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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:
201001-0651-002
Status:
Historical Active
Previous ICR Reference No:
200709-0651-002
Agency/Subagency:
DOC/PTO
Agency Tracking No:
E2010-01
Title:
Patent Term Extension
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
01/27/2010
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/28/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/25/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2010
6 Months From Approved
02/28/2011
Responses
38,859
0
26,859
Time Burden (Hours)
32,945
0
30,905
Cost Burden (Dollars)
5,989,522
0
5,988,050
Abstract:
The Federal Food, Drug and Cosmetic Act of 35 U.S.C. 156 permits the USPTO to restore the patent term lost due to certain types of regulatory review by the Federal Food and Drug Administration or the Department of Agriculture. Only patents for drug products, medical devices, food additives, and color additives are eligible for an extension. Under 35 U.S.C. 154 the USPTO may also in some cases adjust the term of an original patent due to certain delays in the prosecution of the application. The information in this collection is used by the USPTO to consider whether an application 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.
Emergency Justfication:
The United States Patent and Trademark Office (USPTO) requests emergency review of an information collection request associated with 0651-0020 Patent Term Extension. A recent Federal Circuit Court decision has impacted the information collection activities. The USPTO is implementing a new procedure for patentees to seek a revised patent term adjustment in a patent if the patentees sole basis for requesting recalculation of the patent term adjustment in the patent is the USPTOs pre-Wyeth interpretation of 35 U.S.C. 154(b)(2)(A).
Authorizing Statute(s):
US Code:
35 USC 154-156
Name of Law: Federal Food, Drug and Cosmetic Act
Citations for New Statutory Requirements:
US Code: 35 USC 154(b)
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:
72 FR 35222
06/27/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 53233
09/18/2007
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
12
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
38,859
26,859
12,000
0
0
0
Annual Time Burden (Hours)
32,945
30,905
2,040
0
0
0
Annual Cost Burden (Dollars)
5,989,522
5,988,050
1,470
0
2
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:
As a result of a recent Federal Circuit Court decision, the USPTO is implementing a new procedure for patentees to seek a revised patent term adjustment in a patent if the patentees sole basis for requesting recalculation of the patent term adjustment in the patent is the USPTOs pre-Wyeth interpretation of 35 U.S.C. § 154(b)(2)(A). The new procedure permits eligible patentees to request a recalculation of their patent term adjustment in lieu of the petition and fee required by 37 CFR 1.705(d). The USPTO is proposing to add a new form for patentees to request recalculation of their patent term adjustments in light of Wyeth: Request for Recalculation of Patent Term Adjustment in View of Wyeth, Form PTO/SB/131. The addition of this form will add 12,000 responses, 2,040 burden hours, and $1,470 in annual cost burden to this collection as a program change. An administrative adjustment of $2 has also been made to account for a rounding difference in previously reported postage costs for this collection.
Annual Cost to Federal Government:
$509,369
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
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:
Brian Hanlon 5712725047 brian.hanlon@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:
01/25/2010
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