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Submission for OMB Review; Comment Request

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Information about this document as published in the Federal Register.

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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: 30,905 hours annually.

Number of Respondents: 26,859 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. This time range also includes the Petition to Accord a Filing Date to an Application under 1.740 for Extension of a Patent Term, which the USPTO estimates will take 2 hours to complete. This includes the time to gather the necessary information, create the documents, and submit the completed requests.

Needs and Uses: The USPTO is submitting this information collection in support of the notice of proposed rulemaking, “Changes to Support Implementation of the United States Patent and Trademark Office 21st Century Strategic Plan” (RIN 0651-AB64), which the USPTO will forward to the Federal Register for publication. This proposed rule increases the filing fee from $130 to $400 for the Petition to Accord a Filing Date to an Application under 1.740 for Extension of a Patent Term and adds this petition into the collection. This petition is used by the public to request review of a notice of an incomplete application for extension of a patent term and to request a filing date. The USPTO uses this information to determine the filing date for the application for extension of a patent term.

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.

Under 35 U.S.C. 156, the USPTO extends the term of various patents past their original expiration dates, grants interim extensions, reviews applications for patent term extension and final eligibility decisions, obtains additional information from the public that might influence the extension of the patent term, and withdraws applications for patent term extensions. The USPTO administers 35 U.S.C. 156 through 37 CFR 1.705-1.791, which permits the public to submit applications to the USPTO to extend the patent term 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 access 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, (202) 395-3897.

Copies of the above information collection proposal can be obtained by calling or writing Susan K. Brown, Records Officer, Office of the Chief Information Officer, Office of Data Architecture and Services, Data Administration Division, 703-308-7400, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313, Attn: CPK 3 Suite 310; or by e-mail at susan.brown@uspto.gov.

Written comments and recommendations for the proposed information collection should be sent on or before October 9, 2003, to David Rostker, OMB Desk Officer, Room 10202, New Executive Office Building, Washington, DC 20503.

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Dated: September 2, 2003.

Susan K. Brown,

Records Officer, USPTO, Office of the Chief Information Officer, Office of Data Architecture and Services, Data Administration Division.

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[FR Doc. 03-22883 Filed 9-8-03; 8:45 am]

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