Notices - 2010
[Federal Register: December 22, 2010 (Volume 75, Number 245)]
[Notices]
[Page 80536-80538]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de10-100]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-316N]
RIN 1117-AB18
Procedures for the Surrender of Unwanted Controlled Substances by
Ultimate Users; Notice of Meeting
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of meeting.
SUMMARY: The Drug Enforcement Administration (DEA) is conducting a
public meeting to discuss procedures for the surrender of unwanted
controlled substances by ultimate users and long term care facilities
in the development of regulations to implement the Secure and
Responsible Drug Disposal Act of 2010. Specifically, DEA invites all
interested persons, including ultimate users, pharmacies, law
enforcement, reverse distributors, and other third parties to express
their views at the meeting or by written comment concerning the most
safe and effective method of disposal of controlled substances
consistent with the Controlled Substances Act and the Secure and
Responsible Drug Disposal Act of 2010.
DATES: This meeting will be held Wednesday, January 19, 2011, and
Thursday, January 20, 2011, 9 a.m. until 5:30 p.m. Check-in will begin
at 8 a.m. This meeting will be held at the Mayflower Renaissance
Washington, DC Hotel, 1127 Connecticut Avenue, NW., Washington, DC
20036; (202) 347-3000.
MEETING ATTENDANCE: Persons wishing to attend this meeting, space
permitting, must provide attendee information to the Liaison and Policy
Section, Office of Diversion Control, Drug Enforcement Administration,
via e-mail: dea.diversion.policy@usdoj.gov. DEA will only accept
requests to attend this public meeting by e-mail. Please include
"Disposal meeting attendee information" in the subject line of the e-mail. Persons wishing to attend this meeting must provide the
information requested under "Meeting Participation" to the Liaison
and Policy Section via e-mail no later than January 12, 2011. There is
no fee to register for the meeting and registrations will be accepted
on a first-come, first-served basis. Early registration is encouraged
because seating is limited.
MEETING PRESENTATIONS: DEA is accepting requests to make limited oral
presentations during the public meeting, as discussed further in this
document. Persons wishing to give an oral presentation at this meeting,
space and time permitting, must provide attendee information and
indicate the desire to present at this public meeting to the Liaison
and Policy Section, Office of Diversion Control, Drug Enforcement
Administration, via e-mail to dea.diversion.policy@usdoj.gov. DEA will
only accept requests to present at this public meeting by e-mail.
Please include "Disposal meeting: Request to present" in the subject
line of the e-mail.
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Persons wishing to give an oral presentation at this meeting must
provide the information requested under "Meeting Participation" to
the Liaison and Policy Section no later than January 7, 2011. Persons
and groups having similar interests may wish to consider consolidating
their information for an oral presentation through a single
representative. After reviewing the requests to present, DEA will
respond to all persons that request an oral presentation to notify them
of the status of their request. If selected to give an oral
presentation, DEA will notify the presenting person or party of the
amount of time available to present and the approximate time the
participant's presentation is scheduled to begin.
SUBMISSION OF WRITTEN COMMENTS: DEA is accepting written comments as
discussed further in this document. Commenters should reference
"Docket No. DEA-316" on all electronic and written correspondence.
Written comments must be postmarked and electronic comments must be
submitted on or before January 12, 2011. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after midnight Eastern Time on the last day of the comment
period.
Comments may be sent electronically through http://www.regulations.gov using the electronic comment form provided on that
site. Please note that DEA is requesting that electronic comments be
submitted before midnight Eastern time on the day the comment period
closes because http://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern time on the day the
comment period closes. Commenters in time zones other than Eastern time
may want to consider this so that their electronic comments are
received.
Written comments sent via regular or express mail should be sent to
the Drug Enforcement Administration, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. All
comments sent via regular or express mail will be considered timely if
postmarked on the day the comment period closes.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152,
telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION: Posting of Public Comments: All submitted comments will be made
available to be viewed on the Web site: http://www.regulations.gov
prior to the public meeting. A link to this electronic docket will be
available at the DEA Diversion Control Program Web site, http://www.deadiversion.usdoj.gov.
Please note that all comments received are considered part of the
public record and made available for public inspection online at http://www.regulations.gov and in the Drug Enforcement Administration's
public docket. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase "Personal Identifying Information" in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase "Confidential
Business Informationm" in the first paragraph of your comment. You
must also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.
Background
The nonmedical use of prescription drugs is a growing problem in
the United States, particularly among teenagers. According to the
Department of Justice's 2009 National Prescription Drug Threat
Assessment, unintentional overdose deaths involving prescription
opioids increased 114 percent from 2001 to 2005, and the number of
treatment admissions for prescription opioids increased 74 percent from
2002 to 2006. Teens abuse prescription drugs more than any illicit drug
except marijuana--more than cocaine, heroin, and methamphetamine
combined.\1\ In 2009, 2.2 million (nearly one third (28.6%) of first
time drug abusers) persons age 12 or older abused prescription
drugs.\2\
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\1\ Office of National Drug Control Policy 2008 "Prescription
for Danger" January 24, 2008
\2\ 2009 National Survey on Drug Use and Health (NSDUH),
September 2010.
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DEA recognizes that abuse of prescription controlled substances is
a significant issue in our nation's communities. When originally
enacted in 1970, the Controlled Substances Act (CSA) and its
implementing regulations did not contemplate a situation in which an
ultimate user would deliver previously dispensed controlled substances
to another person or entity. The CSA defines an ultimate user of a
controlled substance as "a person who has lawfully obtained, and who
possesses, a controlled substance for his own use or for the use of a
member of his household or for an animal owned by him or a member of
his household" (21 U.S.C. 802(27)). Under the CSA, "the term
`distribute' means to deliver (other than by administering or
dispensing) a controlled substance or a listed chemical." (21 U.S.C.
802(11)). "The terms `deliver' or `delivery' mean the actual,
constructive, or attempted transfer of a controlled substance or a
listed chemical, whether or not there exists an agency relationship."
(21 U.S.C. 802(8)).
On October 12, 2010, the Secure and Responsible Drug Disposal Act
of 2010 (Pub. L. 111-273) was enacted. This act amended the Controlled
Substances Act to allow ultimate users to dispose of unwanted
controlled substances by delivering them to entities authorized by the
Attorney General to accept them. This act also allows the Attorney
General to authorize long term care facilities to dispose of their
residents' controlled substances in certain instances. DEA is currently
drafting regulations that would allow for the disposal of unwanted
controlled substances by those not registered with DEA.
DEA has been charged by Congress with preventing diversion of
controlled substances during the disposal process, and with considering
the public health and safety as well as the ease and cost of program
implementation and participation by various communities in drafting
regulations to implement the
[[Page 80538]]
law. DEA also recognizes concerns raised by State and local
governments, the healthcare industry, the law enforcement community,
public and private environmental organizations, and individual
citizens. In response to these concerns, DEA is holding a public
meeting to gather information from interested persons regarding
potential solutions within the framework of the Controlled Substances
Act.
As discussed above, DEA is seeking input in the form of oral
presentations and written comments. Regardless of the format, specific
concerns which persons are encouraged to address are as follows:
- The process of the disposal of unwanted controlled
substances could create new and unwanted avenues for diversion. What is
the safest manner, in your opinion, to dispose of unwanted controlled
substances while preventing diversion?
- Please explain why you believe the solution you propose
would protect the public health and safety and would curtail diversion.
- Do you foresee any specific obstacles to the disposal of
controlled substances in your community or geographical area? If so,
what are they?
- How is the disposal of controlled substances affected by
State and local laws and regulations?
Meeting Participation
This meeting is open to the public. Persons and organizations
representing state and local governments; law enforcement agencies;
publicly owned treatment works; DEA-registered pharmacies; DEA-registered manufacturers, distributors, and reverse distributors;
ultimate users of controlled substances (i.e., patients and members of
their households); long term care facilities; hospices and in-home care
groups; and other concerned organizations may be particularly
interested in this meeting.
Persons wishing to attend, or provide oral presentations at this
meeting, time and space permitting, must provide the following
information to the Liaison and Policy Section using the contact
information listed above no later than January 7, 2011 (request to
present) and January 12, 2011 (request to attend):
Name:
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Title:
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Company/Organization:
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Address:
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Telephone:
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E-mail address:
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Date(s) you wish to attend:
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Persons should clearly indicate in the subject line of their e-mail
whether they are requesting to attend the meeting or requesting to
present at the meeting, following the "Meeting Attendance" and
"Meeting Presentations" sections of this notice.
Please note that this public meeting will not be webcast. A copy of
the transcript from this public meeting will be made available at the
DEA Diversion Control Program Web site, http://www.deadiversion.usdoj.gov.
Persons needing accommodations (e.g., sign language interpreter)
are requested to notify DEA with their accommodation request no later
than January 7, 2011.
As this meeting is open to the public, confidential business
information or other proprietary information should NOT be shared.
Persons wishing to provide written comments may do so no later than
January 12, 2011. All comments will be made available at http://www.regulations.gov in the electronic docket for this notice of
meeting. A link to the electronic docket may be found at http://www.deadiversion.usdoj.gov. Please see the "Submission of Written
Comments" section for further information regarding providing written
comments.
Dated: December 16, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-32104 Filed 12-21-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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