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:
1117-0012
ICR Reference No:
202204-1117-001
Status:
Historical Active
Previous ICR Reference No:
202012-1117-003
Agency/Subagency:
DOJ/DEA
Agency Tracking No:
Title:
Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/22/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/18/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2025
36 Months From Approved
03/31/2024
Responses
16,338
0
16,301
Time Burden (Hours)
3,253
0
2,090
Cost Burden (Dollars)
225,011
0
144,753
Abstract:
The Controlled Substances Act requires all businesses and individuals who manufacture, distribute, import, export, and conduct research and laboratory analysis with controlled substances to register with the DEA. 21 U.S.C. 822, 21 CFR 1301.11 and 1301.13. Registration is a necessary control measure that prevents diversion by ensuring the closed system of distribution of controlled substances can be monitored by the DEA and that the businesses and individuals handling controlled substances are qualified to do so and are accountable. Any person who is registered may apply to be reregistered no more than 60 days before the expiration date of their registration. 21 CFR 1301.13(b). However, a bulk manufacturer of a schedule I or II controlled substance or an importer of a schedule I or II controlled substance may apply to be reregistered no more than 120 days before the expiration date of their registration. 21 CFR 1301.13(b).
Authorizing Statute(s):
US Code:
21 USC 822
Name of Law: Persons Required to Register
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
1117-AB58
Final or interim final rulemaking
87 FR 21019
04/11/2022
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
87 FR 21019
04/11/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 21019
04/11/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Application for Registration (DEA Form 225); Application for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal (DEA Form 225B)
225, DEA Form 225A, DEA Form 225B
Affidavit for Chain Renewal DEA Distributor Registrations
,
Application for Registration
,
Renewal Application for Registration
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
16,338
16,301
0
37
0
0
Annual Time Burden (Hours)
3,253
2,090
0
1,163
0
0
Annual Cost Burden (Dollars)
225,011
144,753
0
80,258
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:
The regulatory change affecting this information collection, requiring all forms be submitted online, is expected to lower burden. However, the increase in burden hours is a result of adjusting up, the average burden hours per response. Additionally, the increase in annual responses, burden hours, and annual cost reflects the increase in DEA’s registrant population and a small increase in average burden per response.
Annual Cost to Federal Government:
$186,823
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.
Yes
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
Agency Contact:
Alana Moore 202 598-2403 alana.j.moore@usdoj.gov
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:
04/18/2022
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