Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162; GRAFAPEXTM, 54680-54681 [2021-21472]

Download as PDF 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 VerDate Sep<11>2014 22:52 Oct 01, 2021 Jkt 256001 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 forprofit organizations; Not-for-profit PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 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; GRAFAPEXTM (dihydroxybusulfan) United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: 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 SUMMARY: E:\FR\FM\04OCN1.SGM 04OCN1 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 GRAFAPEXTM (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 GRAFAPEXTM (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) United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: VerDate Sep<11>2014 22:52 Oct 01, 2021 Jkt 256001 telephone at 571–272–7728 or by email to raul.tamayo@uspto.gov. BUREAU OF CONSUMER FINANCIAL PROTECTION 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. Consumer Credit Card Market Report of the Bureau of Consumer Financial Protection, 2021 SUPPLEMENTARY INFORMATION: Robert Bahr, Deputy Commissioner for Patents, United States Patent and Trademark Office. 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 SUMMARY: 54681 [FR Doc. 2021–21471 Filed 10–1–21; 8:45 am] BILLING CODE 3510–16–P PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 Bureau of Consumer Financial Protection. ACTION: Consumer Credit Card Market Report of the Bureau of Consumer Financial Protection Bureau. AGENCY: 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: SUMMARY: 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 E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54680-54681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21472]


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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; GRAFAPEXTM (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 [email protected].

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

[[Page 54681]]

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 
GRAFAPEXTM (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 
GRAFAPEXTM (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