2024-24883. Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Previously Approved Collection; Exempt Chemical Preparations Under the Controlled Substance Act

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Department of Justice

1. [OMB Number 1117-0058]

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

30-Day notice.

SUMMARY:

The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

DATES:

Comments are encouraged and will be accepted for 30 days until November 25, 2024.

FOR FURTHER INFORMATION CONTACT:

If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Heather E. Achbach, Regulatory Drafting and Policy Support Section, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: [phone]; Email: [e-mail] or [e-mail].

SUPPLEMENTARY INFORMATION:

This proposed information collection was previously published in the Federal Register on August 23, 2024, at 89 FR 68205, allowing for a 60 day comment period.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

—Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

—Enhance the quality, utility, and clarity of the information to be collected; and/or

—Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function and entering either the title of the information collection or the OMB Control Number 1117-0058. This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Justice, information collections currently under review by OMB.

DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Overview of This Information Collection

1. Type of Information Collection: Extension of previously approved collection.

2. Title of the Form/Collection: Exempt Chemical Preparations under the Controlled Substance Act.

3. Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: No form number is associated with this collection. The applicable component within the Department of Justice is the Drug Enforcement Administration, Diversion Control Division.

4. Affected public who will be asked or required to respond, as well as a brief abstract:

Affected public (Primary): Business or other for-profit.

Affected public (Other): Not-for-profit institutions; Federal, State, local, and tribal governments.

Abstract: Pursuant to 21 U.S.C. 811(g)(3)(B), DEA (by delegation of authority from the Attorney General) may, by regulation, exempt from specific provisions of the Controlled Substances Act (CSA) 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.

5. Obligation to Respond: Mandatory per 21 CFR 1308.23.

6. Total Estimated Number of Respondents: 131.

7. Estimated Time per Respondent: 1 hour.

8. Frequency: 15.98.

9. Total Estimated Annual Time Burden: 2,093 hours.

10. Total Estimated Annual Other Costs Burden: $3,558.

If additional information is required, contact: Darwin Arceo, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218 Washington, DC 20530.

( print page 85240)

Dated: October 22, 2024

Darwin Arceo,

Department Clearance Officer for PRA, U.S. Department of Justice.