Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices 29559 

mechanisms that are designed to yield 

quantitative results. 

The Agency received no comments in 

response to the 60-day notice published 

in the Federal Register on March 23, 

2018 (vol. 83, No. 57, pages 12766– 

12768). 

This is a Revision information 

collection request. The burden hours 

have decreased from the previous 

submission by 6,250 hours. This 

decrease accounts for the hours that 

were unused as well as the planned 

efforts within the Institute during the 

next three years. NIOSH is also planning 

on discontinuing 0920–0940 (expiration 

3/31/2018) which accounts for service 

delivery data collections within 

NIOSH’s Health Hazard Evaluation 

program. The current submission will 

account for all service delivery data 

collections within NIOSH. 

During the past three years the 

information has been used by programs 

within NIOSH to collect feedback from 

customers and stakeholders. 

Respondents will be screened and 

selected from Individuals and 

Households, Businesses, Organizations, 

and/or State, Local or Tribal 

Government. Below we provide 

NIOSH’s projected annualized estimate 

for the next three years. There is no cost 

to respondents other than their time. 

The estimated annualized burden hours 

for this data collection activity are 

13,075. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Individuals and Households, Businesses, Organizations ....... Print Surveys ......................... 50,000 1 15/60 

Focus Groups ........................ 100 1 2 

Online Surveys ...................... 1,500 1 15/60 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–13544 Filed 6–22–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice; Children’s Bureau Proposed 

Research Priorities for Fiscal Years 

2018–2020 

AGENCY: Administration on Children, 

Youth and Families (ACYF), 

Administration for Children and 

Families (ACF), HHS. 

ACTION: Notice of proposed priorities; 

request for comments. 

SUMMARY: The Children’s Bureau (CB) 

within the Administration on Children, 

Youth and Families (ACYF) announces 

the proposed priorities for research on 

the causes, prevention, assessment, 

identification, treatment, cultural and 

socio-economic distinctions, and the 

consequences of child abuse and 

neglect, and solicits comments 

regarding the prioritization. 

DATES: In order to be considered, 

comments must be received no later 

than August 24, 2018. 

ADDRESSES: You may send comments, 

identified by the RIN or dockets number 

in the subject line, by email: 

CBComments@acf.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: Dori 

Sneddon, 202–205–8024, 

Dori.Sneddon@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

104(a)(4) of the Child Abuse Prevention 

and Treatment Act (CAPTA), as 

amended by the CAPTA 

Reauthorization Act of 2010, Public Law 

(Pub. L.) 111–320, requires the Secretary 

of the Department of Health and Human 

Services (HHS) to establish proposed 

priorities for research activities, provide 

an opportunity for public comment on 

those proposed activities, and maintain 

an official record of received public 

comment concerning the priorities. The 

proposed priorities are being announced 

for the 2-year period required by 

CAPTA. Because the amount of federal 

funds available for discretionary 

activities in fiscal years (FY) 2018–2020 

is expected to be limited, respondents 

are encouraged to recommend how the 

proposed issues should be prioritized. 

The actual solicitation of grant 

applications will be posted 

electronically each fiscal year and will 

be available online through http://

www.Grants.gov. Solicitations for 

contracts will be announced at later 

dates, online at FedBizOps. No 

proposals, concept papers, or other 

forms of application should be 

submitted at this time. 

No acknowledgement will be made of 

the comments submitted in response to 

this notice, but all comments received 

by the deadline will be reviewed and 

given thoughtful consideration in the 

preparation of the final funding 

priorities for the announcements. 

I. Background 

As noted above, section 104(a)(4) of 

CAPTA requires the Secretary to 

publish proposed priorities for research 

activities for public comment every 2 

years. In response to this legislative 

mandate, CB has undertaken a review of 

the current legislative language, the 

results of the CAPTA-funded research 

since the last CAPTA announcement of 

research priority areas, findings from 

other relevant research, and input from 

the field. Based on this review, this 

notice of proposed research is being 

disseminated for comment. The FY 2018 

President’s Budget requested 

$32,937,267 for child abuse 

discretionary activities to support efforts 

designed to assist and enhance national, 

state, and local efforts to prevent, 

identify, and treat child abuse and 

neglect. The program funds projects to 

compile, publish, and disseminate 

training materials; provide technical 

assistance; and demonstrate and 

evaluate improved methods and 

procedures to prevent and treat child 

abuse and neglect. Under discretionary 

funds, CB will continue to fund the 

following clearinghouse and technical 

assistance activities: 

• The Child Welfare Information 

Gateway; 

• Family Resource Information, 

Education, and Network Development 

Service (FRIENDS); and 

• National Child Abuse and Neglect 

Data System (NCANDS) technical 

assistance and technical support 

program. 

In addition, the child abuse 

discretionary activities’ account funds a 

number of research and demonstration 


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29560 Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices 

grants and contracts. For those members 

of the public interested in responding to 

this announcement, information on 

previous and continuing projects 

supported by CB are available through 

the following websites: 

• The Child Welfare Information 

Gateway (http://www.childwelfare.gov); 

and 

• Children’s Bureau Reports/ 

Publications (http://www.acf.dhhs.gov/ 

programs/cb/publications/index.htm). 

II. Proposed Child Abuse and Neglect 

Research Priorities for Fiscal Years 

2016–2018 

A. Legislative Topics 

A number of research topics are 

suggested in the 2010 reauthorization of 

CAPTA, section 104 (42 U.S.C. 5105). 

The legislation states that the Secretary 

shall, in consultation with other federal 

agencies and recognized experts in the 

field, carry out a continuing 

interdisciplinary program of research, 

including longitudinal research, that is 

designed to provide information needed 

to better protect children from abuse or 

neglect and to improve the well-being of 

victims of abuse or neglect, with at least 

a portion of such research being field 

initiated. Suggested research includes: 

• The nature and scope of child abuse 

and neglect; 

• The causes, prevention, assessment, 

identification, treatment, cultural and 

socio-economic distinctions, and the 

consequences of child abuse and 

neglect, including the effects of child 

abuse and neglect on a child’s 

development and the identification of 

successful early intervention services or 

other services that are needed; 

• Effective approaches to improving 

the relationship and attachment of 

infants and toddlers who experience 

child abuse or neglect with their parents 

or primary caregivers in circumstances 

where reunification is appropriate; 

• Appropriate, effective, and 

culturally sensitive investigative, 

administrative, and judicial systems, 

including multidisciplinary, 

coordinated decision making 

procedures with respect to cases of 

child abuse and neglect; 

• The evaluation and dissemination 

of best practices, including best 

practices to meet the needs of special 

populations, consistent with the goals of 

achieving improvements in child 

protective services systems of the states 

in accordance with CAPTA, section 

106(a), Grants to States for Child Abuse 

and Neglect Prevention and Treatment 

Programs [42 U.S.C. 5106a], paragraphs 

(1) through (14), which include: 

i. The intake, assessment, screening, 

and investigation of reports of child 

abuse and neglect; 

ii. Creating and improving the use of 

multidisciplinary teams and 

interagency, intra-agency, interstate, and 

intrastate protocols to enhance 

investigation, and improving legal 

preparation and representation; and 

improving legal preparation and 

representation; 

iii. Case management, including 

ongoing case monitoring and delivery of 

services and treatment provided to 

children and their families; 

iv. Enhancing the general child 

protective system by developing, 

improving and implementing risk and 

safety assessment tools and protocols, 

including the use of differential 

response; 

v. Developing and updating systems 

of technology that support the program 

and track reports of child abuse and 

neglect from intake through final 

disposition and allow interstate and 

intrastate information exchange; 

vi. Developing, strengthening and 

facilitating training; 

vii. Improving the skills, 

qualifications, and availability of 

individuals providing services to 

children and families, and the 

supervisors of such individuals, through 

the child protection system, including 

improvements in the recruitment and 

retention of caseworkers; 

viii. Developing, facilitating the use 

of, and implementing research-based 

strategies and training protocols for 

individuals mandated to report child 

abuse or neglect; 

ix. Developing, implementing, or 

operating programs to assist in obtaining 

or coordinating necessary services for 

families of disabled infants with life 

threatening conditions; 

x. Developing and delivering 

information to improve public 

education relating to the role and 

responsibilities of the child protection 

system and the nature and basis for 

reporting suspected incidents of child 

abuse and neglect, including the use of 

differential response; 

xi. Developing and enhancing the 

capacity of community-based programs 

to integrate shared leadership strategies 

between parents and professionals to 

prevent and treat child abuse and 

neglect at the neighborhood level; 

xii. Supporting and enhancing 

interagency collaboration between the 

child protection system and the juvenile 

justice system for improved delivery of 

services and treatment, including 

methods for continuity of treatment 

plans and services as children transition 

between systems; 

xiii. Supporting and enhancing 

interagency collaboration among public 

health agencies, agencies in the child 

protective service system, and agencies 

carrying out private community-based 

programs 

a. To provide child abuse and neglect 

prevention and treatment services 

(including linkages with education 

systems) and the use of differential 

response; and 

b. To address the health needs, 

including mental health needs, of 

children identified as victims of abuse 

or neglect, including supporting 

prompt, comprehensive health and 

developmental evaluations for children 

who are the subject of substantiated 

child maltreatment reports; or 

xiv. Developing and implementing 

procedures for collaboration among 

child protective services, domestic 

violence services, and other agencies in 

a. Investigations, interventions, and 

the delivery of services and treatment 

provided to children and families, 

including the use of differential 

response, where appropriate; and 

b. The provision of services that assist 

children exposed to domestic violence, 

and that also support the caregiving role 

of their non-abusing parents. 

• Effective approaches to interagency 

collaboration between the child 

protection system and the juvenile 

justice system that improve the delivery 

of services and treatment, including 

methods for continuity of treatment 

plans and services as children transition 

between systems; 

• Effective practices and programs to 

improve activities such as the 

identification, screening, medical 

diagnosis, forensic diagnosis, health 

evaluations, and services, including 

activities to promote collaboration 

between— 

i. The child protective service system; 

and 

ii. (I) The medical community, 

including providers of mental health 

and developmental disability services; 

and 

iii. (II) Providers of early childhood 

intervention services and special 

education for children who have been 

victims of child abuse or neglect; 

• An evaluation of the redundancies 

and gaps in services in the field of child 

abuse and neglect prevention in order to 

make better use of resources; 

• Effective collaborations, between 

the child protective system and 

domestic violence service providers, 

that provide for the safety of children 

exposed to domestic violence and their 

non-abusing parents that improve the 

investigations, interventions, delivery of 


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Federal Register / Vol. 83, No. 122 / Monday, June 25, 2018 / Notices 29561 

services, and treatments provided for 

such children and families; 

• The nature, scope, and practice of 

voluntary relinquishment for foster care 

or State guardianship of low-income 

children who need health services, 

including mental health services. 

• The impact of child abuse and 

neglect on the incidence and 

progression of disabilities; 

• The nature and scope of effective 

practices relating to differential 

response, including future analysis of 

the following: 

i. What is the underlying hypothesis 

about the need to engage a parent and/ 

or family in order to achieve specific 

outcomes in Child Protective Services 

(CPS)? Which specific outcomes need to 

be considered? 

ii. Given that ‘‘engagement’’ may vary 

according to the eyes of the beholder, 

can specific aspects of engagement be 

measured with greater consistency and 

replication, particularly between the 

two groups who are part of the 

relationship? 

iii. How should engagement be 

defined in future studies? 

iv. CPS systems, in general, may be 

providing training to their caseworkers, 

regardless of pathway, to help them 

better relate to families and caregivers. 

If Alternative Response (AR) and 

Investigative Response (IR) caseworkers 

receive the same training and use 

similar engagement practices, should 

one still expect differences in family or 

caseworker perceptions of engagement? 

v. Are there specific micro-practices 

that should be examined in more depth 

to determine if they make a difference 

for parents and families? As examples: 

Does setting an appointment to visit a 

family make a difference in engaging a 

family in early stages of relationship 

building? Does solution-focused 

casework result in parent willingness to 

engage with caseworkers? 

vi. Should all low-risk families 

receive AR? 

vii. Should the threshold for 

providing a family with AR be raised? 

viii. Should CPS caseworkers also 

have the discretion to reassign IR 

families to AR? 

ix. If families are encouraged to build 

relationships with their CPS 

caseworkers and are encouraged to 

contact them in the future, should rereferral still be considered a proxy for 

lack of safety? 

• Child abuse and neglect issues 

facing Indians, Alaska Natives, and 

Native Hawaiians, including providing 

recommendations for improving the 

collection of child abuse and neglect 

data for Indian tribes and Native 

Hawaiian communities; or 

• The information on the national 

incidence of child abuse and neglect 

specified in CAPTA, section 104(a) 

specified in clauses (i) through (x) of 

paragraph (1)(O). 

B. Other Topics 

Prevention Practices: CB is interested 

in research that builds on the existing 

body of knowledge of prevention 

practices, in particular primary 

prevention. This includes research to 

measure the efficacy and effectiveness 

of strategies to serve families across a 

spectrum of risk for child maltreatment, 

and strategies that aim to enhance the 

capacity of communities to address the 

physical, social, and emotional wellbeing of families before the occurrence 

of child abuse or neglect. In addition, 

CB is interested in research that 

examines innovative techniques for the 

assessment and detection of the risk of 

incidences of child abuse and neglect, 

including techniques for the detection 

of household opioid and other 

substance misuse, and interventions 

based on such risk detection which 

mitigate or eliminate the incidence of 

abuse and neglect. 

CB has supported a number of 

research and demonstration projects to 

generate knowledge about effective early 

prevention strategies and interventions. 

Over 5 years, from 2009–2014, CB 

funded the Rigorous Evaluation of 

Existing Child Abuse and Neglect 

Prevention Programs grant programs. 

Through a competitive process, grants 

were made to conduct randomized 

controlled trials (RCTs) of four wellestablished, community-based child 

abuse and neglect prevention programs 

located in three regions across the U.S., 

garnering information on the 

effectiveness of interventions to increase 

child, parent, and family safety and 

well-being. Additionally, CB has funded 

research and demonstration grants to 

support initiatives to prevent 

maltreatment and increase the wellbeing of children and youth, including: 

Infrastructure-building grants between 

child welfare agencies, early education, 

and schools; supportive housing models 

for families; and interventions to 

address child trafficking. While this 

work is contributing to the body of 

knowledge about the type and range of 

early intervention strategies to prevent 

the occurrence of maltreatment, much 

more can and must be learned at the 

individual and population level to build 

the protective capabilities of families 

and communities. 

Research interests may include: The 

development and demonstration of 

research methodologies that allow for 

valid and reliable measurement of 

primary prevention activities and 

assessment of risk for child abuse and 

neglect at the individual, community, 

and population level; the innovative use 

of data, including administrative and 

secondary data, to inform our 

understanding of the implementation 

and outcomes of primary prevention 

strategies; and integrating child abuse 

and neglect research into prevention 

practices and techniques for the 

assessment and detection of risk for 

child abuse and neglect. 

Child Protection Systems: CB is 

interested in research that examines 

effective state-level strategies employed 

to improve child protection systems. 

Questions may include: The degree to 

which changes in CPS systems’ policy 

and practice are tied to better outcomes; 

determining the variations in local 

agencies that result in different 

outcomes; and whether or not child 

safety and well-being are improved by 

privatizing part or all of the child 

welfare system. Other research interests 

may include: Effective responses for 

children at risk of being harmed; 

barriers to consistency in CPS 

operations, such as differences in the 

level of resources; lack of clear laws and 

policy and the competing desire for 

local autonomy in government 

functions; the means by which CPS 

agencies try to understand the standards 

of the community they serve through 

outreach to additional panels and 

review teams (fatality review team, 

citizen review panels, external case 

reviews); and collaborations between 

CPS and other agencies. 

Services: CB is interested in research 

focused on the assessment of service 

needs and services provided. Research 

questions may include: What services 

are children and families receiving; to 

what degree are services responsive to 

the needs of the target population; and 

what are the outcomes that result from 

various services. Other research may 

focus on case planning and 

intervention, such as examining the 

development and implementation of 

comprehensive family assessment, 

safety planning, engaging families and 

monitoring risk assessment over the life 

of CPS cases, and increasing knowledge 

of parent and child engaging in the case 

planning process. In addition, topics of 

interest include services needs of 

families and children who are impacted 

by substance use disorders, trafficking, 

and inadequate housing including 

homelessness. 

The findings from the most recent 

Child and Family Service Reviews 

(CFSR) identify strengths and needs 

within state programs, as well as areas 

where technical assistance can lead to 


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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 


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