[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Pages 63855-63857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24951]



Patent and Trademark Office

Deposit of Biological Materials

ACTION: Notice of renewal of information collection; request for 


SUMMARY: The United States Patent and Trademark Office (USPTO), as 
required by the Paperwork Reduction Act of 1995, invites comments on 
the extension of an existing information collection: 0651-0022 (Deposit 
of Biological Materials).

DATES: Written comments must be submitted on or before January 21, 

ADDRESSES: You may submit comments by any of the following methods:
     Email: [email protected]. Include ``0651-
0022 comment'' in the subject line of the message.
     Federal Rulemaking Portal: http://www.regulations.gov.
     Mail: Marcie Lovett, Records and Information Governance 
Branch, Office of the Chief Administrative Officer, United States 
Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Raul Tamayo, Senior Legal Advisor, Office of 
Patent Legal Administration, United States Patent and Trademark Office, 
P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7728; 
or by email to [email protected] with ``0651-0022 comment'' in the 
subject line. Additional information about this collection is also 
available at http://www.reginfo.gov under ``Information Collection 


I. Abstract

    This collection covers information from patent applicants who seek 
to deposit biological materials as part of a patent application. 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 purposes. The 
information collection requirements for these actions are separate, as 
further discussed below.

A. Deposits of Biological Materials

    The deposit of biological materials as part of a patent application 
is authorized by 35 U.S.C. 2(b)(2). 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, sometimes words and figures are not sufficient 
to satisfy the statutory requirement for patentability under 35 U.S.C. 
112 (every patent must contain a description of the invention 
sufficient to enable a person (knowledgeable in the relevant science), 
to make and use the invention as specified by 35 U.S.C. 112). In such 
cases, the required biological material must either be: (1) Known and 
readily available (neither condition alone is sufficient) or (2) 
deposited in a suitable depository that has been recognized as an 
International Depositary Authority (IDA) established under the Budapest 
Treaty, or a depository recognized by the USPTO to meet the 
requirements of 35 U.S.C. 112. Under the authority of 35 U.S.C. 
2(b)(2), the deposit rules (37 CFR 1.801-1.809) set forth examining 
procedures and conditions of deposit which must be satisfied in the 
event a deposit is required. The rules do not address the substantive 
issue of whether a deposit is required under any particular set of 
    In cases where a deposit is necessary, the USPTO collects 
information to determine whether the depositor is in compliance with 
the deposit rules. This includes statements proving notification to the 
interested public on where to obtain samples of the deposits and 
confirming that all restriction on access to the deposit will be 
irrevocably removed upon issuance of the patent. A viability statement 
also must be submitted to the USPTO showing that the biological 
material was tested by the depository or another, the conditions of the 
test, and that it is a viable or acceptable deposit. A viability 
statement is not required when a deposit is made and accepted under the 
Budapest Treaty.
    This 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 materials 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 otherwise is not able to self-
replicate, and a replacement or supplemental deposit needs to be made. 
In that event, this collection covers the requirement that the 
depositor submit a written notification to the USPTO concerning the 
particulars of the situation and request a certificate of correction by 
the USPTO authorizing the replacement or supplemental deposit.
    There are no forms associated with the information collected by the 
USPTO in connection with the deposit of biological materials.

B. Depositories

    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 to make a request demonstrating that they are qualified to 
store and test the biological materials submitted to them under patent 
applications. This collection covers the information gathered in the 
request to allow the USPTO to evaluate whether such an institution has 
demonstrated that its internal practices (both technical and 
administrative) and the technical ability of the staff and the facility 
are sufficient to protect the integrity of the biological materials 
being stored. For example, this collection covers documentation from 
depositories that verifies that their practices and procedures, the 
technical competence of their staff, and their facilities fulfill the 
stringent requirements spelled out under the rules.
    This collection also covers additional information gathered by the 
USPTO that may be needed after a depository has

[[Page 63856]]

been recognized by the USPTO. For example, this collection covers 
requests to handle additional types of biological materials 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 about where to obtain samples.
    There is no application form associated with requests to become a 
recognized depository.

II. Method of Collection

    By mail, hand delivery, or electronically to the USPTO.

III. Data

    OMB Number: 0651-0022.
    Form Number(s): None.
    Type of Review: Extension of a currently approved collection.
    Affected Public: Businesses or other for-profits; and not-for-
profit institutions.
    Estimated Number of Respondents: 951 responses per year. The USPTO 
estimates that approximately 3% (28) of these responses will be from 
small entities.
    Estimated Time per Response: The USPTO estimates that it will take 
the public 1 hour to gather the necessary information, prepare the 
appropriate form or documents, and submit the information to the USPTO 
for a deposit of biological materials. The USPTO estimates that it will 
take the average depository seeking approval to store biological 
materials approximately 5 hours to collect and submit the necessary 
approval information.
    Estimated Total Annual Respondent Burden Hours: 955 hours.
    Estimated Total Annual Respondent Cost Burden: $33,021. The USPTO 
estimates a professional hourly rate of $34.40 for a senior 
administrative assistant (BLS rate; 43-1011 First Line Supervisors of 
Office and Administrative Support Workers) to collect and submit the 
deposit information. The USPTO expects that the average depository 
seeking approval to store biological material will be prepared by 
attorneys at an estimated rate of $68.22 (BLS rate; 23-1011 Lawyers) 
per hour. Therefore, the USPTO estimates that the respondent cost 
burden for this collection will be approximately $33,021 per year.

                                                           Estimated time
           IC No.                        Item               for response    Estimated annual   Estimated annual     Rate  ($/hr)         Total costs
                                                               (hours)          responses        burden hours
                              ..........................               (a)               (b)  (a) x (b)/60 = (c)               (d)           (c) x (d) =
                                                                                                                                    (hourly cost burden)
1...........................  Deposited Materials.......                 1               950                 950            $34.40               $32,680
2...........................  Depository Approval.......                 5                 1                   5             68.22                   341
    Total...................  ..........................  ................               951                 955  ................                33,021

    Estimated Total Annual Non-hour Respondent Cost Burden: $2,823,236. 
There are no maintenance costs, recordkeeping costs, or filing fees 
associated with this information collection. However, this collection 
has annual (non-hour) costs in the form of capital start-up and postage 
    Depositories charge fees to depositors; 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. Most deposits received from outside 
the United States require an import permit from the U.S. Department of 
Agriculture (USDA) as well as a Public Health Service (PHS) permit, 
available from the Centers for Disease Control and Prevention (CDC), 
for importation of agents infectious to humans. There is no extra 
charge for this permit application processing. The USPTO estimates that 
the total non-hour respondent cost burden in the form of capital start-
up costs amounts to $2,375,000.
    In addition, this collection has postage costs. Biological deposits 
are generally shipped to the depository ``Domestic Overnight'' by 
Federal Express (FedEx) and, since depositors are urged to supply 
frozen or freeze-dried material, it must be packed in dry ice according 
to a representative from the Patent Department at ATCC. Dry ice itself 
is considered a dangerous good and requires special packaging. 
Additional FedEx special handling charges for inaccessible dangerous 
goods shipments of $40 per shipment apply for temperature-sensitive 
biological materials and also for the dry ice. An average cost for 
shipping by FedEx ``Domestic Overnight'' is estimated to be $75. If the 
shipment requires pick-up by FedEx, there is an additional charge of 
$4. Special packaging is also required for these shipments. According 
to DG Supplies Inc., a supplier of infectious and diagnostic goods 
packaging, the average cost of frozen infectious shippers is estimated 
to be $352.82 per package for specimen shipments requiring 
refrigeration or dry ice. Therefore, postage costs average $471.82 per 
shipment. The postage cost for a depository seeking recognition is 
estimated to be $7.65, sent to the USPTO by USPS Priority Mail legal 
flat rate envelope.
    The USPTO estimates that the (non-hour) respondent cost burden in 
the form of mailing costs amounts to $448,236.

            Item No.                     Item/type of cost            annual          Amount          Totals
                                           Deposit Costs
1...............................  Deposited Materials...........             950       $2,500.00   $2,375,000.00
                                     Total Fees.................  ..............  ..............    2,375,000.00
                                      Packaging/Postage Costs
1...............................  Deposited Materials--Mailing               950         $119.00     $113,050.00
1...............................  Deposited Materials--Packaging             950          352.82      335,179.00
2...............................  Request for Depository                       1            7.65            7.65

[[Page 63857]]

                                     Total Postage/Packaging....  ..............  ..............      448,236.65
                                       Total Annual (Non-Hour)    ..............  ..............    2,823,236.65
                                        Cost Burden.

    Therefore, the USPTO estimates that the total (non-hour) respondent 
cost burden for this collection in the form of capital start-up costs 
and postage costs is $2,823,236.

IV. Request for Comments

    Comments submitted in response to this notice will be summarized 
and/or included in the request for OMB approval. All comments will 
become a matter of public record.
    USPTO invites public comments on:
    (a) 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) Accuracy of the agency's estimate of the burden (including 
hours and cost) of the proposed collection of information, including 
the validity of the methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on 
respondents, e.g., 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.

Marcie Lovett,
Records and Information Governance Branch, Office of the Chief 
Administrative Officer, USPTO.
[FR Doc. 2019-24951 Filed 11-18-19; 8:45 am]