Grant of Interim Extension of the Term of U.S. Patent No. 5,593,823; INTERCEPT® Blood System for Plasma, 2821-2822 [2014-00723]

Download as PDF ehiers on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Notices 3. Discussion of Public Hearing Draft Amendment 28—Red Snapper Allocation Analysis 4. Report of the Ad Hoc Red Snapper IFQ Advisory Panel 5. Discussion of Amendment 39— Recreational Red Snapper Regional Management 6. Discussion of Amendment 40 Options Paper—Sector Separation 7. Discussion on Final Action of Framework Action to Rescind Amendment 30B Permit Conditions 8. Discussion of Standing and Reef Fish Scientific and Statistical Committee Report 9. Discussion on Exempted Fishing Permits Related to Reef Fish —Recess— Immediately following recess will be the Informal Question & Answer Session on Gulf of Mexico fishery management issues. Mackerel Management Committee, Wednesday, February 5, 8:30 a.m. until 11 a.m. 1. Final Action on CMP Amendment 20B Boundaries and Transit Provisions 2. Discussion of Options Paper for 2014 Joint Framework Action to Modify Spanish Mackerel ACL/ACT 3. Discussion of Purpose and Timing of Scoping Document for CMP Amendment 24—Reallocation of Gulf King Mackerel and Atlantic Spanish Mackerel 4. Discussion of Purpose and Timing of Scoping Document for CMP Amendment 26—Split Permits between the Gulf and South Atlantic for Spanish and King Mackerel Gulf SEDAR Committee, Wednesday, February 5, 2014, 11 a.m. until 12 noon 1. Update on SEDAR 33: Gulf of Mexico Gag and Greater Amberjack 2. Update on SEDAR 38: Gulf of Mexico and South Atlantic King Mackerel 3. Update on SEDAR Steering Committee 4. Review of SEDAR Schedule Council Session Agenda, Wednesday, February 5, 2014, 1:30 p.m. until 5:30 p.m. 1:30 p.m.–1:45 p.m.: Call to Order and Introductions, Adoption of Agenda and Approval of Minutes. 1:45 p.m.–4:30 p.m.: The Council will receive public testimony on Final Action—Mackerel Amendments 20B— Boundaries and Transit Provisions and on Final Action—Framework Action to Rescind Amendment 30B Permit Conditions. The Council will also hold an open public comment period regarding any other fishery issues or concerns. People wishing to speak before the Council should complete a public comment card prior to the comment period. VerDate Mar<15>2010 14:55 Jan 15, 2014 Jkt 232001 4:30 p.m.–4:45 p.m.: The Council will review and vote on Exempted Fishing Permits (EFP), if any. 4:45 p.m.–5:15 p.m.: The Council will receive a committee report from the Outreach and Education Management Committee. 5:15 p.m.–5:30 p.m.: The Council will receive a committee report from the Shrimp Management Committee. Council Session Agenda, Thursday, February 6, 2014, 8:30 a.m. until 4:30 p.m. 8:30 a.m.–11:30 a.m.: The Council will receive a committee report from the Reef Fish Management Committee. 1 p.m.–1:30 p.m.: The Council will receive a committee report from the Sustainable Fisheries/Ecosystem Management Committee. 1:30 p.m.–2:30 p.m.: The Council will receive a committee report from the Mackerel Management Committee. 2:30 p.m.–3:30 p.m.: The Council will receive a committee report from the Administrative Policy Management Committee. 3:30 p.m.–4 p.m.: The Council will receive a committee report from the Gulf SEDAR Management Committee. 4 p.m.–4:30 p.m.: The Council will review Other Business items: Summary of Electronic Monitoring meeting, MREP Summary, and Discussion on the Reauthorization of the MagnusonStevens Fishery Conservation and Management Act. Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified 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 Council’s intent to take final action to address the emergency. Special Accommodations These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Council Office (see ADDRESSES), at least 5 working days prior to the meeting. Note: The times and sequence specified in this agenda are subject to change. Authority: 16 U.S.C. 1801 et seq. PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 2821 Dated: January 13, 2014. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2014–00736 Filed 1–15–14; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2013–0063] Grant of Interim Extension of the Term of U.S. Patent No. 5,593,823; INTERCEPT® Blood System for Plasma 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. 5,593,823. 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 December 3, 2013, Cerus Corporation, 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. 5,593,823. The patent claims the medical device INTERCEPT® Blood System for Plasma. The application indicates that a Premarket Approval Application (PMA) was submitted to the Food and Drug Administration (FDA) in four modules. The PMA Shell number BM120078 was assigned on December 5, 2012. The first module was received by the FDA on March 1, 2013, the second module was received on June 3, 2013, by the FDA, the third module was received by the FDA on September 3, 2013, and the fourth module was received by the FDA SUMMARY: E:\FR\FM\16JAN1.SGM 16JAN1 2822 Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Notices on November 29, 2013. The medical device is currently undergoing regulatory review before the FDA 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 original expiration date of the patent, January 14, 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. 5,593,823 is granted for a period of one year from the original expiration date of the patent. Dated: January 10, 2014. Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office. [FR Doc. 2014–00723 Filed 1–15–14; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF EDUCATION [Docket No.: ED–2013–ICCD–0139] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Evaluation of a District Wide Implementation of a Professional Learning Community Initiative Department of Education (ED), Institute of Education Sciences/National Center for Education Statistics (IES). ACTION: Notice. AGENCY: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection. DATES: Interested persons are invited to submit comments on or before February 18, 2014. ADDRESSES: Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at https:// www.regulations.gov by selecting Docket ID number ED–2013–ICCD–0139 or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery ehiers on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:55 Jan 15, 2014 Jkt 232001 should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L–OM–2–2E319, Room 2E107, Washington, DC 20202. FOR FURTHER INFORMATION CONTACT: For questions related to collection activities or burden, please call Katrina Ingalls, 703–620–3655 or electronically mail ICDocketMgr@ed.gov. Please do not send comments here. We will ONLY accept comments in this mailbox when the regulations.gov site is not available to the public for any reason. SUPPLEMENTARY INFORMATION: The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public’s reporting burden. It also helps the public understand the Department’s information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records. Title of Collection: Evaluation of a District Wide Implementation of a Professional Learning Community Initiative. OMB Control Number: 1850–NEW. Type of Review: A new information collection. Respondents/Affected Public: Individuals or households. Total Estimated Number of Annual Responses: 403. Total Estimated Number of Annual Burden Hours: 214. Abstract: This study aims to address the need for systematic information about district-wide implementation of professional learning communities PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 (PLCs) as a critical element in improving teacher quality and instruction, thereby contributing to increased student achievement. The study will survey (online) a population of teacher participants in school-based PLCs and interview principals face to face about the context and their perceptions of the initiative, pre- and post-implementation. Data collection from teachers will focus on what the PLCs do, how they operate, and to what extent they produce the outcomes expected of them as framed by six conceptual attributes of PLCs and five specific tasks. Data collection from principals will focus on contextual information about school culture and conditions such as resources that support implementation. Teachers and principals will also provide their reflections on the challenges of implementing PLCs and their suggestions for improvement. The analysis will enable comparisons among PLCs within and across schools. Study findings are expected to inform both theory and practice related to implementation of professional learning communities. Dated: January 10, 2014. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management. [FR Doc. 2014–00685 Filed 1–15–14; 8:45 am] BILLING CODE 4000–01–P DEPARTMENT OF ENERGY Agency Information Collection Extension U.S. Department of Energy. Notice and Request for OMB Review and Comment. AGENCY: ACTION: The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a threeyear extension of its Occupational Radiation Protection Program, OMB Control Number 1910–5105. This information collection request covers information necessary to permit DOE and its contractors to provide management control and oversight over health and safety programs concerning worker exposure to ionizing radiation. The Estimated Number of Total Responses in the previously published request for comments, 34, is incorrect; the correct Estimated Number of Total Responses is 170. SUMMARY: E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2821-2822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00723]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2013-0063]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,593,823; INTERCEPT[supreg] Blood System for Plasma

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. 5,593,823.

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 December 3, 2013, Cerus Corporation, 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. 5,593,823. The patent claims 
the medical device INTERCEPT[supreg] Blood System for Plasma. The 
application indicates that a Premarket Approval Application (PMA) was 
submitted to the Food and Drug Administration (FDA) in four modules. 
The PMA Shell number BM120078 was assigned on December 5, 2012. The 
first module was received by the FDA on March 1, 2013, the second 
module was received on June 3, 2013, by the FDA, the third module was 
received by the FDA on September 3, 2013, and the fourth module was 
received by the FDA

[[Page 2822]]

on November 29, 2013. The medical device is currently undergoing 
regulatory review before the FDA 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 original expiration date of the patent, January 14, 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. 5,593,823 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: January 10, 2014.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2014-00723 Filed 1-15-14; 8:45 am]
BILLING CODE 3510-16-P
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