View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
Authorizing Statute(s):
US Code:
21 USC 827
Name of Law: Records and Reports of Registrants
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
1117-AA61
Final or interim final rulemaking
75 FR 16236
03/31/2010
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
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)
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.
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
Agency Contact:
Mark Caverly 202 307-7297
Common Form ICR:
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:
(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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