Patent Term Extension

OMB Control No: 0651-0020	ICR Reference No: 200709-0651-002
Status: Historical Active	Previous ICR Reference No: 200408-0651-001
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: 02/25/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/28/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	02/29/2008
Responses	26,859	0	26,859
Time Burden (Hours)	30,905	0	30,905
Cost Burden (Dollars)	5,988,050	0	5,987,000

---

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.

---

Authorizing Statute(s): US Code: 35 USC 154-156 Name of Law: Federal Food, Drug and Cosmetic Act

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:
	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: 11

IC Title Form No. Form Name Petition to Review Final Eligibility Decision under 37 CFR 1.750 Application to Extend Patent Term under 35 U.S.C. 156 Response to Requirement to Elect Petition for Reinstatement of Reduced Patent Term Adjustment Subsequent Application for Interim Extension under 37 CFR 1.790 Response to Request to Identify Holder of Regulatory Approval 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)

---

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	26,859	26,859	0	0	0	0
Annual Time Burden (Hours)	30,905	30,905	0	0	0	0
Annual Cost Burden (Dollars)	5,988,050	5,987,000	0	0	1,050	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: For this renewal, the USPTO estimates that there will be no change in the total responses and burden hours from the currently approved burden for this collection. However, the USPTO estimates that the total annual (non-hour) cost burden will increase due to revising the estimated postage costs for submitting the information in this collection to the USPTO by mail. Therefore, this collection has an increase in annual (non-hour) cost burden due to an administrative adjustment.

---

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)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Robert Clarke 571 272-7735 [email protected]

---

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: 09/28/2007

---