View Information Collection Request (ICR) Package

OMB Control No: 1117-0008	ICR Reference No: 201911-1117-002
Status: Historical Inactive	Previous ICR Reference No: 201907-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 01/22/2020
	Date Received in OIRA: 11/13/2019
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is withholding approval of this information collection. Prior to the publication of the final rule, the agency must provide to OMB a summary of all comments pertaining to the information collection burden imposed by this rule and any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	09/30/2022
Responses	3,066	0	3,066
Time Burden (Hours)	1,533	0	1,533
Cost Burden (Dollars)	136,253	0	136,253

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).

Authorizing Statute(s): US Code: 21 USC 826 Name of Law: Production Quotas for Controlled Substances

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB49	Proposed rulemaking	84 FR 56712	10/23/2019

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

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, 250	,

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:

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

Agency Contact: Alana Moore 202 598-2403 alana.j.moore@usdoj.gov

View ICR - OIRA Conclusion