Deposit of Biological Materials, 62423-62424 [E6-17855]
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62423
Federal Register / Vol. 71, No. 206 / Wednesday, October 25, 2006 / Notices
Dated: October 19, 2006.
Angela Somma,
Chief, Endangered Species Division, Office
of Protected Resources, National Marine
Fisheries Service.
[FR Doc. E6–17892 Filed 10–24–06; 8:45 am]
Legal Administration, U.S. Patent and
Trademark Office (USPTO), P.O. Box
1450, Alexandria, VA 22313–1450; by
telephone at 571–272–7700; or by e-mail
at bob.spar@uspto.gov.
SUPPLEMENTARY INFORMATION:
patenting, all countries signing the
Budapest Treaty must recognize the
deposit of biological material with any
International Depository Authority
(IDA).
BILLING CODE 3510–22–S
I. Abstract
By mail, facsimile, or hand delivery to
the USPTO when the applicant or agent
files a patent application with the
USPTO or submits subsequent papers
during the prosecution of the
application to the USPTO.
PATENT AND TRADEMARK OFFICE
Deposit of Biological Materials
ACTION:
Proposed collection; comment
request.
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 December 26,
2006.
SUMMARY:
You may submit comments
by any of the following methods:
• E-mail: Susan.Brown@uspto.gov.
Include ‘‘0651–0022 comment’’ in the
subject line of the message.
• Fax: 571–273–0112, marked to the
attention of Susan Brown.
• Mail: Susan K. Brown, Records
Officer, Office of the Chief Information
Officer, Architecture, Engineering and
Technical Services, Data Architecture
and Services Division, U.S. Patent and
Trademark Office, P.O. Box 1450,
Alexandria, VA 22313–1450.
• Federal e-Rulemaking Portal:
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to the attention of
Robert J. Spar, Director, Office of Patent
ADDRESSES:
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 Chapter 1, Subpart G, 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 includes material that is
capable of self-replication either directly
or indirectly. When the invention
involves a biological material,
sometimes words alone cannot
sufficiently describe how to make and
use the invention in a reproducible or
repeatable manner. In such cases, the
required biological material must either
be known and readily (and continually)
available, or be deposited in a suitable
depository to meet the enablement and
written description requirements of 35
U.S.C. 112.
In cases where a novel microorganism
is involved, the USPTO traditionally
requires the deposit of a sample with a
recognized patent depository in order to
meet the above disclosure requirements.
When a deposit is necessary, the USPTO
collects information to determine
whether the depositor is in compliance
with the patent statute. This includes a
statement proving notification to the
interested public on where to obtain
samples of the deposits. A viability
statement showing that the biological
material was tested by the depository,
and is a viable or acceptable deposit,
must also be submitted to the USPTO.
In order to meet and satisfy
requirements for international
II. Method of Collection
III. Data
OMB Number: 0651–0022.
Form Number(s): None.
Type of Review: Extension of a
currently approved collection.
Affected Public: Households and
individuals; business or other for-profit,
not-for-profit institutions; and the
Federal Government.
Estimated Number of Respondents:
3,500 responses per year for deposited
materials and 1 per year for depository
approval.
Estimated Time per Response: The
USPTO estimates that it will take
approximately 1 hour per application
for deposited materials and 5 hours per
application for depository approval.
Estimated Total Annual Respondent
Burden Hours: 3,505 hours per year.
Estimated Total Annual Respondent
Cost Burden: $106,520 per year to
submit the information to the USPTO.
Using the professional hourly rate of
$30 for a senior administrative assistant,
the USPTO estimates $105,000 per year
for salary costs associated with
collecting and submitting the necessary
deposit information. Using the
professional hourly rate of $304 for
associate attorneys in private firms, the
USPTO estimates $1,520 per year for
salary costs associated with the average
depository seeking approval to store
biological material.
Estimated
annual
responses
Estimated
annual burden hours
Estimated time for response
Deposited Materials ..........................................................
Depository Approval ..........................................................
1 hour ...............................................................................
5 hours .............................................................................
3,500
1
3,500
5
Total ...........................................................................
mstockstill on PROD1PC61 with NOTICES
Item
...........................................................................................
3,501
3,505
Estimated Total Annual (Non-hour)
Respondent Cost Burden: $9,850,929.
There are no maintenance costs or filing
fees associated with this information
collection. There are, however, capital
start-up and mailing costs.
Depositories charge fees to depositors;
all depositories charge about the same
rates for their services. For example, the
VerDate Aug<31>2005
15:12 Oct 24, 2006
Jkt 211001
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). Also
PO 00000
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Fmt 4703
Sfmt 4703
required is 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
E:\FR\FM\25OCN1.SGM
25OCN1
62424
Federal Register / Vol. 71, No. 206 / Wednesday, October 25, 2006 / Notices
burden in the form of capital start-up
costs amounts to $8,750,000.
In addition, this collection does have
mailing 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 of $60
per shipment apply for temperaturesensitive biological material 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 $2.50. Special
packaging is also required for these
shipments. According to DG Supplies
Inc., a supplier of infectious and
diagnostic goods packaging, frozen
infectious shippers are estimated to cost
$177.05 per package for specimen
shipments requiring refrigeration or dry
ice. Therefore, mailing costs average
$314.55 per shipment, for a total cost to
all the respondents of $1,100,025. The
postage cost for a depository seeking
recognition is estimated to be $4.05,
sent to the USPTO by priority mail
through the United States Postal
Service. Therefore, the USPTO estimates
that the total non-hour respondent cost
burden in the form of postage costs
amounts to $1,100,929.
Responses
Postage costs
($)
Total non-hour
cost burden
(a)
Item
(b)
(a) × (b)
Deposited Materials ...............................................................................................................
Depository Approval ..............................................................................................................
3,500
1
$314.55
4.05
$1,100,925.00
4.00
Total ................................................................................................................................
3,501
............................
1,100,929.00
The USPTO estimates that the total
non-hour respondent cost burden for
this collection in the form of capital
start-up costs ($8,750,000) and mailing
costs ($1,100,929) amounts to
$9,850,929.
IV. Request for Comments
mstockstill on PROD1PC61 with NOTICES
Dated: October 19, 2006.
Susan K. Brown,
Records Officer, USPTO, Office of the Chief
Information Officer, Architecture,
Engineering and Technical Services, Data
Architecture and Services Division.
[FR Doc. E6–17855 Filed 10–24–06; 8:45 am]
BILLING CODE 3510–16–P
15:12 Oct 24, 2006
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0114]
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden
(including hours and cost) of the
proposed collection of information; (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, including through the
use of automated collection techniques
or other forms of information
technology.
Comments submitted in response to
this notice will be summarized or
included in the request for OMB
approval of this information collection;
they will also become a matter of public
record.
VerDate Aug<31>2005
DEPARTMENT OF DEFENSE
Jkt 211001
Federal Acquisition Regulation;
Submission for OMB Review; Right of
First Refusal of Employment
AGENCIES: Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for public
comments regarding an extension to an
existing OMB clearance (9000–0114).
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the Federal
Acquisition Regulation (FAR)
Secretariat is submitting to the Office of
Management and Budget (OMB) a
request to review and approve an
extension of a currently approved
information collection requirement
concerning right of first refusal of
employment. A request for public
comments was published in the Federal
Register at 71 FR 38137 on July 5, 2006.
No comments were received.
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
PO 00000
Frm 00009
Fmt 4703
Sfmt 4703
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before
November 24, 2006.
ADDRESSES: Submit comments including
suggestions for reducing this burden to:
FAR Desk Officer, OMB, Room 10102,
NEOB, Washington, DC 20503, and a
copy to the General Services
Administration, FAR Secretariat (VIR),
Room 4035 1800 F Street, NW,
Washington, DC 20405.
FOR FURTHER INFORMATION CONTACT: Mr.
Michael Jackson, Contract Policy
Division, GSA, at (202) 208–4949.
SUPPLEMENTARY INFORMATION:
A. Purpose
Right of First Refusal of Employment
is a regulation which establishes policy
regarding adversely affected or
separated Government employees
resulting from the conversion from inhouse performance to performance by
contract. The policy will enable these
employees to have an opportunity to
work for the contractor who is awarded
the contract.
The information gathered will be used
by the Government to gain knowledge of
which employees, adversely affected or
separated as a result of the contract
award, have gained employment with
the contractor within 90 days after
contract performance begins.
B. Annual Reporting Burden
Number of Respondents: 200.
Responses Per Respondent: 1.
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 71, Number 206 (Wednesday, October 25, 2006)]
[Notices]
[Pages 62423-62424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17855]
-----------------------------------------------------------------------
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 December 26,
2006.
ADDRESSES: You may submit comments by any of the following methods:
E-mail: Susan.Brown@uspto.gov. Include ``0651-0022
comment'' in the subject line of the message.
Fax: 571-273-0112, marked to the attention of Susan Brown.
Mail: Susan K. Brown, Records Officer, Office of the Chief
Information Officer, Architecture, Engineering and Technical Services,
Data Architecture and Services Division, U.S. Patent and Trademark
Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Federal e-Rulemaking Portal: https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to the attention of Robert J. Spar, Director, Office
of Patent Legal Administration, U.S. Patent and Trademark Office
(USPTO), P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-
272-7700; or by e-mail at bob.spar@uspto.gov.
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 Chapter 1,
Subpart G, 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 includes material that is capable of self-
replication either directly or indirectly. When the invention involves
a biological material, sometimes words alone cannot sufficiently
describe how to make and use the invention in a reproducible or
repeatable manner. In such cases, the required biological material must
either be known and readily (and continually) available, or be
deposited in a suitable depository to meet the enablement and written
description requirements of 35 U.S.C. 112.
In cases where a novel microorganism is involved, the USPTO
traditionally requires the deposit of a sample with a recognized patent
depository in order to meet the above disclosure requirements. When a
deposit is necessary, the USPTO collects information to determine
whether the depositor is in compliance with the patent statute. This
includes a statement proving notification to the interested public on
where to obtain samples of the deposits. A viability statement showing
that the biological material was tested by the depository, and is a
viable or acceptable deposit, must also be submitted to the USPTO.
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 Depository
Authority (IDA).
II. Method of Collection
By mail, facsimile, or hand delivery to the USPTO when the
applicant or agent files a patent application with the USPTO or submits
subsequent papers during the prosecution of the application to the
USPTO.
III. Data
OMB Number: 0651-0022.
Form Number(s): None.
Type of Review: Extension of a currently approved collection.
Affected Public: Households and individuals; business or other for-
profit, not-for-profit institutions; and the Federal Government.
Estimated Number of Respondents: 3,500 responses per year for
deposited materials and 1 per year for depository approval.
Estimated Time per Response: The USPTO estimates that it will take
approximately 1 hour per application for deposited materials and 5
hours per application for depository approval.
Estimated Total Annual Respondent Burden Hours: 3,505 hours per
year.
Estimated Total Annual Respondent Cost Burden: $106,520 per year to
submit the information to the USPTO. Using the professional hourly rate
of $30 for a senior administrative assistant, the USPTO estimates
$105,000 per year for salary costs associated with collecting and
submitting the necessary deposit information. Using the professional
hourly rate of $304 for associate attorneys in private firms, the USPTO
estimates $1,520 per year for salary costs associated with the average
depository seeking approval to store biological material.
------------------------------------------------------------------------
Estimated
Estimated time Estimated annual
Item for response annual burden
responses hours
------------------------------------------------------------------------
Deposited Materials.......... 1 hour......... 3,500 3,500
Depository Approval.......... 5 hours........ 1 5
������������������������������
Total.................... ............... 3,501 3,505
------------------------------------------------------------------------
Estimated Total Annual (Non-hour) Respondent Cost Burden:
$9,850,929. There are no maintenance costs or filing fees associated
with this information collection. There are, however, capital start-up
and mailing 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). Also required is 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
[[Page 62424]]
burden in the form of capital start-up costs amounts to $8,750,000.
In addition, this collection does have mailing 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 of $60 per
shipment apply for temperature-sensitive biological material 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 $2.50. Special packaging is
also required for these shipments. According to DG Supplies Inc., a
supplier of infectious and diagnostic goods packaging, frozen
infectious shippers are estimated to cost $177.05 per package for
specimen shipments requiring refrigeration or dry ice. Therefore,
mailing costs average $314.55 per shipment, for a total cost to all the
respondents of $1,100,025. The postage cost for a depository seeking
recognition is estimated to be $4.05, sent to the USPTO by priority
mail through the United States Postal Service. Therefore, the USPTO
estimates that the total non-hour respondent cost burden in the form of
postage costs amounts to $1,100,929.
----------------------------------------------------------------------------------------------------------------
Postage costs Total non-hour
Item Responses ($) cost burden
(a) (b) (a) x (b)
----------------------------------------------------------------------------------------------------------------
Deposited Materials........................................... 3,500 $314.55 $1,100,925.00
Depository Approval........................................... 1 4.05 4.00
-------------------------------------------------
Total..................................................... 3,501 ................ 1,100,929.00
----------------------------------------------------------------------------------------------------------------
The USPTO estimates that the total non-hour respondent cost burden
for this collection in the form of capital start-up costs ($8,750,000)
and mailing costs ($1,100,929) amounts to $9,850,929.
IV. Request for Comments
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden
(including hours and cost) of the proposed collection of information;
(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, including through the use of
automated collection techniques or other forms of information
technology.
Comments submitted in response to this notice will be summarized or
included in the request for OMB approval of this information
collection; they will also become a matter of public record.
Dated: October 19, 2006.
Susan K. Brown,
Records Officer, USPTO, Office of the Chief Information Officer,
Architecture, Engineering and Technical Services, Data Architecture and
Services Division.
[FR Doc. E6-17855 Filed 10-24-06; 8:45 am]
BILLING CODE 3510-16-P
