Dispensing Records of Individual Practitioners

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
21 U.S.C. 827.doc	Supplementary Document	Uploaded 2008-05-20	Available
Supporting Statement for 1117-0021 (final).docx	Supporting Statement A	Uploaded 2017-10-05	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
12320	Dispensing Records of Individual Practitioners		Modified

ICR Details

OMB Control No: 1117-0021	ICR Reference No: 201708-1117-002
Status: Active	Previous ICR Reference No: 201405-1117-003
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Dispensing Records of Individual Practitioners
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: 12/04/2017
	Date Received in OIRA: 10/05/2017
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	36 Months From Approved	12/31/2017
Responses	64,751	0	1,511,389
Time Burden (Hours)	3,852	0	89,912
Cost Burden (Dollars)	72,010	0	1,680,820

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Abstract: In accordance with the Controlled Substances 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 a form that required information is readily retrievable from the ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The records maintained by registrants must be kept and be available for at least two years for inspection and copying by officers or employees of the United States as authorized by the Attorney General. 21 U.S.C. 827(b)(3). The DEA may promulgate regulations that specify the information that registrants must maintain in the required records. 21 U.S.C. 827(b)(1). Pursuant to 21 U.S.C. 827(c), practitioners who regularly dispense or administer controlled substances to patients and charge them for the substances and those practitioners who administer controlled substances in the course of maintenance or detoxification treatment shall keep records of such activities, and accordingly must comply with the regulations on recordkeeping. Paragraphs (b), (c), and (d) of 21 CFR 1304.03 identify when individual practitioners are required to maintain records of controlled substances. The recordkeeping requirements for these practitioners are contained in 1304.04(g), 1304.11, 1304.22, and 1304.24.

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

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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 29330	06/28/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 41658	09/01/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Dispensing Records of Individual Practitioners

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ICR Summary of Burden

table that charts list 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	64,751	1,511,389	0	-1,446,638	0	0
Annual Time Burden (Hours)	3,852	89,912	0	-86,060	0	0
Annual Cost Burden (Dollars)	72,010	1,680,820	0	-1,608,810	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The decrease in annual responses reflects the removal of redundant responses that were added in the 2014 information collection request. The decrease in annual burden hours is primarily due to the revised estimated number of respondents for the record keeping requirements of collectors. The decrease in annual burden dollars in 2017 requested annual burden dollars reflects the decrease in burden hours. There are no statutory or regulatory changes related to this information collection.

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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.     No

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

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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: 10/05/2017

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