[Federal Register: March 5, 2001 (Volume 66, Number 43)]
[Proposed Rules]
[Page 13274]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr01-21]
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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.
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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]
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