Application for Registration Under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993

Forms and Documents

Document	Type	Status	Availability
Form DEA Form 510 Application for Registration Under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993	Form and Instruction	Modified	Missing upstream
1117-0031 Supporting Statement (DEA-587)_Final Rule.docx	Supporting Statement A	Uploaded 2022-04-15	Repair queued
21 CFR 1309.32.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 CFR 1309.21.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 958.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 957.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 823.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued
21 USC 822.pdf	Supplementary Document	Uploaded 2019-03-20	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
12332	Application for Registration Under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993	Form and Instruction	Modified

ICR Details

OMB Control No: 1117-0031	ICR Reference No: 202204-1117-004
Status: Received in OIRA	Previous ICR Reference No: 202012-1117-006
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Application for Registration Under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/18/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2022
Responses	1,001	996
Time Burden (Hours)	183	77
Cost Burden (Dollars)	12,681	6,469

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Abstract: The DEA implements the Controlled Substances Act (CSA) which requires that every person who manufactures or distributes a list I chemical shall annually obtain a registration for that purpose. 21 U.S.C. 822 and 823. Additionally, the Controlled Substances Import and Export Act (CSIEA) requires that persons who import or export list I chemicals must obtain a registration prior to conducting such activities. 21 U.S.C. 957 and 958. DEA Form 510 is utilized by applicants desiring to manufacture, distribute, import, and export list I chemicals. DEA Form 510A is utilized for renewal of the registration on an annual basis. DEA is proposing to revise the regulations for application and renewal by requiring all DEA registrants to apply for registration online using the agency’s secure portal. This will eliminate the need for paper forms and payments, streamline the registration process, and save time and expense for both the agency and registration population.

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Authorizing Statute(s): US Code: 21 USC 822
   US Code: 21 USC 823
   US Code: 21 USC 957
   US Code: 21 USC 958
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB58	Final or interim final rulemaking	87 FR 21019	04/11/2022

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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 Under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993	DEA Form 510a, DEA Form 510	Application for Registration ,   Renewal Application for Registration

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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	1,001	996	0	5	0	0
Annual Time Burden (Hours)	183	77	0	106	0	0
Annual Cost Burden (Dollars)	12,681	6,469	0	6,212	0	0

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

Burden Increase Due to: Changing Regulations

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.

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Annual Cost to Federal Government: $14,946

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: 04/18/2022

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