Controlled Substances Import/Export Declaration

Forms and Documents

Document Name	Status
1117-0009 Supporting Statement Aug 2020.docx Supporting Statement A	2020-09-25
DEA Online Import-Export Applcation Introduction and Overview.pdf Supplementary Document	2017-06-16
Create Screenshot- New DEA 236 (Import).pdf Supplementary Document	2017-06-15
Create Screenshot- New DEA 236 (Export).pdf Supplementary Document	2017-06-15
Return Information wording for IMEX forms (DEA Form 236).docx Supplementary Document	2017-01-05
21 U.S.C. 953.doc Supplementary Document	2008-03-26
21 U.S.C. 952.doc Supplementary Document	2008-03-26

IC Document Collections

IC ID	Document Title	Status
12297	Controlled Substances Import/Export Declaration--DEA Form 236 Other-DEA 236 (Import) Web Application	Modified

ICR Details

OMB Control No: 1117-0009	ICR Reference No: 202008-1117-002
Status: Active	Previous ICR Reference No: 201701-1117-003
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Controlled Substances Import/Export Declaration
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: 11/16/2020
	Date Received in OIRA: 09/25/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2023	36 Months From Approved	11/30/2020
Responses	8,154	0	6,321
Time Burden (Hours)	2,039	0	1,779
Cost Burden (Dollars)	132,258	0	144,834

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Abstract: DEA Form 236 provides the DEA with oversight and control over the importation and exportation of controlled substances. 21 CFR part 1312, promulgated pursuant to 21 U.S.C. 952 and 21 U.S.C. 953, requires registrants who desire to import non-narcotic substances in schedules III, IV, and V or to export non-narcotic substances in schedules III and IV and any other substance in schedule V, to furnish a controlled substances import declaration/controlled substances export invoice on a DEA Form 236 (if those activities are not otherwise subject to import/export permit requirements). In addition, Article 12 of the Convention on Psychotropic Substances of 1971 (Convention) requires a system of export declarations for certain substances controlled under the Convention.

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Authorizing Statute(s): US Code: 21 USC 953 Name of Law: Exportation of Controlled Substances
   US Code: 21 USC 952 Name of Law: Importation of Controlled Substances
  

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:
	85 FR 34241	06/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 48267	08/10/2020
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
Controlled Substances Import/Export Declaration--DEA Form 236	236	Controlled Substances Import/Export Declaration

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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	8,154	6,321	0	1,833	0	0
Annual Time Burden (Hours)	2,039	1,779	0	260	0	0
Annual Cost Burden (Dollars)	132,258	144,834	0	-12,576	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: No

Burden Reduction Due to:

Short Statement: The increase in annual responses and annual burden hours reflects adjustments related to normal business activity. The decrease in the burden dollars is due to the elimination of estimate for shipping cost per paper response and a change in calculation method.

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Annual Cost to Federal Government: $373,525

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: 09/25/2020

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