View Information Collection Request (ICR) Package

OMB Control No: 1117-0021	ICR Reference No: 202012-1117-005
Status: Historical Active	Previous ICR Reference No: 201708-1117-002
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: 03/01/2021
	Date Received in OIRA: 12/28/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	36 Months From Approved	02/28/2021
Responses	72,333	0	64,751
Time Burden (Hours)	36,167	0	3,852
Cost Burden (Dollars)	1,028,608	0	72,010

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.

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

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:
	85 FR 44930	07/24/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 68092	10/27/2020
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
Dispensing Records of Individual Practitioners

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	72,333	64,751	7,582
Annual Time Burden (Hours)	36,167	3,852	32,315
Annual Cost Burden (Dollars)	1,028,608	72,010	956,598

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: There was an error in the 2017 Approved Burden. The 2017 Supporting Statement listed the correct numbers, 64,751, 32,376, and 844,974 for annual responses, annual burden hours, and annual burden dollars, respectively. The increases in annual responses, annual burden hours, and annual burden dollars are 7,582, 3,792, and 183,634, respectively. These increases are the result of increase in the number of collectors. There are no statutory or regulatory changes related to this information collection.

Annual Cost to Federal Government: $150,000

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? No

Agency Contact: Alana Moore 202 598-2403 alana.j.moore@usdoj.gov

View ICR - OIRA Conclusion