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

Forms and Documents

Document Name	Status
Form DEA Form 597 Self-certification (regulated seller) Form and Instruction	Modified
1117-0046- Supporting Statement_2020.docx Supporting Statement A	2020-10-30
pl111-268.mht Supplementary Document	2017-08-02

IC Document Collections

IC ID	Document Title	Status
45219	Customer Time	Modified
44920	Transaction record	Modified
44919	Self-certification (regulated seller) Form and Instruction	Modified
44918	Training Record	Modified

ICR Details

OMB Control No: 1117-0046	ICR Reference No: 202010-1117-001
Status: Active	Previous ICR Reference No: 201705-1117-002
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: 01/04/2021
	Date Received in OIRA: 10/30/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2024	36 Months From Approved	12/31/2020
Responses	49,697,075	0	49,016,246
Time Burden (Hours)	863,068	0	841,764
Cost Burden (Dollars)	24,937,829	0	21,028,089

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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 DEA, through 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 DEA, through 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:
	85 FR 44927	07/24/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 68091	10/27/2020
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

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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	49,697,075	49,016,246	0	680,829	0	0
Annual Time Burden (Hours)	863,068	841,764	0	21,304	0	0
Annual Cost Burden (Dollars)	24,937,829	21,028,089	0	3,909,740	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: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The increase in annual responses, annual burden hours, and annual burden dollars reflect adjustments related to increase in estimated number of training records, estimated labor rates, and normal business activity. There have been no statutory or regulatory changes affecting this information collection. There is a table in the Supporting Statement document that summarizes the changes since the last renewal of this information collection.

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Annual Cost to Federal Government: $0

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: 10/30/2020

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