[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Page 5636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01849]



 Patent and Trademark Office

Submission for OMB Review; Comment Request; Patent Term Extension

    The United States Patent and Trademark Office (USPTO) will submit 
to the Office of Management and Budget (OMB) for clearance the 
following proposal for an information collection under the provisions 
of the Paperwork Reduction Act of 1995.
    Agency: United States Patent and Trademark Office, Department of 
    Title: Patent Term Extension.
    OMB Control Number: 0651-0020.
    Form Number(s): There are no forms in this information collection.
    Type of Request: Revision of a currently approved information 
    Number of Respondents: 620 respondents.
    Average Hours per Response: The USPTO estimates that it will take 
the public from 1 hour to 25 hours to gather the necessary information, 
prepare the appropriate form or document, and submit the information to 
the USPTO.
    Burden Hours: 4,102 hours.
    Hourly Cost Burden: $1,796,676.
    Non Hourly Cost Burden: $209,889.
    Needs and Uses: The patent term restoration portion of the Drug 
Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-
417), which is codified at 35 U.S.C. 156, permits the United States 
Patent and Trademark Office (USPTO) to extend the term of protection 
under a patent to compensate for delay during regulatory review and 
approval by the Food and Drug Administration (FDA) or United States 
Department of Agriculture (USDA). Only patents for drug products, 
medical devices, food additives, or color additives are potentially 
eligible for extension. The maximum length that a patent may be 
extended under 35 U.S.C. 156 is 5 years. The USPTO administers 35 
U.S.C. 156 through 37 CFR 1.710-1.791. Separate from the extension 
provisions of 35 U.S.C. 156, the USPTO may in some cases extend the 
term of an original patent due to certain delays in the prosecution of 
the patent application, including delays caused by interference 
proceedings, secrecy orders, or appellate review by the Patent Trial 
and Appeal Board or a Federal court in which the patent is issued 
pursuant to a decision reversing an adverse determination of 
patentability. The patent term provisions of 35 U.S.C. 154(b), as 
amended by Title IV, Subtitle D of the Intellectual Property and 
Communications Omnibus Reform Act of 1999, 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 public uses this information collection to file requests 
related to patent term extensions and reconsideration or reinstatement 
of patent term adjustments. The information in this information 
collection 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.
    Affected Public: Businesses or other for-profits; not-for-profit 
    Frequency: On occasion.
    Respondent's Obligation: Required to obtain or retain benefits.
    OMB Desk Officer: Nicholas A. Fraser, email: 
[email protected]. Once submitted, the request will be 
publicly available in electronic format through reginfo.gov. Follow the 
instructions to view Department of Commerce information collections 
currently under review by OMB.
    Further information can be obtained by:
     Email: [email protected]. Include ``0651-
0020 information request'' in the subject line of the message.
     Mail: Kimberly Hardy, Office of the Chief Administrative 
Officer, United States 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 March 2, 2020 to Nicholas A. 
Fraser, OMB Desk Officer, via email to [email protected], 
or by fax to 202-395-5167, marked to the attention of Nicholas A. 

Marcie Lovett,
Chief, Records and Information Governance Branch, Office of the Chief 
Administrative Officer, Office of Administrative Services, Strategic 
and Data Transport Division.
[FR Doc. 2020-01849 Filed 1-30-20; 8:45 am]