Clinical Center; Notice of Meeting, 77471-77472 [2013-30396]

Download as PDF Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices While there may be some instances where AAAHC’s standards differ from other recognized accrediting entities, AAAHC has met the criteria to be recognized by HHS based on our standards in § 156.275(c). We believe there is a sufficient number of measures applicable to children included in the proposed clinical quality metrics and further note that the AAAHC’s measure set is identical to the set used by a different HHS-recognized accrediting entity (that is, URAC). Lastly, the accreditation standards are propriety documents and we have not required any of the recognized accrediting entities to make their standards public. Therefore, we cannot require AAAHC to make their standards public. In addition, we have previously indicated that we may, at a later date, modify the recognition process of accrediting entities and will solicit comments on any proposed future rulemaking that time. IV. Provisions of the Final Notice Upon completion of our analysis, including evaluation of comments received as a result of the proposed notice, we have determined that the AAAHC meets the requirements and criteria described in the July 20, 2012 final rule, titled ‘‘Data Collection To Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans’’ (77 FR 42658) to be recognized as an accrediting entity. This final notice acknowledges the approval of AAAHC’s application. The AAAHC is now recognized by the Secretary of HHS 4 as an accrediting entity for the purposes of QHP certification. V. Collection of Information Requirements tkelley on DSK3SPTVN1PROD with NOTICES This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. Dated: December 17, 2013. Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2013–30522 Filed 12–20–13; 8:45 am] BILLING CODE 4120–01–P 4 Delegated to CCIIO, 76 FR 53903 through 53906 (August 30, 2011). VerDate Mar<15>2010 18:12 Dec 20, 2013 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License for: Convection Enhanced Delivery of a Therapeutic Agent With a Surrogate Tracer for Treating Cancer and Urological Diseases AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404.7, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in: HHS Ref. No E–202–2002/0 ‘‘Method for Convection Enhanced Delivery of Therapeutic Agents’’, U.S. Provisional Patent Application 60/413,673 (filed September 24, 2002; expired), International Patent Application No. PCT/US2003/30155 (filed September 24, 2003; nationalized), U.S. Patent Application 7,371,225, European Patent Application 03756863.1, Australian Patent 2003299140, to Medicenna Therapeutics, Inc. having a principle place of business in 1075 West Georgia St., Vancouver, BC, Canada V6E 3C9. The United States of America is an assignee to the patent rights of these inventions. The contemplated exclusive license may be in a field of use directed to the treatment of cancers and urological disorders that express IL–4 receptor on their cell surface by administering cpIL4–PE38KDEL by convection enhanced deliver along with a Gd-DTPA surrogate tracer. DATES: Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before January 22, 2014 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael Shmilovich, Esq, CLP, Senior Licensing and Patent Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5019; Facsimile: (301) 402–0220; Email: shmilovm@mail.nih.gov. A signed confidential disclosure agreement may be required to receive copies of the patent application assuming it has not already been published under either the publication rules of either the U.S. SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 77471 Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: The invention is a method for monitoring the spatial distribution of therapeutic substances by MRI or CT that have been administered to tissue using convection enhanced delivery, a technique that is the subject of now expired NIH-owned U.S. Patent No. 5,720,720 (HHS Ref. E– 173–1992/0). The tracer is a molecule, detectable by MRI or CT, which functions as a surrogate for the motion of the therapeutic agent through the solid tissue. In other particular embodiments, the tracer is the therapeutic agent conjugated to an imaging moiety. The method of this invention uses non-toxic macromolecular MRI contrast agents such as chelated Gd(III). These macromolecular imaging agents have clearance properties that mimic the pharmacokinetic properties of coadministrated drugs, so as to be useful in quantifying the range and dosage level of therapeutic drugs using MR imaging. The prospective exclusive license will be royalty-bearing and comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 30 days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: December 17, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–30430 Filed 12–20–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Clinical Center; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is E:\FR\FM\23DEN1.SGM 23DEN1 77472 Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices hereby given of a meeting of the NIH Advisory Board for Clinical Research. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended because the premature disclosure of discussion of personnel matters and the discussions would likely to significantly frustrate implementation of recommendations. tkelley on DSK3SPTVN1PROD with NOTICES Name of Committee: NIH Advisory Board for Clinical Research. Date: January 27, 2014. Open: 10:00 a.m. to 1:00 p.m. Agenda: To review the 2014 Clinical Center Strategic and Annual Operating Plan and provide updates on selected organizational initiatives. Place: National Institutes of Health, Building 10, 10 Center Drive, CRC Medical Board Room (4–2551), Bethesda, MD 20892. Closed: 1:00 p.m. to 2:00 p.m. Agenda: To discuss personnel matters. Place: National Institutes of Health, Building 10, 10 Center Drive, CRC Medical Board Room (4–2551), Bethesda, MD 20892. Contact Person: Maureen E Gormley, Executive Secretary, Mark O. Hatfield Clinical Research Center, National Institutes of Health, Building 10, Room 6–2551, Bethesda, MD 20892 (301) 496–2897. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Dated: December 17, 2013. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–30396 Filed 12–20–13; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 18:12 Dec 20, 2013 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory General Medical Sciences Council. The meeting will be open to the public as indicated below, with a short public comment period at the end. Attendance is limited by the space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (http:// videocast.nih.gov/). The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property, such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory General Medical Sciences Council. Date: January 23–24, 2014. Closed: January 23, 2014, 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892. Open: January 24, 2014, 8:30 a.m. to Adjournment. Agenda: For the discussion of program policies and issues, opening remarks, report of the Director, NIGMS, and other business of the Council. Place: National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892. Contact Person: Ann A. Hagan, Ph.D., Associate Director for Extramural Activities, NIGMS, NIH, DHHS, 45 Center Drive, Room 2AN24H, MSC 6200, Bethesda, MD 20892, (301) 594–4499, hagana@nigms.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles, will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page (http:// www.nigms.nih.gov/About/Council/) where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS). Dated: December 17, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–30406 Filed 12–20–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of an Interagency Autism Coordinating Committee (IACC or Committee) meeting. The purpose of the IACC meeting is to discuss and finalize the 2013 IACC Strategic Plan Update and discuss committee business, agency updates and issues related to autism spectrum disorder (ASD) research and services activities. The meeting will be open to the public and will be accessible by webcast and conference call. Name of Committee: Interagency Autism Coordinating Committee (IACC). Type of meeting: Open Meeting. Date: January 14, 2014. Time: 8:30 a.m. to 5:00 p.m. *Eastern Time *Approximate end time. Agenda: To discuss and finalize the 2013 IACC Strategic Plan Update and discuss committee business, updates and issues related to ASD research and services activities. Place: The National Institutes of Health, 31 Center Drive, Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 20892. Webcast Live: http:// videocast.nih.gov/. Conference Call Access: Dial: 888– 769–9402 Access code: 4632869. Cost: The meeting is free and open to the public. E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Pages 77471-77472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30396]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Clinical Center; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is

[[Page 77472]]

hereby given of a meeting of the NIH Advisory Board for Clinical 
Research.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as 
amended because the premature disclosure of discussion of personnel 
matters and the discussions would likely to significantly frustrate 
implementation of recommendations.

    Name of Committee: NIH Advisory Board for Clinical Research.
    Date: January 27, 2014.
    Open: 10:00 a.m. to 1:00 p.m.
    Agenda: To review the 2014 Clinical Center Strategic and Annual 
Operating Plan and provide updates on selected organizational 
initiatives.
    Place: National Institutes of Health, Building 10, 10 Center 
Drive, CRC Medical Board Room (4-2551), Bethesda, MD 20892.
    Closed: 1:00 p.m. to 2:00 p.m.
    Agenda: To discuss personnel matters.
    Place: National Institutes of Health, Building 10, 10 Center 
Drive, CRC Medical Board Room (4-2551), Bethesda, MD 20892.
    Contact Person: Maureen E Gormley, Executive Secretary, Mark O. 
Hatfield Clinical Research Center, National Institutes of Health, 
Building 10, Room 6-2551, Bethesda, MD 20892 (301) 496-2897.
    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.

    Dated: December 17, 2013.
 Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-30396 Filed 12-20-13; 8:45 am]
BILLING CODE 4140-01-P