Application for Registration-DEA 224, Application of Registration Renewal-DEA 224A

Forms and Documents

Document Name	Status
Form 224A Application for Registration-DEA 224, Application for Registration Renewal-DEA 224A Form and Instruction	Modified
1117-0014 Supporting Statement-EMS NPRM_Clean.docx Supporting Statement A	2020-12-07
1117-0014 30-Day Notice.pdf Supplementary Document	2019-03-20
1117-0014 60-Day Notice.pdf Supplementary Document	2019-03-20
21 CFR 1301.13.pdf Supplementary Document	2019-03-20
21 CFR 1301.11.pdf Supplementary Document	2019-03-20
21 USC 823.pdf Supplementary Document	2019-03-20
21 USC 822.pdf Supplementary Document	2019-03-20
72FR3410 SORN.pdf Supplementary Document	2012-01-05
66FR8425 SORN.pdf Supplementary Document	2012-01-05
52FR47208 SORN.pdf Supplementary Document	2012-01-05

IC Document Collections

IC ID	Document Title	Status
12313	Application for Registration-DEA 224, Application for Registration Renewal-DEA 224A Form and Instruction	Modified

ICR Details

OMB Control No: 1117-0014	ICR Reference No: 202012-1117-002
Status: Received in OIRA	Previous ICR Reference No: 201903-1117-005
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration-DEA 224, Application of Registration Renewal-DEA 224A
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/08/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2022
Responses	621,472	617,979
Time Burden (Hours)	125,786	61,226
Cost Burden (Dollars)	17,649,805	9,080,036

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Abstract: The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1242 (1970), as amended (the “CSA”). 21 U.S.C. 801–971. Through the enactment of the CSA and its amendments, Congress established a closed system of distribution making it unlawful to handle any controlled substance except in a manner authorized by the CSA. In order to maintain this closed system of distribution, the CSA generally requires all persons who handle controlled substances to obtain a registration issued by the Attorney General. 21 U.S.C. 822, 823, 957, and 958.

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Authorizing Statute(s): US Code: 21 USC 822 Name of Law: null
   US Code: 21 USC 823 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:
1117-AB37	Proposed rulemaking	85 FR 62634	10/05/2020

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Federal Register Notices & Comments

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 Registration-DEA 224, Application for Registration Renewal-DEA 224A	224A, 224	Application for Registration Renewal-DEA 224A ,   Application for Registration-DEA 224

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ICR Summary of Burden

	Total Request	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	621,472	617,979	0	3,493	0	0
Annual Time Burden (Hours)	125,786	61,226	0	64,560	0	0
Annual Cost Burden (Dollars)	17,649,805	9,080,036	0	8,569,769	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 increase in the number of respondents reflect new “EMS Agency” business activity that will be added to the application for registration and application for registration renewal forms to allow EMS agencies to obtain a DEA registration. Additionally, there is a change in method for estimating the number of respondents from using the previous year actual registration to a three-year average of the previous three years, as respondents are on a three year registration cycle. The increase in burden hours is a result of adjusting up, doubling, the average time per response. Increase in annual costs are attributed to the increase in registrants and burden hours and the adjustment in burden cost per response.

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Annual Cost to Federal Government: $7,248,745

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? No

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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: 12/08/2020

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