Application for Registration-DEA 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c

Forms and Documents

Document Name	Status
Form DEA-224 Application for Registration-DEA 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c Form and Instruction	Modified
72FR3410 SORN.pdf Supplementary Document	2012-01-05
66FR8425 SORN.pdf Supplementary Document	2012-01-05
52FR47208 SORN.pdf Supplementary Document	2012-01-05
1117-0014 Supporting Statement 2012-4-12.docx Supporting Statement A	2012-10-23
21 U.S.C. 822.doc Supplementary Document	2008-12-17

IC Document Collections

IC ID	Document Title	Status
12313	Application for Registration-DEA 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c Form and Instruction	Modified

ICR Details

OMB Control No: 1117-0014	ICR Reference No: 201208-1117-001
Status: Historical Active	Previous ICR Reference No: 201108-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration-DEA 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/10/2013
	Date Received in OIRA: 11/05/2012
Terms of Clearance: DEA shall continue to offer consistent and accurate burden estimates, continue to upload screenshots of 224c (with a PRA statement), and show its burden calculation methodology. DEA shall calculate its annualized cost burden estimate as the best approximation of the average cost burden each year of the clearance period. DEA shall consider amending its cost burden calculation methodology to factor in only the costs directly related to paperwork (ie., not including fees overall).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2016	36 Months From Approved	01/31/2013
Responses	474,914	0	458,136
Time Burden (Hours)	46,698	0	45,208
Cost Burden (Dollars)	109,230,726	0	110,637,850

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Abstract: Under 21 USC 822, all firms and individuals who distribute or dispense controlled substance must register with the DEA under the Controlled Substances Act. Registration is needed for control measures over legal handlers of controlled substances and is used to monitor their activities.

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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:
	77 FR 47095	08/07/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 62530	10/15/2012
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 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c	DEA Form 224c, DEA 224B, DEA-224, DEA-224A	Application for Registration ,   Application for Registration Renewal ,   Application for Modification of Registration for Online Pharmacies ,   Affidavit for Chain 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	474,914	458,136	0	0	16,778	0
Annual Time Burden (Hours)	46,698	45,208	0	0	1,490	0
Annual Cost Burden (Dollars)	109,230,726	110,637,850	0	0	-1,407,124	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $7,929,516

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: 11/05/2012

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