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Dear Chairwoman DeLauro and Ranking Member Cole:

The undersigned organizations committed to the health of our nation’s mothers, infants, children, and families thank you for your strong support of federal newborn screening programs in the Consolidated Appropriations Act, 2021. The additional funding provided to the Centers for Disease Control and Prevention’s (CDC) Newborn Screening Quality Assurance Program (NSQAP) and the Health Resources and Services Administration’s (HRSA) Heritable Disorders program will ensure states have the resources and technical expertise to support ongoing activities and implement new conditions to their state newborn screening panels. As you begin to craft the fiscal year (FY) 2022 Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill, we urge you to again prioritize funding for programs at CDC and HRSA that provide critical support to state newborn screening programs by appropriating an increase of$10 million for both programs, funding at $28 million and $28.883 million respectively.

Newborn screening is one of our nation’s most successful public health programs. Each year, nearly every one of the approximately 3.8 million infants born in the United States is screened for certain genetic, metabolic, hormonal and/or functional conditions. If left untreated, these conditions can cause disability, developmental delay, serious illness, and even death. The early detection afforded by newborn screening ensures that infants who test positive for a screened condition receive prompt treatment, saving or improving the lives of more than 12,000 infants each year.

Programs at CDC and HRSA make critical contributions to state newborn screening programs. The CDC’s NSQAP performs quality testing for more than 500 laboratories to ensure the accuracy of newborn screening tests in the United States and around the world. Further, the CDC helps states implement new screening tests and works with partners to develop new tests for specific disorders. HRSA’s Heritable Disorders Program provides assistance to states to improve and expand their newborn screening programs and to promote parent and provider education. HRSA also supports the work of the Advisory Committee on Heritable Disorders in Newborns and Children, which provides states with a Recommended Uniform Screening Panel (RUSP) to help ensure every infant is screened for conditions that have a recognized treatment.

CDC and HRSA activities have significantly improved the quality of newborn screening programs throughout the country. In 2007, prior to the passage of the Newborn Screening Saves Lives Act, only 10 states and the District of Columbia required infants to be screened for all 29 disorders that were recommended at that time. Today, all 50states, District of Columbia and Puerto Rico require screening for at least 30 of the 35core conditions on the RUSP.

Unfortunately, current federal funding for newborn screening programs at CDC and HRSA falls short of the level needed to help state newborn screening programs operate optimally. With three new conditions added to the RUSP in the past six years and more expected in the near future, it is vitally important to maintain robust funding to support state efforts to add the new conditions to their newborn screening panels. Further, rapid changes in screening technologies and the addition of more complex disorders to the RUSP escalate the need for additional federal support. To confront these challenges, the federal government must increase its investment in newborn screening programs.

NSQAP: Increased funding will help state laboratories continue to enhance financial and technical assistance to support the development and evaluation of testing methods for new conditions so that more babies are screened for more disorders faster and to modernize the data collection process so that state laboratories can conduct more effective data analysis and disease detection. We urge the Committee to appropriate at least an additional $10million for NSQAP in FY 2022, for a total of $28 million.

Heritable Disorders: The federal government should expand its efforts to support the addition of new conditions to state newborn screening panels that have been added in the last six years. Beginning in FY 2015, Congress provided an additional $2 million annually to support the wider implementation, education and awareness of newborn screening for a single disorder, SCID, and over the last two fiscal years, the annual funding was increased by $1 million. As of September 2019, 100% of newborn screening programs screen for severe combined immunodeficiency (SCID).

We urge Congress to provide HRSA with an additional $10 million to continue to enhance, improve, expand, and provide technical assistance to the state public health newborn screening systems and continue developing and delivering robust education programs about newborn screening, counseling testing, follow-up, treatment, and specialty services to parents, families, patient advocacy, and support groups. This would bring the total amount appropriated to the Heritable Disorders program in FY 2022 to $28.883 million.

We thank you for your attention to our request and look forward to working with you to ensure that the United States identifies and treats each of the one in 300 infants born every year who has a condition that can be detected through newborn screening. If you have questions, please contact KJ Hertzat k[email protected] Rick White at [email protected].


ALD Alliance

American Academy of Pediatrics

American Association for Clinical Chemistry

American College of Medical Genetics and Genomics

Association of Maternal & Child Health Programs

Association of Public Health Laboratories

Boomer Esiason Foundation

CARES Foundation

Cure SMA

Cystic Fibrosis Foundation

EveryLife Foundation

Expecting Health at Genetic Alliance

HCU Network America

Hunter's Hope Foundation

Immune Deficiency Foundation

March of Dimes

Muscular Dystrophy Association

National Organization of Rare Disorders

Rare Disease Innovations Institute

Save Babies Through Screening Foundation

SCID Angels for Life Foundation

Society for Inherited Metabolic Disorders