Regulated Transactions in Tableting/Encapsulating Machine

Forms and Documents

Document Name	Status
Form DEA Form 452 Regulated Transaction in Tableting/Encapsulating Machines Form	Modified
1117-0024 NEW Supporting Statement_11_22_2023.docx Supporting Statement A	2023-11-22
0024 30 day notice publication.pdf Supplementary Document	2023-11-16
0024 60 Day FRN.pdf Supplementary Document	2023-11-16
DEA IMEX Online Introduction and Overview.pdf Supporting Statement B	2017-07-20
DEA Online Import-Export Applcation Introduction and Overview.pdf Supplementary Document	2017-06-16
21 U.S.C. 830.doc Supplementary Document	2008-03-26

IC Document Collections

IC ID	Document Title	Status
12326	Regulated Transaction in Tableting/Encapsulating Machines Form	Modified

ICR Details

OMB Control No: 1117-0024	ICR Reference No: 202311-1117-005
Status: Received in OIRA	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	Date Submitted to OIRA: 11/29/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2023
Responses	25,101	3,827
Time Burden (Hours)	8,283	1,276
Cost Burden (Dollars)	0	70,876

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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).

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Authorizing Statute(s): US Code: 21 USC 830 Name of Law: Regulation of Listed Chemicals and Certain Machines
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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ICR Summary of Burden

	Total Request	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.

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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

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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: 11/29/2023

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