Application for Permit to Export Controlled Substances--DEA Form 161 and 161R

Forms and Documents

Document Name	Status
Form 161R Application for Permit to Export Controlled Substances for Subsequent Reexport - DEA Form 161R Form	New
Form 161 Application for Permit to Export Controlled Substances--DEA Form 161 Form	Modified
1117-0004 Support Statement 2008.doc Supporting Statement A	2008-02-19

IC Document Collections

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

ICR Details

OMB Control No: 1117-0004	ICR Reference No: 200802-1117-002
Status: Historical Active	Previous ICR Reference No: 200711-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Permit to Export Controlled Substances--DEA Form 161 and 161R
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: 06/24/2008
	Date Received in OIRA: 03/21/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	01/31/2011
Responses	4,200	0	2,444
Time Burden (Hours)	1,800	0	1,222
Cost Burden (Dollars)	18,000	0	0

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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:
1117-AB00	Final or interim final rulemaking	72 FR 72921	12/26/2007

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Federal Register Notices & Comments

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	4,200	2,444	0	1,756	0	0
Annual Time Burden (Hours)	1,800	1,222	0	578	0	0
Annual Cost Burden (Dollars)	18,000	0	0	18,000	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: There has been a program change. The Controlled Substances Export Reform Act of 2005 (Pub. L. 109-57) permits the exportation of Schedule I and II controlled substances, and narcotic substances in Schedule III and IV, to a country for subsequent exportation to a second country and requires documentation that the controlled substances have been reexported to a second country. Previous law did not allow this. Because of this change, DEA has created a new Form 161R, Application for Permit to Export Controlled Substances for Subsequent Reexport. Further, DEA is requiring that persons reexporting controlled substances notify DEA of the initial export of those controlled substances to the first country, necessitating an increase in hour burden of 100 hours. Finally, changes made by Pub. L. 109-57 require that certification of reexportation be provided to DEA; this certification is a new aspect of this collection, necessitating an increase in hour burden of 300 hours. Although DEA estimates that it takes 15 more minutes (0.25 more hours) to complete DEA Form 161R, Application for Permit to Export Controlled Substances for Subsequent Reexport, as compared with DEA Form 161, Application for Permit to Export Controlled Substances, this increase in time for the new Form 161R is offset by the need to submit fewer DEA Forms 161. Previously, reexportation of Schedule I and II controlled substances and narcotic controlled substances in Schedule III and IV was not permitted; persons exporting controlled substances sent them to the actual country of destination, rather than sending them to one country and then reexporting them to the (second) country of destination. Thus, individual DEA Forms 161 were required to handle each individual country of destination. DEA anticipates fewer DEA Forms 161 being submitted now that reexportation of these specific controlled substances is permitted.

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Annual Cost to Federal Government: $55,197

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 03/21/2008

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