II 115th CONGRESS 2d Session S. 3521 IN THE SENATE OF THE UNITED STATES September 27, 2018 Mr. Casey (for himself, Mr. Isakson , and Mr. Brown ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to improve the health of children and help better understand and enhance awareness about unexpected sudden death in early life.

1. Short title This Act may be cited as the Scarlett’s Sunshine on Sudden Unexpected Death Act . 2. Amendment to the Public Health Service Act Title III of the Public Health Service Act ( 42 U.S.C. 241 et seq.) is amended by adding at the end the following: W Sudden Unexpected Infant Death and Sudden Unexplained Death in Childhood 399OO. Definitions In this part: (1) Administrator The term Administrator means the Administrator of the Health Resources and Services Administration. (2) Death scene investigator The term death scene investigator means an individual certified or trained as a death scene investigator by an accredited professional certification board. (3) Director The term Director means the Director of the Centers for Disease Control and Prevention. (4) State The term State has the meaning given to such term in section 2, except that such term includes Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act). (5) Sudden unexpected infant death; SUID The terms sudden unexpected infant death and SUID mean the sudden death of an infant under 1 year of age that when first discovered did not have an obvious cause. Such terms include those deaths that are later determined to be from explained as well as unexplained causes. (6) Sudden unexplained death in childhood; SUDC The terms sudden unexplained death in childhood and SUDC mean the sudden death of a child who is 1 year of age or older, which remains unexplained after a thorough case investigation that includes a review of the clinical history and circumstances of death and performance of a complete autopsy with appropriate ancillary testing. 399OO–1. Death scene investigation and autopsy (a) Investigations (1) Reporting The Secretary, acting through the Director, in consultation with board-certified forensic pathologists, medical examiners, coroners, pediatric pathologists, pediatric cardiologists, pediatric neuropathologists and geneticists, and other individuals and groups as the Director determines necessary, shall revise the Sudden Unexplained Infant Death Investigation Reporting Form of the Centers for Disease Control and Prevention and the Child Death Review Case Reporting System to include doll re-enactments and scene investigation information on deaths of children younger than 5. (2) Grants The Secretary, acting through the Director, shall award grants to States to enable such States to improve the completion of comprehensive death scene investigations, and reviews of such investigations, for sudden unexpected infant death and sudden unexplained death in childhood. (3) Application To be eligible to receive a grant under paragraph (1), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (4) Use of funds (A) In general A State shall use amounts received under a grant under paragraph (1) to improve the completion of comprehensive death scene investigations for sudden unexpected infant death and sudden unexplained death in childhood, including through the awarding of subgrants to local jurisdictions to be used to implement standard death scene investigation protocols for sudden unexpected infant death and sudden unexplained death in childhood and conduct comprehensive, standardized autopsies. (B) Protocols A standard death scene protocol implemented under subparagraph (A) shall include the obtaining of information on current and past medical history of the infant or child, the circumstances surrounding the death, including any suspicious circumstances, whether there were any accidental or environmental factors associated with the death, and in the case of a sleep-related death, the sleep position and sleep environment. (b) Autopsies (1) In general The Secretary, acting through the Director, shall award grants to States and local governmental entities to enable such States and entities to increase the rate at which comprehensive, standardized autopsies are performed for sudden unexpected infant death and sudden unexplained death in childhood. (2) Informed consent Grants awarded under this subsection may be used for studies and demonstration projects to increase the rate of consent among families of deceased children for the inclusion of genetic or tissue samples collected during autopsy in registries established for the purposes of conducting research into SUID and SUDC. (3) Application To be eligible to receive a grant under paragraph (1), an eligible entity described in such paragraph shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (4) Comprehensive autopsy For purposes of this subsection, a comprehensive autopsy, which may include minimally invasive techniques, shall include a full external and internal examination, including microscopic examination, of all major organs and tissues including the brain, complete ra­di­o­graphs, vitreous fluid analysis, photo documentation, metabolic testing, toxicology screening, and, when indicated, selected genetic and microbiology analyses of the infant or child involved. (c) Study on genetic analysis The Director, in consultation with medical examiners, coroners, forensic pathologists, geneticists, researchers, public health officials, and other individuals and groups as the Director determines necessary, shall commission a study to determine the benefits and appropriateness of genetic analysis for infant and early childhood deaths that remain unexplained after a complete death scene investigation and comprehensive, standardized autopsy. Such study shall include recommendations on developing a standard protocol for use in determining when to utilize genetic analysis, and standard protocols for the collection and storage of specimens suitable for genetic analysis. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $8,000,000 for each of fiscal years 2018 through 2022. 399OO–2. Training (a) Grants The Secretary, acting through the Director, shall award grants to eligible entities for the provision of training on death scene investigation specific for SUID and SUDC. (b) Eligible entities To be eligible to receive a grant under subsection (a), an entity shall— (1) be— (A) a State or local government entity; or (B) a nonprofit private entity; (2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and (3) make publishing training materials developed using a grant awarded under subsection (a) available on an internet website and at no charge to attendees of training under subsection (c)(1). (c) Use of funds An eligible entity shall use amounts received under a grant under this section to— (1) provide training to medical examiners, coroners, death scene investigators, law enforcement personnel, justices of the peace, emergency medical technicians, paramedics, or emergency department personnel concerning death scene investigations for SUID and SUDC, including the use of standard death scene investigation protocols that include information on the current and past medical history of the infant or child, the circumstances surrounding the death including any suspicious circumstances, the sleep position and sleep environment of the infant or child, and whether there were any accidental or environmental factors associated with the death; (2) provide training directly to individuals who are responsible for conducting and reviewing death scene investigations for sudden unexpected infant death and sudden unexplained death in childhood; (3) provide training to multidisciplinary teams, including teams that have a medical examiner or coroner, death scene investigator, law enforcement representative, and an emergency medical technician or paramedic; (4) in the case of national and State-based grantees that are comprised of medical examiners, coroners, death scene investigators, law enforcement personnel, or emergency medical technicians and paramedics, integrate training under the grant on death scene investigation of SUID and SUDC into professional accreditation and training programs; or (5) in the case of State and local government entity grantees, obtain equipment, including scene investigation kits, to aid in the completion of standard death scene investigation. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $2,000,000 for each of fiscal years 2018 through 2022. 399OO–3. Infant and child death review (a) Prevention (1) Core capacity grants The Secretary, acting through the Administrator and in consultation with the Associate Commissioner of the Children’s Bureau of the Administration for Children and Families, shall award grants to States to build and strengthen State capacity so as to review 100 percent of all infant and child deaths, and to develop and implement prevention strategies, as appropriate. (2) Planning grants The Secretary, acting through the Administrator, shall award planning grants to States that have no existing infant or child death review program or States in which the only infant and child death review programs are State-based, for the development of local infant and child death review programs and prevention strategies. (3) Application To be eligible to receive a grant under paragraph (1) or (2), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (4) Technical assistance The Secretary, acting through the Administrator, shall provide technical assistance to assist States— (A) in developing the capacity for comprehensive infant and child death review programs, including the development of best practices for the implementation of such programs; and (B) in maintaining the National Infant and Child Death Case Reporting System. (b) Authorization of appropriations To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2018 through 2022. 399OO–4. Enhancing the National Infant and Child Death Case Reporting System (a) In general The Secretary, acting through the Director and in consultation with the National Infant and Child Death Case Reporting System, national health organizations, and professional societies with experience and expertise relating to reducing SUID and SUDC, shall maintain current efforts of the National Infant and Child Death Case Reporting System so as to provide population-based data on deaths occurring for children under age 5, in order to facilitate the understanding of the root causes, rates, trends, and geographic variations of SUID and SUDC with respect to such age group. (b) Compilation and availability of data The Secretary shall compile the data submitted under this section and make such data available to the public in a timely manner on an appropriate internet website in a format that is useful to the public and to other entities. (c) Authorization of appropriations To carry out this section, there is authorized to be appropriated $1,000,000 for each of fiscal years 2018 through 2022. 399OO–5. Grants to support infant safe sleep (a) In general The Secretary, acting through the Administrator, shall award grants to national organizations, community-based organizations, municipal public safety departments, and nonprofit organizations for the provision of evidence-based approaches for educational programs, and outreach activities focused on decreasing the risk factors that contribute to SUID. (b) Application To be eligible to receive a grant under subsection (a), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (c) Use of funds Amounts received under a grant awarded under subsection (a) may be used to— (1) provide outreach and education services directly to parents and families, which— (A) may include home visits, 24-hour hotlines, internet-based educational materials, mobile health technologies, and social marketing campaigns; (B) shall apply current safe sleep guidelines published by a professional pediatric organization; and (C) may provide safe sleep-related products to families at no cost or at reduced cost that have published, peer-reviewed evidence to support safer sleep environments for infants through age one; or (2) build capacity in professionals working with families to support safe sleep. (d) Safe-Sleep products Any product related to safe sleep for an infant that is provided under subsection (c)(1)(C) shall— (1) be a full-sized crib, a non-full-sized crib, or a play yard; (2) provide a flat surface; (3) not include a supplemental mattress or soft bedding; and (4) be covered by, and be in compliance with, a regulation or mandatory standard promulgated by the Consumer Product Safety Commission. (e) Preference In awarding grants under subsection (a), the Secretary shall give preference to applicants that have a proven history of developing or delivering interventions for infants and families to support safe sleep, include plans to report evidence of program outcomes, and can demonstrate experience through collaborations and partnerships for delivering services throughout a State or region. (f) Set-Aside Not more than 5 percent of the amount of funds appropriated to carry out this section may be used to conduct research into the behavioral risks that lead to unsafe sleep practices and ways to mitigate those risks. (g) Authorization of appropriations To carry out this section, there is authorized to be appropriated $5,000,000 for fiscal year 2018 and $7,000,000 for each of fiscal years 2019 through 2022. . 3. Sense of Congress It is the sense of Congress that additional research is needed to improve the understanding of the epidemiology of sudden unexplained death in childhood. 4. Report to Congress Not later than 1 year after the date of enactment of this Act, and annually thereafter, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Director of the National Institutes of Health and the Administrator of the Health Resources and Services Administration, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that contains, with respect to the preceding 1-year reporting period— (1) information regarding the absolute number and incidence of both sudden unexpected infant death and sudden unexplained death in childhood, information about such conditions by racial and ethnic groups, information about such conditions by State, aggregate information obtained from death scene investigations and autopsies, and recommendations for reducing the incidence of sudden unexpected infant death and sudden unexplained death in childhood; (2) an assessment of the extent to which various approaches of preventing sudden unexpected infant death have been effective; (3) a description of the activities carried out under part W of title III of the Public Health Service Act (as added by section 2); and (4) any recommendations of the Secretary regarding such part W.