Recordkeeping Requirements for the Electronic Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling

Forms and Documents

Document Name	Status
Supporting Statement DEA-637 EPCS Transfer NPRM.docx Supporting Statement A	2022-03-08

IC Document Collections

IC ID	Document Title	Status
252032	Recordkeeping for EPCS in Schedules II-V between Pharmacies for Initial Filling	New

ICR Details

OMB Control No:	ICR Reference No: 202203-1117-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Recordkeeping Requirements for the Electronic Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/08/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	25,000,000	0
Time Burden (Hours)	12,500,000	0
Cost Burden (Dollars)	110,000,000	0

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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. 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 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). This information request would require pharmacies to create and maintain records documenting the transfer between pharmacies of unfilled electronic prescriptions for controlled substances in schedules II-V.

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Authorizing Statute(s): US Code: 21 USC 827 and 958 Name of Law: Controlled Substances Act
  

Citations for New Statutory Requirements: US Code: 21 USC 827 Name of Law: Controlled Substances Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB64	Proposed rulemaking	86 FR 64881	11/19/2021

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Federal Register Notices & Comments

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
Recordkeeping for EPCS in Schedules II-V between Pharmacies for Initial Filling

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ICR Summary of Burden

	Total Request	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	25,000,000	0	0	25,000,000	0	0
Annual Time Burden (Hours)	12,500,000	0	0	12,500,000	0	0
Annual Cost Burden (Dollars)	110,000,000	0	0	110,000,000	0	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new Information Collection being created and therefore there were no numbers for the past years. Please see Supporting Statement for full analysis.

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Annual Cost to Federal Government:

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.     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? No

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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: 03/08/2022

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