02-796. 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.

ADDRESSES:

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C., 20537, Attention: Vickie Seeger, R.Ph., ODLP; fax: [phone]; 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 [phone]. The Business Contact is Mike Patnode, PEC Solutions Inc., [phone], the Administrative Contact is: Steve Bruck, PEC Solutions Inc., [phone], the Technical contact is: Trung Tran, PEC Solutions Inc., [phone], the Testing contact is: Margaret Leary, PEC Solutions Inc., [phone].

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 [phone] 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.