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/161R-EEA Form	Modified
Form 161 Application for Permit to Export Controlled Substances--DEA Form 161 Form	Modified
1117-0004 Supporting Statement Aug 2020.docx Supporting Statement A	2020-08-17
161EEA Reexport-orgs-screenshot3.png Supplementary Document	2017-08-08
DEA Online Import-Export Applcation Introduction and Overview.pdf Supplementary Document	2017-06-16
Create Screenshot- New DEA 161R (Export).pdf Supplementary Document	2017-06-15
Create Screenshot- New DEA 161 (Export).pdf Supplementary Document	2017-06-15
161r-EEA_instruct.docx Supplementary Document	2017-06-12
161r_form_EEA.pdf Supplementary Document	2017-06-12
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/161R-EEA 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: 202008-1117-001
Status: Active	Previous ICR Reference No: 201710-1117-001
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: 11/16/2020
	Date Received in OIRA: 08/19/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2023	36 Months From Approved	11/30/2020
Responses	7,282	0	6,116
Time Burden (Hours)	3,839	0	3,301
Cost Burden (Dollars)	249,018	0	281,709

---

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.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 34240	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

---

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-EEA	161R, 161R-EEA	Application for Permit to Export Controlled Substances for Subsequent Reexport ,   RE-EXPORTS AMONG EUROPEAN ECONOMIC AREA (EEA) MEMBERS
Application for Permit to Export Controlled Substances--DEA Form 161	161	Application for Permit to Export Controlled Substances

---

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	7,282	6,116	0	1,166	0	0
Annual Time Burden (Hours)	3,839	3,301	0	538	0	0
Annual Cost Burden (Dollars)	249,018	281,709	0	-32,691	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: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The increase in annual responses and annual burden hours reflect adjustments related to normal business activity. The decrease in the annual cost is due to the elimination of paper response shipping cost, which were included in the 2017 annual cost figure, as responses have moved to electronic responses. There have been no statutory or regulatory changes affecting this information collection. There is a table in the Supporting Statement which summarizes the changes since the last renewal of this information collection.

---

Annual Cost to Federal Government: $260,589

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.     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? No

---

Common Form ICR:  No

---

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: 08/19/2020

---