Registrant Record of Controlled Substances Destroyed-DEA Form 41

Forms and Documents

Document Name	Status
Form 41 Registrants Inventory of Drugs Surrendered--DEA Form 41 Form	Modified
Disposal PRA Supporting Statement_DEA Form 41.docx Supporting Statement A	2014-08-27
PL111-273.txt Supplementary Document	2012-06-26
21 U.S.C. 827.doc Supplementary Document	2008-03-26

IC Document Collections

IC ID	Document Title	Status
12289	Registrants Inventory of Drugs Surrendered--DEA Form 41 Form	Modified

ICR Details

OMB Control No: 1117-0007	ICR Reference No: 201302-1117-001
Status: Historical Active	Previous ICR Reference No: 201206-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Registrant Record of Controlled Substances Destroyed-DEA Form 41
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: 09/26/2014
	Date Received in OIRA: 08/29/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	09/30/2014
Responses	87,736	0	22,500
Time Burden (Hours)	43,868	0	11,250
Cost Burden (Dollars)	928,247	0	18,900

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Abstract: The existing collection of information is affected by the new regulations that implement the Secure and Responsible Drug Disposal Act of 2010. (Disposal Act) (Pub. L. 111-273). The Disposal of Controlled Substances final rule (RIN 1117–AB18), published on September 9, 2014 with an effective data of October 9, 2014, expands disposal options for ultimate users, reorganizes and consolidates existing regulations on the disposal of controlled substances, and establishes a comprehensive regulatory framework for the collection and destruction of controlled substances consistent with the Controlled Substances Act.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and Reports of Registrants
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 273 3 Name of Law: Secure and Responsible Drug Disposal Act of 2010

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB18	Final or interim final rulemaking	79 FR 53520	09/09/2014

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 29802	05/23/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 45460	08/05/2014
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
Registrants Inventory of Drugs Surrendered--DEA Form 41	41, 41	Registrants Inventory of Drugs Surrendered ,   DEA Form 41

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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	87,736	22,500	65,236	0	0	0
Annual Time Burden (Hours)	43,868	11,250	32,618	0	0	0
Annual Cost Burden (Dollars)	928,247	18,900	909,347	0	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: No

Burden Reduction Due to:

Short Statement: DEA advises the increase in burden is due to implementation of the Secure and Responsible Drug Disposal Act of 2010. (Disposal Act) (Pub. L. 111-273). Revised 21 USC 822 includes provisions for the ultimate user to deliver controlled substances to specific registrants. 21 USC 827(a)(3) mandates "every registrant under this subchapter manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by him.... Disposal is considered "otherwise disposed.

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Annual Cost to Federal Government: $0

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: 08/29/2014

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