Application for Individual manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

Forms and Documents

Document Name	Status
Form DEA-189 Application for Individual manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Form	Unchanged
1117-0006 Supporting Statement 3-15-2016.docx Supporting Statement A	2016-03-29
1117-0006 21 CFR 1315.22 2010.doc Supplementary Document	2010-08-03
1117-0006 21 CFR 1303.22 2010.doc Supplementary Document	2010-08-03
1117-0006 21 USC 826 2010.doc Supplementary Document	2010-08-03

IC Document Collections

IC ID	Document Title	Status
179146	Application for Individual manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Form	Unchanged
12286	Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance Instruction	Modified

ICR Details

OMB Control No: 1117-0006	ICR Reference No: 201512-1117-001
Status: Historical Active	Previous ICR Reference No: 201211-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Individual manufacturing Quota for a Basic Class of Controlled Substance and 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 without change	Conclusion Date: 05/31/2016
	Date Received in OIRA: 04/06/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2019	36 Months From Approved	05/31/2016
Responses	661	0	641
Time Burden (Hours)	331	0	321
Cost Burden (Dollars)	26,291	0	0

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Abstract: Any person who is registered to manufacture any basic class of controlled substances listed in Schedule I or II and who desires to manufacture a quantity of such class; or who desires to manufacture using the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine, must complete the DEA Form 189 online, for a manufacturing quota for such quantity of such class or List I chemical. 21 U.S.C. 826 and 21 CFR 1303.22 and 1315.22.

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Authorizing Statute(s): US Code: 21 USC 826 Name of Law: null
  

Citations for New Statutory Requirements: PL: Pub.L. 109 - 177 713 Name of Law: The 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:
	81 FR 1219	01/11/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 13828	03/15/2016
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 Individual manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine	DEA-189	Application for Individual manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance	DEA Form 189	Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance and 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	661	641	0	20	0	0
Annual Time Burden (Hours)	331	321	0	10	0	0
Annual Cost Burden (Dollars)	26,291	0	0	26,291	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: Changes reflect a small increase in the number of respondents and a change in calculation method*. There have been no statuory or regulatory changes affecting this information collection. The table below summarizes the changes since the last renewal of this information collection. In prior information collection requests, the estimated annual burden dollars was implied to be usual and customary business expense not directly associated with this information collection. The DEA believes the estimated annual burden associated with this information collection should be included. This change in calculation method is employed in this and future information collection requests

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Annual Cost to Federal Government: $297,209

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: 04/06/2016

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