01-20252. Submission for OMB Review; Comment Request

The United States Patent and Trademark Office (USPTO) has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

Agency: United States Patent and Trademark Office (USPTO).

Title: Patent Term Extension.

Form Number(s): No forms associated.

Agency Approval Number: 0651-0020.

Type of Request: Revision of a currently approved collection.

Burden: 30,903 hours annually.

Number of Respondents: 26,858 responses per year.

Avg. Hours Per Response: The time needed to respond is estimated to range from 1 to 25 hours, depending upon the complexity of the situation. It is estimated that the time needed to complete the applications, petitions, declarations, and requests associated with the patent term and interim extensions ranges from 1 to 25 hours. It is estimated that the time needed to complete a petition for reconsideration of a patent term adjustment determination is approximately one hour, and the petition for reinstatement of reduced patent term adjustment is estimated to take approximately two hours. This includes time to gather the necessary information, create the documents, and submit the completed requests.

Needs and Uses: The United States Patent and Trademark Office (USPTO), together with the Secretary of Health and Human Services and the Department of Agriculture, administers the Federal Food, Drug and Cosmetic Act, 35 U.S.C. 156. This Act permits the USPTO to restore the patent term lost due to certain types of regulatory review by the Federal Food and Drug Administration or the Department of Agriculture. Only patents for drug products, medical devices, food additives, and color additives are eligible for extension. The maximum length that a patent may be extended (the maximum of patent term that may be restored) is five years.

An application for patent term extension must identify the approved product, the patent to be extended, the claims of the patent that claim the approved product, a method of use of the approved product, or a method of manufacturing the approved product. In addition, the application for patent term extension must provide a brief description of the activities undertaken by the applicant during the regulatory review period with respect to the approved product and the significant dates of these activities.

The statute (35 U.S.C. 156) requires the USPTO to extend the term of various patents past their original expiration dates, to grant interim extensions, to review applications for patent term extension and final eligibility decisions, to obtain additional information from the public that might influence the extension of the patent term, and to withdraw an application for a patent term extension.

The USPTO administers 35 U.S.C. through 37 CFR 1.705-1.791, which permits the public to submit application to the USPTO to extend the term of a patent past its original expiration date; to petition for reviews of informal extensions of applications, final eligibility decisions, and interim extensions; and to withdraw an application requesting a patent term extension after it is submitted.

Use of the USPTO's information allows the Director of the USPTO, the Secretary of Health and Human Services, and the Secretary of Agriculture to have access to the information required to determine whether the applicant is eligible for a patent term extension or reconsideration of patent term adjustment determination and, if so, the period of the extension or adjustment.

Affected Public: Business or other for-profit; individuals or households; not-for-profit institutions; farms; the Federal Government; and state, local or tribal Government.

Frequency: On occasion.

Respondent's Obligation: Required to obtain or retain benefits.

OMB Desk Officer: David Rostker, [phone].

Copies of the above information collection proposal can be obtained by calling or writing Susan K. Brown, Records Officer, Office of Data Management, Data Administration Division, [phone], USPTO, Suite 310, 2231 Crystal Drive, Washington, DC 20231, or by e-mail at [e-mail].

Written comments and recommendations for the proposed information collection should be sent on or before September 12, 2001 to David Rostker, OMB Desk Officer, Room 10202, New Executive Office Building, Washington, D.C. 20503.

Dated: August 7, 2001.

Susan K. Brown,

Records Officer, USPTO, Office of Data Management, Data Administration Division.