Grant of Interim Extension of the Term of U.S. Patent No. 5,808,146; fluciclovine (18, 73168-73169 [2015-29887]

Download as PDF 73168 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices to apply. ITA expects to issue the results of this process in April 2016. Legal Authority: The statutory program authority for ITA to conduct the IBP is 15 U.S.C. 4724. ITA has the legal authority to enter into MOAs with show organizers under the provisions of the Mutual Educational and Cultural Exchange Act of 1961 (MECEA), as amended (22 U.S.C.s 2455(f) and 2458(c)). MECEA allows ITA to accept contributions of funds and services from firms for the purposes of furthering its mission. The Office of Management and Budget (OMB) has approved the information collection requirements of the application to this program (0625–0143) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (OMB Control No. 0625–0143). Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number. For further information please contact: Vidya Desai, Acting Director, International Buyer Program (IBP2017@trade.gov). Frank Spector, Acting Director, Trade Promotion Programs. [FR Doc. 2015–29858 Filed 11–23–15; 8:45 am] BILLING CODE P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Pacific Fishery Management Council; Public Meeting National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of a public workshop. AGENCY: The Pacific Fishery Management Council (Council) and the NMFS Northwest and Southwest Fisheries Science Centers (NWFSC and SWFSC, respectively) will hold a public workshop to review and critique its groundfish stock assessment process in 2015. The Groundfish Stock Assessment Process Review Workshop is open to the public. DATES: The Groundfish Stock Assessment Process Review Workshop will commence at 8:30 a.m. PT, Wednesday, December 9, 2015 and continue until 5:30 p.m. or as necessary to complete business for the day. The workshop will reconvene at 8:30 a.m. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:20 Nov 23, 2015 Jkt 238001 PT, Thursday, December 10, 2015 and continue until 5:30 p.m. or as necessary to complete business for the day The Groundfish Stock Assessment Process Review Workshop will be held at Room 203, Fishery Sciences Building (FSH), University of Washington, 1122 NE Boat Street, Seattle, WA 98105. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Mr. John DeVore, Pacific Council; telephone: (503) 820–2413. The purpose of the Groundfish Stock Assessment Process Review Workshop webinar is for participants in the Council’s 2015 stock assessment process to consider the procedures used in 2015 to assess and update groundfish stock abundance and develop recommendations for improving the process for future assessments and future assessment reviews. No management actions will be decided in this workshop. Any recommendations developed at the workshop will be submitted for consideration by the Council at its March 2016 meeting in Sacramento, CA or its April 2016 meeting in Vancouver, WA (see the Council’s Web site at www.pcouncil.org for future Council meeting agendas). Although non-emergency issues not identified in the workshop agenda may come before the workshop participants for discussion, those issues may not be the subject of formal action during this workshop. Formal action at the workshop will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson Stevens Fishery Conservation and Management Act, provided the public has been notified of the workshop participants’ intent to take final action to address the emergency. SUPPLEMENTARY INFORMATION: Special Accommodations This workshop is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820–2425 at least 5 days prior to the workshop date. Dated: November 19, 2015. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2015–29891 Filed 11–23–15; 8:45 am] BILLING CODE 3510–22–P PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 DEPARTMENT OF COMMERCE United States Patent and Trademark Office [Docket No.: PTO–P–2015–0075] Grant of Interim Extension of the Term of U.S. Patent No. 5,808,146; fluciclovine (18F) United States Patent and Trademark Office, Commerce. ACTION: Notice of Interim Patent Term Extension. AGENCY: The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one-year interim extension of the term of U.S. Patent No. 5,808,146. FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 272– 7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313– 1450; by fax marked to her attention at (571) 273–7755; or by email to Mary.Till@uspto.gov. SUMMARY: Section 156 of Title 35, United States Code, 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, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent. On October 22, 2015, Emory University, the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 5,808,146. The patent claims the active ingredient fluciclovine (18F) of the drug product AxuminTM. The application for patent term extension indicates that New Drug Application (NDA) 208054 was submitted to the Food and Drug Administration (FDA) on September 28, 2015. In a letter dated October 8, 2015, FDA acknowledged receipt of NDA 208054 for ‘‘AxuminTM ([F–18] Fluciclovine)’’. Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period SUPPLEMENTARY INFORMATION: E:\FR\FM\24NON1.SGM 24NON1 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices has continued beyond the original expiration date of the patent, November 9, 2015, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate. An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 5,808,146 is granted for a period of one year from the original expiration date of the patent. Dated: November 18, 2015. Robert Bahr, Acting Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office. [FR Doc. 2015–29887 Filed 11–23–15; 8:45 am] BILLING CODE 3510–16–P BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No: CFPB–2015–0051] Agency Information Collection Activities: Comment Request Bureau of Consumer Financial Protection. ACTION: Notice and request for comment. AGENCY: In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) titled, ‘‘Report of Terms of Credit Card Plans (FR 2572)’’. DATES: Written comments are encouraged and must be received on or before January 25, 2016 to be assured of consideration. ADDRESSES: You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods: • Electronic: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552. • Hand Delivery/Courier: Consumer Financial Protection Bureau (Attention: PRA Office), 1275 First Street NE., Washington, DC 20002. Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included. FOR FURTHER INFORMATION CONTACT: Documentation prepared in support of mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:20 Nov 23, 2015 Jkt 238001 this information collection request is available at www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435–9575, or email: PRA@cfpb.gov. Please do not submit comments to this mailbox. SUPPLEMENTARY INFORMATION: Title of Collection: Report of Terms of Credit Card Plans (FR 2572). OMB Control Number: 3170–0001. Type of Review: Extension without change of a currently approved collection. Affected Public: Private Sector. Estimated Number of Respondents: 150. Estimated Total Annual Burden Hours: 75. Abstract: Form FR 2572 collects data on credit card pricing and availability from a sample of at least 150 financial institutions that offer credit cards. The data enable the Consumer Financial Protection Bureau (CFPB or the Bureau) to present information to the public on terms of credit card plans. Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau’s estimate of the burden of the collection of information, including the validity of the methods and the 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, including through the use of automated collection techniques or other forms of information technology. 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. Dated: November 17, 2015. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection. [FR Doc. 2015–29818 Filed 11–23–15; 8:45 am] BILLING CODE 4810–AM–P BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No: CFPB–2015–0048] Agency Information Collection Activities: Comment Request Bureau of Consumer Financial Protection. AGENCY: PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 ACTION: 73169 Notice and request for comment. In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection titled, ‘‘Financial Well-Being National Survey.’’ SUMMARY: Written comments are encouraged and must be received on or before January 25, 2016 to be assured of consideration. ADDRESSES: You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods: • Electronic: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552. • Hand Delivery/Courier: Consumer Financial Protection Bureau (Attention: PRA Office), 1275 First Street NE., Washington, DC 20002. Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included. FOR FURTHER INFORMATION CONTACT: Documentation prepared in support of this information collection request is available at www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435–9575, or email: PRA@cfpb.gov. Please do not submit comments to this mailbox. SUPPLEMENTARY INFORMATION: Title of Collection: Financial WellBeing National Survey. OMB Control Number: 3170–XXXX. Type of Review: New collection (Request for a new OMB control number). Affected Public: Individuals. Estimated Number of Respondents: 6,000. Estimated Total Annual Burden Hours: 2,000. Abstract: Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111–203, the Bureau’s Office of Financial Education is responsible for developing and implementing a strategy to improve the financial literacy of consumers that DATES: E:\FR\FM\24NON1.SGM 24NON1

Agencies

[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73168-73169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29887]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No.: PTO-P-2015-0075]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,808,146; fluciclovine (\18\F)

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of Interim Patent Term Extension.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office has issued an 
order granting interim extension under 35 U.S.C. 156(d)(5) for a one-
year interim extension of the term of U.S. Patent No. 5,808,146.

FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 
272-7755; by mail marked to her attention and addressed to the 
Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, 
Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-
7755; or by email to Mary.Till@uspto.gov.

SUPPLEMENTARY INFORMATION: Section 156 of Title 35, United States Code, 
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, and that the patent may be extended for interim 
periods of up to one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On October 22, 2015, Emory University, the patent owner of record, 
timely filed an application under 35 U.S.C. 156(d)(5) for an interim 
extension of the term of U.S. Patent No. 5,808,146. The patent claims 
the active ingredient fluciclovine (\18\F) of the drug product 
AxuminTM. The application for patent term extension 
indicates that New Drug Application (NDA) 208054 was submitted to the 
Food and Drug Administration (FDA) on September 28, 2015. In a letter 
dated October 8, 2015, FDA acknowledged receipt of NDA 208054 for 
``AxuminTM ([F-18] Fluciclovine)''.
    Review of the patent term extension application indicates that, 
except for permission to market or use the product commercially, the 
subject patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156, and that the patent should be extended for one 
year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory 
review period

[[Page 73169]]

has continued beyond the original expiration date of the patent, 
November 9, 2015, interim extension of the patent term under 35 U.S.C. 
156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 5,808,146 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: November 18, 2015.
Robert Bahr,
Acting Deputy Commissioner for Patent Examination Policy, United States 
Patent and Trademark Office.
[FR Doc. 2015-29887 Filed 11-23-15; 8:45 am]
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