[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Pages 16472-16474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06046]



United States Patent and Trademark Office

Deposit of Biological Materials

ACTION: Proposed collection; comment request.


SUMMARY: The United States Patent and Trademark Office (USPTO), as part 
of its continuing effort to reduce paperwork and respondent burden, 
invites the general public and other Federal agencies to take this 
opportunity to comment on the continuing information collection, as 
required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 
U.S.C. 3506(c)(2)(A)).

DATES: Written comments must be submitted on or before May 14, 2013.

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.
     Mail: Susan K. Fawcett, Records Officer, Office of the 
Chief Information Officer, United States Patent and Trademark Office, 
P.O. Box 1450, Alexandria, VA 22313-1450.
     Federal Rulemaking Portal: http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Raul Tamayo, 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 ``Paperwork'' in the subject 
line. Additional information about this collection is also available at 
http://www.reginfo.gov under ``Information Collection Review.''


I. Abstract

    The deposit of biological materials as part of a patent application 
is required by 35 U.S.C. 2(b)(2) and outlined in 37 CFR 1.801-1.809. 
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. The term ``biological 
material'' is defined by 37 CFR 1.801 as including material that is 
capable of self-replication, either directly or indirectly. When the 
invention involves a biological material, sometimes words and figures 
are not sufficient to satisfy the statutory requirement for 
patentability under 35

[[Page 16473]]

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.
    In cases where a deposit is necessary, it must be made under 
conditions that assure access to those entitled thereto under 37 CFR 
1.14 and 35 U.S.C. 122 and upon issuance as a patent that all 
restriction to public access is permanently removed.
    In order to meet and satisfy requirements for international 
patenting, all countries signing the Budapest Treaty must recognize the 
deposit of biological material with any International Depositary 
Authority (IDA).

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: Revision of a currently approved collection.
    Affected Public: Businesses or other for-profits; and not-for-
profit institutions.
    Estimated Number of Respondents: 2,001 responses per year. The 
USPTO estimates that approximately 5% 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: 2,005 hours.
    Estimated Total Annual Respondent Cost Burden: $61,855 per year to 
submit the information to the USPTO. Using the professional hourly rate 
of $30 for a senior administrative assistant, the USPTO estimates 
$60,000 per year for salary costs associated with collecting and 
submitting the necessary deposit information to the USPTO. The USPTO 
expects that the information in this collection associated with the 
average depository seeking approval to store biological material will 
be prepared by attorneys at an estimated rate of $371 per hour, for a 
total of $1,855. Therefore, the USPTO estimates that the respondent 
cost burden for this collection will be approximately $61,855 per year.

                                                                                     Estimated       Estimated
                              Item                                Estimated time      annual       annual burden
                                                                   for response      responses         hours
Deposited Materials.............................................          1 hour           2,000           2,000
Depository Approval.............................................         5 hours               1               5
    Totals......................................................  ..............           2,001           2,005

    Estimated Total Annual Non-hour Respondent Cost Burden: $5,938,646. 
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 $5,000,000.
    In addition, this collection does have 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 dangerous goods and requires special packaging. 
Additional FedEx special handling charges for inaccessible dangerous 
goods shipments of $37.50 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 of four for specimen shipments requiring 
refrigeration or dry ice. Therefore, postage costs average $469.32 per 
shipment, for a total cost to respondents of $938,640.
    The postage cost for a depository seeking recognition is estimated 
to be $5.95, sent to the USPTO by priority mail through the United 
States Postal Service. Since the USPTO estimates that it receives one 
request for recognition from a depository every four years, the average 
postage cost to respondents is approximately $6 per year.
    The USPTO estimates that the (non-hour) respondent cost burden in 
the form of mailing costs amounts to $938,646.
    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 $5,938,646.

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.
    The USPTO is soliciting public comments to: (a) Evaluate whether 
the proposed 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 proposed collection of 
information, including the validity of the methodology and assumptions 
used; (c) Enhance the quality, utility, and clarity of the information 
to be

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collected; and (d) Minimize the burden of the collection of information 
on 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.

    Dated: March 12, 2013.
Susan K. Fawcett,
Records Officer, USPTO, Office of the Chief Information Officer.
[FR Doc. 2013-06046 Filed 3-14-13; 8:45 am]