[Federal Register Volume 64, Number 238 (Monday, December 13, 1999)]
[Notices]
[Pages 69548-69549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32101]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA-188N]


Contingency Plans for Year 2000

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice; Guidance.

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SUMMARY: In light of the possibility that computer or operational 
difficulties may arise due to the transition to the year 2000, the Drug 
Enforcement Administration (DEA) is detailing its contingency plans for 
the Year 2000. In consultation with the regulated chemical and 
pharmaceutical industries, DEA has prepared these plans to ensure a 
smooth transition to the new millennium.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Washington, D.C. 20537, 
(202) 307-7297.

SUPPLEMENTARY INFORMATION: 

What Is the Purpose of This Notice?

    This notice makes public the Drug Enforcement Administration's 
(DEA's) business continuity and contingency plans to deal with any 
computer or operational difficulties which may result from Year 2000 
(Y2K) problems.

Background

    Concerns have arisen within both the public and private sectors as 
to possible computer or operational problems which might occur due to 
the use of two-digit date fields in computer files as dates change from 
December 31, 1999 to January 1, 2000. Functionality of key systems, 
including telephones, power and other utilities, as well as computer-
based business functionality have been questioned. Much discussion has 
occurred as to the types of problems which might be encountered and the 
best contingency plans available to deal with them should they arise.
    DEA undertook a thorough review of its systems to determine where 
problems might exist and to work proactively, both internally and 
externally, to ensure that the regulated industries are prepared for 
2000.

What Steps Has DEA Taken To Prepare for the Possibility of 
Problems?

    In order to prepare for the possibility that problems might arise, 
either internally or externally, DEA has developed a business 
continuity and contingency plan to have in place back-up systems, where 
necessary, to deal with problems, should they arise.

Registration and Reregistration

    Many registrant services are computer-based. While all efforts have 
been made to ensure that DEA's registration systems are unaffected, as 
a contingency against interruption of controlled substance registration 
service, DEA has taken a number of precautionary steps:
    1. All renewal applications that would normally be printed in 
January, February, and March 2000, have been preprinted. Matching 
certificates of registration have also been preprinted. the forms and 
certificates will be manually sent to registrants.
    2. Until computer-generated certificates can be issued, form 
letters will be provided to new registrations to serve as proof of 
registration.
    3. Until computer generated certificates can be issued, form 
letters will also be provided to registrants requiring modification of 
their registration.

Quotas for the Manufacture of Controlled Substances

    Concerns have been expressed that there may be some stockpiling of 
controlled substances by patients worried about the availability of 
controlled substances. This stockpiling, should it occur, could result 
in shortages of controlled substances for patients in the early part of 
2000. In an effort to ensure that any stockpiling does not strain the 
controlled substances system, and to ensure that manufacturers and 
distributors of controlled substances do not experience shortages of 
raw materials, DEA has adjusted the aggregate production quotas to 
include the allowable maximum of 50 percent inventories for each basic 
class of controlled substances manufactured for legitimate medical use 
(64 FR 56366; October 19, 1999).

Automation of Reports and Consolidated Orders System

    The Automation of Reports and Consolidated Orders System (ARCOS) is 
the automated system used by DEA to monitor selected controlled 
substances inventories and transactions. All registrants required to 
submit ARCOS reports should do so under the normal schedule of 
reporting. If there are interruptions in the computer system, the ARCOS 
Unit of DEA will collect the reports and catalog them into a library 
until such time as they can be entered into the computer system.

Importation and Exportation of Controlled Substances

    Many countries, including the United States, use import/export 
permits which expire on December 31 of each calendar year, mainly due 
to annual United Nations reporting requirements. Therefore, as a matter 
of routine, there is a large influx of applications for import and 
export permits submitted to DEA during the last week of November and 
the first two weeks of December of each calendar year in the hopes of 
meeting the December 31 deadline. Registrants should coordinate with 
their foreign importer or exporter as much as possible so that they 
receive the import or export authorization as soon as possible. 
Registrants should make every attempt to submit their application and 
supporting documents as early as possible. If, after January 1, 2000, 
Y2K problems exist, DEA will implement measures to assist registrants 
in working through the international authorities. If a problem exists, 
registrants should contact the International Drug Unit, Office of 
Diversion Control, Drug Enforcement Administration at (202) 307-4747.
    Unlike the permit process, import/export declarations (DEA form 
236) will not be overly impacted by Y2K issues, should they occur, 
since registrants are not dependent upon DEA to take any action prior 
to an import or export of controlled substances pursuant to an import/
export declaration. However, if the situation arises, DEA will take 
similar actions as set forth for the import and export permits 
describes above.

Chemicals

    There are four major functions associated with the chemical control 
program which could be impacted by Y2K: import/export declarations from 
the chemical industry, registration of chemical handlers, transmission 
of letters to no objection, and the transmission of multilateral 
notifications to other governments. Outlines below are the 
contingencies associated with each area.
    Import/export (DEA form 486): Industry should not submit import/
export declarations (DEA form 486) in the days immediately preceding 
and following January 1, 2000. For

[[Page 69549]]

shipments scheduled to depart near the year end, the industry should 
file their DEA form 486 as far as possible prior to January 1, 2000. 
Many forms are submitted to DEA through the use of facsimile 
transmission. Should this technology be unavailable to DEA or industry, 
industry should overnight mail the forms to DEA. Forms should be sent 
to: Drug Enforcement Administration Headquarters, ATTN.: ODIA--Chemical 
import/export Declaration, 2401 Jefferson Davis Highway, Alexandria, VA 
22301.
    Processing of registration applications: DEA has discussed 
previously in this notice steps which are being taken to process 
controlled substances registrations and reregisterations. The process 
of chemical registrations will be accomplished in the same manner as 
the processing of controlled substances registrations.
    Transmission of letters of no objection: Transmissions of letters 
of no objection to industry is normally accomplished through facsimile. 
If this method of transmission is unavailable to DEA, letters will be 
sent through the regular mail system.
    Transmission of multilateral notifications to other governments: 
Normally, multilateral notifications to other governments are sent by 
facsimile. If this method of transmission is unavailable to DEA, only 
urgent notifications will be addressed and express mailed to overseas 
DEA offices.

Delegation of Authority

    It is impossible to anticipate every potential problem which might 
occur within the regulated industries as a result of Y2K. As part of 
its plans to deal with such problems, DEA is considering the 
possibility of having certain authorities presently delegated to the 
Deputy Assistant Administrator, Office of Diversion Control, 
temporarily delegated to field managers. DEA's goal is to ensure that 
registrants and regulated persons have a means of contacting DEA if 
exigent circumstances related to Y2K require the waiver of regulatory 
requirements. If DEA determines that this action is appropriate, it 
will publish a separate rule in the Federal Register delegating these 
authorities.

What Has the DEA Done To Work With Industry To Proactively Address 
Y2K Concerns?

    In July 1999, DEA sent a letter to the regulated industries 
detailing its contingency plans and requesting feedback regarding 
concerns or foreseen difficulties. Responses received indicated that no 
problems were foreseen. Further, in its direct contacts with the 
regulated industries, DEA has been assured that they are fully aware of 
the potential for Y2K problems and are actively working to ensure that 
they will not be impacted by these potential difficulties.

What Does DEA Recommend to Registrants as Contingencies To Prepare 
for Y2K?

    In an effort to prevent problems from occurring, DEA wishes to 
offer suggestions to registrants to prepare for Y2K.
    Registrants who use fairly substantial numbers of order forms 
should take steps to ensure that they have an adequate supply on hand. 
DEA's Registration Unit contacted the high volume order form users 
directly to ensure extra order forms were requested. If a registrant 
has not been contacted, and desires additional order forms, the 
registrant should contact the Registration Unit of DEA at (800) 882-
9539.
    Pharmacies maintaining prescription refill information 
electronically may wish to create a hard copy backup of this 
information shortly before the new year. This would allow these 
pharmacies to have hard copy information on hand regarding all 
prescriptions pending refills in the event that problems arise, and to 
guard against the possibility of diversion through multiple 
prescription filling or filling of prescriptions for which refill 
orders do not exist.
    Registrants using alarm systems to secure their controlled 
substances are advised to be aware of telephone and computer problems 
related to the companies administering those alarm systems. DEA 
suggests that these registrants have contingency plans in place with 
security companies so that, should difficulties with automated alarm 
systems arise, alternate nonautomated physical security plans are in 
place and immediately available for the registrant's use.

Conclusion

    It is hoped that the contingency plan DEA has outlined here, along 
with the preparedness measures the regulated industries have already 
taken, will create a seamless, trouble-free, transition to the year 
2000. However, if further concerns arise, regulated persons, 
registrants and other interested parties are encouraged to contact the 
Liaison and Policy Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Telephone (202) 307-
7297.

    Dated: December 6, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 99-32101 Filed 12-10-99; 8:45 am]
BILLING CODE 4410-09-M