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

Forms and Documents

Document Name	Status
Form PTO/SB/93 Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) Form	Modified
0651-0024-SupStmt-May2013-update.pdf Supporting Statement A	2013-05-10
0651-USPTO-InfoQuality-Guidelines-01_07_2013.pdf Supplementary Document	2013-02-22
r13ter.pdf Supplementary Document	2009-12-02
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	Modified
45200	Sequence Listing in Application (CD)	Modified
190812	Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) Form	Modified

ICR Details

OMB Control No: 0651-0024	ICR Reference No: 201302-0651-003
Status: Historical Active	Previous ICR Reference No: 200909-0651-002
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 with change	Conclusion Date: 05/14/2013
	Date Received in OIRA: 02/25/2013
Terms of Clearance: Supporting statement updated.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved	05/31/2013
Responses	25,250	0	19,750
Time Burden (Hours)	138,225	0	103,750
Cost Burden (Dollars)	2,546,400	0	920,959

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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 issued patents. Applicants use sequence data when preparing biotechnology patent applications and may also search sequence listings after publication.

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Authorizing Statute(s): US Code: 35 USC 22 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:
	77 FR 65537	10/29/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 12744	02/25/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Electronic Sequence Listing in Application
Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e)	PTO/SB/93	Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e)
Sequence Listing in Application (paper)
Sequence Listing in Application (CD)

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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	25,250	19,750	0	0	5,500	0
Annual Time Burden (Hours)	138,225	103,750	0	0	34,475	0
Annual Cost Burden (Dollars)	2,546,400	920,959	0	434,575	1,190,866	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 total annual responses and burden hours will increase from the currently approved burden for this collection due to administrative adjustments from updated annual response estimates. The estimated total annual (non-hour) cost burden will also increase due to both program changes and administrative adjustments. The program changes include an increase in fee amounts and the removal of capital start-up and recordkeeping costs from the requirements in this collection. The administrative adjustments include an increase in the estimated responses that may incur fees and increased costs due to increases in postage rates since the previous renewal.

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Annual Cost to Federal Government: $392,688

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: 02/25/2013

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