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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:
202205-0651-001
Status:
Historical Active
Previous ICR Reference No:
201906-0651-003
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:
06/13/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/20/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2022
09/30/2022
09/30/2022
Responses
23,850
0
28,850
Time Burden (Hours)
133,955
0
163,955
Cost Burden (Dollars)
1,263,473
0
1,573,140
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. This information collection covers the submission of the sequence listing information itself. Information pertaining to the filing of the initial U.S. patent application is collected under OMB Control Number 0651-0032, and information pertaining to the filing of the initial international application is collected under OMB Control Number 0651-0021. In particular, this information collection accounts for sequence listings submitted on paper, compact disc (CD), or through EFS-Web, the USPTO’s online filing system. Sequence listings may be submitted via EFS-Web as an ASCII text file or in Portable Document Format (PDF). For U.S. applications, § 1.821(c) permits all modes of submission: paper, CD, or EFS-Web. Sequence listings for international applications may be submitted on paper or through EFS-Web only, though sequence listings that are too large to be filed electronically though EFS-Web may be submitted on CD. This information collection also accounts for the requirement under § 1.821(e) that a copy of the sequence listing required by § 1.821(c) be submitted in computer readable form (CRF) in accordance with the requirements of § 1.824. Under §§ 1.821(e)–(f), applicants who submit their sequence listings on paper, CD, or as a PDF via EFS-Web must submit a copy of the sequence listing in CRF with a statement indicating that the CRF copy of the sequence listing is identical to the paper, CD, or PDF copy provided under § 1.821(c). Applicants may submit the CRF copy of the sequence listing to the USPTO on CD or other acceptable media as provided in § 1.824. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of §§ 1.824(a)(2)–(6) and (b), and applicant has not filed a sequence listing on paper, CD or as a PDF file, the text file will serve as both the copy required by § 1.821(c) and the CRF required by § 1.821(e). Moreover, the associated statement of identity would not be required. This information collection also covers the mechanism in § 1.821(e) where an applicant may request, in limited circumstances, a transfer of the CRF from the application already on file to the new application, if the CRF sequence listing in a new application is identical to the CRF sequence listing of another application that the applicant already has on file at the USPTO. In such a case, the applicant may submit a letter identifying the application and CRF sequence listing that is already on file and stating that the sequence listing submitted in the new application is identical to the CRF copy already filed with the previous application. The USPTO provides a form, Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93), in order to assist customers in submitting this statement.
Authorizing Statute(s):
US Code:
35 USC 22
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
87 FR 30806
05/20/2022
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 16652
04/22/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 35376
07/23/2019
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
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 (CD)
Sequence Listing in Application (paper)
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
23,850
28,850
0
-5,000
0
0
Annual Time Burden (Hours)
133,955
163,955
0
-30,000
0
0
Annual Cost Burden (Dollars)
1,263,473
1,573,140
0
-309,667
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:
Yes
Burden Reduction Due to:
Changing Regulations
Short Statement:
This request is to remove the paper-based Sequence Listing in Application (IC No. 1) in response to rulemaking 0651-AD53 (Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference), because the Rule amends the rules of practice for these submissions by incorporating by reference certain provisions of World Intellectual Property Office Standard ST.26 (WIPO Standard ST.26) into the USPTO rules of practice. With this change in submissions the annual number of responses will decrease by 5,000 and the annual time burden will decrease by 30,000 in this request. The annual non-hour cost burden will decrease by $309,667 because of the removal of fees and postage associated with the removed item.
Annual Cost to Federal Government:
$514,435
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?
No
Agency Contact:
Parikha Mehta 571 272-3248
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:
05/20/2022
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