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
Form DEA-225 Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B) Form and Instruction	Modified
dea_ pia_060414.pdf Supplementary Document	2015-06-30
72FR3410 SORN.pdf Supplementary Document	2012-03-20
66FR8425 SORN.pdf Supplementary Document	2012-03-20
52FR47208 SORN.pdf Supplementary Document	2012-03-20
21 U.S.C. 822.doc Supplementary Document	2008-12-17
1117-0012 Supporting Statement 4-21-2015 Final ODW.docx Supporting Statement A	2015-04-21

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) Form and Instruction	Modified

ICR Details

OMB Control No: 1117-0012	ICR Reference No: 201504-1117-001
Status: Historical Active	Previous ICR Reference No: 201110-1117-001
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: Approved without change	Conclusion Date: 07/06/2015
	Date Received in OIRA: 04/23/2015
Terms of Clearance: Previous terms of clearance for the privacy impact assessment and firm 225B have been satisfied.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2018	36 Months From Approved	07/31/2015
Responses	13,589	0	13,097
Time Burden (Hours)	1,879	0	2,790
Cost Burden (Dollars)	158,040	0	5,105,847

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 5137	01/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 18257	04/03/2015
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-225, DEA-225B, DEA-225A	Application For Registration ,   Chain Renewal Affadavit Distributor ,   Application for Registration Renewal

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ICR Summary 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	13,589	13,097	0	492	0	0
Annual Time Burden (Hours)	1,879	2,790	0	-911	0	0
Annual Cost Burden (Dollars)	158,040	5,105,847	0	-4,947,807	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: In prior information collection requests, the associated registration fee was included in the cost burden calculation. The DEA believes the registration fee should be excluded from the information collection cost burden because the time and capital expense burden to provide the information is not tied to the registration fee. This change in calculation method is employed in this and future information collection requests.

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Annual Cost to Federal Government: $2,367,134

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 04/23/2015

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