Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

Forms and Documents

Document Name	Status
Form DEA 488 Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Form	Modified
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
1117-0047 supporting statement 2012-4-6 (1).doc Supporting Statement A	2012-04-10

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: 201110-1117-003
Status: Historical Active	Previous ICR Reference No: 201007-1117-003
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
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 with change	Conclusion Date: 04/12/2012
	Date Received in OIRA: 01/24/2012
Terms of Clearance: Prior to any further approval of this information collection, DEA shall either provide OMB with a joint Information Collection Request/Privacy Impact Assessment or shall post a separate Privacy Impact Assessment addressing systems that support this information collection. OMB will update DEA on its preferred methodology for the calculation of cost burden. As shown by the corrections to this collection, DEA shall continue to explain any burden changes in Q15 of the supporting statement. For the next time the electronic PDF is edited, DEA shall delete the extra comma in “under the Federal, Food, Drug & Cosmetic Act” on its IC.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	36 Months From Approved	04/30/2012
Responses	52	0	80
Time Burden (Hours)	52	0	80
Cost Burden (Dollars)	905	0	1,464

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Abstract: Under 21 U.S.C. 952 and 21 CFR 1315.34 the DEA requires a Form 488 application from persons who desire to import the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in order to determine import quotas for such List I chemicals.

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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:
	76 FR 66084	10/25/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 1085	01/09/2012
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	52	80	0	0	-28	0
Annual Time Burden (Hours)	52	80	0	0	-28	0
Annual Cost Burden (Dollars)	905	1,464	0	0	-559	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: There have not been any program changes. Adjustments have occurred based on responses received.

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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: 01/24/2012

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