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 Supporting Statement.docx Supporting Statement A	2019-03-25
1117-0047 30-Day Notice.pdf Supplementary Document	2019-03-20
1117-0047 60-Day Notice.pdf Supplementary Document	2019-03-20
21 CFR 1315.34.pdf Supplementary Document	2019-03-18
21 USC 952.pdf Supplementary Document	2019-03-18

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: 201903-1117-003
Status: Active	Previous ICR Reference No: 201510-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine (DEA Form 488)
Type of Information Collection: 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: 05/29/2019
	Date Received in OIRA: 03/28/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2022	36 Months From Approved	05/31/2019
Responses	126	0	80
Time Burden (Hours)	63	0	80
Cost Burden (Dollars)	5,599	0	6,409

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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:
	83 FR 64367	12/14/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 6439	02/27/2019
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	126	80	0	46	0	0
Annual Time Burden (Hours)	63	80	0	-17	0	0
Annual Cost Burden (Dollars)	5,599	6,409	0	-810	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The changes in burden for this information collection reflect an increase in the number of annual responses and a lower estimated average time per response. There have been no statutory or regulatory changes affecting this collection.

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Annual Cost to Federal Government: $121,516

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? 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: 03/28/2019

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