System Notice: 09-30-0052 1

Opioid Treatment Waiver Notification System (OTWNS)

SYSTEM NAME:

Opioid Treatment Waiver Notification System (OTWNS)

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

An individual practitioner (physician) or a practitioner in a group practice who submits a written notification of intent to use schedule III, IV, or V opioid drugs for the maintenance or detoxification treatment of opiate addiction under 21 U.S.C. § 823 (g)(2).

CATEGORIES OF RECORDS IN THE SYSTEM:

Physician name, address, phone, facsimile, state medical license number, DEA registration number, credentialing and specialized training information. In addition, for those practitioners in group practices, the group practice EIN.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Controlled Substance Act (21 U.S.C. § 823 (g)(2)).

PURPOSE(S):

To determine (as required by 21 U.S.C. § 823 (g)(2)) whether practitioners who submit notifications meet all of the requirements for a waiver under 21 U.S.C. § 823 (g)(2)(B). The established criteria for a waiver include: a written notification that states the practitioner's name, the practitioner's registration under 21 U.S.C. § 823 (f), the practitioner's physician license under State law, and the qualifying physician criteria. The record system will also allow disclosure with consent of limited information to the Treatment Facility Locator.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:

  1. Medical specialty societies to verify practitioner qualifications.
  2. Other federal law enforcement and regulatory agencies for law enforcement and regulatory purposes.
  3. State and local law enforcement and regulatory agencies for law enforcement and regulatory purposes.
  4. Persons registered under the Controlled Substance Act (PL 91-513) for the purpose of verifying the registration of customers and practitioners.
  5. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual.
  6. The Department of Health and Human Services (HHS) may disclose information from this system of records to the Department of Justice, or to a court or other tribunal, when (a) HHS, or any component thereof; or (b) any HHS employee in his or her official capacity; or (c) any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or (d) the United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components, is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the court or other tribunal is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided however, that in each case, HHS determines that such disclosure is compatible
    with the purpose for which the records were collected.
  7. SAMHSA intends to disclose information from this system to an expert, consultant, or contractor (including employees of the contractor) of SAMHSA if necessary to further the implementation and operation of this program.
  8. Disclosure limited to the individual's name, address, and phone number will also be made to the SAMHSA Treatment Facility Locator pursuant to express consent.
  9. To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department’s efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and necessary for that assistance.

DISCLOSURES TO CONSUMER REPORTING AGENCIES:

None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM STORAGE:

Documents are filed in manual files in enclosed and/or locked file cabinets and in secured computers. The same basic data is maintained in an automated system for quick retrieval.

RETRIEVABILITY:

Records are retrieved by the individual practitioner's name and cross indexed by the practitioner's DEA registration number.

SAFEGUARDS:

  1. Authorized Users: Federal contract and support personnel.
  2. Physical Safeguards: All folders are in file cabinets in a room that is locked after business hours in a building with controlled entry (picture identification). Files are withdrawn from cabinet for Federal staff who have a need to know by a sign in and out procedure.
  3. Procedural Safeguards: Access to records is strictly limited to those staff members trained in accordance with the Privacy Act.
  4. Implementation Guidelines: DHHS Chapter 45-13 of the General Administration Manual.

RETENTION AND DISPOSAL:

Records are retained for a period of five years and then destroyed.

SYSTEM MANAGER(S) AND ADDRESS:

Ivette Ruiz
Division of Pharmacologic Therapies
Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration
13E25A
5600 Fishers Lane
Rockville, Maryland 20857

NOTIFICATION PROCEDURES:

To determine if a record exists, write to the appropriate System Manager at the address above or appear in person to the Division of Contracts Management. An individual may learn if a record exists about himself/herself upon written request with notarized signature. An individual who is the subject of records maintained in this record system may also request an accounting of all disclosures that have been made from that individual's records, if any.

RECORD ACCESS PROCEDURES:

Same as notification procedures. Requesters should specify the record contents being sought. An individual may also request an accounting of disclosures of his/her record, if any.

CONTESTING RECORD PROCEDURES:

Contact the official at the address specified under notification procedures above and identify the record, specify the information being contested, the corrective action sought, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:

Individual practitioner notifications of intent to use Schedule III, IV, or V opioid drugs for the Maintenance and Detoxification Treatment of Opiate Addiction under 21 USC § 823(g)(2)

SYSTEM EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:

None.


  1. Published in the Federal Register, Vol. 75, No. 97, Thursday, May 20, 2010 (pages 28264-28275)
Last Updated: 09/15/2017