U.S. Official Order Forms for Schedules I & II Controlled Substances (Accountable Forms), Order Form Requisition

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form DEA 222 U.S. Official Order Forms for Schedules I & II Controlled Substances (Accountable Forms), Order Form Requisition	Form and Instruction	Modified	Repair queued
1117-0010 Supporting Statement 20190725CLEAN.docx	Supporting Statement A	Uploaded 2020-07-09	Available
21 CFR 1305.pdf	Supplementary Document	Uploaded 2019-07-26	Available
21 USC 828.pdf	Supplementary Document	Uploaded 2019-07-26	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
12302	U.S. Official Order Forms for Schedules I & II Controlled Substances (Accountable Forms), Order Form Requisition	Form and Instruction	Modified

ICR Details

OMB Control No: 1117-0010	ICR Reference No: 202007-1117-002
Status: Active	Previous ICR Reference No: 201907-1117-006
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: U.S. Official Order Forms for Schedules I & II Controlled Substances (Accountable Forms), Order Form Requisition
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/10/2020
	Date Received in OIRA: 07/10/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2023	36 Months From Approved	07/31/2020
Responses	5,350,000	0	9,079,980
Time Burden (Hours)	1,030,000	0	1,453,348
Cost Burden (Dollars)	85,376,700	0	127,240,638

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Abstract: The Controlled Substances Act (CSA) (21 U.S.C. 801-971) establishes a closed system of distribution for controlled substances. To this end, controlled substances are closely monitored and tightly regulated as they are distributed through the supply chain. One tool that helps to maintain the closed system of distribution is the CSA provision that states it “shall be unlawful for any person to distribute a controlled substance in schedules I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) of this section . . . .” 21 U.S.C. 828(a). The regulations implementing this provision are contained in 21 CFR part 1305. Pursuant to the CSA, the DEA provides authorized registrants (e.g., purchasers) with DEA Forms 222 for ordering schedules I and II controlled substances. 21 U.S.C. 828(d). The DEA Form 222 is subsequently provided by the purchaser to a supplier because, without the appropriate DEA Form 222, the supplier is prohibited from distributing schedules I or II controlled substances to the purchaser. Suppliers must then forward an executed copy of each DEA Form 222 to the DEA. This system in which the DEA provides a pre-printed order form to the purchaser, who then submits the annotated order form to the supplier, who then submits the completed form to the DEA, helps maintain the closed system of distribution because each registrant in the transaction serves as a check against the other. Since 2005, registrants have also been permitted to issue orders for schedules I and II controlled substances electronically, provided that the electronic order is signed using a digital certificate issued by the DEA Certification Authority. This electronic ordering system is called the “Controlled Substances Ordering System,” or CSOS. The regulations governing the creation, transmission, and storage of electronic orders are contained in 21 CFR part 1311, subpart B. .

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Authorizing Statute(s): US Code: 21 USC 828 Name of Law: Order Forms
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB44	Final or interim final rulemaking	84 FR 51368	09/30/2019

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5395	02/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5395	04/22/2019
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
U.S. Official Order Forms for Schedules I & II Controlled Substances (Accountable Forms), Order Form Requisition	DEA 222	U.S. Official Order Forms - Schedules I & II

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	5,350,000	9,079,980	0	-3,729,980	0	0
Annual Time Burden (Hours)	1,030,000	1,453,348	0	-423,348	0	0
Annual Cost Burden (Dollars)	85,376,700	127,240,638	0	-41,863,938	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The DEA is adjusting annual responses, burden hours, and annual burden dollars to reflect actual orders issued in calendar year 2015. The 2013 annual responses of 152,609 was an error and should have been 5,751,635. The increase in annual responses reflects adjustments related to normal business activity. The increase in annual burden hours refelects the increase in annual responses and an adjustment to estimated burden per paper response, from 11 minutes to 15 minutes. The 2013 annual burden dollars erroneously excluded labor burden and should have been 68,070,345. The increase in annual burden dollars reflects the increase in annual burden hours and an estimated increase in burden dollar per hour. There are no statutory or regulatory changes related to this information collection.

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Annual Cost to Federal Government: $1,341,117

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.     No

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.     No

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: 07/10/2020

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