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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0651-0020
ICR Reference No:
201308-0651-001
Status:
Historical Active
Previous ICR Reference No:
201007-0651-002
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:
10/23/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/23/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2016
36 Months From Approved
10/31/2013
Responses
1,950
0
13,586
Time Burden (Hours)
7,252
0
7,808
Cost Burden (Dollars)
90
0
396,916
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 Patent Trial and Appeal Board 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:
78 FR 31885
07/29/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 52166
08/22/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
11
IC Title
Form No.
Form Name
Application to Extend Patent Term Under 35 U.S.C. 156
Declaration to Withdraw an Application to Extend Patent Term
Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5)
Petition for Reconsideration of Patent Term Adjustment Determination
Petition for Reinstatement of Reduced Patent Term Adjustment
Petition to Accord a Filing Date to an Application Under 37 CFR 1.740 for Extension of a Patent Term
Petition to Review Final Eligibility Decision Under 37 CFR 1.750
Request for Interim Extension Under 35 U.S.C. 156(e)(2)
Request for Recalculation of Patent Term Adjustment in View of Wyeth
PTO/SB/131
Request for Recalculation of Patent Term Adjustment in View of Wyeth
Response to Request to Identify Holder of Regulatory Approval
Response to Requirement to Elect
Subsequent Application for Interim Extension Under 37 CFR 1.790
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
1,950
13,586
0
-12,000
364
0
Annual Time Burden (Hours)
7,252
7,808
0
-2,040
1,484
0
Annual Cost Burden (Dollars)
90
396,916
0
-396,850
24
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:
Miscellaneous Actions
Short Statement:
The changes to estimated annual responses and burden hours are due to administrative adjustments from updated annual response estimates and program changes from the removal of one item from this collection: the Request for Recalculation of Patent Term Adjustment in View of Wyeth (PTO/SB/131). The net decrease in annual (non-hour) costs is primarily due to program changes from the removal of associated fees that have been moved into collection 0651-0072, the removal of recordkeeping costs that are not required, and a net decrease in postage from the removal of the Request for Recalculation of Patent Term Adjustment in View of Wyeth (PTO/SB/131) from this collection.
Annual Cost to Federal Government:
$42,290
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]?
No
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
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:
08/23/2013
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