Reporting and Recordkeeping Requirements Related to Suspicious Orders

Forms and Documents

Document	Type	Status	Availability
Form Not Applicable Reporting and Recordkeeping Requirements Related to Suspicious Orders	Form and Instruction	New	Repair queued
1117-NEW Supporting Statement _SORS (1).docx	Supporting Statement A	Uploaded 2020-12-07	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
244785	Reporting and Recordkeeping Requirements Related to Suspicious Orders	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202012-1117-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Reporting and Recordkeeping Requirements Related to Suspicious Orders
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/08/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	338,840	0
Time Burden (Hours)	90,357	0
Cost Burden (Dollars)	4,740,372	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 801-971 Name of Law: The Controlled Substances Act
   PL: Pub.L. 115 - 271 3291, 3292 Name of Law: The Preventing Drug Diversion Act of 2018
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 271 3291-3292 Name of Law: The Preventing Drug Diversion Act of 2018

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB47	Proposed rulemaking	85 FR 69282	11/02/2020

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Reporting and Recordkeeping Requirements Related to Suspicious Orders	Not Applicable	Suspicious Orders of Controlled Substances Database

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	338,840	0	0	338,840	0	0
Annual Time Burden (Hours)	90,357	0	0	90,357	0	0
Annual Cost Burden (Dollars)	4,740,372	0	0	4,740,372	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection. Therefore there is not a previous burden to compare it to.

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Annual Cost to Federal Government:

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 12/08/2020

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