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. 

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. 

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 

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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices 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 

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 

AGENCY: Coast Guard, DHS. 

ACTION: Sixty-day notice requesting 

comments. 

SUMMARY: 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 http://www.regulations.gov. 

See the ‘‘Public participation and 

request for comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

A copy of the ICR is available through 

the docket on the internet at http://

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 http://

www.regulations.gov. If your material 

cannot be submitted using http://

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 

http://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 http://

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. 


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