Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a)

Forms and Documents

Document Name	Status
Form DEA-363 Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a) Form and Instruction	Modified
1117-0015 Supporting Statement 2021.docx Supporting Statement A	2021-09-23
21 CFR 1301.1.mht Supplementary Document	2012-03-20
72FR3410 SORN.pdf Supplementary Document	2012-03-20
66FR8425 SORN.pdf Supplementary Document	2012-03-20
52FR47208 SORN.pdf Supplementary Document	2012-03-20
21 U.S.C. 822.doc Supplementary Document	2008-12-17

IC Document Collections

IC ID	Document Title	Status
12317	Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a) Form and Instruction	Modified

ICR Details

OMB Control No: 1117-0015	ICR Reference No: 202109-1117-001
Status: Received in OIRA	Previous ICR Reference No: 201802-1117-002
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/23/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2021
Responses	1,900	1,726
Time Burden (Hours)	357	189
Cost Burden (Dollars)	24,715	11,754

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Abstract: The Controlled Substances Act requires practitioners conducting narcotic treatment to register annually with DEA. 21 U.S.C. 822, 823(g)(1); 21 CFR 1301.11, 1301.13. Registration is a necessary control measure that prevents diversion by ensuring the closed system of distribution of controlled substances can be monitored by DEA and that the businesses and individuals handling controlled substances are qualified to do so and are accountable.

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Authorizing Statute(s): US Code: 21 USC 822 Name of Law: Persons required to register
   US Code: 21 USC 823 Name of Law: Registration Requirements
  

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:
	86 FR 1030	01/07/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 52923	09/23/2021
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 Form 363) and Application for Registration Renewal (DEA Form 363a)	DEA-363, DEA-363A	Application for Registration ,   Application for Registration Renewal

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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	1,900	1,726	0	174	0	0
Annual Time Burden (Hours)	357	189	0	168	0	0
Annual Cost Burden (Dollars)	24,715	11,754	0	12,961	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 regulatory change affecting this information collection, requiring all forms be submitted online, is expected to lower burden. However, the increase in burden hours is a result of adjusting up, the average burden hours per response. Additionally, the increase in annual responses, burden hours, and annual cost reflects the increase in DEA’s registrant population and a small increase in average burden per response. The table in the Supporting Statement summarizes the changes since the last renewal of this information collection.

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Annual Cost to Federal Government: $22,419

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.     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: 09/23/2021

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