Reports of Regulated Transactions Involving Extraordinary Quantities, Uncommon Methods of Payment, Unusual/Excessive Loss or Disappearance and Regulated Transactions in Tableting/Encapsulating Machine

Forms and Documents

Document Name	Status
Form DEA Form 452 Reports of Suspicious Orders or Theft/Loss of Listed Chemicals/Machines Form	Modified
1117-0024 Supporting Statement_Aug 2020.docx Supporting Statement A	2020-08-17
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	Reports of Suspicious Orders or Theft/Loss of Listed Chemicals/Machines Form	Modified

ICR Details

OMB Control No: 1117-0024	ICR Reference No: 202008-1117-005
Status: Active	Previous ICR Reference No: 201610-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Reports of Regulated Transactions Involving Extraordinary Quantities, Uncommon Methods of Payment, Unusual/Excessive Loss or Disappearance and Regulated Transactions in Tableting/Encapsulating Machine
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: 11/16/2020
	Date Received in OIRA: 08/19/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2023	36 Months From Approved	11/30/2020
Responses	3,827	0	63
Time Burden (Hours)	1,276	0	21
Cost Burden (Dollars)	70,876	0	31

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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:
	85 FR 34238	06/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 48268	08/10/2020
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
Reports of Suspicious Orders or Theft/Loss of Listed Chemicals/Machines	DEA Form 107, DEA Form 452	Regulated Transactions in Tableting/Encapsulating Machines ,   Report of Loss or Disappearance of Listed Chemicals

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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	3,827	63	0	3,764	0	0
Annual Time Burden (Hours)	1,276	21	0	1,255	0	0
Annual Cost Burden (Dollars)	70,876	31	0	70,845	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: There was an error in the 2017 approved burden; based on the approved 2017 approved supporting statement, the correct annual responses, annual burden hours, and annual burden dollars for 2017 are: 4,100; 1,367, and $71,149, respectively. The decreases in the number of responses, burden hours, and burden dollars, are 273; 91, and $273, respectively, from the corrected 2017 approved burden to 2020 requested burden. The decreases reflect adjustments related to normal business activity. There have been no statutory or regulatory changes affecting this information collection. There is a table in the Supporting Statement which summarizes the changes since the last renewal of this information collection.

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Annual Cost to Federal Government: $93,373

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: 08/19/2020

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