USPTO Notice on Biological Materials Deposit Collection Renewal

Content

ACTION:

Notice of information collection; request for comments.

SUMMARY:

The United States Patent and Trademark Office (USPTO) will submit the following information collection request to the Office
of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after
the date of publication of this notice. The USPTO invites comments on the information collection renewal of 0651-0022, which
helps the USPTO assess the impact of its information collection requirements and minimize the reporting burden to the public.
Public comments were previously requested via the
Federal Register
on November 19, 2025 during a 60-day comment period (90 FR 52038). This notice allows for an additional 30 days for public
comments.

DATES:

To ensure consideration, you must submit comments regarding this information collection on or before April 8, 2026.

ADDRESSES:

Written comments and recommendations for this information collection should be submitted within 30 days of the publication
of this notice on the following website, http://www.reginfo.gov/public/do/PRAMain. You may find this particular information collection by selecting “Currently under 30-day Review-Open for Public Comments”
or by using the search function and entering either the title of the information collection or the OMB Control Number, 0651-0022.
Do not submit Confidential Business Information or otherwise sensitive or protected information.

FOR FURTHER INFORMATION CONTACT:

• This information collection request may be viewed at http://www.reginfo.gov. Follow the instructions to view the Department of Commerce, USPTO information collections currently under review by OMB.

• Email: InformationCollection@uspto.gov. Include “0651-0022 information request” in the subject line of the message.

• Mail: Justin Isaac, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria,
VA 22313-1450.

• Telephone: Raul Tamayo, Senior Legal Advisor, 571-272-7728.

SUPPLEMENTARY INFORMATION:

Title: Deposit of Biological Materials.

OMB Control Number: 0651-0022.

Abstract: This information collection covers information from patent applicants who seek to deposit biological material in connection
with a patent application according to 37 CFR 1.801-1.809. The information collected from such patent applicants consists
of information and documentation demonstrating the applicant's compliance with regulatory requirements, as well as information
regarding the biological sample after it is deposited. This collection also covers communications from institutions that wish
to be recognized by the USPTO as a suitable depository to receive deposits for patent application purposes. The information
collection requirements for these actions are separate, as discussed below.

A. Deposits of Biological Materials

The deposit of biological material as part of a patent application is authorized by 35 U.S.C. 2(b)(2) and 112. The term “biological
material” is defined in 37 CFR 1.801 as including material that is capable of self-replication, either directly or indirectly.
When an invention involves a biological material, words and figures may not sufficiently describe how to make and use the
invention in a reproducible material as required by 35 U.S.C. 112. In such cases, the inventive biological material must be
known and readily available to the public or can be made or isolated without undue experimentation (see 37 CFR 1.802). In
order to satisfy the “known and readily available” requirement, the biological material may be deposited in a suitable depository
that has been recognized as an International Depository Authority (IDA) established under the Budapest Treaty per 37 CFR 1.803(a)(1),
or any other depository recognized to be suitable by the USPTO per 37 CFR 1.803(a)(2). Under the authority of 35 U.S.C. 2(b)(2),
the deposit rules (37 CFR 1.801-1.809) set forth examination procedures and conditions of deposit which must be satisfied
in the event a deposit is required.

In cases where a deposit of biological material that is capable of self-replication either directly or indirectly is made,
and the deposit is not made under the Budapest Treaty, the USPTO collects information to determine whether the deposit meets
the viability requirements of 37 CFR 1.807. This information includes a viability statement under 37 CFR 1.807, such statement
identifying:

(1) The name and address of the depository where the deposit was made;

(2) The name and address of the depositor;

(3) The date of the deposit;

(4) The identity of the deposit and the accession number given by the depository;

(5) The date of the viability test;

(6) The procedure used to obtain a sample if the test was not done by the depository; and

(7) A statement that the deposit is capable of reproduction.

A viability statement is not required when a deposit is made and accepted under the Budapest Treaty.

This information collection also covers additional information that may be gathered by the USPTO after a biological material
is deposited into the recognized depository. For example, depositors may be required to submit verification statements for
biological material deposited after the effective filing date of a patent application, or written notification that an acceptable
deposit will be made. Occasionally a deposit may be lost, contaminated, or is not able to self-replicate, and a replacement
or supplemental deposit needs to be made. This information collection includes a required written notification that the depositor
must submit to the USPTO disclosing the particulars of such situation and, in the case of an issued patent, requesting a certificate
of correction.

There are no forms associated with the information collected by the USPTO in connection with the deposit of biological material.
However, there are forms available under the Budapest Treat for use with international depositories.

B. Request for Depository Approval

Institutions that wish to be recognized by the USPTO as a suitable depository to receive deposits for patent purposes are
required by 37 CFR 1.803(b) to make a request demonstrating that they are qualified to store and test the biological material
submitted to them under patent applications (see also MPEP 2405). This information collection covers the information that
a depository must submit to the USPTO when seeking recognition by the USPTO as a suitable depository under 37 CFR 1.803(a)(2).
This information enables the USPTO to evaluate whether such a depository has internal practices (both technical and administrative)
and the technical ability sufficient to protect the integrity of the biological material being stored by U.S. patent applicants
and patent owners. This information includes:

(1) The name and address of the depository seeking recognition under 37 CFR 1.803(a)(2),

(2) Detailed information as to the capacity of the depository to comply with the requirements of 37 CFR 1.803(a)(2), including
information on its legal status, scientific standing, staff, and facilities;

(3) An indication that the depository intends to be available, for the purposes of deposit, to any depositor under these same
conditions;

(4) Where the depository intends to accept for only certain kinds of biological material, specify such kinds; and

(5) An indication of the amount of any fees that the depository will, upon acquiring the status of suitable depository under
paragraph (a)(2) of this section, charge for storage, viability statements and furnishings of the samples of the deposit.

This collection also includes additional information gathered by the USPTO that may be needed after a depository has been
recognized by the USPTO under 37 CFR 1.803(a)(2), such as requests to handle additional types of biological material other
than the material originally recognized, and viability statements that depositories may submit on behalf of depositors for
deposits tested at the depository and/or documentation proving the public has been notified where to obtain samples. There
are no forms associated with requests under 37 CFR 1.803(b) to become a recognized depository.

Forms:

• BP/1 (Statement in the Case of an Original Deposit (Rule 6.1))
• BP/2 (Statement in the Case of a New Deposit with the Same International Depository Authority (Rule 6.2))
• BP/3 (Statement in the Case of a New Deposit with Another International Depository Authority (Rule 6.2))
• BP/9 (Viability Statement (Rule 10.2) (International Form)) Type of Review: Extension and revision of a currently approved information collection.

Affected Public: Private sector.

Respondent's Obligation: Required to obtain or retain benefits.

Frequency: On occasion.

Estimated Number of Annual Respondents: 1,501 respondents.

Estimated Number of Annual Responses: 1,501 responses.

Estimated Time per Response: The USPTO estimates that the responses in this information collection will take the public approximately 1 to 5 hours to complete,
depending on the complexity of the situation. This includes the time to gather the necessary information, create the document,
and submit the completed item to the USPTO.

Estimated Total Annual Respondent Burden Hours: 1,505 hours.

Estimated Total Annual Respondent Non-hourly Cost Burden: $4,306,511.

Justin Isaac, Information Collections Officer, Office of the Chief Administrative Officer, United States Patent and Trademark Office. [FR Doc. 2026-04519 Filed 3-6-26; 8:45 am] BILLING CODE 3510-16-P

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