II 111th CONGRESS 1st Session S. 1445 IN THE SENATE OF THE UNITED STATES July 14, 2009 Mr. Lautenberg (for himself, Mrs. Gillibrand, and Mr. Nelson of Nebraska) 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 reduce the occurrence of sudden unexpected infant death and to enhance public health activities related to stillbirth.

1.

Short title

This Act may be cited as the Stillbirth and SUID Prevention, Education, and Awareness Act of 2009.

2.

Findings

Congress makes the following findings: (1)Every year, there are more than 25,000 stillbirths in the United States. (2)Common diagnosable causes for stillbirth include genetic abnormalities, umbilical cord accidents, infections, and placental problems. (3)A number of risk factors for stillbirth have been described in pregnant women such as maternal age, obesity, smoking, diabetes, and hypertension. (4)Because of advances in medical care over the last 30 years, much more is known about the causes of stillbirth. But for as many as 50 percent of stillbirths, the cause is never identified. (5)Sudden Unexpected Infant Death (SUID) is the sudden death of an infant under 1 year of age that when first discovered did not have an obvious cause. These include those deaths that are later determined to be from explained as well as unexplained causes. (6)In 2004, approximately 4,600 infants died suddenly and unexpectedly of no immediate obvious cause. Each year approximately 200 deaths of children between the ages of 1 and 4 remain unexplained after a thorough case investigation is conducted. (7)The Sudden Infant Death Syndrome (SIDS) rate has been declining significantly since the early 1990s. However, research has found that the decline in SIDS since 1999 can be explained by increasing Sudden Unexpected Infant Death rates. (8)Many Sudden Unexpected Infant Deaths are not investigated and, even when they are, cause-of-death data are not collected and reported consistently. (9)Inaccurate or inconsistent classification of cause and manner of death impedes prevention efforts and complicates the ability to understand risk factors related to these deaths. (10)The National Child Death Review Case Reporting System collects comprehensive information on the risk factors associated with SUID deaths. As of March 2009, 29 of the 49 States conducting child death reviews are voluntarily submitting data to this reporting system.

3.

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: S

Sudden unexpected infant death and sudden unexplained death in childhood

399HH.

Definition

In this part: (1)

Administrator

The term Administrator means the Administrator of the Health Resources and Services Administration. (2)

Director

The term Director means the Director of the Centers for Disease Control and Prevention. (3)

State

The term State includes the 50 States and the District of Columbia. (4)

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. (5)

Sudden unexplained death in childhood; SUDC

The terms sudden unexplained death in childhood and SUDC mean the sudden death of a child older than 1 year of age which remains unexplained after a thorough case investigation, including a review of the clinical history and circumstances of death, and performance of a complete autopsy with appropriate ancillary testing.

399II.

Death scene investigation and autopsy

(a)

Investigations

(1)

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 for sudden unexpected infant death and sudden unexplained death in childhood. (2)

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. (3)

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 and to conduct 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/child, the circumstances surrounding the death including any suspicious circumstances, the sleep position and sleep environment of the infant/child, and whether there were any accidental or environmental factors associated with the death. The Director in consultation with medical examiners, coroners, death scene investigators, law enforcement, emergency medical technicians and paramedics, public health agencies, and other individuals or groups determined necessary by the Director shall develop a standard death scene protocol for children from 1 to 4 years of age using existing protocols developed for SUID. (b)

Autopsies

(1)

In general

The Secretary, acting through the Director, shall award grants to States to enable such States to increase the rate at which comprehensive and standardized autopsies are performed for sudden unexpected infant death and sudden unexplained death in childhood. (2)

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. (3)

Comprehensive autopsy

For purposes of this subsection, a comprehensive autopsy shall include a full external and internal examination of all major organs and tissues including the brain, complete radiographs, metabolic testing, and toxicology screening of the infant/child involved. (4)

Guidelines

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 determined necessary by the Director shall develop national guidelines for a standard autopsy protocol for sudden unexpected infant death and sudden unexplained death in childhood. The Director shall ensure that the majority of such consultation is with board certified forensic pathologists, medical examiners, and coroners. The Director is encouraged to seek additional input from child abuse experts, bereavement specialists, parents, and public health agencies on non-medical aspects of the autopsy guidelines. In developing such protocol, the Director shall consider autopsy protocols used by State and local jurisdictions. (c)

Study on genetic testing

The Director, in consultation with medical examiners, coroners, forensic pathologists, geneticists, researchers, public health officials, and other individuals and groups determined necessary by the Director, shall commission a study to determine the benefits and appropriateness of genetic testing for infant and early childhood deaths that remain unexplained after a complete death scene investigation and comprehensive and standardized autopsy. Such study shall include recommendations on developing a standard protocol for use in determining when to utilize genetic testing and standard protocols for the collection and storage of specimens suitable for genetic testing. (d)

Authorization of appropriations

There is authorized to be appropriated, such sums as may be necessary for each of fiscal years 2010 through 2014, to carry out this section.

399JJ.

Training

(a)

Grants

The Secretary, acting through the Director, shall award grants to eligible entities for the provision of training on death scene investigation. (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 non-profit private entity; and (2)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

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, and emergency medical technicians or paramedics concerning death scene investigations, including the use of standard death scene investigation protocols that include information on the current and past medical history of the infant/child, the circumstances surrounding the death including any suspicious circumstances, the sleep position and sleep environment of the infant/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 is 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 into professional accreditation and training programs; (5)in the case of State and local government entity grantees, obtain equipment, including computer equipment, to aid in the completion of standard death scene investigation; or (6)conduct training activities for medical examiners, coroners, and forensic pathologists concerning standard autopsy protocols for sudden unexpected infant death and sudden unexplained death in childhood. (d)

Authorization of appropriations

There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2010 through 2014.

399KK.

Child death review

(a)

Prevention

(1)

Core capacity grants

The Secretary, acting through the Administrator, shall award grants to States to build State capacity and implement State and local child death review programs and prevention strategies. (2)

Planning grants

The Secretary, acting through the Administrator, shall award planning grants to States that have no existing child death review program or States in which the only child death review programs are State-based, for the development of local 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 child death review programs, including the development of best practices for the implementation of such programs; and (B)in maintaining the national child death case reporting system. (b)

Authorization of appropriations

There is authorized to be appropriated, such sums as may be necessary for each of fiscal years 2010 through 2014, to carry out subsection (a).

300LL.

National registry for sudden unexpected infant deaths and sudden unexplained death in childhood

(a)

Establishment

The Secretary, acting through the Director and in consultation with the national child death case reporting system, the Administrator of the Health Resources and Services Administration, national health organizations, and professional societies with experience and expertise relating to reducing SUID and SUDC, shall establish a population-based SUID and SUDC case registry that can facilitate the understanding of the root causes, rates, and trends of SUID and SUDC. (b)

National registry

The national registry established under subsection (a) shall facilitate the collection, analysis, and dissemination of data by— (1)implementing a surveillance and monitoring system based on thorough and complete death scene investigation data, clinical history, and autopsy findings; (2)collecting standardized information about the environmental, medical, genetic, and social circumstances of death (including sleep environment and quality of the death scene investigation) if determined that such may correlate with infant and early childhood deaths, as well as information from other law enforcement, medical examiner, coroner, emergency medical services (EMS), medical records, and vital records (if possible); (3)supporting multidisciplinary infant and early childhood death reviews such as those performed by child death review committees to collect and review the standardized information and accurately and consistently classify and characterize SUID and SUDC; and (4)facilitating the sharing of information to improve the public reporting of surveillance and vital statistics describing the epidemiology of SUID and SUDC. (c)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, such sums as necessary for each of fiscal years 2010 through 2014.

399MM.

Public awareness and education campaign

(a)

Establishment

The Secretary, acting through the Administrator and in consultation with the Director and the Director of the National Institutes of Health, shall establish and implement a culturally competent public health awareness and education campaign to provide information that is focused on decreasing the risk factors for sudden unexpected infant death and sudden unexplained death in childhood, including educating individuals about safe sleep environments, sleep positions, and reducing exposure to smoking during pregnancy and after birth. (b)

Targeted populations

The campaign under subsection (a) shall be designed to reduce health disparities through the targeting of populations with high rates of sudden unexpected infant death and sudden unexplained death in childhood. (c)

Consultation

In establishing and implementing the campaign under subsection (a), the Secretary shall consult with national organizations representing health care providers, including nurses and physicians, parents, child care providers, children's advocacy and safety organizations, maternal and child health programs and women's, infants and children nutrition professionals, and other individuals and groups determined necessary by the Secretary for such establishment and implementation. (d)

Grants

(1)

In general

In carrying out the campaign under subsection (a), the Secretary shall award grants to national organizations, State and local health departments, and community-based organizations for the conduct of education and outreach programs for nurses, parents, child care providers, public health agencies, and community organizations. (2)

Application

To be eligible to receive a grant under paragraph (1), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (e)

Authorization of appropriations

There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2010 through 2014.

399NN.

Grants for support services

(a)

In general

The Secretary, acting through the Administrator, shall award grants to national organizations, State and local health departments, and community-based organizations, for the provisions of support services to families who have had a child die of sudden unexpected infant death and sudden unexplained death in childhood. (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 provide grief counseling, education, home visits, 24-hour hotlines, and support groups for families who have lost a child to sudden unexpected infant death or sudden unexplained death in childhood. (d)

Preference

In awarding grants under subsection (a), the Secretary shall give preference to community-based applicants that have a proven history of effective direct support services and interventions for sudden unexpected infant death and sudden unexplained death in childhood and can demonstrate experience through collaborations and partnerships for delivering services throughout a State or region. (e)

Authorization of appropriations

There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2010 through 2014.

399OO.

Evaluation of State and regional needs

The Secretary, acting through the Director and in consultation with the Administrator, shall conduct a needs assessment on a State and regional basis of the availability of personnel, training, technical assistance, and resources for investigating and determining sudden unexpected infant death and sudden unexplained death in childhood death and make recommendations to increase collaboration on a State and regional level for investigation and determination.

.

4.

Enhancing public health activities related to stillbirth

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended— (1)by redesignating the second section 399R (relating to the amyotrophic lateral sclerosis registry (42 U.S.C. 280g–7)) and the third section 399R (relating to support for patients receiving a positive diagnosis of down syndrome or other prenatally or postnatally diagnosed conditions (42 U.S.C. 280g–8)) as sections 399S and 399T, respectively; and (2)by adding at the end the following:

399U.

Enhancing public health activities related to stillbirth

(a)

Grants

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible States and metropolitan areas to enhance and expand surveillance efforts to collect thorough and complete epidemiologic information on stillbirths, including through the utilization of the infrastructure of existing surveillance systems. (b)

Eligibility

To be eligible to receive a grant under subsection (a), an entity shall be— (1)a State or a major metropolitan area (as defined by the Secretary); and (2)submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including an assurance that the applicant will implement the standardized surveillance protocol developed under subsection (c). (c)

Surveillance protocol

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall— (1)provide for the continued development and dissemination of a standard protocol for stillbirth data collection and surveillance, in consultation with representatives of health and advocacy organizations, State and local governments, and other interested entities determined appropriate by the Secretary; (2)monitor trends and identify potential risk factors for further study using existing sources of surveillance data and expanded sources of data from targeted surveillance efforts, and methods for the evaluation of stillbirth prevention efforts; and (3)develop and evaluate methods to link existing data to provide more complete information for research into the causes and conditions associated with stillbirth. (d)

Postmortem evaluation and Data Collection

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with physicians, nurses, pathologists, geneticists, parents, and other groups determined necessary by the Director, shall develop guidelines for increasing the performance and data collection of postmortem stillbirth evaluation, including conducting and reimbursing autopsies, placental histopathlogy and cytogentic testing. The guidelines should take into account cultural competency issues related to postmortem stillbirth evaluation. (e)

Public health programmatic activities related to stillbirth

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall— (1)develop behavioral surveys for women experiencing stillbirth, using existing State-based infrastructure for pregnancy-related information gathering; and (2)increase the technical assistance provided to States, Indian tribes, territories, and local communities to enhance capacity for improved investigation of medical and social factors surrounding stillbirth events. (f)

Public education and prevention programs

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with health care providers, public health organizations, maternal and child health programs, parents, and other groups deemed necessary by the Director, shall directly or through grants, cooperative agreements, or contracts to eligible entities, develop and conduct evidence-based public education and prevention programs aimed at reducing the occurrence of stillbirth overall and addressing the racial and ethnic disparities in its occurrence, including— (1)public education programs, services, and demonstrations which are designed to increase general awareness of stillbirths; and (2)the development of tools for the education of health professionals and women concerning the known risks factors for stillbirth, promotion of fetal movement awareness, taking proactive steps to monitor a baby’s movement beginning at approximately 28 weeks into the pregnancy, and the importance of early and regular prenatal care to monitor the health and development of the fetus up to and during delivery. (g)

Task force

The Secretary, in consultation with the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and health care providers, researchers, parents, and other groups deemed necessary by the Directors, shall establish a task force to develop a national research plan to determine the causes of, and how to prevent, stillbirth. (h)

Grants for support services

(1)

In general

The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants to national organizations, State and local health departments, and community-based organizations, for the provisions of support services to families who have experienced stillbirth. (2)

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. (3)

Use of funds

Amounts received under a grant awarded under subsection (a) may be used to provide grief counseling, education, home visits, 24-hour hotlines, and support groups for families who have experienced stillbirth. (4)

Preference

In awarding grants under subsection (a), the Secretary shall give preference to applicants that are community-based organizations that have a proven history of providing effective direct support services and interventions related to stillbirths and can demonstrate experience through collaborations and partnerships for delivering services throughout a State or region. (i)

Definition

In this section, the term stillbirth means a spontaneous, not induced, pregnancy loss 20 weeks or after, or if the age of the fetus is not known, then a fetus weighing 350 grams or more. (j)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2010 through 2014.

.

5.

Report to Congress

Not later than 2 years after the date of enactment of this Act, 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 Congress a report describing the progress made in implementing this Act (and the amendments made by this Act).