Deposit of Biological Materials, 63855-63857 [2019-24951]
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Federal Register / Vol. 84, No. 223 / Tuesday, November 19, 2019 / Notices
completion of agenda items. The
meeting will begin on December 10,
2019 at 9 a.m. Other than the start time,
interested parties should be aware that
discussions may start earlier or later
than indicated. In addition, the meeting
may be extended from, or completed
prior to the date established in this
notice.
Special Accommodations
These meetings are physically
accessible to people with disabilities.
For more information or request for sign
language interpretation and other
auxiliary aids, please contact Mr.
Miguel A. Rolo´n, Executive Director,
Caribbean Fishery Management Council,
270 Mun˜oz Rivera Avenue, Suite 401,
San Juan, Puerto Rico 00918–1903,
telephone: (787) 766–5926, at least 5
days prior to the meeting date.
Dated: November 14, 2019.
Tracey L. Thompson,
Acting Deputy Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. 2019–25051 Filed 11–18–19; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Deposit of Biological Materials
Notice of renewal of information
collection; request for comment.
ACTION:
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, 2020.
ADDRESSES: You may submit comments
by any of the following methods:
• Email: InformationCollection@
uspto.gov. Include ‘‘0651–0022
comment’’ in the subject line of the
message.
• Federal Rulemaking Portal: https://
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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16:47 Nov 18, 2019
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telephone at 571–272–7728; or by email
to Raul.Tamayo@uspto.gov with ‘‘0651–
0022 comment’’ in the subject line.
Additional information about this
collection is also available at https://
www.reginfo.gov under ‘‘Information
Collection Review.’’
SUPPLEMENTARY INFORMATION:
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
facts.
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
PO 00000
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63855
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
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63856
Federal Register / Vol. 84, No. 223 / Tuesday, November 19, 2019 / Notices
II. Method of Collection
By mail, hand delivery, or
electronically to the USPTO.
III. Data
OMB Number: 0651–0022.
IC No.
Item
Estimated time
for response
(hours)
Estimated annual
responses
Estimated annual
burden hours
Rate
($/hr)
Total costs
(a)
(b)
(a) × (b)/60 = (c)
(d)
(c) × (d) =
(hourly cost burden)
1 .....................
2 .....................
Deposited Materials ..................................
Depository Approval .................................
1
5
950
1
950
5
$34.40
68.22
$32,680
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 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),
khammond on DSKJM1Z7X2PROD with NOTICES
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.
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
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.
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 freezedried 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 (nonhour) respondent cost burden in the
form of mailing costs amounts to
$448,236.
Estimated
annual
responses
Item No.
Item/type of cost
1 ..................
Deposit Costs
Deposited Materials ...........................................................................................
950
$2,500.00
$2,375,000.00
Total Fees ...................................................................................................
........................
........................
2,375,000.00
Packaging/Postage Costs
Deposited Materials—Mailing Costs ..................................................................
Deposited Materials—Packaging Supplies ........................................................
Request for Depository Approval .......................................................................
950
950
1
$119.00
352.82
7.65
$113,050.00
335,179.00
7.65
1 ..................
1 ..................
2 ..................
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Federal Register / Vol. 84, No. 223 / Tuesday, November 19, 2019 / Notices
Estimated
annual
responses
Amount
Total Postage/Packaging ............................................................................
........................
........................
448,236.65
Total Annual (Non-Hour) Cost Burden ................................................
........................
........................
2,823,236.65
Item No.
Item/type of cost
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]
BILLING CODE 3510–16–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Patent Term Extension
Notice of renewal of information
collection; request for comment.
ACTION:
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: 0651–0020 (Patent Term
Extension).
DATES: Written comments must be
submitted on or before January 21, 2020.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
63857
16:47 Nov 18, 2019
Jkt 250001
You may submit comments
by any of the following methods:
• Email: InformationCollection@
uspto.gov. Include ‘‘0651–0020
comment’’ in the subject line of the
message.
• Federal Rulemaking Portal: https://
www.regulations.gov.
• Mail: Marcie Lovett, Records and
Information Governance Branch, Office
of the Chief Administration 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 Raul.Tamayo@uspto.gov with ‘‘0651–
0020 comment’’ in the subject line.
Additional information about this
collection is also available at https://
www.reginfo.gov under ‘‘Information
Collection Review.’’
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Abstract
The patent term restoration portion of
the Drug Price Competition and Patent
Term Restoration Act of 1984 (Pub. L.
98–417), which is codified at 35 U.S.C.
156, permits the United States Patent
and Trademark Office (USPTO) to
extend the term of protection under a
patent to compensate for delay during
regulatory review and approval by the
Food and Drug Administration (FDA) or
Department of Agriculture. Only patents
for drug products, medical devices, food
additives, or color additives are
potentially eligible for extension. The
maximum length that a patent may be
extended under 35 U.S.C. 156 is five
years. The USPTO administers 35 U.S.C.
156 through 37 CFR 1.710–1.791.
This collection covers information
gathered in patent term extension
applications submitted under 35 U.S.C.
156(d). Under this provision, an
application for patent term extension
must identify the approved product; the
patent to be extended; and the claims
included in the patent that cover the
approved product, a method of using
the approved product, or a method of
manufacturing the approved product. 35
PO 00000
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Fmt 4703
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Totals
U.S.C. 156(d) also requires the
application for patent term extension to
provide a brief description of the
activities undertaken by the applicant
during the regulatory review period
with respect to the approved product
and the significant dates of these
activities.
This collection also covers
information gathered in requests for
interim extensions pursuant to 35 U.S.C.
156(e). Under this provision an interim
extension may be granted if the term of
an eligible patent for which an
application for patent term extension
has been submitted would expire before
a certificate of extension is issued.
Under 35 U.S.C. 156(d)(5), an interim
extension may be granted if the
applicable regulatory review period that
began for a product is reasonably
expected to extend beyond the
expiration of the patent term in effect.
In addition, this collection covers
requests for review of final eligibility
decisions, and to withdraw an
application requesting a patent term
extension after it is submitted.
Separate from the extension
provisions of 35 U.S.C. 156, the USPTO
may in some cases extend the term of an
original patent under the provisions at
35 U.S.C. 154 due to certain delays in
the prosecution of the patent
application, including delays caused by
interference proceedings, secrecy
orders, or appellate review by the Patent
Trial and Appeal Board or a Federal
court in which the patent is issued
pursuant to a decision reversing an
adverse determination of patentability.
The USPTO administers 35 U.S.C. 154
through 37 CFR 1.701–1.705. The patent
term provisions of 35 U.S.C. 154(b), as
amended by Title IV, Subtitle D of the
Intellectual Property and
Communications Omnibus Reform Act
of 1999, allow the applicant an
opportunity to request reconsideration
of the USPTO’s patent term adjustment
determination. This collection covers
information gathered in such a request.
In addition, this collection covers
instances when the USPTO may reduce
the amount of patent term adjustment
granted if delays were caused by an
applicant’s failure to make a reasonable
effort to respond within three months of
the mailing date of a communication
from the USPTO. Applicants may
E:\FR\FM\19NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63855-63857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24951]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Deposit of Biological Materials
ACTION: Notice of renewal of information collection; request for
comment.
-----------------------------------------------------------------------
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,
2020.
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: https://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 https://www.reginfo.gov under ``Information Collection
Review.''
SUPPLEMENTARY INFORMATION:
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
facts.
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
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 $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.
----------------------------------------------------------------------------------------------------------------
Estimated
Item No. Item/type of cost annual Amount Totals
responses
----------------------------------------------------------------------------------------------------------------
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
Costs.
1............................... Deposited Materials--Packaging 950 352.82 335,179.00
Supplies.
2............................... Request for Depository 1 7.65 7.65
Approval.
-----------------------------------------------
[[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]
BILLING CODE 3510-16-P
