and sale of bottled 

pseudoephedrine products to a relatively 

small market by OTC Distribution (a supplier 

of listed chemicals to Respondent) versus 

that of nationally recognized pharmaceutical 

manufacturers and distributors of those 

products (i.e., Pfizer and the L. Perrigo 

Company). The Acting Deputy Administrator 

also finds telling, the testimony of Pfizer and 

Perrigo representatives that neither were 

aware of OTC Distribution as a possible 

competitor. More persuasive however, was 

the testimony and documentary evidence 

prepared by the Government expert in 

statistical analysis, Jonathan Robbin. * * *

[T]he Acting Deputy Administrator . . . 

finds compelling Mr. Robbin’s conclusion of 

the unlikelihood that convenience stores 

would sell more than $27.00 worth of 

pseudoephedrine per month to consumers 

purchasing decongestant products, as 

purportedly sold by Respondent’s customers. 

The Acting Deputy Administrator further 

credits Mr. Robbin’s finding regarding the 

inconceivability of customers purchasing a 

year’s supply of list I chemical products from 

convenience stores and related 

establishments on a monthly basis. 

The Acting Deputy Administrator also 

finds persuasive the conclusion of Mr. 

Robbin that the pseudoephedrine products 

supplied by Respondents to its customers did 

not follow the normal channel of distribution 

of goods of this kind. This finding is given 

further credence when one considers the 

quantities of pseudoephedrine the 

respondent sold to its convenience store 

customers and the exorbitant price some of 

these customers were willing to pay the 

Respondent for those products. The Acting 

Deputy Administrator finds that the 

compelling nature of Mr. Robbin’s market 

study casts doubt on the legitimacy of the 

Respondent’s customers, and brings some 

context to the diversion of the respondent’s 

listed chemical product.

Branex, supra, 69 FR at 8,693; see e.g., 

Xtreme Enterprises, Inc, supra, 67 FR at 

76,197 (denying registration as a listed 

chemical distributor after testimony by 

Mr. Robbin on graymarket and holding 

that applicant’s positive factors were 

‘‘far outweighed’’ by lack of experience 

and ‘‘the fact that she intends to sell 

ephedrine almost exclusively in the gray 

market.’’). See also Value Wholesale, 69 

FR 58,548 (2004) (citing Xtreme 

Enterprises, Inc. and denying 

registration inpart on intent to distribute 

to grey market); K & Z Enterprises, Inc., 

69 FR 51475 (2004) (same); William E. 

‘‘Bill’’ Smith d/b/a B&B Wholesale, 69 

FR 22559 (2004) (same); John E. McCrae 

d/b/a J & H Wholesale, 69 FR 51480 

(2004) (same); SPA Dynamic 

Wholesalers, 68 FR 61466 (2003) (citing 

Robbin study and denying registration 

as distributor to grey market). 

While DEA has concluded in the 

above series of cases that grey market 

establishments, such as convenience 

stores and gas stations, constitute 

sources for the diversion of listed 

chemical products and can form the 

basis for adverse action against 

registrants and potential registrants, the 

Government’s evidence which formed 

the basis for those holdings was not 

presented at PDK’s hearing. Thus, PDK 

has not had an opportunity to refute or 

contest that evidence and it is outside 

the record. 

Accordingly, the Deputy 

Administrator will continue to apply 

the Mediplas evidentiary standard to the 

instant record and declines to find that 

the vidence concerning the gray market 

introduced in this specific case supports 

a factual finding that the listed 

chemicals which are the subject of the 

two suspension orders ‘‘may be 

diverted.’’10

In arriving at this decision, the 

Deputy Administrator has considered 

PDK’s stature and business activities in 

the business community, its efforts at 

compliance, as well as the evidence 

available to DEA up to the time of the 

hearing. The Deputy Administrator 

finds that there was sufficient evidence 

at the time of the hearing to support 

DEA’s contention that the chemicals 

may be diverted. ‘‘As the Deputy 

Administrator has previously noted, 

[e]vidence of a violation of law is not 

necessary to demonstrate that 

suspensions were lawful.’’ Mediplas, 

supra, 67 FR at 41,262 citing 

Suspension of Shipments, supra, 65 FR 

at 51337. Therefore, the Deputy 

Administrator concludes that the 

suspensions set forth in the January 25 

and 26, 2001, Order to Suspend 

Shipments of ephedrine hydrochloride 

issued to Indace and Malladi were 

justified. 

Accordingly, the Deputy 

Administrator of the Drug Enforcement 

Administration, pursuant to the 

authority vested in her by 21 U.S.C. 971 

and 28 CFR 0.100(b) and 0.104, hereby 

orders that the suspensions of the above 

described shipments, be, and hereby 

are, sustained, and that these 

proceedings are hereby concluded. 

This final order is effective 

immediately.

Dated: November 9, 2004. 

Michele M. Leonhart, 

Deputy Administrator.

[FR Doc. 04–25695 Filed 11–19–04; 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 August 19, 

2004, ISP, Freetown Fine Chemicals, 

Inc., 238 South Main Street, Assonet, 

Massachusetts 02702, made application 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67963

by renewal to the Drug Enforcement 

Administration (DEA) for registration as 

a bulk manufacturer of the basic classes 

of controlled substances listed:

Drug Schedule 

2, 5–Dimethoxyamphetamine 

(7396).

I 

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

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

The company plans to manufacture 

phenylacetone to be used in the 

manufacture of the amphetamine. The 

bulk 2, 5–dimethoxyamphetamine will 

be used for conversion into noncontrolled substances. 

Any other such applicant and any 

person who is presently registered with 

DEA to manufacture such substance 

may file comments or objections to the 

issuance of the proposed registration 

pursuant to 21 CFR 1301.33(a). 

Any such comments or objections 

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, Office 

of Liaison and Policy (ODLR) and must 

be filed no later than January 21, 2005.

Dated: November 8, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–25767 Filed 11–19–04; 8:45 am] 

BILLING CODE 4410–09–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application 

Pursuant to 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 registration under 21 U.S.C. 

952(a)(2)(B) 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 21 CFR 

1301.34(a), this is notice that on August 

20, 2004, ISP Freetown Fine Chemicals, 

238 South Main Street, Assonet, 

Massachusetts 02702, made application 

by renewal to the Drug Enforcement 

Administration (DEA) for registration as 

an importer of Phenylacetone (8501), a 

basic class of controlled substance listed 

in Schedule II. 

The company plans to import 

Phenylacetone to manufacture 

amphetamine. 

Any manufacturer who is presently, 

or is applying to be, registered with DEA 

to manufacture such basic class of 

controlled substance may file comments 

or objections to the issuance of the 

proposed registration and may, at the 

same time, file a written request for a 

hearing on such application pursuant to 

21 CFR 1301.43 and in such form as 

prescribed by 21 CFR 1316.47. 

Any such comments or objections or 

requests for 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, Office of Liaison and 

Policy (ODLR) and must be filed no later 

than December 22, 2004. 

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 published in the 

Federal Register on September 23, 1975, 

(40 FR 43745–46), all applicants for 

registration to import a basic class of 

any controlled substances 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(b), (c), (d), (e) and (f) are 

satisfied.

Dated: November 8, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–25768 Filed 11–19–04; 8:45 am] 

BILLING CODE 4410–09–P

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 September 

28, 2004, Orasure Technologies, Inc., 

Lehigh University, Seeley G. MuddBuilding 6, Bethlehem, Pennsylvania 

18015, made application by renewal to 

the Drug Enforcement Administration 

(DEA) for registration as a bulk 

manufacturer of the basic classes of 

controlled substances listed:

Drug Schedule 

Alphamethadol (9605) .................. I 

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

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

The company plans to manufacture 

the listed controlled substances in bulk 

to manufacture other controlled 

substances. 

Any other such applicant and any 

person who is presently registered with 

DEA to manufacture such substances 

may file comments or objections to the 

issuance of the proposed registration 

pursuant to 21 CFR 1301.33(a). 

Any such comments or objections 

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, Office 

of Liaison and Policy (ODLR) and must 

be filed no later than January 21, 2005.

Dated: November 8, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration.

[FR Doc. 04–25769 Filed 11–19–04; 8:45 am] 

BILLING CODE 4410–09–P

DEPARTMENT OF LABOR

Employment and Training 

Administration 

Trade Adjustment Assistance 

Program: Training and Employment 

Guidance Letter Interpreting Federal 

Law; Correction

AGENCY: Employment and Training 

Administration, Labor.

ACTION: Correction.

SUMMARY: In notice document 04–22919 

beginning on page 60903 in the issue of 

Wednesday, October 13, 2004, make the 

following correction: 

On page 60903, the heading to the 

document was omitted and should be 

added to read: Employment and 

Training Advisory System, U.S. 

Department of Labor, Washington, DC 

20210. 

Classification: TAA. 

Correspondence Symbol: ONR. 

Date: November 6, 2003.