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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form DEA Form 597 CMEA Self-Certification	Form and Instruction	Modified	Available
Form DEA Form 597 Self-certification (regulated seller)	Form and Instruction	Modified	Repair queued
1117-0046- New Supporting Statement_2024_1_19.docx	Supporting Statement A	Uploaded 2024-01-19	Repair queued
0046 2023-28818 30 Day Notice FR Publication.pdf	Supplementary Document	Uploaded 2024-01-19	Repair queued
0046 2023-23643 60 Day Notice FR Publication.pdf	Supplementary Document	Uploaded 2024-01-19	Repair queued
pl111-268.mht	Supplementary Document	Uploaded 2017-08-02	Repair queued

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 1117-0046	ICR Reference No: 202401-1117-002
Status: Active	Previous ICR Reference No: 202010-1117-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/11/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/23/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	36 Months From Approved	04/30/2024
Responses	41,564,295	0	49,697,075
Time Burden (Hours)	728,816	0	863,068
Cost Burden (Dollars)	319,392	0	24,937,829

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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
   PL: Pub.L. 109 - 177 Title V Name of Law: USA PATRIOT Improvement and Re
   PL: Pub.L. 111 - 268 et. al. Name of Law: Combat Methamphetamine Enhancement Act of 2010
   PL: Pub.L. 110 - 415 et. al. Name of Law: The Methamphetamine Production Prevention Act of 2008
  

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:
	88 FR 73624	10/26/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 100	01/02/2024
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	41,564,295	49,697,075	0	-8,132,780	0	0
Annual Time Burden (Hours)	728,816	863,068	0	-134,252	0	0
Annual Cost Burden (Dollars)	319,392	24,937,829	0	-24,618,437	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: Changes in annual responses, annual burden hours, and annual burden dollars reflect adjustments related to changes in estimated number of training records, estimated labor rates, and normal business activity and a change in calculation method. In prior requests, the number of customer transaction records was based on states that did not already have similar requirements under state law at time of DEA’s regulation was implemented. However, this request includes all U.S. transactions subject to this information collection. There have been no statutory or regulatory changes affecting this information collection.

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Annual Cost to Federal Government: $157,279

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: 01/23/2024

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