Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer, 29562-29563 [2018-13486]

Download as PDF amozie on DSK3GDR082PROD with NOTICES1 29562 Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices program improvements. CB encourages research on underlying issues in practice areas contributing to poor performance on CFSR outcomes. State performance on identifying, assessing, and addressing children’s mental needs, in particular, was found as an area needing improvement in the CFSRs. Areas of interest for research may include examining CPS procedures for identifying, assessing, and responding to children’s mental health challenges, as well as the prevalence, type, and severity of mental health needs among children identified in state child welfare systems. In addition, findings from the National Survey of Child and Adolescent Well-Being show that high rates of mental health needs among parents, coupled with low rates of identification, assessment, and referral, is a serious issue. CB is interested in research that examines support services to strengthen families, including mental health services to parents and children. Secondary Data Analysis: CB encourages the utilization of existing data sources, particularly the use of service data through the National Child Abuse and Neglect Data System (NCANDS) and other child welfare data available through the National Data Archive on Child Abuse and Neglect. CB is interested in secondary data analyses using NCANDS, focusing on service utilization, recurrence, and perpetrators. Service utilization: While not all states provide complete service data to NCANDS, for those states that do provide complete service data, the following areas could be examined: The services that are provided to Substance Exposed Newborns and their families; services to victims of human trafficking; differences in service patterns that exist between child victims who remain in their homes and those who are removed; and the variations in service patterns within states according to county characteristics. Perpetrators: CB continues to be interested in perpetrators, with the notion that understanding who this group is and what their characteristics are can help to inform more effective intervention and prevention efforts. According to the most recent analysis of NCANDS data, female caregivers between the ages of 18–30 are most often identified as maltreators of children ages birth–3. Further exploration of these phenomena is necessary to identify subgroups within this population of female caregivers, to identify services that mitigate risk to infants and toddlers of young adult parents, and to develop targeted prevention strategies. VerDate Sep<11>2014 17:58 Jun 22, 2018 Jkt 244001 Field Initiated Research on Child Abuse and Neglect The generation of new knowledge for understanding critical issues in child abuse and neglect improves prevention, identification, assessment, and treatment. Research areas to be addressed may be those that will expand the current knowledge base, build on prior research, contribute to practice enhancements, inform policy, improve science, and provide insights into new approaches to the assessment, prevention, intervention, and treatment of child maltreatment (i.e., physical abuse, sexual abuse, emotional maltreatment, or neglect) on any of the topics listed in (A) Legislative Topics, (B) Other Topics, above, or any other child maltreatment topic. In addition to the topics cited above, practitioners and researchers are encouraged to propose other relevant subjects for research topics in child abuse and neglect. Dated: June 19, 2018. Jerry Milner, Acting Commissioner, Administration on Children, Youth and Families. [FR Doc. 2018–13526 Filed 6–22–18; 8:45 am] BILLING CODE 4184–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patent Applications listed in the Summary Information section of this notice to Apexx Oncology, Inc., located in New York, NY. DATES: Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences on or before July 10, 2018 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, National Center for Advancing Translational Sciences, SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 NIH, 9800 Medical Center Drive, Rockville, MD 20850, Phone: 301–217– 9197, Fax: 301–217–5736, or email sury.vepa@nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Intellectual Property 1. International Application No. PCT/ US15/067406 filed on 12/22/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No: E–243–2014/0–PCT–02), and 2. U.S. Provisional Application No. 62/353298 filed on 06/22/2016 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E–189–2016/0–US–01). The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America and the University of North Carolina at Chapel Hill. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Therapeutics for cancers in humans which result from or characterized by the presence of mutant IDH1.’’ The inventions relate to a series of novel compounds that potently and selectively inhibit mIDH1. These compounds reduce 2–HG levels in cell lines in vitro as well as in human cancer cells grown in mouse xenografts in vivo. These compounds show greater than 250-fold selectivity for the mutant enzyme over the wild-type, show favorable in vitro stability (in mouse, rat, dog and human hepatocyte exposure studies), are AMES negative, and exhibit no significant metabolic CYP liabilities. These compounds possess very favorable in vivo rodent pharmacokinetics and bioavailability and are well tolerated in rodents, even when dosed at high levels. Thus, the compounds of the subject inventions can be used individually or in combination to develop new therapies to treat diseases which result from mutant IDH1 activity. The diseases caused by mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, glioma, cholangiocarcinoma and potentially other solid tumors) and selected rare diseases, such as Ollier Disease. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless E:\FR\FM\25JNN1.SGM 25JNN1 Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices within fifteen (15) days from the date of this published notice, the National Center for Advancing Translational Sciences 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. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. Comments and objections submitted 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: June 11, 2018. Christopher P. Austin, Director, Office of the Director, National Center for Advancing Translational Sciences. [FR Doc. 2018–13486 Filed 6–22–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2018–0282] Information Collection Request to Office of Management and Budget; OMB Control Number: 1625–0096 Coast Guard, DHS. Sixty-day notice requesting comments. AGENCY: ACTION: In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625–0096, Report of Oil or Hazardous Substance Discharge and Report of Suspicious Maritime Activity; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below. DATES: Comments must reach the Coast Guard on or before August 24, 2018. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2018–0282] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. See the ‘‘Public participation and request for comments’’ portion of the SUPPLEMENTARY INFORMATION section for amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:58 Jun 22, 2018 Jkt 244001 further instructions on submitting comments. A copy of the ICR is available through the docket on the internet at https:// www.regulations.gov. Additionally, copies are available from: Commandant (CG–612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710, Washington, DC 20593–7710. FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of Information Management, telephone 202–475–3532, or fax 202–372–8405, for questions on these documents. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection’s purpose, the Collection’s likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period. We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG–2018–0282], and must be received by August 24, 2018. Submitting Comments We encourage you to submit comments through the Federal eRulemaking Portal at https:// www.regulations.gov. If your material PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 29563 cannot be submitted using https:// www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website’s instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted. We accept anonymous comments. All comments received will be posted without change to https:// www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086). Information Collection Request Title: Report of Oil or Hazardous Substance Discharge and Report of Suspicious Maritime Activity. OMB Control Number: 1625–0096. Summary:Any discharge of oil or a hazardous substance must be reported to the National Response Center (NRC) so that the pre-designated on-scene coordinator can be informed and appropriate spill mitigation action carried out. The NRC also receives suspicious activity reports from the public and disseminates this information to appropriate entities. Need: Titles 33 CFR 153.203, 40 CFR 263.30 and 264.56, and 49 CFR 171.15 mandate that the NRC be the central place for the public to report all pollution spills. Title 33 CFR 101.305 mandates that owners or operators of those vessels or facilities required to have security plans, report activities that may result in a Transportation Security Incident (TSI) or breaches of security to the NRC. Voluntary reports are also accepted. Forms: None. Respondents: Persons-in-charge of a vessel or onshore/offshore facility; owners or operators of vessels or facilities required to have security plans; and the public. Frequency: On occasion. Hour Burden Estimate: The estimated burden has decreased from 3,144 hours to 1,980 hours a year due to a decrease in the estimated annual number of responses. Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)]
[Notices]
[Pages 29562-29563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Mutant IDH1 
Inhibitors Useful for Treating Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: National Center for Advancing Translational Sciences, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to practice the inventions embodied in the Patent Applications 
listed in the Summary Information section of this notice to Apexx 
Oncology, Inc., located in New York, NY.

DATES: Only written comments and/or applications for a license which 
are received by the National Center for Advancing Translational 
Sciences on or before July 10, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting 
Manager, National Center for Advancing Translational Sciences, NIH, 
9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-217-9197, 
Fax: 301-217-5736, or email [email protected]. A signed Confidential 
Disclosure Agreement may be required to receive copies of the patent 
applications.

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    1. International Application No. PCT/US15/067406 filed on 12/22/
2015 which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' (HHS Ref. No: E-243-2014/0-PCT-02), and
    2. U.S. Provisional Application No. 62/353298 filed on 06/22/2016 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' 
(HHS Ref. No. E-189-2016/0-US-01).
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America 
and the University of North Carolina at Chapel Hill.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Therapeutics for cancers in humans which result 
from or characterized by the presence of mutant IDH1.''
    The inventions relate to a series of novel compounds that potently 
and selectively inhibit mIDH1. These compounds reduce 2-HG levels in 
cell lines in vitro as well as in human cancer cells grown in mouse 
xenografts in vivo. These compounds show greater than 250-fold 
selectivity for the mutant enzyme over the wild-type, show favorable in 
vitro stability (in mouse, rat, dog and human hepatocyte exposure 
studies), are AMES negative, and exhibit no significant metabolic CYP 
liabilities. These compounds possess very favorable in vivo rodent 
pharmacokinetics and bioavailability and are well tolerated in rodents, 
even when dosed at high levels.
    Thus, the compounds of the subject inventions can be used 
individually or in combination to develop new therapies to treat 
diseases which result from mutant IDH1 activity. The diseases caused by 
mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, 
glioma, cholangiocarcinoma and potentially other solid tumors) and 
selected rare diseases, such as Ollier Disease.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless

[[Page 29563]]

within fifteen (15) days from the date of this published notice, the 
National Center for Advancing Translational Sciences 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.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License Agreement. 
Comments and objections submitted 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: June 11, 2018.
Christopher P. Austin,
Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2018-13486 Filed 6-22-18; 8:45 am]
 BILLING CODE 4140-01-P

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