Application for Permit to Export Controlled Substances, Application for Permit to Export Controlled Substances for Subsequent Reexport

Forms and Documents

Document Name	Status
Form 161R Application for Permit to Export Controlled Substances for Subsequent Reexport - DEA Form 161R Form	Modified
Form 161 Application for Permit to Export Controlled Substances--DEA Form 161 Form	Modified
1117-0004 Application for Permit to Export Controlled Substances -- DEA Form 161-161r (8-12-16).rtf Supporting Statement A	2016-08-12
21 U.S.C. 953 2011-3-31.docx Supplementary Document	2011-04-21

IC Document Collections

IC ID	Document Title	Status
183791	Application for Permit to Export Controlled Substances for Subsequent Reexport - DEA Form 161R Form	Modified
12282	Application for Permit to Export Controlled Substances--DEA Form 161 Form	Modified

ICR Details

OMB Control No: 1117-0004	ICR Reference No: 201605-1117-001
Status: Historical Active	Previous ICR Reference No: 201405-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Permit to Export Controlled Substances, Application for Permit to Export Controlled Substances for Subsequent Reexport
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: 11/02/2016
	Date Received in OIRA: 09/07/2016
Terms of Clearance: OMB appreciates DEA's efforts to make progress towards providing a fully electronic option for reporting. This collection is approved for 2 years while DEA continues to make progress on this issue.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved	11/30/2016
Responses	6,116	0	5,812
Time Burden (Hours)	3,301	0	3,083
Cost Burden (Dollars)	281,709	0	107,813

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Abstract: Section 1003 of the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 953) and Title 21, Code of Federal Regulations (21 CFR), Sections 1312.21 and 1312.22 require that any person who desires to export or reexport controlled substances listed in schedules I or II, any narcotic substance listed in schedules III or IV, or any non-narcotic substance in schedule III which the Administrator has specifically designated by regulation in §1312.30, or any nonnarcotic substance in schedule IV or V which is also listed in schedule I or II of the Convention on Psychotropic Substances, must have an export permit. To obtain the export permit, an application for the permit must be made to the DEA on DEA Form 161 for exports, and DEA Form 161R for reexports.

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Authorizing Statute(s): US Code: 21 USC 953 Name of Law: Exportation 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:
	81 FR 38220	06/13/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 53163	08/11/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Application for Permit to Export Controlled Substances for Subsequent Reexport - DEA Form 161R	161R	Application for Permit to Export Controlled Substances for Subsequent Reexport
Application for Permit to Export Controlled Substances--DEA Form 161	161	Application for Permit to Export Controlled Substances

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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	6,116	5,812	0	304	0	0
Annual Time Burden (Hours)	3,301	3,083	0	218	0	0
Annual Cost Burden (Dollars)	281,709	107,813	0	173,896	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 burden hours is due to an increase in the number of responses. The increase in the burden dollars is due to increase in burden hours and a change in calculation method.* There have been no statutory or regulatory changes affecting this information collection. In prior information collection requests, the estimated cost burden was described as “a usual and customary business expense not directly associated with this information collection.” The DEA believes the estimated cost burden associated with this information collection should be included. This change in calculation method is employed in this and future information collection requests.

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Annual Cost to Federal Government: $168,951

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 09/07/2016

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