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Federal Register / Vol. 72, No.

28 / Monday, February 12, 2007 / Notices 6579

Administration (DEA) to be registered as bulk manufacturer of a controlled Administration, that the requirements
an importer of Noroxymorphone (9668), substance in schedule I or II and prior for such registration pursuant to 21
a basic class of controlled substance to issuing a regulation under 21 U.S.C. U.S.C. 958(a), 21 U.S.C. 823(a), and 21
listed in schedule II. 952(a)(2)(B) authorizing the importation CFR 1301.34(b), (c), (d), (e) and (f) are
The company plans to import the of such a substance, provide satisfied.
listed substance for analytical research manufacturers holding registrations for Dated: February 5, 2007.
and clinical trials. the bulk manufacture of the substance Joseph T. Rannazzisi,
Any bulk manufacturer who is an opportunity for a hearing.
presently, or is applying to be, Deputy Assistant Administrator, Office of
Therefore, in accordance with 21 CFR Diversion Control, Drug Enforcement
registered with DEA to manufacture 1301.34(a), this is notice that on Administration.
such basic class of controlled substance December 14, 2006, Mallinckrodt Inc., [FR Doc. E7–2326 Filed 2–9–07; 8:45 am]
may file comments or objections to the 3600 North Second Street, St. Louis,
BILLING CODE 4410–09–P
issuance of the proposed registration Missouri 63147, made application by
and may, at the same time, file a written renewal to the Drug Enforcement
request for a hearing on such Administration (DEA) to be registered as DEPARTMENT OF JUSTICE
application pursuant to 21 CFR 1301.43 an importer of the basic classes of
and in such form as prescribed by 21 controlled substances listed in schedule Drug Enforcement Administration
CFR 1316.47. II:
Any such written comments or Manufacturer of Controlled
objections being sent via regular mail Drug Schedule Substances; Notice of Application
should be addressed, in quintuplicate,
to the Deputy Assistant Administrator, Phenylacetone (8501) .................. II Pursuant to § 1301.33(a) of Title 21 of
Office of Diversion Control, Drug Coca Leaves (9040) ..................... II the Code of Federal Regulations (CFR),
Enforcement Administration, Opium, raw (9600) ....................... II this is notice that on December 12, 2006,
Poppy Straw (9650) ..................... II Orasure Technologies, Inc., Lehigh
Washington, DC 20537, Attention: DEA
Poppy Straw Concentrate (9670) II University, Seeley G Mudd-Building 6,
Federal Register Representative/ODL; or
any being sent via express mail should 220 East First Street, Bethlehem,
The company plans to import the Pennsylvania 18015, made application
be sent to DEA Headquarters, Attention: listed controlled substances for the
DEA Federal Register Representative/ by renewal to the Drug Enforcement
manufacture of controlled substances in Administration (DEA) as a bulk
ODL, 2401 Jefferson-Davis Highway, bulk for distribution to its customers.
Alexandria, Virginia 22301; and must be manufacturer of the basic classes of
Any bulk manufacturer who is controlled substances listed in schedule
filed no later than March 14, 2007. presently, or is applying to be,
This procedure is to be conducted I and II:
registered with DEA to manufacture
simultaneously with and independent
such basic classes of controlled Drug Schedule
of the procedures described in 21 CFR
substances may file comments or
1301.34(b), (c), (d), (e) and (f). As noted
objections to the issuance of the Lysergic acid diethylamide (LSD) I
in a previous notice published in the
proposed registration and may, at the (7315).
Federal Register on September 23, 1975, 4–Methoxyamphetamine (7411) ... I
same time, file a written request for a
(40 FR 43745–46), all applicants for Normorphine (9313) ..................... I
hearing on such application pursuant to
registration to import a basic class of Tetrahydrocannabinols (THC) I
21 CFR 1301.43 and in such form as
any controlled substance listed in (7370).
prescribed by 21 CFR 1316.47. Alphamethadol (9605) .................. I
schedule I or II are, and will continue
Any such written comments or Amphetamine (1100) .................... II
to be required to demonstrate to the
objections being sent via regular mail Methamphetamine (1105) ............ II
Deputy Assistant Administrator, Office
should be addressed, in quintuplicate, Cocaine (9041) ............................. II
of Diversion Control, Drug Enforcement
to the Deputy Assistant Administrator, Hydromorphone (9150) ................ II
Administration, that the requirements Benzoylecgonine (9180) ............... II
Office of Diversion Control, Drug
for such registration pursuant to 21 Hydrocodone (9193) ..................... II
Enforcement Administration,
U.S.C. 958(a), 21 U.S.C. 823(a), and 21 Morphine (9300) ........................... II
Washington, D.C. 20537, Attention: DEA
CFR 1301.34(b), (c), (d), (e) and (f) are Oxycodone (9143) ........................ II
Federal Register Representative/ODL; or
satisfied. Meperidine (9230) ........................ II
any being sent via express mail should Methadone (9250) ........................ II
Dated: February 5, 2007. be sent to DEA Headquarters, Attention: Oxymorphone (9652) ................... II
Joseph T. Rannazzisi, DEA Federal Register Representative/
Deputy Assistant Administrator, Office of ODL, 2401 Jefferson-Davis Highway, The company plans to manufacture
Diversion Control, Drug Enforcement Alexandria, Virginia 22301; and must be the listed controlled substances in bulk
Administration. filed no later than March 14, 2007. to manufacture controlled substance
[FR Doc. E7–2328 Filed 2–9–07; 8:45 am] This procedure is to be conducted derivatives. These derivatives will be
BILLING CODE 4410–09–P simultaneously with and independent used in diagnostic products created
of the procedures described in 21 CFR specifically for internal use only.
1301.34(b), (c), (d), (e) and (f). As noted Any other such applicant and any
DEPARTMENT OF JUSTICE in a previous notice published in the person who is presently registered with
Federal Register on September 23, 1975, DEA to manufacture such a substance
Drug Enforcement Administration
(40 FR 43745–46), all applicants for may file comments or objections to the
registration to import a basic class of issuance of the proposed registration
sroberts on PROD1PC70 with NOTICES

Importer of Controlled Substances;


Notice of Application any controlled substance listed in pursuant to 21 CFR 1301.33(a).
schedule I or II are, and will continue Any such written comments or
Pursuant to 21 U.S.C. 958(i), the to be required to demonstrate to the objections being sent via regular mail
Attorney General shall, prior to issuing Deputy Assistant Administrator, Office should be addressed, in quintuplicate,
a registration under this Section to a of Diversion Control, Drug Enforcement to the Deputy Assistant Administrator,

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6580 Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Notices

Office of Diversion Control, Drug Dated: February 5, 2007. executed a search warrant at
Enforcement Administration, Joseph T. Rannazzisi, Respondent’s medical office and seized
Washington, DC 20537, Attention: DEA Deputy Assistant Administrator, Office of several vials of steroids for which there
Federal Register Representative/ODL; or Diversion Control, Drug Enforcement were no records. Id. The OSC further
any being sent via express mail should Administration. alleged that in June 1996, DEA obtained
be sent to DEA Headquarters, Attention: [FR Doc. E7–2330 Filed 2–9–07; 8:45 am] from Henry Schein, Inc., copies of
DEA Federal Register Representative/ BILLING CODE 4410–09–P invoices which documented that
ODL, 2401 Jefferson-Davis Highway, Respondent had purchased controlled
Alexandria, Virginia 22301; and must be substances on nine different occasions
filed no later than April 13, 2007. DEPARTMENT OF JUSTICE between January 1995 and May 1996. Id.
at 3. The OSC alleged that Respondent
Dated: February 5, 2007. Drug Enforcement Administration had failed to keep accurate records of
Joseph T. Rannazzisi, [Docket Nos. 02–09, 02–43] the purchase, inventory, and
Deputy Assistant Administrator, Office of dispensation of controlled substances.
Diversion Control, Drug Enforcement Edmund Chein, M.D.; Revocation of Id.
Administration. Practitioner’s Registration, Denial of The 2001 OSC next alleged that on
[FR Doc. E7–2320 Filed 2–9–07; 8:45 am] Application for Exporter’s Registration January 31, 2001, DEA Diversion
BILLING CODE 4410–09–P Investigators (DIs) went to Respondent’s
Introduction and Procedural History Palm Springs medical office, the Palm
This is a consolidated proceeding. On Springs Life Extension Institute
DEPARTMENT OF JUSTICE November 7, 2001, the then (hereinafter PSLEI), to conduct an
Administrator of the Drug Enforcement administrative inspection. Id. The OSC
Drug Enforcement Administration Administration, issued an Order to alleged that the invoices documenting
Show Cause and Notice of Immediate the purchases of controlled substances
Importer of Controlled Substances; Suspension of the practitioner’s were at an accounting firm and not at
Notice of Registration Certificate of Registration, AC1643661, the office. Id. The 2001 OSC further
issued to Edmund Chein, M.D. alleged that ‘‘none of [the] required
By Notice dated October 12, 2006 and (Respondent) of Palm Springs, controlled substance records were
published in the Federal Register on California. The Notice of Immediate accessible,’’ because the records were
October 19, 2006, (71 FR 61800–61801), Suspension was based on the stored in a computer and none of the
Tocris Cookson, Inc., 16144 Westwoods Administrator’s preliminary conclusion office personnel then present were
Business Park, Ellisville, Missouri that Respondent’s continued registration capable of retrieving them. Id. The OSC
63021–7683, made application by letter constituted ‘‘an imminent danger to the thus alleged that Respondent had
to the Drug Enforcement Administration public health and safety because of the violated the Controlled Substance Act
(DEA) to be registered as an importer of substantial likelihood that [Respondent by failing ‘‘to maintain in a readily
would] continue exporting and available condition’’ initial and biennial
Marihuana (7360), a basic class of
diverting controlled substances.’’ Order inventory records, purchase invoices,
controlled substance listed in schedule
to Show Cause and Notice of Immediate and dispensing records. Id.
I. The 2001 OSC further alleged that on
Suspension at 6 (2001 OSC). The Order
The company plans to import this further proposed to revoke Respondent’s February 5, 2001, DEA personnel
product for non-clinical laboratory practitioner’s registration and deny any returned to Respondent’s office and
based research only. pending applications for renewal of the obtained an inventory of controlled
No comments or objections have been registration on the ground that substances that was dated February 5,
received. DEA has considered the Respondent’s continued registration 2001, dispensing records for the period
factors in 21 U.S.C. § 823(a) and 952(a) would be inconsistent with the public July 1, 2000, through February 1, 2001,
and determined that the registration of interest. See id. at 1; see also 21 U.S.C. and invoices for purchases of controlled
Tocris Cookson, Inc. to import the basic 823(f) & 824(a)(4). substances from Barnes Wholesale, Inc.,
Subsequently, on May 24, 2002, the for the period January 1, 1999, through
class of controlled substance is
Deputy Assistant Administrator, Office February 4, 2001. Id. The OSC also
consistent with the public interest and
of Diversion Control, issued an alleged that the dispensing records
with United States obligations under
additional Order to Show Cause showed that between July 1, 2000, and
international treaties, conventions, or (hereinafter 2002 OSC) to Respondent. February 5, 2001, Respondent dispensed
protocols in effect on May 1, 1971, at This Show Cause Order proposed to anabolic steroids, a Schedule III
this time. DEA has investigated Tocris deny Respondent’s pending application controlled substance, and phentermine,
Cookson, Inc. to ensure that the for a registration as an exporter on the a Schedule IV controlled substance, to
company’s registration is consistent ground that issuance of a registration persons in Korea, Belgium, Indonesia,
with the public interest. The would be inconsistent with the public Canada, Japan, Spain, Germany,
investigation has included inspection interest. 2002 OSC at 1; see also 21 Switzerland, Mexico, England, and
and testing of the company’s physical U.S.C. 958(c) &(d); id. 823(d). Hong Kong. Id. at 3–4.
security systems, verification of the The 2001 OSC alleged that More specifically, the OSC alleged
company’s compliance with state and Respondent had purchased ‘‘large that Respondent had made 328 illegal
local laws, and a review of the amounts of anabolic steroids’’ from a exports comprised of 20 exports of
company’s background and history. Mexican pharmacy and ‘‘other phentermine 30 mg., 58 exports of
Therefore, pursuant to 21 U.S.C. 952(a) illegitimate sources’’ and had phentermine 15 mg., 73 exports of
sroberts on PROD1PC70 with NOTICES

and 958(a), and in accordance with 21 distributed these substances to testosterone gel 8 mg., 12 exports of
CFR 1301.34, the above named company individuals who did not have a testosterone gel 100 mg., 50 exports of
is granted registration as an importer of legitimate medical need for them. 2001 testosterone estradiol gel 4 mg, 113
the basic class of controlled substance OSC at 2. The OSC further alleged that exports of Depo testosterone 200 mg.,
listed. on May 28, 1996, Federal agents and two exports of testosterone 50 mg.

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