Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis C Virus Infection, 16389-16390 [2015-06974]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices corporations: 15.15 hours; investment Edge and agreement corporations: 9.60 hours. Number of respondents: Banking Edge and agreement corporations (quarterly): 7; banking Edge and agreement corporations (annual): 1; investment Edge and agreement corporations (quarterly): 20; investment Edge and agreement corporations (annual): 19. General description of report: This information is mandatory (12 U.S.C. 602, 625). In addition, with respect to the contact information collected in the Patriot Act Contact Information section, the Board’s regulation’s (12 CFR part 211.5(m)) instruct Edge and agreement corporations to comply with the information sharing regulations that the Department of the Treasury issued pursuant to Section 314(a) of the USA Patriot Act of 2001, Public Law 107–56, 115 Stat. 307 (31 U.S.C. 5318(h)); and implemented at 31 CFR part 1010.520(b). For Edge corporations engaged in banking, current Schedules RC–M (with the exception of item 3) and RC–V are held confidential pursuant to Section (b)(4) of FOIA (5 U.S.C. 552(b)(4)). For investment Edge corporations, only information collected on Schedule RC– M (with the exception of item 3) are given confidential treatment pursuant to Section (b)(4) of FOIA (5 U.S.C. 552(b)(4)). In addition, the information provided in the Patriot Act Contact Information section may be withheld as confidential under FOIA to prevent unauthorized individuals from falsely posing as an institution’s point-of-contact in order to gain access to the highly sensitive and confidential communications sent by email between the Financial Crimes Enforcement Network or federal law enforcement officials and the Patriot Act point-of-contact. The identity and contact information of private individuals, which is collected and maintained for law enforcement purposes under the Patriot Act, may be exempt from disclosure pursuant to exemption 7(C) of FOIA (5 U.S.C. 552(b)(7)(C)). Lastly, the language indicating that the Emergency Contact information will not be released to the public will be removed. Abstract: The FR 2886b collects quarterly financial data from banking Edge and agreement corporations and investment (nonbanking) Edge and agreement corporations. Except for examination reports, it provides the only financial data available for these corporations. The Federal Reserve is solely responsible for authorizing, supervising, and assigning ratings to Edge and agreement corporations. The VerDate Sep<11>2014 20:59 Mar 26, 2015 Jkt 235001 Federal Reserve uses the data collected on the FR 2886b to identify present and potential problems and monitor and develop a better understanding of activities within the industry. Current Actions: The Federal Reserve proposes to add questions regarding confidential treatment in the form of check boxes to all of the reports listed above so institutions may indicate whether they are requesting confidential treatment for any portion of the data provided, and whether they are submitting a formal justification with the data or separately. The proposed revision would enhance existing processes related to the handling of data confidentiality requests. The questions regarding confidential treatment in the form of check boxes would be effective June 30, 2015. Board of Governors of the Federal Reserve System, March 24, 2015. Robert deV. Frierson, Secretary of the Board. [FR Doc. 2015–07067 Filed 3–26–15; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis C Virus Infection AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive commercial patent license agreement to practice the inventions embodied in U.S. provisional patent application no. 61/909,414 (NIH Ref. No. E–011–2014/0–US–01) filed November 27, 2013; International PCT application no. PCT/US2014/066680 (NIH Ref. No. E–011–2014/0–PCT–02) filed November 20, 2014; Taiwanese patent application no. 103141004 (NIH Ref. No. E–011–2014/0–TW–03) filed November 26, 2014; and U.S. provisional patent application no. 62/ 011,462 (NIH Ref. No. E–161–2014/0– US–01) filed June 12, 2014; all entitled, ‘‘Heterocyclic Compounds and Methods of Use Thereof;’’ and all continuing applications and foreign counterparts to Virotas Biopharmaceuticals, LLC, a company having a place of business in California. The patent rights in these inventions have (a) been assigned to the SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 16389 United States of America, as represented by the Secretary, Department of Health and Human Services who has delegated authority for the licensing of inventions to the National Institutes of Health or (b) been exclusively licensed to the National Institutes of Health. The prospective exclusive license territory may be ‘‘worldwide’’, and the field of use may be limited to the following: ‘‘Prevention and treatment of Hepatitis C Virus infection.’’ DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 13, 2015 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Kevin W. Chang, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5018; Facsimile: (301) 402– 0220; Email: changke@mail.nih.gov. SUPPLEMENTARY INFORMATION: The subject technologies are small molecule compounds for the treatment of HCV infection identified using a novel cellbased high throughput assay. Some of these compounds are derivatives of chlorcyclizine that show potent antiviral properties against HCV. Chlorcyclizine is already on the market for the treatment of allergic reactions, have been used extensively in humans, and have excellent safety profiles with known pharmaceutical properties. The other compounds are also heterocyclic compounds that show anti-HCV activity. The subject technologies can potentially be used in combination with each other and/or with other HCV therapeutics. The prospective start-up exclusive commercial patent license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive commercial patent license may be granted unless within fifteen (15) days from the date of this published notice, the 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 part 404. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available E:\FR\FM\27MRN1.SGM 27MRN1 16390 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 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. and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Dated: March 23, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. Proposed Project Health Insurance Plans Research Study—New—Office of Health System Collaboration, Office of the Associate Director for Policy, Office of the Director, Centers for Disease Control and Prevention (CDC). [FR Doc. 2015–06974 Filed 3–26–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–15–15CF] mstockstill on DSK4VPTVN1PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management VerDate Sep<11>2014 20:59 Mar 26, 2015 Jkt 235001 Background and Brief Description The CDC Office of the Associate Director for Policy intends to request that the Office of Management and Budget (OMB) approve a new collection of information under the Paperwork Reduction Act for three years. This data collection will occur once, and respondents will be surveyed once. The Health Insurance Plans Research Study will uniquely examine the prevalence, characteristics, and differences of prevention and wellness programs offered by health insurance plans in this critical era of healthcare reform. There are no known studies that have addressed the prevalence of prevention and wellness programs across health plans or explored the granular details of these programs as this study is intended to do. Not conducting this study would be one less step toward increasing healthy years of life. Furthermore, the Health Insurance Plans Research Study will address the priorities and goals of the CDC Office of the Associate Director for Policy, Office of Health System Collaboration: (a) Identify and catalyze policy opportunities such as the Affordable Care Act to enhance healthcare transformation, (b) advance CDC’s public health-healthcare strategy to improve population health, (c) strengthen strategic partnerships with healthcare systems and payers, federal and non-federal, and (d) fully leverage performance measures as a tool to improve the health of individuals across health systems and payers. The results of this study are of great interest not only to the CDC Office of the Associate Director for Policy but to other CDC Centers, Institutes, and Offices; and other federal agencies and partners such as the Health Resources and Services Administration (HRSA), the members of the CDC Advisory Committee to the Director, and the CDC Public Health-Health Care Collaboration Workgroup (federal, state, and local public health; public and private organizations; healthcare providers; professional membership associations; and academia representation). PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 CDC will select a sample of approximately 150 commercial health insurance plans in the United States that differ by size and geography, in the 50 states and the District of Columbia, to complete a web-based survey, the Prevention and Wellness Assessment Survey. The project team will provide information and instructions about the survey to health plan points of contact in advance. The team will also make information and instructions available on the Web site, eliminating any interactions between the respondent and the project team, unless a respondent(s) has questions or concerns during completion of the survey. The Prevention and Wellness Assessment Survey will take approximately 30 minutes to complete per respondent for a total estimated burden of 75 hours. Key health plan contacts (e.g., medical directors, nurse directors, or other healthcare professional) will incur burden associated with coordinating the time and identifying a person to take the survey. The burden associated with this activity is estimated at 30 minutes per key health plan contact for a maximum of one key contact per health plan (1 key contact × 150 health plans = 150 key contacts), resulting in a total burden of 75 hours. In addition, administrative support staff at select health plans may assist with coordinating communications between key health plan points of contact and America’s Health Insurance (AHIP). The estimated administrative support burden is 30 minutes per health plan, resulting in a total burden of 75 hours. Following the analysis of survey data, the project team will conduct one-hour telephone interviews with no more than nine health plans (1 hour × 9 health plans) to gain a better understanding of lessons learned and best practices associated with the design and implementation of prevention and wellness programs by commercial health insurance plans. The project team will use this information to build upon the knowledge gained through the survey. For example, there may be differences in how health plans structure prevention and wellness programs for different employer accounts based on employer requests. The estimated burden is one hour per health plan, resulting in a total burden of nine hours. Best practices in outreach will be utilized to maximize survey response rates. Key health plan contacts at nonresponding health plans will receive follow up by telephone, and one-to-one assistance will be provided if needed. E:\FR\FM\27MRN1.SGM 27MRN1

Agencies

[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16389-16390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06974]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Small Molecule 
Therapeutics Against Hepatitis C Virus Infection

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of a start-up exclusive 
commercial patent license agreement to practice the inventions embodied 
in U.S. provisional patent application no. 61/909,414 (NIH Ref. No. E-
011-2014/0-US-01) filed November 27, 2013; International PCT 
application no. PCT/US2014/066680 (NIH Ref. No. E-011-2014/0-PCT-02) 
filed November 20, 2014; Taiwanese patent application no. 103141004 
(NIH Ref. No. E-011-2014/0-TW-03) filed November 26, 2014; and U.S. 
provisional patent application no. 62/011,462 (NIH Ref. No. E-161-2014/
0-US-01) filed June 12, 2014; all entitled, ``Heterocyclic Compounds 
and Methods of Use Thereof;'' and all continuing applications and 
foreign counterparts to Virotas Biopharmaceuticals, LLC, a company 
having a place of business in California. The patent rights in these 
inventions have (a) been assigned to the United States of America, as 
represented by the Secretary, Department of Health and Human Services 
who has delegated authority for the licensing of inventions to the 
National Institutes of Health or (b) been exclusively licensed to the 
National Institutes of Health.
    The prospective exclusive license territory may be ``worldwide'', 
and the field of use may be limited to the following: ``Prevention and 
treatment of Hepatitis C Virus infection.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 13, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Kevin W. Chang, Ph.D., Senior Licensing 
and Patenting Manager, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-5018; Facsimile: (301) 402-0220; 
Email: changke@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The subject technologies are small molecule 
compounds for the treatment of HCV infection identified using a novel 
cell-based high throughput assay. Some of these compounds are 
derivatives of chlorcyclizine that show potent antiviral properties 
against HCV. Chlorcyclizine is already on the market for the treatment 
of allergic reactions, have been used extensively in humans, and have 
excellent safety profiles with known pharmaceutical properties. The 
other compounds are also heterocyclic compounds that show anti-HCV 
activity. The subject technologies can potentially be used in 
combination with each other and/or with other HCV therapeutics.
    The prospective start-up exclusive commercial patent license will 
be royalty bearing and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive 
commercial patent license may be granted unless within fifteen (15) 
days from the date of this published notice, the 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 part 404.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted to 
this notice will not be made available

[[Page 16390]]

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 23, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-06974 Filed 3-26-15; 8:45 am]
 BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.