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Federal Register / Vol. 72, No.

16 / Thursday, January 25, 2007 / Notices 3417

filed for the purpose of extending the regulations, applications to import narcotic raw materials, including raw
Act’s provisions limiting the recovery of narcotic raw materials, including raw opium and concentrate of poppy straw,
antitrust plaintiffs to actual damages opium, poppy straw, and concentrate of are not required to be published in the
under specified circumstances. poppy straw, are not required to be Federal Register. Further, the notice of
Specifically, Keithley Instruments, Inc., published in the Federal Register. application, although not required to be
Solon, OH; and PLX Technology, Further, the notice of application, published at all, should have stated that
Sunnyvale, CA have been added as although not required to be published at ‘‘bulk manufacturers’’ of raw opium or
parties to this venture. Also, Mapsuka all, should have stated that ‘‘bulk concentrate of poppy straw may file a
Industries Co., Ltd., Taipei, TAIWAN manufacturers’’ of raw opium, poppy written request for a hearing. As
has withdrawn as a party to this straw, or concentrate of poppy straw explained below, since there are no
venture. may file a written request for a hearing. domestic bulk manufacturers of narcotic
No other changes have been made in As explained in the Correction to Notice raw materials registered with DEA, no
either the membership or planned of Application pertaining to Rhodes registrant has a statutory or regulatory
activity of the group research project. Technologies published today, since right to a hearing on the application.
Membership in this group research there are no domestic bulk In response to the notice, several
project remains open, and PXI Systems manufacturers of narcotic raw materials importers of narcotic raw materials who
Alliance, Inc. intends to file additional registered with DEA, no registrant has a also hold manufacturing registrations
written notifications disclosing all statutory or regulatory right to a hearing (but not as ‘‘bulk manufacturers’’ of
changes in membership. on the application. For the reasons set narcotic raw materials) requested a
On November 22, 2000, PXI Systems forth therein, I correct the Notice of hearing on the application. DEA’s
Alliance, Inc. filed its original Application dated January 23, 2006. I Administrative Law Judge (ALJ)
notification pursuant to Section 6(a) of direct the Administrative Law Judge to accepted the requests for hearings and
the Act. The Department of Justice remove from the agency’s administrative placed the case on DEA’s administrative
published a notice in the Federal docket the hearing on the application of hearing docket. This correction notifies
Register pursuant to Section 6(b) of the Cody Laboratories, Inc. to be registered the applicant, the public, and those
Act on march 8, 2001 (66 FR 13971). as an importer of narcotic raw materials. importers/manufacturers that requested
The last notification was filed with Dated: January 18, 2007. a hearing that DEA is denying the
the Department on October 5, 2006. A requests for hearing and dismissing the
Michele M. Leonhart,
notice was published in the Federal case on the agency’s administrative
Deputy Administrator.
Register pursuant to Section 6(b) of the docket.
[FR Doc. E7–1052 Filed 1–24–07; 8:45 am]
Act on November 22, 2006 (71 FR Statutory and Regulatory Provisions
BILLING CODE 4410–09–P
67642).
As set forth in 21 U.S.C. 958(i), the
Patricia A. Brink, Attorney General (by delegation, the
Deputy Director of Operations, Antitrust DEPARTMENT OF JUSTICE Administrator and Deputy
Division. Administrator of DEA) 1 shall, prior to
[FR Doc. 07–319 Filed 1–24–07; 8:45 am] Drug Enforcement Administration issuing an importer registration to a
BILLING CODE 4410–11–M
Importer of Controlled Substances; bulk manufacturer of a controlled
Correction to Notice of Application substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
DEPARTMENT OF JUSTICE The Drug Enforcement 952(a) authorizing the importation of
Administration (DEA) is hereby such a substance, provide
Drug Enforcement Administration correcting a notice of application that ‘‘manufacturers holding registrations for
appeared in the Federal Register on the bulk manufacture of the substance
Importer of Controlled Substances;
April 17, 2006 (71 FR 20729). That an opportunity for a hearing.’’
Correction to Notice of Application
document announced the application of (Emphasis added.) Thus, the CSA
The Drug Enforcement Rhodes Technologies to be registered as contemplates that only ‘‘bulk
Administration (DEA) is hereby an importer of raw opium and manufacturers’’ shall be entitled to
correcting a notice of application that concentrate of poppy straw. This is the hearing on an application to import a
appeared in the Federal Register on second correction to the original notice schedule I or II controlled substance
January 23, 2006 (71 FR 3545). That of application. This document augments and, further, that only those who are
document announced the application of the correction which was published in registered to bulk manufacture the
Cody Laboratories, Inc., to be registered the Federal Register on May 22, 2006 particular substance that the applicant
as an importer of raw opium, poppy (71 FR 29354). seeks to import. Accordingly, if no one
straw, and concentrate of poppy straw. The April 17, 2006, notice of is registered to bulk manufacture the
The January 23, 2006, notice of application incorrectly stated that substance that the applicant seeks to
application incorrectly stated that ‘‘[a]ny manufacturer who is presently, import, no one is entitled to a hearing
‘‘[a]ny manufacturer who is presently, or is applying to be, registered with DEA on that application.
or is applying to be, registered with DEA to manufacture such basic classes of DEA’s registration database confirms
to manufacture such basic classes of controlled substances may file that no person holds a registration as a
controlled substances may file comments or objections to the issuance bulk manufacturer of raw opium,
comments or objections to the issuance of the proposed registration and may, at concentrate of poppy straw, or any of
of the proposed registration and may, at the same time, file a written request for the other narcotic raw materials listed in
the same time, file a written request for a hearing on such application pursuant 21 U.S.C. 952(a)(1).2 Accordingly, the
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a hearing on such application pursuant to 21 CFR 1301.43 and in such form as


1 21 U.S.C. 871(a); 28 CFR 0.100(b) and 0.104,
to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47.’’
appendix to subpart R, sec. 12.
prescribed by 21 CFR 1316.47.’’ Correctly stated, under the Controlled 2 When applying for registration, manufacturers
Correctly stated, under the Controlled Substances Act (CSA) and DEA are required to complete DEA Form-225, which
Substances Act (CSA) and DEA regulations, applications to import Continued

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3418 Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices

CSA provides no right to a hearing to theoretical legal authority to grant such an agency under the Administrative
any person seeking to challenge the hearing requests, I now conclude that Procedure Act requires to conclude
application of another to become the most sound reading of the statute adjudications ‘‘with due regard to the
registered to import such narcotic raw and regulations is that which limits the convenience and necessity of the parties
materials. right to a hearing to those situations in * * * and within a reasonable time.’’ 5
Consistent with the CSA, the DEA which Congress expressly provided U.S.C. 555(b). Moreover, if DEA were to
regulations provide that the only such a right. maintain a policy (not contemplated by
persons who are entitled to a hearing on As stated above, 21 U.S.C. 958(i), by the CSA) whereby a competitor could
an application for a registration to its plain terms, gives the right to request simply request a hearing without
import a schedule I or II controlled a hearing not in the case of all making any showing that the hearing
substance are those who are either applications for a registration to import, either would assist the agency in
‘‘registered as a bulk manufacturer of but only in those in which the applicant deciding whether to grant the
that controlled substance’’ or an for the import registration is a ‘‘bulk application or otherwise advance the
‘‘applicant therefor.’’ 21 CFR manufacturer’’ and only where the
goals of the CSA, it would be difficult
1301.34(a).3 person seeking the hearing is a ‘‘bulk
In sum, neither the CSA nor the DEA to envision how the agency could act on
manufacturer’’ of the substance the
regulations provide a right to a hearing such hearing requests other than on
applicant is seeking to import. Because
for anyone seeking to contest the there are no registered bulk arbitrary basis. Basic principles of
application of Rhodes Technologies to manufacturers of narcotic raw fairness dictate against such an
import narcotic raw material. materials,4 the facts triggering the right outcome.
to a hearing under section 958(i) are not Of course, the consideration of delay
Historical Agency Practice and Other
Statutory Considerations present in cases in which the applicant to the applicant also exists when a bulk
for an import registration is seeking to manufacturer seeks a hearing on the
DEA is aware that the agency has, in import narcotic raw materials under application of a potential competitor as
some prior cases of applications to section 952(a)(1). In contrast, the facts allowed under section 958(i). However,
import narcotic raw materials, granted needed to invoke the hearing right of that Congress expressly provided for a
requests for hearings made by persons section 958(i) will be present when the hearing right in such circumstances
that were not bulk manufacturers of the applicant is seeking to import the indicates that Congress weighed the
narcotic raw material—despite the fact substances referred to in section consideration of delay and, on balance,
that no such hearing right is 952(a)(2), since there are registered bulk determined the goals of the CSA were
contemplated by the governing statute manufacturers of the substances referred advanced by providing a hearing right
or implementing regulations. See, e.g., to in section 952(a)(2) (substances in such circumstances. Again, that
Penick Corp.; Importation and which are not narcotic raw materials).5
Manufacture of Controlled Substances, Congress expressed clear criteria as to
Congress could have extended the when the hearing right applied reflects
Objections, Requests for Hearing, and hearing right under 958(i) to importers
Hearing, 42 FR 82760 (1980); a clear delineation by Congress as to
of narcotic raw materials. That it instead
Mallinckrodt, Inc.; Approval of when such hearing right does—or does
chose to limit that right to bulk
Registration, 46 FR 24747 (1981); not—advance the overall goals of the
manufacturers indicates a determination
Johnson Matthey, Inc.; Conditional Act.
on its part that extending the hearing
Grant of Registration to Import Schedule right to others is not necessary to The mere fact that the agency has
II Substances, 67 FR 39041 (2002); advance the goals of the CSA. Among followed a procedural practice in the
Penick Corporation, Inc.; Grant of other considerations, invocation of the past does not, by itself, compel that the
Registration to Import Schedule II hearing right by a competitor can add agency repeat the procedure in
Substances, 68 FR 6947, 6948 (2003); considerable time (months and perpetuity. Finding no valid
Chattem Chemicals, Inc.; Grant of sometimes years) to the process by justification for the past practice, and
Registration to Import Schedule II which the agency determines whether to finding such practice inconsistent with
Substances, 71 FR 9834 (2006). In these grant the application. An existing the particular criteria for a hearing
past cases, the agency did not state that registrant could ask for a hearing simply rights set forth in the CSA and
such non-bulk-manufacturers were to delay a competitor’s entry into the implementing regulations, I decline to
entitled to a hearing under 21 U.S.C. market—particularly given that DEA has follow this practice.
958(i) or 21 CFR 1301.34(a). Rather, the not promulgated any criteria for
agency either granted the hearing It should be emphasized, however,
deciding whether to grant these types of
without explanation or did so based on that this decision to disallow a hearing
hearing requests. Such a delay would
what it termed its ‘‘discretionary right beyond that stated in the statute or
tend to run counter to the obligation of
authority.’’ See, e.g., Penick regulations by no means should be
Corporation, Inc.; Grant of Registration 4 Since well before the CSA was enacted construed as an indication that this
to Import Schedule II Substances, 68 FR (beginning with the Narcotic Drugs Import and application will be approved without
6947, 6948 (2003). Without addressing Export Act of 1922), it has been the policy of the the appropriate scrutiny. As mandated
United States (reflected in legislation enacted by by the CSA, DEA will—prior to deciding
whether the agency indeed has the Congress) to favor the importation of narcotic raw
materials for conversion in the United States into whether to issue an order to show cause
requires the applicant to specify the nature of the finished narcotic drug products over domestic to deny this application—evaluate the
proposed manufacturing activity. The categories production of the raw materials and over the application in accordance with the
include, among others, ‘‘bulk synthesis/extraction’’ importation of processed narcotic materials and
and ‘‘dosage form manufacture.’’ Likewise, the finished narcotic products. This is currently
applicable statutory criteria (21 U.S.C.
registration database maintained by DEA indicates reflected in part by in 21 U.S.C. 952(a) and, in 952(a)(1) and 958(a)). Section 958(a)
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the specific type of manufacturing activity that is particular, by comparing subsection 952(a)(1) with requires DEA to evaluate the application
authorized by each registration. subsection 952(a)(2) (the latter being more under the six public interest factors set
3 Moreover, as set forth in 21 CFR 1301.34(a), the restrictive than the former).
right to a hearing is limited to cases in which the 5 Section 958(i) expressly excludes from the
forth in 21 U.S.C. 823(a). See Penick
applicant is seeking to import a controlled hearing right applications pursuant to section Corporation, 68 FR 6947 (2003); Roxane
substance pursuant to 21 U.S.C. 952(a)(2)(B). 952(a)(2)(A) (emergency situations). Laboratories, Inc., 63 FR 55891 (1998).

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Federal Register / Vol. 72, No. 16 / Thursday, January 25, 2007 / Notices 3419

Conclusion In order for an affirmative have become totally or partially


For the reasons and in the manner set determination to be made for workers of separated, or are threatened to become
forth above, I correct the Notice of a primary firm and a certification issued totally or partially separated;
regarding eligibility to apply for worker (2) The workers’ firm (or subdivision)
Application dated April 17, 2006. I
adjustment assistance, each of the group is a supplier or downstream producer to
direct the ALJ to remove from the
eligibility requirements of Section a firm (or subdivision) that employed a
agency’s administrative docket the
222(a) of the Act must be met. group of workers who received a
hearing on the application of Rhodes
I. Section (a)(2)(A) all of the following certification of eligibility to apply for
Technologies to register as an importer trade adjustment assistance benefits and
must be satisfied:
of narcotic raw materials. such supply or production is related to
A. A significant number or proportion
Dated: January 18, 2007. of the workers in such workers’ firm, or the article that was the basis for such
Michele M. Leonhart, an appropriate subdivision of the firm, certification; and
Deputy Administrator. have become totally or partially (3) Either—
[FR Doc. E7–1053 Filed 1–24–07; 8:45 am] separated, or are threatened to become (A) The workers’ firm is a supplier
totally or partially separated; and the component parts it supplied for
BILLING CODE 4410–09–P
B. The sales or production, or both, of the firm (or subdivision) described in
such firm or subdivision have decreased paragraph (2) accounted for at least 20
absolutely; and percent of the production or sales of the
DEPARTMENT OF LABOR C. Increased imports of articles like or workers’ firm; or
directly competitive with articles (B) A loss or business by the workers’
Employment and Training produced by such firm or subdivision firm with the firm (or subdivision)
Administration have contributed importantly to such described in paragraph (2) contributed
workers’ separation or threat of importantly to the workers’ separation
[TA–W–60,627] or threat of separation.
separation and to the decline in sales or
production of such firm or subdivision; In order for the Division of Trade
Advanced Technology Corp., Geneva, Adjustment Assistance to issue a
OH; Notice of Termination of or
II. Section (a)(2)(B) both of the certification of eligibility to apply for
Investigation Alternative Trade Adjustment
following must be satisfied:
Pursuant to Section 221 of the Trade A. A significant number or proportion Assistance (ATAA) for older workers,
Act of 1974, as amended, an of the workers in such workers’ firm, or the group eligibility requirements of
investigation was initiated on December an appropriate subdivision of the firm, Section 246(a)(3)(A)(ii) of the Trade Act
18, 2006 in response to a worker have become totally or partially must be met.
petition filed by the United separated, or are threatened to become 1. Whether a significant number of
Steelworkers, Local 905L on behalf of totally or partially separated; workers in the workers’ firm are 50
workers of Advanced Technology Corp., B. There has been a shift in years of age or older.
production by such workers’ firm or 2. Whether the workers in the
Geneva, Ohio.
subdivision to a foreign country of workers’ firm possess skills that are not
The petitioner has requested that the
articles like or directly competitive with easily transferable.
petition be withdrawn. Consequently, 3. The competitive conditions within
the investigation has been terminated. articles which are produced by such
the workers’ industry (i.e., conditions
firm or subdivision; and
Signed at Washington, DC this 17th day of within the industry are adverse).
January, 2007. C. One of the following must be
satisfied: Affirmative Determinations for Worker
Linda G. Poole,
1. The country to which the workers’ Adjustment Assistance
Certifying Officer, Division of Trade firm has shifted production of the
Adjustment Assistance. The following certifications have been
articles is a party to a free trade issued. The date following the company
[FR Doc. E7–1075 Filed 1–24–07; 8:45 am] agreement with the United States; name and location of each
BILLING CODE 4510–30–P 2. The country to which the workers’ determination references the impact
firm has shifted production of the date for all workers of such
articles to a beneficiary country under determination.
DEPARTMENT OF LABOR the Andean Trade Preference Act, The following certifications have been
Employment and Training African Growth and Opportunity Act, or issued. The requirements of Section
Administration the Caribbean Basin Economic Recovery 222(a)(2)(A) (increased imports) of the
Act; or Trade Act have been met.
Notice of Determinations Regarding 3. There has been or is likely to be an
None.
Eligibility To Apply for Worker increase in imports of articles that are The following certifications have been
Adjustment Assistance and Alternative like or directly competitive with articles issued. The requirements of Section
Trade Adjustment Assistance which are or were produced by such 222(a)(2)(B) (shift in production) of the
firm or subdivision. Trade Act have been met.
In accordance with Section 223 of the Also, in order for an affirmative
Trade Act of 1974, as amended (19 determination to be made for TA–W–60,534; Ceramaspeed, Inc.,
U.S.C. 2273) the Department of Labor secondarily affected workers of a firm Maryville, TN: December 4, 2005.
herein presents summaries of and a certification issued regarding The following certifications have been
determinations regarding eligibility to eligibility to apply for worker issued. The requirements of Section
apply for trade adjustment assistance for adjustment assistance, each of the group 222(b) (supplier to a firm whose workers
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workers (TA–W) number and alternative eligibility requirements of Section are certified eligible to apply for TAA)
trade adjustment assistance (ATAA) by 222(b) of the Act must be met. of the Trade Act have been met.
(TA–W) number issued during the (1) Significant number or proportion None.
period of January 1 through January 5, of the workers in the workers’ firm or The following certifications have been
2007. an appropriate subdivision of the firm issued. The requirements of Section

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