Patent Term Extension and Adjustment

OMB Control No: 0651-0020	ICR Reference No: 202410-0651-017
Status: Active	Previous ICR Reference No: 202303-0651-021
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Patent Term Extension and Adjustment
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/25/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/20/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	03/31/2026	03/31/2026
Responses	915	0	915
Time Burden (Hours)	6,038	0	6,038
Cost Burden (Dollars)	556,106	0	327,003

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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:
	87 FR 70788	11/21/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 5861	01/30/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 22

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

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ICR Summary of Burden

	Total Approved	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	915	915	0	0	0	0
Annual Time Burden (Hours)	6,038	6,038	0	0	0	0
Annual Cost Burden (Dollars)	556,106	327,003	0	229,103	0	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: $25,139

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

Agency Contact: Raul Tamayo 571 272-7728 [email protected]

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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: 11/20/2024

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