2010-32104. 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; [phone].

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: [e-mail]. 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 [e-mail]. 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. 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: [phone].

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]

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 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:

Title:

Company/Organization:

Address:

Telephone:

E-mail address:

Date(s) you wish to attend:

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.

Footnotes

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.