[Federal Register Volume 66, Number 156 (Monday, August 13, 2001)]
[Notices]
[Pages 42524-42525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20252]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office


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, (202) 395-3897.
    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, (703) 308-7400, USPTO, Suite 
310, 2231 Crystal Drive, Washington, DC 20231, or by e-mail at 
[email protected].
    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.


[[Page 42525]]


    Dated: August 7, 2001.
Susan K. Brown,
Records Officer, USPTO, Office of Data Management, Data Administration 
Division.
[FR Doc. 01-20252 Filed 8-10-01; 8:45 am]
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