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

Forms and Documents

Document Name	Status
Form DEA-224 Application for Registration-DEA 224, Application for Registration Renewal-DEA 224A Form and Instruction	Modified
1117-0014 Supporting Statement.docx Supporting Statement A	2019-03-25
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: 201903-1117-005
Status: Active	Previous ICR Reference No: 201510-1117-001
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
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	617,979	0	534,082
Time Burden (Hours)	61,226	0	47,756
Cost Burden (Dollars)	9,080,036	0	6,459,789

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 64367	12/14/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5721	02/22/2019
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 Registration-DEA 224, Application for Registration Renewal-DEA 224A	DEA-224A, DEA-224	Application for Registration ,   Renewal Application for Registration

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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	617,979	534,082	0	83,897	0	0
Annual Time Burden (Hours)	61,226	47,756	0	13,470	0	0
Annual Cost Burden (Dollars)	9,080,036	6,459,789	0	2,620,247	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: Changes reflect population adjustments and greater use of online applications, which take less time to complete. Although there was a slight increase in the percentage of applicants applying online, having a greater number of respondents from October 2017 to September 2018 results in a net increase in the annual burden hours. Although practitioners are registered for a three-year cycle and the number of registrants is not equally distributed between years of the cycle, October 1, 2017 to September 30, 2018 is a reasonable approximation of the average annual burden as it is very close to the average of the three years. Additionally, the growth rate in the number of practitioners is low enough where the actual numbers for this period would not be materially different from the number expected for the next several years. Although there is a small increase in the burden hours, the increase in the annual cost is attributed to the mean hourly wage increase of physicians and surgeons. There have been no statutory or regulatory changes affecting this information collection.

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Annual Cost to Federal Government: $5,611,787

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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