05-18903. Agency Information Collection Activities: Proposed Collection; Comments Requested

ACTION:

60-Day Emergency Notice of Information Collection Under Review: Application for Procurement Quota for Controlled Substances.

The Department of Justice, Drug Enforcement Administration (DEA), has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with emergency review procedures of the Paperwork Reduction Act of 1995. OMB approval has been requested by September 30, 2005. The proposed information collection is published to obtain comments from the public and affected agencies. If granted, the emergency approval is only valid for 180 days. Comments should be directed to the Office of Management and Budget, Office of Information and Regulation Affairs, Attention: Department of Justice Desk Officer, Washington, DC 20503. Comments are encouraged and will be accepted for 60 days until November 21, 2005.

During the first 60 days of this same review period, a regular review of this information collection is also being undertaken. All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Patricia M. Good, Chief, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537.

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 this information:

(1) Type of information collection: Revision of a Currently Approved Collection.

(2) The title of the form/collection: Application for procurement quota for controlled substances.

(3) The agency form number, if any, and the applicable component of the department sponsoring the collection: Form Number: DEA Form 250. Office of Diversion Control, Drug Enforcement Administration, 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: none. Title 21 U.S.C. 826 and 21 CFR 1303.12, require that U.S. companies who desire to use any basic class of controlled substances listed in Schedule I or II for purposes of manufacturing during the next calendar year shall apply on DEA Form 250 for procurement quota for such class.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 255 persons submit 1,106 completed DEA Forms 250, at 1 hour per form, for an annual burden of 1,106 hours. It is estimated that 25 companies submit information pertaining to new drug applications or abbreviated new drug applications, at 2 hours per response, for an annual burden of 50 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: It is estimated that the total annual burden associated with this information collection is 1,156 hours.

If additional information is required contact: Brenda E. Dyer, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Patrick Henry Building, Suite 1600, 601 D Street NW., Washington, DC 20530, or by e-mail at [e-mail].

Dated: September 16, 2005.

Brenda E. Dyer,

Department Clearance Officer, Department of Justice.