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	Modified
110-425.pdf Supplementary Document	2009-09-17
0014_Justification for emergency action_DEA224c 4Mar09 FINAL.doc Supplementary Document	2009-08-25
21 U.S.C. 822.doc Supplementary Document	2008-12-17
1117-0014 Supporting Statement 2009_09_24 FINdoc.doc Supporting Statement A	2009-09-28

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	Modified

ICR Details

OMB Control No: 1117-0014	ICR Reference No: 200908-1117-010
Status: Historical Active	Previous ICR Reference No: 200811-1117-001
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: 11/20/2009
	Date Received in OIRA: 09/22/2009
Terms of Clearance: The agency will revise this collection when the interim rule with request for comments associated with it becomes final. In addition, the agency will explore expanding the educational degree choices for mid level practicioners on the collection instruments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2011	36 Months From Approved	02/29/2012
Responses	440,606	0	440,966
Time Burden (Hours)	56,354	0	56,038
Cost Burden (Dollars)	76,097,816	0	75,980,292

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Abstract: 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: PL: Pub.L. 110 - 425 102, 303, 307, 309, 310, 311 Name of Law: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB20	Final or interim final rulemaking	74 FR 15596	04/06/2009

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 28274	06/15/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 42328	08/21/2009
Did the Agency receive public comments on this ICR? Yes

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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-224, DEA-224A, DEA Form 224c	Application for Registration ,   Application for Registration Renewal ,   Application for Modification of Registration for Online Pharmacies

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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	440,606	440,966	0	0	-360	0
Annual Time Burden (Hours)	56,354	56,038	0	0	316	0
Annual Cost Burden (Dollars)	76,097,816	75,980,292	0	0	117,524	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: Changes reflect population adjustments and time it takes to complete electronic form DEA Form 224c based on new statutory requirements for online pharmacies to obtain a modification to registration (Pub. L. 110-425).

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Annual Cost to Federal Government: $8,209,670

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 09/22/2009

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