II 110th CONGRESS 2d Session S. 3142 IN THE SENATE OF THE UNITED STATES June 17, 2008 Mr. Reid (for Mr. Obama) 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 enhance public health activities related to stillbirth and sudden unexpected infant death.

1.

Short title

This Act may be cited as the Preventing Stillbirth and SUID Act of 2008.

2.

Findings

Congress makes the following findings: (1)Every year, more than 25,000 women in the United States experience stillbirth. (2)Common diagnosable causes for stillbirth include genetic abnormalities, umbilical cord accidents, infections, and placental problems, however, more than half of all stillbirths remain unexplained. (3)A number of risk factors for stillbirth have been described in pregnant women such as maternal age, obesity, smoking, diabetes, hypertension, and previous stillbirth. (4)Good prenatal care, not smoking, and not drinking alcohol are helpful strategies for pregnant women to reduce the risk of stillbirth, however, researchers continue to perform studies into other effective modes of reducing the risk, including monitoring fetal activity or in utero movement starting at approximately 28 weeks. (5)Half of the more than 4,500 sudden, unexpected infant deaths (SUID) that occur each year in the United States are due to sudden infant death syndrome (SIDS), which is the leading cause of SUID and of all deaths among infants aged 1 to 12 months. (6)Sudden infant death syndrome is a diagnosis of exclusion and is only determined after all known causes are excluded by a thorough examination of the death scene, a review of the clinical history, and performance of an autopsy. However, some SUID are not investigated and, even when they are, cause-of-death data are not collected and reported consistently. (7)Inaccurate classification of cause and manner of death impedes prevention efforts and complicates our ability to understand risk factors related to these deaths. (8)Death certificate data cannot fully characterize the sudden, unexpected infant deaths nor identify potential risk factors amenable to prevention.

3.

Enhancing public health activities related to stillbirth

(a)

In general

Part B of title XI of the Public Health Service Act (42 U.S.C. 300c–12 et seq.) is amended by adding at the end the following:

1123.

National registry and public health programs for stillbirth

(a)

Determination of standard stillbirth definition and protocol

(1)

In general

For purposes of this section, the Secretary shall provide for the development of— (A)a standard definition of stillbirth; and (B)a standard protocol for stillbirth data collection and surveillance, including— (i)enhancing the National Vital Statistics System for the reporting of stillbirths; and (ii)expanding active population-based surveillance efforts currently underway at the Centers for Disease Control and Prevention, including utilizing the infrastructure of existing birth defects surveillance registries to collect thorough and complete epidemiologic information on stillbirths. (2)

Consultation

The Secretary shall ensure that the standard definition and protocol described in paragraph (1) are developed in a manner that ensures the consultation of representatives of health and advocacy organizations, State and local governments, and other interested entities specified by the Secretary. (b)

Establishment

The Secretary, acting through the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health, and in consultation with national health organizations and professional societies with expertise relating to reducing stillbirths and infant mortality, shall establish— (1)a national registry that can facilitate the understanding of root causes, rates, and trends of stillbirth; and (2)public education and prevention programs aimed at reducing the occurrence of stillbirth. (c)

National registry

The national registry established under subsection (b)(1) shall facilitate the collection, analysis, and dissemination of data by— (1)implementing a surveillance and monitoring system based on the protocols developed in subsection (a)(1)(B); (2)developing standardized protocols for thorough and complete investigation of stillbirth, including protocols for autopsy and pathological examinations of the fetus and placenta, and other postmortem tests for surveillance of stillbirth; (3)identifying trends, potential risk factors for further study, and methods for the evaluation of prevention efforts; and (4)supporting efforts in collection of vital records, active case finding, linkage studies, and other epidemiologic efforts to identify potential risk factors and prevention opportunities. (d)

Public education and prevention programs

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall directly or through grants, cooperative agreements, or contracts to eligible entities, develop and conduct public education and prevention programs established under subsection (b)(2), 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 pregnant women about the early-warning signs of stillbirth, which may include monitoring of fetal movement or baby in-utero. (e)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, $5,000,000 for fiscal year 2009 and such sums as may be necessary for each of fiscal years 2010 through 2013.

. (b)

Conforming amendment

The heading of part B of title XI of the Public Health Service Act (42 U.S.C. 300c–12 et seq.) is amended by adding at the end the following: and Stillbirth.

4.

Enhancing public health activities related to sudden unexpected infant death

(a)

In general

Part B of title XI of the Public Health Service Act (42 U.S.C. 300c–12 et seq.), as amended by section 3, is further amended by adding at the end the following:

1124.

National registry for sudden unexpected infant deaths

(a)

Definition

In this section, the term sudden, unexpected infant deaths (referred to in this section as SUID) means infant deaths that have no obvious cause of death, are not the result of a chronic disease or known illness, are unexpected, and not explainable without a more careful examination. These deaths may include deaths due to suffocation, poisoning, injuries, falls, sudden infant death syndrome, or previously unrecognized illness or disorder. (b)

Establishment

The Secretary, acting through the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health, and in consultation with national health organizations and professional societies with experience and expertise relating to reducing SUID, shall establish a population-based SUID case registry that can facilitate the understanding of the root causes, rates, and trends of SUID. (c)

National registry

The national registry established under subsection (b) 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, social, and genetic circumstances that may correlate with infant deaths (including sleep environment and the quality of the death scene investigation) from the SUID Initiative Reporting Form or equivalent, as well as other law enforcement, medical examiner, coroner, emergency medical services (EMS), and medical records; (3)promoting the use of Centers for Disease Control and Prevention standardized SUID death investigation and reporting tools as well as standardized autopsy protocols; (4)establishing a standardized classification system for defining subcategories of SIDS and SUID for surveillance and prevention research activities; (5)supporting multidisciplinary infant death reviews such as those performed by child death review committees and fetal infant mortality committees to collect and review the standardized information and accurately and consistently classify and characterize SUID; and (6)improving public reporting of surveillance and descriptive epidemiology of SUID by supplementing vital statistics data. (d)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, $5,000,000 for fiscal year 2009 and such sums as necessary for each of fiscal years 2010 through 2013.

. (b)

Conforming amendment

The heading of part B of title XI of the Public Health Service Act (42 U.S.C. 300c–12 et seq.), as amended by section 3, is further amended by adding at the end the following: , and Sudden Unexpected Infant Death.