[Federal Register Volume 91, Number 45 (Monday, March 9, 2026)]
[Notices]
[Pages 11292-11293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04519]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Deposit of Biological Materials
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice of information collection; request for comments.
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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: [email protected]. 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.
[[Page 11293]]
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]
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