81 FR 64875 - Deposit of Biological Materials
DEPARTMENT OF COMMERCE
United States Patent and Trademark Office Federal Register Volume 81, Issue 183 (September 21, 2016)
United States Patent and Trademark Office
Federal Register Volume 81, Issue 183 (September 21, 2016)
| Page Range | 64875-64877 | |
| FR Document | 2016-22684 |
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)] [Notices] [Pages 64875-64877] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22684] ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE United States Patent and Trademark Office Deposit of Biological Materials ACTION: Notice and request for comment. ----------------------------------------------------------------------- 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 comment on the renewal of a 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 November 21, 2016. 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 Management Division Director, Office of the Chief Information 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 Review.'' SUPPLEMENTARY INFORMATION: I. Abstract This information collection covers both deposits of biological materials and the depositories in which they are stored. While these two topics are related, the information collection requirements for a respondent depositing biological material are not the same as those that must be followed by a respondent seeking approval from the USPTO to store biological materials. These different requirements are addressed in separate sections. Section I.A. deals with the deposit of biological materials and section I.B. deals with the depositories. There are no forms associated with this collection. 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. Once a depositor has deposited biological materials into a recognized depository, occasions may arise necessitating additional communication between the depositor and the USPTO. 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, the depositor must 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. To summarize, the nature of the information collected by the USPTO in association with the deposit of biological materials is that of certifications/statements, as described above, regarding a biological sample deposited at a depository. There is no form 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. A depository seeking recognition from the USPTO to store biological materials must show that 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. USPTO rules are stringent to ensure the competence and quality of depositories. Depositories must submit documentation to the USPTO 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. Once a depository has been recognized by the USPTO, occasions may arise where additional communication between the depository [[Page 64876]] and the USPTO is necessary. For example, a depository must request and obtain written approval from the USPTO to handle additional types of biological materials other than the material originally recognized. Depositories may (on behalf of depositors) submit viability statements for deposits tested at the depository and/or documentation proving the public has been notified about where to obtain samples. To summarize, the nature of the information collected by the USPTO in connection with a respondent seeking approval from the USPTO to store biological materials is that of a written request to the Director of the USPTO containing the information outlined above. There is no form for the request. 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: 901 responses per year. The USPTO estimates that approximately 3% 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: 905 hours. Estimated Total Annual Respondent Cost Burden: $27,0327.55. The USPTO estimates a professional hourly rate of $30 for a senior administrative assistant 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 $65.51 (BLS rate; 23-1011 Lawyers) per hour. Therefore, the USPTO estimates that the respondent cost burden for this collection will be approximately $27,327.55 per year. -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimated time Estimated No. Item for response annual Estimated annual Rate ($/hr) Total costs (minutes) responses burden hours (a) (b) (a) x (b)/60 = e (c) x (d) = (c) (hourly cost burden) -------------------------------------------------------------------------------------------------------------------------------------------------------- 1................................. Deposited Materials.............. 1 hour 900 900 30 27,000 2................................. Depository Approval.............. 5 hours 1 5 65.51 327.55 --------------------------------------------------------------------------------------------------------------------- Total............................................................................ 901 905 ........... 27,327.55 -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimated Total Annual Non-hour Respondent Cost Burden: $2,674,644.45. 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 $2,250,000. 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 of four 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 $6.45, 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 $6.45 per year. ---------------------------------------------------------------------------------------------------------------- Estimated Item No. Item/type of cost annual Amount Totals responses ---------------------------------------------------------------------------------------------------------------- FEES ---------------------------------------------------------------------------------------------------------------- 1................................. Deposited Materials......... 900 $2,500.00 $2,250,000 [[Page 64877]] 2................................. Request for Depository 1 0.00 0.00 Approval. ----------------------------------------------------------------------------- Total Fees.................................................................................. 2,250,000 ---------------------------------------------------------------------------------------------------------------- PACKAGING/POSTAGE COSTS ---------------------------------------------------------------------------------------------------------------- 1................................. Deposited Materials--Federal 900 $119.00 $107,100.00 Express. 1................................. Deposited Materials-- 900 352.82 317,538.00 Packaging Supplies. 2................................. Request for Depository 1 6.45 6.45 Approval. ---------------------------------------------------------------------------------------------------------------- Total Postage/Packaging..................................................................... 424,644.45 ----------------------------------------------------------------------------- Total Annual (Non-Hour) Cost Burden......................................................... 2,674,644.45 ---------------------------------------------------------------------------------------------------------------- The USPTO estimates that the (non-hour) respondent cost burden in the form of mailing costs amounts to $424,644.45. 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 $2,674,644.45. 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 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: September 15, 2016. Marcie Lovett, Records Management Division Director, OCIO United States Patent and Trademark Office. [FR Doc. 2016-22684 Filed 9-20-16; 8:45 am] BILLING CODE 3510-16-P
![Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64875
This information collection request SUPPLEMENTARY INFORMATION: depository or another, the conditions of
may be viewed at reginfo.gov. Follow the test, and that it is a viable or
I. Abstract
the instructions to view Department of acceptable deposit. A viability statement
Commerce collections currently under This information collection covers is not required when a deposit is made
review by OMB. both deposits of biological materials and and accepted under the Budapest
Written comments and the depositories in which they are Treaty.
recommendations for the proposed stored. While these two topics are Once a depositor has deposited
information collection should be sent related, the information collection biological materials into a recognized
within 30 days of publication of this requirements for a respondent depository, occasions may arise
notice to OIRA_Submission@ depositing biological material are not necessitating additional communication
omb.eop.gov or fax to (202) 395–5806. the same as those that must be followed between the depositor and the USPTO.
by a respondent seeking approval from For example, depositors may be
Dated: September 15, 2016.
the USPTO to store biological materials. required to submit verification
Sarah Brabson, These different requirements are statements for biological materials
NOAA PRA Clearance Officer. addressed in separate sections. Section deposited after the effective filing date
[FR Doc. 2016–22648 Filed 9–20–16; 8:45 am] I.A. deals with the deposit of biological of a patent application or written
BILLING CODE 3510–22–P materials and section I.B. deals with the notification that an acceptable deposit
depositories. There are no forms will be made.
associated with this collection. Occasionally a deposit may be lost,
DEPARTMENT OF COMMERCE contaminated, or otherwise is not able
A. Deposits of Biological Materials
to self-replicate, and a replacement or
United States Patent and Trademark The deposit of biological materials as supplemental deposit needs to be made.
Office part of a patent application is In that event, the depositor must submit
authorized by 35 U.S.C. 2(b)(2). The a written notification to the USPTO
Deposit of Biological Materials term ‘‘biological material’’ is defined in concerning the particulars of the
37 CFR 1.801 as including material that situation and request a certificate of
ACTION: Notice and request for comment.
is capable of self-replication, either correction by the USPTO authorizing
SUMMARY: The United States Patent and directly or indirectly. When an the replacement or supplemental
Trademark Office (USPTO), as part of its invention involves a biological material, deposit.
continuing effort to reduce paperwork sometimes words and figures are not To summarize, the nature of the
and respondent burden, invites the sufficient to satisfy the statutory information collected by the USPTO in
general public and other Federal requirement for patentability under 35 association with the deposit of
agencies to comment on the renewal of U.S.C. 112 (every patent must contain a biological materials is that of
a continuing information collection, as description of the invention sufficient to certifications/statements, as described
required by the Paperwork Reduction enable a person (knowledgeable in the above, regarding a biological sample
Act of 1995, Public Law 104–13 (44 relevant science), to make and use the deposited at a depository. There is no
U.S.C. 3506(c)(2)(A)). invention as specified by 35 U.S.C. 112). form associated with the information
In such cases, the required biological collected by the USPTO in connection
DATES: Written comments must be
material must either be: (1) Known and with the deposit of biological materials.
submitted on or before November 21,
readily available (neither condition
2016. B. Depositories
alone is sufficient) or (2) deposited in a
ADDRESSES: You may submit comments suitable depository that has been Institutions that wish to be recognized
by any of the following methods: recognized as an International by the USPTO as a suitable depository
• Email: InformationCollection@ Depositary Authority (IDA) established to receive deposits for patent purposes
uspto.gov. Include ‘‘0651–0022 under the Budapest Treaty, or a are required by 37 CFR 1.803 to make
comment’’ in the subject line of the depository recognized by the USPTO to a request demonstrating that they are
message. meet the requirements of 35 U.S.C. 112. qualified to store and test the biological
• Federal Rulemaking Portal: http:// Under the authority of 35 U.S.C. 2(b)(2), materials submitted to them under
www.regulations.gov. the deposit rules (37 CFR 1.801–1.809) patent applications. A depository
• Mail: Marcie Lovett, Records set forth examining procedures and seeking recognition from the USPTO to
Management Division Director, Office of conditions of deposit which must be store biological materials must show
the Chief Information Officer, United satisfied in the event a deposit is that internal practices (both technical
States Patent and Trademark Office, required. The rules do not address the and administrative) and the technical
P.O. Box 1450, Alexandria, VA 22313– substantive issue of whether a deposit is ability of the staff and the facility are
1450. required under any particular set of sufficient to protect the integrity of the
FOR FURTHER INFORMATION CONTACT: facts. biological materials being stored.
Requests for additional information In cases where a deposit is necessary, USPTO rules are stringent to ensure
should be directed to Raul Tamayo, the USPTO collects information to the competence and quality of
Senior Legal Advisor, Office of Patent determine whether the depositor is in depositories. Depositories must submit
Legal Administration, United States compliance with the deposit rules. This documentation to the USPTO that
Patent and Trademark Office, P.O. Box includes statements proving notification verifies that their practices and
1450, Alexandria, VA 22313–1450; by to the interested public on where to procedures, the technical competence of
mstockstill on DSK3G9T082PROD with NOTICES
telephone at 571–272–7728; or by email obtain samples of the deposits and their staff, and their facilities fulfill the
to Raul.Tamayo@uspto.gov with ‘‘0651– confirming that all restriction on access stringent requirements spelled out
0022 comment’’ in the subject line. to the deposit will be irrevocably under the rules.
Additional information about this removed upon issuance of the patent. A Once a depository has been
collection is also available at http:// viability statement also must be recognized by the USPTO, occasions
www.reginfo.gov under ‘‘Information submitted to the USPTO showing that may arise where additional
Collection Review.’’ the biological material was tested by the communication between the depository
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![Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64877
Estimated
Item No. Item/type of cost annual Amount Totals
responses
2 ........................ Request for Depository Approval ................................................................. 1 0.00 0.00
Total Fees ..................................................................................................................................................................................... 2,250,000
PACKAGING/POSTAGE COSTS
1 ........................ Deposited Materials—Federal Express ........................................................ 900 $119.00 $107,100.00
1 ........................ Deposited Materials—Packaging Supplies ................................................... 900 352.82 317,538.00
2 ........................ Request for Depository Approval ................................................................. 1 6.45 6.45
Total Postage/Packaging .............................................................................................................................................................. 424,644.45
Total Annual (Non-Hour) Cost Burden ......................................................................................................................................... 2,674,644.45
The USPTO estimates that the (non- PATENT AND TRADEMARK OFFICE DEPARTMENT OF COMMERCE
hour) respondent cost burden in the
form of mailing costs amounts to Submission for OMB Review; United States Patent and Trademark
$424,644.45. Comment Request, Pro Bono Survey; Office
Therefore, the USPTO estimates that Correction
Submission for OMB Review;
the total (non-hour) respondent cost AGENCY:United States Patent and Comment Request; Legal Processes
burden for this collection in the form of Trademark Office, Commerce.
capital start-up costs and postage costs The United States Patent and
is $2,674,644.45. ACTION: Notice; correction. Trademark Office (USTPO) will submit
to the Office of Management and Budget
IV. Request for Comments SUMMARY: The United States Patent and (OMB) for clearance the following
Trademark Office published a document proposal for collection of information
Comments submitted in response to under the provisions of the Paperwork
this notice will be summarized and/or in the Federal Register on August 22,
2016, concerning requests for comments Reduction Act (44 U.S.C. Chapter 35).
included in the request for OMB Agency: United States Patent and
approval. All comments will become a on a Pro Bono Survey. The Pro Bono
Survey is used by the Pro Bono Trademark Office, (USPTO).
matter of public record. Title: Legal Processes.
Advisory Council (PBAC) and the
The USPTO is soliciting public OMB Control Number: 0651–0046.
USPTO to provide information to the Form Number(s): None.
comments to: USPTO regarding the current status and Type of Request: Renewal.
(a) Evaluate whether the proposed effectiveness of each region’s pro bono Number of Respondents: 309
collection of information is necessary hub. The document contained an responses per year.
for the proper performance of the incorrect cost burden based on the Average Hours per Response: The
functions of the agency, including estimate of the hourly burden rate. The USPTO estimates that it will take the
whether the information will have hourly rate estimate should use the public from 5 minutes (0.08 hours) to 6
practical utility; (b) Evaluate the Bureau of Labor Statistics hourly wage hours to prepare a single item in this
accuracy of the agency’s estimate of the for lawyers instead of the American collection, including gathering the
burden of the proposed collection of Intellectual Property Law Association necessary information, preparing the
information, including the validity of hourly wage for intellectual property appropriate documents, and submitting
the methodology and assumptions used; lawyers. the information required for this
(c) Enhance the quality, utility, and FOR FURTHER INFORMATION CONTACT: John collection.
clarity of the information to be Burden Hours: 130 hours.
Kirkpatrick, 571–270–3343 or email
collected; and (d) Minimize the burden Cost Burden: $8,479.54. The USPTO
InformationCollection@uspto.gov.
of the collection of information on those expects that the information in this
Include ‘‘Pro Bono Survey’’ in the
who are to respond, including through collection will be prepared by attorneys
subject line of the message.
and former employees at an hourly rate
the use of appropriate automated,
Correction of $65.51. Using these hourly rates, the
electronic, mechanical, or other
USPTO estimates that the total
technological collection techniques or In the Federal Register notice respondent cost burden for this
other forms of information technology, published on August 22, 2016 (81 FR collection will be approximately
e.g., permitting electronic submission of 56612), in the second column, correct $8,479.54 per year.
responses. the ‘‘Cost Burden’’ caption to read: Needs and Uses: The purpose of this
Dated: September 15, 2016. Cost Burden: $10,480.00 collection is to cover information
requirements related to civil actions and
mstockstill on DSK3G9T082PROD with NOTICES
Marcie Lovett, Dated: September 13, 2016.
Records Management Division Director, OCIO
claims involving current and former
Marcie Lovett, employees of the United States Patent
United States Patent and Trademark Office.
Records Management Division Director, and Trademark Office (USPTO). The
[FR Doc. 2016–22684 Filed 9–20–16; 8:45 am]
USPTO Office of the Chief Information rules for these legal processes may be
BILLING CODE 3510–16–P Officer. found under 37 CFR part 104, which
[FR Doc. 2016–22683 Filed 9–20–16; 8:45 am] outlines procedures for service of
BILLING CODE 3510–16–P process, demands for employee
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Document Created: 2016-09-21 01:31:27
Document Modified: 2016-09-21 01:31:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice and request for comment. | |
| Dates | Written comments must be submitted on or before November 21, 2016. | |
| 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 Review.'' | |
| FR Citation | 81 FR 64875 |
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