Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine (DEA Form 488)

Forms and Documents

Document Name	Status
Form DEA 488 Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Form	Modified
1117-0047 SupState_011416.doc Supporting Statement A	2016-01-13
1117-0047 21 CFR 1315.34 2010.doc Supplementary Document	2012-01-24
1117-0047 21 USC 952 2010.doc Supplementary Document	2010-08-02

IC Document Collections

IC ID	Document Title	Status
179147	Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Form	Modified

ICR Details

OMB Control No: 1117-0047	ICR Reference No: 201510-1117-002
Status: Historical Active	Previous ICR Reference No: 201210-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine (DEA Form 488)
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: 03/14/2016
	Date Received in OIRA: 01/13/2016
Terms of Clearance: As the collection contains no program changes as indicated by the supporting statement, the collection should have been submitted as an extension without change, not a revision.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	03/31/2016
Responses	80	0	52
Time Burden (Hours)	80	0	52
Cost Burden (Dollars)	6,409	0	905

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Abstract: Title 21, United States Code (U.S.C.), Section 952, and Title 21, Code of Federal Regulations (CFR), § 1315.34 require that persons who desire to import the List I chemicals Ephedrine, Pseudoephedrine, or Phenylpropanolamine during the next calendar year shall apply to DEA on DEA Form 488 for an import quota for those List I chemicals. The Controlled Substances Act states: "It shall be unlawful for any person to import … ephedrine, pseudoephedrine, and phenylpropanolamine, … except … such amounts of … ephedrine, pseudoephedrine, and phenylpropanolamine as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes" (21 U.S.C. 952).

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Authorizing Statute(s): US Code: 21 USC 952 Name of Law: Importation of Controlled of Substances
  

Citations for New Statutory Requirements: US Code: 21 USC 802 Name of Law: Combat Methamphetamine Epidemic Act of 2005

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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:
	80 FR 67422	11/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 1215	01/11/2016
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 Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine	DEA 488	Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

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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	80	52	0	0	28	0
Annual Time Burden (Hours)	80	52	0	0	28	0
Annual Cost Burden (Dollars)	6,409	905	0	0	5,504	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $50,825

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: 01/13/2016

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