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
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
1117-0015 Supporting Statement 04-23-2015 Final ODW.docx Supporting Statement A	2015-04-23

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: 201504-1117-002
Status: Historical Active	Previous ICR Reference No: 201110-1117-002
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/23/2015
	Date Received in OIRA: 04/27/2015
Terms of Clearance: In accordance with 5 CFR 1320, this information collection is approved for 3 years. Previous TOC have been satisfied.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2018	36 Months From Approved	06/30/2015
Responses	1,046	0	1,484
Time Burden (Hours)	123	0	272
Cost Burden (Dollars)	6,227	0	331,199

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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:
	80 FR 5138	01/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 18258	04/03/2015
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 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	1,046	1,484	0	-438	0	0
Annual Time Burden (Hours)	123	272	0	-149	0	0
Annual Cost Burden (Dollars)	6,227	331,199	0	-324,972	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: In prior information collection requests, the associated registration fee was included in the cost burden calculation. The DEA believes the registration fee should be excluded from the information collection cost burden because the time and capital expense burden to provide the information is not tied to the registration fee. This change in calculation method is employed in this and future information collection requests.

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Annual Cost to Federal Government: $376,239

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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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: 04/27/2015

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