View Information Collection Request (ICR) Package

OMB Control No: 0651-0020	ICR Reference No: 201912-0651-003
Status: Historical Active	Previous ICR Reference No: 201908-0651-012
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Patent Term Extension
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/31/2020
	Date Received in OIRA: 01/31/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2023	36 Months From Approved	03/31/2020
Responses	620	0	1,340
Time Burden (Hours)	4,102	0	6,187
Cost Burden (Dollars)	209,889	0	369,455

Abstract: The patent term restoration portion of the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), which is codified at 35 U.S.C. 156, permits the 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 USPTOs patent term adjustment determination. The USPTO administers 35 U.S.C. 154 through 37 CFR 1.701-1.705. 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 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.

Authorizing Statute(s): US Code: 35 USC 154-156 Name of Law: Drug Price Competition and Patent Term Restoration Act of 1984

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 63857	11/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 5636	01/31/2020
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	620	1,340	-720
Annual Time Burden (Hours)	4,102	6,187	-2,085
Annual Cost Burden (Dollars)	209,889	369,455	-159,566

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The USPTO estimates that this information collection will receive 720 fewer annual responses over the 3-year period covered by this renewal request. This adjustment also causes the number of burden hours for this activity to decrease 2,085 hours. Despite minor increases due to the rise in postage rates, the overall decrease in non-hourly costs is due to the decreased number of responses.

Annual Cost to Federal Government: $16,769

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Raul Tamayo 571 272-7728 raul.tamayo@uspto.gov

View ICR - OIRA Conclusion