View Information Collection Request (ICR) Package

OMB Control No: 0651-0020	ICR Reference No: 201007-0651-002
Status: Historical Active	Previous ICR Reference No: 201001-0651-002
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: 08/17/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/14/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	36 Months From Approved	08/31/2010
Responses	13,586	0	38,859
Time Burden (Hours)	7,808	0	32,945
Cost Burden (Dollars)	396,916	0	5,989,522

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 Department of Agriculture. 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 five 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 Board of Patent Appeals and Interferences 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

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:
	75 FR 20561	04/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 39913	07/13/2010
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	13,586	38,859	-25,273
Annual Time Burden (Hours)	7,808	32,945	-25,137
Annual Cost Burden (Dollars)	396,916	5,989,522	-5,592,606

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: All burden changes for this collection are due to administrative adjustments. The decreases in total annual responses and burden hours are due to revised annual response estimates, which were partially offset by an increase in the time estimates for two of the petitions included in this collection, the Petition for Reconsideration of Patent Term Adjustment Determination and the Petition for Reinstatement of Reduced Patent Term Adjustment. The decrease in annual cost burden for this collection is primarily due to overall decreases in the estimated responses for items that have associated fees and a decrease in the estimated number of items being submitted by mail and incurring postage costs, which were partially offset by an increase in the estimated number of items submitted electronically and incurring recordkeeping costs.

Annual Cost to Federal Government: $59,845

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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]? Uncollected

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 5712727728 Raul.Tamayo@uspto.gov

View ICR - OIRA Conclusion