[Federal Register Volume 90, Number 221 (Wednesday, November 19, 2025)]
[Notices]
[Pages 52038-52041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-20244]
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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 (hereafter
``USPTO'' or ``Agency''), as required by the Paperwork Reduction Act of
1995, invites comments on the extension and revision of an existing
information collection: 0651-0022 (Deposit of Biological Materials).
The purpose of this notice is to allow 60 days for public comments
preceding submission of the information collection to the Office of
Management and Budget (OMB).
DATES: To ensure consideration, you must submit comments regarding this
[[Page 52039]]
information collection on or before January 20, 2026.
ADDRESSES: Interested persons are invited to submit written comments by
any of the following methods. Do not submit Confidential Business
Information or otherwise sensitive or protected information.
Email: [email protected]. Include ``0651-
0022 comment'' in the subject line of the message.
Federal eRulemaking Portal: http://www.regulations.gov.
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.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Raul Tamayo, Senior Legal Advisor at: Office of
Patent Legal Administration, United States Patent and Trademark Office,
P.O. Box 1450, Alexandria, VA 22313-1450; 571-272-7728; or
[email protected] with ``0651-0022 comment'' in the subject line.
Additional information about this information collection is also
available at http://www.reginfo.gov under ``Information Collection
Review.''
SUPPLEMENTARY INFORMATION:
I. Abstract
This information collection covers information from patent
applicants who seek to deposit biological material for patent purposes
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 applications 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 Material
The deposit of biological material for patent purposes is
authorized by 35 U.S.C. 2(b)(2). The term ``biological material'' is
defined in Sec. 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 manner 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 be capable to be made
or isolated without undue experimentation (see Sec. 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 Sec. 1.803(a)(1), or any
other depository recognized to be suitable by the USPTO per Sec.
1.803(a)(2). Under the authority of 35 U.S.C. 2(b)(2), the deposit
rules (Sec. Sec. 1.801-1.809) set forth the 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
Sec. 1.807. This information includes a viability statement under
Sec. 1.807 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. As another
example, occasionally a deposit may become lost, contaminated, or
incapable of functioning as described in the specification, and a
replacement or supplemental deposit needs to be made. This information
collection includes the written notification that the depositor must
submit to the USPTO disclosing the particulars of the need for a
replacement or supplemental deposit, as well as the request for
certificate of correction that is required when the replacement or
supplemental deposit is being made in connection with a patent.
The USPTO does not provide forms for the information it collects in
connection with the deposit of biological material. The International
Bureau of the World Intellectual Property Organization provides forms
for the deposit of biological material at an IDA under the Budapest
Treaty.
B. Depositories
Institutions that wish to be recognized by the USPTO as a suitable
depository to receive deposits for patent purposes are required by
Sec. 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 when seeking
recognition by the USPTO as a suitable depository under Sec.
1.803(a)(2). Depositories should comply with the requirements of Sec.
1.803(b) when requesting to become a recognized depository.
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. The
information that the depository provides includes:
(1) The name and address of the depository seeking recognition
under Sec. 1.803(a)(2),
(2) Detailed information as to the capacity of the depository to
comply with the requirements of Sec. 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 deposit only certain
kinds of biological material, such kinds must be specified; and
(5) An indication of the amount of any fees that the depository
will, upon acquiring the status of a 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 Sec. 1.803(a)(2). This information could include
requests to handle additional types of biological
[[Page 52040]]
material other than the material originally recognized, viability
statements that depositories may submit on behalf of depositors for
deposits tested at the depository, and documentation that the public
has been notified about where to obtain samples.
II. Method of Collection
Items in this information collection may be submitted
electronically. Applicants may also submit the information in paper
form by mail, fax, or hand delivery.
III. Data
OMB Control Number: 0651-0022.
Forms: (BP = Budapest)
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 Hourly Cost Burden: $672,735.
Table 1--Total Reporting Burden Hours and Hourly Costs to Private Sector Respondents
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Estimated
Estimated Responses per Estimated annual Estimated time Estimated Rate \1\ ($/ annual
Item No. Item annual respondent responses for response burden (hour/ hour) respondent
respondents (hours) year) Cost Burden
(a) (b) (a) x (b) = (c) (d) (c) x (d) = (f) (e) x (f) =
(e) (g)
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1............... Deposited 1,500 1 1,500 1 1,500 447 $670,500
Materials.
2............... Request for 1 1 1 5 5 447 $2,235
Depository
Approval.
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Totals...... .................. 1,501 ............... 1,501 .............. 1,505 .............. $672,735
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\1\ 2023 Report of the Economic Survey, published by the Committee on Economics of Legal Practice of the American Intellectual Property Law Association,
pg. F-41. The USPTO uses the average billing rate for intellectual property work in all firms, which is $447 per hour (www.aipla.org/home/news-publications/economic-survey).
Estimated Total Annual Respondent Non-hourly Cost Burden:
$4,306,511. There are no maintenance costs, recordkeeping costs, or
filing fees associated with this information collection. However, the
USPTO estimates that the total annual non-hour cost burden for this
information collection, in the form of capital start-up costs and
postage, is $4,306,511.
Capital Start-Up Costs
Depositories charge fees to depositors, and all depositories charge
about the same rates for their services. For example, the American Type
Culture Collection (ATCC), one of the world's leading biological supply
houses and recognized patent depositories, offers comprehensive patent
services for $2,500 per deposit.\2\ Any deposit made from outside the
U.S. may have additional requirements from other federal agencies as
part of their importation process. For the purposes of this information
collection, the USPTO estimates that the depository fee is $2,500 per
deposit. The breakout for these costs is listed in the table below.
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\2\ The ATCC Patent Depository service fee is $2,500 per
deposit, which is incurred at the time of receipt of a portion or
all of the materials (https://www.atcc.org/services/depositing-with-atcc/patent-deposit).
Table 2--Capital Start Up Costs
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Estimated annual Non-hourly cost
Item No. Item responses Filing fee ($) burden
(a) (b) (a) x (b) = (c)
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1................................. Deposited Material 1,500 2,500 $3,750,000
Depository Fee.
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Totals........................ .................... 1,500 ................ $3,750,000
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Postage Costs
Biological deposits are generally shipped to the depository
``Domestic Overnight'' by Federal Express (FedEx). Since depositors are
urged to supply frozen or freeze-dried materials, it must be packed in
dry ice. Dry ice itself is considered a dangerous good and requires
special packaging. Additional FedEx special handling charges for
inaccessible dangerous goods shipments is $73 per shipment,\3\ which
applies to temperature-sensitive biological materials and dry ice.
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\3\ FedEx, How to Ship Dangerous Goods (https://www.fedex.com/en-us/service-guide/dangerous-goods/how-to-ship.html).
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An average cost for shipping by FedEx ``Domestic Overnight'' can
vary depending on the size of the package, the delivery time, and the
delivery distance. For purposes of this information collection, the
USPTO estimates that the FedEx Domestic Overnight charge for a
biological deposit is $120 per shipment. If the shipment requires a
pick-up by FedEx, there is an
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additional charge of $7.50.\4\ Special packaging is also required for
these shipments. The average cost of frozen infectious shipments is
estimated to be $170 per package of four for specimen shipments
requiring refrigeration or dry ice. Therefore, the USPTO estimates that
the total average postage cost is $371 per shipment. The USPTO
estimates that respondents to this information collection will ship
1,500 biological deposits, for a total of $556,500. The USPTO estimate
that it will receive 1 depository request for recognition. The USPTO
estimates that the postage cost for this type of mailed submission,
using a Priority Mail legal flat-rate envelope, will be $11.20.
Combining these rates, the USPTO therefore estimates that the total
mailing costs for this information collection is $556,511 per year.
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\4\ FedEx, U.S. Parcel Pickup Options (https://www.fedex.com/content/dam/fedex-com/hdn/FedEx-US-Pickup-Options-with-rates-2025.pdf).
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IV. Request for Comments
The USPTO is soliciting public comments to:
(a) Evaluate whether the collection of information is necessary for
the proper performance of the functions of the Agency, including
whether the information will have practical utility;
(b) Evaluate the accuracy of the Agency's estimate of the burden of
the collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected; and
(d) Minimize the burden of the collection of information for those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
All comments submitted in response to this notice are a matter of
public record. The USPTO will include or summarize each comment in the
request to OMB to approve this information collection. Before including
an address, phone number, email address, or other personally
identifiable information (PII) in a comment, be advised that the entire
comment--including PII--may be made publicly available at any time.
While you may request to withhold PII from public view, the USPTO
cannot guarantee that it will be able to do so.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2025-20244 Filed 11-18-25; 8:45 am]
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