Application for Registration-DEA 224, Application of Registration Renewal-DEA 224A

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form DEA-224/224a Application for Registration and Application for Registration Renewal	Form and Instruction	Modified	Available
1117-0014 Supporting Statement A_052023_Rev1.docx	Supporting Statement A	Uploaded 2023-05-26	Repair queued
21 CFR 1301.13.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 CFR 1301.11.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 823.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 822.pdf	Supplementary Document	Uploaded 2019-03-20	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
12313	Application for Registration-DEA 224, Application for Registration Renewal-DEA 224A	Form and Instruction	Modified	Application for Registration and Application for Registration Renewal
12313	Application for Registration-DEA 224, Application for Registration Renewal-DEA 224A	Other-Self Attestation Questions	Modified

ICR Details

OMB Control No: 1117-0014	ICR Reference No: 202305-1117-003
Status: Historical Active	Previous ICR Reference No: 202204-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration-DEA 224, Application of Registration Renewal-DEA 224A
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: 06/27/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/28/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	36 Months From Approved	09/30/2025
Responses	670,481	0	617,086
Time Burden (Hours)	136,128	0	124,766
Cost Burden (Dollars)	22,475,937	0	17,679,160

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Abstract: The 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 (the “CSA”). 21 U.S.C. 801–971. Through the enactment of the CSA and its amendments, Congress established a closed system of distribution making it unlawful to handle any controlled substance except in a manner authorized by the CSA. In order to maintain this closed system of distribution, the CSA generally requires all persons who handle controlled substances to obtain a registration issued by the Attorney General. 21 U.S.C. 822, 823, 957, and 958.

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Authorizing Statute(s): US Code: 21 USC 822
   US Code: 21 USC 823
   PL: Pub.L. 91 - 513 1242 Name of Law: Federal Substance Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 13469	03/03/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 34185	05/26/2023
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
Application for Registration-DEA 224, Application for Registration Renewal-DEA 224A	DEA-224/224a	Application for Registration and Application for Registration Renewal

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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	670,481	617,086	0	53,395	0	0
Annual Time Burden (Hours)	136,128	124,766	0	11,362	0	0
Annual Cost Burden (Dollars)	22,475,937	17,679,160	0	4,796,777	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: The regulatory change affecting this information collection, is expected to have minimal impact on burden per response. The increase in the number of respondents, burden hours and annual cost is due to normal growth in registrant population. The table in the Supporting Statement summarizes the changes since the last renewal of this information collection.

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Annual Cost to Federal Government: $7,664,713

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: 05/28/2023

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