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OMB Control No: 1117-0055	ICR Reference No: 201911-1117-005
Status: Historical Inactive	Previous ICR Reference No: 201907-1117-004
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Procurement Quota Certification and Recordkeeping Requirements
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	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		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

Abstract: Any person to whom a procurement quota has been issued, authorizing that person to procure and use a quantity of a basic class of controlled substances listed in Schedules I or II and ephedrine, pseudoephedrine, phenylpropanolamine during the current calendar year, shall, at or before the time of giving an order to another registrant requiring the distribution of a quantity of such basic class and the chemical, certify in writing to such other registrant that the quantity of such basic class and list I chemical ordered does not exceed the person's unused and available procurement quota of such basic class and chemical for the current calendar year. Registrants shall not fill an order from a person required to apply for a procurement quota unless the order is accompanied by such a certification. Manufacturers procuring schedules I and II controlled substances or list I chemicals must maintain a copy of the certification they provide with their order for a period of two years from the date of the certification. 21 U.S.C. 826; 21 CFR 1303.12(f), 1315.32(h).

Authorizing Statute(s): US Code: 21 USC 826

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
Procurement Quota Certification and Recordkeeping Requirements

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: This is a new collection being created as part of the DEA’s "Management of Quotas for Controlled Substances and List I Chemicals" rulemaking, RIN 1117-AB49. The DEA is proposing to revise the regulations for procurement quota certification by requiring all DEA registrants supplying schedules I and II controlled substances or list I chemicals to DEA manufacturers to obtain certification of the manufacturer’s procurement quota before completing the transaction.

Annual Cost to Federal Government: $0

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. No

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. 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

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

View ICR - OIRA Conclusion