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

Forms and Documents

Document	Type	Status	Availability
1117-0012 Supporting Statement 3.23.20 FINAL.docx	Supporting Statement A	Uploaded 2020-03-23	Available
21 CFR 1301.11.pdf	Supplementary Document	Uploaded 2019-07-25	Repair queued
21 USC 822.pdf	Supplementary Document	Uploaded 2019-07-25	Available
dea_ pia_060414.pdf	Supplementary Document	Uploaded 2015-06-30	Repair queued
72FR3410 SORN.pdf	Supplementary Document	Uploaded 2012-03-20	Repair queued
66FR8425 SORN.pdf	Supplementary Document	Uploaded 2012-03-20	Repair queued
52FR47208 SORN.pdf	Supplementary Document	Uploaded 2012-03-20	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
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: 201907-1117-005
Status: Historical Inactive	Previous ICR Reference No: 201802-1117-001
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
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 07/01/2020
	Date Received in OIRA: 03/24/2020
Terms of Clearance: OMB files this comment on the proposed rule and requests that DEA respond to all comments received on the proposed rule related to this information collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	36 Months From Approved	09/30/2021
Responses	15,919	0	15,919
Time Burden (Hours)	2,076	0	2,076
Cost Burden (Dollars)	175,109	0	175,109

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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.

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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-AB54	Proposed rulemaking	85 FR 16292	03/23/2020

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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
Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B)	DEA Form 225, DEA Form 225A, DEA Form 225B	Application for Registration ,   Renewal Application for Registration ,   Affidavit for Chain Renewal DEA Distributor Registrations

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The increase in annual responses and burden hours reflects the increase in the DEA's registrant population. The decrease in annual cost is due to a lower estimated hourly rate for employees completing the responses.

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Annual Cost to Federal Government: $186,758

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.     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: 03/24/2020

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