Procurement Quota Certification and Recordkeeping Requirements

ICR 201911-1117-005

OMB: 1117-0055

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-11-13
Supplementary Document
2019-07-05
Supplementary Document
2019-07-05
Supplementary Document
2019-07-05
IC Document Collections
ICR Details
1117-0055 201911-1117-005
Historical Inactive 201907-1117-004
DOJ/DEA
Procurement Quota Certification and Recordkeeping Requirements
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 01/22/2020
Retrieve Notice of Action (NOA) 11/13/2019
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
36 Months From Approved
0 0 0
0 0 0
0 0 0

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).

US Code: 21 USC 826 Name of Law: null
  
None

1117-AB49 Proposed rulemaking 84 FR 56712 10/23/2019

No

1
IC Title Form No. Form Name
Procurement Quota Certification and Recordkeeping Requirements

Yes
Changing Regulations
No
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.

$0
No
    No
    No
No
No
No
Uncollected
Alana Moore 202 598-2403 alana.j.moore@usdoj.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/13/2019


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