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	Modified
1117-0006 Supporting Statement.docx Supporting Statement A	2019-03-25
1117-0006 30-Day Notice.pdf Supplementary Document	2019-03-20
1117-0006 60-Day Notice.pdf Supplementary Document	2019-03-20
1117-0006 21 CFR 1315.22.pdf Supplementary Document	2019-03-13
1117-0006 21 CFR 1303.22.pdf Supplementary Document	2019-03-13
1117-0006 21 USC 826.pdf Supplementary Document	2019-03-13

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	Modified
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: 201903-1117-001
Status: Active	Previous ICR Reference No: 201512-1117-001
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: 06/04/2019
	Date Received in OIRA: 04/02/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	06/30/2019
Responses	860	0	661
Time Burden (Hours)	431	0	331
Cost Burden (Dollars)	38,174	0	26,291

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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: 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:
	83 FR 64369	12/14/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5722	02/22/2019
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	860	661	0	199	0	0
Annual Time Burden (Hours)	431	331	0	100	0	0
Annual Cost Burden (Dollars)	38,174	26,291	0	11,883	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: The changes in burden for this information collection reflect a small increase in the number of annual responses. There have been no statutory or regulatory changes affecting this collection.

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Annual Cost to Federal Government: $259,516

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: 04/02/2019

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