Patent Term Extension and Adjustment

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0651-0020 CWS 03 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-27	Available
0651-0020 CWS 03 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-27	Repair queued
Drug Price Competition and Patent Term Restoration Act of 1984.pdf	Supplementary Document	Uploaded 2023-01-30	Available
Drug Price Competition and Patent Term Restoration Act of 1984.pdf	Supplementary Document	Uploaded 2023-01-30	Repair queued
0651-0020 Supporting Statement 2023 Final.docx	Supporting Statement A	Uploaded 2023-01-30	Available
0651-0020 Supporting Statement 2023 Final.docx	Supporting Statement A	Uploaded 2023-01-30	Repair queued
USPTO Information Quality Guidelines.pdf	Supplementary Document	Uploaded 2022-12-23	Available
USPTO Information Quality Guidelines.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued

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

ICR Details

OMB Control No: 0651-0020	ICR Reference No: 202303-0651-021
Status: Historical Active	Previous ICR Reference No: 202212-0651-003
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: 04/04/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/30/2023
Terms of Clearance:

table that charts list comparision

	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	6,113
Cost Burden (Dollars)	327,003	0	327,003

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Abstract: This request is to update one of the items attached to collection 0651-0020 (Patent Term Extension) that are affected by the Final Rule RIN 0651–AD59. The rule removes the requirement to file PTE applications in paper in triplicate and the additional requirements of newly added 37 CFR 1.790(c)(1) and (d)(1). The USPTO estimates that this change will result in 30 minutes less work for each respondent filing an application to extend patent terms. As a result, the overall burden reduction is 75 hours (0.5 hours x 150 respondents).

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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

table that charts list of burden

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

table that charts list 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	6,113	0	-75	0	0
Annual Cost Burden (Dollars)	327,003	327,003	0	0	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: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: This request is to update one of the items attached to collection 0651-0020 (Patent Term Extension) that are affected by the Final Rule RIN 0651–AD59. The rule removes the requirement to file PTE applications in paper in triplicate and the additional requirements of newly added 37 CFR 1.790(c)(1) and (d)(1). The USPTO estimates that this change will result in 30 minutes less work for each respondent filing an application to extend patent terms. As a result, the overall burden reduction is 75 hours (0.5 hours x 150 respondents).

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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

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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: 03/30/2023

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