11 January 2002
Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html
-------------------------------------------------------------------------
[Federal Register: January 11, 2002 (Volume 67, Number 8)]
[Notices]
[Page 1507-1508]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja02-96]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA-224N]
RIN 1117-AA60
Notice of Intent To Conduct Performance Verification Testing of
Public Key Infrastructure Enabled Controlled Substance Orders
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As part of its Electronic Commerce Initiatives, DEA, in
partnership with the Health Care Distribution Management Association
(HDMA) and the National Association of Chain Drug Stores (NACDS),
announces its intent to conduct a pilot project to test PKI-enabled
controlled substances orders.
DATES: Persons interested in participating in this pilot project must
notify DEA of participation no later than January 25, 2002.
[[Page 1508]]
ADDRESSES: Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, Washington, D.C., 20537, Attention:
Vickie Seeger, R.Ph., ODLP; fax: (202) 307-8570; http://
www.deadiversion.usdoj.gov
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Telephone (202) 307-7297. The
Business Contact is Mike Patnode, PEC Solutions Inc., (703) 679-4900,
the Administrative Contact is: Steve Bruck, PEC Solutions Inc., (703)
679-4900, the Technical contact is: Trung Tran, PEC Solutions Inc.,
(703) 679-4900, the Testing contact is: Margaret Leary, PEC Solutions
Inc., (703) 679-4900.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the Controlled Substances Act of 1970 (CSA),
DEA, regulates the manufacture and distribution of controlled
substances in the United States. This regulatory control is designed to
ensure there is a sufficient supply of controlled substances for
legitimate medical, scientific, research, and industrial purposes while
preventing the diversion of legitimate controlled substances into
illegal channels. To do this, the CSA creates a closed system of
distribution. For Schedules I and II controlled substances, the CSA
requires that distributions be made only in response to a DEA FORM 222,
``U.S. Official Order Forms for Schedules I and II Controlled
Substances (Accountable Forms)''. Currently, this is a paper-based
system using a triplicate form issued by DEA. DEA is working to modify
its regulations to allow for a secure electronic system for the
transmission of controlled substances orders without the supporting
paper DEA Form 222. The Controlled Substances Ordering System (CSOS) is
expected to bring numerous benefits to the manufacturing, distribution,
and pharmacy community by allowing more efficient and cost effective
means of ordering and distributing Schedule I and II controlled
substances.
The Pilot Project
As a first step, DEA is establishing a pilot project, which will
allow industry participants to test their internal order systems using
proposed DEA PKI standards, and identify and resolve technical and
operational issues. DEA is working with PEC Solutions, Inc. (PEC) which
will operate the pilot project and act as a technical point of contact
for Industry participants.
DEA believes that the development of these new standards and
regulations must be based on a clear understanding of industry
practices, health care delivery issues, and legal/regulatory
requirements at both the state and Federal levels. As a result, the
pilot project is designed to allow interested parties to evaluate the
use of DEA's planned controlled substances Public Key Infrastructure
for digitally signed controlled substances orders. Participants will be
expected to operate their system in accordance with DEA's proposed
standards, which can be found on the Diversion Control Program web site
(http://www.deadiversion.usdoj.gov). The pilot project is expected to
be conducted in multiple phases over a 6-month period during 2002:
Phase I, online registration; Phase II, application; Phase III, order
processing; Phase IV, reporting; Phase V, DEA auditing.
How To Participate
During the course of the pilot project, DEA will be coordinating
with Industry representatives to identify and resolve technological and
policy issues. This input will be used to refine the system standards.
Any organization that supports registrants in the supply chain business
category wishing to participate in the pilot project should notify DEA
in writing. The letter should contain the following information, and
should be provided to DEA at the address listed in the Addresses
section of this notice: (1) company/organization name; (2) company/
organization address; (3) DEA registration number, if applicable; (4)
the name, address, phone number, and e-mail address of the primary and
secondary points of contact coordinating the company's/organization's
pilot project participation.
Note: Due to current delays in receiving mail, DEA recommends that
interested participants submit notice of participation via facsimile at
(202) 307-8570 and submit the original participation notification to
follow via mail. The deadline for notification of participation in the
pilot project is January 25, 2002. Periodic announcements will be made
to coordinate follow-on phases of the pilot project. Such announcements
will be made on the Diversion Control Program web site at http://
www.deadiversion.usdoj.gov,and will also be made directly to identified
participants. Pilot project participants will be expected to secure the
resources to support their participation in the project. A conference
call will be held in January, 2002 to explain the pilot process to
potential participants.
Dated: January 4, 2002.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 02-796 Filed 1-10-02; 8:45 am]
BILLING CODE 4410-09-P