Reporting and Recordkeeping
Requirements Related to Suspicious Orders
New
collection (Request for a new OMB Control Number)
No
Regular
12/08/2020
Requested
Previously Approved
36 Months From Approved
338,840
0
90,357
0
4,740,372
0
This new information collection is
related to the reporting of orders received under suspicious
circumstances (ORUSCs). DEA implements and enforces titles II and
III of the Comprehensive Drug Abuse Prevention and Control Act of
1970, Pub. L. No. 91-513, 84 Stat. 1242 (1970), as amended
(collectively, the CSA). 21 U.S.C. 801–971. The CSA requires
registrants to design and operate a system to disclose to the
registrant suspicious orders of controlled substances, i.e., orders
of unusual size, orders deviating from a normal pattern, and orders
of unusual frequency. Registrants are also required to “inform the
Field Division Office of the Administration in his area of
suspicious orders when discovered by the registrant.” The
collection would include two distinct components: the reporting of
suspicious orders, and recordkeeping related to suspicious orders
and ORUSCs. The collection would be applicable to registrants that
distribute controlled substances, including manufacturers,
distributors, importers, and pharmacies (and other practitioners in
certain cases). Registrants would be required to file suspicious
order reports through DEA's centralized database. Each report must
contain: the DEA registration number of the registrant placing the
order for controlled substances; the date the order was received;
the DEA registration number of the registrant making the report;
the National Drug Code number, unit, dosage strength, and quantity
of the controlled substances ordered; the order form number for
schedule I and schedule II controlled substances; the unique
transaction identification number for the suspicious order; and
what information and circumstances rendered the order actually
suspicious.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form Not Applicable Reporting and Recordkeeping Requirements Related to Suspicious Orders
1117-NEW Supporting Statement _SORS (1).docx
Reporting and Recordkeeping Requirements Related to Suspicious Orders