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	Repair queued
1117-0014 Supporting Statement A_092024.docx	Supporting Statement A	Uploaded 2025-01-08	Repair queued
1117-0014 Supporting Statement A_092024.docx	Supporting Statement A	Uploaded 2025-01-08	Repair queued
21 CFR 1301.13.pdf	Supplementary Document	Uploaded 2019-03-20	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 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 823.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 822.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: 202410-1117-001
Status: Active	Previous ICR Reference No: 202305-1117-003
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: 04/11/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/08/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2028	36 Months From Approved	06/30/2026
Responses	670,481	0	670,481
Time Burden (Hours)	136,127	0	136,128
Cost Burden (Dollars)	0	0	22,475,937

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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:
	89 FR 81109	10/07/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 100536	12/12/2024
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	670,481	0	0	0	0
Annual Time Burden (Hours)	136,127	136,128	0	-1	0	0
Annual Cost Burden (Dollars)	0	22,475,937	0	-22,475,937	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: DEA is revising the proposed information collections by adding a checkbox to the new application and renewal application for applicants to affirm that they have completed the new eight-hour training requirement. DEA is also adding three questions to the applications in regards to the training requirements, in which they will be required to answer yes to at least one of the questions in order to proceed. The change in annual burden hours is due to rounding in the calculation. The change in annual cost burden is due to change in method. Previously, the approved 2023 figure represents the annual labor burden hours calculated in section 12. The new requested annual cost burden represents the figure from section 13.

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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: 01/08/2025

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