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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:
1117-0024
ICR Reference No:
202311-1117-005
Status:
Active
Previous ICR Reference No:
202008-1117-005
Agency/Subagency:
DOJ/DEA
Agency Tracking No:
Title:
Regulated Transactions in Tableting/Encapsulating Machine
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:
02/27/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/29/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2027
36 Months From Approved
02/29/2024
Responses
25,101
0
3,827
Time Burden (Hours)
8,283
0
1,276
Cost Burden (Dollars)
0
0
70,876
Abstract:
Each regulated person is required to report any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, any unusual or excessive loss or disappearance of a listed chemical, and any regulated transaction in a tableting or encapsulating machine, to include any domestic regulated transaction in a tableting or encapsulating machine and any import or export of a tableting or encapsulating machine. 21 U.S.C. 830 (b)(1)(A), (C) and (D); 21 CFR 1310.05(a)(1), (3)–(4); 21 CFR 1310.05(c). Regulated persons include manufacturers, distributors, importers, and exporters of listed chemicals, tableting machines, or encapsulating machines, or persons who serve as brokers or traders for international transactions involving a listed chemical, tableting machine, or encapsulating machine. 21 CFR 1300.02(b).
Authorizing Statute(s):
US Code:
21 USC 830
Name of Law: Regulation of Listed Chemicals and Certain Machines
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
88 FR 62398
09/11/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 78792
11/16/2023
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
Regulated Transaction in Tableting/Encapsulating Machines
DEA Form 452
Regulated Transactions in Tableting/Encapsulating Machines
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
25,101
3,827
0
21,274
0
0
Annual Time Burden (Hours)
8,283
1,276
0
7,007
0
0
Annual Cost Burden (Dollars)
0
70,876
0
-70,876
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:
The increase in the number of responses, burden hours, and burden dollars, are 21,274; 7,007, and $490,337, respectively, from the 2020 approved burden to 2023 requested burden. The increase reflect adjustments related to an increase in normal business activity. There have been no statutory or regulatory changes affecting this information collection. The table below summarizes the changes since the last renewal of this information collection.
Annual Cost to Federal Government:
$331,615
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:
Christa Frye 571 362-8248 christa.frye@dea.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:
11/29/2023
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