View Information Collection Request (ICR) Package

OMB Control No: 1117-0014	ICR Reference No: 201108-1117-002
Status: Historical Active	Previous ICR Reference No: 200908-1117-010
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 with change	Conclusion Date: 04/08/2012
	Date Received in OIRA: 10/27/2011
Terms of Clearance: DEA shall 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. Prior to any further approval of this information collection, DEA shall either provide OMB with a joint Information Collection Request/Privacy Impact Assessment or shall post a separate Privacy Impact Assessment addressing systems that support this information collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	36 Months From Approved	04/30/2012
Responses	458,136	0	440,606
Time Burden (Hours)	45,208	0	56,354
Cost Burden (Dollars)	110,637,850	0	76,097,816

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.

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 50498	08/15/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 64380	10/18/2011
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	458,136	440,606	17,530
Annual Time Burden (Hours)	45,208	56,354	-11,146
Annual Cost Burden (Dollars)	110,637,850	76,097,816	34,540,034

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:

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

Agency Contact: Cathy Gallagher 202 307-7297 cathy.a.gallagher@usdoj.gov

View ICR - OIRA Conclusion