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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0651-0024
ICR Reference No:
202509-0651-001
Status:
Active
Previous ICR Reference No:
202411-0651-005
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:
11/28/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/24/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2028
36 Months From Approved
11/30/2025
Responses
30,000
0
28,550
Time Burden (Hours)
180,000
0
171,300
Cost Burden (Dollars)
336,973
0
1,261,487
Abstract:
Patent applications that contain nucleotide and/or amino acid sequence disclosures falling within the definitions of 37 CFR 1.831 (for applications filed on or after July 1, 2022) or 37 CFR 1.821(a) (for applications filed on or before June 30, 2022) must include, as a separate part of the application disclosure, a copy of the sequence listing in accordance with the requirements in 37 CFR 1.831-1.835 or 37 CFR 1.821-1.825, respectively. Applicants may submit sequence listings for both U.S. and international patent applications. For more information concerning the submission of sequence listings in international applications, see the Patent Cooperation Treaty (PCT) Rules 5.2 and 13ter, Annex C of the PCT Administrative Instructions, and section 1848 of the Manual of Patent Examining Procedure (MPEP) (9th ed., Rev. 01.2024, November 2024). This information collection covers the submission of the sequence listing information itself. Information pertaining to the initial filing of U.S. patent applications is collected under OMB Control Number 0651-0032, and information pertaining to the initial filing of international applications is collected under OMB Control Number 0651-0021. Sequence listings for applications having a filing date of on or after July 1, 2022, must be submitted in XML format in accordance with 37 CFR 1.831-1.835. The submission of a sequence listing in XML format must be made either electronically via the USPTO patent electronic filing system (currently Patent Center) as an XML file not exceeding 100MB without file compression, or as an XML file on a read-only optical disc in accordance with 37 CFR 1.834(b)(2). Sequence listings may still be filed in applications having a filing date of on or before June 30, 2022, as amendments that meet the requirements of 37 CFR 1.825. Sequence listings submitted as amendments in accordance with 37 CFR 1.825 must be submitted as: • An ASCII plain text file via Patent Center or on a read-only optical disc; • A PDF file via Patent Center; or • Physical sheets of paper. When an amendment that meets the requirements of 37 CFR 1.825 is submitted as a PDF or on physical sheets of paper in an application having a filing date of on or before June 30, 2022, the applicant may also need to submit a new or substitute computer readable form (CRF) copy of the sequence listing under 37 CFR 1.821(e) and 1.824, with the amendment incorporated therein, if necessary, under 37 CFR 1.825(a)(5)(ii) or (b)(6)(ii). Applicants may submit the CRF copy via Patent Center or on a read-only optical disc as provided in 37 CFR 1.824(b). When a new or substitute CRF copy is necessary, applicants must submit a statement indicating that the CRF copy of the sequence listing is identical to the PDF or paper copy. This information collection also accounts for these CRF copy and statement requirements.
Authorizing Statute(s):
US Code:
35 USC 22
Name of Law: Leahy Smith America Invents 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:
90 FR 27284
06/26/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 48553
10/24/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Sequence Listing in Application
Sequence Listing in Application (Individuals and Households)
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
30,000
28,550
0
0
1,450
0
Annual Time Burden (Hours)
180,000
171,300
0
0
8,700
0
Annual Cost Burden (Dollars)
336,973
1,261,487
0
0
-924,514
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:
Change in Responses and Hourly Burden due to Adjustment in Agency Estimate The total number of responses has increased by 1,450 due to estimated fluctuations in the number of submissions in this information collection. This increase in the number of respondents and responses results in an increase of 8,700 hours in the annual time burden estimates. Change in Annual Non-hour Costs due to Adjustment in Agency Estimate For this renewal, the USPTO estimates that the total annual non-hour costs will decrease by $924,514 from the previous approval. This decrease is largely due to the fact that sequence listings for applications filed on or after July 1, 2022, must be submitted as XML files, either by electronically transmitting the XML file through Patent Center, where the file does not exceed 100MB without compression, or on read-only optical discs. Accordingly, the size fees for excess pages under 35 U.S.C. 41(a)(1)(G) and 37 CFR §§ 1.16(s), 1.52(f), and 1.492(j), from which XML file submissions via Patent Center or read-only optical discs are excluded, do not apply to sequence listings filed in applications having a filing date of on or after July 1, 2022.
Annual Cost to Federal Government:
$714,120
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.
Yes
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.
Yes
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?
No
Agency Contact:
Raul Tamayo 571 272-7728 raul.tamayo@uspto.gov
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:
10/24/2025
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