Patent Term Extension

Forms and Documents

Document Name	Status
0651-0020 January 2016 Change Worksheet.docx Justification for No Material/Nonsubstantive Change	2016-01-29
0651-USPTO-InfoQuality-Guidelines-01_07_2013.pdf Supplementary Document	2013-08-20
0651-0020-SupStmt-Aug2013.pdf Supporting Statement A	2013-08-20

IC Document Collections

IC ID	Document Title	Status
4686	Application to Extend Patent Term Under 35 U.S.C. 156	Unchanged
219665	Subsequent application for interim extension (see 37 CFR 1.790)	New
219664	Initial application for interim extension (see 37 CFR 1.790)	New
219663	Extension of term of patent	New
219661	Request for reinstatement of term reduced	New
219660	Filing an application for patent term adjustments	New
182039	Petition to Accord a Filing Date to an Application Under 37 CFR 1.740 for Extension of a Patent Term	Unchanged
182038	Petition for Reinstatement of Reduced Patent Term Adjustment	Unchanged
182037	Petition for Reconsideration of Patent Term Adjustment Determination	Unchanged
182036	Declaration to Withdraw an Application to Extend Patent Term	Unchanged
182035	Response to Request to Identify Holder of Regulatory Approval	Unchanged
182034	Response to Requirement to Elect	Unchanged
182033	Subsequent Application for Interim Extension Under 37 CFR 1.790	Unchanged
182032	Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5)	Unchanged
182031	Petition to Review Final Eligibility Decision Under 37 CFR 1.750	Unchanged
182030	Request for Interim Extension Under 35 U.S.C. 156(e)(2)	Unchanged

ICR Details

OMB Control No: 0651-0020	ICR Reference No: 201601-0651-007
Status: Historical Active	Previous ICR Reference No: 201308-0651-001
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Patent Term Extension
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: 03/21/2016
	Date Received in OIRA: 01/29/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	10/31/2016	10/31/2016
Responses	3,389	0	1,950
Time Burden (Hours)	12,914	0	7,252
Cost Burden (Dollars)	345,330	0	90

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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 USPTO’s 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.

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Authorizing Statute(s): US Code: 35 USC 154-156 Name of Law: null
  

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:
	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

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Number of Information Collection (IC) in this ICR: 16

IC Title	Form No.	Form Name
Request for reinstatement of term reduced
Initial application for interim extension (see 37 CFR 1.790)
Subsequent application for interim extension (see 37 CFR 1.790)
Subsequent Application for Interim Extension Under 37 CFR 1.790
Response to Request to Identify Holder of Regulatory Approval
Response to Requirement to Elect
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
Request for Interim Extension Under 35 U.S.C. 156(e)(2)
Declaration to Withdraw an Application to Extend Patent Term
Petition for Reconsideration of Patent Term Adjustment Determination
Initial Application for Interim Extension Under 35 U.S.C. 156(d)(5)
Petition to Review Final Eligibility Decision Under 37 CFR 1.750
Application to Extend Patent Term Under 35 U.S.C. 156
Filing an application for patent term adjustments
Extension of term of patent

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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	3,389	1,950	0	1,439	0	0
Annual Time Burden (Hours)	12,914	7,252	0	5,662	0	0
Annual Cost Burden (Dollars)	345,330	90	0	345,240	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: IC instruments are being returned to collection 0651-0020 from collection 0651-0072 following the discontinuation of the latter. As a result of the insertion of these items, as well as associated filing fees, this collection is experiencing an increase in the number of responses as well as in the hourly time burden and annual (non-hour) cost burden.

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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

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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: 01/29/2016

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