Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B)

Forms and Documents

Document Name	Status
1117-0012 Supporting Statement 12.21.2020.docx Supporting Statement A	2020-12-21
21 CFR 1301.11.pdf Supplementary Document	2019-07-25
21 USC 822.pdf Supplementary Document	2019-07-25
dea_ pia_060414.pdf Supplementary Document	2015-06-30

IC Document Collections

IC ID	Document Title	Status
12306	Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B) Other-Supplementary Questionnaire	Modified

ICR Details

OMB Control No: 1117-0012	ICR Reference No: 202204-1117-001
Status: Received in OIRA	Previous ICR Reference No: 202012-1117-003
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/18/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2024
Responses	16,338	16,301
Time Burden (Hours)	3,253	2,090
Cost Burden (Dollars)	225,011	144,753

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Abstract: The Controlled Substances Act requires all businesses and individuals who manufacture, distribute, import, export, and conduct research and laboratory analysis with controlled substances to register with the DEA. 21 U.S.C. 822, 21 CFR 1301.11 and 1301.13. Registration is a necessary control measure that prevents diversion by ensuring the closed system of distribution of controlled substances can be monitored by the DEA and that the businesses and individuals handling controlled substances are qualified to do so and are accountable. Any person who is registered may apply to be reregistered no more than 60 days before the expiration date of their registration. 21 CFR 1301.13(b). However, a bulk manufacturer of a schedule I or II controlled substance or an importer of a schedule I or II controlled substance may apply to be reregistered no more than 120 days before the expiration date of their registration. 21 CFR 1301.13(b).

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Authorizing Statute(s): US Code: 21 USC 822 Name of Law: Persons Required to Register
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB58	Final or interim final rulemaking	87 FR 21019	04/11/2022

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 21019	04/11/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 21019	04/11/2022
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
Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B)	225, DEA Form 225A, DEA Form 225B	Affidavit for Chain Renewal DEA Distributor Registrations ,   Application for Registration ,   Renewal Application for Registration

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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	16,338	16,301	0	37	0	0
Annual Time Burden (Hours)	3,253	2,090	0	1,163	0	0
Annual Cost Burden (Dollars)	225,011	144,753	0	80,258	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, requiring all forms be submitted online, is expected to lower burden. However, the increase in burden hours is a result of adjusting up, the average burden hours per response. Additionally, the increase in annual responses, burden hours, and annual cost reflects the increase in DEA’s registrant population and a small increase in average burden per response.

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Annual Cost to Federal Government: $186,823

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: 04/18/2022

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