Dispensing Records of Individual Practitioners

Forms and Documents

Document Name	Status
21 U.S.C. 827.doc Supplementary Document	2008-05-20
1117-0021 Supporting Statement_09.09.2014.docx Supporting Statement A	2014-09-09

IC Document Collections

IC ID	Document Title	Status
12320	Dispensing Records of Individual Practitioners	Modified

ICR Details

OMB Control No: 1117-0021	ICR Reference No: 201405-1117-003
Status: Historical Active	Previous ICR Reference No: 201101-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Dispensing Records of Individual Practitioners
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: 10/20/2014
	Date Received in OIRA: 07/31/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	36 Months From Approved	10/31/2014
Responses	1,511,389	0	81,397
Time Burden (Hours)	89,912	0	40,699
Cost Burden (Dollars)	1,680,820	0	0

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Abstract: Under 21 USC 827, the Drug Enforcement Administration requires that individual practitioners keep records of the dispensing and administration of controlled substances in order to maintain a closed system of distribution.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and reports of Registrants
   US Code: 21 USC 822(g) Name of Law: Secure and Responsible Drug Disposal Act of 2010
  

Citations for New Statutory Requirements: US Code: 21 USC 822(g) 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 21952	04/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 35572	06/23/2014
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
Dispensing Records of Individual Practitioners

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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	1,511,389	81,397	1,429,992	0	0	0
Annual Time Burden (Hours)	89,912	40,699	49,213	0	0	0
Annual Cost Burden (Dollars)	1,680,820	0	1,680,820	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:

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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: 07/31/2014

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