Patent Term Extension and Adjustment

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0651-0020 Supporting Statement 2026_Final.docx	Supporting Statement A	Uploaded 2026-02-26	Repair queued
0651-0020 60 Day CRF Comments to PTO Patent Term Adjustment ICR FINAL 012026.pdf	Public Comments	Uploaded 2026-01-20	Repair queued
Drug Price Competition and Patent Term Restoration Act of 1984.pdf	Supplementary Document	Uploaded 2026-02-25	Repair queued
USPTO Information Quality Guidelines.pdf	Supplementary Document	Uploaded 2026-02-25	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
4686	Application to Extend Patent Term Under 35 U.S.C. 156		Modified
257613	Petition to Accord a Filing Date to an Application Under 37 CFR 1.740 for Extension of a Patent Term (Individuals and Households)		Removed
257612	Petition for Reinstatement of Reduced Patent Term Adjustment (Individuals and Households)		Removed
257611	Petition for Reconsideration of Patent Term Adjustment Determination (Individuals and Households)		Removed
257610	Declaration to Withdraw an Application to Extend Patent Term (Individuals and Households)		Removed
257609	Response to Request to Identify Holder of Regulatory Approval (Individuals and Households)		Removed
257607	Response to Requirement to Elect a Single Patent to Extend from a Single Regulatory Review Period (Individuals and Households)		Removed
257606	Subsequent Application for Interim Extension Under 37 CFR 1.790 (Individuals and Households)		Removed
257603	Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5) (Individuals and Households)		Removed
257602	Petition to Review Final Eligibility Decision Under 37 CFR 1.750 (Individuals and Households)		Removed
257601	Request for Interim Extension Under 35 U.S.C. 156(e)(2) (Individuals and Households)		Removed
257600	Application to Extend Patent Term Under 35 U.S.C. 156 (Individuals and Households)		Removed
182039	Petition to Accord a Filing Date to an Application Under 37 CFR 1.740 for Extension of a Patent Term		Modified
182038	Petition for Reinstatement of Reduced Patent Term Adjustment		Modified
182037	Petition for Reconsideration of Patent Term Adjustment Determination		Modified
182036	Declaration to Withdraw an Application to Extend Patent Term		Modified
182035	Response to Request to Identify Holder of Regulatory Approval		Modified
182034	Response to Requirement to Elect a Single Patent to Extend from a Single Regulatory Review Period		Modified
182033	Subsequent Application for Interim Extension Under 37 CFR 1.790		Modified
182032	Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5)		Modified
182031	Petition to Review Final Eligibility Decision Under 37 CFR 1.750		Modified
182030	Request for Interim Extension Under 35 U.S.C. 156(e)(2)		Modified

ICR Details

OMB Control No: 0651-0020	ICR Reference No: 202512-0651-004
Status: Received in OIRA	Previous ICR Reference No: 202410-0651-017
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Patent Term Extension and Adjustment
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/26/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2026
Responses	903	915
Time Burden (Hours)	6,807	6,038
Cost Burden (Dollars)	489,440	556,106

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Abstract: This information collection covers information gathered in patent term extension applications submitted under 35 U.S.C. 156(d). Under this provision, an application for patent term extension must identify the approved product; the patent to be extended; and the claims included in the patent that cover the approved product, a method of using the approved product, or a method of manufacturing the approved product. 35 U.S.C. 156(d) also requires the submission of information that enables the USPTO to determine the eligibility of the patent for extension, and the rights that will be derived from the extension, and information to enable the USPTO and the Secretary of Health and Human Services or the Secretary of Agriculture to determine the period of the extension. Additionally, 35 U.S.C. 156(d) requires the applicant for patent term extension to 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. This information collection also covers information gathered in requests for interim extensions pursuant to 35 U.S.C. 156(d)(5) and 156(e)(2). Under 35 U.S.C. 156(d)(5), an interim extension may be granted if the applicable regulatory review period that began for a product is reasonably expected to extend beyond the expiration of the patent term in effect. Under 35 U.S.C. 156(e)(2), an interim extension may be granted if the term of an eligible patent for which an application for patent term extension has been submitted would expire before a certificate of extension is issued. In addition, this information collection covers requests for review of final eligibility decisions, and requests to withdraw an application requesting a patent term extension after it is submitted.

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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

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52043	11/19/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 9600	02/26/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

table that charts list of burden

IC Title	Form No.	Form Name
Application to Extend Patent Term Under 35 U.S.C. 156
Application to Extend Patent Term Under 35 U.S.C. 156 (Individuals and Households)
Declaration to Withdraw an Application to Extend Patent Term
Declaration to Withdraw an Application to Extend Patent Term (Individuals and Households)
Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5)
Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5) (Individuals and Households)
Petition for Reconsideration of Patent Term Adjustment Determination
Petition for Reconsideration of Patent Term Adjustment Determination (Individuals and Households)
Petition for Reinstatement of Reduced Patent Term Adjustment
Petition for Reinstatement of Reduced Patent Term Adjustment (Individuals and Households)
Petition to Accord a Filing Date to an Application Under 37 CFR 1.740 for Extension of a Patent Term
Petition to Accord a Filing Date to an Application Under 37 CFR 1.740 for Extension of a Patent Term (Individuals and Households)
Petition to Review Final Eligibility Decision Under 37 CFR 1.750
Petition to Review Final Eligibility Decision Under 37 CFR 1.750 (Individuals and Households)
Request for Interim Extension Under 35 U.S.C. 156(e)(2)
Request for Interim Extension Under 35 U.S.C. 156(e)(2) (Individuals and Households)
Response to Request to Identify Holder of Regulatory Approval
Response to Request to Identify Holder of Regulatory Approval (Individuals and Households)
Response to Requirement to Elect a Single Patent to Extend from a Single Regulatory Review Period
Response to Requirement to Elect a Single Patent to Extend from a Single Regulatory Review Period (Individuals and Households)
Subsequent Application for Interim Extension Under 37 CFR 1.790
Subsequent Application for Interim Extension Under 37 CFR 1.790 (Individuals and Households)

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ICR Summary of Burden

table that charts list of burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	903	915	0	0	-12	0
Annual Time Burden (Hours)	6,807	6,038	0	0	769	0
Annual Cost Burden (Dollars)	489,440	556,106	0	0	-66,666	0

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:

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Annual Cost to Federal Government: $28,533

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? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/26/2026

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