80 FR 16389 - Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis C Virus Infection
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 59 (March 27, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 59 (March 27, 2015)
| Page Range | 16389-16390 | |
| FR Document | 2015-06974 |
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)] [Notices] [Pages 16389-16390] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16389
corporations: 15.15 hours; investment Federal Reserve uses the data collected United States of America, as represented
Edge and agreement corporations: 9.60 on the FR 2886b to identify present and by the Secretary, Department of Health
hours. potential problems and monitor and and Human Services who has delegated
Number of respondents: Banking Edge develop a better understanding of authority for the licensing of inventions
and agreement corporations (quarterly): activities within the industry. to the National Institutes of Health or (b)
7; banking Edge and agreement Current Actions: The Federal Reserve been exclusively licensed to the
corporations (annual): 1; investment proposes to add questions regarding National Institutes of Health.
Edge and agreement corporations confidential treatment in the form of The prospective exclusive license
(quarterly): 20; investment Edge and check boxes to all of the reports listed territory may be ‘‘worldwide’’, and the
agreement corporations (annual): 19. above so institutions may indicate field of use may be limited to the
General description of report: This whether they are requesting confidential following: ‘‘Prevention and treatment of
information is mandatory (12 U.S.C. treatment for any portion of the data Hepatitis C Virus infection.’’
602, 625). In addition, with respect to provided, and whether they are DATES: Only written comments and/or
the contact information collected in the submitting a formal justification with applications for a license which are
Patriot Act Contact Information section, the data or separately. The proposed received by the NIH Office of
the Board’s regulation’s (12 CFR part revision would enhance existing Technology Transfer on or before April
211.5(m)) instruct Edge and agreement processes related to the handling of data 13, 2015 will be considered.
corporations to comply with the confidentiality requests. The questions ADDRESSES: Requests for copies of the
information sharing regulations that the regarding confidential treatment in the patent application, inquiries, comments,
Department of the Treasury issued form of check boxes would be effective and other materials relating to the
pursuant to Section 314(a) of the USA June 30, 2015. contemplated exclusive license should
Patriot Act of 2001, Public Law 107–56, Board of Governors of the Federal Reserve be directed to: Kevin W. Chang, Ph.D.,
115 Stat. 307 (31 U.S.C. 5318(h)); and System, March 24, 2015.
implemented at 31 CFR part Senior Licensing and Patenting
Robert deV. Frierson, Manager, Office of Technology Transfer,
1010.520(b).
For Edge corporations engaged in Secretary of the Board. National Institutes of Health, 6011
banking, current Schedules RC–M (with [FR Doc. 2015–07067 Filed 3–26–15; 8:45 am] Executive Boulevard, Suite 325,
the exception of item 3) and RC–V are BILLING CODE 6210–01–P Rockville, MD 20852–3804; Telephone:
held confidential pursuant to Section (301) 435–5018; Facsimile: (301) 402–
(b)(4) of FOIA (5 U.S.C. 552(b)(4)). For 0220; Email: changke@mail.nih.gov.
investment Edge corporations, only DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: The
information collected on Schedule RC– HUMAN SERVICES subject technologies are small molecule
M (with the exception of item 3) are compounds for the treatment of HCV
given confidential treatment pursuant to National Institutes of Health infection identified using a novel cell-
Section (b)(4) of FOIA (5 U.S.C. based high throughput assay. Some of
Prospective Grant of Exclusive these compounds are derivatives of
552(b)(4)).
In addition, the information provided License: Small Molecule Therapeutics chlorcyclizine that show potent
in the Patriot Act Contact Information Against Hepatitis C Virus Infection antiviral properties against HCV.
section may be withheld as confidential AGENCY: National Institutes of Health, Chlorcyclizine is already on the market
under FOIA to prevent unauthorized HHS. for the treatment of allergic reactions,
individuals from falsely posing as an ACTION: Notice. have been used extensively in humans,
institution’s point-of-contact in order to and have excellent safety profiles with
gain access to the highly sensitive and SUMMARY: This is notice, in accordance known pharmaceutical properties. The
confidential communications sent by with 35 U.S.C. 209 and 37 CFR part 404, other compounds are also heterocyclic
email between the Financial Crimes that the National Institutes of Health, compounds that show anti-HCV
Enforcement Network or federal law Department of Health and Human activity. The subject technologies can
enforcement officials and the Patriot Act Services, is contemplating the grant of a potentially be used in combination with
point-of-contact. The identity and start-up exclusive commercial patent each other and/or with other HCV
contact information of private license agreement to practice the therapeutics.
individuals, which is collected and inventions embodied in U.S. provisional The prospective start-up exclusive
maintained for law enforcement patent application no. 61/909,414 (NIH commercial patent license will be
purposes under the Patriot Act, may be Ref. No. E–011–2014/0–US–01) filed royalty bearing and will comply with
exempt from disclosure pursuant to November 27, 2013; International PCT the terms and conditions of 35 U.S.C.
exemption 7(C) of FOIA (5 U.S.C. application no. PCT/US2014/066680 209 and 37 CFR part 404. The
552(b)(7)(C)). Lastly, the language (NIH Ref. No. E–011–2014/0–PCT–02) prospective start-up exclusive
indicating that the Emergency Contact filed November 20, 2014; Taiwanese commercial patent license may be
information will not be released to the patent application no. 103141004 (NIH granted unless within fifteen (15) days
public will be removed. Ref. No. E–011–2014/0–TW–03) filed from the date of this published notice,
Abstract: The FR 2886b collects November 26, 2014; and U.S. the NIH receives written evidence and
quarterly financial data from banking provisional patent application no. 62/ argument that establishes that the grant
Edge and agreement corporations and 011,462 (NIH Ref. No. E–161–2014/0– of the license would not be consistent
mstockstill on DSK4VPTVN1PROD with NOTICES
investment (nonbanking) Edge and US–01) filed June 12, 2014; all entitled, with the requirements of 35 U.S.C. 209
agreement corporations. Except for ‘‘Heterocyclic Compounds and Methods and 37 CFR part 404.
examination reports, it provides the of Use Thereof;’’ and all continuing Applications for a license in the field
only financial data available for these applications and foreign counterparts to of use filed in response to this notice
corporations. The Federal Reserve is Virotas Biopharmaceuticals, LLC, a will be treated as objections to the grant
solely responsible for authorizing, company having a place of business in of the contemplated exclusive license.
supervising, and assigning ratings to California. The patent rights in these Comments and objections submitted to
Edge and agreement corporations. The inventions have (a) been assigned to the this notice will not be made available
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![16390 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
for public inspection and, to the extent and Budget, Washington, DC 20503 or CDC will select a sample of
permitted by law, will not be released by fax to (202) 395–5806. Written approximately 150 commercial health
under the Freedom of Information Act, comments should be received within 30 insurance plans in the United States
5 U.S.C. 552. days of this notice. that differ by size and geography, in the
Dated: March 23, 2015. 50 states and the District of Columbia,
Proposed Project
Richard U. Rodriguez,
to complete a web-based survey, the
Health Insurance Plans Research Prevention and Wellness Assessment
Acting Director, Office of Technology Study—New—Office of Health System
Transfer, National Institutes of Health.
Survey. The project team will provide
Collaboration, Office of the Associate information and instructions about the
[FR Doc. 2015–06974 Filed 3–26–15; 8:45 am] Director for Policy, Office of the survey to health plan points of contact
BILLING CODE 4140–01–P Director, Centers for Disease Control in advance. The team will also make
and Prevention (CDC). information and instructions available
DEPARTMENT OF HEALTH AND Background and Brief Description on the Web site, eliminating any
HUMAN SERVICES interactions between the respondent
The CDC Office of the Associate
and the project team, unless a
Director for Policy intends to request
Centers for Disease Control and respondent(s) has questions or concerns
that the Office of Management and
Prevention during completion of the survey.
Budget (OMB) approve a new collection
of information under the Paperwork The Prevention and Wellness
[30Day–15–15CF] Assessment Survey will take
Reduction Act for three years. This data
collection will occur once, and approximately 30 minutes to complete
Agency Forms Undergoing Paperwork
respondents will be surveyed once. per respondent for a total estimated
Reduction Act Review
The Health Insurance Plans Research burden of 75 hours. Key health plan
The Centers for Disease Control and Study will uniquely examine the contacts (e.g., medical directors, nurse
Prevention (CDC) has submitted the prevalence, characteristics, and directors, or other healthcare
following information collection request differences of prevention and wellness professional) will incur burden
to the Office of Management and Budget programs offered by health insurance associated with coordinating the time
(OMB) for review and approval in plans in this critical era of healthcare and identifying a person to take the
accordance with the Paperwork reform. There are no known studies that survey. The burden associated with this
Reduction Act of 1995. The notice for have addressed the prevalence of activity is estimated at 30 minutes per
the proposed information collection is prevention and wellness programs key health plan contact for a maximum
published to obtain comments from the across health plans or explored the of one key contact per health plan (1 key
public and affected agencies. granular details of these programs as contact × 150 health plans = 150 key
Written comments and suggestions this study is intended to do. Not contacts), resulting in a total burden of
from the public and affected agencies conducting this study would be one less 75 hours. In addition, administrative
concerning the proposed collection of step toward increasing healthy years of support staff at select health plans may
information are encouraged. Your life. assist with coordinating
comments should address any of the Furthermore, the Health Insurance communications between key health
following: (a) Evaluate whether the Plans Research Study will address the plan points of contact and America’s
proposed collection of information is priorities and goals of the CDC Office of Health Insurance (AHIP). The estimated
necessary for the proper performance of the Associate Director for Policy, Office administrative support burden is 30
the functions of the agency, including of Health System Collaboration: (a) minutes per health plan, resulting in a
whether the information will have Identify and catalyze policy total burden of 75 hours.
practical utility; (b) Evaluate the opportunities such as the Affordable Following the analysis of survey data,
accuracy of the agencies estimate of the Care Act to enhance healthcare the project team will conduct one-hour
burden of the proposed collection of transformation, (b) advance CDC’s telephone interviews with no more than
information, including the validity of public health-healthcare strategy to nine health plans (1 hour × 9 health
the methodology and assumptions used; improve population health, (c) plans) to gain a better understanding of
(c) Enhance the quality, utility, and strengthen strategic partnerships with lessons learned and best practices
clarity of the information to be healthcare systems and payers, federal associated with the design and
collected; (d) Minimize the burden of and non-federal, and (d) fully leverage implementation of prevention and
the collection of information on those performance measures as a tool to wellness programs by commercial
who are to respond, including through improve the health of individuals across health insurance plans. The project
the use of appropriate automated, health systems and payers. team will use this information to build
electronic, mechanical, or other The results of this study are of great upon the knowledge gained through the
technological collection techniques or interest not only to the CDC Office of survey. For example, there may be
other forms of information technology, the Associate Director for Policy but to differences in how health plans
e.g., permitting electronic submission of other CDC Centers, Institutes, and structure prevention and wellness
responses; and (e) Assess information Offices; and other federal agencies and programs for different employer
collection costs. partners such as the Health Resources accounts based on employer requests.
To request additional information on and Services Administration (HRSA), The estimated burden is one hour per
health plan, resulting in a total burden
mstockstill on DSK4VPTVN1PROD with NOTICES
the proposed project or to obtain a copy the members of the CDC Advisory
of the information collection plan and Committee to the Director, and the CDC of nine hours.
instruments, call (404) 639–7570 or Public Health-Health Care Collaboration Best practices in outreach will be
send an email to omb@cdc.gov. Written Workgroup (federal, state, and local utilized to maximize survey response
comments and/or suggestions regarding public health; public and private rates. Key health plan contacts at non-
the items contained in this notice organizations; healthcare providers; responding health plans will receive
should be directed to the Attention: professional membership associations; follow up by telephone, and one-to-one
CDC Desk Officer, Office of Management and academia representation). assistance will be provided if needed.
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Document Created: 2015-12-18 11:36:46
Document Modified: 2015-12-18 11:36:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 80 FR 16389 |
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