2012-25160. Agency Information Collection Activities; Proposed Collection; Comments Requested: Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal; Application for Modification of Registration for Online ...

ACTION:

30-Day Notice.

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 is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register at 77 FR 47095, August 7, 2012, allowing for a 60 day comment period.

The purpose of this notice is to allow for an additional 30 days for public comment until November 14, 2012. This process is conducted in accordance with 5 CFR 1320.10.

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 John W. Partridge, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152; [phone].

Written comments concerning this information collection should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attn: DOJ Desk Officer. The best way to ensure your comments are received is to email them to [e-mail] or fax them to [phone]. All comments should reference the eight-digit OMB number for the collection or the title of the collection. If you have questions concerning the collection, please contact John W. Partridge, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, [phone], or the DOJ Desk Officer at [phone].

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 agencies 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
• 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.

Overview of Information Collection 1117-0014

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

(2) Title of the Form/Collection: Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal; Application for Modification of Registration for Online Pharmacies.

(3) Agency form number, if any, and the applicable component of the Department sponsoring the collection:

Form number: DEA Forms 224, 224a, 224b, 224c.

Component: Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.

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

Primary: Business or other for-profit.

Other: Not-for-profit institutions; State, local, or tribal government.

Abstract: All firms and individuals who dispense controlled substances must register with the DEA under the Controlled Substances Act. Pharmacies wishing to be online pharmacies must apply to modify their registrations. Such registration is mandatory under the law and needed for control measures over legal handlers of controlled substances and to monitor their activities.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:

	Number of annual respondents	Average time per response	Total annual hours
DEA-224 (paper)	5,867	0.2 hours (12 minutes)	1,173.4
DEA-224 (electronic)	79,057	0.13 hours (8 minutes)	10,540.9
DEA-224a (paper)	66,200	0.2 hours (12 minutes)	13,240
DEA-224a (electronic	323,758	0.07 hours (4 minutes)	21,583.8
DEA-224b (chain renewal)*	32	5 hours	160
DEA-224c	0	0.25 hours (15 minutes)	0
Total	474,914		46,698.1
* In total, 64 chain pharmacies represent 36,660 individual pharmacy registrants. Pharmacies register for a three-year registration period. In calendar year 2011, the year for which estimates are calculated, 32 chains registered 6,472 individual pharmacies.

(6) An estimate of the total public burden (in hours) associated with the collection: It is estimated that there are 46,698 annual burden hours associated with this information collection. If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, 145 N Street NE., Suite 2E-508, Washington, DC 20530.

Dated: October 9, 2012.

Jerri Murray,

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