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): None.

Agency Approval Number: 0651-0020.

Type of Request: Extension of a currently approved collection.

Burden: 30,905 hours annually.

Number of Respondents: 26,859 responses per year.

Avg. Hours Per Response: The USPTO estimates that it will take the public between 1 to 25 hours, depending on the complexity of the situation, to gather the necessary information, prepare the appropriate documents, and submit the applications, petitions, and requests associated with patent term extensions and patent term adjustments to the USPTO.

Needs and Uses: The Federal Food, Drug and Cosmetic Act at 35 U.S.C. 156 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 an extension, which may be a maximum of five years. In some cases the USPTO may also extend the term of an original patent due to delays in the prosecution of the patent application. The provisions of 35 U.S.C. 154(b) require the USPTO to notify the applicant of the patent term adjustment in the notice of allowance and give the applicant an opportunity to request reconsideration of the USPTO's patent term adjustment determination. The USPTO administers 35 U.S.C. 154 and 156 through 37 CFR subpart F (1.701-1.791).

The public uses this information collection to file requests related to patent term extensions and petitions for reconsideration or reinstatement of patent term adjustments. This information is used by the USPTO to consider whether an applicant is eligible for a patent term extension or reconsideration of a patent term adjustment and, if so, to determine the length of the patent term extension or adjustment. There are no forms associated with this collection.

Affected Public: Individuals or households, businesses or other for-profits, not-for-profit institutions, farms, the Federal government, and State, local or tribal governments.

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 any of the following methods:

• E-mail: Susan.Brown@uspto.gov. Include “0651-0020 copy request” in the subject line of the message.
• Fax: 703-308-7407, marked to the attention of Susan Brown.
• Mail: Susan K. Brown, Records Officer, Office of the Chief Information Officer, Office of Data Architecture and Services, Data Administration Division, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

Written comments and recommendations for the proposed information collection should be sent on or before September 10, 2004, to David Rostker, OMB Desk Officer, Room 10202, New Executive Office Building, 725 17th Street, NW., Washington, DC 20503.