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50408 Federal Register / Vol. 70, No.

165 / Friday, August 26, 2005 / Notices

Consortium, Inc. intends to file requirements for an enclosure controller 1. As the Interim Policy Statement
additional written notification slot that will support a variety of storage states, ‘‘For a physician to prepare
disclosing all changes in membership. controllers from a variety of multiple prescriptions [for a schedule II
On November 19, 2004, Network independent hardware vendors and controlled substance] on the same day
Centric Operations Industry independent software vendors. Any with instructions to fill on different
Consortium, Inc. filed its original storage controller design based on this dates is tantamount to writing a
notification pursuant to Section 6(a) of specification shall be able to fit, prescription authorizing refills of a
the Act. The Department of Justice connect, and operate within any storage schedule II controlled substance.’’ To do
published a notice in the Federal enclosure controller slot design based so conflicts with the provision of the
Register pursuant to Section 6(b) of the on the same specification. CSA which provides: ‘‘No prescription
Act on February 2, 2005 (70 FR 5486). for a controlled substance in schedule II
The last notification was filed with Dorothy B. Fountain, may be refilled.’’
the Department on May 11, 2005. A Deputy Director of Operations Antitrust 2. Many of the comments that DEA
notice was published in the Federal Division. received were from patients who said
Register pursuant to Section 6(b) of the [FR Doc. 05–16959 Filed 8–25–05; 8:45 am] they have been receiving prescriptions
Act on June 13, 2005 (70 FR 34150). BILLING CODE 4410–11–M for schedule II controlled substances for
several years (for example, for the
Dorothy B. Fountain,
treatment of severe pain or attention
Deputy Director of Operations, Antitrust DEPARTMENT OF JUSTICE deficit hyperactivity disorder) and have
Division.
gotten into a routine of seeing their
[FR Doc. 05–16961 Filed 8–25–05; 8:45 am] Drug Enforcement Administration physician once every three months.
BILLING CODE 4410–11–M
Many such commenters were under the
[Docket No. DEA–271N]
mistaken impression that, because of the
Clarification of Existing Requirements Interim Policy Statement, they now
DEPARTMENT OF JUSTICE
Under the Controlled Substances Act must begin seeing their physician every
Antitrust Division for Prescribing Schedule II Controlled month. DEA wishes to make clear that
Substances the Interim Policy did not state that
Notice Pursuant to the National such patients must visit their
Cooperative Research and Production AGENCY: Drug Enforcement physician’s office every month to pick
Act of 1993—Storage Bridge Bay Administration (DEA), Justice. up a new prescription. There is no such
Working Group, Inc. ACTION: Clarification. requirement in the CSA or DEA
regulations. What is required, in each
Notice is hereby given that, on August SUMMARY: On January 18, 2005, DEA instance where a physician issues a
9, 2005, pursuant to Section 6(a) of the published in the Federal Register a prescription for any controlled
National Cooperative Research and solicitation of comments on the subject substance, is that the physician properly
Production Act of 1993, 15 U.S.C. 4301 of dispensing controlled substances for determine there is a legitimate medical
et. seq. (‘‘the Act’’), Storage Bridge Bay the treatment of pain. Many of the purpose for the patient to be prescribed
Working Group, Inc. (‘‘SBB’’) has filed comments that the agency received that controlled substance and that the
written notifications simultaneously indicate that there is a need to issue a physician be acting in the usual course
with the Attorney General and the clarification regarding certain aspects of of professional practice. 21 CFR
Federal Trade Commission disclosing the prescription requirements for 1306.04(a); United States v. Moore, 423
(1) the name and principal place of schedule II controlled substances. This U.S. 122 (1975).
business of the standards development document provides such clarification. At the same time, schedule II
organization and (2) the nature and controlled substances, by definition,
DATES: August 26, 2005.
scope of its standards development have the highest potential for abuse, and
activities. The notifications were filed FOR FURTHER INFORMATION CONTACT:
are the most likely to cause dependence,
for the purpose of invoking the Act’s Patricia M. Good, Chief, Liaison and of all the controlled substances that
provisions limiting the recovery of Policy Section, Office of Diversion have an approved medical use. 21
antitrust plaintiffs to actual damages Control, Drug Enforcement U.S.C. 812(b). Physicians must,
under specified circumstances. Administration, Washington, DC 20537; therefore, use the utmost care in
Pursuant to Section 6(b) of the Act, Telephone: (202) 307–7297. determining whether their patients for
the name and principal place of SUPPLEMENTARY INFORMATION: On whom they are prescribing schedule II
business of the Standards development January 18, 2005, the Drug Enforcement controlled substances should be seen in
organization is: Storage Bridge Bay Administration (DEA) published in the person each time a prescription is
Working Group, Inc., Redwood City, Federal Register a Solicitation of issued or whether seeing the patient in
CA. The nature and scope of SBB’s Comments on the subject of dispensing person at somewhat less frequent
standards development activities are: controlled substances for the treatment intervals is consistent with sound
Promoting the computer industry by of pain. 70 FR 2883. Most of the medical practice and appropriate
supporting and facilitating the comments that the agency received safeguards against diversion and
development of interoperable and sought clarification on the legal misuse. Physicians must also abide by
compatible storage components with requirements governing the prescribing any requirements imposed by their state
reference to controller slot compatibility of schedule II controlled substances by medical boards with respect to proper
between and among storage solutions. physicians in view of DEA’s November prescribing practices and what
These purposes include the objective of 16, 2004, Interim Policy Statement. 69 constitutes a bona fide physician-patient
developing and publishing a ‘‘storage FR 67170. Given these comments, DEA relationship. 21 U.S.C. 823(f)(1), (4).
bridge bay’’ specification that will serve wishes to reiterate the following 3. Under the circumstances described
as a reference and guideline for defining principles under the Controlled in paragraph 2, in those instances where
physical, mechanical, electrical and Substances Act (CSA) and DEA the physician (who regularly sees a
low-level enclosure management regulations. patient) issues a prescription for a

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Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices 50409

schedule II controlled substance for a DEPARTMENT OF LABOR DEPARTMENT OF LABOR


legitimate medical purpose without
seeing the patient in person, the Employment and Training Employment and Training
physician may mail the prescription to Administration Administration
the patient or pharmacy. In addition, as [TA–W–56,114]
the DEA regulations state: ‘‘A [TA–W–57,428]
prescription for a schedule II controlled Bourns Microelectronics Modules, Inc.,
substance may be transmitted by the Americal Corporation, Henderson, NC; a Subsidiary of Bourns Inc., New
practitioner or the practitioner’s agent to Notice of Termination of Investigation Berlin, WI; Notice of Revised
a pharmacy via facsimile equipment, Determination on Remand
provided that the original written, Pursuant to Section 221 of the Trade
On June 29, 2005, the United States
signed prescription is presented to the Act of 1974, as amended, an Court of International Trade (USCIT)
pharmacist for review prior to the actual investigation was initiated on June 22, granted the Department of Labor’s
dispensing of the controlled substance, 2005 in response to a petition filed by motion for voluntary remand in Former
except as noted [elsewhere in this a company official on behalf of workers Employees of Bourns Microelectronics
section of the regulations].’’ 21 CFR at Americal Corporation, Henderson, Modules, Inc. v. U.S. Secretary of Labor
1306.11(a). Thus, as this provision of North Carolina. (Court No. 045–00350).
the regulations provides, faxing may be The petitioner has requested that the A petition, dated November 30, 2004,
used to facilitate the filling of a petition be withdrawn. Consequently, for Trade Adjustment Assistance (TAA)
schedule II prescription, but only if the the investigation has been terminated. and Alternative Trade Adjustment
pharmacy receives the original written, Assistance (ATAA) was filed on behalf
Signed at Washington, DC, this 29th day of of workers and former workers of MMC
signed prescription prior to dispensing July, 2005.
the drug to the patient. Bidding, Inc., Division of Bourns, New
Linda G. Poole, Berlin, Wisconsin. The investigation
4. The CSA and DEA regulations Certifying Officer, Division of Trade revealed that the workers previously
contain no specific limit on the number Adjustment Assistance. worked for Microelectronics Modules
of days worth of a schedule II controlled [FR Doc. E5–4678 Filed 8–25–05; 8:45 am] Corporation (MMC), New Berlin,
substance that a physician may BILLING CODE 4510–30–P Wisconsin and that the workers’
authorize per prescription. Some states, employment with MMC was terminated
however, do impose specific limits on when Bourns acquired the assets of
the amount of a schedule II controlled DEPARTMENT OF LABOR MMC on October 30, 2003. The
substance that may be prescribed. Any investigation also revealed that the
limitations imposed by state law apply Employment and Training Department granted a certification for
in addition to the corresponding Administration the former workers of MMC (TA–W–
requirements under Federal law, so long 42,217; expired December 6, 2004).
as the state requirements do not conflict [TA–W–57,639 and TA-W–57,639A] On December 27, 2004, the
with or contravene the Federal investigation for the case at hand was
requirements. 21 U.S.C. 903. Again, the Bernhardt Furniture Company, Plant # terminated because it was believed that
essential requirement under Federal law 9, Shelby, NC, and Bernhardt Furniture the workers were covered by the
is that the prescription for a controlled Company, Plant # 14, Cherryville, NC; previous certification for MMC (TA–W–
Notice of Termination of Investigation 42,217). (The Department had also
substance be issued for a legitimate
terminated another investigation for a
medical purpose in the usual course of
Pursuant to Section 221 of the Trade previous petition for the same location
professional practice. In addition, (TA–W–54,790) on June 4, 2004 because
physicians and pharmacies have a duty Act of 1974, an investigation was
initiated on July 28, 2005 in response to the Department found that the workers
as DEA registrants to ensure that their were covered by the certification for
prescribing and dispensing of controlled a petition filed by a company official on
MMC (TA–W–42,217)). The
substances occur in a manner consistent behalf of workers at Bernhardt Furniture
Department’s Notice of Termination of
with effective controls against diversion Company, Plant #9, Shelby, North
Investigation for this case was published
and misuse, taking into account the Carolina (TA–W–57,639) and Bernhardt in the Federal Register (70 FR 3732).
nature of the drug being prescribed. 21 Furniture Company, Plant #14, By letter dated January 14, 2005, the
U.S.C. 823(f). Cherryville, North Carolina (TA–W– petitioner requested administrative
57,639A). reconsideration, stating that the workers
Finally, as stated in the Solicitation of
Comments, once DEA has completed its The petitioner has requested that the were hired by and then separated from
review of the comments, the agency petition be withdrawn. Consequently, Bourns, that the petitioner helped ship
plans to issue a new Federal Register the investigation has been terminated. machines and documentation to, and
document, which will provide a provided training to persons in Costa
Signed in Washington, DC, this 10th day of
Rica, China and Taiwan, and that parts
recitation of the pertinent legal August, 2005.
were being imported to satisfy
principles relating to the dispensing of Elliott S. Kushner, customers’ demands.
controlled substances for the treatment Certifying Officer, Division of Trade By letter dated March 10, 2005, the
of pain. Adjustment Assistance. petitioner’s request for reconsideration
Dated: August 19, 2005. [FR Doc. E5–4683 Filed 8–25–05; 8:45 am] was dismissed based on the finding that
Michele M. Leonhart, BILLING CODE 4510–30–P no new facts of a substantive nature
Deputy Administrator.
which would bear importantly on the
Department’s determination was
[FR Doc. 05–16954 Filed 8–25–05; 8:45 am]
provided by the petitioner. On March
BILLING CODE 4410–09–P 11, 2005, the Dismissal of Application

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