[Federal Register Volume 71, Number 93 (Monday, May 15, 2006)]
[Notices]
[Pages 28052-28054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7302]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-218N]
RIN 1117-AA61


Electronic Prescriptions for Controlled Substances; Notice of 
Meeting

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of meeting.

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SUMMARY: The Drug Enforcement Administration (DEA), in conjunction with 
the Department of Health and Human Services (HHS), is conducting a 
public meeting to discuss electronic prescriptions for controlled 
substances. Specifically, this meeting is intended to allow industry--
prescribers, pharmacies, software/hardware vendors, and other 
interested third parties--to address how electronic prescribing systems 
can meet DEA's prescription requirements under the Controlled 
Substances Act, without unduly burdening the parties to electronic 
prescribing transactions.

DATES: This meeting will be held Tuesday, July 11, 2006, and Wednesday, 
July 12, 2006, 8:30 a.m. until 5:30 p.m. Registration will begin at 
7:30 a.m. This meeting will be held at the Marriott Crystal City at 
Reagan National Airport, 1999 Jefferson-Davis Highway, Arlington, VA 
22202; (703) 413-5500. The meeting will take place in the Crystal Forum 
amphitheatre, adjacent to the hotel.
    Meeting Attendance: To ensure proper handling, please reference 
``Docket No. DEA-218N'' on all written and electronic correspondence 
regarding this meeting. 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 to [email protected], or via facsimile, (202) 
353-1079, as specified below. Persons wishing to attend the meeting 
must provide this information to the Liaison and Policy Section no 
later than June 26, 2006.
    Comments: All written comments will be made available at the 
Diversion Control Program Web site, http://www.deadiversion.usdoj.gov 
prior to the public meeting. Therefore, as this is a public meeting, 
confidential business information or other proprietary information 
SHOULD NOT be presented at this meeting.
    Persons wishing to provide written comments must do so no later 
than June 26, 2006. To ensure proper handling of

[[Page 28053]]

comments, please reference ``Docket No. DEA-218N'' on all written and 
electronic correspondence. Written comments being sent via regular mail 
should be sent to the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, Washington, DC 
20537, Attention: DEA Federal Register Representative/ODL. Written 
comments sent via express mail should be sent to DEA Headquarters, 
Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-
Davis Highway, Alexandria, VA 22301. Comments may be directly sent to 
DEA electronically by sending an electronic message to 
[email protected]. DEA will accept attachments to 
electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file format other than those 
specifically listed here.
    This meeting will consist of panel presentations. There will be 
limited opportunities for attendees to make oral comments at the 
meeting.

FOR FURTHER INFORMATION, CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION: Many within the health care industry are 
encouraging the adoption of electronic prescriptions because such 
prescriptions would improve patient safety by eliminating medical 
errors that arise from misread or misunderstood handwritten 
prescriptions. These parties also focus on the potential cost savings, 
both to industry and the public, realized from, among other benefits: 
fewer medical errors and adverse drug events; fewer callbacks from 
pharmacies to practitioners to clarify handwritten prescription 
information; and reduced ability and opportunity to commit fraud and 
diversion of prescription medications. The focus of these parties is to 
facilitate adoption of electronic prescribing as quickly as possible to 
obtain the benefits that are expected to follow.
    Both the Drug Enforcement Administration (DEA) and the Department 
of Health and Human Services (HHS) have an interest in electronic 
prescribing. DEA is responsible for enforcing the Controlled Substances 
Act, including the prescribing and dispensing of controlled substances 
to the public by DEA-registered practitioners and pharmacies. Such 
enforcement includes the writing and signature of prescriptions and 
retention of prescription records.
    The Department of Health and Human Services has a statutory mandate 
to facilitate adoption of electronic prescribing. The Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 requires 
that ``prescriptions * * * for covered Part D drugs prescribed for Part 
D eligible individuals that are transmitted electronically shall be 
transmitted only in accordance with such standards under an electronic 
prescription drug program'' that meets the requirements of the MMA 
(Pub. L. 108-173). HHS is required to promulgate transmission standards 
for the Medicare electronic prescription drug program. HHS adopted 
foundation standards regarding transmission of electronic prescriptions 
for covered Part D drugs prescribed for Part D eligible individuals by 
publication of a Final Rule which became effective January 1, 2006 (70 
FR 67567, November 7, 2005).
    HHS also has a statutory mandate under the Health Insurance 
Portability and Accountability Act (HIPAA), the Administrative 
Simplification provisions of which require HHS to adopt standards for 
the electronic transmission of health information contained in certain 
financial and administrative transactions. HIPAA also requires HHS to 
adopt standards for the security of electronic health information, and, 
in consultation with the Department of Commerce, to adopt standards for 
electronic signatures for certain HIPAA transactions. These regulations 
and standards are applicable to all health plans (including federal 
health programs), healthcare clearinghouses, and all health care 
providers who conduct electronic transactions.
    Therefore, DEA, in conjunction with HHS, is conducting a public 
meeting to allow the public, including prescribers, pharmacies, 
software/hardware vendors, and other interested third parties, to 
identify electronic signature solutions for electronic prescribing 
which mitigate, to the greatest extent possible, any cost and burdens 
associated with adoption of the new technology while addressing the 
security and accountability requirements under the Controlled 
Substances Act of 1970 as they relate to controlled substances. 
Specific questions which persons are encouraged to address are as 
follows:
     What is your perception of the current risks associated 
with electronic prescribing?
     How did you identify those risks?
     How does your electronic prescribing system address those 
risks?
     Are risks pertaining to prescriptions for controlled 
substances different from prescriptions for non-controlled substances? 
Please explain.
     What additional modifications would be necessary for your 
system to be used for electronic prescribing of controlled substances? 
Please be specific as to how this would be done, and the burden (cost 
or otherwise) this would entail.
     How does your system authenticate the person signing the 
prescription?
     How does your system ensure the integrity of the 
prescription records?
     What current and future threats (e.g., eavesdropping, man-
in-the-middle attack, hijacking, impersonation) to system-wide security 
have you considered during your design, development, and 
implementation?
     If smart cards, open networks or other methods of 
transmission are used to facilitate electronic prescribing, can your 
system work within those environments? Please specifically explain how 
it can or why it cannot.

Meeting Participation

    This meeting is open to the public. Persons and organizations 
representing prescribers, pharmacies, and vendors who design, develop, 
or market electronic prescribing software or hardware/software used to 
permit electronic prescribing [authenticate individuals or used to sign 
or secure electronic documents] may be particularly interested in this 
meeting.
    Persons wishing to attend this meeting, space permitting, must 
provide the following information to the Liaison and Policy Section, 
Office of Diversion Control, Drug Enforcement Administration, no later 
than June 26, 2006 via e-mail or facsimile using the contact 
information listed above:

 Name:-----------------------------------------------------------------

 Title:----------------------------------------------------------------

 Company/Organization:-------------------------------------------------

 Address:--------------------------------------------------------------

 Telephone:------------------------------------------------------------

 E-mail address:-------------------------------------------------------

    Persons needing accommodations (e.g., sign language interpreter) 
are requested to notify DEA with their accommodation request no later 
than June 26, 2006.
    This meeting will consist of panel presentations. There will be 
limited opportunities for attendees to make oral comments at the 
meeting.
    Persons wishing to provide written comments may do so no later than 
June 26, 2006. All written comments will be made available at the 
Diversion Control Program Web site, http://

[[Page 28054]]

www.deadiversion.usdoj.gov prior to the public meeting. Therefore, as 
this is a public meeting, confidential business information or other 
proprietary information SHOULD NOT be presented at this meeting. Please 
see the ``Comments'' section above for further information regarding 
providing written comments.

    Dated: May 9, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
 [FR Doc. E6-7302 Filed 5-12-06; 8:45 am]
BILLING CODE 4410-09-P