Notices - 1999
[Federal Register: December 13, 1999 (Volume 64, Number 238)] [Notices] [Page 69548-69549] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13de99-96]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Contingency Plans for Year 2000
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice; Guidance.
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.
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.
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:
- 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.
- Until computer-generated certificates can be issued, form letters will be provided to new registrations to serve as proof of registration.
- 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.
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
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.
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).