View Information Collection Request (ICR) Package
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Brief and OIRA conclusion
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IC List
Burden
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Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
1117-0014
ICR Reference No:
200908-1117-010
Status:
Historical Active
Previous ICR Reference No:
200811-1117-001
Agency/Subagency:
DOJ/DEA
Agency Tracking No:
Title:
Application for Registration-DEA 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/20/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/22/2009
Terms of Clearance:
The agency will revise this collection when the interim rule with request for comments associated with it becomes final. In addition, the agency will explore expanding the educational degree choices for mid level practicioners on the collection instruments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2011
36 Months From Approved
02/29/2012
Responses
440,606
0
440,966
Time Burden (Hours)
56,354
0
56,038
Cost Burden (Dollars)
76,097,816
0
75,980,292
Abstract:
All firms and individuals who distribute or dispense controlled substance must register with the DEA under the Controlled Substances Act. Registration is needed for control measures over legal handlers of controlled substances and is used to monitor their activities.
Authorizing Statute(s):
US Code:
21 USC 822
Name of Law: Persons Required to Register
Citations for New Statutory Requirements:
PL: Pub.L. 110 - 425 102, 303, 307, 309, 310, 311 Name of Law: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
1117-AB20
Final or interim final rulemaking
74 FR 15596
04/06/2009
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
74 FR 28274
06/15/2009
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 42328
08/21/2009
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Application for Registration-DEA 224, App for Reg Renewal-DEA 224a, Affidavit for Chain Renewal DEA Retail Pharmacy Reg-DEA 244b, Application for Modification of Reg for Online Pharmacies-DEA 224c
DEA-224, DEA-224A, DEA Form 224c
Application for Registration
,
Application for Registration Renewal
,
Application for Modification of Registration for Online Pharmacies
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
440,606
440,966
0
0
-360
0
Annual Time Burden (Hours)
56,354
56,038
0
0
316
0
Annual Cost Burden (Dollars)
76,097,816
75,980,292
0
0
117,524
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Changes reflect population adjustments and time it takes to complete electronic form DEA Form 224c based on new statutory requirements for online pharmacies to obtain a modification to registration (Pub. L. 110-425).
Annual Cost to Federal Government:
$8,209,670
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]?
Uncollected
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:
Lillian Bivens 202 307-7029 l.ursula.bivens@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:
09/22/2009
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