Recordkeeping for electronic prescriptions for controlled substances

Forms and Documents

Document Name	Status
1117-0049 Supporting Statement-2021 Reinstatement FINAL.docx Supporting Statement A	2021-10-25
21 USC 827.rtf Supplementary Document	2010-03-12

IC Document Collections

IC ID	Document Title	Status
192251	Recordkeeping for electronic prescriptions for controlled substances (Pharmacies)	Modified
183687	Recordkeeping for electronic prescriptions for controlled substances (Hospitals)	Modified
183654	Recordkeeping for electronic prescriptions for controlled substances (Practitioners)	Modified

ICR Details

OMB Control No: 1117-0049	ICR Reference No: 202107-1117-006
Status: Received in OIRA	Previous ICR Reference No: 200909-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Recordkeeping for electronic prescriptions for controlled substances
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/26/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	132,697	0
Time Burden (Hours)	89,717	0
Cost Burden (Dollars)	10,702,112	0

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Abstract: DEA requires that each registered practitioner apply to an approved credential service provider to obtain identity proofing and a credential. Hospitals and other institutional practitioners may conduct this process in house as part of their credentialing. For practitioners currently working at or affiliated with a registered hospital or clinic, the hospital/clinic have to check a government-issued photographic identification. This may be done when the hospital/clinic issues credentials to new hires or newly affiliated physicians. For individual practitioners, two people need to enter logical access control data to grant permission for practitioners authorized to approve and sign controlled substance prescriptions using the electronic prescription application. For institutional practitioners, logical access control data is entered by two people from an entity within the hospital/clinic that is separate from the entity that conducts identity proofing in-house. Similarly, pharmacies have to set logical access controls in the pharmacy application so that only authorized employees have permission to annotate or alter prescription records. Finally, if the electronic prescription or pharmacy application generates an incident report, practitioners, hospitals/clinics, and pharmacies have to review the incident report to determine if the event identified by the application represents a security incident.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and Reports of Registrants
  

Citations for New Statutory Requirements: None

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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:
	86 FR 46016	08/17/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 58960	10/25/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Recordkeeping for electronic prescriptions for controlled substances (Hospitals)
Recordkeeping for electronic prescriptions for controlled substances (Pharmacies)
Recordkeeping for electronic prescriptions for controlled substances (Practitioners)

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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	132,697	0	0	132,697	0	0
Annual Time Burden (Hours)	89,717	0	0	89,717	0	0
Annual Cost Burden (Dollars)	10,702,112	0	0	10,702,112	0	0

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: This is a reinstatement of a previously discontinued information collection. DEA reviewed the numbers of registrants that this collection would affect, and updated where necessary.

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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.     Yes

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: 10/26/2021

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