Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952

Forms and Documents

Document Name	Status
Form 357 Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952 Form	Modified
1117-0013 Supporting Statement_Aug 2020.docx Supporting Statement A	2020-08-17
DEA Online Import-Export Applcation Introduction and Overview.pdf Supplementary Document	2017-06-16
Create Screenshot- New DEA 357 (Import).pdf Supplementary Document	2017-06-15
Return Information wording for IMEX (DEA form - 357).docx Supporting Statement B	2017-06-12
21USC952.doc Supplementary Document	2007-07-13

IC Document Collections

IC ID	Document Title	Status
12309	Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952 Form	Modified

ICR Details

OMB Control No: 1117-0013	ICR Reference No: 202008-1117-003
Status: Active	Previous ICR Reference No: 201702-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952
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	1,949	0	1,332
Time Burden (Hours)	497	0	333
Cost Burden (Dollars)	32,236	0	43,552

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Abstract: Section 1002 of the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 952) and Title 21, Code of Federal Regulations (21 CFR), Sections 1312.11, 1312.12 and 1312.13 requires any person who desires to import 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 import permit. To obtain the permit to import controlled substances for domestic and or scientific purposes, an application for the permit must be made to the DEA on DEA Form 357.

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Authorizing Statute(s): 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 34237	06/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 48270	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
Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952	357	Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes

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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	1,949	1,332	0	617	0	0
Annual Time Burden (Hours)	497	333	0	164	0	0
Annual Cost Burden (Dollars)	32,236	43,552	0	-11,316	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 reflect adjustments related to normal business activity. The decrease in the burden dollars is due to the elimination of most of shipping cost per paper response as most responses have moved to electronic responses, and a change in calculation method, which is discussed in a footnote within the Supporting Statement. There has 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.

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Annual Cost to Federal Government: $275,566

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: 08/19/2020

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