Grant of Interim Extension of the Term of U.S. Patent No. 5,496,801; Recombinant Human Parathyroid Hormone, 73279-73280 [2014-28951]

Download as PDF Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices Nominations should be sent to the web address specified below and must be received by January 9, 2015. ADDRESSES: Applications should be submitted electronically to noaa.sab.newmembers@noaa.gov. FOR FURTHER INFORMATION CONTACT: Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA, Rm. 11230, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone: 301– 734–1156, Fax: 301–713–1459, Email: Cynthia.Decker@noaa.gov); or visit the NOAA SAB Web site at https:// www.sab.noaa.gov. DATES: SUPPLEMENTARY INFORMATION: Individuals are sought with expertise in meteorology, operational weather and water forecasting, water resources and climate. Individuals with expertise in the physical sciences, social sciences, and communications in these fields will all be given consideration. Dated: December 5, 2014. Jason Donaldson, Chief Financial Officer, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration. [FR Doc. 2014–28939 Filed 12–9–14; 8:45 am] BILLING CODE 3510–KD–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2014–0065] Grant of Interim Extension of the Term of U.S. Patent No. 5,693,323; Recombinant Humanized Monoclonal Antibody (IgG1, Kappa)-Mepolizumab 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. 5,693,323. 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 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 November 24, 2014, GlaxoSmithKline LLC and SmithKline Beecham Limited timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 5,693,323. The patent claims the human biological product Mepolizumab, a recombinant humanized monoclonal antibody (IgG1, Kappa). The application indicates that a Biologics License Application, BLA 125526, for the human biological product has been filed, and is currently undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially. Review of the 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 it is apparent that the regulatory review period will continue beyond the original expiration date of the patent, December 23, 2014, 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. 5,693,323 is granted for a period of one year from the original expiration date of the patent. Dated: December 5, 2014. Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office. [FR Doc. 2014–28966 Filed 12–9–14; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2014–0067] Grant of Interim Extension of the Term of U.S. Patent No. 5,496,801; Recombinant Human Parathyroid Hormone United States Patent and Trademark Office, Commerce. ACTION: Notice of interim patent term extension. AGENCY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 73279 The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a second one-year interim extension of the term of U.S. Patent No. 5,496,801. SUMMARY: 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. 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 29, 2014, NPS Pharmaceuticals, Inc., timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 5,496,801. The patent claims the human biological product recombinant human parathyroid hormone. The application indicates that Biologics License Application 125511 for the drug product, recombinant human parathyroid hormone, was filed on October 24, 2013, and is currently undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially. Review of the 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 will continue beyond the extended expiration date of the patent, December 23, 2014, 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. 5,496,801 is granted for a period of one year from the extended expiration date of the patent. SUPPLEMENTARY INFORMATION: E:\FR\FM\10DEN1.SGM 10DEN1 73280 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices Dated: December 5, 2014. Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office. [FR Doc. 2014–28951 Filed 12–9–14; 8:45 am] BILLING CODE 3510–16–P CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Revision of Information Collection; Comment Request Corporation for National and Community Service. ACTION: Notice. AGENCY: The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed. Currently, CNCS is soliciting comments concerning proposed revision of its Senior Corps Grant Application (424–NSSC) (OMB Control Number 3045–0035). The Grant Application is used by the Foster Grandparent, Senior Companion, and RSVP programs. CNCS proposes the following modifications to increase both the flexibility and the utility of the Senior Corps Grant Application so that it can serve as the source instructional document for data fields required to complete and submit an application for funding. Currently, the Grant Application contains two types of information needed by applicants: Instructional or ‘‘how-to’’ information and narrative questions and other content. While the instructions rarely change from year to year, the narrative questions and performance measures content can and do change annually, resulting in an ongoing need for Grant Application revisions for the upcoming year or competition. With this proposed change, CNCS will use the Senior Corps Grant Application exclusively to define data fields and describe how to enter the required data and information in each field. The Grant mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 Application will not contain the content questions. The proposed change will be achieved by: (1) Removing and relocating narrative questions and other content materials from the Grant Application to applicable competitive Notices of Funding Opportunity and/or non-competitive Notices of Invitation to Apply for grant funds; (2) Removing performance measures requirements from the Grant Application and referring applicants to the OMB approved Performance Measures Requirements documents for the Senior Corps programs; and (3) replacing all existing Grant Application instructions with step-by-step eGrants instructions correlated to the Grant Application screens in eGrants. With these changes, applicants for Senior Corps grants can use a set of interrelated and readily available documents to complete the Grant Application. The proposed revisions do not change the estimated respondent burden. The proposed revisions do not change the data fields or data collected with the Senior Corps Grant Application. Copies of the information collection request can be obtained by contacting the office listed in the addresses section of this Notice. DATES: Written comments must be submitted to the individual and office listed in the ADDRESSES section by February 9, 2015. ADDRESSES: You may submit comments, identified by the title of the information collection activity, by any of the following methods: (1) By mail sent to: Corporation for National and Community Service, Senior Corps, Attention: Ms. Angela Roberts, Associate Director, 9401; 1201 New York Avenue NW., Washington, DC 20525. (2) By hand delivery or by courier to the CNCS mailroom at Room 8100 at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Monday through Friday, except Federal holidays. (3) By fax to: (202) 606–3475, Attention: Ms. Angela Roberts, Associate Director. (4) Electronically through www.regulations.gov. Individuals who use a telecommunications device for the deaf (TTY–TDD) may call (202) 606– 3472 between 8:30 a.m. and 5:00 p.m. Eastern Time, Monday through Friday. FOR FURTHER INFORMATION CONTACT: Angela Roberts by email at aroberts@cns.gov. SUPPLEMENTARY INFORMATION: CNCS is particularly interested in comments that: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility; • 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; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submissions of responses). Background The Senior Corps Grant Application is completed by applicant organizations interested in sponsoring a Senior Corps program. The grant application is also used by existing grantees to apply for continuation year grants (annual submissions in years two and three of a three year grant). The grant application is completed electronically using the CNCS web-based grants management system, eGrants. Current Action CNCS seeks to revise the current application with modifications. The proposed revisions do not change the estimated respondent burden. The information collection will otherwise be used for the same purpose as the existing application. CNCS also seeks to continue using the current application until the revised application is approved by OMB. The current application is due to expire on September 30, 2015. Type of Review: Revision. Agency: Corporation for National and Community Service. Title: National Senior Service Corps Grant Application. OMB Number: 3045–0035. Agency Number: SF 424–NSSC. Affected Public: Current and prospective sponsors of National Senior Service Corps Grants. Total Respondents: 1,350. Frequency: Annually, with exceptions. Average Time per Response: Estimated at 13.2 hours each. Estimated Total Burden Hours: 17,820 hours. Total Burden Cost (capital/startup): None. E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73279-73280]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28951]


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DEPARTMENT OF COMMERCE

 Patent and Trademark Office

[Docket No. PTO-P-2014-0067]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,496,801; Recombinant Human Parathyroid Hormone

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 second 
one-year interim extension of the term of U.S. Patent No. 5,496,801.

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 29, 2014, NPS Pharmaceuticals, Inc., timely filed an 
application under 35 U.S.C. 156(d)(5) for a second interim extension of 
the term of U.S. Patent No. 5,496,801. The patent claims the human 
biological product recombinant human parathyroid hormone. The 
application indicates that Biologics License Application 125511 for the 
drug product, recombinant human parathyroid hormone, was filed on 
October 24, 2013, and is currently undergoing regulatory review before 
the Food and Drug Administration for permission to market or use the 
product commercially.
    Review of the 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 will continue 
beyond the extended expiration date of the patent, December 23, 2014, 
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. 5,496,801 is granted for a period of one year from the 
extended expiration date of the patent.


[[Page 73280]]


    Dated: December 5, 2014.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2014-28951 Filed 12-9-14; 8:45 am]
BILLING CODE 3510-16-P
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