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 Name	Status
Form DEA-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
Justification DEA-284 RIN 1117-AB11.doc Justification for No Material/Nonsubstantive Change	2007-08-29

IC Document Collections

IC ID	Document Title	Status
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: 200708-1117-005
Status: Historical Active	Previous ICR Reference No: 200705-1117-002
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 06/04/2007
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/14/2007
	Date Received in OIRA: 08/30/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2008	02/29/2008	02/29/2008
Responses	2,580	0	2,576
Time Burden (Hours)	878	0	877
Cost Burden (Dollars)	3,403,304	0	3,398,027

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Abstract: The Domestic Chemical Diversion Control Act requires that manufacturers, distributors, importers, and exporters of List I chemicals which may be diverted in the United States for the production of illicit drugs must register with DEA. Registration provides a system to aid in the tracking of the distribution of List I chemicals.

Emergency Justfication: This is a request for emergency processing of two information collections associated with a Drug Enforcement Administration (DEA) Final Rule “Changes in the Regulation of Iodine Crystals and Chemical Mixtures Containing Over 2.2 Percent Iodine” [Docket No. DEA-257, RIN 1117-AA93]. DEA notes that this Final Rule is being finalized with a 30-day effective date. The two collections for which emergency processing is requested are: “Application for Registration under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993” [OMB information collection 1117-0031] and “Import/Export Declaration for list I and List II Chemicals” [OMB information collection 1117-0023].

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and Reports of Registrants
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AA93	Final or interim final rulemaking	72 FR 20039	04/23/2007

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 26834	05/11/2007
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-510, DEA-510A	APPLICATION FOR REGISTRATION Under the Controlled Substances Act ,   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	2,580	2,576	0	4	0	0
Annual Time Burden (Hours)	878	877	0	1	0	0
Annual Cost Burden (Dollars)	3,403,304	3,398,027	0	5,277	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 change to this information collection reflects the additional burden associated with implementation of the DEA rule entitled "Elimination of Exemptions for Chemical Mixtures Containing Ephedrine and/pr Pseudoephedrine" [Docket no. DEA-284, RIN 1117-AB11]. Although the sale of dietary supplements containing these List I chemicals has been banned by the Food and Drug Administration, there may be legitimate uses for these chemical mixtures. The change to this information collection reflects those potential impacts.

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Annual Cost to Federal Government: $113,698

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 08/30/2007

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