ARCOS Transaction Reporting

Forms and Documents

Document Name	Status
Form 333 ARCOS Transaction Reporting -- DEA Form 333 Form	Modified
1117-0003 ARCOS Supporting Statement 10-16-17.docx Supporting Statement A	2017-10-16
21 USC 827.rtf Supplementary Document	2017-08-08

IC Document Collections

IC ID	Document Title	Status
12279	ARCOS Transaction Reporting -- DEA Form 333 Form	Modified

ICR Details

OMB Control No: 1117-0003	ICR Reference No: 201708-1117-001
Status: Active	Previous ICR Reference No: 201405-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: ARCOS Transaction Reporting
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: 12/21/2017
	Date Received in OIRA: 10/16/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	36 Months From Approved	12/31/2017
Responses	12,156	0	7,932
Time Burden (Hours)	2,342	0	7,932
Cost Burden (Dollars)	147,817	0	272

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Abstract: Title 21 U.S.C. 827 requires controlled substance manufacturers and distributors to make periodic reports to the DEA regarding the sale, delivery, and other disposal of certain controlled substances. The implementing regulations are found at 21 CFR 1304.33. The Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971, impose certain reporting obligations on the United States, and aggregate data from Form 333s are provided to the International Narcotics Control Board to meet those obligations.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and Reports of Registrants
  

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:
	82 FR 37613	08/11/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 47580	10/12/2017
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
ARCOS Transaction Reporting -- DEA Form 333	333	ARCOS

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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	12,156	7,932	0	4,224	0	0
Annual Time Burden (Hours)	2,342	7,932	0	-5,590	0	0
Annual Cost Burden (Dollars)	147,817	272	0	147,545	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: The decrease in annual burden hours reflects the adjustment to estimated burden per electronic response, from one hour to ten minutes, and the increase in the portion of total responses that are electronic responses. The 2014 annual burden dollars erroneously excluded labor burden in the annual burden dollars calculation and should have been $455,046. The increase in 2017 requested annual burden dollars reflects the inclusion of labor burden. If the labor burden had been included in 2014, the 2017 requested annual burden dollars would be a decrease that is consistent with the decrease in annual burden hours. There are no statutory or regulatory changes related to this information collection.

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Annual Cost to Federal Government: $150,000

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.     No

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? 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: 10/16/2017

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