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	Unchanged
0024 Supporting Statement May 2016.docx Supporting Statement A	2017-12-11
0651-0024 November 2017 CWS.docx Justification for No Material/Nonsubstantive Change	2017-11-15
WIPO Standard ST.25.pdf Supplementary Document	2016-05-27
PCT Rule 13ter.pdf Supplementary Document	2016-05-27
0651-USPTO-InfoQuality-Guidelines-01_07_2013.pdf Supplementary Document	2016-05-27

IC Document Collections

IC ID	Document Title	Status
4695	Sequence Listing in Application (paper)	Unchanged
45201	Electronic Sequence Listing in Application	Unchanged
45200	Sequence Listing in Application (CD)	Unchanged
190812	Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) Form	Unchanged

ICR Details

OMB Control No: 0651-0024	ICR Reference No: 201712-0651-004
Status: Historical Active	Previous ICR Reference No: 201711-0651-014
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: 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: 12/13/2017
	Date Received in OIRA: 12/11/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2019	07/31/2019	07/31/2019
Responses	27,200	0	27,200
Time Burden (Hours)	152,285	0	152,285
Cost Burden (Dollars)	1,932,182	0	1,815,458

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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. Applicants submit copies of sequence listings for both U.S. and international biotechnology patent applications. The USPTO uses the sequence listings during the examination process to determine the patentability of the associated patent application. The USPTO also uses the sequence listings to support publication of patent applications and issued patents. Sequence listings are searchable 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	82 FR 52780	11/14/2017

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 14425	03/17/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 33480	05/26/2016
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
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)
Electronic Sequence Listing in Application

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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	27,200	27,200	0	0	0	0
Annual Time Burden (Hours)	152,285	152,285	0	0	0	0
Annual Cost Burden (Dollars)	1,932,182	1,815,458	0	116,724	0	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:

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Annual Cost to Federal Government: $446,015

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 12/11/2017

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