Recordkeeping for electronic prescriptions for controlled substances

Forms and Documents

Document Name	Status
21 USC 827.rtf Supplementary Document	2010-03-12
EPCS supporting statement 2010-3-10 clean[1].docx Supporting Statement A	2010-03-10

IC Document Collections

IC ID	Document Title	Status
192251	Recordkeeping for electronic prescriptions for controlled substances (Pharmacies)	New
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: 200909-1117-001
Status: Historical Active	Previous ICR Reference No: 200802-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Recordkeeping for electronic prescriptions for controlled substances
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/30/2010
	Date Received in OIRA: 04/29/2010
Terms of Clearance: DEA is reminded that this collection is not to be used until the rule it is associated with ("Electronic Prescriptions for Controlled Substances" RIN 1117-AA61 Docket No. DEA-218), becomes effective, which is Tuesday, June 1, 2010.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved
Responses	97,283	0	0
Time Burden (Hours)	98,949	0	0
Cost Burden (Dollars)	16,978,702	0	0

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Abstract: DEA is requiring that each registered practitioner apply to a credential service provider approved by the Federal government 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 will have to check a government-issued photographic identification. In the future, this will be done when the hospital/clinic issues credentials to new hires or newly affiliated physicians. At practitioner offices, two people will need to enter logical access control data into the electronic prescription application to grant permissions for individual practitioner registrants to approve and sign controlled substance prescriptions. For larger offices (more than two registrants), DEA registrations will be checked prior to granting access. Similarly pharmacies will have to enter permissions for access to prescription records. Finally, practitioners, hospitals/clinics, and pharmacies will have to check security logs periodically to determine if security incidents have occurred.

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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:
1117-AA61	Final or interim final rulemaking	75 FR 16236	03/31/2010

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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: 3

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

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ICR Summary 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	97,283	0	0	97,283	0	0
Annual Time Burden (Hours)	98,949	0	0	98,949	0	0
Annual Cost Burden (Dollars)	16,978,702	0	0	16,978,702	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: Changes from the publishing of the NPRM for Recordkeeping for electronic prescriptions for controlled substances to the Interim Final Rule were made. Information Collection 1117-0049 has not been used since approved.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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]? Uncollected

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: 04/29/2010

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