[Federal Register Volume 67, Number 8 (Friday, January 11, 2002)]
[Pages 1507-1508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-796]



Drug Enforcement Administration

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.



    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 

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]