Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine

Forms and Documents

Document Name	Status
Form DEA-250 Application for Procurement Quota for Controlled Substances Form	Modified
21 CFR 1315.32.pdf Supplementary Document	2010-08-31
21 CFR 1303.12(b).pdf Supplementary Document	2010-08-31
21 USC 826.pdf Supplementary Document	2010-08-31
Updated_1117-0008 DEA-250 Supporting Statement 2010-12-1.doc Supporting Statement A	2010-12-20

IC Document Collections

IC ID	Document Title	Status
179145	Application for Procurement Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Instruction	Modified
12294	Application for Procurement Quota for Controlled Substances Form	Modified

ICR Details

OMB Control No: 1117-0008	ICR Reference No: 201008-1117-003
Status: Historical Active	Previous ICR Reference No: 200707-1117-003
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/18/2011
	Date Received in OIRA: 10/21/2010
Terms of Clearance: The agency plans to make this collection fully electronic by the next submission. The agency is reminded that this ICR should have been submitted as an extension without change because there were no programmatic or other substantive changes made to the collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved	01/31/2011
Responses	2,348	0	1,346
Time Burden (Hours)	2,348	0	1,346
Cost Burden (Dollars)	242,197	0	17,094

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Abstract: Under 21 U.S.C. § 826 and 21 CFR §§ 1303.12 and 1315.32, the DEA requires those U.S. companies who desire to use any basic class of controlled substances listed in Schedule I or II or the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for purposes of manufacturing during the next calendar year shall apply for procurement quota for such class or List I chemical using DEA Form 250.

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Authorizing Statute(s): US Code: 21 USC 826 Name of Law: Production Quotas for 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:
	75 FR 42133	07/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 59294	09/27/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Application for Procurement Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine	DEA250	Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine
Application for Procurement Quota for Controlled Substances	DEA-250	Application For Procurement Quota for Controlled Substances

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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	2,348	1,346	0	0	1,002	0
Annual Time Burden (Hours)	2,348	1,346	0	0	1,002	0
Annual Cost Burden (Dollars)	242,197	17,094	0	0	225,103	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 been no program changes. The adjustment is due to responses received.

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Annual Cost to Federal Government: $273,206

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: 10/21/2010

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