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View ICR - OIRA Conclusion
OMB Control No:
0651-0020
ICR Reference No:
202303-0651-021
Status:
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:
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
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).
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:
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
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)
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
6,113
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).
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:
Parikha Mehta 571 272-3248
Common Form ICR:
No
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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