Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures

Forms and Documents

Document Name	Status
0024-JS-final.doc Supporting Statement A	2006-09-13
Information Quality Guidelines.doc Supplementary Document	2006-09-13
PCT Rule 13ter.pdf Supplementary Document	2006-09-13
03-25-01.pdf Supplementary Document	2006-09-13

IC Document Collections

IC ID	Document Title	Status
4695	Sequence Listing in Application (paper)	Modified
45201	Electronic Sequence Listing in Application (EFS)	New
45200	Sequence Listing in Application (CD)	New

ICR Details

OMB Control No: 0651-0024	ICR Reference No: 200609-0651-001
Status: Historical Active	Previous ICR Reference No: 200307-0651-001
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures
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: 12/07/2006
	Date Received in OIRA: 09/14/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2009	36 Months From Approved	12/31/2006
Responses	15,382	0	23,750
Time Burden (Hours)	17,297	0	29,856
Cost Burden (Dollars)	4,285,838	0	7,608,000

---

Abstract: Patent applications that contain nucleotide and/or amino acid sequence disclosures must include a copy of the sequence listing in accordance with the requirements in 37 CFR 1.821-1.825 and World Intellectual Property Organization (WIPO) Standard ST.25 (1998). Applicants may submit sequence listings for both U.S. and international patent applications. The sequence listings may be submitted on paper, compact disc, or electronically over the Internet. The USPTO uses the sequence listings to determine the patentability of the associated patent application and to support the publication of applications and issued patents. Applicants use sequence data when preparing biotechnology patent applications and may also search sequence listings after publication.

---

Authorizing Statute(s): US Code: 35 USC 22 Name of Law: null
  

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:
	71 FR 34601	06/15/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 54031	09/13/2006
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Sequence Listing in Application (paper)
Sequence Listing in Application (CD)
Electronic Sequence Listing in Application (EFS)

---

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	15,382	23,750	0	0	-8,368	0
Annual Time Burden (Hours)	17,297	29,856	0	0	-12,559	0
Annual Cost Burden (Dollars)	4,285,838	7,608,000	0	416,250	-3,738,412	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 the annual responses and burden hours will decrease. The net decrease in burden hours is due to administrative adjustments based on expected filings, with expected decreases in filing sequence listings on paper and CD being partially offset by expected increases in filing sequence listings electronically. The USPTO also estimates that the annual (non-hour) cost burden for this collection will have a net decrease involving both program changes and administrative adjustments. The program change is from the addition of application size fees and results in an increase of $416,250 in annual cost burden, but this increase is offset by a larger overall net decrease in other annual costs due to administrative adjustments, primarily from decreases in other filing fees and postage costs based on expected overall decreases in filings.

---

Annual Cost to Federal Government: $28,346

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

---

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: 09/14/2006

---