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

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
179146	Application for Individual manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine		New
12286	Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance		Modified

ICR Details

OMB Control No: 1117-0006	ICR Reference No: 200703-1117-006
Status: Historical Active	Previous ICR Reference No: 200603-1117-001
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/31/2007
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/29/2007
	Date Received in OIRA: 03/22/2007
Terms of Clearance: Approved consistent with the following terms of clearance: DEA is reminded to ensure that information collections covered by the Paperwork Reduction Act should be addressed timely during the development of rules by the Agency.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2007	6 Months From Approved	05/31/2009
Responses	298	0	264
Time Burden (Hours)	150	0	132
Cost Burden (Dollars)	3,772	0	0

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Abstract: 21 U.S.C. § 826 and 21 CFR §§ 1303.22 and 1315.22 require that 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 apply on DEA Form 189 for a manufacturing quota for such quantity of such class or List I chemical.

Emergency Justfication: The Drug Enforcement Administration (DEA) is requesting emergency processing of the revision of Office of Management and Budget (OMB) information collections 1117-0006 “Application for an Individual Manufacturing Quota for a Basic Class of Controlled Substance and of Ephedrine, Pseudoephedrine, and Phenylpropanolamine,” 1117-0008 “Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine,” and approval of new information collection 1117-XXXX “Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine” as discussed below. The revision of these information collections and the approval of the new collection are associated with, and essential for the implementation of, the DEA Interim Rule with Request for comment entitled “Import and Production Quotas for Certain List I Chemicals” [Docket No. DEA-293, RIN 1117-AB08].

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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: 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:
1117-AB08	Final or interim final rulemaking

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Federal Register Notices & Comments

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
Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance	DEA-189

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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	298	264	0	1	33	0
Annual Time Burden (Hours)	150	132	0	1	17	0
Annual Cost Burden (Dollars)	3,772	0	0	-228	4,000	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The Combat Methamphetamine Epidemic Act of 2005 (Title VII of Pub. L. 109-177) amended the Controlled Substances Act (21 U.S.C. 826) to require the establishment of production quotas for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. One firm will need to apply for an individual manufacturing quota to comply with the Controlled Substances Act as amended. The 3.5 hour annual burden increase is a result of this statutory change.

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Annual Cost to Federal Government: $83,184

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 03/22/2007

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