Programs and Policy Newborn Screening Legislation
Newborn Screening Saves Lives Act
The Screening for Heritable Disorders Legislation was created to enhance, improve, and expand the ability of state and local public health agencies to provide screening, counseling, and health care services to newborns and children who have, or are at risk for, heritable disorders. This legislation established the Heritable Disorders Program and created the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC).
In 2008, The Newborn Screening Saves Lives Act (H.R. 3825, S. 1858) was enacted to amend the Heritable Disorders Program legislation. This added several programs and further defined the activities for ACHDNC.
Specifically, this Act:
- Established grant programs to provide education in congenital, genetic, and metabolic disorders;
- Established grant programs for training in newborn screening technologies;
- Established grant programs to coordinate follow-up care;
- Created an increase of consumer awareness and knowledge of family support services, research, and other resources in newborn screening;
- Improved laboratory quality standards;
- Developed a national contingency plan if a public health situation arises; and
- Established a central online clearinghouse.
Newborn Screening Saves Lives Reauthorization Act of 2014 (H.R. 1281, S. 1417):
On September 26, 2013, Natasha Bonhomme, Director of Baby's First Test, testified in front of the Sentate Subcommittee on Children and Families advocating for the reauthorization of the Newborn Screening Save Lives Act. You can read Natasha's testimony here. To see video of the Senate Subcommittee Hearing - Newborn Screening Saves Lives: The Past, Present, and Future of the Newborn Screening System, click here.
The Newborn Screening Saves Lives Reauthorization Act of 2013 (H.R. 1281, S. 1417) was passed by the Senate with an amendment by Unanimous Consent on January 29, 2014.
On February 27, 2014, markup of The Newborn Screening Saves Lives Reauthorization Act of 2013 (H.R. 1281, S. 1417) was conducted by the House Subcommittee on Health of the 113th Congress. H.R. 1281 was moved forward to full committee vote. The webcast can be seen below.
On April 3, 2014, The House Energy & Commerce committee passed H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act of 2014, with only modest changes to the version the Health Subcommittee of Energy & Commerce agreed to in February. The amendment to the bill can be seen here, and the full webcast can is available below.
On June 24, 2014, the House of Representatives passed H.R. 1281, sending the bill to the Senate for a final vote. The Senate unanimously passed H.R. 1281 on December 8, 2014 after adding an amendment on informed consent. This amendment requires consent from parents before newborn blood spots may be used in federally-funded research. This requirement only applies to newborn dried blood spots collected after March 17, 2015 and does not affect the initial screening and testing of newborn blood spots. More details on the new provision can be seen here.
On December 18, 2014, Obama signed the Newborn Screening Saves Lives Reauthorization Act (P.L.113-240) into law. The law went into effect March 16, 2015. The final recommendation from the Secretary's Advisory Committee on Human Research Protections (SACHRP) on the law can be found here.
You can read the U.S. Department of Health and Human Services' 2015 Report to Congress on Newborn Screening Activities here.
The Advisory Committee on Heritable Disorders in Newborns and Children
The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) was chartered in February 2003 to advise the Secretary of Health and Human Services regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines, and standards for effectively reducing morbidity and mortality in newborns and children who have, or are at risk for, heritable disorders.
ACHDNC assists the Secretary of Health and Human Services specifically by providing:
- advice and recommendations concerning the grants and projects authorized under the Heritable Disorders Program;
- technical information to develop policies and priorities for this program that will enhance the ability of the state and local health agencies to provide screening, counseling, and other health care services for newborns and children who have, or are at risk for, heritable disorders; and
- recommendations, advice, or information that may be necessary to enhance, expand, or improve upon the ability of the Secretary to reduce the mortality and morbidity in newborns and children from heritable disorders.
You can read the archived ACHDNC Annual Reports by clicking the links below: