[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Proposed Rules]
[Page 13274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5362]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1304, 1305, 1306, 1311

[DEA-214A]
RIN 1117-AA60, 1117-AA61


Electronic Commerce: Electronic Orders for Schedule I and II 
Controlled Substances; Electronic Prescriptions for Controlled 
Substances

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Advance notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) is publishing this 
Advance Notice of Proposed Rulemaking to formally notify the interested 
public of DEA's intent to publish Notices of Proposed Rulemaking 
regarding two electronic initiatives. The first electronic initiative 
(RIN 1117-AA60) will propose regulations to provide DEA registrants 
with the option of ordering Schedule I and II controlled substances 
electronically in a manner consistent with the requirements of the 
Controlled Substances Act (21 U.S.C. 801 et seq.). The regulations will 
propose that this electronic system may also be used for ordering 
controlled substances in Schedules III, IV and V. The second electronic 
initiative (RIN 1117-AA61) will propose regulations to permit DEA 
registered prescribers to electronically write, sign and transmit 
prescriptions. These proposed regulations would be an addition to, not 
a replacement of, the existing rules. Through these electronic 
initiatives, DEA will be proposing regulations consistent with the 
Government Paperwork Elimination Act (Pub. L. 105-277) (GPEA) and the 
Electronic Signatures in Global and National Commerce Act (Pub. L. 106-
229) (E-Sign). Publication of this Advance Notice of Proposed 
Rulemaking also responds to the requirements of E-Sign which state that 
for a Federal agency which has announced, proposed, or initiated a 
rulemaking proceeding to prescribe a regulation responding to E-Sign on 
or before March 1, 2001, the effect of E-Sign's record retention 
provision is delayed until June 1, 2001.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, Telephone (202) 307-7297, Web 
site: http://www.deadiversion.usdoj.gov.

SUPPLEMENTARY INFORMATION:

Why Is DEA Publishing This Advance Notice of Proposed Rulemaking?

    DEA is publishing this Advance Notice of Proposed Rulemaking to 
formally notify the interested public that DEA intends to publish, in 
the near future, two Notices of Proposed Rulemaking regarding two 
electronic initiatives DEA has undertaken. These electronic 
initiatives, and their accompanying regulations, will permit DEA to 
comply with GPEA and E-Sign, while ensuring appropriate controls over 
the ordering and prescribing of controlled substances in order to 
prevent diversion. DEA is publishing this Advance Notice of Proposed 
Rulemaking to comply with Sec. 107(b)(1)(B) of Pub. L. 106-229 which 
states: ``DELAYED EFFECT FOR PENDING RULEMAKINGS. If on March 1, 2001, 
a Federal regulatory agency or State regulatory agency has announced, 
proposed, or initiated, but not completed, a rulemaking proceeding to 
prescribe a regulation under section 104(b)(3) with respect to a 
requirement described in subparagraph (A), this title shall be 
effective on June 1, 2001, with respect to such requirement.''

What Electronic Initiatives Does DEA Intend To Propose?

    DEA expects to publish, in the near future, two Notices of Proposed 
Rulemaking to propose new regulations for two electronic initiatives. 
The first electronic initiative (RIN 1117-AA60) will propose 
regulations to provide DEA registrants with the option of ordering 
Schedule I and II controlled substances electronically in a manner 
consistent with the requirements of the Controlled Substances Act (21 
U.S.C. 801 et seq.). The regulations will propose that this electronic 
system may also be used for controlled substances in Schedules III, IV 
and V. The second electronic initiative (RIN 1117-AA61) will propose 
regulations to permit DEA registered prescribers to electronically 
write, sign and transmit prescriptions. These proposed regulations 
would be an addition to, not a replacement of, the existing rules.

What Actions Has DEA Already Undertaken Regarding These Electronic 
Initiatives?

    In 1999, PEC Solutions, Inc. (PEC) (formerly Performance 
Engineering Corporation) was selected by DEA's Office of Diversion 
Control to analyze mandated, paper-based regulatory processes and to 
design and develop proposed concepts for public key infrastructures 
(PKIs) that would allow DEA and industry the option of using the 
current paper-based systems or electronic formats to order or prescribe 
controlled substances. As part of the project methodology, DEA/PEC 
sought input from persons within the interested industries to gain an 
understanding of processes involved in these regulated activities. DEA 
has published relevant documents and information regarding both 
electronic initiatives on the Office of Diversion Control's web site, 
at http://www.deadiversion.usdoj.gov, link to ``Electronic Commerce 
Initiatives''. Finally, DEA has held a number of public meetings 
(announced on DEA's web site and in letters to the industry) to detail 
progress of the projects, answer questions and solicit further input. 
DEA continues to provide information on its web site regarding project 
documents, updates and future meetings.

Rulemaking Analyses and Notices

    Due to the preliminary nature of this document, information to 
complete the rulemaking analyses and notice is unavailable, and thus, 
not contained in this Advance Notice of Proposed Rulemaking.

    Dated: February 27, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 01-5362 Filed 3-1-01; 11:12 am]
BILLING CODE 4410-09-P