Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162; GRAFAPEXTM
| Published date | 04 October 2021 |
| Citation | 86 FR 54680 |
| Record Number | 2021-21472 |
| Section | Notices |
| Court | Commerce Department,Patent And Trademark Office |
54680
Federal Register / Vol. 86, No. 189 / Monday, October 4, 2021 / Notices
Dated: September 28, 2021.
Alexa Cole,
Director, Office of International Affairs and
Seafood Inspection, National Marine
Fisheries Service.
[FR Doc. 2021–21463 Filed 10–1–21; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Agency Information Collection
Activities; Submission to the Office of
Management and Budget (OMB) for
Review and Approval; Comment
Request; Seafood Inspection and
Certification Requirements
The Department of Commerce will
submit the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995, on or after the date of publication
of this notice. We invite the general
public and other Federal agencies to
comment on proposed, and continuing
information collections, which helps us
assess the impact of our information
collection requirements and minimize
the public’s reporting burden. Public
comments were previously requested
via the Federal Register on May 25,
2021, during a 60-day comment period.
This notice allows for an additional 30
days for public comments.
Agency: National Oceanic &
Atmospheric Administration (NOAA),
Commerce.
Title: Seafood Inspection and
Certification Requirements.
OMB Control Number: 0648–0266.
Form Number(s): 89–800, 89–814, 89–
819.
Type of Request: Regular submission
(extension of a current information
collection).
Number of Respondents: 1,012.
Average Hours per Response: Contract
Completion, 5 minutes; Request for
Service, 5 minutes; Label Approval, 1
hour; Appeals, 30 minutes; HACCP
application new respondents, 60 hours;
HACCP application current
respondents, 40 hours.
Total Annual Burden Hours: 23,089.
Needs and Uses: This request is for
the revision and extension of a current
information collection.
The National Marine Fisheries Service
(NMFS) operates the fee-for-service
Seafood Inspection Program (SIP) under
the authorities of the Agricultural
Marketing Act of 1946, as amended, the
Fish and Wildlife Act of 1956, and the
Reorganization Plan No. 4 of 1970. The
regulations for the SIP are contained in
50 CFR part 260. The SIP offers
inspection, grading and certification
services, including the use of official
grade marks and statements which
indicate that specific products have
been federally inspected. The SIP is the
only Federal entity which establishes
quality grade standards for seafood
marketed in the United States, and is
the competent authority for the United
States for issuing export health and
catch certificates for seafood and certain
other marine ingredients. Qualified
participants are permitted to use SIP’s
official grade marks and statements on
their products to facilitate the domestic
and global trade of fishery products and
other marine ingredients. Participation
in the SIP is open to all segments of the
seafood industry, from harvesters and
growers to retailers. When inspection
service is desired, participants are
required to submit specific information
pertaining to the type of service needed
(§ 260.15). This includes the type of
products to be inspected, the quantity,
the location of the product, and the date
when the inspection is needed.
Customers complete the NOAA Form
89–814 Request for Inspection Services
and submit it to their local inspection
office via email or over the phone. There
are also application requirements (i.e., a
letter from the participant) if there is an
appeal on previous service results
(§ 260.36). Participants requesting
regular inspection services on a
contractual basis submit a contract
using the NOAA Form 89–800
(§ 260.96). Any changes to the contract
require a contract amendment, using the
same form. When export or certain other
forms of certification is desired,
applicants are required to submit
specific information regarding the
consignment and the type of documents
required, including details about the
product, the shipper and the destination
of the consignment, through an online
portal system.
In July 1992, NMFS announced new
inspection services, which were fully
based on guidelines recommended by
the National Academy of Sciences,
known as Hazard Analysis Critical
Control Point (HACCP). The information
collection requirements fall under
§ 260.15 of the regulations. These
guidelines require that a facility’s
quality control system have a written
plan of the operation, identification of
control points with acceptance criteria
and a corrective action plan, as well as
personnel identified with responsibility
for oversight of the system.
Affected Public: Business or other for-
profit organizations; Not-for-profit
institutions; State, Local, or Tribal
government.
Frequency: On occasion.
Respondent’s Obligation: Required to
obtain or maintain benefits.
Legal Authority: 7 U.S.C. 1621 et seq.
This information collection request
may be viewed at www.reginfo.gov.
Follow the instructions to view the
Department of Commerce collections
currently under review by OMB.
Written comments and
recommendations for the proposed
information collection should be
submitted within 30 days of the
publication of this notice on the
following website www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function and
entering either the title of the collection
or the OMB Control Number 0648–0266.
Sheleen Dumas,
Department PRA Clearance Officer, Office of
the Chief Information Officer, Commerce
Department.
[FR Doc. 2021–21503 Filed 10–1–21; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2021–0052]
Grant of Interim Extension of the Term
of U.S. Patent No. 7,199,162;
GRAFAPEX
TM
(dihydroxybusulfan)
AGENCY
: United States Patent and
Trademark Office, Department of
Commerce.
ACTION
: Notice of interim patent term
extension.
SUMMARY
: The United States Patent and
Trademark Office has issued an order
granting a one-year interim extension of
the term of U.S. Patent No. 7,199,162
(‘162 patent).
FOR FURTHER INFORMATION CONTACT
: Raul
Tamayo, Senior Legal Advisor, Office of
Patent Legal Administration, by
telephone at 571–272–7728 or by email
to raul.tamayo@uspto.gov.
SUPPLEMENTARY INFORMATION
: 35 U.S.C.
156 generally provides that the term of
a patent may be extended for a period
of up to five years, if the patent claims
a product, or a method of making or
using a product, that has been subject to
certain defined regulatory review. 35
U.S.C. 156(d)(5) generally provides that
the term of such a patent may be
extended for no more than five interim
periods of up to one year each, if the
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54681
Federal Register / Vol. 86, No. 189 / Monday, October 4, 2021 / Notices
approval phase of the regulatory review
period is reasonably expected to extend
beyond the expiration date of the patent.
On September 23, 2021, Medac
Gesellschaft fur Klinische
Spezialpraparate mbH, the owner of
record of the ‘162 patent, timely filed an
application under 35 U.S.C. 156(d)(5)
for a first interim extension of the term
of the ‘162 patent. The ‘162 patent
claims a method of using the human
drug product known by the tradename
GRAFAPEX
TM
(dihydroxybusulfan).
The application for interim patent term
extension indicates that a regulatory
review period (RRP) as described in 35
U.S.C. 156(g)(1)(B)(ii) began for
GRAFAPEX
TM
(dihydroxybusulfan) and
is ongoing before the Food and Drug
Administration for permission to market
and use the product commercially.
Review of the interim patent term
extension application indicates that,
except for permission to market or use
the product commercially, the ‘162
patent would be eligible for an
extension of the patent term under 35
U.S.C. 156. Because it is apparent that
the RRP will continue beyond the
original expiration date of the ‘162
patent, i.e., October 12, 2021, interim
extension of the patent term under 35
U.S.C. 156(d)(5) is appropriate.
A first interim extension under 35
U.S.C. 156(d)(5) of the term of U.S.
Patent No. 7,199,162 is granted for a
period of one year from the original
expiration date of the ‘162 patent.
Robert Bahr,
Deputy Commissioner for Patents, United
States Patent and Trademark Office.
[FR Doc. 2021–21472 Filed 10–1–21; 8:45 am]
BILLING CODE 3510–16–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2021–0053]
Grant of Interim Extension of the Term
of U.S. Patent No. 6,406,699; ECI
®
(ELIAS Cancer Immunotherapy)
AGENCY
: United States Patent and
Trademark Office, Department of
Commerce.
ACTION
: Notice of interim patent term
extension.
SUMMARY
: The United States Patent and
Trademark Office has issued an order
granting a one-year interim extension of
the term of U.S. Patent No. 6,406,699
(‘699 patent).
FOR FURTHER INFORMATION CONTACT
: Raul
Tamayo, Senior Legal Advisor, Office of
Patent Legal Administration, by
telephone at 571–272–7728 or by email
to raul.tamayo@uspto.gov.
SUPPLEMENTARY INFORMATION
: 35 U.S.C.
156 generally provides that the term of
a patent may be extended for a period
of up to five years, if the patent claims
a product, or a method of making or
using a product, that has been subject to
certain defined regulatory review. 35
U.S.C. 156(d)(5) generally provides that
the term of such a patent may be
extended for no more than five interim
periods of up to one year each, if the
approval phase of the regulatory review
period is reasonably expected to extend
beyond the expiration date of the patent.
On August 25, 2021, TVAX
Biomedical I, LLC, the owner of record
of the ‘699 patent, timely filed an
application under 35 U.S.C. 156(d)(5)
for a third interim extension of the term
of the ‘699 patent. The ‘699 patent
claims a method of using a veterinary
biological product in the cancer
immunotherapy treatment known by the
tradename ECI
®
(ELIAS Cancer
Immunotherapy). The application for
interim patent term extension indicates
that an application for a license for the
veterinary biological product was
submitted under the Virus-Serum-Toxin
Act and is currently undergoing
regulatory review by the United States
Department of Agriculture, Center for
Veterinary Biologics.
Review of the interim patent term
extension application indicates that,
except for permission to market or use
the product commercially, the ‘699
patent would be eligible for an
extension of the patent term under 35
U.S.C. 156. Because it appears the
approval phase of the regulatory review
period will continue beyond the
extended expiration date of the ‘699
patent, i.e., October 5, 2021, further
interim extension of the patent term
under 35 U.S.C. 156(d)(5) is appropriate.
A third interim extension under 35
U.S.C. 156(d)(5) of the term of U.S.
Patent No. 6,406,699 is granted for a
period of one year from the extended
expiration date of the ‘699 patent.
Robert Bahr,
Deputy Commissioner for Patents, United
States Patent and Trademark Office.
[FR Doc. 2021–21471 Filed 10–1–21; 8:45 am]
BILLING CODE 3510–16–P
BUREAU OF CONSUMER FINANCIAL
PROTECTION
Consumer Credit Card Market Report
of the Bureau of Consumer Financial
Protection, 2021
AGENCY
: Bureau of Consumer Financial
Protection.
ACTION
: Consumer Credit Card Market
Report of the Bureau of Consumer
Financial Protection Bureau.
SUMMARY
: The Bureau of Consumer
Financial Protection (Bureau) is issuing
its fifth biennial Consumer Credit Card
Market Report to Congress. The report
reviews developments in this consumer
market since the Bureau’s most recent
biennial report on the same subject in
2019.
DATES
: The Bureau released the 2021
Consumer Credit Card Market Report on
its website on September 29, 2021.
FOR FURTHER INFORMATION CONTACT
: Wei
Zhang, Credit Card Program Manager,
Division of Research, Markets &
Regulations (wei.zhang@cfpb.gov), or
Margaret Seikel, Financial Analyst,
Division of Research, Markets &
Regulations (margaret.seikel@cfpb.gov).
If you require this document in an
alternative electronic format, please
contact CFPB_Accessibility@cfpb.gov.
SUPPLEMENTARY INFORMATION
:
Message From David Uejio, Acting
Director
Credit cards are one of the most
commonly-held and widely-used
financial products in America—over
175 million Americans hold at least one
credit card. During the COVID–19
pandemic, credit cards played a vital
role as both a source of credit in
emergencies and a payment method as
more transactions occurred online.
As the fifth biennial report to
Congress on the credit card market, this
report details how swift actions by both
the public and private sectors likely
impacted how many consumers used
their credit cards and managed their
debts during the pandemic. To address
hardships caused by COVID–19, the
Federal government provided
consumers direct relief by issuing a
series of economic impact payments,
providing enhanced unemployment
benefits, suspending student loan
payments and interest accrual for
federally held loans, offering mortgage
forbearance, and enacting a moratorium
on evictions. At the same time, credit
card issuers provided voluntary relief to
consumers by offering payment deferral
and fee waivers.
Supported by these efforts, this report
finds that the decline in credit card debt
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