[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16472-16474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06046]
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DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Deposit of Biological Materials
ACTION: Proposed collection; comment request.
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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.''
SUPPLEMENTARY INFORMATION:
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.
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Estimated Estimated
Item Estimated time annual annual burden
for response responses hours
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Deposited Materials............................................. 1 hour 2,000 2,000
Depository Approval............................................. 5 hours 1 5
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Totals...................................................... .............. 2,001 2,005
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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
costs.
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
[[Page 16474]]
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]
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