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

ICR 202307-1117-003

OMB: 1117-0061

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2023-07-27
Supporting Statement A
2023-07-27
IC Document Collections
ICR Details
1117-0061 202307-1117-003
Received in OIRA 202203-1117-002
DOJ/DEA
Recordkeeping Requirements for the Electronic Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling
New collection (Request for a new OMB Control Number)   No
Regular 08/14/2023
  Requested Previously Approved
36 Months From Approved
25,000,000 0
1,250,000 0
110,000,000 0

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.

US Code: 21 USC 827 and 958 Name of Law: Controlled Substances Act
  
US Code: 21 USC 827 Name of Law: Controlled Substances Act

1117-AB64 Final or interim final rulemaking 88 FR 48365 07/27/2023

No

1
IC Title Form No. Form Name
Recordkeeping for EPCS in Schedules II-V between Pharmacies for Initial Filling

  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) 1,250,000 0 0 1,250,000 0 0
Annual Cost Burden (Dollars) 110,000,000 0 0 110,000,000 0 0
Yes
Changing Regulations
No
This is a new collection being created as part of DEA’s Transfer of Prescription Information between Pharmacies for Initial Filling of Electronic Prescriptions for Schedules II-V Controlled Substances rulemaking, RIN 1117-AB64. The number is different in ROCIS due to an extra "0" being placed at the end. The numbers in the Supporting Statement from the NPRM are correct.

No
    No
    No
No
No
No
No
Christa Frye 571 362-8248 christa.frye@dea.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/14/2023


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