Exempt Chemical Preparations Under the Controlled Substances Act

Forms and Documents

Document Name	Status
Exempt Chemical Preparations Application Form	New
21 CFR 1308.23(c) application requirements.docx Supplementary Document	2021-07-12
21 USC 811 (g)(3).docx Supplementary Document	2021-07-12
1117-NEW Exempt Chemicals Supporting Statement FINAL.docx Supporting Statement A	2021-07-12

IC Document Collections

IC ID	Document Title	Status
248294	Exempt Chemical Preparations Application Form	New

ICR Details

OMB Control No:	ICR Reference No: 202107-1117-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Exempt Chemical Preparations Under the Controlled Substances Act
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/13/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,093	0
Time Burden (Hours)	2,093	0
Cost Burden (Dollars)	113,169	0

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Abstract: Pursuant to 21 U.S.C. 811(g)(3)(B), DEA may exempt from specific provisions of the Controlled Substances Act any compound, mixture, or preparation containing any controlled substance, which is not for administration to a human being or animal, and which is packaged in a certain manner, so that as packaged it does not present any significant potential for abuse. In accordance with 21 CFR 1308.23(f), the Administrator (or the Deputy Assistant Administrator), at any time, may: revoke or modify any exemption granted pursuant to 21 CFR 1308.23; modify or revoke the criteria by which exemptions are granted; and modify the scope of exemptions. This application will provide a uniform way for registrants to request the exemptions.

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Authorizing Statute(s): US Code: 21 USC 811 Name of Law: Controlled Substances Act
  

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 22070	04/26/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 35535	07/06/2021
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
Exempt Chemical Preparations Application	N/A	Exempt Chemical Preparations Application

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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	2,093	0	0	2,093	0	0
Annual Time Burden (Hours)	2,093	0	0	2,093	0	0
Annual Cost Burden (Dollars)	113,169	0	0	113,169	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: This is a new information collection.

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Annual Cost to Federal Government: $214,758

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: 07/13/2021

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