Prospective Grant of Exclusive License: Chimeric West Nile/Dengue Viruses, 16505-16506 [2013-05990]

Download as PDF Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices Dickson, Fairfax, Minnesota; each to acquire voting shares of Fort Ridgely National Bancorporation, Inc., and thereby indirectly acquire voting shares of First National Bank of Fairfax, both in Fairfax, Minnesota. Board of Governors of the Federal Reserve System, March 12, 2013. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2013–06006 Filed 3–14–13; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer’s Research, Care, and Services Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. ACTION: Request for Nominations. srobinson on DSK4SPTVN1PROD with NOTICES AGENCY: SUMMARY: HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer’s Research, Care, and Services to fill the position of representative of a voluntary health association as described in Public Law 111–375 (42 U.S.C. 11225). Nominations should include the nominee’s contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume. DATES: Submit nominations by email or FedEx or UPS before COB on April 12, 2013. ADDRESSES: Nominations should be sent to Helen Lamont at helen.lamont@hhs.gov; Helen Lamont, Ph.D., Office of the Assistant Secretary for Planning and Evaluation, Room 424E Humphrey Building, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Helen Lamont (202) 690–7996, helen.lamont@hhs.gov. SUPPLEMENTARY INFORMATION: The Advisory Council on Alzheimer’s Research, Care, and Services meets quarterly to discuss programs that impact people with Alzheimer’s disease and related dementias and their caregivers. The Advisory Council makes recommendations about ways to reduce the financial impact of Alzheimer’s disease and related dementias and to improve the health outcomes of people with these conditions. The Advisory Council provides feedback on the National Plan to Address Alzheimer’s VerDate Mar<14>2013 17:37 Mar 14, 2013 Jkt 229001 Disease. On an annual basis, the Advisory Council shall evaluate the implementation of the recommendations through an updated national plan. The Advisory Council consists of designees from Federal agencies including the Centers for Disease Control and Prevention, Administration on Aging, Centers for Medicare and Medicaid Services, Indian Health Service, Office of the Director of the National Institutes of Health, National Science Foundation, Department of Veterans Affairs, Food and Drug Administration, Agency for Healthcare Research and Quality, and the Surgeon General. The Advisory Council also consists of 12 non-federal members selected by the Secretary who are Alzheimer’s patient advocates (2), Alzheimer’s caregivers (2), health care providers (2), representatives of State health departments (2), researchers with Alzheimer’s-related expertise in basic, translational, clinical, or drug development science (2), and voluntary health association representatives (2). Members serve for overlapping 4 year terms, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member’s term until a successor has taken office. Members serve as Special Government Employees. This announcement is seeking nominations for a ‘‘representative of a voluntary health association’’ who is not a Federal employee. Donald B. Moulds, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2013–06065 Filed 3–14–13; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Prospective Grant of Exclusive License: Chimeric West Nile/Dengue Viruses Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. ACTION: Notice. AGENCY: SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 16505 Services (HHS), is thinking about giving an exclusive license, in the field of use of in vitro diagnostics for dengue virus infection, to practice the inventions listed in the patent applications referred to below to CTK Biotech Inc., having a place of business in San Diego, California. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are: U.S. Provisional Application 61/049,342, filed 4/30/2008, entitled ‘‘Engineered, Chimeric West Nile/Dengue Viruses;’’ PCT Application PCT/US2009/041824, filed 4/27/2009, entitled ‘‘Engineered, Chimeric WN/Flavivirus as Reagents to Enhance Flavivirus Diagnostics and Vaccine Development;’’ U.S. National Stage Application 12/990,322, filed 10/29/2010, entitled ‘‘Chimeric West Nile/Dengue Viruses;’’ and all related continuing and foreign patents/patent applications for the technology family. CDC Technology ID No. I– 020–08. Status: Pending. Priority Date(s): 4/30/2008. The planned exclusive license will bring in royalties and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. Technology HHS/CDC has developed chimeric West Nile/Dengue viruses which express the immunogenic premembrane (prM) and envelope (E) surface proteins of dengue virus (DEN) in the genetic background of a West Nile (WN) virus. The genetic background in the chimeric virus contains the nonstructural genes of the WN virus. Due to the robust replication ability of WN virus, whose nonstructural proteins control replication in the chimeric virus, the WN/DEN virus exhibits much more robust viral replication in cell cultures, compared to the slow growing DEN viruses. The chimeric WN/DEN virus can be used as a substitute for wild-type dengue virus in multiple applications, including diagnostics, vaccine development, vaccine testing, and biological research. These applications are highly important to public health by offering improvements in DEN diagnostics and prevention of DEN viral disease. DATES: Only written comments and/or applications for a license which are received by HHS/CDC on or before April 15, 2013 will be considered. ADDRESSES: Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the planned license should be directed to Donald Prather, J.D., Ph.D., Technology Licensing and Marketing E:\FR\FM\15MRN1.SGM 15MRN1 16506 Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices Specialist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K–79, Atlanta, GA 30341, Telephone: (770) 488–8612; Facsimile: (770) 488–8615; Email: dmprather@cdc.gov. SUPPLEMENTARY INFORMATION: Applications for a license filed in response to this notice will be treated as objections to the giving of the planned 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: March 8, 2013. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2013–05990 Filed 3–14–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval of Florida State Plan Amendments (SPA) 12–015 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of hearing. srobinson on DSK4SPTVN1PROD with NOTICES AGENCY: SUMMARY: This notice announces an administrative hearing to be held on April 30, 2013, at the CMS Atlanta Regional Office, Atlanta Federal Center, 3rd Floor, 61 Forsyth Street SW., Suite 3B52, Atlanta, Georgia 30303–8909, to reconsider CMS’ decision to disapprove Florida SPA 12–015. DATES: Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by (15 days after publication). FOR FURTHER INFORMATION CONTACT: Benjamin Cohen, Presiding Officer, CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244, Telephone: (410) 786–3169. SUPPLEMENTARY INFORMATION: This notice announces an administrative hearing to reconsider CMS’ decision to disapprove Florida SPA 12–015 which was submitted on September 14, 2012, and disapproved on December 13, 2012. The SPA reflects a Florida state law that would limit outpatient hospital emergency room visits to six per fiscal year for non-pregnant adults, 21 years of age and older, effective August 1, 2012. VerDate Mar<14>2013 17:37 Mar 14, 2013 Jkt 229001 CMS disapproved this SPA after consulting with the Secretary as required at 42 CFR 430.15(c)(2), because it appeared to impose a limitation on outpatient hospital services that was based on the individual’s diagnosis, illness, or condition and because the state failed to demonstrate that the limitation is consistent with the provision of a sufficient amount, duration, and scope to reasonably achieve the purpose of the benefit. As a result, CMS concluded that the proposed coverage under the SPA would not be sufficient to meet statutory requirements set forth in section 1902(a)(10)(A) of the Social Security Act (the Act), which incorporates by reference the provisions of 1905(a)(2)(A) of the Act, and 42 CFR 440.20(a)(3)(ii), and the requirements of section 1902(a)(10)(B) of the Act. We explain in more detail below. Under section 1902(a)(10)(A) of the Act, a state plan must provide for making medical assistance available to eligible individuals, including for most eligible individuals the medical assistance specified in section 1905(a)(2) of the Act. This provision includes in the definition of medical assistance ‘‘outpatient hospital services.’’ Section 1902(a)(17) of the Act requires the state plan to include reasonable standards for determining the extent of medical assistance, and under section 1902(a)(19) of the Act, the state plan must assure that eligibility for care and services are provided in the best interest of the recipients. As the implementing regulations at 42 CFR 440.230(b) require, a state plan must ‘‘specify the amount, duration, and scope of each service that it provides,’’ and ‘‘each service must be sufficient in amount, duration, and scope to reasonably achieve its purpose.’’ While states may place ‘‘appropriate limits on a service based such criteria as medical necessity or utilization control procedures’’ under CFR 440.230(d), 42 CFR 440.230(c) specifies that a state may not arbitrarily deny or reduce the amount, duration, or scope of required services, including physicians’ services, solely because of the diagnosis, type of illness, or condition. The proposed limitation on certain outpatient hospital services appeared to be based on the diagnosis, illness, or condition because it is limited to outpatient services furnished at a hospital emergency room, which are designed to address acute and immediate conditions. Thus, the limitation appeared to violate the requirements of 42 CFR 440.230(c). Even if that were not the case, the state has not demonstrated that the limitation PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 is consistent with provision of a sufficient amount, duration, and scope to reasonably achieve the purpose of the benefit, which in this case would be providing reasonable coverage that meets the needs of most beneficiaries who need the outpatient hospital services, consistent with 42 CFR 440.230(b). In disapproving SPA 12–015, CMS staff suggested to the state some alternate methods to address inappropriate utilization of hospital emergency rooms, including the development of payment rates for hospital emergency rooms that are lower if the individual does not require care for an acute and immediate condition, or the use of the alternative cost sharing authority available to states under section 1916(d) of the Act, permitting higher beneficiary cost sharing for elective non-emergency use of the emergency room. CMS offered to work with the state on these options and technical assistance. At issue in this appeal are the following issues, which are more detailed than set out in the disapproval letter: • Whether the exceptions to the proposed general service limitations on outpatient hospital services violate comparability requirements under section 1902(a)(10)(B) of the Act and implementing regulations at 42 CFR 440.230(c) because they provide that some individuals described in section 1902(a)(10)(A) of the Act, who have particular diagnoses or conditions, will receive benefits that individuals with other diagnoses and conditions will not receive. • Whether the imposition of a limit specifically on emergency outpatient hospital visits would violate those comparability requirements because the limitation would be imposed only on outpatient hospital visits that are warranted to address acute and immediate conditions, which means that the limitation is based on the diagnosis or condition. • Whether the exception to the limitation on emergency room visits for ‘‘aliens’’ would violate section 1902(a)(10)(B) of the Act because it would provide that aliens would receive a greater amount, duration and scope of emergency outpatient hospital benefits than other individuals described in section 1902(a)(10)(A) of the Act. • Whether the state has demonstrated that the resulting outpatient hospital benefits are of a sufficient amount, duration and scope to reasonably achieve the purpose of the benefit, consistent with the requirements of sections 1902(a)(10)(A) and 1905(a)(2) of E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16505-16506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Prospective Grant of Exclusive License: Chimeric West Nile/Dengue 
Viruses

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice.

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

SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37 
CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for 
Disease Control and Prevention (CDC), Department of Health and Human 
Services (HHS), is thinking about giving an exclusive license, in the 
field of use of in vitro diagnostics for dengue virus infection, to 
practice the inventions listed in the patent applications referred to 
below to CTK Biotech Inc., having a place of business in San Diego, 
California. The patent rights in these inventions have been assigned to 
the government of the United States of America. The patent 
applications(s) to be licensed are:

    U.S. Provisional Application 61/049,342, filed 4/30/2008, 
entitled ``Engineered, Chimeric West Nile/Dengue Viruses;'' PCT 
Application PCT/US2009/041824, filed 4/27/2009, entitled 
``Engineered, Chimeric WN/Flavivirus as Reagents to Enhance 
Flavivirus Diagnostics and Vaccine Development;'' U.S. National 
Stage Application 12/990,322, filed 10/29/2010, entitled ``Chimeric 
West Nile/Dengue Viruses;'' and all related continuing and foreign 
patents/patent applications for the technology family. CDC 
Technology ID No. I-020-08.

    Status: Pending.
    Priority Date(s): 4/30/2008.
    The planned exclusive license will bring in royalties and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.

Technology

    HHS/CDC has developed chimeric West Nile/Dengue viruses which 
express the immunogenic pre-membrane (prM) and envelope (E) surface 
proteins of dengue virus (DEN) in the genetic background of a West Nile 
(WN) virus. The genetic background in the chimeric virus contains the 
nonstructural genes of the WN virus. Due to the robust replication 
ability of WN virus, whose nonstructural proteins control replication 
in the chimeric virus, the WN/DEN virus exhibits much more robust viral 
replication in cell cultures, compared to the slow growing DEN viruses. 
The chimeric WN/DEN virus can be used as a substitute for wild-type 
dengue virus in multiple applications, including diagnostics, vaccine 
development, vaccine testing, and biological research. These 
applications are highly important to public health by offering 
improvements in DEN diagnostics and prevention of DEN viral disease.

DATES: Only written comments and/or applications for a license which 
are received by HHS/CDC on or before April 15, 2013 will be considered.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comments, and other materials relating to the planned license should be 
directed to Donald Prather, J.D., Ph.D., Technology Licensing and 
Marketing

[[Page 16506]]

Specialist, Technology Transfer Office, Centers for Disease Control and 
Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 
30341, Telephone: (770) 488-8612; Facsimile: (770) 488-8615; Email: 
dmprather@cdc.gov.

SUPPLEMENTARY INFORMATION: Applications for a license filed in response 
to this notice will be treated as objections to the giving of the 
planned 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: March 8, 2013.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2013-05990 Filed 3-14-13; 8:45 am]
BILLING CODE 4163-18-P