2021-20592. Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Application for Registration, Application for Registration Renewal, DEA Forms 363, 363a

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. The proposed information collection was previously published in the Federal Register , allowing for a 60-day comment period. The burden in this 30-day notice differs from that in the previously published information collection, as that analysis was based on a proposal to remove the option of submitting a paper application. The proposed rule would mandate all applications be submitted online; however, that rule has yet to be finalized. Therefore, DEA has returned to a burden analysis which shows both options an application can be submitted.

DATES:

Comments are encouraged and will be accepted for 30 days until October 25, 2021.

FOR FURTHER INFORMATION CONTACT:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 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.

SUPPLEMENTARY INFORMATION:

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;

—Evaluate whether and if so how the quality, utility, and clarity of the information proposed to be collected can be enhanced; and

—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 forms of information technology, e.g., permitting electronic submission of responses.

Overview of This Information Collection

1. Type of Information Collection: Extension of a currently approved collection.

2. Title of the Form/Collection: Application for Registration, Application for Registration Renewal.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form numbers are DEA Forms 363, 363a. 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: Business or other for-profit. Affected public (Other): Not-for-profit institutions, Federal, State, local, and tribal governments.

Abstract: The Controlled Substances Act requires practitioners who dispense narcotic drugs to individuals for maintenance or detoxification treatment to register annually with DEA.^[1] 21 U.S.C. 822, 823; 21 CFR 1301.11 and 1301.13. Registration is a necessary control measure and helps to prevent diversion by ensuring the closed system of distribution of controlled substances can be monitored by DEA and the businesses and individuals handling controlled substances are qualified to do so and are accountable.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: DEA Form 363 is submitted on an as needed basis by persons seeking to become registered; DEA Form 363a is submitted on an annual basis thereafter to renew existing registrations. The below table presents information regarding the number of respondents, responses and associated burden hours.

	Number of annual respondents	Average time per response	Total annual hours *
DEA Form 363 (paper)	5	0.33 hours (20 minutes)	2
DEA Form 363 (online)	239	0.33 hours (20 minutes)	80
DEA Form 363a (paper)	21	0.17 hours (10 minutes)	4
DEA Form 363a (online)	1,635	0.17 hours (10 minutes)	273
Total	1,900		357
* Figures are rounded.

6. An estimate of the total public burden (in hours) associated with the proposed collection: The DEA estimates that this collection takes 357 annual burden hours.

If additional information is required please contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, Suite 3E.405B, Washington, DC 20530.

Dated: September 20, 2021.

Melody Braswell,

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

Footnotes

1.  This registration requirement is waived for certain practitioners under specified circumstances. See 21 U.S.C. 823(g)(2).