Application for Permit to Export Controlled Substances

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 and Instruction	Modified
21 U.S.C. 953 2011-3-31.docx Supplementary Document	2011-04-21
1117-0004 Supporting Statement 2014.docx Supporting Statement A	2014-07-31

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 and Instruction	Modified

ICR Details

OMB Control No: 1117-0004	ICR Reference No: 201405-1117-002
Status: Historical Active	Previous ICR Reference No: 201103-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Permit to Export Controlled Substances
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: 09/15/2014
	Date Received in OIRA: 07/31/2014
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	09/30/2016	36 Months From Approved	09/30/2014
Responses	5,812	0	5,773
Time Burden (Hours)	3,083	0	3,043
Cost Burden (Dollars)	107,813	0	107,089

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Abstract: Title 21 CFR Section 1312.22 requires persons who export controlled substances in Schedules I and II to obtain a permit from DEA. Information is used to issue export permits, exercise control over exportation of controlled substances, and compile data for submission to United Nations to comply with treaty requirements.

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Authorizing Statute(s): US Code: 21 USC 952 Name of Law: Importation of Controlled Substances
   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:
	79 FR 21953	04/19/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 35574	06/23/2014
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	5,812	5,773	0	0	39	0
Annual Time Burden (Hours)	3,083	3,043	0	0	40	0
Annual Cost Burden (Dollars)	107,813	107,089	0	0	724	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: Miscellaneous Actions

Short Statement: The burden information changed due to the number of respondents and responses based on the registrant population and number of exports and reexports of controlled substances.

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Annual Cost to Federal Government: $222,468

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: 07/31/2014

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