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