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Federal Register / Vol. 70, No.

63 / Monday, April 4, 2005 / Notices 17123

benefits of prompt and less costly a standard of whether it is certain to DEPARTMENT OF JUSTICE
settlement through the consent decree eliminate every anticompetitive effect of
process.’’ 119 Cong. Rec. 24,598 (1973) a particular practice or whether it Drug Enforcement Administration
(statement of Senator Tunney).1 Rather: mandates certainty of free competition
in the future. Court approval of a final Importation of Controlled Substances;
[a]bsent a showing of corrupt failure of the
government to discharge its duty, the Court, judgment requires a standard more Notice of Application
in making its public interest finding, should flexible and less strict than the standard Pursuant to 21 U.S.C. 958(1), the
* * * carefully consider the explanations of required for a finding of liability. ‘‘[A] Attorney General shall, prior to issuing
the government in the competitive impact proposed decree must be approved even
statement and its responses to comments in a registration under this Section to a
if it falls short of the remedy the court bulk manufacturer of a controlled
order to determine whether those
explanations are reasonable under the would impose on its own, as long as it substance in Schedule I or II and prior
circumstances. falls within the range of acceptability or to issuing a regulation under 21 U.S.C.
is ‘within the reaches of public 952(a)(2)(b) authorizing the importation
United States v. Mid-America interest.’’’ United States v. AT&T, 552 F.
Dairymen, Inc., 1977–1 Trade Cas. of such substances, provide
Supp. 131, (D.D.C. 1982) (citations manufacturers holding registrations for
(CCH) ¶ 61,508, at 71,980 (W.D. Mo. omitted) (quoting Gillette, 406 F. Supp.
1977). the bulk manufacture of the substances
at 716), aff’d sub nom. Maryland v. an opportunity for a hearing.
Accordingly, with respect to the
United States, 460 U.S. 1001 (1983); see Therefore, in accordance with Title 21
adequacy of the relief secured by the
also United States v. Alcan Aluminum CFR 1301.34(a), this is notice that on
decree, a court may not ‘‘engage in an
Ltd., 605 F. Supp. 619, 622 (W.D. Ky. July 26, 2004, Aveva Drug Delivery
unrestricted evaluation of what relief
would best serve the public.’’ United 1985) (approving the consent decree Systems Inc., 3250 Commerce Parkway,
States v. BNS, Inc., 858 F.2d 456, 462 even though the court would have Miramar, Florida 33025–3907, made
(9th Cir. 1988) (citing United States v. imposed a greater remedy). application to the Drug Enforcement
Bechtel Corp., 648 F.2d 660, 666 (9th Moreover, the Court’s role under the Administration (DEA) for registration as
Cir. 1981)); see also Microsoft, 56 F.3d APPA is limited to reviewing the an importer of Fentanyl (9801), a basic
at 1460–62. Courts have held that: remedy in relationship to the violations class of controlled substance listed in
[t]he balancing of competing social and that the United States has alleged in its Schedule II.
political interests affected by a proposed Complaint; the APPA does not authorize The company plans to import the
antitrust consent decree must be left, in the the Court to ‘‘construct [its] own listed controlled substance for the
first instance, to the discretion of the hypothetical case and then evaluate the manufacture of analytical reference
Attorney General. The court’s role in decree against that case.’’ Microsoft, 56 standards.
protecting the public interest is one of F.3d at 1459. Because the ‘‘court’s Any manufacturer who is presently,
insuring that the government has not authority to review the decree depends or is applying to be, registered with DEA
breached its duty to the public in consenting to manufacture such basic classes of
to the decree. The court is required to entirely on the government’s exercising
determine not whether a particular decree is its prosecurtorial discretion by bringing controlled substances may file written
the one that will best serve society, but a case in the first place,’’ it follows that comments or objections to the issuance
whether the settlement is ‘‘within the reaches ‘‘the court is only authorized to review of the proposed registration and may, at
of the public interest.’’ More elaborate the decree itself,’’ and not to ‘‘effectively the same time, file a written request for
requirements might undermine the redraft the complaint’’ to inquire into a hearing on such application pursuant
effectiveness of antitrust enforcement by other matters that the United States did to 21 CFR 1301.43 and in such form as
consent decree. prescribed by 21 CFR 1316.47.
not pursue. Id. at 1459–60.
Bechtel, 648 F.2d at 666 (emphasis Any such written comments or
added) (citations omitted).2 VIII. Determinative Documents objections being sent via regular mail
The proposed Final Judgment, may be addressed, in quintuplicate, to
There are no determinative materials
therefore, should not be reviewed under the Deputy Assistant Administrator,
or documents within the meaning of the
APPA that were considered by the Office of Diversion Control, Drug
1 See United States v. Gillette Co., 406 F. Supp.
United States in formulating the Enforcement Administration,
713, 716 (D. Mass. 1975) (recognizing it was not the
court’s duty to settle; rather, the court must only proposed Final Judgment. Washington, DC 20537, Attention: DEA
answer ‘‘whether the settlement achieved [was] Federal Register Representative, Liaison
within the reaches of the public interest’’). A Dated: March 21, 2005. and Policy Section (ODL); or any being
‘‘public interest’’ determination can be made Respectfully submitted, sent via express mail should be sent to
properly on the basis of the Competitive Impact
Statement and Response to Comments filed by the Mark J. Botti, DEA Headquarters, Attention: DEA
Department of Justice pursuant to the APPA. Chief, Litigation I. Federal Register Representative/ODL,
Although the APPA authorizes the use of additional 2401 Jefferson Davis Highway,
procedures, 15 U.S.C. 16(f), those procedures are Kasey Warner,
discretionary. A court need not invoke any of them United States Attorney. Alexandria, Virginia 22301; and must be
unless it believes that the comments have raised filed no later than May 4, 2004.
significant issues and that further proceedings Peter J. Mucchetti, This procedure is to be conducted
would aid the court in resolving those issues. See Joan S. Huggler, simultaneously with and independent
H.R. Rep. No. 93–1463, 93rd Cong 2d Sess. 8–9 Mitchell H. Glende,
(1974), reprinted in 1974 U.S.C.C.A.N. 6535, 6538. of the procedures described in 21 CFR
2 Cf. BNS, 858 F.2d at 464 (holding that the
Attorneys for the United States, United States 1301.34(b), (c), (d), (e), and (f). As noted
court’s ‘‘ultimate authority under the [APPA] is
Department of Justice, 1401 H Street, NW., in a previous notice published in the
limited to approving or disapproving the consent Suite 4000, Washington, DC 20530. Federal Register on September 23, 1975,
decree’’); Gillette, 406 F. Supp. at 716 (noting that, Telephone: (202) 353–4211. Facsimile:
in this way, the court is constrained to ‘‘look at the (40 FR 43745–46), all applicants for
(202) 307–5802.
overall picture not hypercritically, nor with a registration to import the basic class of
microscope, but with an artist’s reducing glass’’). Stephen M. Horn, any controlled substance listed in
See generally Microsoft, 56 F3.d at 1461 (discussing Assistant United States Attorney. Schedule I or II are and will continue to
whether ‘‘the remedies [obtained in the decree are]
so inconsonant with the allegations charged as to
[FR Doc. 05–6536 Filed 4–1–05; 8:45 am] be required to demonstrate to the
fall outside of the ‘reaches of the public interest’’’ BILLING CODE 4410–11–M Deputy Assistant Administrator, Office

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17124 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices

of Diversion Control, Drug Enforcement Dated: March 25, 2005. (CFR), this is notice that on January 4,
Administration that the requirements William J. Walker, 2005, Mallinckrodt Inc., Mallinckrodt &
for such registration pursuant to 21 Deputy Assistant Administrator, Office of Second Streets, St. Louis, Missouri
U.S.C. 958(a), 21 U.S.C. 823(a), and 21 Diversion Control, Drug Enforcement 63147, made application by renewal to
CFR 1301.34(b), (c), (d), (e), and (f) are Administration. the Drug Enforcement Administration
satisfied. [FR Doc. 05–6592 Filed 4–1–05; 8:45 am] (DEA) to be registered as a bulk
BILLING CODE 4410–09–P manufacturer of the basic classes of
Dated: March 25, 2005.
controlled substances listed in
William J. Walker, Schedules I and II:
Deputy Assistant Administrator, Office of DEPARTMENT OF JUSTICE
Diversion Control, Drug Enforcement Drug Schedule
Administration. Drug Enforcement Administration
[FR Doc. 05–6585 Filed 4–1–05; 8:45 am] Tetrahydrocannabinols (7370) ..... I
Manufacturer of Controlled Codeine-N-oxide (9053) ............... I
BILLING CODE 4410–09–P Dihydromorphine (9145) ............... I
Substances; Notice of Application
Difenoxin (9168) ........................... I
Pursuant to 21 CFR 1301.33(a), Title Heroin (9200) ............................... I
DEPARTMENT OF JUSTICE 21 of the Code of Federal Regulations Morphine-N-oxide (9307) ............. I
(CFR), this is notice that on February 7, Nicomorphine (9312) .................... I
Drug Enforcement Administration 2005, Johnson Matthey, Inc., Custom Normorphine (9313) ..................... I
Pharmaceuticals Department, 2003 Norlevorphanol (9634) .................. I
Manufacturer of Controlled Nolte Drive, West Deptford, New Jersey Amphetamine (1100) .................... II
Substances; Notice of Registration Methamphetamine (1105) ............ II
08066, made application by letter to the Methylophenidate (1724) .............. II
Drug Enforcement Administration Codeine (9050) ............................. II
By Notice dated December 21, 2004, (DEA) for registration as a bulk Diprenorphine (9058) ................... II
and published in the Federal Register manufacturer of Methamphetamine Etorphine HCL (9059) .................. II
on January 4, 2005, (70 FR 390), (1105), a basic class of controlled Dihydrocodeine (9120) ................. II
Cedarburg Pharmaceuticals, Inc., 870 substance listed in Schedule II. Hydromorphone (9150) ................ II
Badger Circle, Grafton, Wisconsin The company plans to manufacture Oxycodone (9143) ........................ II
53024, made application by letter to the the listed controlled substance in bulk Diphenoxylate (9170) ................... II
for distribution to its customers. Benzoylecgonine (9180) ............... II
Drug Enforcement Administration Hydrocodone (9193) ..................... II
(DEA) to be registered as a bulk Any other such applicant and any
Levorphanol (9220) ...................... II
manufacturer of the basic classes of person who is presently registered with Meperidine (9230) ........................ II
controlled substances listed in Schedule DEA to manufacture such a substance Methadone (9250) ........................ II
II: may file comments or objections to the Methadone Intermediate (9254) ... II
issuance of the proposed registration Metopon (9260) ............................ II
Drug Schedule pursuant to 21 CFR 1301.33(a). Dextropropoxyphene (9273) ......... II
Any such written comments or Morphine (9300) ........................... II
Dihydrocodeine (9120) ................. II objections being sent via regular mail Thebaine (9333) ........................... II
may be addressed, in quintuplicate, to Opium extracts (9610) .................. II
Remifentanil (9739) ...................... II
Opium fluid extract (9620) ............ II
Sufentanil (9740) .......................... II the Deputy Assistant Administrator,
Opium tincture (9630) .................. II
Office of Diversion Control, Drug Opium, powdered (9639) ............. II
The company plans to manufacture Enforcement Administration, Opium, granulated (9640) ............ II
the listed controlled substances in bulk Washington, DC 20537, Attention: DEA Levo-alphacetylmethadol (9648) .. II
for distribution to its customers. Federal Register Representative, Liaison Oxymorphone (9652) ................... II
and Policy Section (ODL); or any being Alfentanil (9737) ........................... II
No comments or objections have been sent via express mail should be sent to Remifentanil (9739) ...................... II
received. DEA has considered the DEA Headquarters, Attention: DEA Sufentanil (9740) .......................... II
factors in 21 U.S.C. 823(a) and Federal Register Representative/ODL, Fentanyl (9801) ............................ II
determined that the registration of 2401 Jefferson Davis Highway,
Cedarburg Pharmaceuticals, Inc. to Alexandria, Virginia 22301; and must be The company plans to manufacture
manufacture the listed basic classes of filed no later than June 3, 2005. the listed controlled substances for
controlled substances is consistent with internal use and for distribution to its
Dated: March 25, 2005. customers.
the public interest at this time. DEA has William J. Walker, Any other such applicant and any
investigated Cedarburg Pharmaceuticals,
Deputy Assistant Administrator, Office of person who is presently registered with
Inc. to ensure that the company’s Diversion Control, Drug Enforcement DEA to manufacture such a substance
registration is consistent with the public Administration. may file comments or objections to the
interest. The investigation has included [FR Doc. 05–6586 Filed 4–1–05; 8:45 am] issuance of the proposed registration
inspection and testing of the company’s BILLING CODE 4410–09–P pursuant to 21 CFR 1301.33(a).
physical security systems, verification Any such written comments or
of the company’s compliance with state objections being sent via regular mail
and local laws, and a review of the DEPARTMENT OF JUSTICE may be addressed, in quintuplicate, to
company’s background and history. the Deputy Assistant Administrator,
Therefore, pursuant to 21 U.S.C. 823, Drug Enforcement Administration Office of Diversion Control, Drug
and in accordance with 21 CFR Enforcement Administration,
1301.33(a), the above named company is Manufacturer of Controlled
Washington, DC 20537, Attention: DEA
granted registration as a bulk Substances; Notice of Application
Federal Register Representative, Liaison
manufacturer of the basic classes of Pursuant to section 1301.33(a) of Title and Policy Section (ODL); or any being
controlled substances listed. 21 of the Code of Federal Regulations sent via express mail should be sent to

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