Self-Certification, Training, and Logbooks for Regulated Sellers and Mail-Order Distributors Selling Scheduled Listed Chemical Products.

Forms and Documents

Document	Type	Status	Availability
Form DEA Form 597 Self-certification (regulated seller)	Form and Instruction	Modified	Available
Form DEA from 597 Self-certification (mail-order distributors)	Form and Instruction	Removed	Repair queued
pl111-268.mht	Supplementary Document	Uploaded 2017-08-02	Repair queued
1117-0046- Self-Certification Training and Logbooks (Supporting Statement) Final (8-2-17).docx	Supporting Statement A	Uploaded 2017-08-02	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
45219	Customer Time		Modified
44920	Transaction record		Modified
44919	Self-certification (regulated seller)	Form and Instruction	Modified
44918	Training Record		Modified
197039	Self-certification (mail-order distributors)	Form and Instruction	Removed

ICR Details

OMB Control No: 1117-0046	ICR Reference No: 201705-1117-002
Status: Historical Active	Previous ICR Reference No: 201405-1117-004
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Self-Certification, Training, and Logbooks for Regulated Sellers and Mail-Order Distributors Selling Scheduled Listed Chemical Products.
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: 10/30/2017
	Date Received in OIRA: 08/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	10/31/2017
Responses	49,016,246	0	51,470,052
Time Burden (Hours)	841,764	0	1,735,516
Cost Burden (Dollars)	21,028,089	0	218,473

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Abstract: The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177), requires that on and after September 30, 2006, a regulated seller must not sell at retail over-the-counter (non-prescription) products containing the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine (referred to here as "scheduled listed chemical products”), unless it has self-certified to the DEA, through the DEA’s Web site. The Combat Methamphetamine Enhancement Act of 2010 (Pub. L. 111-268) (MEA) requires that on and after April 10, 2011, a regulated person that sells scheduled listed chemical products at retail and uses or attempts to use the U.S. Postal Service or a private or commercial carrier to deliver the product to the customer (referred to as a “mail-order distributor”), must not sell those products unless it has self-certified to the DEA, through the DEA’s Web site. The Methamphetamine Production Prevention Act of 2008 (MPPA) (Pub. L. 110-415) was enacted in 2008 to clarify the information entry and signature requirements for electronic logbook systems permitted for the retail sale of scheduled listed chemical products. The MPPA expressly permits the regulated seller to capture information regarding the name of the product and the quantity sold through bar code, electronic data capture, or similar technology.

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Authorizing Statute(s): US Code: 21 USC 830 Name of Law: Controlled Substances Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 268 2 Name of Law: Combat Methamphetamine Enhancement Act of 2010

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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 22351	05/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32872	07/18/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Transaction record
Customer Time
Training Record
Self-certification (regulated seller)	DEA Form 597	CMEA Self-Certification
Self-certification (mail-order distributors)	DEA from 597	CMEA self certification

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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	49,016,246	51,470,052	0	-2,453,797	-9	0
Annual Time Burden (Hours)	841,764	1,735,516	0	-893,747	-5	0
Annual Cost Burden (Dollars)	21,028,089	218,473	0	20,809,616	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 DEA is adjusting annual responses, burden hours, and annual burden dollars to reflect updated estimates based on calendar year 2016. The decrease in annual responses reflects adjustments related to normal business activity (transactions in scheduled listed chemical products). The decrease in annual burden hours reflects the decrease in annual responses and an adjustment to estimated burden per transaction record, from 2 minutes to 1 minute. The 2014 annual burden dollars erroneously excluded labor burden in the annual burden dollars calculation and should have been $39,302,861. The increase in annual burden dollars 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: $187,179

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? 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: 08/29/2017

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