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

Forms and Documents

Document	Type	Status	Availability
Form DEA Form 250 Application for Procurement Quota for Controlled Substances	Form	Modified	Repair queued
1117-0008 Supporting Statement.docx	Supporting Statement A	Uploaded 2019-03-25	Repair queued
1117-0008 30-Day Notice.pdf	Supplementary Document	Uploaded 2019-03-20	Available
1117-0008 60-Day Notice.pdf	Supplementary Document	Uploaded 2019-03-20	Available
1117-0008 21 CFR 1315.32.pdf	Supplementary Document	Uploaded 2019-03-13	Available
1117-0008 21 CFR 1303.12.pdf	Supplementary Document	Uploaded 2019-03-13	Available
1117-0008 21 USC 826.pdf	Supplementary Document	Uploaded 2019-03-13	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
12294	Application for Procurement Quota for Controlled Substances	Form	Modified

ICR Details

OMB Control No: 1117-0008	ICR Reference No: 201903-1117-002
Status: Active	Previous ICR Reference No: 201512-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Procurement Quota for Controlled Substances and 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	3,066	0	2,960
Time Burden (Hours)	1,533	0	1,480
Cost Burden (Dollars)	136,253	0	117,912

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Abstract: Any United States companies that desire to use any basic class of controlled substances listed in schedule I or II or the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine for purposes of manufacturing during the next calendar year shall apply on DEA Form 250 for a procurement quota for such class. 21 U.S.C. 826 and 21 CFR 1303.12(b) and 1315.32. The DEA is required to limit the production of schedule I and II controlled substances and ephedrine, pseudoephedrine, and phenylpropanolamine to the amounts necessary to meet "the estimated legitimate medical, scientific, research and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks." 21 U.S.C. 826(c).

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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:
	83 FR 64365	12/14/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5502	02/21/2019
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 Procurement Quota for Controlled Substances	DEA Form 250	Application for Procurement Quota for 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	3,066	2,960	0	106	0	0
Annual Time Burden (Hours)	1,533	1,480	0	53	0	0
Annual Cost Burden (Dollars)	136,253	117,912	0	18,341	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: $1,044,655

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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