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

Forms and Documents

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

IC Document Collections

IC ID	Document Title	Status
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: 201907-1117-006
Status: Historical Inactive	Previous ICR Reference No: 201606-1117-001
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: Improperly submitted and continue	Conclusion Date: 07/09/2020
	Date Received in OIRA: 08/12/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved	07/31/2020
Responses	9,079,980	0	9,079,980
Time Burden (Hours)	1,453,348	0	1,453,348
Cost Burden (Dollars)	127,240,638	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

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
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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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: Changing Regulations

Short Statement: The DEA is adjusting its burden estimates to account for the new single-sheet format of DEA Form 222. The decrease in annual responses reflects efficiencies of the new DEA Form 222 format including having more lines per form, an anticipated reduction in instances of form failure, allowing the use of a printer, and general ease of use over the current format. DEA also adjusted its methodology to estimate the amount of online responses relative to paper responses due to the change in paper format, causing the amount of online responses to decrease. The new DEA Form 222 format doubles the amount of ordering lines per form from 10 to 20, requiring the number of online transaction items to be divided by 20 instead of 10. The decrease in annual burden hours reflects the decrease in annual responses. The decrease in annual burden dollars reflects the decrease in annual burden hours and includes an estimated increase in burden dollar per hour.

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Annual Cost to Federal Government: $921,967

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: 08/12/2019

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