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	Type	Status	Availability
21 U.S.C. 830.doc	Supplementary Document	Uploaded 2008-03-26	Available
1117-0024 Supporting Statement 04-23-2015.docx	Supporting Statement A	Uploaded 2015-04-24	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
12326	Reports of Suspicious Orders or Theft/Loss of Listed Chemicals/Machines		Modified

ICR Details

OMB Control No: 1117-0024	ICR Reference No: 201504-1117-003
Status: Historical Active	Previous ICR Reference No: 201401-1117-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/30/2015
	Date Received in OIRA: 04/27/2015
Terms of Clearance: In accordance with 5 CFR 1320, this information collection is approved for 3 years. OMB would like to remind the agency that existing ICR packages that contain non-substantive changes should be submitted as extension requests, and not revisions. OMB requests that upon resubmission of this package that the agency provide an update on the status of allowing electronic submission of the necessary forms.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2018	36 Months From Approved	06/30/2015
Responses	63	0	100
Time Burden (Hours)	21	0	25
Cost Burden (Dollars)	31	0	44

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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:
	80 FR 6766	02/06/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 18256	04/03/2015
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

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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	63	100	0	-37	0	0
Annual Time Burden (Hours)	21	25	0	-4	0	0
Annual Cost Burden (Dollars)	31	44	0	-13	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Any changes are due to population adjustments as fewer entities have registered as chemical handlers.

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Annual Cost to Federal Government: $19,389

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]? 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? Uncollected

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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: 04/27/2015

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