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
1117-0007- Supporting Statement- Registrant Record of Controlled Substances Destroyed - Final.docx Supporting Statement A	2017-08-22
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: 201705-1117-001
Status: Historical Active	Previous ICR Reference No: 201302-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Registrant Record of Controlled Substances Destroyed-DEA Form 41
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: 10/30/2017
	Date Received in OIRA: 08/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	10/31/2017
Responses	92,924	0	87,736
Time Burden (Hours)	46,462	0	43,868
Cost Burden (Dollars)	985,234	0	928,247

---

Abstract: In accordance with the Controlled Substance Act (CSA), every DEA registrant must make a biennial inventory and maintain, on a current basis, a complete and accurate record of each controlled substance manufactured, received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827 and 958. These records must be maintained separately from all other records of the registrant or, alternatively, in the case of non-narcotic controlled substances, be in such form that required information is readily retrievable from the ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The records must be kept and be available for at least two years for inspection and copying by officers or employees of the United States authorized by the Attorney General. 21 U.S.C. 827(b)(3). The records must be in accordance with and contain such relevant information as may be required by regulations promulgated by DEA. 21 U.S.C. 827(b)(1). These record requirements help to deter and detect diversion of controlled substances and ensure that registrants remain accountable for all controlled substances within their possession and/or control.

---

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

---

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:
	82 FR 22349	05/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32873	07/18/2017
Did the Agency receive public comments on this ICR? No

---

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

---

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	92,924	87,736	0	5,188	0	0
Annual Time Burden (Hours)	46,462	43,868	0	2,594	0	0
Annual Cost Burden (Dollars)	985,234	928,247	0	56,987	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The increase in annual responses reflects the increase in the number of registrations related to normal business activity. The increase in annual burden hours and annual burden dollars reflects the increase in annual responses. There are no statutory or regulatory changes related to this information collection.

---

Annual Cost to Federal Government: $0

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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

---

Common Form ICR:  No

---

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: 08/29/2017

---